Federal Register, Vol. 85, No. 90, Friday, May 8, 2020 — Rules and Regulations, Department of Health and Human Services
Summary
A Federal Register interim final rule with comment period, Vol. 85, No. 90, Friday, May 8, 2020, from the Centers for Medicare & Medicaid Services (CMS), HHS, under file code CMS–5531–IFC and RIN 0938–AU32. The rule gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries flexibilities to respond to the coronavirus disease 2019 (COVID–19). It amends several Medicare policies on an interim basis, including coverage of FDA-authorized COVID–19 serology tests and new specimen collection fees for COVID–19 testing. The effective date is May 8, 2020, and the policies apply beginning March 1, 2020, or January 27, 2020, except as further described in a table. Comments are due by 5 p.m. on July 7, 2020.
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“Federal Register, Vol. 85, No. 90, Friday, May 8, 2020 — Rules and Regulations, Department of Health and Human Services.”
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27550 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
DEPARTMENT OF HEALTH AND health clinics, hospitals, critical access CMHCs to furnish outpatient services at
HUMAN SERVICES hospitals (CAHs), community mental temporary expansion sites, including
health centers (CMHCs), clinical the beneficiary’s home and expanded
Centers for Medicare & Medicaid laboratories, teaching hospitals, CMHCs; expansion of the extraordinary
Services providers of the laboratory testing circumstances relocation exception
benefit in Medicaid, Opioid treatment policy for on-campus and excepted off-
42 CFR Parts 409, 410, 412, 413, 414, programs, and quality reporting campus provider-based departments
415, 424, 425, 440, 483, 484, and 600 programs (QRPs) for inpatient (PBDs) that relocate in response to the
rehabilitation facilities (IRFs), long-term COVID–19 PHE; teaching physician
Office of the Secretary care hospitals (LTCHs), skilled nursing policies, including time spent by
facilities (SNFs), home health agencies residents at another hospital and the
45 CFR Part 156 (HHAs) and durable medical equipment, medical education methodology of
[CMS–5531–IFC] prosthetics, orthotics, and supplies counting teaching hospital beds;
(DMEPOS) suppliers. counting beds for provider-based rural
RIN 0938–AU32 DATES: health clinic payment level; services
Effective date: These regulations are furnished by opioid treatment programs;
Medicare and Medicaid Programs, modified requirements for ordering
effective on May 8, 2020.
Basic Health Program, and Exchanges; Applicability date: The policies in COVID–19 diagnostic laboratory tests;
Additional Policy and Regulatory this IFC are applicable beginning on payment to hospitals and physician’s
Revisions in Response to the COVID– March 1, 2020, or January 27, 2020, offices for specimen collection; counting
19 Public Health Emergency and Delay except as further described in the table time for telehealth evaluation and
of Certain Reporting Requirements for in SUPPLEMENTARY INFORMATION. management visits; method for updating
the Skilled Nursing Facility Quality Comment date: To be assured the telehealth list during the PHE;
Reporting Program consideration, comments must be paying for remote monitoring services;
AGENCY: Centers for Medicare & received at one of the addresses and increased payment for telephone
Medicaid Services (CMS), HHS. provided below, no later than 5 p.m. on evaluation and management visits (Note
July 7, 2020. this email address has an underscore‘‘_
ACTION: Interim final rule with comment
ADDRESSES: In commenting, please refer ’’ between ‘‘HAPG’’ and ‘‘COVID–19’’.)
period.
to file code CMS–5531–IFC. IRFCoverage@cms.hhs.gov, for issues
SUMMARY: This interim final rule with Comments, including mass comment related to the Medicare IRF benefits.
comment period (IFC) gives individuals submissions, must be submitted in one DMEPOS@cms.hhs.gov, for issues
and entities that provide services to of the following three ways (please related to section 3712 of the CARES
Medicare, Medicaid, Basic Health choose only one of the ways listed): Act.
Program, and Exchange beneficiaries 1. Electronically. You may submit Hillary Loeffler, (410) 786–0456,
needed flexibilities to respond electronic comments on this regulation HomeHealthPolicy@cms.hhs.gov, or
effectively to the serious public health to http://www.regulations.gov. Follow HospicePolicy@cms.hhs.gov, for issues
threats posed by the spread of the the ‘‘Submit a comment’’ instructions. related to the Medicare home health and
coronavirus disease 2019 (COVID–19). 2. By regular mail. You may mail hospice benefits.
Recognizing the critical importance of written comments to the following PHPPaymentPolicy@cms.hhs.gov, for
expanding COVID–19 testing, we are address ONLY: Centers for Medicare & issues related to the Partial
amending several Medicare policies on Medicaid Services, Department of Hospitalization Program (PHP) and
an interim basis to cover FDA- Health and Human Services, Attention: CMHC issues.
authorized COVID–19 serology tests, to CMS–5531–IFC, P.O. Box 8016, MedicaidHomeHealthRule@
allow any healthcare professional Baltimore, MD 21244–8016. cms.hhs.gov, for issues pertaining to the
authorized to do so under State law to Please allow sufficient time for mailed Medicaid home health benefit related to
order COVID–19 diagnostic laboratory comments to be received before the section 3708 of the CARES Act.
tests (including serological and antibody close of the comment period. Kari Vandegrift, (410) 786–4008, and
tests), and to provide for new specimen 3. By express or overnight mail. You Elizabeth November, (410) 786–4518 or
collection fees for COVID–19 testing may send written comments to the SharedSavingsProgram@cms.hhs.gov,
under the Physician Fee Schedule and following address ONLY: Centers for for issues related to the Medicare
Outpatient Prospective Payment Medicare & Medicaid Services, Shared Savings Program.
System, during the public health Department of Health and Human Leigha Basini, (301) 492–4380, for
emergency (PHE) for the COVID–19 Services, Attention: CMS–5531–IFC, issues related to the separate billing
pandemic. Recognizing the urgency of Mail Stop C4–26–05, 7500 Security requirement.
this situation, and understanding that Boulevard, Baltimore, MD 21244–1850. Sheri Gaskins, (410) 786–9274, for
some pre-existing CMS rules may For information on viewing public issues related to Medicaid laboratory
inhibit innovative uses of technology comments, see the beginning of the flexibilities.
and capacity that might otherwise be SUPPLEMENTARY INFORMATION section. Cassandra Lagorio, (410) 786–4554,
effective in the efforts to mitigate the FOR FURTHER INFORMATION CONTACT: for issues related to the BHP.
impact of the pandemic on beneficiaries Rebecca Cole, (410) 786–1589, for Molly MacHarris, (410) 786–4461, or
and the American public, we are general information, or contact one of QPP@cms.hhs.gov, for issues related to
amending several CMS policies and the following: the Merit-based Incentive Payment
regulations in response to the COVID– HHVBPquestions@cms.hhs.gov, for System (MIPS).
19 PHE and recent legislation, as issues related to the HHVBP Model. NCDsPublicHealthEmergency@
outlined in this IFC. These changes HAPG_COVID-19@cms.hhs.gov, for cms.hhs.gov, for issues related to
apply to physicians and other issues related to scope of practice national coverage determination and
practitioners, hospice providers, issues; additional flexibilities for local coverage determination
federally qualified health centers, rural hospital outpatient departments and requirements.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27551
Joan Proctor, (410) 786–0949, or Julia Venanzi, (410) 786–1471, for SUPPLEMENTARY INFORMATION: The
HHQRPQuestions@cms.hhs.gov, for issues related to the Hospital VBP policies in this IFC are applicable
issues related to the following Post- Program. beginning on March 1, 2020, or January
Acute Care QRPs: HH QRP, IRF QRP, Adam Rubin, (410–786–1919), for 27, 2020, except as further described in
LTCH QRP, and SNF QRP. issues related to Certification of Home the following table:
Health Services.
Provision Applicability date
Medicare Shared Savings Program—Expansion We are revising § 425.400 to expand the definition of primary care services used in the Shared
of Codes used in Beneficiary Assignment. Savings Program beneficiary assignment methodology for the performance year starting on
January 1, 2020, and for any subsequent performance year that starts during the PHE for
the COVID–19 pandemic, as defined in § 400.200, which includes any subsequent renewals.
Modification to Medicare Rules and Medicaid We are revising §§ 409.41 through 409.48; 424.22; 424.507(b)(1); § 440.70(a)(2) and (3), and
Concerning Certification and Provision of (b)(1), (2) and (4); and several sections of 42 CFR part 484 to include physician assistants,
Home Health Services. nurse practitioners, and clinical nurse specialists as individuals who can certify the need for
home health services and order services. These changes are permanent, and applicable to
services provided on or after March 1, 2020.
Flexibility for Medicaid Laboratory Services ....... We are revising § 440.30 to provide states with flexibility to provide Medicaid coverage for cer-
tain laboratory tests and X-ray services that may not meet certain requirements in
§ 440.30(a) or (b) (such as the requirement that tests be furnished in an office or similar fa-
cility). This flexibility is retroactive to March 1, 2020, during the period of the COVID–19
PHE and for any subsequent periods of active surveillance. The flexibility also applies to fu-
ture PHEs resulting from outbreaks of communicable disease and subsequent periods of ac-
tive surveillance.
Requirement for Facilities to Report Nursing We are revising § 483.80 to establish explicit reporting requirements for long-term care (LTC)
Home Residents and Staff Infections, Poten- facilities to report information related to COVID–19 cases among facility residents and staff.
tial Infections, and Deaths Related to These reporting requirements are applicable on the effective date of this IFC.
COVID–19.
Separate Billing and Segregation of Funds for We are delaying by 60 days the date when individual market qualified health plan (QHP)
Abortion Services. issuers must be in compliance with the separate billing policy for non-Hyde abortion serv-
ices. Under this 60-day delay, individual market QHP issuers must comply with the separate
billing policy beginning on or before the QHP issuer’s first billing cycle following August 26,
2020.
DME Interim Pricing in the CARES Act ............. We are revising § 414.210 to provide increased fee schedule amounts in certain areas starting
on March 6, 2020, and for the duration of the PHE for the COVID–19 pandemic.
Merit-based Incentive Payment System (MIPS) For the reasons discussed in section II.R. of this IFC, we are delaying the implementation of
Qualified Clinical Data Registry (QCDR) the completion of QCDR measure testing policy by 1 year. Specifically, we are amending
Measure Approval Criteria: § 414.1400(b)(3)(v)(C) to state that beginning with the 2022 performance period, all QCDR
—Completion of QCDR Measure Testing measures must be fully developed and tested, with complete testing results at the clinician
—Collection of Data on QCDR Measures level, prior to submitting the QCDR measure at the time of self-nomination. This change is
applicable on the effective date of this IFC.
For the reasons discussed in section II.R. of this IFC, we are delaying the implementation of
the collection of data on QCDR measures policy by one year. Specifically, we are amending
§ 414.1400(b)(3)(v)(D) to state that beginning with the 2022 performance period, QCDRs are
required to collect data on a QCDR measure, appropriate to the measure type, prior to sub-
mitting the QCDR measure for CMS consideration during the self-nomination period. This
change is applicable on the effective date of this IFC.
Hospital VBP Program ........................................ We are revising the extraordinary circumstances exception policy to allow CMS to grant an ex-
ception to hospitals located in an entire region or locale without a request and we are codi-
fying the updated policy at § 412.165(c). This change is permanent, and is applicable begin-
ning on the effective date of this IFC.
IRF QRP ............................................................. We are revising the compliance date for the IRF QRP to October 1st of the year that is at
least one full fiscal year after the end of the PHE. This change is applicable on the effective
date of this IFC.
LTCH QRP .......................................................... We are revising the compliance date for the LTCH QRP to October 1st of the year that is at
least one full fiscal year after the end of the PHE. This change is applicable on the effective
date of this IFC.
HH QRP .............................................................. We are revising the compliance date for the HH QRP to January 1st of the year that is at least
one full calendar year after the end of the PHE. This change is applicable on the effective
date of this IFC.
SNF QRP ............................................................ We are revising the compliance date for the SNF QRP to October 1st of the year that is at
least two full fiscal years after the end of the PHE. This change is applicable on the effective
date of this IFC.
Inspection of Public Comments: All received before the close of the Table of Contents
comments received before the close of comment period on the following I. Background
the comment period are available for website as soon as possible after they II. Provisions of the Interim Final Rule With
viewing by the public, including any have been received: http:// Comment Period (IFC)
personally identifiable or confidential regulations.gov. Follow the search A. Reporting Under the Home Health
business information that is included in instructions on that website to view Value-Based Purchasing Model for CY
2020 During the COVID–19 Public
a comment. We post all comments public comments.
Health Emergency
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27552 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
B. Scope of Practice V. Response to Comments COVID–19 illness is mild, the Centers
C. Modified Requirements for Ordering VI. Regulatory Impact Analysis for Disease Control and Prevention
COVID–19 Diagnostic Laboratory Tests Regulations Text (CDC) reports find that in the United
D. Opioid Treatment Programs (OTPs)—
CPT (Current Procedural Terminology) States, between March 1 and 28, 2020,
Furnishing Periodic Assessments via
Communication Technology Copyright Notice the overall laboratory-confirmed
E. Treatment of Certain Relocating COVID–19-associated hospitalization
Throughout this IFC, we use CPT
Provider-Based Departments During the rate was 4.6 per 100,000 population.1 A
codes and descriptions to refer to a
COVID–19 PHE pandemic is a global outbreak of
F. Furnishing Hospital Outpatient Services variety of services. We note that CPT
disease. Pandemics happen when a new
in Temporary Expansion Locations of a codes and descriptions are copyright
virus emerges to infect people and can
Hospital or a Community Mental Health 2019 American Medical Association. All
spread sustainably, from person-to-
Center (Including the Patient’s Home) Rights Reserved. CPT is a registered
person. The virus, SARS-CoV–2, that
G. Medical Education trademark of the American Medical
H. Rural Health Clinics (RHCs) causes COVID–19 is infecting people
Association (AMA). Applicable Federal
I. Durable Medical Equipment (DME) and spreading easily worldwide from
Acquisition Regulations (FAR) and
Interim Pricing in the CARES Act person-to-person because there is little
Defense Federal Acquisition Regulations
J. Care Planning for Medicare Home Health to no pre-existing immunity. This is the
Services (DFAR) apply.
first pandemic known to be caused by
K. CARES Act Waiver of the ‘‘3-Hour Rule’’ I. Background the emergence of a new coronavirus.2
and Modification of IRF Coverage and People in places where ongoing
Classification Requirements for The United States is responding to an
outbreak of respiratory disease caused community spread of the virus that
Freestanding IRF Hospitals for the PHE
During the COVID–19 Pandemic by a novel (new) coronavirus that was causes COVID–19 has been reported are
L. Medicare Shared Savings Program first detected in China and which has at elevated risk of exposure, with the
M. Additional Flexibility Under the now been detected in more than 190 level of risk dependent on the location.
Teaching Physician Regulations countries internationally, and all 50 Healthcare workers caring for patients
N. Payment for Audio-Only Telephone States and the District of Columbia. The with COVID–19 are at elevated risk of
Evaluation and Management Services exposure. Close contacts of persons with
O. Flexibility for Medicaid Laboratory
virus has been named ‘‘severe acute
respiratory syndrome coronavirus 2’’ COVID–19 also are at elevated risk of
Services exposure.
P. Improving Care Planning for Medicaid (SARS-CoV–2’’) and the disease it
causes has been named ‘‘coronavirus The CDC has reported that some
Home Health Services
disease 2019’’ (‘‘COVID–19’’). people are at higher risk of getting very
Q. Basic Health Program Blueprint
Revisions On January 30, 2020, the International sick from this illness.3 This includes:
R. Merit-Based Incentive Payment System Health Regulations Emergency • Older adults, with risk increasing by
(MIPS) Qualified Clinical Data Registry Committee of the World Health age.
(QCDR) Measure Approval Criteria Organization (WHO) declared the • People who have serious chronic
S. Application of Certain National medical conditions like:
outbreak a ‘‘Public Health Emergency of
Coverage Determination and Local ++ Obesity
Coverage Determination Requirements international concern’’. On January 31,
2020, Health and Human Services ++ Cardiovascular disease
During the PHE for the COVID–19
Secretary, Alex M. Azar II, determined ++ Diabetes mellitus
Pandemic
T. Delay in the Compliance Date of Certain that a Public Health Emergency (PHE) ++ Hypertension
Reporting Requirements Adopted for exists for the United States to aid the ++ Chronic lung disease.
IRFs, LTCHs, HHAs and SNFs nation’s healthcare community in The CDC has developed guidance to
U. Update to the Hospital Value-Based responding to COVID–19 (hereafter help in the risk assessment and
Purchasing (VBP) Program Extraordinary referred to as the PHE for the COVID– management of people with potential
Circumstance Exception (ECE) Policy exposures to COVID–19, including
19 pandemic) and on April 21, 2020,
V. COVID–19 Serology Testing recommending that health care
W. Modification to Medicare Provider Secretary Azar renewed, effective April
Enrollment Provision Concerning 26, 2020, the determination that a PHE professionals make every effort to
Certification of Home Health Services exists. On March 11, 2020, the WHO interview a person under investigation
X. Health Insurance Issuer Standards publicly declared COVID–19 a for infection by telephone, text
Under the Affordable Care Act, Including pandemic. On March 13, 2020, the monitoring system, or video
Standards Related to Exchanges: President of the United States declared conference.4
Separate Billing and Segregation of the COVID–19 pandemic a national As the healthcare community
Funds for Abortion Services emergency. establishes and implements
Y. Requirement for Facilities To Report Coronaviruses are a large family of
Nursing Home Residents and Staff
recommended infection prevention and
Infections, Potential Infections, and
viruses that are common in people and control practices, regulatory agencies
Deaths Related to COVID–19 many different species of animals, under appropriate waiver authority
Z. Time Used for Level Selection for including camels, cattle, cats, and bats. granted by the PHE for the COVID–19
Office/Outpatient Evaluation and Rarely, animal coronaviruses can infect pandemic declaration are also working
Management Services Furnished Via people and then spread between people to revise and implement regulations that
Medicare Telehealth such as with MERS-CoV, SARS-CoV, work in concert with healthcare
AA. Updating the Medicare Telehealth List and now with this new virus (SARS- community infection prevention and
BB. Payment for COVID–19 Specimen CoV–2).
Collection to Physicians, Nonphysician The complete clinical picture with 1 https://www.cdc.gov/mmwr/volumes/69/wr/
Practitioners and Hospitals
regard to COVID–19 is not fully known. mm6915e3.htm.
CC. Payment for Remote Physiologic 2 https://www.cdc.gov/coronavirus/2019-ncov/
Monitoring (RPM) Services Furnished Reported illnesses have ranged from
cases-updates/summary.html.
During the COVID–19 Public Health very mild (including some with no 3 https://www.cdc.gov/mmwr/volumes/69/wr/
Emergency reported symptoms) to severe, including mm6915e3.htm.
III. Waiver of Proposed Rulemaking illness resulting in death. While 4 https://www.cdc.gov/coronavirus/2019-ncov/
IV. Collection of Information Requirements information so far suggests that much cases-updates/summary.html.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27553
treatment practices. Based on the overall risk to public health. Notably, all II. Provisions of the Interim Final Rule
current and projected increase in the final provisions included in this IFC are With Comment Period (IFC)
rate of incidence of the COVID–19 only for the duration of the PHE for the In this IFC, we use the term, ‘‘Public
disease in the US population, and COVID–19 pandemic, unless otherwise Health Emergency (PHE),’’ as defined at
observed fatalities in the elderly indicated. 42 CFR 400.200. The definition
population, who are particularly We also acknowledge that the
identifies the PHE determined to exist
vulnerable due to age and co- COVID–19 PHE has created a lack of
nationwide by the Secretary of Health
morbidities, and additionally, the predictability for many ACOs regarding
and Human Services (the Secretary)
impact on health workers who are at the impact of expenditure and
under section 319 of the Public Health
increased risk due to treating the utilization changes on historical
Service Act on January 31, 2020, and
population, we believe that certain benchmarks and financial performance,
renewed effective April 26, 2020, as a
regulations should be reviewed and created uncertainty around future
result of confirmed cases of COVID–19.
revised as appropriate to offer providers program participation, and disrupted
and suppliers additional flexibilities in population health activities as A. Reporting Under the Home Health
furnishing services to combat the clinicians, care coordinators, and Value-Based Purchasing Model for CY
COVID–19 pandemic. We are addressing financial and other resources are 2020 During the COVID–19 PHE
some of these regulations in a previous diverted to address immediate acute
Through this IFC, we are
IFC which appeared in the April 6, 2020 care needs. We are amending the Shared
implementing a policy to align the
Federal Register (85 FR 19230) with an Savings Program regulations in order to
Home Health Value-Based Purchasing
effective date of March 31, 2020 address the impact of the COVID–19
(HHVBP) Model data submission
(hereafter referred to as the ‘‘March 31st pandemic and encourage continued
requirements with any exceptions or
COVID–19 IFC’’). In this interim final participation by ACOs. In addition, this
extensions granted for purposes of the
rule with comment period (IFC), we are IFC also provides flexibility to states
Home Health Quality Reporting Program
revising additional regulations to ensure operating a BHP to seek certification for
(HH QRP) during the PHE for COVID–
that sufficient health care items and temporary significant changes to its BHP
19. We are also implementing a policy
services are available to meet the needs Blueprint that are directly tied to the
PHE for the COVID–19 pandemic, for granting exceptions to the New
of individuals enrolled in the programs Measures data reporting requirements
under Title XVIII (Medicare) and Title including the ability to apply the
changes retroactively to the start of the under the HHVBP Model during the
XIX (Medicaid) of the Social Security PHE for COVID–19. Specifically, during
Act (the Act), or in the identified PHE. Finally, in light of these
extraordinary circumstances and the the PHE for COVID–19, to the extent
programs authorized under the that the data that participating HHAs in
Affordable Care Act. In addition, we are immediate need for QHP issuers to
divert resources to responding to the the nine HHVBP Model states are
implementing regulations in response to required to report are the same data that
recent legislation including the COVID–19 PHE, we are delaying by 60
days the date when individual market those HHAs are also required to report
Coronavirus Preparedness and Response for the HH QRP, HHAs are required to
Supplemental Appropriations Act, 2020 issuers must be in compliance with the
separate billing policy. Under this 60- report those data for the HHVBP Model
(Pub. L. 116–123, March 6, 2020), the in the same time, form and manner that
Families First Coronavirus Response day delay, QHP issuers must comply
with the separate billing policy HHAs are required to report those data
Act (Pub. L. 116–127, March 18, 2020), for the HH QRP. As such, if CMS grants
beginning on or before the QHP issuer’s
and the Coronavirus Aid, Relief, and an exception or extension that either
first billing cycle following August 26,
Economic Security Act (CARES Act) excepts HHAs from reporting certain
2020.
(Pub. L. 116–136, March 27, 2020). As QHP issuers and Exchanges work quality data altogether, or otherwise
In this extraordinary circumstance, to respond to the COVID–19 PHE and extends the deadlines by which HHAs
we recognize that the COVID–19 implement and establish policies to must report those data, the same
pandemic greatly increases the overall ensure access to COVID–19-related care exceptions and/or extensions apply to
risk to public health. We believe that for enrollees, HHS is working to assess the submission of those same data for
this increased risk results in an and extend regulatory flexibility to QHP the HHVBP Model. In addition, in this
immediate change, not only in the issuers, Exchanges, and other health IFC, we are adopting a policy to allow
circumstances under which services can industry stakeholders where doing so exceptions or extensions to New
safely occur, but also in to the business may enable these stakeholders to divert Measure reporting for HHAs
relationships among providers, existing resources to aiding the COVID– participating in the HHVBP Model
suppliers, and practitioners. By 19 PHE response. We believe extending during the PHE for COVID–19.
increasing access to hospital and the deadline 60 days for QHP issuers As authorized by section 1115A of the
community mental health services and Exchanges to comply with the Act and finalized in the CY 2016 HH
furnished in temporary expansion separate billing policy is appropriate so PPS final rule (80 FR 68624), the
locations of the hospital including the that they may adequately respond to HHVBP Model has an overall purpose of
patient’s home, increasing access to and divert resources to address the improving the quality and delivery of
laboratory and diagnostic testing in a COVID–19 PHE. home health care services to Medicare
patient’s home or other settings that Also, consistent with section 3708 of beneficiaries. The specific goals of the
could help to minimize transmission of the CARES Act, we are expanding 42 Model are to: (1) Provide incentives for
communicable disease, and improving CFR parts 409, 424.22, 424.507(b), better quality care with greater
infection control, this IFC will provide 440.70 and part 484 to permit nurse efficiency; (2) study new potential
the necessary flexibility for Medicare practitioners (NPs), clinical nurse quality and efficiency measures for
and Medicaid beneficiaries to be able to specialists (CNSs), and physician appropriateness in the home health
receive medically necessary services assistants (PAs) to certify the need for setting; and (3) enhance the current
without jeopardizing their health or the home health services and to order public reporting process. All Medicare
health of those who are providing those services in the Medicare and Medicaid certified HHAs providing services in
services, while also minimizing the programs. Arizona, Florida, Iowa, Nebraska, North
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27554 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Carolina, Tennessee, Maryland, separately report these measures for New Measures submission period began
Massachusetts, and Washington are purposes of the HHVBP Model, and in 2019, the data collected during this
required to compete in the Model. The those same exceptions apply to the period are used for the calculation of the
HHVBP Model uses the waiver authority submission of those same data for the TPSs for CY 2020 performance, not CY
under section 1115A(d)(1) of the Act to HHVBP Model. In accordance with this 2019 data. We further note that HHAs
adjust Medicare payment rates under policy, if CMS grants an exception or may optionally submit part or all of
section 1895(b) of the Act based on the extension under the HH QRP that either these data by the applicable submission
competing HHAs’ performance on excepts HHAs from reporting certain deadlines. If we make the determination
applicable measures. The maximum quality data altogether, or otherwise to grant an exception to New Measure
payment adjustment percentage extends the deadlines by which HHAs data reporting for periods beyond the
increases incrementally over the course must report those data, the same April and July 2020 submission periods,
of the HHVBP Model in the following exceptions and/or extensions apply to for example if the PHE for COVID–19
manner, upward or downward: (1) 3 the submission of those same data for extends beyond the New Measure
percent in CY 2018; (2) 5 percent in CY the HHVBP Model. submission periods we have listed in
2019; (3) 6 percent in CY 2020; (4) 7 In response to the PHE for COVID–19, this IFC, we will communicate this
percent in CY 2021; and (5) 8 percent in on March 27, 2020, we issued decision through routine
CY 2022. Payment adjustments are supplemental public guidance (https:// communication channels to the HHAs
based on each HHA’s Total Performance www.cms.gov/files/document/guidance- participating in the HHVBP Model,
Score (TPS) in a given performance year memo-exceptions-and-extensions- including but not limited to issuing
(PY), which is comprised of quality-reporting-and-value-based- memos, emails and posting on the
performance on: (1) A set of measures purchasing-programs.pdf) excepting HHVBP Connect website (https://
already reported via the Outcome and HHAs from the requirement to report app.innovation.cms.gov/
Assessment Information Set (OASIS),5 any HH QRP data for the following HHVBPConnect).
completed Home Health Consumer quarters: We acknowledge that the exceptions
Assessment of Healthcare Providers and • October 1, 2019–December 31, 2019 to the HH QRP reporting requirements,
Systems (HHCAHPS) surveys, and select (Q4 2019). as well as the modified submission
claims data elements; and (2) three New • January 1, 2020–March 31, 2020 deadlines for OASIS data and our
Measures for which points are achieved (Q1 2020). exceptions for the New Measures
for reporting data. • April 1, 2020–June 30, 2020 (Q2 reporting requirements, may impact the
The HHVBP Model utilizes some of 2020). calculation of performance under the
the same quality measure data that are Under our policy to align HHVBP data HHVBP Model for the performance year
reported by HHAs for the HH QRP, submission requirements with any (PY) 2020. We also note that while we
including HHCAHPS survey data. The exceptions or extensions granted for are able to extract the claims-based data
other HHVBP measures are calculated purposes of the HH QRP during the PHE from submitted Medicare FFS claims,
using OASIS data, which are still for COVID–19, HHAs in the nine we may need to assess the
required to be reported during the PHE; HHVBP Model states are not required to appropriateness of using the claims data
however, we have given providers separately report measure data for these submitted for the period of the PHE for
additional time to submit OASIS data quarters for purposes of the HHVBP COVID–19 for purposes of performance
(https://www.cms.gov/files/document/ Model. We note that with regard to the calculations under the HHVBP Model.
covid-home-health-agencies.pdf); exception from the requirement to We are evaluating possible changes to
claims-based data extracted from report Q4 2019 HH QRP data, we do not our payment methodologies for CY 2022
Medicare fee-for-service (FFS) claims; anticipate any issues in calculating the in light of this more limited data, such
and New Measure data. To assist HHAs TPSs based on CY 2019 data under the as whether we would be able to
while they direct their resources toward HHVBP Model because HHAs had the calculate payment adjustments for
caring for their patients and ensuring opportunity to submit these Q4 2019 participating HHAs for CY 2022,
the health and safety of patients and data on a rolling basis. including those that continue to report
staff, we are adopting a policy for the In addition, to ensure that HHAs are data during CY 2020, if the overall data
HHVBP Model to align the HHVBP data able to focus on patient care in lieu of is not sufficient, as well as whether we
submission requirements with any data submission during the PHE for may consider a different weighting
exceptions or extensions granted for COVID–19, in this IFC, we are methodology given that we may have
purposes of the HH QRP during the PHE establishing a policy to allow us to grant sufficient data for some measures and
for COVID–19. For the same reason, we exceptions to New Measure reporting not others. We are also evaluating
are also establishing a policy for for HHAs participating in the HHVBP possible changes to our public reporting
granting exceptions to New Measure Model during the PHE for COVID–19. of CY 2020 performance year data. We
reporting requirements for HHAs We are codifying these changes at intend to address any such changes to
participating in the HHVBP Model § 484.315(b). In accordance with this our payment methodologies for CY 2022
during the PHE for COVID–19. policy, we are granting an exception to or public reporting of data in future
Under this policy, to the extent CMS all HHAs participating in the HHVBP rulemaking.
has granted an exception to the HH QRP Model for the following New Measure B. Scope of Practice
(for 2019 Q4 and 2020 Qs 1–2 as noted reporting requirements:
below in this section), or may grant any • April 2020 New Measures In December 2019, CMS issued a
submission period (data collection request for feedback in response to part
future exceptions or extensions under
period October 1, 2019–March 31, of the President’s Executive Order (E.O.)
this same program for other CY 2020
2020). 13890 on ‘‘Protecting and Improving
reporting periods, HHAs in the nine
HHVBP Model states do not need to • July 2020 New Measures Medicare for Our Nation’s Seniors,’’
submission period (data collection seeking the public’s help in identifying
5 OASIS is the instrument/data collection tool period April 1, 2020–June 30, 2020). additional Medicare regulations which
used to collect and report performance data by We note that although the data contain more restrictive supervision
HHAs. collection period for the April 2020 requirements than existing state scope
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27555
of practice laws, or which limit health they use the results of the tests in the flexibility and availability of health care
professionals from practicing at the top management of the beneficiary’s specific professionals to provide needed care,
of their license (for a link to this request medical problem. However, under our we are finalizing on an interim basis
for feedback see https://www.cms.gov/ current regulation at § 410.32(b), only changes to our regulation at § 410.32(b)
files/document/request-information- physicians are generally permitted to to add flexibility for NPs, CNSs, PAs,
reducing-scope-practice-burden.pdf). In supervise diagnostic tests. The and CNMs, which are types of
response to this request, we received regulation at § 410.32(b)(1) provides as a practitioners that have separately
several recommendations from basic rule that all diagnostic tests paid enumerated benefit categories under
nonphysician practitioners (NPPs) that under the Physician Fee Schedule (PFS) Medicare law that permit them to
inform CMS policymaking to ensure an must be furnished under an appropriate furnish services that would be
adequate number of clinicians are able specified minimum level of supervision physicians’ services if furnished by a
to furnish critical services and tests by a physician as defined in section physician and be paid under Medicare
during the COVID–19 PHE. According 1861(r) of the Act. Section 410.32(b)(2) Part B for the professional services they
to the American Association of Nurse then provides for certain exceptions to furnish directly and ‘‘incident to’’ their
Practitioners, currently, twenty-two which the general basic rule does not own professional services, to the extent
states and DC are considered Full apply. For instance, under authorized under their State scope of
Practice Authority (FPA) states because § 410.32(b)(2)(v), the requirement that practice. The interim changes will
their licensure laws allow full and diagnostic tests must be furnished under ensure that these practitioners may
direct patient access to NPs. We are the appropriate level of supervision by order, furnish directly, and supervise
finalizing provisions that address a physician does not apply for tests the performance of diagnostic tests,
several of those recommendations in performed by an NP or CNS authorized subject to applicable state law, during
this section of the IFC, on an interim under applicable state law to furnish the the PHE. As we observe how rapidly the
basis for the duration of the PHE. We test. (We note that, as for all services COVID–19 virus is transmitted in the
note that the responses to our request they furnish, the NP or CNS necessarily population, we believe this policy will
for information on these topics did not would be working in collaboration with help to ensure that an adequate number
indicate the number of states having a physician under §§ 410.75 and 410.76, of health care professionals are available
more flexible scope of practice rules respectively). Similarly, at to support critical COVID–19-related
than our federal regulations. In this rule, § 410.32(b)(2)(vii), the requirement that and other diagnostic testing needs, and
we are also seeking public feedback diagnostic tests must be furnished under provide needed medical care. This
indicating the number of states to help the appropriate level of supervision by policy will support the rapid expansion
us understand the scope of impact of a physician does not apply for tests of COVID–19-related diagnostic testing
these changes. performed by a CNM authorized under capacity to quickly identify affected
1. Supervision of Diagnostic Tests by applicable state law to furnish the test. individuals and protect against
Certain Nonphysician Practitioners There are not currently any exceptions transmission of the virus to vulnerable
under § 410.32(b)(2) for services populations, and help to address
Rapid expansion of COVID–19-related
furnished by PAs. As such, any potential clinical workforce shortages
diagnostic testing capacity (such as lab
diagnostic tests furnished by PAs would that may impact access to services and
tests and respiratory imaging) is a top
need to be under the appropriate level other diagnostic tests that still need to
priority in the strategy to combat the
of supervision by a physician in be furnished during the PHE.
pandemic. In response to the request for
feedback discussed above, PAs and NPs accordance with § 410.32(b)(1). We note Specifically, we are amending the
recommended regulatory changes that further that our regulation at regulation at § 410.32(b)(1) to specify in
would allow them to supervise § 410.32(b)(3) specifies that only a the basic rule that diagnostic tests
diagnostic tests because they stated that general level of physician supervision is covered under section 1861(s)(3) of the
they are currently authorized to do so required for diagnostic tests performed Act and payable under the PFS must be
under their State scope of practice rules. by a PA that the PA is legally authorized furnished under the appropriate level of
We also received feedback from to perform under state law. Of course, supervision by a physician as defined
radiologists who did not support all services furnished by PAs must meet under section 1861(r) of the Act or,
making any changes to our regulations the physician supervision requirements during the PHE, by a NP, CNS, PA, and
that would result in any inappropriate under § 410.74, which generally defers CNM, as described above. Additionally,
expansion of the role of NPPs. to state law requirements that address we are amending the regulation at
Currently, under 42 CFR 410.32(a)(3) of the requisite practice relationship § 410.32(b)(2)(iii)(B) which addresses
our regulations, physicians and NPPs between PAs and physicians, or requires supervision of COVID–19-related
who are treating a beneficiary for a certain documentation of the working diagnostic psychological and
specific medical problem may order relationship between the PA and neuropsychological testing services to
diagnostic tests when they use the physicians to supervise PA services if allow these services to be supervised by
results of the tests in the management of the issue is not addressed in state law. a NP, CNS, PA and CNM as described
the beneficiary’s specific medical Thus, while NPs, CNSs, PAs, and CNMs above, during the PHE, in addition to
problem. Specifically, NPPs who are permitted to furnish diagnostic tests physicians and CPs who are currently
furnish services that would be to the extent they are otherwise authorized to supervise these tests. We
physicians’ services if furnished by a authorized under state law to do so, the are also amending the regulation at
physician (that is, NPs, PAs, CNSs, regulations at § 410.32 does not address § 410.32 by adding a new paragraph
clinical psychologists (CPs), clinical whether NPs, CNSs, PAs and CNMs may (b)(2)(viii) to allow diagnostic tests to be
social workers (CSWs), and certified supervise others when furnishing performed by a PA without physician
nurse-midwives (CNMs)), and who are diagnostic tests. supervision (although as noted above,
operating within the scope of their In light of the need to reinforce and the regulation at § 410.74 continues to
authority under State law and within increase COVID–19-related diagnostic apply) when authorized to perform the
the scope of their Medicare statutory testing capacity throughout the duration tests under applicable state law.
benefit may order diagnostic tests when of the PHE, and to increase the Furthermore, we are amending the
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27556 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
regulation at § 410.32(b)(3) regarding the OTAs are permitted to furnish these registered nurse anesthetist (CRNAs)
levels of supervision, to also authorize services. They recommended that we who furnish and bill for their
NPs, CNSs, PAs, and CNMs, as revise our policy to permit the treating professional services to review and
described above, during the PHE to therapist who established or is verify, rather than re-document,
provide the appropriate level of responsible for the maintenance information included in the medical
supervision assigned to diagnostic tests. program plan to determine when it is record by physicians, residents, nurses,
Since we are adding PAs under clinically appropriate to delegate the students or other members of the
§ 410.32(b)(2)(viii) to the list of performance of maintenance therapy medical team. We explained that this
exceptions to the general basic rule for services to PTAs and OTAs, as they are principle would apply across the
supervision during the PHE, and given charged with overseeing a patient’s spectrum of all Medicare-covered
that the physician supervision course of treatment and assigning services paid under the PFS. We noted
requirement in the regulation at § 410.74 responsibilities to assistants. They that the policy was intended to apply
continues to apply, we are removing the suggested that permitting PTAs and broadly, and accordingly amended
parenthetical regarding general OTAs to furnish maintenance therapy regulations for teaching physicians,
physician supervision for diagnostic services would give Medicare patients other physicians, PAs, and APRNs to
tests furnished by PAs from greater access to care and permit expressly provide for this flexibility for
§ 410.32(b)(3). We are also correcting the therapists and therapy providers more medical record documentation
typographical error under flexibility for resource utilization. requirements for professional services
§ 410.32(d)(2)(i) regarding To increase availability of needed furnished by physicians, PAs and
documentation and recordkeeping health care services during the COVID– APRNs in all settings.
requirements to state that when ordering 19 PHE, we believe it is appropriate to
To increase the availability of
diagnostic tests, the physician (or synchronize our Part B payment policies
clinicians who may furnish healthcare
qualified NPP, as defined in paragraph as suggested by the stakeholders, and to
services during the PHE, we are
(a)(2) of this section), who orders the permit the PT or OT who established
announcing a general policy that there
service must maintain documentation of the maintenance program to delegate the
is broad flexibility for all members of
medical necessity in the beneficiary’s performance of maintenance therapy
the medical team to add documentation
medical record. services to a PTA or OTA when
in the medical record which is then
clinically appropriate. We believe that,
2. Therapy—Therapy Assistants reviewed and verified (signed) by the
by allowing PTAs and OTAs to perform
Furnishing Maintenance Therapy (PFS) appropriate clinician. Specifically, on
maintenance therapy services, PTs and
We currently make payment under an interim basis during the PHE for the
OTs will be freed up to furnish other
Medicare Part B for outpatient COVID–19 pandemic, any individual
services, including such services as non-
occupational and physical therapy who has a separately enumerated
medication pain management therapies
(§§ 410.59(a) and 410.60(a), benefit under Medicare law that
that may reduce reliance on opioids or
respectively) when they are furnished authorizes them to furnish and bill for
other medications, as well as those
by an individual meeting qualifications their professional services, whether or
services related to the COVID–19 PHE
in part 484 for an occupational therapist not they are acting in a teaching role,
that require a therapist’s assessment and
(OT) or physical therapist (PT), or an may review and verify (sign and date),
evaluation skills, including
appropriately supervised occupational rather than re-document, notes in the
communication technology-based
therapy assistant (OTA) or physical medical record made by physicians,
services (CTBS) that were made
therapy assistant (PTA). This includes residents, nurses, and students
available for PTs, OTs and speech-
our policy for rehabilitative services for (including students in therapy or other
language pathologists (SLPs) during the
which improvement of the beneficiary’s clinical disciplines), or other members
PHE in the March 31st COVID–19 IFC
functional status is expected. However, of the medical team. We note that
(85 FR 19245 and 19265 through 19266).
in cases where it is medically necessary although there are currently no statutory
to maintain, prevent or slow the 3. Therapy—Student Documentation or regulatory documentation
deterioration of a patient’s condition, a (PFS) requirements that would impact
separate policy requires the skills of a In the CY 2020 PFS final rule,6 we payment for therapists when
physical or OT, not a PTA or OTA, to simplified medical record documentation is added to the medical
carry out a therapist-established documentation requirements and record by persons other than the
maintenance program, which is finalized a general principle to allow the therapist, we are discussing this issue in
generally known as ‘‘maintenance physician, PA, or the advanced practice response to stakeholder concerns about
therapy.’’ For services furnished by registered nurses (APRNs), specifically, burden and in consideration of the
PTAs and OTAs, claims from therapists NPs, CNSs, CNMs, and certified current COVID–19 PHE. Specifically,
and providers are required to use the this policy will ensure that therapists, as
‘‘CO’’ and ‘‘CQ’’ modifiers for their 6 Medicare Program; CY 2020 Revisions to members of the clinical workforce, are
respective OTA and PTA therapy Payment Policies under the Physician Fee Schedule able to spend more time furnishing
services, to indicate that a supervised and Other Changes to Part B Payment Policies; therapy services, including pain
Medicare Shared Savings Program Requirements;
therapy assistant performed the Medicaid Promoting Interoperability Program
management therapies to patients that
rehabilitative or maintenance therapy Requirements for Eligible Professionals; may minimize the use of opioids and
services. Establishment of an Ambulance Data Collection other medications, rather than spending
In response to the request for feedback System; Updates to the Quality Payment Program; time documenting in the medical
Medicare Enrollment of Opioid Treatment Programs
discussed above, therapists and therapy and Enhancements to Provider Enrollment
record. We emphasize that our
providers pointed out that our Part B Regulations Concerning Improper Prescribing and established principle is focused on the
policy specifying that maintenance Patient Harm; and Amendments to Physician Self- clinician, as described above who
therapy requires the skills of a therapist Referral Law Advisory Opinion Regulations Final furnishes and bills for their professional
Rule; and Coding and Payment for Evaluation and
is not consistent with the policy for Management, Observation and Provision of Self-
services rather than the individuals who
services furnished in SNF and Home Administered Esketamine Interim Final Rule (84 FR may enter information into the medical
Health Part A settings where PTAs and 62568–63563). record. We want to emphasize that
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27557
information entered into the medical federal authorities.7 In combination Medicare beneficiaries quickly as part of
record should document that the with the availability of point of care the rapid expansion of COVID–19
furnished services are reasonable and tests that provide rapid results, these testing capacity to combat the
necessary. sites are a key component in the pandemic. Therefore, the need for a
expansion of COVID–19 testing patient to first have a visit with a
4. Pharmacists Providing Services
Incident to a Physicians’ Service capacity. physician or practitioner to obtain an
Under Medicare Part B, clinical order for COVID–19 testing to meet
In response to the request for feedback diagnostic laboratory tests, including Medicare ordering requirements could
discussed above, numerous stakeholders COVID–19 diagnostic tests, are paid for still present a significant barrier to
asked us to clarify that pharmacists are under the Clinical Laboratory Fee patients who might otherwise seek a
permitted to provide services to Schedule (CLFS), without any test.
Medicare beneficiaries incident to the beneficiary cost-sharing requirements Prior to the Guidance for Licensed
professional services of a physician, like (coinsurance or Part B deductible). See Pharmacists, COVID–19 Test, and
other clinical staff or certain other generally sections 1861(s)(3), Immunity Under the PREP Act, which
clinicians. These stakeholders have 1833(a)(1)(D)(i)(II), (b)(3)(A), (h)(5)(C) HHS issued on April 8, 2020 (April
asked us, in particular, about and (D), and 1834A of the Act, and 42 Guidance),9 state governments had
pharmacists who provide medication CFR part 414, subpart G. sought to increase access to testing by
management services. Medication Under our current regulation at removing prior authorization of COVID–
management is covered under both § 410.32(a), diagnostic laboratory tests 19 tests in the commercial health
Medicare Part B and Part D. We are such as the COVID–19 tests are covered insurance market.10 States and State
clarifying explicitly that pharmacists only when they are ordered by a Boards of Pharmacy had also sought to
fall within the regulatory definition of physician or other practitioner who is increase physician capacity by
auxiliary personnel under our treating the beneficiary, and who uses permitting pharmacists to test for and
regulations at § 410.26. As such, the results of the test in managing the treat influenza and streptococcus
pharmacists may provide services patient’s specific medical condition. If a infections under protocols.11 State
incident to the services, and under the patient arrives at a community testing Boards of Pharmacy have in turn sought
appropriate level of supervision, of the site without an order for the test from to increase pharmacist capacity by
billing physician or NPP, if payment for his or her physician or practitioner, relaxing pharmacist to pharmacy
the services is not made under the Medicare would not currently cover the technician supervision ratios.12 With
Medicare Part D benefit. This includes growing supplies of tests and in light of
test.
providing the services incident to the the April Guidance we anticipate that
We have taken substantial steps to
services of the billing physician or NPP States will look increasingly to
broaden access to safely-delivered care
and in accordance with the pharmacist’s pharmacists and other qualified
via telehealth and other communication
state scope of practice and applicable healthcare professionals to order and
technology-based services during the
state law. This clarification does not furnish COVID–19 tests.
COVID–19 PHE in an attempt to ensure
alter current payment policy for Information provided by the CDC
that a COVID–19 test could be ordered
pharmacist services furnished incident shows that the likelihood of severe
by a physician or other practitioner
to the professional services of a outcomes of COVID–19 illness is highest
treating the beneficiary.
physician or NPP. in adults aged 65 and older and people
Although fully consistent with Notwithstanding these flexibilities, not
all beneficiaries have access to a doctor with underlying health conditions,
current CMS policy, we believe this which suggests that the Medicare
clarification may encourage pharmacists to obtain a COVID–19 diagnostic
laboratory test. The most recently beneficiary population is at particularly
to work with physicians and NPPs in high risk from the disease.13
new ways that expand the availability of available results from the Medicare
Current Beneficiary Survey indicated Additionally, as noted by the CDC in
health care services during the COVID– guidance on how to protect against
19 PHE, and increase access to that only 70 percent of Medicare
beneficiaries view a doctor’s office as COVID–19 infection, some studies have
medication management of individuals
with substance/opioid use disorder. We their source of care. In the same survey,
9 HHS Statements on Authorizing Licensed
emphasize that consistent with the 23 percent of beneficiaries indicated
Pharmacists to Order and Administer COVID–19
Controlled Substances Act (Pub. L. 91– that a medical clinic, urgent care center, Tests, HHS, April 8, 2020, https://www.hhs.gov/
513, enacted October 27, 1970), or hospital outpatient department about/news/2020/04/08/hhs-statements-on-
methadone should continue to be (HOPD) was their source of care. HOPDs authorizing-licensed-pharmacists-to-order-and-
and urgent care clinics may not be able administer-covid-19-tests.html.
dispensed from certified and accredited 10 Karen Pollitz, ‘‘Private Health Coverage of
Opioid Treatment Programs (OTPs) to furnish community patient visits
COVID–19: Key Facts and Issues,’’ Kaiser Family
under the supervision of clinicians who because they are treating an excess Foundation, March 18, 2020, https://www.kff.org/
have received appropriate training and number of patients already testing private-insurance/issue-brief/private-health-
fully understand the risks of that positive for the virus. The survey also coverage-of-covid-19-key-facts-and-issues/.
11 National Alliance of State Pharmacy
medication as is required by statute. indicated that 7 percent of beneficiaries
Associations (NASPA), Pharmacist Prescribing:
reported no source of care.8 We ‘‘Test and Treat,’’ February 8, 2019, available at
C. Modified Requirements for Ordering anticipate needing to test many https://naspa.us/resource/pharmacist-prescribing-
COVID–19 Diagnostic Laboratory Tests for-strep-and-flu-test-and-treat/
7 Guidance for Licensed Pharmacists, COVID–19 12 NASPA. ‘‘COVID–19: Information from the
The rapid expansion of COVID–19
Test, and Immunity Under the PREP Act, HHS, States,’’ April 14, 2020, available at https://
diagnostic laboratory testing capacity is April 8, 2020, https://www.hhs.gov/sites/default/ naspa.us/resource/covid-19-information-from-the-
a top priority in our strategy to combat files/authorizing-licensed-pharmacists-to-order- states/.
the pandemic. To that end, several large and-administer-covid-19-tests.pdf. 13 Preliminary Estimates of the Prevalence of
8 Centers for Medicare & Medicaid Services. Selected Underlying Health Conditions Among
clinical diagnostic laboratory and
Medicare Current Beneficiary Survey Chart Book Patients with Coronavirus Disease 2019—United
pharmacy businesses are operating 2016. https://www.cms.gov/Research-Statistics- States, February 12–March 28, 2020. MMWR Morb
community testing sites across the Data-and-Systems/Research/MCBS/Data-Tables- Mortal Wkly Rep 2020;69:382–386. DOI: http://
country in cooperation with state and Items/2016Chartbook. dx.doi.org/10.15585/mmwr.mm6913e2.
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27558 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
suggested that COVID–19 may be spread the COVID–19 PHE, as these additional counseling or therapy, to be
by people who are not showing requirements would not be relevant in furnished using audio-only telephone
symptoms.14 We believe it is vital for the absence of a treating physician’s or calls rather than via two-way interactive
Medicare beneficiaries to have broad NPP’s order. While no order is required audio-video communication technology
access to COVID–19 testing so that they under Medicare, we do expect the entity during the PHE for the COVID–19
can properly monitor their symptoms, submitting the claim to include the pandemic if beneficiaries do not have
make prompt decisions about seeking ordering or referring NPI information on access to two-way audio/video
further care, and take appropriate the claim form when an order is written communications technology, provided
precautions to prevent further spread of for the test, consistent with current all other applicable requirements are
the disease. billing instructions. met (85 FR 19258).
Given the critical importance of When COVID–19 tests are furnished In addition to the flexibilities
expanding COVID–19 testing to combat without a physician’s or NPP’s order as described above, we have determined
the pandemic and the heightened risk set forth in this regulation during the that it is also necessary to revise
that the disease presents to Medicare COVID–19 PHE, the laboratory § 410.67(b)(7) on an interim final basis
beneficiaries, we are amending our conducting the tests is required to to allow periodic assessments to be
regulation at § 410.32(a) to remove the directly notify the patient of the results furnished during the PHE for the
requirement that certain diagnostic tests consistent with other applicable laws, as COVID–19 pandemic via two-way
are covered only based on the order of well as meet other applicable test result interactive audio-video communication
a treating physician or NPP. Under this reporting requirements. Comprehensive technology. In addition, in cases where
interim policy, during the COVID–19 and timely reporting of all testing beneficiaries do not have access to two-
PHE, COVID–19 tests may be covered results to local officials is critical to way audio-video communications
when ordered by any healthcare public health management of the technology, the periodic assessments
professional authorized to do so under pandemic, and we would expect any may be furnished using audio-only
state law. Additionally, because the clinician or laboratory receiving results telephone calls rather than via two-way
symptoms for influenza and COVID–19 to report those results promptly, interactive audio-video communication
might present in the same way, during consistent with state and local public technology, provided all other
the COVID–19 PHE, we are also health requirements, typically within 24 applicable requirements are met. We
removing the same ordering hours. believe this change is necessary to
requirements for a diagnostic laboratory D. Opioid Treatment Programs (OTPs)— ensure that beneficiaries with opioid
test for influenza virus and respiratory Furnishing Periodic Assessments via use disorders are able to continue to
syncytial virus, a type of common Communication Technology receive these important services during
respiratory virus. CMS will make a list the PHE for the COVID–19 pandemic.
of diagnostic laboratory tests for which In the CY 2020 PFS final rule (84 FR
62634), we finalized an add-on code While we will allow this flexibility
we are removing the ordering during the PHE for the COVID–19
requirements publicly available. We are describing periodic assessments
furnished by OTPs. The finalized add- pandemic, we expect that OTPs will use
removing the treating physician or NPP clinical judgment to determine whether
on code is Healthcare Common
ordering requirement for these they can adequately perform the
Procedure Coding System (HCPCS) code
additional diagnostic laboratory tests periodic assessment over audio-only
G2077 (Periodic assessment; assessing
only when they are furnished in phone calls, and if not, then they should
periodically by qualified personnel to
conjunction with a COVID–19 perform the assessment using two-way
determine the most appropriate
diagnostic laboratory test as medically interactive audio-video communication
combination of services and treatment).
necessary in the course of establishing technology or in person as clinically
The medical services described by this
or ruling out a COVID–19 diagnosis or appropriate. Regardless of the format
add-on code can be furnished by a
of identifying patients with an adaptive that is used, the OTP should document
program physician, a primary care
immune response to SARS-CoV–2 in the medical record the reason for the
physician or an authorized healthcare
indicating recent or prior infection. We professional under the supervision of a assessment and the substance of the
would not expect there to be any program physician or qualified assessment.
medical necessary reason to use the personnel such as NPs and PAs. The Additionally, we note that SAMHSA
specimen for unrelated or repeat testing. other assessments, including has offered flexibilities to states to
When COVID–19 diagnostic laboratory psychosocial assessments can be ensure that individuals being treated
testing becomes sufficiently prevalent, furnished by practitioners who are with medication for opioid use
sensitive, and specific such that eligible to do so under their state law disorders can continue to receive their
laboratory tests for influenza or related and scope of licensure. We note that to medication during the PHE for the
respiratory conditions are no longer bill for the add-on code, the services COVID–19 pandemic. SAMHSA
needed to establish a definitive COVID– need to be medically reasonable and provides specific guidance for OTPs on
19 diagnosis, we expect that additional necessary and that OTPs should its website at SAMHSA.gov/coronavirus.
testing for influenza or related document the rationale for billing the The following is a list of resources
respiratory viral illness would no longer add-on code in the patient’s medical posted on the SAMHSA website as of
be medically necessary. We are also record (84 FR 62647). the time of publication of this rule:
making conforming amendments to our In light of the PHE for the COVID–19 • Opioid Treatment Program (OTP)
regulations at § 410.32(d)(2) and (3) to pandemic, during which the public has Guidance (March 16, 2020) available at
remove certain documentation and been instructed to practice self-isolation https://www.samhsa.gov/sites/default/
recordkeeping requirements associated or social distancing, in the March 31st files/otp-guidance-20200316.pdf.
with orders for COVID–19 tests during COVID–19 IFC, we revised • OTP Guidance for Patients
14 Coronavirus Disease 2019 (COVID–19): How to
§ 410.67(b)(3) and (4) to allow the Quarantined at Home with the
Protect Yourself & Others, CDC, https://
therapy and counseling portions of the Coronavirus available at https://
www.cdc.gov/coronavirus/2019-ncov/prevent- weekly bundles of services furnished by www.samhsa.gov/sites/default/files/otp-
getting-sick/prevention.html. OTPs, as well as the add-on code for covid-implementation-guidance.pdf.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27559
• FAQs: Provision of Methadone and finalized policies that define whether We note that on March 30, 2020, the
Buprenorphine for the Treatment of certain items and services furnished by Secretary issued several waivers 15
Opioid Use Disorder in the COVID–19 a given off-campus PBD may be under section 1135(b) of the Act in
Emergency available at https:// considered excepted, and thus, continue response to the PHE for the COVID–19
www.samhsa.gov/sites/default/files/ to be paid under the OPPS; established pandemic, including a waiver of
faqs-for-oud-prescribing-and- the requirements for the off-campus Medicare’s provider-based rules in
dispensing.pdf. PBDs to maintain excepted status (both § 413.65. Importantly, the waiver does
• COVID–19 Public Health for the excepted off-campus PBDs and not determine whether a PBD is
Emergency Response and 42 CFR part 2 for the items and services furnished by excepted or non-excepted for purposes
Guidance available at https:// excepted off-campus PBDs); and of section 603 of the BBA 2015, and the
www.samhsa.gov/sites/default/files/ described the applicable payment definitions in § 413.65 that section 603
covid-19-42-cfr-part-2-guidance- system for non-excepted items and cross-references, including the
03192020.pdf. services (generally, the PFS). definition of campus at § 413.65(a)(2),
• Considerations for the Care and We created the ‘‘PO’’ modifier in the remain relevant to that determination.
Treatment of Mental and Substance Use CY 2015 Outpatient Prospective We note that the definition of
Disorders in the COVID–19 Epidemic: Payment System Final Rule (79 FR ‘‘applicable items and services’’
March 20, 2020 available at https:// 66910–66914), which is reported with specifically excludes items and services
www.samhsa.gov/sites/default/files/ every HCPCS code for all outpatient furnished by a dedicated emergency
considerations-care-treatment-mental- hospital items and services furnished in department as defined at 42 CFR
substance-use-disorders-covid19.pdf. an excepted off-campus PBD of a 489.24(b). Section 1833(t)(21)(B)(ii) of
hospital. In the CY 2017 OPPS/ASC the Act also excepts from the definition
E. Treatment of Certain Relocating
final rule with comment period (81 FR of ‘‘off-campus outpatient department of
Provider-Based Departments During the
79699 through 79719) and the interim a provider,’’ for purposes of paragraphs
COVID–19 PHE
final rule with comment period (81 FR (1)(B)(v) and (21)(B) of the section, an
1. Background 79720 through 79729), we created the off-campus PBD that was billing under
In 2015, the Congress addressed ‘‘PN’’ modifier to collect data for section 1833(t) of the Act with respect
payments for services furnished by purposes of implementing section 603 to covered OPD services furnished prior
certain off-campus provider-based of the BBA 2015 and also to trigger to November 2, 2015, the date of
departments (PBDs) through section 603 payment under the newly adopted PFS- enactment of the BBA 2015. As a result,
of the Bipartisan Budget Act of 2015 equivalent rates (50 percent of the OPPS the definition of ‘‘off-campus outpatient
(BBA 2015) (Pub. L. 114–74, enacted for CY 2017) for non-excepted items and department of a provider’’ does not
November 2, 2015). In the CY 2017 services. In the CY 2018 PFS final rule include:
Outpatient Prospective Payment System (82 FR 53023 through 53030), the PFS • Off-campus PBDs that were billing
(OPPS) and Ambulatory Surgical Center Relativity Adjuster was revised to be 40 under the OPPS for covered OPD
Payment System (ASC) proposed rule, percent of the OPPS rate beginning in services furnished prior to November 2,
we discussed the provisions of section CY 2018. 2015;
• PBDs located on the campus of a
603 of the BBA 2015, which amended 2. Definition of Off-Campus Outpatient hospital;
section 1833(t) of the Act (81 FR 45681). Department (OPD) • Those PBDs within the distance
For the full discussion of our initial (described in the definition of campus at
implementation of this provision, we Under section 603 of the BBA 2015,
certain ‘‘off-campus departments of a § 413.65(a)(2), as of November 2, 2015)
refer readers to the CY 2017 OPPS/ASC of a remote location of a hospital
final rule with comment period (81 FR provider’’ are considered ‘‘non-
excepted’’ and paid under the facility; or
79699 through 79719) and interim final • Those PBDs determined by the CMS
rule with comment period (81 FR 79720 ‘‘applicable payment system’’ instead of
the OPPS. In defining the term ‘‘off- Regional Office to be part of the
through 79729). provider’s campus.
Section 603 of the BBA 2015 amended campus outpatient department of a
provider,’’ section 1833(t)(21)(B)(i) of The items and services furnished by
section 1833(t) of the Act by amending these excepted off-campus PBDs on or
paragraph (1)(B) and adding a new the Act specifies that the term means a
department of a provider (as defined at after January 1, 2017 continue to be paid
paragraph (21). As a general matter, under the OPPS.
under sections 1833(t)(1)(B)(v) and 42 CFR 413.65(a)(2) as that regulation
(t)(21) of the Act, applicable items and was in effect on November 2, 2015, the 3. Extraordinary Circumstances Policy
services furnished by certain off-campus date of enactment of the BBA 2015) that
In implementing section 603 of the
outpatient departments (OPD) of a is not located on the campus (as defined
BBA 2015, we recognized the need to
provider on or after January 1, 2017 are in § 413.65(a)(2)), of the provider or
determine the status of PBDs that had
not considered covered OPD services as within the distance (described in the
been excepted but subsequently
defined under section 1833(t)(1)(B) of definition of campus) from a remote
relocated. In 42 CFR 419.48(a)(2), we
the Act for purposes of payment under location of a hospital facility (as defined
established a policy that excepted off-
the OPPS and are instead paid ‘‘under in § 413.65(a)(2)). The definition of
campus PBDs that have not
the applicable payment system’’ under ‘‘campus’’ in § 413.65(a)(2) includes the
impermissibly relocated can remain
Medicare Part B if the requirements for physical area immediately adjacent to
excepted. Generally speaking, this
payment are otherwise met. the provider’s main buildings, other
means that excepted PBDs that relocate
In the CY 2017 OPPS/ASC final rule areas and structures that are not strictly
will typically lose their excepted status
with comment period (81 FR 79699 contiguous to the main buildings but are
and be paid under the applicable
through 79719) and the interim final located within 250 yards of the main
payment system (generally the PFS)
rule with comment period (81 FR 79720 buildings, and any other areas
instead. In the CY 2017 OPPS/ASC final
through 79729), we established a determined on an individual case basis,
number of policies to implement section by the CMS regional office (RO), to be 15 https://www.cms.gov/files/document/summary-
603 of the BBA 2015. Broadly, we part of the provider’s campus. covid-19-emergency-declaration-waivers.pdf.
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27560 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
rule (81 FR 79705), we also explained believe these constraints may have led, circumstances relocation exception so
that on-campus PBDs, which are in certain cases, to hospitals furloughing that they may bill at the OPPS rate, as
considered excepted due to their on- or otherwise laying off clinical staff. long as their relocation is not
campus status, that relocate off-campus Congress recognized these financial inconsistent with the state’s emergency
would be considered non-excepted constraints in the passage of the CARES preparedness or pandemic plan. We
following their relocation. In other Act and the $100 billion believe it is important for hospitals to
words, excepted on-campus and off- appropriation 18 for Medicare and align their PBD relocations with the
campus PBDs that relocate to an off- Medicaid providers and suppliers for, state’s emergency preparedness or
campus location are then typically paid among other things, health care-related pandemic plans to ensure continuity
the PFS-equivalent rate for items and expenses or lost revenues that are with state efforts, as well as efforts by
services. attributable to coronavirus. Nonetheless, other health care providers in their
In the CY 2017 OPPS/ASC proposed we remain concerned that if an excepted community, to mitigate the effects of the
rule (81 FR 45684), we sought comment PBD that was previously paid the OPPS PHE for the COVID–19 pandemic.
on potential extraordinary rate relocates off-campus due to the We note that this temporary
circumstances outside of a hospital’s COVID–19 PHE, some hospitals would extraordinary circumstances policy is
control that may lead a hospital to have difficulty sustaining operations for time-limited to the PHE for COVID–19
relocate an off-campus PBD. In the CY necessary services during the COVID–19 to enable short-term hospital relocation
2017 OPPS/ASC final rule (81 FR 79704 PHE at the PBD if they were paid a of excepted off-campus and on-campus
through 79706), we finalized a policy to reduced rate for services that would departments to improve access to care
allow excepted off-campus PBDs to have otherwise been paid the OPPS rate for patients during this time. The
relocate, temporarily or permanently, but for the fact that the COVID–19 PHE temporary extraordinary circumstances
without loss of excepted status, for necessitated the temporary relocation of relocation policy established here will
extraordinary circumstances outside of the excepted off-campus or on-campus end following the end of the PHE for the
the hospital’s control, such as natural department. Recognizing the urgency of COVID–19 pandemic, and we anticipate
disasters, significant seismic building this situation and understanding that that most, if not all, PBDs that relocate
code requirements, or significant public hospitals may need additional during the COVID–19 PHE will relocate
health and public safety issues. We also flexibilities and financial stability to back to their original location prior to,
finalized that CMS Regional Offices quickly expand capacity to mitigate the or soon after, the COVID–19 PHE
would evaluate and approve or deny impact of the pandemic on Medicare concludes. Hospitals that choose to
these relocation requests. In 2017, we beneficiaries and the American public, permanently relocate these PBDs off-
provided additional subregulatory we are adopting a temporary relocation campus would be considered new off-
guidance on the process to request an exception policy specific to the PHE for campus PBDs billing after November 2,
extraordinary circumstances relocation the COVID–19 pandemic so that 2015, and therefore, would be required
exception, including the requested hospitals can maintain treatment to bill using the PN modifier for hospital
minimum information hospitals should capacity and deliver needed care for outpatient services furnished from that
submit to support such a request.16 patients. PBD location and would be paid the
For purposes of enabling greater PFS-equivalent rate following the end of
4. Extraordinary Circumstances for
hospital flexibility, and, in particular, the COVID–19 PHE.
Relocating PBDs During the PHE for the
enabling hospitals to rapidly develop Following the COVID–19 PHE,
COVID–19 Pandemic
temporary expansion sites for patient hospitals may seek an extraordinary
We continue to believe that our care, we are temporarily adopting an circumstances relocation exception for
current extraordinary circumstances expanded version of the extraordinary excepted off-campus locations that have
policy is appropriate under normal circumstances relocation policy during permanently relocated, but these
circumstances. However, we wish to the COVID–19 PHE to include on- hospitals would need to follow the
give hospitals that provide services to campus PBDs that relocate off-campus standard extraordinary circumstances
Medicare beneficiaries the flexibility to during the COVID–19 PHE for the application process we adopted in CY
respond effectively to the serious public purposes of addressing the COVID–19 2017 19 and file an updated CMS–855A
health threats posed by the COVID–19 pandemic. Our policy has historically enrollment form to reflect the new
PHE. We are aware that many hospitals applied only to excepted off-campus address(es) of the PBD(s). We note that
are repurposing existing clinical and departments that relocate to a different our standard relocation exception policy
non-clinical space for use as temporary off-campus location for extraordinary only applies to excepted off-campus
expansion sites to furnish inpatient and circumstances outside of the hospital’s PBDs that relocate; on-campus PBDs
outpatient care during the PHE for the control, that submit an extraordinary that wish to permanently relocate off-
COVID–19 pandemic. In addition, we relocation exception request to their campus will not be able to receive an
recognize that many hospitals are CMS Regional Office, and for which the
extraordinary circumstances relocation
financially constrained due to the CMS Regional Office evaluates and
exception under the standard
reduction in volume caused by the PHE approves the request. However, on-
extraordinary circumstances relocation
for the COVID–19 pandemic.17 We campus departments that relocate on or
request process after the conclusion of
after March 1, 2020 through the
the COVID–19 PHE. We also note that
16 https://www.cms.gov/Medicare/Medicare-Fee-
remainder of the PHE for the purposes
for-Service-Payment/HospitalOutpatientPPS/ hospitals should not rely on having
of addressing the COVID–19 pandemic
Downloads/Subregulatory-Guidance-Section-603- relocated the off-campus PBD during the
Bipartisan-Budget-Act-Relocation.pdf. may also seek an extraordinary
COVID–19 PHE as the reason the off-
17 For example, analysis of Medicare claims in the
knee arthroplasty and total hip arthroplasty. We
campus PBD should be permanently
Integrated Data Repository paid through mid-April
2020 for hospital inpatient services furnished in the note that any analysis of 2020 claims data is excepted following the end of the
final week of March 2020 shows significant preliminary since providers have up to a year after
decreases (more than 50%), relative to claims paid a service is rendered to submit a claim. 19 https://www.cms.gov/Medicare/Medicare-Fee-
through mid-April 2019 for hospital services 18 This appropriation is included in Title VIII of for-Service-Payment/HospitalOutpatientPPS/
furnished in the final week of March 2019, for the CARES Act as part of the Public Health and Downloads/Subregulatory-Guidance-Section-603-
certain high-volume elective procedures, like total Social Services Emergency Fund. Bipartisan-Budget-Act-Relocation.pdf.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27561
COVID–19 PHE. In other words, the fact comment period (81 FR 79704 through hospital relocates part of an excepted
that the off-campus PBD relocated in 79705) and included in the existing PBD to one or more off-campus PBD
response to the pandemic will not, by subregulatory guidance under which locations, it would be permissible for
itself, be considered an ‘‘extraordinary off-campus PBDs can apply for an the original excepted PBD location, as
circumstance’’ for purposes of a extraordinary circumstance relocation well as the relocated off-campus PBD
permanent relocation exception, exception,20 all hospitals that relocate location(s) of that excepted PBD, to
although CMS Regional Offices will excepted on- or off-campus PBDs to off- continue to bill under the OPPS under
continue to have discretion to approve campus locations in response to the the revised extraordinary circumstances
or deny relocation requests for hospitals COVID–19 PHE should notify their CMS policy that is in place during the
that apply after the COVID–19 PHE, Regional Office by email of their COVID–19 PHE so long as the
depending on if the relocation request hospital’s CCN; the address of the extraordinary circumstances policy in
meets the requirements for the normal current PBD; the address(es) of the effect during the COVID–19 PHE
extraordinary circumstances exception. relocated PBD(s); the date which they (described earlier in this section) is
Following the COVID–19 PHE, if began furnishing services at the new followed. We believe these flexibilities
temporarily relocated off-campus PBDs PBD(s); a brief justification for the are needed for hospitals to respond
do not go back to their original location, relocation and the role of the relocation effectively to the COVID–19 PHE. For
they will be considered to be non- in the hospital’s response to COVID–19; example, one PBD may need to utilize
excepted PBDs and paid the PFS- and an attestation that the relocation is two locations to maintain separation
equivalent rate. not inconsistent with their state’s between COVID-positive and COVID-
emergency preparedness or pandemic negative patients. Further, the relocation
5. New Exception Process for
plan. We expect hospitals to include in or partial relocation of an excepted PBD
Extraordinary Circumstances Relocation
their justification for the relocation why for the extraordinary circumstance of
of Existing On-Campus and Excepted
the new PBD location (including the COVID–19 PHE could involve a
Off-Campus PBDs
instances where the relocation is to the single excepted PBD that relocates (or
We are also taking steps to streamline patient’s home) is appropriate for partially relocates) to a patient’s home
the process for the extraordinary furnishing covered outpatient items and (for purposes of furnishing a covered
circumstances relocation exceptions for services. OPD service), which under the
purposes of addressing the COVID–19 To the extent that a hospital may Hospitals without Walls initiative, can
pandemic during the PHE. Specifically, relocate to an off-campus PBD that be provider-based to the hospital during
using the process outlined below, both otherwise is the patient’s home, only the COVID–19 PHE. We note that,
excepted off-campus and on-campus one relocation request during the during the COVID–19 PHE, a patient’s
PBDs may relocate to off-campus COVID–19 PHE is necessary. In other home would be considered a PBD of the
locations during the COVID–19 PHE and words, the hospital would not have to hospital when the patient is registered
begin furnishing and billing for services submit a unique request each time it as a hospital outpatient (as discussed in
under the OPPS in the new location registers a hospital outpatient for a PBD section II.F. of this IFC) and is receiving
prior to submitting documentation to that is otherwise the patient’s home; a covered OPD services from the hospital.
the RO to support the extraordinary single submission per location is However, in most cases we do not
circumstances relocation request. anticipate that excepted PBDs would
sufficient. Hospitals must send this
Importantly, if the relocation is need to relocate or partially relocate into
email to their CMS Regional Office
denied by the RO under the many different new locations. Rather,
extraordinary circumstances policy, and within 120 days of beginning to furnish
and bill for services at the relocated on- we anticipate most multi-relocations or
the hospital did not bill for them using partial relocations would be to a limited
the ‘‘PN’’ modifier, any claims billed or off-campus PBD.
• To provide additional flexibility, for number of locations as needed to
under the OPPS in the new location respond to the COVID–19 PHE in a
purposes of addressing the PHE for the
would need to be reprocessed as having manner not inconsistent with the state’s
COVID–19 pandemic, hospitals may
been billed by a non-excepted PBD and preparedness and pandemic plan, with
divide their PBD into multiple locations
will instead be paid the PFS-equivalent the exception being multiple relocations
during a relocation. That is, if a single
rate. Non-excepted off-campus to accommodate care in patient’s homes.
excepted PBD location relocates to
departments will continue to be non- We also expect hospitals exercising this
multiple off-campus PBD locations in
excepted during the COVID–19 PHE, flexibility to be able to support that the
response to the COVID–19 PHE and in
even if they relocate, and thus, will excepted PBD is still the same PBD, just
a manner that is not inconsistent with
continue to be paid the PFS-equivalent split into more than one location. For
the state’s emergency preparedness or
rate. They do not need to follow the example, if the excepted PBD was an
pandemic plan, it will be permissible
process outlined below for relocation oncology clinic, we would expect that
for all of the off-campus PBDs to which
approval since they are already, and the relocated PBD(s) during the COVID–
the excepted PBD relocated to continue
will continue to be, non-excepted. 19 PHE would still be providing
• Hospitals with on-campus and to bill under the OPPS under the
oncologic services, including in the
excepted off-campus PBDs that relocate temporary extraordinary circumstances
patient’s home to the extent such
due to the COVID–19 PHE in a manner policy that is in place during the
location is made provider based to the
that is not inconsistent with their state’s COVID–19 PHE. In addition, for
hospital.
emergency preparedness or pandemic purposes of the COVID–19 PHE, • If Medicare-certified hospitals will
plan should append modifier ‘‘PO’’ to hospitals may relocate part of their be rendering services in relocated
OPPS claims for services furnished at excepted PBD to a new off-campus excepted PBDs, but intend to bill
the relocated PBDs. This modifier location while maintaining the original Medicare for the services under the
indicates a service that is provided at an PBD location. Said differently, if a main hospital, no additional provider
excepted off-campus PBD and is paid 20 https://www.cms.gov/Medicare/Medicare-Fee-
enrollment actions are required (for
the OPPS payment rate. for-Service-Payment/HospitalOutpatientPPS/
example, hospitals do not need to
• In place of the process adopted in Downloads/Subregulatory-Guidance-Section-603- submit an updated CMS–855A
the CY 2017 OPPS/ASC final rule with Bipartisan-Budget-Act-Relocation.pdf. enrollment form) for the off-campus
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27562 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
relocated site during the COVID–19 billed only under the hospital OPPS COVID–19 PHE. That is, while certain
PHE. Following the COVID–19 PHE, as when furnished by the hospital and locations would not normally be
noted in section II.E.4. of this IFC, there is no professional service that is permitted to be considered part of a
hospitals that wish to permanently separately billable under the PFS. hospital, during the COVID–19 PHE, the
relocate their excepted PBD must file an In addition, we have received section 1135 waivers of the provider-
updated CMS–855A enrollment form to questions about how the hospital should based rules allow temporary expansion
reflect the new address(es) of the bill during the COVID–19 PHE when the locations to become provider-based to
PBD(s). practitioners typically furnishing the hospital to bill for medically
In summary, and as discussed in more services in HOPDs are now instead necessary hospital outpatient
detailed above, we are adopting a furnishing professional services as therapeutic services furnished at those
temporary extraordinary circumstances Medicare telehealth services under locations, assuming all other applicable
relocation exception policy for excepted section 1834(m) of the Act under the requirements are met (including, to the
off-campus PBDs that relocate off- flexibilities provided by both the waiver extent not waived, the hospital
campus during the COVID–19 PHE. We of requirements under section conditions of participation).
are extending that temporary policy to 1135(b)(8) of the Act and the March 31st For purposes of clarifying regulatory
on-campus PBDs that relocate off- COVID–19 IFC. Because we continue to flexibilities for hospital outpatient
campus during the COVID–19 PHE, and believe that it is important for therapeutic services furnished to
permitting the relocating PBDs to beneficiaries to be able to receive care beneficiaries in their homes or other
continue to be paid under the OPPS. in temporary expansion locations to temporary expansion locations for the
Finally, we are streamlining the process maintain infection control, we explain duration of the COVID–19 PHE, we
for relocating PBDs to obtain the in this section the flexibilities that are considered hospital outpatient
temporary extraordinary circumstances available to hospitals to enable them to therapeutic services in three categories:
policy exception. furnish outpatient services to (1) Hospital outpatient therapy,
beneficiaries in their homes (or other education, and training services,
F. Furnishing Outpatient Services in
temporary expansion locations), when including partial hospitalization
Temporary Expansion Locations of a
such a location is considered to be a program services, that can be furnished
Hospital or a Community Mental Health
PBD of the hospital, as permitted under other than in-person, and are furnished
Center (Including the Patient’s Home)
the waivers in effect during the COVID– in a temporary expansion location
Infection control is one of the primary 19 PHE. (which may be the patient’s home) that
goals of many initiatives CMS has Under ordinary circumstances, is a PBD of the hospital or an expanded
undertaken during the COVID–19 PHE. Medicare would not pay for hospital CMHC; (2) hospital outpatient clinical
Through all of the flexibilities offered, outpatient therapeutic services that are staff services furnished in-person to the
we have concentrated on increasing furnished to a beneficiary in the beneficiary in a temporary expansion
providers’ ability to furnish services at beneficiary’s home or any other location location; and (3) hospital services
temporary expansion locations, that could not ordinarily be provider- associated with a professional service
including the patient’s home, to limit based to the hospital. Our regulations at delivered by telehealth. We address
the need for patients to receive care in § 410.27(a)(1)(iii) explicitly include a each of these three categories in more
the hospital itself, which could requirement that therapeutic outpatient detail below.
unnecessarily expose the patients or hospital services must be furnished in
providers to the pandemic contagion. 1. Hospital Outpatient and CMHC
the hospital or CAH or in a department
Among the types of services that Therapy, Education, and Training
of the hospital or CAH.
beneficiaries would benefit from However, as noted above, we have Services
receiving at temporary expansion issued numerous blanket section 1135 In many cases, hospitals provide
locations are those critical outpatient waivers to give health care providers hospital outpatient therapy (including
services that hospitals, CMHCs, and needed flexibility to address the behavioral health), education, and
CAHs furnish in their service areas. COVID–19 PHE.21 As part of this training services that are furnished by
HOPDs, in particular, furnish a wide initiative, we have waived the hospital-employed counselors or other
array of services, from clinic visits and requirements associated with becoming licensed professionals. Examples of
counseling services, to complex surgical a PBD of a hospital at § 413.65, as well these services include psychoanalysis,
procedures and emergency care. as certain requirements under the psychotherapy, diabetes self-
We have taken several actions to Medicare conditions of participation in management training, and medical
create regulatory flexibilities in §§ 482.41 and 485.623, to facilitate the nutrition therapy. With few exceptions,
response to the COVID–19 PHE, availability of temporary expansion the Medicare statute does not have a
including publishing the March 31st locations. Because of these waivers, benefit category that would allow these
COVID–19 IFC, issuing numerous during the COVID–19 PHE, temporary types of professionals (for example,
blanket waivers of requirements for expansion locations, including counselors, nurses, and registered
health care providers under section beneficiaries’ homes, can become PBDs dieticians) to bill Medicare directly for
1135 of the Act, and exercising the of hospitals and therapeutic outpatient their services. These services can, in
authority granted under section 1812(f) hospital services furnished to many cases, be billed by providers such
of the Act. Since that time, we have beneficiaries in these provider-based as hospitals under the OPPS or by
received many questions about how locations can meet the requirement that physicians and other practitioners as
hospital outpatient services can be these services be furnished in the services incident to their professional
furnished when the patient is in a hospital so long as all other services under the PFS.
temporary expansion location, requirements are met, including the Potentially the most prominent of
including his or her home, particularly hospital conditions of participation, to these services are partial hospitalization
for those hospital outpatient services the extent not waived, during the program (PHP) services, which comprise
that typically do not co-occur with a an intensive outpatient program of
physician or NPP furnishing a 21 https://www.cms.gov/files/document/summary- psychiatric services provided as an
professional service. Those services are covid-19-emergency-declaration-waivers.pdf. alternative to inpatient psychiatric care
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27563
for individuals who have an acute that falls into this category and we intensive ambulatory treatment service,
mental illness. We discuss treatment of intend to update the list periodically, to offering less than 24-hour-daily care, in
PHP services separately within this the extent that would be helpful for a location other than an individual’s
section of this IFC. public awareness. home or inpatient or residential setting.
Outpatient therapy, education, and All services furnished by the hospital Section 1861(ff)(3)(B) of the Act defines
training services require communication still require an order by a physician or a CMHC for purposes of this benefit.
and interaction. Facility staff can qualified NPP and must be supervised In CY 2018, which is the most recent
effectively furnish these services using by a physician or other NPP appropriate period for which we have complete PHP
telecommunication technology and, for supervising the service given their claims data, there were a total of
unlike many hospital services, the hospital admitting privileges, state 482,973 paid PHP days, including
clinical staff and patient are not licensing, and scope of practice, 394,311 paid PHP days for hospital-
required to be in the same location to consistent with the requirements in based providers and 88,662 paid PHP
furnish them. We have already stated § 410.27. We note that hospitals may bill days for CMHCs. In comparison,
that section 1135 blanket waivers in for these services as if they were inpatient psychiatric facilities (IPFs)
effect during the COVID–19 PHE allow furnished in the hospital and consistent billed 4,291,461 utilization days in FY
the hospital to consider the beneficiary’s with any specific requirements for 2019, the most recent period for which
home, and any other temporary billing Medicare in general, including we have complete IPF claims data.
expansion location operated by the any relevant modifications in effect Based on this comparison, we estimate
hospital during the COVID–19 PHE, to during the COVID–19 PHE.23 We note that IPF services are utilized between 8
be a PBD of the hospital, so long as the that when these services are provided and 9 times more frequently than PHP
hospital can ensure the locations meet by clinical staff of the physician or other services.
all of the conditions of participation, to practitioner and furnished incident to Previously in this section, we
the extent not waived. In light of the their professional services, and are not identified that infection control is a
need for infection control and a desire provided by staff of the hospital, the primary goal of CMS initiatives
for continuity of behavioral health care hospital would not bill for the services. undertaken during the COVID–19 PHE.
and treatment services, we recognize the The physician or other practitioner We also believe continuity of behavioral
ability of the hospital’s clinical staff to should bill for such services incident to health services is critical for those
continue to deliver these services even their own services and would be paid participating in a PHP, particularly at a
when they are not physically located in under the PFS. As always, time of heightened anxiety and
the hospital. Provided a hospital’s documentation in the medical record of uncertainty. As noted above, we have
clinical staff is furnishing hospital the reason and necessity of the visit is issued numerous blanket waivers under
outpatient therapy, education, and required. section 1135 of the Act, including for
training services to a patient in the hospitals and CMHCs providing PHP
hospital (which can include the a. Partial Hospitalization Program (PHP) services, to give health care providers
patient’s home so long as it is provider A PHP is an intensive outpatient needed flexibility to address the
based to the hospital), and the patient is program of psychiatric services COVID–19 PHE and support the goal of
registered as an outpatient of the provided as an alternative to inpatient infection control while maintaining
hospital, we will consider the psychiatric care for individuals who access to partial hospitalization services
requirements of the regulations at have an acute mental illness, which and ensuring continuity of care for
§ 410.27(a)(1) to be met. We remind includes, but is not limited to, patients. Effective as of March 1, 2020
readers that the physician supervision conditions such as depression and and for the duration of the COVID–19
level for the vast majority of hospital schizophrenia. Section 1861(ff)(1) of the PHE, a temporary expansion location
outpatient therapeutic services is Act defines partial hospitalization where the beneficiary may be located,
currently general supervision under services as the items and services including a beneficiary’s home, may be
§ 410.27. This means a service must be described in paragraph (2) prescribed by a PBD of the hospital, or may be a
furnished under the physician’s overall a physician and provided under a temporary extension of the CMHC
direction and control, but the program described in paragraph (3) (discussed in more detail below).
physician’s presence is not required under the supervision of a physician Consistent with the goals of infection
during the performance of the service. pursuant to an individualized, written control and maintaining access, for the
To facilitate public understanding of plan of treatment established and duration of the COVID–19 PHE only,
the types of services we believe can be periodically reviewed by a physician (in providers can furnish certain partial
furnished by the hospital to a patient in consultation with appropriate staff hospitalization services remotely to
the hospital (including the patient’s participating in such program), which patients in a temporary expansion
home if it is a PBD of the hospital) using sets forth the physician’s diagnosis, the location of the hospital or CMHC, which
telecommunications technology, we type, amount, frequency, and duration may include the patient’s home to the
have provided on our website 22 a list of of the items and services provided extent it is made provider-based to the
the outpatient therapy, counseling, and under the plan, and the goals for hospital or an extension of the CMHC.
educational services that hospital treatment under the plan. Section PHP services consist of unique
clinical staff can furnish incident to a 1861(ff)(2) of the Act describes the items combinations of services designated at
physician’s or qualified NPP’s service section 1861(ff)(2) of the Act, including
and services included in partial
during the COVID–19 PHE to a individual psychotherapy, patient
hospitalization services. Section
beneficiary in their home or other education, and group psychotherapy.
1861(ff)(3)(A) of the Act specifies that a
temporary expansion location that Certain PHP services such as these
PHP is a program furnished by a
functions as a PBD of the hospital when require communication and interaction,
hospital to its outpatients or by a
the beneficiary is registered as an but do not require the clinical staff or
CMHC, as a distinct and organized
outpatient of the hospital. We note that patient to be in the same location, nor
this list may not include every service 23 https://www.cms.gov/About-CMS/Agency- do clinical staff need to be in the
Information/Emergency/EPRO/Current- hospital or CMHC when furnishing
22 www.cms.gov. Emergencies/Current-Emergencies-page. these PHP services. Therefore, the
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27564 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
following types of services—to the provided by clinical staff of the § 485.918(b)(1)(iii) for the purpose of
extent they were already billable as PHP physician or other practitioner and providing PHP services to CMHC
services in accordance with existing furnished incident to their professional patients in their homes, which will be
coding requirements prior to the services, and are not provided by staff considered a temporary expansion
COVID–19 PHE—can now be furnished of the hospital or CMHC, the hospital or location of a CMHC. A temporary
to beneficiaries by facility staff using CMHC would not bill for the services. expansion location where the
telecommunications technology during The physician or other practitioner beneficiary may be located, including
the COVID–19 PHE: (1) Individual should bill for such services incident to the beneficiary’s home, can be
psychotherapy; (2) patient education; their own services and would be paid considered part of a CMHC, and certain
and (3) group psychotherapy. Because of under the PFS. therapeutic services furnished to
the intensive nature of PHP, we expect beneficiaries, when the beneficiary is
(i.) Hospital-Based PHP Providers
PHP services to be furnished using registered as an outpatient of the CMHC,
telecommunications technology As detailed above, in CY 2018, in these temporary expansion locations
involving both audio and video. hospital-based providers furnished can meet the requirement that these
However, we recognize that in some 394,311 paid PHP days to Medicare services be furnished in the CMHC.
cases beneficiaries might not have beneficiaries, approximately 81.6 Specifically, for the purposes of the
access to video communication percent of Medicare-paid PHP days in COVID–19 PHE and effective as of
technology. In order to maintain that year. As part of the initiative to March 1, 2020, we will consider
beneficiary access to PHP services, only promote infection control and maintain temporary expansion locations where
in the case that both audio and video are access to PHP services, we have waived the beneficiary may be located,
not possible can the service be the requirements for being a PBD of the including a beneficiary’s home, to be a
furnished exclusively with audio. To be hospital in § 413.65, as well as certain part of the CMHC once a patient is
clear, services that require drug requirements under the Medicare registered as an outpatient of the CMHC,
administration cannot be furnished conditions of participation in §§ 482.41 while PHP services are being furnished
using telecommunications technology. and 485.623, to facilitate the availability at that location by CMHC staff in
To facilitate public understanding of the of temporary expansion locations. As accordance with the supervising
types of PHP services that can be noted above, for purposes of the practitioner’s scope of practice.
furnished using telecommunications COVID–19 PHE and effective as of Therefore, we will consider services
technology by the hospital to a patient March 1, 2020, a temporary expansion furnished in that location to have been
in the hospital (including the patient’s location where the beneficiary may be furnished in the CMHC. The CMHC
home if it is a PBD of the hospital) or located, including a beneficiary’s home, should bill for these services as if they
by the CMHC to a patient in an may be a PBD of the hospital where the were furnished in the CMHC and
expanded CMHC location, we have location meets the non-waived consistent with any specific
provided on our website 24 a list of the conditions of participation. Together, requirements for billing Medicare
individual psychotherapy, patient these waivers allow hospitals to during the COVID–19 PHE.
education, and group psychotherapy consider a temporary expansion
location where the beneficiary may be 2. Hospital In-Person Clinical Staff
services that hospital or CMHC staff can
located, including their homes, an Services in a Temporary Expansion
furnish during the COVID–19 PHE to a
HOPD only in the context of the Location (Which May the Home)
beneficiary in their home or other
temporary expansion location that COVID–19 PHE. Thus, for the duration Hospitals also provide services that
functions as a PBD of the hospital or of the COVID–19 PHE, we will consider are furnished by clinical staff under a
expanded CMHC when the beneficiary the PHP services furnished by hospital physician’s or qualified NPP’s order that
is registered as an outpatient. We note clinical staff, when the beneficiary is do not require professional work by the
that this list may not include every registered as an outpatient of the physician or qualified NPP, and thus,
service that falls into this category and hospital and in accordance with the are billed only under the OPPS when
we intend to update the list supervising practitioner’s scope of furnished by the hospital and are not
periodically, to the extent that would be practice, to the beneficiary in a separately billable under the PFS.
helpful for public awareness. temporary expansion location where the Wound care, chemotherapy
Although these services can be beneficiary may be located, including a administration, and other drug
furnished remotely, all other PHP beneficiary’s home, to have been administration are examples 25 of these
requirements are unchanged and still in furnished in the hospital so long as the types of services. We note that while
effect, including that all services temporary expansion location is made surgical services also fall under this
furnished under the PHP still require an provider-based to the hospital. The category, we would not anticipate that
order by a physician, must be hospital should bill for these services as they would be furnished in a home that
supervised by a physician, must be if they were furnished in the hospital becomes provider-based to the hospital,
certified by a physician, and must be and consistent with any specific due to infection control and operating
furnished in accordance with coding requirements for billing Medicare room requirements. In addition, there
requirements by a clinical staff member during the COVID–19 PHE. are several other hospital outpatient
working within his or her scope of therapeutic services that require the
(ii.) Community Mental Health Centers hospital’s clinical staff’s presence to
practice. In accordance with the
longstanding requirements that are A CMHC is a provider of PHP services furnish the service. The current section
detailed in the Medicare Benefit Policy defined under section 1861(ff)(3)(B) of 1135 blanket waivers in place during
Manual, Pub 100–02, chapter 6, section the Act. As detailed above, in CY 2018, the COVID–19 PHE allow the patient’s
70.3, documentation in the medical CMHCs furnished 88,662 paid PHP days home to be considered an outpatient
record of the reason for the visit and the to Medicare beneficiaries,
substance of the visit is required. As approximately 18.4 percent of Medicare- 25 With regard to observation services, we note
paid PHP days in that year. For the that to bill for observation services all existing
noted above, when these services are requirements must be met. These requirements are
duration of the COVID–19 PHE, we are identified in Chapter 4, Section 290 of the Medicare
24 www.cms.gov. waiving the restriction at Claims Processing Manual.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27565
PBD of the hospital. With a primary goal providers or suppliers who may furnish beneficiaries in their homes as
of infection control and understanding services in the home, but not in the permitted during the COVID–19 PHE to
that hospitals must meet the conditions ‘‘hospital,’’ we note that hospitals bill for those services in the same way
of participation, to the extent not should only consider the patient home they would if they were furnishing the
waived during the COVID–19 PHE, we to be provider-based to the hospital services in person (85 FR 19233). For
are making the public aware of the when the patient is registered as a many professionals, the HOPD is the
flexibilities that exist during the hospital outpatient. When the patient is usual location where they furnish
COVID–19 PHE that enable hospitals to not receiving outpatient services by the services. For the duration of the COVID–
furnish these clinical staff services in hospital, the patient’s home can be 19 PHE and effective March 1, 2020,
the patient’s home as an outpatient PBD considered a home for purposes of the when a practitioner who ordinarily
and to bill and be paid for these services home health benefit and the HHA can practices in a HOPD furnishes a
as HOPD services when the patient is furnish and bill for home health telehealth service to a patient who is
registered as a hospital outpatient. services. The hospital should be aware located at home (or otherwise not in a
Because these services have to be if the patient is under a home health telehealth originating site), they would
provided in person by clinical staff, plan of care, and it must not furnish submit a professional claim with the
these services cannot be furnished by services to the patient that could be place of service code indicating the
telecommunication technology by the furnished by the HHA while the plan of service was furnished in the HOPD and
hospital. In these instances, hospital care is active. That is, to the extent that using the Current Procedural
clinical staff must be physically present there is some overlap between the types Terminology (CPT) telehealth modifier,
in the patient’s home or other temporary of services a HHA and a HOPD can modifier 95. Medicare would pay the
expansion location that is provider provide, and the patient has a current practitioner under the PFS at the
based to the hospital to furnish the home health plan of care, the hospital ‘‘facility’’ rate as if the service was
hospital outpatient therapeutic service. should only furnish services that cannot furnished in the HOPD. We adopted the
The physician supervision level must be be furnished by the HHA. aforementioned interim rule because we
met for these services, and we note that The fact that these services can be believed that, but for the COVID–19
for the vast majority of therapeutic furnished in a patient’s home or another PHE, the physician or practitioner
hospital outpatient services, the temporary expansion location that is would likely have furnished the service
required supervision level is currently temporarily provider based to the in person at their usual practice
general supervision under § 410.27. This hospital does not change the location; and that the service was
means a service is furnished under the requirements that all services furnished instead furnished via telehealth for
physician’s overall direction and by the hospital require an order by a purposes of infection control. The
control, but the physician’s presence is physician or qualified NPP and must be March 31st COVID–19 IFC did not
not required during the performance of supervised by a physician or other NPP provide for the hospital to submit any
the service. This includes non-surgical appropriate for supervising the service claim for the service under the
extended duration therapeutic services given their hospital admitting aforementioned scenario.
(NSEDTSs), which are services that can privileges, state licensing, and scope of We acknowledge that when a
last a significant period of time, have a practice consistent with the physician or practitioner who ordinarily
substantial monitoring component that requirements in § 410.27. Hospitals practices in the HOPD furnishes a
should bill for these services as they telehealth service to a patient who is
is typically performed by auxiliary
ordinarily bill for services along with located at home, the hospital would
personnel, have a low risk of requiring
any specific billing requirements for often still provide some administrative
the physician’s or appropriate NPP’s
relocating PBDs specific to billing and clinical support for that service.
immediate availability after the
during a COVID–19 PHE as discussed in When a registered outpatient of the
initiation of the service, and are not
section II.D. of this IFC (that is, hospital is receiving a telehealth service,
primarily surgical in nature. Direct
appending the PO modifier for excepted the hospital may bill the originating site
supervision is generally required for the
items and services and the PN modifier facility fee to support such telehealth
initiation of these NSEDTs, followed by
for nonexcepted services). Information services furnished by a physician or
a general supervision requirement for
regarding the application of section 603 practitioner who ordinarily practices
the duration of the service. In the March of the BBA 2015 to relocating PBDs is there. This includes patients who are at
31st COVID–19 IFC, we changed the available in section II.F.4. of this IFC, as home, when the home is made provider-
supervision requirement for NSEDTs to well as section II.E. of this IFC. based to the hospital (which means that
instead require a general level of all applicable conditions of
supervision throughout the service, 3. Hospital Services Accompanying a
participation, to the extent not waived,
including at service initiation, for the Professional Service Furnished Via
are met), under the current waivers in
duration of the COVID–19 PHE. Telehealth
effect for the COVID–19 PHE.
Importantly, during the time period The majority of hospital services are More specifically, when a telehealth
that the patient is receiving services furnished in conjunction with service is furnished by a practitioner
from the hospital clinical staff as a professional services of physicians and located at a distant site to a patient who
registered outpatient, the patient’s place other practitioners. In these instances, is located in the HOPD, the hospital is
of residence cannot be considered a practitioners furnish and bill separately presumed to provide administrative and
home for purposes of HHA services. for their professional services indicating clinical support resources. In such
This is because HHAs cannot bill for the place of service as a HOPD, and the circumstances, section 1834(m)(2)(B) of
services furnished in PBDs of hospitals, hospital bills separately to be paid for the Act allows for an originating site
and a patient’s home has provider-based the clinical labor, equipment, overhead, facility fee to be paid to the hospital.
status when the patient is a registered and capital to support the delivery of Section 1834(m)(2)(B)(ii) of the Act
hospital outpatient and HOPD services that professional service. In the March further provides that no facility fee shall
are being furnished. Because the home 31st COVID–19 IFC, we instructed be paid to an originating site described
is not a traditional PBD, and because physicians and other practitioners in paragraph (4)(C)(ii)(X) (that is, the
there are interactions with other types of furnishing telehealth services to home). However, as described
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27566 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
throughout this section, the patient’s availability of temporary expansion registered outpatient of the hospital and
home may be considered a PBD of the sites. Importantly, these waivers do not the patient’s home is made provider-
hospital during the COVID–19 PHE if determine whether a PBD is excepted or based to the hospital. In this
other applicable requirements non-excepted for purposes of section circumstance, if the hospital considers
(including the non-waived conditions of 603 of the BBA 2015, and the the beneficiary’s home a relocated (or
participation) are met. As noted above, definitions in § 413.65 that section 603 partially relocated) PBD, and follows the
because the home is not a traditional cross-references, including the temporary extraordinary circumstances
PBD, and because there are interactions definition of campus at § 413.65(a)(2), exception policy discussed in section
with other types of providers or remain relevant to that determination. II.E. of this IFC, the hospital would bill
suppliers who may furnish services in However, in section II.E. of this IFC, we the applicable HCPCS code (for
the home, but not in the ‘‘hospital,’’ we discuss a temporary extraordinary example, HCPCS code 90832) along
note that hospitals should only furnish circumstances relocation policy for on- with modifier ‘‘PO’’ to receive the full
hospital outpatient services to a patient campus and excepted off-campus OPPS payment amount. The hospital
(who is registered as a hospital hospital outpatient PBDs that relocate
outpatient) after the patient’s home has will be paid under the PFS for services
due to the COVID–19 PHE, under which
been made provider-based to the furnished to a beneficiary in their home
these PBDs that relocate in accordance
hospital for the provision of such if the hospital does not seek an
with that policy can continue to bill and
services. In that event, the home would extraordinary circumstances relocation
be paid as an on-campus or excepted
be serving as a PBD of the hospital, and exception for their PBD and, if
off-campus PBD at the full OPPS
as the originating site for the telehealth payment rate. The hospital’s relocation applicable, include the patient’s home
service furnished by a physician or must not be inconsistent with their address as one of the locations to which
practitioner located at a distant site. state’s emergency preparedness or the PBD relocated and bill the claim for
The originating site facility fee is the pandemic plan. For purposes of the the services furnished in the patient’s
statutory payment that is made to the COVID–19 PHE, on-campus or excepted home using the PO modifier.
facility for providing the site where the off-campus PBDs can be considered to 5. Summary
patient is located, and any other have relocated (or partially relocated) to
administrative or clinical support, for a a beneficiary’s home, or other temporary As discussed above, we clarified that
telehealth service. Therefore, during the expansion location of the hospital, hospital and CMHC staff can furnish
COVID–19 PHE, when telehealth when the beneficiary is registered as an certain outpatient therapy, counseling,
services are furnished by a physician or outpatient of the hospital during service and educational services (including PHP
practitioner who ordinarily practices in delivery. Under this policy, the PBD is services) incident to a physician’s
the HOPD to a patient who is located at still considered either an on-campus or service during the COVID–19 PHE to a
home or other applicable temporary excepted off-campus PBD that is not beneficiary in their home or other
expansion location that has been made subject to section 603 of the BBA 2015 temporary expansion location using
provider based to the hospital, we and would bill with the ‘‘PO’’ modifier telecommunications technology. In
believe it would be appropriate to for services furnished to beneficiaries in these circumstances, the hospital can
permit the hospital to bill and be paid their homes as a relocated (or partially
the originating site facility fee amount furnish services to a beneficiary in a
relocated) PBD and will receive the full temporary expansion location
for those telehealth services, just as they OPPS rate. However, we note that if the
would have ordinarily done outside of (including the beneficiary’s home) if
hospital does not relocate (or partially that beneficiary is registered as an
the COVID–19 PHE in this relocate) an existing on-campus or
circumstance. outpatient; and the CMHC can furnish
excepted off-campus PBD to the services in an expanded CMHC
As such, for the duration of the patient’s home and does not seek an
COVID–19 PHE, we are making the (including the beneficiary’s home) to a
exception under the temporary
public aware that under the flexibilities beneficiary who is registered as an
extraordinary circumstances relocation
already in effect, when a patient is outpatient. We also clarified that
exception policy discussed in section
receiving a professional service via II.E. of this IFC, the patient’s home hospitals can furnish clinical staff
telehealth in a temporary expansion would be considered a new non- services (for example, drug
location that is a PBD of the hospital, excepted off-campus PBD and the administration) in the patient’s home,
and the patient is a registered outpatient hospital would bill with the ‘‘PN’’ which is considered provider-based to
of the hospital, the hospital in which modifier and receive the PFS-equivalent the hospital during the COVID–19 PHE,
the patient is registered may bill the rate. and to bill and be paid for these services
originating site facility fee for the when the patient is registered as a
Under section II.F.1. of this IFC, we
service. As always, documentation in hospital outpatient. Further, we
have identified certain outpatient
the medical record of the reason for the clarified that when a patient is receiving
therapy, counseling, and educational
visit and the necessity of the visit is a professional service via telehealth in
services that hospital clinical staff can
required. a location that is considered a hospital
furnish (using telecommunications
4. Intersection With Payment Policy for technology) incident to a physician’s PBD, and the patient is a registered
Hospital Outpatient PBDs service during the COVID–19 PHE to a outpatient of the hospital, the hospital
beneficiary who is registered as an in which the patient is registered may
As discussed previously, we have
outpatient when those services are bill the originating site facility fee for
waived 26 the requirements for being a
furnished in the beneficiary’s home, the service. Finally, we clarified the
PBD of the hospital in § 413.65, as well
as certain requirements under the which functions as a PBD of the applicability of section 603 of the BBA
Medicare conditions of participation in hospital. For example, hospital clinical 2015 to hospitals furnishing care in the
§§ 482.41 and 485.623, to facilitate the staff can now remotely furnish beneficiaries’ homes (or other temporary
psychotherapy (for example, HCPCS expansion locations), and whether those
26 https://www.cms.gov/files/document/summary- code 90832) to the beneficiary in their locations are considered relocated,
covid-19-emergency-declaration-waivers.pdf. home, as long as the beneficiary is a partially relocated, or new PBDs.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27567
G. Medical Education units of teaching institutions. This We continue to believe that our
adjustment is made on a claim basis as current policies for calculating IME
1. Indirect Medical Education
an interim payment and the final payments and the IRF and IPF teaching
a. Overview of Indirect Medical payment in full for the claim is made status adjustments are consistent with
Education during the final settlement of the cost the statute and appropriate under
Section 1886(d)(5)(B) of the Act report. normal circumstances. However, we
provides for a payment adjustment Under the regulatory authority set out wish to give hospitals, IRFs, and IPFs
known as the indirect medical at § 412.624(e)(4), the IRF teaching that provide services to Medicare
education (IME) adjustment under the adjustment is based on the ratio of the beneficiaries the flexibility to respond
inpatient prospective payment system number of FTE residents training in the effectively to the serious public health
(IPPS) for hospitals that have residents IRF divided by the facility’s average threats posed by COVID–19.
in an approved Graduate Medical daily census (ADC), subject to a cap. Recognizing the urgency of this
Education (GME) program, to account Specifically, the amount of the situation, and understanding that
for the higher indirect patient care costs adjustment is calculated by adding 1 to hospitals may need additional
of teaching hospitals relative to non- the ratio of interns and residents to the flexibilities to expand capacity in the
teaching hospitals. The statute describes ADC, and then raising that sum to the efforts to mitigate the impact of the
the calculation of the IME payment 1.0163 power, as described in Chapter 3, pandemic on Medicare beneficiaries and
adjustment, which is applied to the Section 140.2.5.4 of the Medicare the American public, we are changing
Claims Processing Manual (Pub. 100– our policies during the PHE for the
(Medicare Severity-Diagnosis Related
04) at https://www.cms.gov/Regulations- COVID–19 pandemic so that hospitals,
Group) MS–DRG payments based on the
and-Guidance/Guidance/Manuals/ IRFs, and IPFs do not experience undue
ratio of the hospital’s number of full-
Internet-Only-Manuals-IOMs. reductions in IME or teaching status
time equivalent (FTE) residents training
For IPFs, section 1886(s) of the Act adjustment payment amounts.
in the portion of the hospital subject to
the IPPS or in such hospital’s outpatient authorizes the Secretary to develop a b. Holding Hospitals Harmless From
departments (OPDs), as well as per diem PPS for inpatient hospital Reductions in IME Payments Due to
qualifying non-provider sites to the services furnished in psychiatric Increases in Bed Counts Due to COVID–
number of inpatient hospital beds. The hospitals and psychiatric units (IPFs) in 19
regulation regarding the calculation of accordance with section 124 of the We have been asked by multiple
this additional payment is located at 42 Balanced Budget Refinement Act of teaching hospitals if CMS can hold
CFR 412.105. 1999 (BBRA) (Pub. L. 106–113, hospitals harmless from a reduction in
The calculation of IME payments is November 29, 1999); section 124(a)(1) of IME payments resulting from the
affected by a hospital’s resident-to-bed the BBRA, in turn requires the Secretary temporary increase in the number of
ratio, which is the ratio of the number to develop an adequate patient available hospital beds due to the influx
of FTE residents that a hospital is classification system that reflects the of COVID–19 patients. The IME
allowed to count to the number of differences in patient resource use and payment formula (under section
available beds at the hospital. Generally, costs among IPFs. Under this authority, 1886(d)(5)(B) of the Act and § 412.105)
the greater the number of allowable FTE we adjust the IPF federal per diem base is determined in part using each
residents a hospital counts, the greater rate to account for facility-level teaching hospital’s ratio of allowable
the amount of Medicare IME payments characteristics such as being located in FTE residents in the numerator and
the hospital will receive. Conversely, a rural area, teaching status, and the cost available beds in the denominator. To
the greater number of beds at the of living for IPFs located in Alaska and accommodate the increase in COVID–
hospital for the same number of Hawaii, if applicable, as described in 19-related patients, many hospitals are
residents, the lower the amount of the § 412.424(d). For cost reporting periods increasing their number of inpatient
IME payments the hospital will receive. beginning on or after January 1, 2005 beds. Using our exceptions and
Similar payment adjustments to under § 412.424(d)(1)(iii), we adjust the adjustments authority under section
reflect the higher costs of facilities that Federal per diem base rate by a factor 1886(d)(5)(I)(i) of the Act, and to
train medical interns and residents are to account for indirect teaching costs. mitigate IME payment changes from pre-
applied in the inpatient rehabilitation This adjustment is made on a claim COVID levels, for the duration of the
facility (IRF) and IPF contexts (referred basis as an interim payment and the COVID–19 PHE, for purposes of
to as ‘‘teaching status adjustments’’). For final payment in full for the claim is determining a hospital’s IME payment
IRFs, section 1886(j)(3)(A)(v) of the Act made during the final settlement of the amount, the hospital’s available bed
confers broad authority upon the cost report. count is considered to be the same as it
Secretary to adjust the per unit payment In accordance with was on the day before the COVID–19
rate by such factors as the Secretary § 412.424(d)(1)(iii), an IPF’s teaching PHE was declared. We are revising
determines are necessary to properly adjustment is based on the ratio of the § 412.105(d)(1), to state that beds
reflect variations in necessary costs of number of FTE residents training in the temporarily added during the timeframe
treatment. For example, we adjust the IPF divided by the facility’s ADC, of the COVID–19 PHE, as defined in
federal IRF prospective payment subject to a cap. Specifically, the § 400.200, is in effect, are excluded from
amount to account for facility-level amount of the adjustment is calculated the calculations to determine IME
characteristics such as an IRF’s low- by adding 1 to the ratio of interns and payment amounts.
income percentage, teaching status, and residents to the ADC, and then raising
location in a rural area, if applicable, as that sum to the 0.5150 power, as c. Holding IRFs and IPFs Harmless From
described in § 412.624(e). Under described in Chapter 3, Section 190.6.3 Reductions to Teaching Status
§ 412.624(e)(4), for discharges on or after of the Medicare Claims Processing Adjustment Payments Due to COVID–19
October 1, 2005, we adjust the Federal Manual (Pub. 100–04) at https:// We have been asked by IRFs and IPFs
prospective payment on a facility basis www.cms.gov/Regulations-and- if CMS can hold facilities harmless from
by a factor as specified by CMS for Guidance/Guidance/Manuals/ a reduction in teaching status
facilities that are teaching institutions or Downloads/clm104c03.pdf. adjustment payments resulting from the
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27568 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
temporary increase in facilities’ ADC that have residents in an approved GME b. Time Spent by Residents at Another
due to the influx of COVID–19 patients. program, to account for the higher Hospital During the COVID–19 PHE
We are concerned that, if a teaching IRF indirect patient care costs of teaching We have been asked about the
or IPF accepts patients from the hospitals relative to non-teaching Medicare GME payment consequences
inpatient acute care hospital to alleviate hospitals. The regulation regarding the of teaching hospitals sending residents
bed capacity during the PHE for the calculation of this additional payment is assigned to them to other hospitals to
COVID–19 pandemic, the IRF’s or IPF’s located at § 412.105. The hospital’s IME meet COVID–19-related surges in
ADC would increase, which would adjustment applied to the MS–DRG patient volume.
artificially decrease the IRF’s or IPF’s payments is calculated based on the Under our current regulations, a
ratio of number of interns and residents ratio of the hospital’s number of FTE hospital cannot claim the time spent by
to ADC and thereby decrease the residents training in the portion of the residents training at another hospital for
facility’s teaching status adjustment. To hospital subject to the IPPS or the OPDs purposes of GME payments
ensure that teaching IRFs or teaching of such hospital, as well as qualifying (§§ 412.105(f)(1)(iii)(A) for IME and
IPFs can alleviate bed capacity issues by nonprovider sites to the number of 413.78(b) for DGME).
taking patients from the inpatient acute inpatient hospital beds. In the unprecedented context of the
care hospitals without being penalized The calculation of both DGME and nationwide COVID–19 PHE, when
by lower teaching status adjustments, IME payments is affected by the number teaching hospitals need flexibility to
we believe it is appropriate to freeze the of FTE residents that a hospital is determine resident training on an
IRFs’ or IPFs’ teaching status adjustment allowed to count. Generally, the greater emergency basis to respond to the
payments at their values prior to the the number of FTE residents a hospital COVID–19 pandemic and hospitals are
COVID–19 PHE. Therefore, for the counts, the greater the amount of facing significant workforce challenges,
duration of the COVID–19 PHE, an IRF’s Medicare DGME and IME payments the we believe that teaching hospitals
or an IPF’s teaching status adjustment hospital will receive. Congress, through should be able to send residents, on an
payment amount will be the same as it the Balanced Budget Act of 1997 (Pub. emergency basis, without regard to GME
was on the day before the COVID–19 L. 105–33, enacted August 5, 1997), financial considerations, to hospitals
PHE was declared. established a limit (that is, a cap) on the where they are most needed to treat
2. Time Spent by Residents at Another number of allopathic and osteopathic COVID–19 or non-COVID–19 patients.
Hospital During the COVID–19 PHE residents that a hospital may include in Therefore, we are revising
its FTE resident count for DGME and §§ 412.105(f)(1)(iii)(A) for IME and
a. Overview of Graduate Medical IME payment purposes. Under section 413.78 for DGME to allow teaching
Education 1886(h)(4)(F) of the Act, for cost hospitals during the COVID–19 PHE to
Section 1886(h) of the Act, as added reporting periods beginning on or after claim for purposes of IME and DGME
by section 9202 of the Consolidated October 1, 1997, a hospital’s payments the time spent by residents
Omnibus Budget Reconciliation Act of unweighted FTE count of allopathic and training at other hospitals. We recognize
1985 (COBRA) (Pub. L. 99–272, enacted osteopathic residents for purposes of this is a significant departure from
April 7, 1986), establishes a DGME may not exceed the hospital’s existing policy and this action is being
methodology for determining Medicare unweighted FTE count for DGME in its taken only during this PHE due to the
payments to hospitals for the direct most recent cost reporting period ending unprecedented nature of the COVID–19
costs of approved GME programs. on or before December 31, 1996. Under PHE. If the teaching hospital to which
Section 1886(h)(2) of the Act sets forth section 1886(d)(5)(B)(v) of the Act, a a resident is assigned sends the resident
a methodology for the determination of similar limit based on the allopathic and to another hospital and claims the
a hospital-specific base-period per osteopathic FTE count for IME during resident’s time, no other hospital,
resident amount that is calculated by that cost reporting period is applied teaching or non-teaching, would be able
dividing a hospital’s allowable direct effective for discharges occurring on or to claim that time. During the COVID–
costs of GME in a base period by its after October 1, 1997. Dental and 19 PHE, the presence of residents in
number of FTE residents in the base podiatric residents are not included in non-teaching hospitals will not trigger
period. The base period is, for most this statutorily mandated cap. establishment of per resident amounts
hospitals, the hospital’s cost reporting We continue to believe that our or FTE resident caps at those non-
period beginning in FY 1984 (that is, current policies for calculating DGME teaching hospitals.
October 1, 1983 through September 30, and IME payments are consistent with Specifically, for the timeframe that
1984). The base year per resident the statute and are appropriate under the PHE associated with COVID–19 is in
amount is updated annually for normal circumstances. However, we effect, we are using our authority under
inflation. In general, Medicare direct wish to give hospitals that provide section 1886(h)(4)(A) and (B) of the Act
GME (DGME) payments are calculated services to Medicare beneficiaries the to suspend the requirement that a
by multiplying the hospital’s updated flexibility to respond effectively to the hospital cannot claim the time spent by
per resident amount by the weighted serious public health threats posed by residents training at another hospital so
number of FTE residents working in all COVID–19. Recognizing the urgency of that a hospital which sends residents to
areas of the hospital complex (and at this situation, and understanding that another hospital can claim those FTE
non-provider sites, when applicable), our current policies may inhibit use of residents on its Medicare cost report
and the hospital’s Medicare share of residents or capacity that might while they are training at another
total inpatient days. The provisions of otherwise be effective in the efforts to hospital in its FTE count, if all of the
section 1886(h) of the Act are mitigate the impact of the COVID–19 following conditions and all other
implemented in regulations at §§ 413.75 pandemic on Medicare beneficiaries and applicable requirements are met:
through 413.83. the American public, we are changing • The sending hospital sends the
As noted earlier, section 1886(d)(5)(B) our policies during the PHE for the resident to another hospital in response
of the Act provides for a payment COVID–19 pandemic so that hospitals to the COVID–19 pandemic. This
adjustment known as the IME do not experience undue reductions in criterion would be met if either the
adjustment under the IPPS for hospitals DGME or IME payment amounts. sending hospital or the other hospital
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27569
are treating COVID–19 patients. We H. Rural Health Clinics (RHCs) the duration of the PHE for the COVID–
would not require that the resident be 19 pandemic, as defined at § 400.200.
1. Revision of Bed Count Methodology
involved in patient care activities for for Determining Provider-Based RHCs I. Durable Medical Equipment (DME)
patients with COVID–19 for the sending Exemption to the RHC Payment Limit Interim Pricing in the CARES Act
hospital to demonstrate that it sent the
resident to the other hospital in RHCs furnish services in rural areas 1. Background
response to the COVID–19 pandemic. that have been determined to be
medically underserved areas or health a. Durable Medical Equipment,
• Time spent by the resident at the professional shortage areas. RHCs are Prosthetics, Orthotics, and Supplies
other hospital would be considered to paid an all-inclusive rate (AIR) for Competitive Bidding Program
be time spent in approved training if the medically-necessary, face-to-face visits Section 1847(a) of the Act, as
activities performed by the resident at with an RHC practitioner. Section amended by section 302(b)(1) of the
the other hospital are consistent with 1833(f) of the Act established an RHC Medicare Prescription Drug,
any guidance in effect during the payment limit, which is adjusted Improvement, and Modernization Act of
COVID–19 PHE for the approved annually based on the Medicare 2003 (Pub. L. 108–173, enacted on
medical residency program at the Economic Index (MEI). Under section December 8, 2003), mandates the
sending hospital. 1833(f) of the Act, an RHC that is Medicare Durable Medical Equipment,
• The time that the resident spent provider-based to a hospital with fewer Prosthetics, Orthotics, and Supplies
training immediately prior to and/or than 50 beds is exempt from the (DMEPOS) Competitive Bidding
subsequent to the timeframe that the national per-visit payment limit. Program (CBP) for contract award
PHE associated with COVID–19 was in To determine which provider-based purposes to furnish certain
effect was included in the sending RHCs are exempt from the payment competitively priced DMEPOS items
hospital’s FTE resident count. limit, we use the same methodology that and services subject to the CBP:
is used to calculate hospital bed count • Off-the-shelf (OTS) orthotics, for
We believe that this policy will allow for the Indirect Medical Education which payment would otherwise be
hospitals to react quickly and in ‘‘real adjustment at § 412.105(b). Specifically, made under section 1834(h) of the Act;
time’’ to send residents to facilities a provider-based RHC (as authorized by • Enteral nutrients, equipment, and
where they are most needed during the § 413.65(a)(1)(ii)(L)) that is an integral supplies described in section
PHE associated with COVID–19. and subordinate part of a hospital 1842(s)(2)(D) of the Act; and
We are revising § 413.78(b), adding (including a CAH) is excepted from the • Certain DME and medical supplies,
new § 413.78(i), and revising per-visit payment limit if the hospital which are covered items (as defined in
§ 412.105(f)(1)(iii)(A) to state the has fewer than 50 beds. We have used section 1834(a)(13) of the Act) for which
conditions under which a hospital may the methodology set out at § 412.105(b) payment would otherwise be made
claim, in its FTE resident count, to make this calculation. under section 1834(a) of the Act.
residents that it sends to another Due to the COVID–19 pandemic, For a list of product categories
hospital during the PHE associated with health care providers such as hospitals included in the DMEPOS CBP, please
COVID–19. have been or are planning to increase refer to https://www.cms.gov/Medicare/
inpatient bed capacity to address the Medicare-Fee-for-Service-Payment/
For the duration of the PHE related to surge in need for inpatient care. Given DMEPOSCompetitiveBid/Round-2021/
COVID–19, CMS has waived certain this, we do not believe that RHCs that PCs.
requirements under the Medicare are currently exempt from the national Areas in which the CBP are not
conditions of participation at §§ 482.41 per-visit payment limit should now be implemented are known as non-
and 485.623, and the PBD requirements subject to the per-visit payment limit competitive bidding areas (non-CBAs).
at § 413.65, to the extent necessary, in due to the COVID–19 PHE, and we do Currently, there are no CBAs due to the
order to allow hospitals to establish and not want to discourage them from 2-year gap period in the DMEPOS CBP,
operate as part of the hospital any increasing bed capacity if needed. allowing any Medicare-enrolled
location meeting those non-waived Allowing for these provider-based RHCs DMEPOS suppliers to furnish DMEPOS
conditions of participation for hospitals to continue to receive the payment items.27 However, we use the term
that continue to apply during the PHE. amounts they would otherwise receive ‘‘former CBAs’’ to refer to areas that
(See https://www.cms.gov/files/ in the absence of the PHE will help were CBAs prior to the 2-year gap, to
document/summary-covid-19- maintain their ability to provide distinguish those areas from non-CBAs
emergency-declaration-waivers.pdf). necessary health care services to in which the CBP has not previously
Time spent by residents at these underserved communities. We are been implemented.
locations is not treated any differently implementing, on an interim basis, a
from time spent by residents at locations b. Fee Schedule Adjustment
change to the period of time used to
established and operated by the hospital Methodology for Non-CBAs
determine the number of beds in a
prior to the COVID–19 PHE. hospital at § 412.105(b) for purposes of Section 1834(a)(1)(F)(ii) of the Act
Also, for the duration of the PHE determining which provider-based requires the Secretary to use
related to COVID–19, CMS has adopted RHCs are subject to the payment limit. information on the payment determined
a policy that if routine services are For the duration of the PHE, we will use under the Medicare DMEPOS CBP to
provided under arrangements outside the number of beds from the cost adjust the fee schedule amounts for
the hospital to its inpatients, these reporting period prior to the start of the DME items and services furnished in all
services are deemed to have been PHE as the official hospital bed count non-CBAs on or after January 1, 2016.
provided by the hospital (85 FR 19280). for application of this policy. As such, Section 1834(a)(1)(F)(iii) of the Act
Similarly, time spent by residents at RHCs with provider-based status that
27 All DMEPOS CBP contracts expired on
these locations is not treated any were exempt from the national per-visit
December 31, 2018. There is currently a temporary
differently from time spent by residents payment limit in the period prior to the gap in the DMEPOS CBP. Round 2021 of the CBP
at locations established and operated by effective date of the PHE (January 27, is scheduled to begin again in January 2021 and
the hospital prior to the COVID–19 PHE. 2020) would continue to be exempt for extend through December 31, 2023.
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27570 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
requires the Secretary to continue to average price (79 FR 66225). Under accordance with the current
make these adjustments as additional § 414.210(g)(1)(v), adjusted fee schedule methodologies under § 414.210(g)(1)
covered items are phased in under the amounts for rural areas are based on 110 through (8) (83 FR 57029). These rules
CBP or information is updated as new percent of the national average of are located at § 414.210(g)(9) and, again,
CBP contracts are awarded. Similarly, regional prices. Under § 414.210(g)(2), apply to items and services furnished
sections 1842(s)(3)(B) and fee schedule amounts for non- from January 1, 2019 through December
1834(h)(1)(H)(ii) of the Act authorize the contiguous areas are adjusted based on 31, 2020 (83 FR 57039; 83 FR 57070
Secretary to use payment information the higher of the average of the single through 57071).
from the DMEPOS CBP to adjust the fee payment amounts for CBAs in non-
2. Current Issues
schedule amounts for enteral nutrition contiguous areas in the United States, or
and OTS orthotics, respectively, the national ceiling amount. Section 3712 of the CARES Act
furnished in all non-CBAs. Section We use ZIP codes for rural, non-rural, revises the fee schedule amounts for
1834(a)(1)(G) of the Act requires the and non-contiguous areas to establish certain DME and enteral nutrients,
Secretary to specify the methodology to geographic areas that are then used to supplies, and equipment furnished in
be used in making these fee schedule define non-CBAs for the purposes of the non-CBAs other than former CBAs
adjustments by regulation, and to DMEPOS fee schedule adjustments. A through the duration of the emergency
consider, among other factors, the costs rural area is defined in § 414.202 as a period described in section
of items and services in non-CBAs geographic area represented by a postal 1135(g)(1)(B) of the Act.
(where the adjustments would be ZIP code, if at least 50 percent of the Section 3712(a) of the CARES Act
applied) compared to the single total geographic area of the area directs the Secretary to implement
payment amounts for such items and included in the ZIP code is estimated to § 414.210(g)(9)(iii) (or any successor
services in the CBAs. be outside any Metropolitan Statistical regulation), to apply the transition rule
In accordance with the requirements Area (79 FR 66228). A rural area also described in such section to all
of section 1834(a)(1)(G) of the Act, we includes a geographic area represented applicable items and services as
conducted notice and comment by a postal ZIP code that is a low planned through December 31, 2020,
rulemaking in 2014 to specify population density area excluded from and through the duration of the
methodologies for adjusting the fee a CBA in accordance with section emergency period described in section
schedule amounts for DME, enteral 1847(a)(3)(A) of the Act at the time the 1135(g)(1)(B) of the Act, if longer.
nutrition, and OTS orthotics in non- rules in § 414.210(g) are applied. Non- Therefore, section 3712(a) of the CARES
CBAs in § 414.210(g). We refer readers contiguous areas refer to areas outside Act continues our current policy at
to the proposed rule entitled ‘‘Medicare the contiguous United States—that is, § 414.210(g)(9)(iii) of paying for
Program; End-Stage Renal Disease areas such as Alaska, Guam, and Hawaii DMEPOS items and services furnished
Prospective Payment System, Quality (81 FR 77936). in rural and non-contiguous non-CBAs
Incentive Program, and Durable Medical In the final rule entitled ‘‘Medicare based on a 50/50 blend of adjusted and
Equipment, Prosthetics, Orthotics, and Program; End-Stage Renal Disease unadjusted fee schedule amounts
Supplies,’’ published on July 11, 2014 Prospective Payment System, Payment through December 31, 2020, or through
(79 FR 40208), (hereinafter CY 2015 for Renal Dialysis Services Furnished to the duration of the emergency period,
ESRD PPS DMEPOS proposed rule), and Individuals With Acute Kidney Injury, whichever is longer. This fee schedule
the final rule entitled ‘‘Medicare End-Stage Renal Disease Quality adjustment in rural and non-contiguous
Program; End-Stage Renal Disease Incentive Program, Durable Medical areas results in fee schedule amounts
Prospective Payment System, Quality Equipment, Prosthetics, Orthotics and that are approximately 66 percent
Incentive Program, and Durable Medical Supplies (DMEPOS) Competitive higher than the fully adjusted fee
Equipment, Prosthetics, Orthotics, and Bidding Program (CBP) and Fee schedule amounts that we currently pay
Supplies,’’ published on November 6, Schedule Amounts, and Technical for DMEPOS items and services
2014 (79 FR 66120), (hereinafter CY Amendments To Correct Existing furnished in non-rural areas in the
2015 ESRD PPS DMEPOS final rule) for Regulations Related to the CBP for contiguous United States.
additional details. Certain DMEPOS,’’ published in the Section 3712(b) of the CARES Act
The methodologies set forth in November 14, 2018 Federal Register (83 states, for items and services furnished
§ 414.210(g) account for regional FR 56922), we established fee schedule on or after the date that is 30 days after
variations in prices, including for rural adjustment methodologies for items and the date of the enactment of this
and non-contiguous areas of the United services furnished from January 1, 2019 legislation, the Secretary shall apply
States. In accordance with through December 31, 2020. § 414.210(g)(9)(iv) (or any successor
§ 414.210(g)(1), we determine regional For the fee schedule amounts for regulation), as if the reference to ‘‘dates
adjustments to fee schedule amounts for items and services furnished from of service from June 1, 2018 through
each state in the contiguous United January 1, 2019 through December 31, December 31, 2020, based on the fee
States and the District of Columbia, 2020, in all rural and non-contiguous schedule amount for the area is equal to
based on the definition of region in non-CBAs, the fee schedule amounts are 100 percent of the adjusted payment
§ 414.202, which refers to geographic based on a blend of 50 percent of the amount established under this section’’
areas defined by the Bureau of unadjusted fee schedule amounts and were instead a reference to ‘‘dates of
Economic Analysis (BEA) in the 50 percent of the fee schedule amounts service from March 6, 2020, through the
Department of Commerce for economic adjusted in accordance with the current remainder of the duration of the
analysis purposes (79 FR 66226). Under methodologies under § 414.210(g)(1) emergency period described in section
§ 414.210(g)(1)(i) through (iv), adjusted through (8) (83 FR 57029). For items and 1135(g)(1)(B) of the Act (42 U.S.C.
fee schedule amounts for areas within services furnished from January 1, 2019 1320b–5(g)(1)(B)), based on the fee
the contiguous United States are through December 31, 2020 in all non- schedule amount for the area is equal to
determined based on regional prices CBAs other than rural or non- 75 percent of the adjusted payment
limited by a national ceiling of 110 contiguous areas, the fee schedule amount established under this section
percent of the regional average price and amounts are based on 100 percent of the and 25 percent of the unadjusted fee
a floor of 90 percent of the regional fee schedule amounts adjusted in schedule amount.’’ Therefore, section
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27571
3712(b) of the CARES Act directs the does not specify the fee schedule 2018 through March 5, 2020, based on
Secretary to increase the fee schedule amounts that should be in effect if the the fee schedule amount for the area is
amounts for DMEPOS items and emergency period ends before December equal to 100 percent of the adjusted
services furnished in non-CBAs other 31, 2020. If not for section 3712(b) of the payment amount established under
than rural and non-contiguous non- CARES Act, CMS would be paying the § 414.210(g)(1) through (8) (‘‘this
CBAs through the duration of the PHE fully adjusted fee schedule amounts for section’’ in the regulation text).
period described in section DME items and services furnished in J. Care Planning for Medicare Home
1135(g)(1)(B) of the Act. In accordance non-rural and contiguous non-CBAs Health Services
with § 414.210(g)(9)(iv), the fee schedule until December 31, 2020. As such, we
amounts in these non-CBA areas are are specifying in § 414.210(g)(9)(v) that Historically, sections 1814(a)(2)(C)
currently based on 100 percent of the the fee schedule amounts in non-rural and 1835(a)(2)(A) of the Act have stated
adjusted fee schedule amount, but and contiguous non-CBAs will again be that for Medicare to make payment for
section 3712(b) of the CARES Act based on 100 percent of the fee schedule home health services, a physician, who
requires CMS to pay for these DMEPOS amounts adjusted in accordance with does not have a direct or indirect
items and services based on 75 percent § 414.210(g)(9)(1) through (8) if the employment relationship with the HHA,
of the adjusted fee schedule amount and emergency period described in section must certify that home health services
25 percent of the historic, unadjusted 1135(g)(1)(B) of the Act (42 U.S.C. are required because the individual is
fee schedule amount until the end of the 1320b–5(g)(1)(B)) ends before December confined to his or her home and is in
emergency period. This increases 31, 2020. need of skilled nursing care on an
payments so that they are approximately intermittent basis, physical or speech
In summary, we are making therapy, or a continued need for
33 percent higher than the payments at conforming changes to § 414.210(g)(9),
the fully adjusted fee schedule amounts. occupational therapy as defined at
consistent with section 3712(a) and (b) section 1861(m) of the Act. The
Section 3712 of the CARES Act does
of the CARES Act, but we are omitting certifying physician must establish and
not affect the current adjusted fee
the language in section 3712(b) of the periodically review a plan for furnishing
schedule amounts in former CBAs. In
CARES Act that references an effective such services to such individual while
accordance with § 414.210(g)(10), the
date that is 30 days after the date of the individual is under the care of a
fee schedule amounts in the former
enactment of the law. We are revising physician. The physician must
CBAs will continue to be based on the
§ 414.210(g)(9)(iii), which describes the document that the physician himself or
single payment amounts from 2018
increased by update factors for 50/50fee schedule adjustment blend for herself or a NP or CNS (as those terms
subsequent calendar years until new items and services furnished in rural are defined in section 1861(aa)(5) of the
competitive bidding contracts are in and noncontiguous areas, to address Act), who is working in collaboration
place. dates of service from June 1, 2018 with the physician in accordance with
Section 3712(b) of the CARES Act through December 31, 2020 or through State law, or a CNM (as defined in
references two dates on which CMS the duration of the emergency period section 1861(gg) of the Act) as
should implement the payment amount described in section 1135(g)(1)(B) of the authorized by State law, or a PA (as
increases for items and services Act (42 U.S.C. 1320b–5(g)(1)(B)), defined in section 1861(aa)(5) of the
furnished in non-rural and contiguous whichever is later. We are also adding Act) under the supervision of the
non-CBAs: April 26, 2020 (April 26th is § 414.210(g)(9)(v) which will state that, physician, has had a face-to-face
30 days after March 27th, the date of the for items and services furnished in areas encounter related to the reason the
enactment of the CARES Act); and other than rural or noncontiguous areas home health services are needed.
March 6, 2020. We believe that the law with dates of service from March 6, Section 3708 of the CARES Act
was written in a way that is ambiguous 2020, through the remainder of the amended sections 1814(a) and 1835(a)
and essentially mandates two different duration of the emergency period of the Act to allow NPs, CNSs, and PAs
and conflicting effective dates for the described in section 1135(g)(1)(B) of the (as those terms are defined in section
increase in the fee schedule amounts in Act (42 U.S.C. 1320b–5(g)(1)(B)), based 1861(aa) of the Act), to order and certify
non-rural and contiguous non-CBAs. on the fee schedule amount for the area patients for eligibility under the
Due to this ambiguity, we believe that is equal to 75 percent of the adjusted Medicare home health benefit.
we could implement the higher fee payment amount established under Additionally, section 3708 of the
schedule amounts in non-rural and ‘‘this section’’ (by which we mean CARES Act amended sections
contiguous non-CBAs on either March § 414.210(g)(1) through (8)), and 25 1814(a)(2)(C), 1835 (a)(2)(A)(ii), and
6, 2020 or April 26, 2020. Because we percent of the unadjusted fee schedule 1861(m) of the Act to allow the home
believe the purpose of the law is to aid amount. For items and services health plan of care to be established and
suppliers in furnishing items under very furnished in areas other than rural or periodically reviewed by a physician,
challenging situations during the noncontiguous areas with dates of NP, CNS, or PA where such services are
COVID–19 PHE, we believe it is in the service from the expiration date of the or were furnished while the individual
public’s interest to implement the emergency period described in section was under the care of a physician, NP,
higher fee schedule amounts starting 1135(g)(1)(B) of the Act (42 U.S.C. CNS, or PA. The CARES Act also
with the earlier date of March 6, 2020. 1320b–5(g)(1)(B)) through December 31, amended sections 1861(o)(2) and
Therefore, we are revising the 2020, based on the fee schedule amount 1861(kk) of the Act to allow (CNMs,
regulations to implement the higher fee for the area is equal to 100 percent of NPs, CNSs, or PAs to perform the role
schedule amounts required under the the adjusted payment amount originally reserved for a physician in
CARES Act as of March 6, 2020. established under § 414.210(g)(1) establishing HHA policies that govern
Additionally, section 3712(b) of the through (8) (referred to as ‘‘this section’’ the services (and supervision of such
CARES Act requires CMS to pay the in the regulation text). In addition, we services) provided to patients under the
higher fee schedule amounts for the are revising § 414.210(g)(9)(iv) to specify Medicare home health benefit, as well
duration of the emergency period for items and services furnished in areas as certify that an individual has suffered
described in section 1135(g)(1)(B) of the other than rural and noncontiguous a bone fracture related to post-
Act (42 U.S.C. 1320b–5(g)(1)(B)), but it areas with dates of service from June 1, menopausal osteoporosis and that the
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27572 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
individual is unable to learn the skills and prescriptive authority. A review of K. CARES Act Waiver of the ‘‘3-Hour
needed to self-administer the these websites reveals that the majority Rule’’ and Modification of IRF Coverage
osteoporosis drug or is otherwise of states require physician collaboration and Classification Requirements for
mentally or physically incapable of self- for these NPPs. We note that even in Freestanding IRF Hospitals for the PHE
administering such drug. Finally, states that allow independent practice During the COVID–19 Pandemic
section 3708 of the CARES Act amended authority, many of these practitioners a. CARES Act Waiver of the ‘‘3-Hour
section 1895(c) of the Act to allow continue to work in a practice Rule’’
payment for the furnishing of items and environment (inpatient facility or
services under the home health In the March 31st COVID–19 IFC (85
outpatient or physician’s office) that FR 19252, 19287), we provided a
prospective payment system (HH PPS)
includes a physician. clarification regarding § 412.622(a)(3)(ii)
when these items and services are
prescribed by an NP, CNS, or PA. Section 1861(aa)(5) of the Act allows (commonly referred to as the ‘‘3-hour
In accordance with section 3708 of the Secretary regulatory discretion rule’’). On March 27, 2020, the CARES
the CARES Act, these changes are regarding the requirements for NPs, Act was enacted and further addressed
required to take effect within 6 months CNSs, and PAs. As such, the regulations § 412.622(a)(3)(ii). Specifically, section
of enactment of the law and the at §§ 410.74 through 410.76 set out in 3711(a) of the CARES Act requires the
Secretary shall issue an IFC, if necessary detail the qualifications needed and Secretary to waive § 412.622(a)(3)(ii)
to comply with the required effective services provided by these practitioners during the emergency period described
date. Per the explicit statutory under the Medicare program. We in section 1135(g)(1)(B) of the Act. This
instructions at section 3708(f) of the believe that we should align, for waiver was issued on April 15 2020,
CARES Act, we are addressing changes Medicare home health purposes, the and is available at https://www.cms.gov/
in the regulations in this IFC to ensure definitions for such practitioners with files/document/summary-covid-19-
these requirements are issued within the emergency-declaration-waivers.pdf. We
the existing definitions in regulation at
timeframe required by statute. These note that the clarification provided in
§§ 410.74 through 410.76 for the March 31st COVID–19 IFC does not
regulations are effective on May 8, 2020,
consistency across the Medicare address section 3711(a) of the CARES
and will be retroactively applicable to
March 1, 2020.We believe that enacting program and to ensure that Medicare Act as it was developed prior to the
these provisions at this time will afford home health beneficiaries are afforded enactment of the CARES Act. Because
maximum flexibility for providers the same standard of care. Therefore, we § 412.622(a)(3)(ii) is more directly and
seeking to order home health care are amending the regulations at parts comprehensively addressed by section
services during the PHE for the COVID– 409, 424, and 484 to define a NP, a CNS, 3711(a) of the CARES Act, the
19 pandemic. That is, NPs, CNSs, and and a PA (as such qualifications are clarification provided in the March 31st
PAs would be able to practice to the top defined at §§ 410.74 through 410.76) as COVID–19 IFC is moot and hereby
of their state licensure to certify an ‘‘allowed practitioner’’. This means rescinded.
eligibility for home health services, as that in addition to a physician, as We note that the waiver required by
well as establish and periodically defined at section 1861(r) of the Act, an section 3711(a) of the CARES Act is not
review the home health plan of care. ‘‘allowed practitioner’’ may certify, limited to particular IRFs or patients,
This is imperative during the PHE for establish and periodically review the and therefore, is available during the
the COVID–19 pandemic as more plan of care, as well as supervise the emergency period described in section
beneficiaries may be considered provision of items and services for 1135(g)(1)(B) of the Act regardless of
‘‘homebound’’, either because a beneficiaries under the Medicare home whether a patient was admitted for
practitioner has determined that it is health benefit. Additionally, we are standard IRF care or to relieve acute
medically contraindicated for a amending the regulations to reflect that care hospital capacity. In this IFC, we
beneficiary to leave the home because we would expect the allowed are waiving § 412.622(a)(3)(ii) to reflect
he or she has a confirmed or suspected the waiver required by section 3711(a)
practitioner to also perform the face-to-
diagnosis of COVID–19, or because a of the CARES Act.
face encounter for the patient for whom
practitioner has determined that it is
they are certifying eligibility; however, b. Modification of IRF Coverage and
medically contraindicated for a
if a face-to-face encounter is performed Classification Requirements for
beneficiary to leave the home because
by an allowed NPP, as set out at 42 CFR Freestanding IRF Hospitals for the PHE
the patient has a condition that may
424.22(a)(1)(v)(A), in an acute or post- During the COVID–19 Pandemic
make the patient more susceptible to
contracting COVID–19. acute facility, from which the patient IRF care is only considered by
In accordance with section was directly admitted to home health, Medicare to be reasonable and necessary
1861(aa)(5) of the Act, NPs, CNSs, and the certifying practitioner may be under section 1862(a)(1) of the Act if the
PAs are required to practice in different from the provider performing patient meets all of the IRF coverage
accordance with state law in the state in the face-to-face encounter. These requirements outlined in
which the individual performs such regulation changes will become § 412.622(a)(3), (4), and (5). Failure to
services. Individual states have varying permanent and are not time limited to meet the IRF coverage criteria in a
requirements for conditions of practice, the period of the PHE for COVID–19. We particular case results in denial of the
which determine whether a practitioner will review and respond to any IRF claim. We note that the March 31st
may work independently without a comments received on this IFC in the COVID–19 IFC removes the requirement
written collaborative agreement or CY 2021 HH PPS final rule. at § 412.622(a)(4)(ii) to complete a post-
supervision from a physician, or admission physician evaluation during
whether general or direct supervision the COVID–19 PHE, as defined in
and collaboration is required. HHAs or § 400.200.
other practitioners should check with While we generally believe that all
the relevant state licensing authority IRFs should have to comply with the
websites to ensure that practitioners are requirements at § 412.29(d), (e), (h), and
working within their scope of practice (i) and § 412.622(a)(3), (4), and (5), we
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27573
recognize that there are certain stay if the same flexibilities apply for each individual patient needs during
institutional differences between the duration of a patient’s IRF stay. the PHE for the COVID–19 pandemic.
freestanding IRF hospitals and IRF These limitations only apply to the To effectuate these changes, we are
distinct part units of hospitals that may provisions in this IFC and not to any amending § 412.622(a)(3)(i), (ii), (iii),
impose barriers on freestanding IRF blanket waivers issued, which have and (iv) to state that these IRF coverage
hospitals seeking to admit patients to their own conditions. Freestanding IRF criteria continue to be required, except
relieve acute care hospital capacity hospitals must document the particular for care furnished to patients in a
during the COVID–19 PHE. Specifically, phase for the state when admitting the freestanding IRF hospital solely to
freestanding IRF hospitals do not have patient and electing to exercise these relieve acute care hospital capacity in a
the same close affiliations with acute flexibilities. state (or region, as applicable) that is
care hospitals that IRF distinct part For billing purposes, we are requiring experiencing a surge during the PHE, as
units of hospitals have, and are not as freestanding IRF hospitals to append the defined in § 400.200. Similarly, in
able to establish billing procedures ‘‘DS’’ modifier to the end of the IRF’s § 412.622(a)(4), we are amending this
under the IPPS as have IRF distinct part unique patient identifier number (used paragraph to state that the IRF
units by virtue of the fact that the to identify the patient’s medical record documentation requirements must be
distinct part units have access to (or at in the IRF) to identify patients who are present in the IRF medical record,
least affiliations with) their parent being treated in a freestanding IRF except for care furnished to patients in
hospitals’ billing departments. hospital solely to alleviate inpatient bed a freestanding IRF hospital solely to
Therefore, we are amending the capacity in a state that is experiencing relieve acute care hospital capacity in a
requirements at §§ 412.29(d), (e), (h), a surge during the PHE for the COVID– state (or region, as applicable) that is
and (i) and 412.622(a)(3), (4), and (5) to 19 pandemic. The modifier will be used experiencing a surge during the PHE, as
add an exception for care furnished to to identify those patients for whom the defined in § 400.200. In § 412.622(a)(5),
patients admitted to freestanding IRF requirements in § 412.622(a)(3)(i), (iii), we are amending this paragraph to state
hospitals (identified as those facilities (iv), (4) and (5) do not apply. that an interdisciplinary team approach
with the last 4 digits of their Medicare Freestanding IRF hospitals will be paid to care is required, except for care
provider numbers between 3025 at the IRF PPS rates for patients with the furnished to patients in a freestanding
through 3099) solely to relieve acute ‘‘DS’’ modifier. IRF hospital solely to relieve acute care
care hospital capacity during the hospital capacity in a state (or region, as
We anticipate that freestanding IRF applicable) that is experiencing a surge
COVID–19 PHE. hospitals will take advantage of these during the PHE, as defined in § 400.200.
We believe that freestanding IRF flexibilities for those beneficiaries (who We are also amending § 412.29(d), (e),
hospitals need the flexibility during this are surge patients from inpatient (h), and (i) to align the provisions we
COVID–19 PHE to determine the best hospitals), while continuing to provide have waived in § 412.622 with the
care for each patient who is admitted standard IRF-level care for those classification criteria for payment to
solely to relieve acute care hospital beneficiaries who would benefit from freestanding IRF hospitals under the IRF
capacity. Consistent with the Guidelines IRF-level care and would otherwise prospective payment system. Finally,
for Opening Up America Again at receive such care in the absence of the we are amending § 412.622(c) to add a
https://www.whitehouse.gov/ COVID–19 PHE. This will provide definition of state (or region, as
openingamerica/, for the purposes of crucial flexibility to allow freestanding applicable) that are experiencing a surge
exercising these IRF flexibilities that are IRF hospitals to aid in the response to and § 412.29 to cross-reference that
intended to provide broad flexibility for the COVID–19 pandemic in several definition where applicable.
freestanding IRF hospitals to provide ways. First, we expect that some of the
surge capacity in support of acute care patients that freestanding IRF hospitals L. Medicare Shared Savings Program
hospitals in their state or community, care for during the COVID–19 PHE in a As of January 1, 2020, there are 517
CMS considers surge to be alleviated state that is experiencing a surge would Medicare Shared Savings Program
with regard to exercising these need high-acuity clinical care but may (Shared Savings Program) Accountable
flexibilities when the state (or region, as not need or be able to tolerate the Care Organizations (ACOs) serving
applicable) in which the freestanding intensive rehabilitation therapy approximately 11.2 million Medicare
IRF is located is in phase 2 or phase 3. typically provided in an IRF, such as at FFS beneficiaries across the country: 37
In other words, the flexibilities in this least two types of therapy. Second, percent of ACOs (192 of 517) are
IFC are available for freestanding IRF waiving the documentation participating under two-sided shared
hospitals admitting patients in support requirements in § 412.622(a)(4) and (5) savings and shared losses models; and
of acute care hospitals when the state is for patients alleviating inpatient 160 ACOs have agreements ending
in phase 1 or prior to entering phase 1, hospital bed capacity allows December 31, 2020, and must renew
but are no longer available to the freestanding IRF hospitals to under the BASIC track or ENHANCED
freestanding IRF hospital when the state concentrate on providing care for surge track to continue in the Shared Savings
is in phase 2 or phase 3 of these patients from the acute care hospitals in Program, including 20 ACOs
Guidelines. These flexibilities apply to a state that is experiencing a surge, participating in the Medicare ACO
specific patients who must be instead of completing documentation Track 1+ Model (Track 1+ Model).
discharged from the acute care hospitals that may not be applicable to these The COVID–19 pandemic, and the
to the freestanding IRFs to provide surge acute patients during the PHE. Third, resulting PHE as defined in § 400.200,
capacity for the acute care hospitals, this flexibility allows freestanding IRF have created a lack of predictability for
and therefore apply only when those hospitals to maximize their available many ACOs regarding the impact of
specific patients are admitted to the beds to take advantage of space where expenditure and utilization changes on
freestanding IRF hospitals and continue COVID–19 patients or surge patients historical benchmarks and performance
for the duration of that patient’s care. could be safely managed. We believe year expenditures, and for those under
We believe this will allow for continuity this policy will allow freestanding IRF performance-based risk, the potential
of care and care planning consistency at hospitals to make a clinical liability for shared losses, as well as
admission and throughout a patient’s determination about what level of care disrupting population health activities,
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27574 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
as clinicians, care coordinators and between ACOs’ expenditures for PY stakeholders have expressed concern
financial and other resources are 2020 and ACOs’ updated historical about focusing resources on applying to
diverted to address immediate acute benchmarks and that ACOs are not the Shared Savings Program rather than
care needs. ACOs and other program rewarded or penalized for having on patient care. Additionally,
stakeholders have advocated for CMS to higher/lower COVID–19 spread in their stakeholders have expressed uncertainty
modify Shared Savings Program policies patient populations which, in turn, will over their continued participation in the
to address the impact of the COVID–19 help to protect ACOs from owing Shared Savings Program in 2021 given
pandemic including to: excessive shared losses and the the lack of predictability of the impact
• Adjust the methodology for Medicare Trust Funds from paying out of COVID–19 on expenditures used to
determining shared savings and shared windfall shared savings. As described in establish an ACO’s historical
losses, such as by: Reducing or this section of this IFC, we are benchmark.
eliminating liability for ACOs under modifying Shared Savings Program In response to stakeholder feedback,
performance-based risk for shared losses policies to: (1) Allow ACOs whose we are forgoing the application cycle for
for PY 2020; not sharing savings or current agreement periods expire on a January 1, 2021 start date (herein
losses with ACOs for PY 2020; or December 31, 2020, the option to extend referred to as the 2021 application
adjusting program calculations to their existing agreement period by 1- cycle). We believe it is appropriate to
address the impact of COVID–19 on year, and allow ACOs in the BASIC forgo the 2021 application cycle as the
benchmark and PY expenditures, track’s glide path the option to elect to COVID–19 PHE continues because this
particularly for calendar year 2020. maintain their current level of will allow ACOs and their ACO
• Eliminate or extend the deadline for participation for PY 2021; (2) clarify the providers/suppliers currently
ACOs to voluntarily terminate from the applicability of the program’s extreme participating in the Shared Savings
program without being financially and uncontrollable circumstances Program to continue focusing on
reconciled for PY 2020, which under policy to mitigate shared losses for the treating patients during the pandemic.
§ 425.221(b)(2)(ii)(A) is June 30, 2020, period of the COVID–19 PHE; (3) adjust There are 160 ACO Shared Savings
with notification 30 days prior (no later program calculations to mitigate the Program participation agreements that
than June 1). impact of COVID–19 on ACOs; and (4) will end on December 31, 2020,
• Maintain or ‘‘freeze’’ ACOs in their expand the definition of primary care including 20 ACOs participating in the
current participation options so that services for purposes of determining Track 1+ Model. These ACOs are
ACOs required to renew their beneficiary assignment to include eligible to apply to renew their
participation for a new agreement telehealth codes for virtual check-ins, e- participation agreement for the Shared
period starting on January 1, 2021, are visits, and telephonic communication. Savings Program effective January 1,
not burdened with meeting application We also address how these adjustments 2021. To reduce burden and allow these
deadlines and forgo the requirement to program policies will apply to ACOs ACOs to continue participating in the
that ACOs participating in the BASIC participating in the Track 1+ Model. program without a 2021 application
track’s glide path advance to the next cycle, ACOs that entered a first or
level for PY 2021. 1. Application Cycle for January 1, 2021 second agreement period with a start
• Account for changes in billing and Start Date and Extension of Agreement date of January 1, 2018, may elect to
care patterns in determining beneficiary Periods Expiring on December 31, 2020 extend their agreement period for an
assignment. A renewing ACO is defined as an optional fourth performance year. The
ACOs and other program stakeholders ACO that continues its participation in fourth performance year would span 12
have indicated that there is an urgent the program for a consecutive agreement months from January 1, 2021, to
need to address these concerns because period, without a break in participation, December 31, 2021. This election to
ACOs need to make participation because it is an ACO whose extend the agreement period is
decisions for PY 2020 and PY 2021 soon participation agreement expired and voluntary and an ACO could choose not
and may choose to terminate their that immediately enters a new to make this election, and therefore,
participation in the Shared Savings agreement period to continue its conclude its participation in the
Program on or before June 30th, rather participation in the program, or an ACO program with the expiration of its
than face the potential of pro-rated that terminated its current participation current agreement period on December
losses for PY 2020 if the COVID–19 PHE agreement under § 425.220 and 31, 2020. Under this approach, eligible
does not extend for the entire year or the immediately enters a new agreement ACOs will be able to remain under their
program’s policies do not adequately period to continue its participation in existing historical benchmark for an
mitigate liability for shared losses. the program (see § 425.20). Section additional year, which will increase
We believe it is vital to the stability 425.224 specifies application stability and predictability given the
of the Shared Savings Program to procedures for a renewing ACO potential impact of the pandemic on
encourage continued participation by applying to enter a new participation beneficiary expenditures under FFS
ACOs by adjusting program policies as agreement with CMS for participation in Medicare and help provide greater
necessary to address the impact of the the Shared Savings Program. We are certainty for ACOs making
COVID–19 pandemic, including by seeking to reduce operational burden for determinations regarding their future
offering certain flexibilities in program ACOs and their health care providers participation in the Shared Savings
participation options to currently while they respond to the serious health Program.
participating ACOs and addressing threats posed by the spread of the Additionally, by forgoing the 2021
potential distortions in expenditures COVID–19. We have received feedback application cycle for new applicants, CY
resulting from the pandemic to ensure from ACO stakeholders requesting that 2020 will not serve as benchmark year
that ACOs are treated equitably CMS delay the Shared Savings Program 3 for a cohort of ACOs that would
regardless of the degree to which their application cycle for a January 1, 2021 otherwise be January 1, 2021 starters.
assigned beneficiary populations are start date (occurring in CY 2020), since An ACO’s historical benchmark is
affected by the pandemic. The changes they have reassigned staff and care determined based on the 3 most recent
we are making in this IFC will help to coordinators to respond to the current years prior to the start of its agreement
ensure a more equitable comparison pandemic. Due to COVID–19, period. For ACOs in a first agreement
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27575
period, benchmark year 3 is given the activities during PY 2021 to comply agreements that are scheduled to expire
highest weight of the 3 benchmark years with the program’s requirements on December 31, 2020.
and, because CY 2020 is an anomalous through December 31, 2021. We note
2. Allow BASIC Track ACOs To Elect To
year, we believe it could be that to remain in compliance with
Maintain Their Participation Level for
disadvantageous to include CY 2020 § 425.116, an ACO may need to extend One Year
expenditures as the third benchmark the duration of its agreements with ACO
year for this cohort of ACOs. Cancelling participants and ACO providers/ We finalized a redesign of Shared
the 2021 application cycle would suppliers. Savings Program’s participation options
provide us with additional time to We believe there is good cause to in the final rule entitled ‘‘Medicare
consider and develop approaches to address the extension of expiring Program; Medicare Shared Savings
further mitigate the role of 2020 as a participation agreements in this IFC. It Program; Accountable Care
benchmark year given the unusual would be impracticable and contrary to Organizations—Pathways to Success
expenditure and utilization trends likely the public interest to undertake and Extreme and Uncontrollable
to result from the pandemic. traditional notice and comment Circumstances Policies for Performance
The ACO’s voluntary election to rulemaking for this policy because we Year 2017’’, which appeared in the
extend its agreement period must be previously announced on our website Federal Register on December 31, 2018
made in the form and manner and by a that the 2021 application cycle would (83 FR 67816). We finalized the BASIC
deadline established by CMS, and an begin on April 20, 2020 (https:// track, added as a new provision at
ACO executive who has the authority to www.cms.gov/Medicare/Medicare-Fee- § 425.605, which includes an option for
legally bind the ACO must certify the for-Service-Payment/ eligible ACOs to begin participation
election. We note that this optional 12- sharedsavingsprogram/for-acos/ under a one-sided model and
month agreement period extension is a incrementally phase-in risk (calculated
application-types-and-timeline). If we
one-time exception for all ACOs with based on ACO participant revenue and
delayed finalizing this policy until after
agreements expiring on December 31, capped at a percentage of the ACO’s
the public has had an opportunity to
2020; it will not be available to other updated benchmark) and potential
comment on it, ACOs might begin
ACOs or to future program entrants. We reward over the course of a single
applying (or make preparations to
anticipate that eligible ACOs will be agreement period, an approach referred
apply) to the Shared Savings Program
able to elect to extend their agreement to as the glide path (83 FR 67841). The
for an agreement period beginning
starting June 18, 2020, and the glide path includes five levels: A one-
January 1, 2021, rather than devote their
anticipated final date to make the sided model available only for the first
scarce resources to care delivery and
election will be September 22, 2020. We 2 consecutive performance years of a 5-
coordination activities. year agreement period, each year of
will provide additional guidance
We are revising § 425.200(b)(3)(ii) to which is identified as a separate level
regarding the form and manner, and the
allow ACOs that entered a first or (Levels A and B); and three levels of
timeframe (including any changes to the
second agreement period with a start progressively higher risk and potential
above dates), for making the election.
Under the existing provision at date of January 1, 2018, to elect to reward in performance years 3 through
§ 425.210(a), the ACO must provide a extend their agreement period for an 5 of the agreement period (Levels C, D,
copy of its participation agreement with optional fourth performance year. and E). ACOs are automatically
CMS to all ACO participants, ACO Lastly, while we will forgo the advanced along the progression of risk/
providers/suppliers, and other application cycle for ACOs to apply to reward levels at the start of each
individuals and entities involved in enter an agreement period beginning on participation year, over the course of a
ACO governance. In the case of an ACO January 1, 2021, we note that eligible, 5-year agreement period, unless the
that elects to extend its agreement currently participating ACOs will be ACO elects to advance more quickly,
period pursuant to this IFC, we will able to apply for a SNF 3-day rule until ACOs reach the BASIC track’s
consider the ACO to be in compliance waiver (§ 425.612(a)(1)(i)), apply to maximum level of risk/reward (Level E)
with § 425.210(a) if it notifies these establish a beneficiary incentive (83 FR 67844). For ACOs that entered
parties that it will continue to program (§ 425.304(c)(2)), modify ACO the BASIC track’s glide path for an
participate in the program for an participant (§ 425.118(b)) and/or SNF agreement period beginning on July 1,
additional year. Further, under affiliate lists (§ 425.612(a)(1)(i)(B)), and 2019, the progression through the levels
§ 425.210(b), all contracts or elect to change their assignment of risk and potential reward spans 6
arrangements between or among the methodology (§ 425.226(a)(1)) for PY performance years, including the ACO’s
ACO, ACO participants, ACO providers/ 2021. Also, an ACO participating under first performance year from July 1, 2019,
suppliers, and other individuals or the BASIC track’s glide path may still through December 31, 2019; these ACOs
entities performing functions or services elect to transition to a higher level of were not automatically advanced to the
related to ACO activities must require risk and potential reward within the next risk/reward level at the start of PY
compliance with the requirements and BASIC track’s glide path other than the 2020 (42 CFR 425.200(b)(4)(ii), (c)(3);
conditions of the program’s regulations, level of risk and potential reward that § 425.600(a)(4)(i)(B)(2)(i)).
including, but not limited to, those the ACO would be automatically Stakeholders have expressed concern
specified in the participation agreement transitioned to for PY 2021, absent the that due to the unpredictable impact of
with CMS (see also §§ 425.116(a)(3) (as ACO’s election to maintain its current COVID–19 during PY 2020 and the
to agreements with ACO participants) participation level for one year as uncertainty as to their ability to secure
and 425.116(b)(3) (as to agreements with described in section II.L.2. of this IFC. a repayment mechanism for PY 2021,
ACO providers/suppliers)). Thus, an For example, an ACO participating in ACOs are uncertain they will continue
ACO that elects to extend its BASIC track Level B in PY 2020 can still participating in the program if they are
participation agreement pursuant to this elect to transition to BASIC track level automatically transitioned to downside
IFC must require its ACO participants, D or E in PY 2021. risk or a higher level of downside risk
ACO providers/suppliers, and other We seek comment on the approach we in PY 2021. Specifically, stakeholders
individuals or entities performing are establishing with this IFC to address have requested we ‘‘freeze,’’ or forgo the
functions or services related to ACO the extension of participation automatic advancement of, BASIC track
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27576 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
ACOs at their current level of its current level of participation for PY § 425.600(a)(4)(i)(B)(2)(iii) as
participation for PY 2021. Additionally, 2021, it will participate under Level B § 425.600(a)(4)(i)(B)(2)(iv) and adding a
per § 425.204(f)(3)(iii), an ACO entering for PY 2021 and then will automatically new § 425.600(a)(4)(i)(B)(2)(iii) to allow
an agreement period in Level A or Level advance to Level D for PY 2022, since ACOs currently participating in the
B of the BASIC track must demonstrate the ACO would have moved BASIC track’s glide path to elect to
the adequacy of its repayment automatically to Level C for PY 2021 maintain their current participation
mechanism prior to the start of any under current program rules, absent this level for PY 2021.
performance year in which it either change. The ACO could also elect to We seek comment on the
elects to participate in, or is advance more quickly by opting to move advancement deferral option we are
automatically transitioned to a two- to Level E instead of Level D for PY establishing with this IFC.
sided model of the BASIC track, 2022, in which case the ACO would 3. Applicability of Extreme and
including Level C, Level D, or Level E. participate under Level E for the Uncontrollable Circumstances Policies
We have concerns whether some ACOs, remainder of its agreement period. to the COVID–19 Pandemic
particularly those that would The ACO’s voluntary election to
automatically transition to Level C of maintain its participation level must be In December 2017, we issued an
the BASIC track, will have the ability to made in the form and manner and by a interim final rule with comment period
establish a repayment mechanism prior deadline established by CMS, and an entitled ‘‘Medicare Program; Medicare
to the start of PY 2021 because the ACO executive who has the authority to Shared Savings Program: Extreme and
source of capital to cover potential legally bind the ACO must certify the Uncontrollable Circumstances Policies
losses may be uncertain for some ACOs election. We anticipate that eligible for Performance Year 2017’’ (hereinafter
given the resource intensity of ACOs will be able to elect to maintain referred to as the ‘‘December 2017 IFC’’),
their participation level for PY 2021 which appeared in the Federal Register
responding to the pandemic. Currently,
starting June 18, 2020, and the on December 26, 2017 (82 FR 60912
the Shared Savings Program has 136
anticipated final date to make the through 60919). The December 2017 IFC
ACOs participating under Level B of the
election will be September 22, 2020. We established a policy for mitigating
BASIC track that are scheduled to
will provide additional guidance shared losses for Shared Savings
automatically advance to Level C on
regarding the form and manner, and the Program ACOs participating in a
January 1, 2021. Some stakeholders
timeframe (including any changes to the performance-based risk track, when the
have indicated that they may be unable
above dates), for making the election; an ACO’s assigned beneficiaries were
to secure a letter of credit at this time,
ACO that does not elect to maintain its located in geographic areas that were
while other stakeholders have indicated
current participation level for PY 2021 impacted by extreme and uncontrollable
that their discretionary funds are circumstances, such as hurricanes,
currently fully committed to responding by the final date specified by CMS in
this guidance will be automatically wildfires, or other triggering events,
to the COVID–19 PHE. during PY 2017. In the final rule
advanced to the next level of the glide
We are also concerned that some of path for that performance year (unless it entitled ‘‘Medicare Program; Revisions
the care coordination processes ACOs elects to advance more quickly). This to Payment Policies Under the
have been developing may be option is a one-time exception for ACOs Physician Fee Schedule and Other
interrupted by the pandemic. For currently participating in the Shared Revisions to Part B for CY 2019;
example, ACOs may have reallocated Savings Program under the BASIC track’ Medicare Shared Savings Program
funding and staff resources to respond glide path and will not be available to Requirements; Quality Payment
to the COVID–19 PHE, thereby other ACOs that are currently Program; Medicaid Promoting
temporarily disrupting their ability to participating in the program or to future Interoperability Program; Quality
implement redesigned care processes program entrants. Payment Program-Extreme and
that would support their transition to We believe there is good cause to Uncontrollable Circumstance Policy for
risk. We agree that most ACOs do not address the automatic advancement of the 2019 MIPS Payment Year;
know the impact that COVID–19 will BASIC track ACOs along the glide path Provisions From the Medicare Shared
have on their expenditures or in this IFC. We believe we need to Savings Program-Accountable Care
beneficiary population and the potential provide ACOs adequate time in 2020 to Organizations-Pathways to Success; and
for losses under risk arrangements. determine their participation options for Expanding the Use of Telehealth
Therefore, through this IFC, we are PY 2021. It would be infeasible to Services for the Treatment of Opioid
permitting ACOs participating in the finalize the necessary amendments to Use Disorder Under the Substance Use-
BASIC track glide path to elect to the program regulations with sufficient Disorder Prevention That Promotes
maintain their current level under the time for ACOs to be aware of the Opioid Recovery and Treatment
BASIC track for PY 2021. Prior to the advancement deferral option, make (SUPPORT) for Patients and
automatic advancement for PY 2021, an related program participation decisions, Communities Act’’ (hereinafter referred
applicable ACO may elect to remain in and provide their election to CMS, if we to as the ‘‘CY 2019 PFS final rule’’) (83
the same level of the BASIC track’s glide did not implement this policy through FR 59452), we extended the extreme
path that it entered for PY 2020. For PY this IFC. Additionally, this policy will and uncontrollable circumstances
2022, an ACO that elects this provide further relief to ACOs that may policy finalized for PY 2017 to PY 2018
advancement deferral option will be not currently have the ability to and subsequent performance years.
automatically advanced to the level of establish a repayment mechanism prior Under the policy adopted in that final
the BASIC track’s glide path in which it to PY 2021 and that otherwise would be rule, for a given performance year, as set
would have participated during PY 2022 struggling during this period to establish forth in §§ 425.605(f) (applicable to
if it had advanced automatically to the one, or perhaps seeking to terminate ACOs in two-sided models of the BASIC
next level for PY 2021 (unless the ACO their participation agreements early, track), 425.606(i) (applicable to ACOs in
elects to advance more quickly before rather than devoting scarce resources to Track 2) and 425.610(i) (applicable to
the start of PY 2022). For example, if an care delivery and coordination and ACOs in the ENHANCED track), CMS
ACO participating in the BASIC track, continuing in the program. Therefore, reduces the amount of the ACO’s shared
Level B, in PY 2020 elects to maintain we are redesignating losses by an amount determined by
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27577
multiplying the shared losses by the difficult to identify whether a claim agreement period (as further discussed
percentage of the total months in the would otherwise have been denied in section II.L.4. of this IFC). These
performance year affected by an extreme under normal Medicare FFS rules. factors could jeopardize the ACO’s
and uncontrollable circumstance, and Absent this relief, we explained that ability to succeed in the Shared Savings
the percentage of the ACO’s assigned ACOs participating in performance- Program, and ACOs, especially those in
beneficiaries who reside in an area based risk tracks might reconsider performance-based risk tracks, may
affected by an extreme and whether they are able to continue their reconsider whether they are able to
uncontrollable circumstance. Further, as participation in the Shared Savings continue their participation in the
specified in the Track 1+ Model Program under a performance-based risk program.
participation agreement available at track. Therefore, we believe it is important
https://www.cms.gov/Medicare/ In the March 31st COVID–19 IFC (85 to make clear that, under the existing
Medicare-Fee-for-Service-Payment/ FR 19230), we briefly addressed extreme and uncontrollable
sharedsavingsprogram/Downloads/ considerations related to applying the circumstances policies for the Shared
track-1plus-model-par-agreement.pdf, Shared Savings Program’s extreme and Savings Program, the timeframe for the
CMS adjusts the amount of shared uncontrollable circumstances policies extreme and uncontrollable
losses for Track 1+ Model ACOs for for mitigating shared losses for ACOs in circumstance of the COVID–19
extreme and uncontrollable PY 2020 because of the COVID–19 pandemic for purposes of mitigating
circumstances in the manner described pandemic. We explained that for shared losses will extend for the
in § 425.610(i). purposes of PY 2020 financial duration of the COVID–19 PHE as
As specified in the Shared Savings reconciliation, we will reduce the specified in § 400.200, which begins in
Program regulations at §§ 425.605(f), amount of an ACO’s shared losses by an January 2020. If the COVID–19 PHE
425.606(i) and 425.610(i), CMS applies amount determined by multiplying the extends through all of CY 2020, all
determinations made under the Quality shared losses by the percentage of the shared losses for PY 2020 will be
Payment Program with respect to total months in the performance year mitigated for all ACOs participating in
whether an extreme and uncontrollable affected by an extreme and a performance-based risk track:
circumstance has occurred and the uncontrollable circumstance, and the Including Track 2, the ENHANCED
affected areas. Further, CMS has sole percentage of the ACO’s assigned track, Levels C, D and E of the BASIC
discretion to determine the time period beneficiaries who reside in an area track, and the Track 1+ Model (as
during which an extreme and affected by an extreme and discussed in section II.L.6. of this IFC).
uncontrollable circumstance occurred uncontrollable circumstance (85 FR At this time, the COVID–19 PHE has
and the percentage of the ACO’s 19268). We explained that the PHE for already covered 4 months (January
assigned beneficiaries residing in the the COVID–19 pandemic applies to all through April 2020) meaning any shared
affected areas. In November 2017, we counties in the country; therefore, 100 losses an ACO incurs for PY 2020 will
issued an interim final rule with percent of assigned beneficiaries for all be reduced by at least one-third.
comment period for the Quality Shared Savings Program ACOs reside in Further, if the COVID–19 PHE extends
Payment Program entitled ‘‘Medicare an affected area. However, in describing for a large portion, if not all of the year,
Program; CY 2018 Updates to the the timeframe during which the extreme the existing extreme and uncontrollable
Quality Payment Program; and Quality and uncontrollable circumstances circumstances policy under the Shared
Payment Program: Extreme and policy would apply for mitigating Savings Program would mitigate a
Uncontrollable Circumstance Policy for shared losses because of the COVID–19 significant portion of, if not all, shared
the Transition Year’’ IFC (hereinafter pandemic, we inadvertently stated that losses an ACO may owe for PY 2020.
referred to the ‘‘Quality Payment it would begin in March 2020 and For example, if the COVID–19 PHE
Program IFC’’) (82 FR 53568), which continue through the end of the COVID– covers 6 months (January through June
appeared in the Federal Register on 19 PHE, as defined in § 400.200. This 2020) any shared losses an ACO incurs
November 16, 2017. In the Quality statement was inconsistent with the
for PY 2020 would be reduced by one-
Payment Program IFC (82 FR 53897), we beginning of the COVID–19 PHE as
half; if the COVID–19 PHE covers 9
explained that we anticipated that the defined in § 400.200 (January 2020).
months (January through September
types of events that could trigger the Therefore, we are clarifying in this IFC
2020) any shared losses an ACO incurs
extreme and uncontrollable that, for purposes of the Shared Savings
for PY 2020 would be reduced by three-
circumstances policies would be events Program, the months affected by an
fourths; and if the COVID–19 PHE
designated a FEMA major disaster or a extreme and uncontrollable
covers the full year (January through
PHE declared by the Secretary, although circumstance will begin with January
December 2020) any shared losses an
we indicated that we would review each 2020, consistent with the COVID–19
ACO incurs for PY 2020 would be
situation on a case-by-case basis. PHE determined to exist nationwide as
In the CY 2019 PFS final rule (83 FR of January 27, 2020, by the Secretary on reduced completely, and the ACO
59969), we explained our belief that the January 31, 2020, and will continue would not owe any shared losses.
extreme and uncontrollable through the end of the PHE, as defined 4. Adjustments to Shared Savings
circumstance policies under the Shared in § 400.200, which includes any Program Calculations To Address the
Savings Program address stakeholders’ subsequent renewals. COVID–19 Pandemic
concerns that ACOs participating under Catastrophic events outside the ACO’s
a performance-based risk track could be control can also increase the difficulty a. Background
held responsible for sharing losses with of coordinating care for patient Section 1899(d)(1)(B)(ii) of the Act
the Medicare program resulting from populations, and due to the addresses how ACO benchmarks are to
catastrophic events outside the ACO’s unpredictability of changes in be established and updated under the
control given the increase in utilization, utilization and cost of services Shared Savings Program. This provision
difficulty of coordinating care for furnished to beneficiaries, may have a specifies that the Secretary shall
patient populations leaving the significant impact on expenditures for estimate a benchmark for each
impacted areas, and the use of natural the applicable performance year and the agreement period for each ACO using
disaster payment modifiers making it ACO’s benchmark in the subsequent the most recent available 3 years of per
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27578 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
beneficiary expenditures for Parts A and payment models,30 and to mitigate weighting factor that would otherwise
B services for Medicare FFS shared losses owed by ACOs affected by apply to the diagnosis-related group
beneficiaries assigned to the ACO. Such extreme and uncontrollable (DRG) to which the discharge is
benchmark shall be adjusted for circumstances during PY 2017 and assigned by 20 percent. Further, the
beneficiary characteristics and such subsequent performance years.31 Secretary shall identify a discharge of
other factors as the Secretary determines Under the Shared Savings Program, such an individual through the use of
appropriate, and updated by the providers and suppliers continue to bill diagnosis codes, condition codes, or
projected absolute amount of growth in for services furnished to Medicare other such means as may be necessary.
national per capita expenditures for beneficiaries and receive FFS payments In this section of this IFC, we refer to
Parts A and B services. Section under traditional Medicare. CMS uses this increase in the weighting factor for
1899(d)(1)(B)(i) of the Act specifies that, payment amounts for Parts A and B FFS DRGs as the ‘‘DRG adjustment.’’
in each year of the agreement period, an claims for a variety of Shared Savings We anticipate that the localized
ACO is eligible to receive payment for Program operations, which include: nature of infections (for example, rapid
shared savings only if the estimated Calculations under the benchmarking outbreaks in individual nursing
average per capita Medicare methodology; determining an ACO’s facilities (NFs)) and the unanticipated
expenditures under the ACO for eligibility for shared savings and increase in expenditures, along with the
Medicare FFS beneficiaries for Parts A liability for shared losses for each increased flexibilities that have been
and B services, adjusted for beneficiary performance year under the program’s implemented to allow health care
characteristics, is at least the percent financial models as specified in the providers to identify and treat COVID–
regulations in subpart G; determining an 19 patients will affect the level of
specified by the Secretary below the
ACO’s eligibility for certain Medicare Parts A and B expenditures
applicable benchmark under section
participation options as set forth in during 2020, both for the Medicare FFS
1899(d)(1)(B)(ii) of the Act.
§ 425.600(d); and calculating the beneficiaries assigned to ACOs and for
Section 1899(i)(3) of the Act grants amount of the repayment mechanism the other populations of Medicare FFS
the Secretary the authority to use other required for ACOs participating in a beneficiaries whose expenditures are
payment models if the Secretary two-sided model according to considered in performing calculations
determines that doing so would improve § 425.204(f)(4). These operations under the Shared Savings Program. The
the quality and efficiency of items and typically require the determination of localized nature of outbreaks and the
services furnished under Title XVIII and expenditures for Parts A and B services increased utilization of acute care
the alternative methodology would under the original Medicare FFS occurring in PY 2020 and the associated
result in program expenditures equal to program for a specified population of higher costs are not reflected in ACOs’
or lower than those that would result Medicare FFS beneficiaries or the historical benchmarks, which are
under the statutory payment model. The Medicare Parts A and B FFS revenue of determined under §§ 425.601(b),
authority under section 1899(i)(3) of the ACO participants. We note that the 425.602(b), or 425.603(d), as applicable,
Act to use other payment models Medicare FFS beneficiary population for based on Parts A and B expenditures for
includes authority to adopt alternatives which expenditures are determined may the beneficiaries who would have been
to the benchmarking methodology set differ depending on the specific assigned to that ACO during the three
forth in section 1899(d)(1)(B)(ii) of the program operation being performed and benchmark years. For some ACOs, the
Act, and alternatives to the methodology may reflect expenditures for the ACO’s higher costs associated with COVID–19
for determining expenditures for each assigned beneficiaries, assignable may not be fully accounted for (or in
performance year as set forth in section beneficiaries as defined in § 425.20, or other cases may be over-represented) by
1899(d)(1)(B)(i) of the Act. As discussed all Medicare FFS beneficiaries. The the retrospective application of the
in earlier rulemaking, we have used our applicable Medicare FFS beneficiary update factor to the benchmark at the
authority under section 1899(i)(3) of the population is specified in the time of financial reconciliation. In
Act to adopt alternative policies to the regulations governing each program addition, the prospective CMS–HCC risk
provisions of section 1899(d)(1)(B) of operation. scores, which are used to adjust the
the Act for updating the historical historical benchmark each performance
benchmark,28 and calculating b. Removing Payment Amounts for year for changes in severity and case
performance year expenditures.29 We Episodes of Care for Treatment of mix (refer to §§ 425.601(a)(10),
have also used our authority under COVID–19 From Shared Savings 425.602(a)(9) and 425.603(c)(10); and
section 1899(i)(3) of the Act to establish Program Expenditure and Revenue §§ 425.604(a)(1), 425.605(a)(1),
the Shared Savings Program’s two-sided Calculations 425.606(a)(1), 425.610(a)(1), (2)), would
Section 3710 of the CARES Act not be expected to meaningfully adjust
28 Such as using only assignable beneficiaries
amended section 1886(d)(4)(C) of the for such variability because they are
instead of all Medicare FFS beneficiaries in Act to specify that for discharges prospective, and therefore, use
calculating the benchmark update based on national
occurring during the emergency period diagnoses from 2019 to predict costs in
FFS expenditures (81 FR 37986–37989), calculating 2020.
the benchmark update using factors based on described in section 1135(g)(1)(B) of the
Furthermore, including the increased
regional FFS expenditures (81 FR 37977–37981), Act, in the case of a discharge of an
and calculating the benchmark update using a expenditures related to treatment of
individual diagnosed with COVID–19,
blend of national and regional expenditure growth COVID–19 in calculations of ACO
rates (83 FR 68027–68030). the Secretary shall increase the
benchmarks for which CY 2020 is a
29 Such as excluding indirect medical education
30 See earlier rulemaking establishing two-sided
benchmark year could lead to higher
and disproportionate share hospital payments from
ACO performance year expenditures (76 FR 67921– models: Track 2 (76 FR 67904–67909), Track 3 than anticipated future historical
67922), and determining shared savings and shared (subsequently renamed the ENHANCED track) (80 benchmarks unnecessarily advantaging
losses for the 6-month performance years (or FR 32771–32772), and the BASIC track (83 FR some ACOs once the prevalence of
performance period) in 2019 using expenditures for 67834–67841). COVID–19 in the population begins to
the entire CY 2019 and then pro-rating these 31 See earlier rulemaking establishing policies for
amounts to reflect the shorter performance year or mitigating shared losses owed by ACOs affected by
decrease, and the corresponding
performance period (83 FR 59949–59951, 83 FR extreme and uncontrollable circumstances (82 FR reduction in expenditures is reflected in
67950–67956). 60916–60917, 83 FR 59974–59977). performance year expenditures. In
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27579
contrast, we anticipate that the decisions in advance of this June 1, Shared Savings Program calculations all
methodology used to update 2020 deadline, and may choose to Parts A and B FFS payment amounts for
benchmarks will appropriately reflect terminate their participation in the an episode of care for treatment of
any reduction in expenditures due to a Shared Savings Program on or before COVID–19, triggered by an inpatient
cumulative yearlong decline in elective June 30th, rather than risk owing pro- service, and as specified on Parts A and
services and the deferral of other rated shared losses for PY 2020. We note B claims with dates of service during
services as a result of regionally-uniform that as we explain in section II.L.3. of the episode. We are relying on our
responses by beneficiaries and this IFC, the Shared Savings Program’s authority under section 1899(d)(1)(B)(ii)
providers/suppliers to directives issued extreme and uncontrollable of the Act to adjust benchmark
at federal, state, and local levels. circumstances policy will mitigate expenditures for other factors in order to
Therefore, the retrospective application shared losses for these ACOs. However, remove COVID–19-related expenditures
of the historical benchmark update given the uncertainty surrounding from the determination of benchmark
(which for PY 2020 is either an update whether the COVID–19 PHE will cover expenditures. As discussed elsewhere in
factor based on national growth rates, the entire year and absent information this section, we are also exercising our
regional growth rates, or a blend of regarding the steps that CMS intends to authority under section 1899(i)(3) of the
national and regional growth rates, take to address the high costs associated Act to apply this adjustment to certain
depending on the start date of the ACO’s with COVID–19 patients, many risk- other program calculations, including
agreement period) is expected to based ACOs may choose to leave the the determination of performance year
reasonably account for lower utilization program by June 30, 2020, to avoid the expenditures.
of services by non-COVID–19 patients risk of owing shared losses.
and prevent windfall shared savings We believe it is necessary to revise the We believe an approach that makes
payments to ACOs for PY 2020. policies governing Shared Savings the triggering event for this adjustment
Including payment amounts for Program financial calculations, as well the beneficiary’s receipt of inpatient
treatment of acute care for COVID–19 in as certain other program operations, to care for COVID–19, will identify the
calculations for which calendar year mitigate the impact of unanticipated most acutely ill patients and, as a result,
2020 is used as a reference year could increased expenditures related to the those patients with the highest-costs
also distort repayment mechanism treatment of COVID–19. Given that associated with acute care treatment. In
estimates and the identification of high ACOs in two-sided models have very contrast, we believe that treatment for
and low revenue ACOs and influence limited time (less than 2 months at the COVID–19 that does not result in an
ACO participation options. For time of development of this IFC) to inpatient admission does not raise the
example, ACOs could potentially be decide whether to continue their same level of concern in terms of
misclassified as either high revenue or participation in the program or generating unexpected performance year
low revenue, due to changes in voluntarily terminate without being expenditures that are not appropriately
expenditures arising from the COVID– liable for shared losses, we believe there reflected in the benchmark calculations.
19 pandemic, and either moved more is an urgent need to establish policies As William Bleser and colleagues have
quickly to higher levels of risk and that address the impact of COVID–19 on described,32 citing a recent actuarial
reward if they are identified as high Shared Savings Program financial estimate of COVID–19 costs,33
revenue ACOs or allowed additional calculations. More generally, ACOs outpatient care was approximately 10
time under a one-sided model (if engage in care coordination and percent of the cost of hospital care,
eligible) or in relatively lower levels of population-based activities for Medicare indicating that hospital costs are the
performance-based risk if they are FFS beneficiaries, as they work towards dominant source of overall costs for
identified as low revenue ACOs. achieving the Shared Savings Program’s treatment of COVID–19. We believe
ACOs currently participating in a goals of lowering growth in Medicare these findings support an approach that
performance-based risk track have an FFS expenditures and improving the bases the exclusion of expenditures on
urgent need to understand how we will quality of care furnished to Medicare the triggering event of an inpatient
address any distortions in expenditures beneficiaries. We believe there is an admission for treatment of COVID–19.
resulting from the COVID–19 pandemic. urgency in taking steps to avoid Furthermore, we believe that some
Under the Shared Savings Program’s adversely impacting ACOs, many of outpatient care will occur close-in-time
regulations at § 425.221(b)(2)(ii)(A), an which have rapidly adapted to current to an eventual inpatient admission and
ACO under a two-sided model that circumstances in order to continue to following discharge. Under the
voluntarily terminates its participation coordinate care and deliver value-based approach we are establishing, where an
agreement with an effective date of care to Medicare FFS beneficiaries and episode of care includes the month of
termination after June 30th of the meet program goals. In the absence of admission and the month following
applicable performance year is liable for policies that adjust certain program discharge, outpatient care occurring
a pro-rated share of any shared losses calculations to remove payment within the timeframe for an episode of
determined for that performance year. amounts for episodes of care for care would also be excluded from
Under § 425.220(a) of the regulations, treatment of COVID–19, ACOs may financial calculations.
ACOs are required to provide CMS at choose to leave the Shared Savings
least 30 days’ advance notice of their Program, setting back progress made in 32 Bleser WK, et al. Maintaining Progress Toward
decision to voluntarily terminate from transitioning the health care system Accountable Care And Payment Reform During A
the program. As a result, ACOs that are from volume-based to value-based Pandemic, Part 1: Utilization And Financial Impact.
Health Affairs. April 14, 2020. Available at https://
participating under a two-sided model payment. For these reasons, we find www.healthaffairs.org/do/10.1377/
would need to provide notice to CMS no good cause to waive prior notice and hblog20200410.281882/full/.
later than June 1, 2020, to avoid liability comment rulemaking to establish 33 COVERED California. The Potential National
for a pro-rated share of any shared policies to mitigate the impact of the Health Cost Impacts to Consumers, Employers and
losses that may be determined for PY COVID–19 pandemic on Shared Savings Insurers Due to the Coronavirus (COVID–19).
Policy/Actuarial Brief (March 22, 2020). Available
2020. ACOs and other program Program financial calculations. at https://hbex.coveredca.com/data-research/
stakeholders have expressed concern We are revising our policies under the library/COVID-19-NationalCost-Impacts03-21-
that ACOs need to make participation Shared Savings Program to exclude from 20.pdf.
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27580 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Accordingly, under the approach we ‘‘Medicare Program; Medicare Shared between an ACO’s performance year
are adopting in this IFC, we will Savings Program; Accountable Care expenditures and its historical
identify an episode of care triggered by Organizations—Revised Benchmark benchmark and will help to ensure that
an inpatient service for treatment of Rebasing Methodology, Facilitating ACOs are not rewarded or penalized for
COVID–19, based on either: (1) Transition to Performance-Based Risk, having higher/lower COVID–19 spread
Discharges for inpatient services eligible and Administrative Finality of Financial in their assigned beneficiary
for the 20 percent DRG adjustment Calculations’’, which appeared in the populations which, in turn, will help to
under section 1886(d)(4)(C) of the Act; Federal Register on June 10, 2016 (81 protect CMS against paying out windfall
or (2) discharges for acute care inpatient FR 37950), we account for shared savings and ACOs in two-sided
services for treatment of COVID–19 from circumstances where a beneficiary is models from owing excessive shared
facilities that are not paid under the enrolled in a Medicare enrollment type losses. Further, as described previously
IPPS, such as CAHs, when the date of for only a fraction of a year (see 81 FR in this section of this IFC, we believe
admission occurs within the COVID–19 37981). Specifically, we determine the that the retrospective application of the
PHE as defined in § 400.200. number of months that an assigned historical benchmark update, which
For example, we will identify beneficiary is enrolled in each specific will be calculated based on factors that
discharges of an individual diagnosed Medicare enrollment type and divide by reflect actual expenditure and
with COVID–19 using the following 12. Summing these fractions across all utilization changes nationally and
ICD–10–CM codes: assigned beneficiaries in each Medicare regionally, other than expenditures for
• B97.29 (Other coronavirus as the enrollment type results in total person episodes of care for treatment of
cause of diseases classified elsewhere) years for the beneficiaries assigned to COVID–19, will also help to mitigate the
for discharges occurring on or after the ACO. Benchmark and performance potential for windfall savings due to
January 27, 2020, and on or before year expenditures for each enrollment potentially lower utilization of services
March 31, 2020. type are calculated on a per capita basis. not related to treatment for COVID–19.
• U07.1 (COVID–19) for discharges The numerator of the per capita We will adjust the following Shared
occurring on or after April 1, 2020, expenditure calculation for a particular Savings Program calculations to exclude
through the duration of the COVID–19 enrollment type reflects the total Parts A all Parts A and B FFS payment amounts
PHE period, as defined in § 400.200.34 and B expenditures incurred by all for a beneficiary’s episode of care for
Episodes of care for treatment of assigned beneficiaries in that enrollment treatment of COVID–19:
COVID–19 may be triggered by an type during the year, with adjustments • Calculation of Medicare Parts A and
inpatient admission for acute care either made to exclude indirect medical B FFS expenditures for an ACO’s
at an acute care hospital or other education and disproportionate share assigned beneficiaries for all purposes,
healthcare facility, which may include hospital payments, to include including the following: Establishing,
temporary expansion sites, Medicare- individually beneficiary identifiable adjusting, updating, and resetting the
enrolled ASCs providing hospital final payments made under a ACO’s historical benchmark and
services to help address the urgent need demonstration, pilot or time limited determining performance year
to increase hospital capacity to treat program, and to truncate beneficiary expenditures.
COVID–19 patients, CAHs, and expenditures to minimize variation from • Calculation of FFS expenditures for
potentially other types of providers.35 catastrophically large claims. The assignable beneficiaries as used in
We will define the episode of care as denominator reflects total person years determining county-level FFS
starting in the month in which the for the enrollment type. expenditures and national Medicare
inpatient stay begins as identified by the In addition to excluding Parts A and FFS expenditures, including the
admission date, all months during the B payment amounts with dates of following calculations:
inpatient stay, and the month following service in the months associated with an ++ Determining average county FFS
the end of the inpatient stay as episode of care for treatment of COVID– expenditures based on expenditures for
indicated by the discharge date. This 19, we will also exclude the affected the assignable population of
approach to measuring the length of the months from total person years used in beneficiaries in each county in the
episode of care in units of months aligns per capita expenditure calculations. For ACO’s regional service area according to
with the Shared Savings Program’s example, if a beneficiary had an episode §§ 425.601(c) and 425.603(e) for
existing methodology for calculating of care for COVID–19 that lasted for 2 purposes of calculating the ACO’s
benchmark year and performance year months, but was otherwise enrolled as regional FFS expenditures. For example,
expenditures by performing separate an aged/non-dual eligible beneficiary for for ACOs in agreement periods
calculations for each of four Medicare the full calendar PY, we will exclude beginning on July 1, 2019, and in
enrollment types (ESRD, disabled, aged/ their Parts A and B expenditures for subsequent years, we will use county
dual eligible for Medicare and those two months and compute their FFS expenditures from which we
Medicaid, and aged/non-dual eligible fraction of the year enrolled in the aged/ exclude all Parts A and B FFS payment
for Medicare and Medicaid). As non-dual eligible population as 10/12. amounts for a beneficiary’s episode of
described in the final rule entitled Adjusting both expenditures and person care for treatment of COVID–19 in
years will ensure that both the determining the regional component of
34 See for example, MLN Matters, ‘‘New Waivers numerator and denominator used to the blended national and regional
for Inpatient Prospective Payment System (IPPS) calculate per capita expenditures are growth rates used to (1) trend forward
Hospitals, Long-Term Care Hospitals (LTCHs), and based on the same number of months of benchmark year 1 and benchmark year
Inpatient Rehabilitation Facilities (IRFs) due to 2 expenditures to benchmark year 3
Provisions of the CARES Act’’ (April 15, 2020),
beneficiary experience and allow ACOs
available at https://www.cms.gov/files/document/ to be treated equitably regardless of the according to § 425.601(a)(5)(iii), and (2)
se20015.pdf. degree to which their assigned to update the benchmark according to
35 See CMS fact sheet, ‘‘Hospitals: CMS
beneficiary population is affected by the § 425.601(b)(3). Further, we will use
Flexibilities to Fight COVID–19’’, dated March 30, pandemic. county expenditures from which we
2020, available at https://www.cms.gov/files/
document/covid-hospitals.pdf, describing
We believe that the approach exclude all Parts A and B FFS payment
flexibilities CMS specified for hospitals for the described in this section will provide amounts for a beneficiary’s episode of
provision of inpatient care to fight COVID–19. for a more equitable comparison care for treatment of COVID–19 to
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27581
update the ACO’s rebased historical We note that there are certain from program calculations expenditures
benchmark, according to § 425.603(d) payments related to the COVID–19 PHE that are outside of an ACO’s control, but
for ACOs in a second agreement period that fall outside of Medicare FFS Parts that could significantly affect the ACO’s
beginning on or before January 1, 2019, A and B claims, and by virtue of this performance under the program. In
based on regional growth rates in fact, these payments would not be particular, we believe that failing to
Medicare FFS expenditures. utilized under the Shared Savings remove this spending would likely
++ Determining the 99th percentile of Program methodology for determining create highly variable savings and loss
national Medicare FFS expenditures for beneficiary expenditures. For example, results for individual ACOs that happen
assignable beneficiaries for purposes of we would not account for recoupment to have over-representation or under-
the following: (1) Truncating assigned of accelerated or advance payments,36 representation of COVID–19
beneficiary expenditures used in which occurs outside of the FFS claims hospitalizations in their assigned
calculating benchmark expenditures processing system. This is because the beneficiary populations.
(§§ 425.601(a)(4), 425.602(a)(4), underlying Parts A and B claims used in As described in the Regulatory Impact
425.603(c)(4)), and performance year Shared Savings Program expenditure Analysis (section VI. of this IFC), we do
expenditures (§§ 425.604(a)(4), calculations would continue to reflect not believe excluding payment amounts
425.605(a)(3), 425.606(a)(4), the amount the providers/suppliers are for episodes of care for treatment of
425.610(a)(4)); and (2) truncating eligible to be paid, although that COVID–19 from the specified
expenditures for assignable beneficiaries payment may be subject to offset for calculations will result in an increase in
in each county for purposes of repayment of accelerated or advance spending beyond the expenditures that
determining county FFS expenditures payments. Further, Shared Savings would otherwise occur under the
according to §§ 425.601(c)(3) and Program expenditure calculations statutory payment methodology in
425.603(e)(3). would also not account for lump sum section 1899(d) of the Act. Further, we
++ Determining 5 percent of national payments made to hospitals and other believe that these adjustments to our
per capita expenditures for Parts A and healthcare providers through the CARES payment calculations to remove
B services under the original Medicare Act Provider Relief Fund,37 that occur expenditures associated with treatment
FFS program for assignable beneficiaries outside of Parts A and B claims. We will of COVID–19, in combination with the
for purposes of capping the regional continue to capture Medicare FFS Parts optional 1-year extension for ACOs
adjustment to the ACO’s historical A and B payments to providers/ whose current agreement periods expire
benchmark according to suppliers in Shared Savings Program on December 31, 2020 (as discussed in
§ 425.601(a)(8)(ii)(C). calculations from hospitals and other section II.L.1. of this IFC), and the
healthcare providers receiving these option for ACOs in the BASIC track’s
++ Determining the flat dollar
funds. glide path to elect to maintain their
equivalent of the projected absolute
It is necessary to use our authority current level of risk and reward for PY
amount of growth in national per capita
under section 1899(i)(3) of the Act to 2021 (as discussed in section II.L.2. of
expenditures for Parts A and B services
remove payment amounts for episodes this IFC) will provide greater certainty
under the original Medicare FFS
of care for treatment of COVID–19 from for currently participating ACOs. As a
program for assignable beneficiaries, for
the following calculations: (1) result, we expect these policies will
purposes of updating the ACO’s
Performance year expenditures; (2) support ACOs’ continued participation
historical benchmark according to
updates to the historical benchmark; in the Shared Savings Program in the
§ 425.602(b)(2).
and (3) ACO participants’ Medicare FFS face of significant uncertainty arising
++ Determining national growth rates from the disruptions due to the COVID–
that are used as part of the blended revenue used to determine the loss
sharing limit in the two-sided models of 19 pandemic and the resulting PHE.
growth rates used to trend forward This, in turn, means that these
benchmark year 1 and benchmark year the BASIC track. To use our authority
under section 1899(i)(3) of the Act to organizations would continue working
2 expenditures to benchmark year 3 towards meeting the Shared Savings
according to § 425.601(a)(5)(ii) and as adopt an alternative payment
methodology to remove payment Program’s goals of lowering growth in
part of the blended growth rates used to Medicare FFS expenditures and
update the benchmark according to amounts for episodes of care for
treatment of COVID–19 from these improving the quality of care furnished
§ 425.601(b)(2). to Medicare beneficiaries.
• Calculation of Medicare Parts A and calculations, we must determine that
the alternative payment methodology Based on these considerations, and as
B FFS revenue of ACO participants for specified in the Regulatory Impact
purposes of calculating the ACO’s loss will improve the quality and efficiency
of items and services furnished to Analysis (section VI. of this IFC), we
recoupment limit under the BASIC track believe adjusting certain Shared Savings
as specified in § 425.605(d). Medicare beneficiaries, without
resulting in additional program Program calculations to remove
• Calculation of total Medicare Parts payment amounts for episodes of care
A and B FFS revenue of ACO expenditures. We believe that these
adjustments, which will remove for treatment of COVID–19 from the
participants and total Medicare Parts A calculation of performance year
and B FFS expenditures for the ACO’s payment amounts for episodes of care
expenditures, updates to the historical
assigned beneficiaries for purposes of for treatment of COVID–19 from the
benchmark, and ACO participants’
identifying whether an ACO is a high specified Shared Savings Program
Medicare FFS revenue used to
revenue ACO or low revenue ACO, as calculations, will capture and remove
determine the loss sharing limit in the
defined under § 425.20, and 36 See CMS, ‘‘Fact Sheet: Expansion of the
two-sided models of the BASIC track,
determining an ACO’s eligibility for Accelerated and Advance Payments Program for meets the requirements for use of our
participation options according to Providers and Suppliers During COVID–19 authority under section 1899(i)(3) of the
§ 425.600(d). Emergency,’’ available at https://www.cms.gov/files/ Act.
• Calculation or recalculation of the document/accelerated-and-advanced-payments- We also acknowledge that some
fact-sheet.pdf.
amount of the ACO’s repayment 37 See HHS website, CARES Act Provider Relief trends and longer lasting effects of the
mechanism arrangement according to Fund, at https://www.hhs.gov/provider-relief/ COVID–19 pandemic are challenging to
§ 425.204(f)(4). index.html. anticipate at the time of development of
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27582 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
this IFC, and we will continue to • 99319 through 99340 (codes for In the March 31st COVID–19 IFC, to
evaluate the ongoing impact of the patient domiciliary, rest home, or facilitate the use of telecommunications
COVID–19 pandemic to determine custodial care visit). technology as a safe substitute for in-
whether additional rulemaking is • 99341 through 99350 (codes for person services, we added, on an
necessary to further adjust Shared evaluation and management services interim basis, many services to the list
Savings Program policies. For example, furnished in a patient’s home for claims of eligible Medicare telehealth services,
it is unclear whether the COVID–19 identified by place of service modifier eliminated frequency limitations and
pandemic may have longer-term effects 12). other requirements associated with
into 2021, such as through rebounding • 99487, 99489 and 99490 (codes for particular services furnished via
elective procedure costs in 2021 chronic care management). telehealth, and clarified several
following potentially sustained • 99495 and 99496 (codes for payment rules that apply to other
reductions in 2020 or to what extent the transitional care management services). services that are furnished using
reduction in these procedures may • 99497 and 99498 (codes for telecommunications technologies that
persist. Further, we anticipate learning advance care planning). can reduce exposure risks (85 FR
more about the potential longer-term • 96160 and 96161 (codes for 19232).
implications of the COVID–19 pandemic administration of health risk Section 1834(m) of the Act specifies
on Medicare beneficiaries’ health and assessment). the payment amounts and
the health care system. • 99354 and 99355 (add-on codes, for circumstances under which Medicare
We are adding a new provision at prolonged evaluation and management makes payment for a discrete set of
§ 425.611 to describe the adjustments or psychotherapy services beyond the services, all of which must ordinarily be
CMS will make to Shared Savings typical service time of the primary furnished in-person, when they are
Program calculations to address the procedure; when the base code is also instead furnished using interactive, real-
impact of the COVID–19 pandemic. a primary care service code). time telecommunication technology.
• 99484, 99492, 99493 and 99494 When furnished under the telehealth
We seek comment on the approach to (codes for behavioral health integration rules, many of these specified Medicare
adjusting program calculations to services). telehealth services are still reported
mitigate the financial impact of the HCPCS codes: using codes that describe ‘‘face-to-face’’
COVID–19 pandemic on ACOs that we • G0402 (code for the Welcome to services but are furnished using audio/
are establishing with this IFC. Medicare visit). video, real-time communication
5. Expansion of Codes Used in • G0438 and G0439 (codes for the technology instead of in-person. As
Beneficiary Assignment annual wellness visits). such, the majority of the codes for
• G0463 (code for services furnished primary care services included in the
a. Background in ETA hospitals). additional telehealth services added in
Section 1899(c)(1) of the Act, as • G0506 (code for chronic care the March 31st COVID–19 IFC on an
amended by the 21st Century Cures Act management). interim basis for the duration of the PHE
(Pub. L. 114–255, enacted December 13, • G0444 (code for annual depression for COVID–19 are already included in
2016) and the Bipartisan Budget Act of screening service). the definition of primary care services
2018 (BBA 2018) (Pub. L. 115–123, • G0442 (code for alcohol misuse for purposes of the Shared Savings
enacted February 9, 2018), provides that screening service). Program assignment methodology in
for performance years beginning on or • G0443 (code for alcohol misuse § 425.400(c)(1)(iv).
after January 1, 2019, the Secretary shall counseling service). The March 31st COVID–19 IFC also
On March 17, 2020, we announced established flexibilities and separate
assign beneficiaries to an ACO based on
the expansion of payment for telehealth payment for certain services that are
their utilization of primary care services
services on a temporary and emergency furnished virtually using technologies
provided by physicians participating in
basis pursuant to waiver authority but that are not considered Medicare
the ACO and all services furnished by
added under section 1135(b)(8) of the telehealth services such as virtual
RHCs and Federally Qualified Health
Act by the Coronavirus Preparedness check-ins, e-visits, and telephone E/M
Centers (FQHCs) that are ACO
and Response Supplemental services, for which payment has been
participants. However, the statute does
Appropriations Act, 2020 such that authorized during the COVID–19 PHE.
not specify which kinds of services may
Medicare can pay for telehealth The codes for these virtual services are
be considered primary care services for
services, including office, hospital, and not currently included in the definition
purposes of beneficiary assignment.
other visits furnished by physicians and of primary care services for purposes of
For performance years beginning on other practitioners to patients located the Shared Savings Program assignment
January 1, 2019, and subsequent anywhere in the country, including in a methodology. We believe it is critical to
performance years, we defined primary patient’s place of residence, starting include these additional codes in the
care services in § 425.400(c)(1)(iv) for March 6, 2020. In the context of the PHE definition of primary care services to
purposes of assigning beneficiaries to for the COVID–19 pandemic, we ensure these services are included in
ACOs under § 425.402 as the set of recognize that physicians and other our determination of where
services identified by the following health care professionals are faced with beneficiaries receive the plurality of
HCPCS/CPT codes: new challenges regarding potential their primary care for purposes of
CPT codes: exposure risks, including for Medicare beneficiary assignment, so that the
• 99201 through 99215 (codes for beneficiaries, for health care providers, assignment methodology appropriately
office or other outpatient visit for the and for members of the community at reflects the expanded use of technology
evaluation and management of a large. For example, the CDC has urged that is helping people who need routine
patient). health care professionals to make every care during the PHE for the COVID–19
• 99304 through 99318 (codes for effort to interview persons under pandemic and allowing vulnerable
professional services furnished in a NF; investigation for COVID–19 infection by beneficiaries and beneficiaries with
services identified by these codes telephone, text messaging system, or mild symptoms to remain in their
furnished in a SNF are excluded). video conference instead of in-person. homes, while maintaining access to the
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27583
care they need. By including services or whether they have designated an services that could be furnished via
provided virtually, either through ACO professional as their primary telecommunications technology, but
telehealth, virtual check-ins, e-visits or clinician, responsible for their overall that are not Medicare telehealth
telephone, in the definition of primary care, and hold ACOs accountable for the services. Specifically, beginning with
care services, we ensure that physicians resulting assigned beneficiary CY 2019, we finalized separate payment
and other practitioners can offer options population. Including these codes in the for remote evaluation of video and/or
to beneficiaries whom they treat, while definition of primary care services used images, HCPCS code G2010 (Remote
also allowing this care to be included in in assignment for performance years evaluation of recorded video and/or
our consideration of where beneficiaries during the PHE for the COVID–19 images submitted by an established
receive the plurality of their primary pandemic will result in a more accurate patient (e.g., store and forward),
care, for purposes of assigning identification of where beneficiaries including interpretation with follow-up
beneficiaries to ACOs. As a result, have received the plurality of their with the patient within 24 business
revising the definition of primary care primary care services. hours, not originating from a related E/
services used in assignment to include In preamble discussion below, we are M service provided within the previous
these services will further allow for also clarifying that CPT codes 99304, 7 days nor leading to an E/M service or
continuity and coordination of care. We 99305 and 99306, 99315 and 99316, procedure within the next 24 hours or
also reiterate our policy defined at 99327 and 99328, 99334 through 99337, soonest available appointment), and
§ 425.404(b) that, for performance years 99341 through 99345, and 99347 virtual check-in, HCPCS code G2012
starting on January 1, 2019, and through 99350 will be included in the (Brief communication technology-based
subsequent performance years, under assignment methodology when these service, e.g. virtual check-in, by a
the assignment methodology in services are furnished using telehealth, physician or other qualified health care
§ 425.402, CMS treats a service reported consistent with additions to the professional who can report E/M
on an FQHC/RHC claim as a primary Medicare telehealth list for the duration services, provided to an established
care service performed by a primary of the PHE for the COVID–19 pandemic patient, not originating from a related E/
care physician. as discussed in the March 31st COVID– M service provided within the previous
19 IFC (85 FR 19235 through 19237). We 7 days nor leading to an E/M service or
b. Use of Codes for Virtual Check-Ins, use the assignment methodology procedure within the next 24 hours or
Remote Evaluation E-Visits, Telephone described in §§ 425.402 and 425.404 for soonest available appointment; 5–10
Evaluation and Management Services, purposes of assigning beneficiaries to minutes of medical discussion).
and Telehealth in Beneficiary ACOs for a performance year or These codes were finalized as part of
Assignment benchmark year based on preliminary the set of codes that is only reportable
Based on feedback from ACOs and the prospective assignment with by the physicians and practitioners who
expansion of payment, on an interim retrospective reconciliation (including can furnish E/M services. Per the March
basis, for the virtual services discussed quarterly updates) or prospective 31st COVID–19 IFC, on an interim basis
above, we are revising the definition of assignment. for the PHE for the COVID–19
primary care services used in the Shared With the emergence of the virus that pandemic, we will allow these codes to
Savings Program assignment causes COVID–19, there is an urgency to be used for new patients. In the March
methodology for the performance year expand the use of technology to allow 31st COVID–19 IFC (85 FR 19244), we
starting on January 1, 2020, and for any people who need routine care, explained that, in the context of the PHE
subsequent performance year that starts vulnerable beneficiaries, and for the COVID–19 pandemic, when brief
during the PHE for the COVID–19 beneficiaries with mild symptoms to communications with practitioners and
pandemic, as defined in § 400.200, to remain in their homes, while other non-face-to-face services might
include the following additions: (1) maintaining access to the care they mitigate the need for an in-person visit
HCPCS code G2010 (remote evaluation need. Limiting community spread of the that could represent an exposure risk for
of patient video/images) and HCPCS virus, as well as limiting beneficiaries’ vulnerable patients, we believe that
code G2012 (virtual check-in); (2) CPT exposure to other patients and health these services should be available to as
codes 99421, 99422 and 99423 (online care staff members, will slow viral large a population of Medicare
digital evaluation and management spread. We anticipate that the patterns beneficiaries as possible. In some cases,
service (e-visit)); and (3) CPT codes and types of care provided during the use of telecommunication technology
99441, 99442, and 99443 (telephone COVID–19 PHE will be different and, in could mitigate the exposure risk, and in
evaluation and management services). an effort to capture these changes in the such cases, the clinical benefit of using
Because the services listed above and methodology used to assign technology to furnish the service is self-
described in detail in the preamble beneficiaries to ACOs as soon as apparent. This would be especially true
discussion below are similar to and may possible, so that ACOs, particularly should a significant increase in the
replace an E/M service for a beneficiary, those that have elected preliminary number of people or health care
we believe it is appropriate to include prospective assignment with professionals needing treatment or
these CPT and HCPCS codes in the retrospective reconciliation for PY 2020, isolation occur in a way that would
definition of primary care services used can understand the beneficiary limit access to brief communications
for assignment because the services population for which they will be with established providers. Therefore,
represented by these codes are being responsible during PY 2020, we have on an interim basis, during the PHE for
used in place of similar E/M services, determined that there is good cause to the COVID–19 pandemic, we finalized
the codes for which are already waive prior notice and comment that these services, which may only be
included in the list of codes used for rulemaking in order to implement these reported if they do not result in a visit,
assignment. We believe it is important changes to the definition of primary care including a telehealth visit, can be
to include these services in our services in § 425.400(c) immediately. furnished to both new and established
assignment methodology because we As discussed in the March 31st patients
determine assignment to ACOs based COVID–19 IFC (85 FR 19244), in the CY As discussed in the March 31st
upon where beneficiaries receive the 2019 PFS final rule, we finalized COVID–19 IFC (85 FR 19254), in the CY
plurality of their primary care services separate payment for a number of 2019 PFS final rule (83 FR 59452), we
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27584 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
finalized payment for new online digital 19265) and as discussed previously in qualified nonphysician health care
assessment services, also referred to as this IFC, CMS finalized, on an interim professional to an established patient,
‘‘E-Visits,’’ beginning with CY 2020 for basis for the duration of the PHE for the parent, or guardian not originating from
practitioners billing under the PFS. COVID–19 pandemic, separate payment a related assessment and management
These are non-face-to-face, patient- for CPT codes 99441 through 99443 and service provided within the previous 7
initiated communications using online 98966 through 98968, which describe E/ days nor leading to an assessment and
patient portals. These digital assessment M and assessment and management management service or procedure
services are for established patients who services furnished via telephone. While within the next 24 hours or soonest
require a clinical decision that the code descriptors for these services available appointment; 5–10 minutes of
otherwise typically would have been refer to an ‘‘established patient’’ during medical discussion.)
provided in the office. Per the March the COVID–19 PHE we are exercising • 98967 (Telephone assessment and
31st COVID–19 IFC (85 FR 19244), enforcement discretion on an interim management service provided by a
while the code descriptors for these e- basis to relax enforcement of this aspect qualified nonphysician health care
visit codes refer to an ‘‘established of the code descriptors. Practitioners professional to an established patient,
patient’’, during the PHE for the who may independently bill Medicare parent, or guardian not originating from
COVID–19 pandemic, we are exercising for E/M visits (for instance, physicians a related assessment and management
enforcement discretion on an interim and NPs) can bill the following codes: service provided within the previous 7
basis to relax enforcement of this aspect • 99441 (Telephone evaluation and days nor leading to an assessment and
of the code descriptors. Practitioners management service by a physician or management service or procedure
who may independently bill Medicare other qualified health care professional within the next 24 hours or soonest
for E/M visits (for instance, physicians who may report evaluation and available appointment; 11–20 minutes
and NPs) can bill the following codes: management services provided to an of medical discussion.)
• 99421 (Online digital evaluation established patient, parent, or guardian • 98968 (Telephone assessment and
and management service, for an not originating from a related E/M management service provided by a
established patient, for up to 7 days, service provided within the previous 7 qualified nonphysician health care
cumulative time during the 7 days; 5–10 days nor leading to an E/M service or professional to an established patient,
minutes.) procedure within the next 24 hours or parent, or guardian not originating from
• 99422 (Online digital evaluation soonest available appointment; 5–10 a related assessment and management
and management service, for an minutes of medical discussion.) service provided within the previous 7
established patient, for up to 7 days • 99442 (Telephone evaluation and days nor leading to an assessment and
cumulative time during the 7 days; 11– management service by a physician or management service or procedure
20 minutes.) other qualified health care professional within the next 24 hours or soonest
• 99423 (Online digital evaluation who may report evaluation and available appointment; 21–30 minutes
and management service, for an management services provided to an of medical discussion.)
established patient, for up to 7 days, established patient, parent, or guardian Several codes, detailed below, that are
cumulative time during the 7 days; 21 not originating from a related E/M included on the ‘‘Covered Telehealth
or more minutes.) service provided within the previous 7 Services for PHE for the COVID–19
We also considered adding additional days nor leading to an E/M service or pandemic, effective March 1, 2020’’ list
e-visit HCPCS codes which are used by procedure within the next 24 hours or available at https://www.cms.gov/
clinicians who may not independently soonest available appointment; 11–20 Medicare/Medicare-General-
bill for E/M visits and who are not minutes of medical discussion.) Information/Telehealth/Telehealth-
included in the definition of ACO • 99443 (Telephone evaluation and Codes, are already included in the
professional in § 425.20 (for example, management service by a physician or definition of primary care services used
PTs, OTs, SLPs, CPs). However, because other qualified health care professional in the Shared Savings Program
these services are not furnished by ACO who may report evaluation and assignment methodology:
professionals, we determined it was not management services provided to an • 99304 (Initial nursing facility care,
necessary to include the following codes established patient, parent, or guardian per day, for the evaluation and
in our definition of primary care not originating from a related E/M management of a patient, which
services for use in assignment: service provided within the previous 7 requires these 3 key components: A
• G2061 (Qualified nonphysician days nor leading to an E/M service or detailed or comprehensive history; A
healthcare professional online procedure within the next 24 hours or detailed or comprehensive examination;
assessment and management service, soonest available appointment; 21–30 and Medical decision making that is
for an established patient, for up to minutes of medical discussion.) straightforward or of low complexity.
seven days, cumulative time during the We also considered adding the Counseling and/or coordination of care
7 days; 5–10 minutes.) additional telephone assessment and with other physicians, other qualified
• G2062 (Qualified nonphysician management CPT codes which are used health care professionals, or agencies
healthcare professional online by clinicians who may not are provided consistent with the nature
assessment and management service, independently bill for E/M visits and of the problem(s) and the patient’s and/
for an established patient, for up to who are not included in the definition or family’s needs. Usually, the
seven days, cumulative time during the of ACO professional in § 425.20 (for problem(s) requiring admission are of
7 days; 11–20 minutes.) example, PTs, OTs, SLPs, CPs). low severity. Typically, 25 minutes are
• G2063 (Qualified nonphysician However, because these services are not spent at the bedside and on the patient’s
qualified healthcare professional furnished by ACO professionals, we facility floor or unit.)
assessment and management service, determined it was not necessary to • 99305 (Initial nursing facility care,
for an established patient, for up to include these codes in our definition of per day, for the evaluation and
seven days, cumulative time during the primary care services for use in management of a patient, which
7 days; 21 or more minutes.) assignment: requires these 3 key components: A
As discussed in the March 31st • 98966 (Telephone assessment and comprehensive history; A
COVID–19 IFC (85 FR 19264 through management service provided by a comprehensive examination; and
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27585
Medical decision making of moderate • 99334 (Domiciliary or rest home problem requiring immediate physician
complexity. Counseling and/or visit for the evaluation and management attention. Typically, 60 minutes are
coordination of care with other of an established patient, which requires spent with the patient and/or family or
physicians, other qualified health care at least 2 of these 3 key components: A caregiver.)
professionals, or agencies are provided problem focused interval history; A • 99341 (Home visit for the
consistent with the nature of the problem focused examination; evaluation and management of a new
problem(s) and the patient’s and/or Straightforward medical decision patient, which requires these 3 key
family’s needs. Usually, the problem(s) making. Counseling and/or components: A problem focused history;
requiring admission are of moderate coordination of care with other A problem focused examination; and
severity. Typically, 35 minutes are spent physicians, other qualified health care Straightforward medical decision
at the bedside and on the patient’s professionals, or agencies are provided making. Counseling and/or
facility floor or unit.) consistent with the nature of the coordination of care with other
• 99306 (Initial nursing facility care, problem(s) and the patient’s and/or physicians, other qualified health care
per day, for the evaluation and family’s needs. Usually, the presenting professionals, or agencies are provided
management of a patient, which problem(s) are self-limited or minor. consistent with the nature of the
requires these 3 key components: A Typically, 15 minutes are spent with the problem(s) and the patient’s and/or
comprehensive history; A patient and/or family or caregiver.) family’s needs. Usually, the presenting
comprehensive examination; and • 99335 (Domiciliary or rest home problem(s) are of low severity. Typically,
Medical decision making of high visit for the evaluation and management 20 minutes are spent face-to-face with
complexity. Counseling and/or of an established patient, which requires the patient and/or family.)
coordination of care with other at least 2 of these 3 key components: An • 99342 (Home visit for the
physicians, other qualified health care expanded problem focused interval evaluation and management of a new
professionals, or agencies are provided history; An expanded problem focused patient, which requires these 3 key
consistent with the nature of the examination; Medical decision making components: An expanded problem
problem(s) and the patient’s and/or of low complexity. Counseling and/or focused history; An expanded problem
family’s needs. Usually, the problem(s) coordination of care with other focused examination; and Medical
requiring admission are of high severity. physicians, other qualified health care decision making of low complexity.
Typically, 45 minutes are spent at the professionals, or agencies are provided Counseling and/or coordination of care
bedside and on the patient’s facility consistent with the nature of the with other physicians, other qualified
floor or unit.) problem(s) and the patient’s and/or
health care professionals, or agencies
• 99315 (Nursing facility discharge family’s needs. Usually, the presenting
are provided consistent with the nature
day management; 30 minutes or less.) problem(s) are of low to moderate
• 99316 (Nursing facility discharge of the problem(s) and the patient’s and/
severity. Typically, 25 minutes are spent
day management; more than 30 or family’s needs. Usually, the
with the patient and/or family or
minutes.) presenting problem(s) are of moderate
caregiver.)
• 99327 (Domiciliary or rest home • 99336 (Domiciliary or rest home severity. Typically, 30 minutes are spent
visit for the evaluation and management visit for the evaluation and management face-to-face with the patient and/or
of a new patient, which requires these of an established patient, which requires family.)
3 key components: A comprehensive at least 2 of these 3 key components: A • 99343 (Home visit for the
history; A comprehensive examination; detailed interval history; A detailed evaluation and management of a new
and Medical decision making of examination; Medical decision making patient, which requires these 3 key
moderate complexity. Counseling and/ of moderate complexity. Counseling components: A detailed history; A
or coordination of care with other and/or coordination of care with other detailed examination; and Medical
physicians, other qualified health care physicians, other qualified health care decision making of moderate
professionals, or agencies are provided professionals, or agencies are provided complexity. Counseling and/or
consistent with the nature of the consistent with the nature of the coordination of care with other
problem(s) and the patient’s and/or problem(s) and the patient’s and/or physicians, other qualified health care
family’s needs. Usually, the presenting family’s needs. Usually, the presenting professionals, or agencies are provided
problem(s) are of high severity. problem(s) are of moderate to high consistent with the nature of the
Typically, 60 minutes are spent with the severity. Typically, 40 minutes are spent problem(s) and the patient’s and/or
patient and/or family or caregiver.) with the patient and/or family or family’s needs. Usually, the presenting
• 99328 (Domiciliary or rest home caregiver.) problem(s) are of moderate to high
visit for the evaluation and management • 99337 (Domiciliary or rest home severity. Typically, 45 minutes are spent
of a new patient, which requires these visit for the evaluation and management face-to-face with the patient and/or
3 key components: A comprehensive of an established patient, which requires family.)
history; A comprehensive examination; at least 2 of these 3 key components: A • 99344 (Home visit for the
and Medical decision making of high comprehensive interval history; A evaluation and management of a new
complexity. Counseling and/or comprehensive examination; Medical patient, which requires these 3 key
coordination of care with other decision making of moderate to high components: A comprehensive history;
physicians, other qualified health care complexity. Counseling and/or A comprehensive examination; and
professionals, or agencies are provided coordination of care with other Medical decision making of moderate
consistent with the nature of the physicians, other qualified health care complexity. Counseling and/or
problem(s) and the patient’s and/or professionals, or agencies are provided coordination of care with other
family’s needs. Usually, the patient is consistent with the nature of the physicians, other qualified health care
unstable or has developed a significant problem(s) and the patient’s and/or professionals, or agencies are provided
new problem requiring immediate family’s needs. Usually, the presenting consistent with the nature of the
physician attention. Typically, 75 problem(s) are of moderate to high problem(s) and the patient’s and/or
minutes are spent with the patient and/ severity. The patient may be unstable or family’s needs. Usually, the presenting
or family or caregiver.) may have developed a significant new problem(s) are of high severity.
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27586 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Typically, 60 minutes are spent face-to- severity. Typically, 40 minutes are spent of primary care services at
face with the patient and/or family.) face-to-face with the patient and/or § 425.400(c)(1) will continue to apply
• 99345 (Home visit for the family.) for purposes of determining beneficiary
evaluation and management of a new • 99350 (Home visit for the assignment under § 425.402.
patient, which requires these 3 key evaluation and management of an We seek comment on the revisions to
components: A comprehensive history; established patient, which requires at the definition of primary care services
A comprehensive examination; and least 2 of these 3 key components: A that we are adopting in this IFC
Medical decision making of high comprehensive interval history; A including the alternatives considered
complexity. Counseling and/or comprehensive examination; Medical with regard to adding codes used by
coordination of care with other decision making of moderate to high non-ACO professionals.
physicians, other qualified health care complexity. Counseling and/or
6. Applicability of Policies to Track 1+
professionals, or agencies are provided coordination of care with other
Model ACOs
consistent with the nature of the physicians, other qualified health care
problem(s) and the patient’s and/or professionals, or agencies are provided The Track 1+ Model was established
family’s needs. Usually, the patient is consistent with the nature of the under the Innovation Center’s authority
unstable or has developed a significant problem(s) and the patient’s and/or at section 1115A of the Act, to test
new problem requiring immediate family’s needs. Usually, the presenting innovative payment and service
physician attention. Typically, 75 problem(s) are of moderate to high delivery models to reduce program
minutes are spent face-to-face with the severity. The patient may be unstable or expenditures while preserving or
patient and/or family.) may have developed a significant new enhancing the quality of care for
• 99347 (Home visit for the problem requiring immediate physician Medicare, Medicaid, and Children’s
evaluation and management of an attention. Typically, 60 minutes are Health Insurance Program beneficiaries.
established patient, which requires at spent face-to-face with the patient and/ The Track 1+ Model, which is a time-
least 2 of these 3 key components: A or family.) limited model that began on January 1,
problem focused interval history; A Because these CPT codes are already 2018, is based on Shared Savings
problem focused examination; included in the definition of primary Program Track 1, but tests a payment
Straightforward medical decision care services used in the Shared Savings design that incorporates more limited
making. Counseling and/or Program assignment methodology, we downside risk, as compared to Track 2
coordination of care with other are clarifying that these CPT codes will and the ENHANCED track. We
physicians, other qualified health care continue to be included in the discontinued all future application
professionals, or agencies are provided definition of primary care services used cycles for the Track 1+ Model, as
consistent with the nature of the for assignment, including when they are explained in earlier rulemaking (83 FR
problem(s) and the patient’s and/or furnished via telehealth during the PHE 68032 and 68033). As of January 1,
family’s needs. Usually, the presenting for the COVID–19 pandemic, beginning 2020, there are 20 Track 1+ Model ACOs
problem(s) are self limited or minor. March 1, 2020. We believe it is participating in performance year 3 of a
Typically, 15 minutes are spent face-to- important to include these services in 3-year agreement under the model.
face with the patient and/or family.) our assignment methodology, regardless ACOs approved to participate in the
• 99348 (Home visit for the of whether they are furnished in-person Track 1+ Model are required to agree to
evaluation and management of an or via telehealth, because we determine the terms and conditions of the model
established patient, which requires at assignment based upon where by executing a Track 1+ Model
least 2 of these 3 key components: An beneficiaries receive the plurality of Participation Agreement. See https://
expanded problem focused interval their primary care services or whether www.cms.gov/Medicare/Medicare-Fee-
history; An expanded problem focused they have designated an ACO for-Service-Payment/
examination; Medical decision making professional as their primary clinician, sharedsavingsprogram/Downloads/
of low complexity. Counseling and/or responsible for their overall care, and track-1plus-model-par-agreement.pdf.
coordination of care with other hold ACOs accountable for the resulting Track 1+ Model ACOs are also required
physicians, other qualified health care assigned beneficiary population. to have been approved to participate in
professionals, or agencies are provided Include these codes in the definition of the Shared Savings Program (Track 1)
consistent with the nature of the primary care services used in and to have executed a Shared Savings
problem(s) and the patient’s and/or assignment during the PHE for the Program Participation Agreement. As
family’s needs. Usually, the presenting COVID–19 pandemic, even when indicated in the Track 1+ Model
problem(s) are of low to moderate services are furnished via telehealth, Participation Agreement, in accordance
severity. Typically, 25 minutes are spent will result in a more accurate with our authority under section
face-to-face with the patient and/or identification of where beneficiaries 1115A(d)(1) of the Act, we have waived
family.) have received the plurality of their certain requirements of the Shared
• 99349 (Home visit for the primary care services. Savings Program that otherwise would
evaluation and management of an Accordingly, we are adding a be applicable to ACOs participating in
established patient, which requires at paragraph (c)(2) to our regulation at Track 1 of the Shared Savings Program,
least 2 of these 3 key components: A § 425.400, in which we specify as necessary for purposes of testing the
detailed interval history; A detailed additional primary care service codes Track 1+ Model, and established
examination; Medical decision making that will be considered for purposes of alternative requirements for the ACOs
of moderate complexity. Counseling beneficiary assignment for the participating in the Track 1+ Model.
and/or coordination of care with other performance year starting on January 1, Unless stated otherwise in the Track 1+
physicians, other qualified health care 2020, and for any subsequent Model Participation Agreement, the
professionals, or agencies are provided performance year that starts during the requirements of the Shared Savings
consistent with the nature of the PHE for the COVID–19 pandemic, as Program under part 425 continue to
problem(s) and the patient’s and/or defined in § 400.200. Under this apply. Consistent with § 425.212, Track
family’s needs. Usually, the presenting provision the existing CPT codes and 1+ Model ACOs generally are subject to
problem(s) are moderate to high HCPCS codes included in the definition all applicable regulatory changes,
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27587
including but not limited to, changes to Agreement executed by CMS and the furnished under the primary care
the regulatory provisions referenced ACO: exception are specified in Section 100 of
within the Track 1+ Model Participation • Adjustments to revenue Chapter 12 of the Medicare Claims
Agreement that become effective during calculations to remove expenditures for Processing Manual (https://
the term of the ACO’s Shared Savings episodes of care for treatment of www.cms.gov/Regulations-and-
Program Participation Agreement and COVID–19 (section II.L.4. of this IFC). Guidance/Guidance/Manuals/
Track 1+ Model Participation M. Additional Flexibility Under the Downloads/clm104c12.pdf). They are
Agreement, unless otherwise specified Teaching Physician Regulations the following:
through rulemaking or amendment to • CPT code 99201 (Office or other
the Track 1+ Model Participation In the March 31st COVID–19 IFC (85 outpatient visit for the evaluation and
Agreement. We note that the terms of FR 19258 through 19261), we management of a new patient, which
the Track 1+ Model Participation introduced flexibilities in our requires these 3 key components: A
Agreement also permit the parties (CMS regulations governing PFS payment for problem focused history; A problem
and the ACO) to amend the agreement teaching physicians and residents. Since focused examination; Straightforward
at any time by mutual written we published the March 31st COVID–19 medical decision making. Counseling
agreement. IFC, stakeholders have asked us to relax and/or coordination of care with other
Therefore, unless specified otherwise, additional requirements related to the physicians, other qualified health care
provision of services furnished by a professionals, or agencies are provided
the changes to the Shared Savings
resident without the presence of a consistent with the nature of the
Program regulations established in this
teaching physician under the so-called problem(s) and the patient’s and/or
IFC that are applicable to ACOs within
primary care exception specified in our family’s needs. Usually, the presenting
a current agreement period will apply to
regulation at 42 CFR 415.174. problem(s) are self limited or minor.
ACOs in the Track 1+ Model in the same For teaching physicians, section
way that they apply to ACOs in Track Typically, 10 minutes are spent face-to-
1842(b) of the Act specifies that in the face with the patient and/or family);
1, so long as the applicable regulation
has not been waived under the Track 1+
case of physicians’ services furnished to • CPT code 99202 (Office or other
a patient in a hospital with a teaching outpatient visit for the evaluation and
Model. Similarly, to the extent that program, the Secretary shall not provide
certain requirements of the regulations management of a new patient, which
payment for such services unless the requires these 3 key components: An
that apply to ACOs under Track 2 or the physician renders sufficient personal expanded problem focused history; An
ENHANCED track have been and identifiable physicians’ services to expanded problem focused
incorporated for ACOs in the Track 1+ the patient to exercise full, personal examination; Straightforward medical
Model under the terms of the Track 1+ control over the management of the decision making. Counseling and/or
Model Participation Agreement, changes portion of the case for which payment coordination of care with other
to those regulations as adopted in this is sought. Regulations regarding PFS physicians, other qualified health care
IFC will also apply to ACOs in the Track payment for teaching physician services professionals, or agencies are provided
1+ Model in the same way that they are codified in part 415. Under consistent with the nature of the
apply to ACOs in Track 2 or the § 415.174, Medicare makes PFS problem(s) and the patient’s and/or
ENHANCED track. For example, the payment in primary care settings for family’s needs. Usually, the presenting
following policies apply to Track 1+ certain services of lower and mid-level problem(s) are of low to moderate
Model ACOs: complexity furnished by a resident severity. Typically, 20 minutes are spent
• Revisions to the definition of without the physical presence of a face-to-face with the patient and/or
primary care services used in teaching physician, referred to as the family);
beneficiary assignment (section II.L.5. of primary care exception. Our regulation • CPT code 99203 (Office or other
this IFC), to include telehealth codes for at § 415.174(a)(3) requires that the outpatient visit for the evaluation and
virtual check-ins, e-visits, and teaching physician must not direct the management of a new patient, which
telephonic communication. These codes care of more than four residents at a requires these 3 key components: A
are applicable beginning with time, and must direct the care from such detailed history; A detailed
beneficiary assignment for the proximity as to constitute immediate examination; Medical decision making
performance year starting on January 1, availability (that is, provide direct of low complexity. Counseling and/or
2020, and for any subsequent supervision) and must review with each coordination of care with other
performance year that starts during the resident during or immediately after physicians, other qualified health care
PHE for the COVID–19 pandemic, as each visit, the beneficiary’s medical professionals, or agencies are provided
defined in § 400.200. history, physical examination, consistent with the nature of the
• Clarification that the total months diagnosis, and record of tests and problem(s) and the patient’s and/or
affected by an extreme and therapies. Section 415.174(a)(3) also family’s needs. Usually, the presenting
uncontrollable circumstance for the requires that the teaching physician problem(s) are of moderate severity.
COVID–19 pandemic will begin with must have no other responsibilities at Typically, 30 minutes are spent face-to-
January 2020 and continue through the the time, assume management face with the patient and/or family);
end of the COVID–19 PHE, for purposes responsibility for the beneficiaries seen • CPT code 99211 (Office or other
of mitigating shared losses for PY 2020 by the residents, ensure that the services outpatient visit for the evaluation and
(section II.L.3. of this IFC). furnished are appropriate, and review management of an established patient,
• Adjustments to expenditure with each resident during or that may not require the presence of a
calculations to remove expenditures for immediately after each visit the physician or other qualified health care
episodes of care for treatment of beneficiary’s medical history, physical professional. Usually, the presenting
COVID–19 (section II.L.4. of this IFC). examination, diagnosis, and record of problem(s) are minimal. Typically, 5
We will also apply the following tests and therapies. minutes are spent performing or
policies established in this IFC to Track As provided in the regulation at supervising these services);
1+ Model ACOs through an amendment § 415.174(a), the E/M codes of lower and • CPT code 99212 (Office or other
to the Track 1+ Model Participation mid-level complexity that can be outpatient visit for the evaluation and
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27588 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
management of an established patient, outpatient E/M services furnished in appropriate, and review with each
which requires at least 2 of these 3 key primary care centers under the primary resident during or immediately after
components: A problem focused history; care exception to be furnished under each visit the beneficiary’s medical
A problem focused examination; direct supervision of the teaching history, physical examination,
Straightforward medical decision physician by interactive diagnosis, and record of tests and
making. Counseling and/or telecommunications technology. We are therapies.
coordination of care with other making clarifying technical edits to the Since we published the March 31st
physicians, other qualified health care regulation text at §§ 415.172, 415.174, COVID–19 IFC, stakeholders have
professionals, or agencies are provided 415.180, and 415.184 to reflect the requested that additional services be
consistent with the nature of the audio/video real-time requirement for added to the primary care exception,
problem(s) and the patient’s and/or communications technology. such as the telephone E/M services we
family’s needs. Usually, the presenting Since we published the March 31st added for separate payment in the
problem(s) are self limited or minor. COVID–19 IFC, stakeholders have March 31st COVID–19 IFC, as well as
Typically, 10 minutes are spent face-to- requested that we also revise our transitional care management, and
face with the patient and/or family); regulations to allow the teaching communication technology-based
• CPT code 99213 (Office or other physician to meet the requirement to services. Adding services to the primary
outpatient visit for the evaluation and review the service with the resident, care exception would permit the
management of an established patient, during or immediately after the visit, resident to provide a more expansive
which requires at least 2 of these 3 key through virtual or remote means via array of services to patients who may be
components: An expanded problem interactive audio/video real-time quarantined at home or who may need
focused history; An expanded problem communications technology. Given the to be isolated for purposes of
focused examination; Medical decision circumstances of the COVID–19 PHE, minimizing exposure risk based on
making of low complexity. Counseling the teaching physician may be under presumed or confirmed COVID–19
and coordination of care with other quarantine or otherwise not physically infection. Consequently, on an interim
physicians, other qualified health care available to review the service with the basis for the duration of the COVID–19
professionals, or agencies are provided resident. We note that in the March 31st PHE, Medicare may make PFS payment
consistent with the nature of the COVID–19 IFC, we inadvertently to the teaching physician for the
problem(s) and the patient’s and/or deleted the former § 415.174(b) which following additional services when
family’s needs. Usually, the presenting stated that, nothing in paragraph (a) of furnished by a resident under the
problem(s) are of low to moderate the section may be construed as primary care exception:
severity. Typically, 15 minutes are spent providing a basis for the coverage of • CPT code 99441 (Telephone
face-to-face with the patient and/or services not determined to be covered evaluation and management service by
family); under Medicare, such as routine a physician or other qualified health
• HCPCS code G0402 (Initial physical check-ups. We are reinstating care professional who may report
preventive physical examination; face- the former paragraph (b) and adding a evaluation and management services
to-face visit, services limited to new new paragraph (c) to allow that, on an provided to an established patient,
beneficiary during the first 12 months of interim basis for the duration of the PHE parent, or guardian not originating from
Medicare enrollment); for the COVID–19 pandemic, the a related E/M service provided within
• HCPCS code G0438 (Annual teaching physician may not only direct the previous 7 days nor leading to an E/
wellness visit; includes a personalized the care furnished by residents, but also M service or procedure within the next
prevention plan of service (PPS), initial review the services provided with the 24 hours or soonest available
visit); and resident, during or immediately after the appointment; 5–10 minutes of medical
• HCPCS code G0439 (Annual visit, remotely through virtual means discussion);
wellness visit, includes a personalized via audio/video real time • CPT code 99442 (Telephone
prevention plan of service (PPS), communications technology. evaluation and management service by
subsequent visit). We believe that permitting the a physician or other qualified health
In the context of the PHE for the teaching physician to interact with the care professional who may report
COVID–19 pandemic, teaching hospitals resident remotely through virtual means evaluation and management services
have expressed a need to increase their would still allow the teaching physician provided to an established patient,
capacity to respond to the increased to direct, manage, and review the care parent, or guardian not originating from
demand for physicians to meet patient furnished by residents as specified in a related E/M service provided within
needs. Additionally, there are often § 415.174(a). For example, this means the previous 7 days nor leading to an E/
circumstances where the teaching that Medicare may make payment under M service or procedure within the next
physician may be under quarantine or the PFS for teaching physician services 24 hours or soonest available
otherwise at home, or the physical when a resident furnishes services appointment; 11–20 minutes of medical
proximity of the teaching physician permitted under the primary care discussion);
might present additional exposure risks. exception, including via telehealth, and • CPT code 99443 (Telephone
In section II.E. the March 31st COVID– the teaching physician can provide the evaluation and management service by
19 IFC (85 FR 19245 through 19246), we necessary direction, management and a physician or other qualified health
stated that as a general rule under review of the resident’s services using care professional who may report
§ 415.172, the requirement for the interactive audio/video real-time evaluation and management services
presence of a teaching physician can be communications technology. The provided to an established patient,
met, at a minimum, through direct remainder of the policies at parent, or guardian not originating from
supervision by audio/video real-time § 415.174(a)(3) continue to apply in that a related E/M service provided within
communications technology. We also the teaching physician must have no the previous 7 days nor leading to an E/
revised the scope of E/M codes that can other responsibilities at the time, M service or procedure within the next
be furnished under the primary care assume management responsibility for 24 hours or soonest available
exception and amended § 415.174 of our the beneficiaries seen by the residents, appointment; 21–30 minutes of medical
regulations to allow all levels of office/ ensure that the services furnished are discussion);
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27589
• CPT code 99495 (Transitional Care furnished as Medicare Telehealth procedure within the next 24 hours or
Management services with the following services, (85 FR 19268 through 19269), soonest available appointment; 11–20
required elements: Communication we are clarifying that the office/ minutes of medical discussion); and
(direct contact, telephone, electronic) outpatient E/M level selection for • 99443 (Telephone evaluation and
with the patient and/or caregiver within services under the primary care management service by a physician or
two business days of discharge; medical exception when furnished via telehealth other qualified health care professional
decision making of at least moderate can be based on MDM or time, with who may report evaluation and
complexity during the service period; time defined as all of the time management services provided to an
face-to-face visit within 14 calendar associated with the E/M on the day of established patient, parent, or guardian
days of discharge); the encounter; and the requirements not originating from a related E/M
• CPT code 99496 (Transitional Care regarding documentation of history and/ service provided within the previous 7
Management services with the following or physical exam in the medical record days nor leading to an E/M service or
required elements: Communication do not apply. As described in section procedure within the next 24 hours or
(direct contact, telephone, electronic) II.Z. of this IFC, the typical times for soonest available appointment; 21–30
with the patient and/or caregiver within purposes of level selection for an office/ minutes of medical discussion).
two business days of discharge; medical outpatient E/M are the times listed in We noted that, although these services
decision making of at least high the CPT code descriptor. This policy is were previously considered non-
complexity during the service period; similar to the policy that will apply to covered under the PFS, in the context of
face-to-face visit within 7 calendar days all office/outpatient E/M services PHE and with the goal of reducing
of discharge); beginning in 2021 under policies exposure risks associated with the
• CPT code 99421 (Online digital finalized in the CY 2020 PFS final rule. COVID–19 pandemic, especially in the
evaluation and management service, for Taken together, these policies mean case that two-way, audio and video
an established patient, for up to 7 days, that, on an interim basis for the duration technology required to furnish a
cumulative time during the 7 days; 5–10 of the PHE for the COVID–19 pandemic, Medicare telehealth service might not be
minutes); Medicare may make PFS payment for available, we believed there are
• CPT code 99422 (Online digital teaching physician services when a circumstances where prolonged, audio-
evaluation and management service, for resident furnishes a service included in only communication between the
an established patient, for up to 7 days, this expanded list of services in primary practitioner and the patient could be
cumulative time during the 7 days; 11– care centers, including via telehealth, clinically appropriate, yet not fully
20 minutes); and the teaching physician can provide replace a face-to-face visit. For example,
• CPT code 99423 (Online digital the necessary direction, management an established patient who was
evaluation and management service, for and review for the resident’s services experiencing an exacerbation of their
an established patient, for up to 7 days, using audio/video real-time condition could have a 25-minute
cumulative time during the 7 days; 21 communications technology. We believe phone conversation with their physician
or more minutes); that these policies will increase the during which the physician determines
• CPT code 99452 (Interprofessional capacity of teaching settings to respond that an adjustment to the patient’s
telephone/internet/electronic health to the PHE for the COVID–19 pandemic medication would alleviate their
record referral service(s) provided by a as more practitioners are being asked to symptoms. The use of CPT code 99443
treating/requesting physician or assist with the response. in this situation prevents a similar in-
qualified health care professional, 30 person service. We stated we believed
minutes); N. Payment for Audio-Only Telephone that these telephone E/M codes, with
• HCPCS code G2012 (Brief Evaluation and Management Services their established description and
communication technology-based In the March 31st COVID–19 IFC, we valuation, were the best way to
service, e.g., virtual check-in, by a established separate payment for audio- recognize the relative resource costs of
physician or other qualified health care only telephone evaluation and these kinds of services and make
professional who can report evaluation management services. The telephone payment for them under the PFS.
and management services, provided to evaluation and management (E/M) For these codes, we finalized on an
an established patient, not originating services are CPT codes: interim basis during the PHE for the
from a related E/M service provided • 99441 (Telephone evaluation and COVID–19 pandemic, work relative
within the previous 7 days nor leading management service by a physician or value units (RVUs) as recommended by
to an E/M service or procedure within other qualified health care professional the American Medical Association
the next 24 hours or soonest available who may report evaluation and (AMA) Relative Value Scale Update
appointment; 5–10 minutes of medical management services provided to an Committee (RUC) as discussed in the CY
discussion); and established patient, parent, or guardian 2008 PFS final rule (72 CFR 66371) of
• HCPCS code G2010 (Remote not originating from a related E/M 0.25 for CPT code 99441, 0.50 for CPT
evaluation of recorded video and/or service provided within the previous 7 code 99442, and 0.75 for CPT code
images submitted by an established days nor leading to an E/M service or 99443. We also finalized the RUC-
patient (e.g., store and forward), procedure within the next 24 hours or recommended direct practice expense
including interpretation with follow-up soonest available appointment; 5–10 (PE) inputs which consist of 3 minutes
with the patient within 24 business minutes of medical discussion); of post-service Registered Nurse/
hours, not originating from a related E/ • 99442 (Telephone evaluation and Licensed Practical Nurse/Medical
M service provided within the previous management service by a physician or Technical Assistant clinical labor time
7 days nor leading to an E/M service or other qualified health care professional for each code.
procedure within the next 24 hours or who may report evaluation and In the time since we established these
soonest available appointment). management services provided to an payment amounts, stakeholders have
Finally, consistent with policy that established patient, parent, or guardian informed us that use of audio-only
we established in the March 31st not originating from a related E/M services is more prevalent than we had
COVID–19 IFC for selecting the level of service provided within the previous 7 previously considered, especially
Office/Outpatient E/M visits when days nor leading to an E/M service or because many beneficiaries are not
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27590 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
utilizing video-enabled communication place instead of office/outpatient E/M and Drug Administration (FDA)
technology from their homes. In other visits (either in-person or via regulations at 21 CFR 809.3(a)) for the
words, there are many cases where telehealth), the direct crosswalk of detection of SARS-CoV–2 or diagnosis
practitioners would under ordinary RVUs also better maintains overall of the virus that causes COVID–19, and
circumstances utilize telehealth or in- budget neutrality and relativity under the administration of such in vitro
person visits to evaluate and manage the PFS. We believe that the resources diagnostic products. As discussed in
patients’ medical concerns, but are required to furnish these services during CMS guidance issued on April 13,
instead using audio-only interactions to the PHE for the COVID–19 pandemic are 2020,38 FDA has advised that serological
manage more complex care. While we better captured by the RVUS associated tests for COVID–19 meet the definition
previously acknowledged the likelihood with the level 2–4 established patient in 21 CFR 809.3(a) of an in vitro
that, under the circumstances of the office/outpatient E/M visits. diagnostic product for the detection of
PHE, more time would be spent Additionally, given our understanding SARS-CoV–2 or the diagnosis of
interacting with the patient via audio- that these audio-only services are being COVID–19. Therefore, coverage under
only technology, we are now furnished as substitutes for office/ section 1905(a)(3)(B) of the Act must
recognizing that the intensity of outpatient E/M services, we recognize include those serological tests. Section
furnishing an audio-only visit to a that they should be considered as 1905(a)(3)(B) was an addition to the
beneficiary during the unique telehealth services, and are adding them existing mandatory benefit for
circumstances of the COVID–19 to the list of Medicare telehealth laboratory and X-ray services that was
pandemic is not accurately captured by services for the duration of the PHE. We formerly at section 1905(a)(3) of the Act,
the valuation of these services we also note that, for these audio-only E/M and that is now at section 1905(a)(3)(A)
established in the March 31st COVID–19 services, we will be separately issuing a of the Act.
IFC. This is particularly true to the waiver under section 1135(b)(8) of the The regulation currently
extent that these audio-only services are Act, as amended by section 3703 of the implementing section 1905(a)(3) of the
actually serving as a substitute for CARES Act, of the requirements under Act, at 42 CFR 440.30, includes certain
office/outpatient Medicare telehealth section 1834(m) of the Act and our limitations and conditions on Medicaid
visits for beneficiaries not using video- regulation at § 410.78 that Medicare coverage of laboratory tests and X-rays,
enabled telecommunications technology telehealth services must be furnished and describes who may provide
contrary to the situation we anticipated using video technology. The full list of laboratory tests and where laboratory
when establishing payment for them in Medicare telehealth services, including tests may be administered. Specifically,
the March 31st COVID–19 IFC. Given those added during the PHE, is available § 440.30(a) requires that Medicaid-
our new understanding that these audio- here https://www.cms.gov/Medicare/ covered laboratory and X-ray services be
only services are being furnished Medicare-General-Information/ ordered and provided by or under the
primarily as a replacement for care that Telehealth/Telehealth-Codes. We note direction of a physician or other
would otherwise be reported as an in- that these codes describe medical licensed practitioner of the healing arts
person or telehealth visit using the discussion, and should not be used for within the scope of his or her practice
office/outpatient E/M codes, we are administrative or other non-medical as defined by state law or ordered by a
establishing new RVUs for the discussion with the patient. Although physician but provided by a referral
telephone E/M services based on practitioners have been provided laboratory. Section 440.30(b) specifies
crosswalks to the most analogous office/ flexibility around cost-sharing for the that Medicaid will cover laboratory and
outpatient E/M codes, based on the time duration of the PHE, beneficiaries are X-ray services only if provided in an
requirements for the telephone codes still liable for cost-sharing for these office or similar facility other than a
and the times assumed for valuation for services in instances where the HOPD or clinic, and § 440.30(c)
purposes of the office/outpatient E/M practitioner does not waive cost-sharing. specifies that Medicaid will cover these
codes. Specifically, we are crosswalking Practitioners should educate services only if they are furnished by a
CPT codes 99212, 99213, and 99214 to beneficiaries on any applicable cost- laboratory that meets the requirements
sharing. We are seeking comment on
99441, 99442, and 99443 respectively. of 42 CFR part 493.
how best to minimize unexpected cost
We are finalizing, on an interim basis As the CDC noted when issuing
sharing for beneficiaries. We plan to
and for the duration of the COVID–19 advice on how to protect against
monitor utilization of these services and
PHE the following work RVUs: 0.48 for COVID–19 infection, some recent
will consider making refinements to
CPT code 99441; 0.97 for CPT code studies have suggested that COVID–19
billing rules, documentation
99442; and 1.50 for CPT code 99443. We may be spread by people who are not
requirements or claims edits through
are also finalizing the direct PE inputs showing symptoms.39 We believe it is
future rulemaking.
associated with CPT code 99212 for CPT vital for Medicaid beneficiaries to have
code 99441, the direct PE inputs O. Flexibility for Medicaid Laboratory broad access to tests to detect the SARS-
associated with CPT code 99213 for CPT Services CoV–2 virus, antibodies to the SARS-
code 99442, and the direct PE inputs Section 6004(a) of the Families First CoV–2 virus, or COVID–19, so that they
associated with CPT code 99214 for CPT Coronavirus Response Act added a new can properly monitor their symptoms,
code 99443. We are not finalizing mandatory benefit in the Medicaid make decisions about seeking further
increased payment rates for CPT codes statute at section 1905(a)(3)(B) of the care, and take appropriate precautions
98966–98968 as these codes describe Act, and this provision was amended by
services furnished by practitioners who section 3717 of the CARES Act. Section
38 Families First Coronavirus Response Act,
cannot independently bill for E/Ms and Public Law 116–127; Coronavirus Aid, Relief, and
1905(a)(3)(B) of the Act provides that, Economic Security (CARES) Act, Public Law 116–
so these telephone assessment and for any portion of the COVID–19 136; Frequently Asked Questions (FAQs) (April 13,
management services, by definition, are emergency period defined in section 2020) 5–6, at https://www.medicaid.gov/state-
not furnished in lieu of an office/ 1135(g)(1)(B) of the Act that begins on resource-center/downloads/covid-19-section-6008-
outpatient E/M service. CARES-faqs.pdf.
or after March 18, 2020, Medicaid 39 https://www.cdc.gov/mmwr/volumes/69/wr/
We note that to the extent that these coverage must include in vitro mm6913e2.htm; https://www.cdc.gov/coronavirus/
extended phone services are taking diagnostic products (as defined in Food 2019-ncov/prevent-getting-sick/prevention.html.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27591
to prevent further spread of disease. The disease, whichever is sooner. We seek under this new § 440.30(d), must notify
requirements at § 440.30(a) and (b) comments on this definition of the the patient and the patient’s physician
could present an obstacle to Medicaid period of active surveillance. or NPP, if known by the laboratory, of
coverage for administering and To allow similar flexibilities in future the results. Again, in order to protect the
processing COVID–19 laboratory and emergencies with similar circumstances, public, the flexibilities that would
diagnostic tests in certain non-office these amendments would not be limited permit self-collection of testing will
settings, such as parking lots or other to the COVID–19 PHE and any apply only for test systems authorized
temporary outdoor locations, where the subsequent period of active surveillance by the FDA for home use. We are
setting is intended to maximize physical (as defined above), but would also apply soliciting comment on the implications
distancing and thereby minimize to future PHEs resulting from outbreaks of applying this provision to future
transmission of COVID–19. Given the of communicable disease (and public health emergencies, and the
nature and scope of the COVID–19 subsequent periods of active specifications that should be included
pandemic, the critical importance of surveillance, as defined above), during in doing so.
expanding COVID–19 testing to combat which measures are necessary to avoid These changes to § 440.30 apply not
the pandemic, and the heightened risk transmission of the communicable only to the benefit described at section
the disease presents to Medicaid disease, and when such measures might 1905(a)(3)(B) of the Act, but also apply
beneficiaries, we also would like to result in difficulty meeting the to the longstanding laboratory and X-ray
accommodate evolving COVID–19 requirements of § 440.30(a) or (b). The services benefit that was formerly at
diagnostic mechanisms, such as FDA- flexibilities available under this section 1905(a)(3) of the Act, and is now
authorized tests that allow for patients amendment would be applicable as at section 1905(a)(3)(A) of the Act. In
to self-collect a specimen in alternative described below for the COVID–19 PHE, light of the urgent need to provide these
locations (such as at home) to send to and with respect to future PHEs, would flexibilities during the COVID–19 PHE,
a laboratory, to detect the SARS-CoV–2 be applicable only upon formal and because this provision will ease
virus, antibodies to the SARS-CoV–2 declaration of a PHE that CMS restrictions under existing law and
virus, or COVID–19 (sometimes referred determines meets these criteria, and make Medicaid coverage of testing more
to as ‘‘self-collection’’). Self-collection would last for the duration of that future available, new paragraph (d) in § 440.30
of tests at home is likely to minimize PHE and any subsequent period of will be effective retroactive to March 1,
transmission of COVID–19, and the active surveillance. 2020.
need for a Medicaid beneficiary to We are therefore adding a new Lastly, while § 440.30(d) does not
obtain an order for coverage of a self- § 440.30(d) that specifies that, during provide flexibility regarding § 440.30(c),
collected COVID–19 test could present a the COVID–19 PHE or any future PHE which provides that services under
resulting from an outbreak of § 440.30 must be furnished by a
significant barrier to beneficiaries who
communicable disease, and during any laboratory that meets the requirements
might otherwise seek a test that FDA
subsequent period of active surveillance of part 493, we are soliciting comment
authorizes as not requiring a
(as defined above), Medicaid coverage is on whether continuing to apply the
prescription. We are using the term self-
available for laboratory tests and X-ray requirements of § 440.30(c) would
collection to encompass evolving
services that do not meet conditions present any obstacle to providing
mechanisms for testing that would be
specified in § 440.30(a) or (b) so long as Medicaid coverage for COVID–19
processed by a laboratory that can
the purpose of the laboratory or X-ray testing.
receive Medicaid payment.
service is to diagnose or detect SARS-
Accordingly, we are amending CoV–2, antibodies to SARS-CoV–2, P. Improving Care Planning for
§ 440.30 to permit flexibility for COVID–19, or the communicable Medicaid Home Health Services
coverage of COVID–19 tests, including disease named in the PHE or its causes, 1. Background
coverage for tests administered in non- and so long as the deviation from the
office settings, and coverage for a. General Information
conditions specified in § 440.30(a) or (b)
laboratory processing of self-collected is intended to avoid transmission of the Title XIX of the Act requires that to
COVID–19 tests that are FDA-authorized communicable disease. We further receive federal Medicaid matching
for self-collection. The flexibility would specify that under these same funds, a state must offer certain services
apply not only during the current circumstances and subject to these same to the categorically needy populations
COVID–19 PHE, but also during any conditions, Medicaid coverage is specified in the statute. Home health
subsequent periods of active available for laboratory processing of services for Medicaid-eligible
surveillance, to allow for continued self-collected laboratory test systems individuals who are entitled to NF
surveillance as part of strategies to that the FDA has authorized for home services is one of these mandatory
detect recurrence of the virus in use, if available to diagnose or detect services. Individuals entitled to NF
individuals and populations to prevent SARS-CoV–2, antibodies to SARS-CoV– services include the basic categorically
further spread of the disease. State 2, COVID–19, or the communicable needy populations that receive the
officials may continue to need the disease named in the PHE or its causes, standard Medicaid benefit package, and
flexibility offered under this even if those self-collected tests would can include medically needy
amendment during such periods of not otherwise meet the requirements in populations if NF services are offered to
active surveillance after the COVID–19 § 440.30(a) or (b). Among other the medically needy within a state.
PHE ends. We define a period of active flexibilities, these amendments would Home health services include part-time
surveillance as an outbreak of permit states to cover laboratory or intermittent nursing, home health
communicable disease during which no processing of self-collected test systems aide services, medical supplies,
approved treatment or vaccine is widely that the FDA has authorized for home equipment, and appliances, and may
available. A period of active use, without the order of a treating include therapy services (physical
surveillance ends on the date the physician or other licensed non- therapy, occupational therapy, speech
Secretary terminates it, or the date that physician practitioner (NPP). pathology and audiology services). Prior
is two incubation periods after the last Laboratories that process such test to 1997, Medicaid regulations required
known case of the communicable systems without an order, as permitted an individual’s physician to order home
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27592 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
health services as part of a written plan make changes to allow NPPs to provide enactment of section 3708 of the CARES
of care, and review the plan of care certain services within the extent of Act, by a more extensive list of NPPs
every 60 days. In 1997, Medicaid their scope of practice as defined by than the practitioners identified in
regulations (62 FR 47902), were state law. section 3708 of the CARES Act for
amended to allow the plan of care for The recognition of the advanced Medicare home health services.
medical supplies, equipment and training and qualifications of these Comparatively, as noted previously in
appliances to be reviewed by a practitioners continues with the this section of the IFC, the Medicaid
physician annually. enactment of the CARES Act. Section home health benefit includes part-time
Title XIX was amended in 2010, when 3708 of the CARES Act amended or intermittent nursing, home health
section 6407 of the Patient Protection Medicare requirements at sections aide services, and medical supplies,
and Affordable Care Act of 2010 40 1814(a) and 1835(a) of the Act to expand equipment and appliances, also known
added the requirement that physicians the list of practitioners who can order as DME. Therapy services can be
document the occurrence of a face-to- home health services. Specifically, included at the state’s option.
face encounter (including through the sections 1814(a)(2)(C) of the Act under Based on the statutory directive to
use of telehealth) with the Medicaid Part A and section 1835(a)(2)(A) of the apply section 3708 of the CARES Act
beneficiary within reasonable Act under Part B of the Medicare changes to Medicaid in the same
timeframes when ordering home health program were amended to allow an NP, manner as Medicare, we had to
services. Section 504 of the Medicare CNS or PA to order home health determine whether to interpret this
Access and CHIP Reauthorization Act of services in addition to physicians so directive as applying the rules for who
2015 (MACRA) (Pub. L. 114–10, enacted long as these NPPs are permitted to can order services under the more
on April 16, 2015) amended Medicare provide such services under the scope limited Medicare home health services
requirements at section of practice laws in the state. Section benefit only to the subset of Medicaid
1834(a)(11)(B)(ii) of the Act to allow 3708(e) of the CARES Act also provides home health services that align with
certain authorized NPPs to document that the requirements for ordering home Medicare, or to apply the Medicare rules
the face-to-face encounter and applied health services shall apply under title on who can order services to the full
such changes to the Medicaid program. XIX in the same manner and to the same range of Medicaid home health services.
CMS finalized the implementing extent as such requirements apply As discussed earlier in this section,
provisions on February 2, 2016, in the under title XVIII of such Act. In Medicare allows a more extensive list of
Medicaid Program; Face-to-Face accordance with this language on NPPs to order DME, than the
Requirements for Home Health Services; applying these requirements ‘‘in the practitioners identified for Medicaid or
Policy Changes and Clarification same manner’’ as Medicare is, in light the practitioners identified in the
Related to Home Health final rule (81 of the urgent need to provide these CARES Act. Because DME (‘‘medical
FR 5529) became effective July 1, 2016. flexibilities during the COVID–19 PHE, supplies, equipment and appliances’’) is
In the March 31st COVID–19 IFC, we and because this provision will increase covered under the Medicaid home
amended the Medicaid home health flexibility in the delivery of benefits and health benefit, this would mean
regulations to allow other licensed make Medicaid coverage of home health applying the current Medicare rules on
practitioners to order all components of services more available, the Medicaid who can order DME under that
home health services in accordance regulations discussed in this section Medicare benefit to that component of
will take effect on the same date as the the Medicaid home health benefit. We
with state scope of practice laws, for the
Medicare regulations implementing believe that aligning the Medicaid
period of this COVID–19 PHE.
section 3708 discussed in section II.J. of program with Medicare regarding who
b. Changes To Modernize Requirements this IFC, ‘‘Care Planning for Medicare can order medical supplies, equipment
for Ordering Medicaid Home Health Home Health Services.’’ Further, the and appliances promotes access to
Nursing, Aide and Therapy Services; language in section 3708 of the CARES services for Medicaid beneficiaries,
and Modernize Face-to-Face Encounter Act is not time limited to the period of including those who are dually eligible,
Requirements the COVID–19 PHE; the revisions to the and will eliminate burden to states and
When the Medicaid program was Medicaid home health program will be providers on dealing with
signed into law in 1965, most skilled permanently in effect. inconsistencies between the Medicare
The purpose of this regulation is to and Medicaid programs. Specifically,
medical professional services in the
implement this statutory directive in the we are amending the home health
United States were provided by
CARES Act within the Medicaid regulation at § 440.70(a)(3) to allow
physicians, with the assistance of program. In implementing the CARES other licensed practitioners, to order
nurses. Over the decades, the medical Act home health provisions, it is medical equipment, supplies and
professional field has diversified and important to note the structural appliances in addition to physicians,
allowed for a wider range of differences between the Medicare home when practicing in accordance with
certifications and specialties, including health benefit and the Medicaid home state laws.
the establishment of mid-level health benefit that require some For other services covered under the
practitioners such as NPs and PAs that adaptation for the requirement to apply Medicaid home health benefit, we are
are also known as NPPs. Both Medicare the new Medicare rules in section 3708 applying the new list of practitioners set
and Medicaid policies and regulations of the CARES Act to Medicaid ‘‘in the forth in section 3708 of the CARES Act
have been updated over recent years to same manner and to the same extent as to who can order those services,
40 The Patient Protection and Affordable Care Act
such requirements apply’’ under specifically, part-time or intermittent
(Pub. L. 111–148) was enacted on March 23, 2010.
Medicare. Under the Medicare program, nursing services, home health aide
The Health Care and Education Reconciliation Act the home health benefit includes skilled services, and if included in the state’s
of 2010 (Pub. L. 111–152), which amended and part-time or intermittent nursing, home home health benefit, therapy services.
revised several provisions of the Patient Protection health aide service, therapies and Specifically, § 440.70(a)(2) is amended
and Affordable Care Act, was enacted on March 30,
2010. In this IFC, we refer to the two statutes
medical social services. DME is a to allow a NP, CNS and PA to order
collectively as the ‘‘Patient Protection and separate benefit under Medicare, and home health services described in
Affordable Care Act’’. could already be ordered, prior to the § 440.70(b)(1), (2) and (4).
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27593
Through this IFC, we are also York are the only states operating a may need to temporarily waive
amending the current regulation to BHP. limitations on certain benefits covered
remove the requirement that the NPPs under its BHP or temporarily waive
2. Changes to Requirements for
described in § 440.70(a)(2) have to enrollee premiums and cost sharing.
Revisions of a Certified Blueprint Therefore, at § 600.125, we are
communicate the clinical finding of the
face-to-face encounter to the ordering As we explain in § 600.110, the BHP revising paragraph (b) and adding a new
physician. With expanding authority to Blueprint is a comprehensive written paragraph (c) to allow a state to submit
order home health services, the CARES document submitted by the State to the to the Secretary for review and
Act also provides that such practitioners Secretary for certification of a BHP. certification a revised Blueprint that
are now capable of independently Section 600.110(a) specifies what makes temporary significant changes to
performing the face-to-face encounter content needs to be included in the BHP respond to the PHE for the COVID–19
for the patient for whom they are the Blueprint that must be certified by HHS. pandemic with the option for the states
ordering practitioner, in accordance Section 600.125(a) currently requires to make such changes effective
with state law. If state law does not that a state that seeks to make retroactive to the start of the PHE for the
allow such flexibility, the NPP is significant changes to its BHP must COVID–19 pandemic as defined in
required to work in collaboration with submit a revised BHP Blueprint to the § 400.200. While we would generally
a physician. Secretary for review and certification.43 expect that revisions submitted under
Finally, we note that the flexibility We previously explained in the § 600.125(c) would no longer be in effect
allowed in this IFC to NPs, CNSs and September 25, 2013 BHP proposed as of the end of the PHE for the COVID–
PAs to order home health services must rule 44 (78 FR 59125) that, while not an 19 pandemic as defined in § 400.200,
be done in accordance with state law. exhaustive list, the types of changes that there may be instances in which
Individual states have varying would be considered ‘‘significant’’ for policies will need to temporarily be in
requirements for conditions of practice, purposes of this provision include effect for a longer period of time. For
which determine whether a practitioner changes that have a direct impact on the example, following the end of the PHE
may work independently, without a enrollee experience in BHP or the for the COVID–19 pandemic, a state may
written collaborative agreement or program financing. Section 600.125(b) need additional time to process all of
supervision from a physician, or currently requires that a state is the renewals or changes in circumstance
whether general or direct supervision responsible for continuing to operate that were not completed during the
and collaboration is required. State under the terms of the existing PHE. A state may need an additional,
Blueprint until and unless a revised temporary period of time (for example,
Medicaid Agencies can consult the
Blueprint is certified. Taken together, 90 days), before resuming its usual
specific practitioner association or
these regulations require that states processing standards. We will work
relevant state agency website to ensure
wishing to make significant changes to with states to determine a reasonable
that practitioners are working within
a certified Blueprint must do so on a amount of time after the PHE for
their scope of practice and prescriptive
prospective basis and such changes returning to normal course of business.
authority.
cannot be implemented until a revised Specifically, the flexibility in the new
Q. Basic Health Program Blueprint Blueprint is certified by HHS. § 600.125(c) only applies to Blueprint
Revisions We believe that during the PHE for revisions that make temporary
the COVID–19 pandemic, it is not significant changes that are directly tied
1. Background feasible for a state to receive to the PHE for the COVID–19 pandemic
Section 1331 of the Patient Protection certification by HHS prior to and would increase enrollee access to
and Affordable Care Act 41 provides implementing certain necessary coverage.45 States may not submit under
states with a coverage option, the Basic significant changes to their BHP. § 600.125(c), and we will not certify,
Health Program (BHP), for specified Specifically, during the PHE for the retroactive Blueprint revisions under
individuals who do not qualify for COVID–19 pandemic, states may need this provision that are not directly tied
Medicaid but whose income does not to immediately revise certain provisions to the PHE for the COVID–19 pandemic.
exceed 200 percent of the federal of or add certain provisions to their BHP In addition, states may not submit under
poverty level (FPL). More information Blueprints that would be considered § 600.125(c), and we will not certify,
about the BHP is available in the ‘‘Basic significant changes to ensure BHP retroactive Blueprint revisions under
Health Program’’ final rule 42 which was enrollees can access necessary services this provision that are restrictive in
published in the March 12, 2014 without delay or access these services nature, such as Blueprint revisions that
Federal Register (79 FR 14112). The without cost sharing. For example, increase enrollee cost sharing, reduce
BHP regulations are codified at part 600. based on our experience with the PHE BHP benefits, or limit or reduce
As of April 2020, Minnesota and New for the COVID–19 pandemic, we eligibility for BHP coverage. Revised
recognize that states operating a BHP Blueprints submitted under § 600.125(c)
41 The Patient Protection and Affordable Care Act
can only implement temporary revisions
(Pub. L. 111–148) was enacted on March 23, 2010. 43 This provision states that ‘‘in the event that a
The Health Care and Education Reconciliation Act
to increase access to coverage that
State seeks to make significant change(s) that alter
of 2010 (Pub. L. 111–152), which amended and program operations the BHP benefit package, would remain in effect only through the
revised several provisions of the Patient Protection enrollment, disenrollment and verification policies
and Affordable Care Act, was enacted on March 30, described in the certified BHP Blueprint, the State 45 These flexibilities are similar to those that are
2010. In this IFC, we refer to the two statutes must submit a revised Blueprint to the Secretary for currently available in the Medicaid State Plan
collectively as the ‘‘Patient Protection and review and certification.’’ Amendment (SPA) template and instructions that
Affordable Care Act’’. 44 Basic Health Program: State Administration of CMS created in March 2020 to assist states in
42 Basic Health Program: State Administration of Basic Health Programs; Eligibility and Enrollment responding to the PHE for the COVID–19 pandemic
Basic Health Programs; Eligibility and Enrollment in Standard Health Plans; Essential Health Benefits and CHIP SPAs that allow for temporary
in Standard Health Plans; Essential Health Benefits in Standard Health Plans; Performance Standards adjustments to enrollment and redetermination
in Standard Health Plans; Performance Standards for Basic Health Programs; Premium and Cost policies during disaster events. More information
for Basic Health Programs; Premium and Cost Sharing for Basic Health Programs; Federal Funding about these Medicaid and CHIP flexibilities is
Sharing for Basic Health Programs; Federal Funding Process; Trust Fund and Financial Integrity; available at https://www.medicaid.gov/resources-
Process; Trust Fund and Financial Integrity; Final Proposed Rule, 78 FR 59121 at 59125 (September for-states/disaster-response-toolkit/state-plan-
Rule (79 FR 14111 through 14151, March 12, 2014). 25, 2013). flexibilities/index.html.
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27594 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
duration of the PHE for the COVID–19 QCDR measure testing or collect data on During this 1 year delay, we will
pandemic, or a reasonable additional QCDR measures for the 2021 MIPS continue to review QDCR measures as
amount of time as discussed above. To performance period as specified at in past years to ensure they are valid,
submit and receive certification for a § 414.1400(b)(3)(v)(C) and (D). Both reliable, and align with the goals of the
revised Blueprint under § 600.125(c), a QCDR measure approval criteria Meaningful Measure initiative.46 This
state will need to submit a cover letter necessitate QCDRs collecting data from process includes review by quality
to CMS that lists each change for which clinicians in order to assess the measure experts; QCDR policy subject
it is seeking certification alongside an measure. Over 50 percent of the QCDRs matter experts; clinicians, including
explanation for how each change is approved for the 2020 performance physicians, nurses, and PTs/OTs, who
directly related to the PHE for the period are supported by specialty work on our support contractor team;
COVID–19 pandemic and how each societies that represent and support and CMS Medical Officers. We will
change is not restrictive in nature. The clinicians on the front lines of the continue to review QCDR measures for
state should also specify the requested COVID–19 pandemic, or are hospitals potential risk of patient harm (for
duration of each of the changes. If the that are directly impacted by the example, QCDR measures that promote
state is seeking certification to pandemic. We also anticipate that there clinical practices related to overuse). We
implement temporary changes beyond will be a lack of available data for some also will continue to review QCDR
the end of the COVID–19 pandemic, the QCDR measures because clinicians who measures for feasibility and accuracy
state should specify why the later end work in specialties that are not and reliability of results. For more
date is needed. The state should also primarily caring for COVID–19 patients information, we refer readers to the
submit a revised Blueprint that may have their cases or elective 2020 QCDR Measure Development
incorporates the temporary changes. In procedures canceled or delayed so that Handbook.47
addition, as noted above, the process resources can be redistributed. As a
2. Collection of Data on QCDR Measures
outlined in the new section § 600.125(c) result, we anticipate that QCDRs may be
does not apply to Blueprint revisions unable to collect, and clinicians unable In the CY 2020 PFS final rule (84 FR
that do not make significant changes. to submit, data on QCDR measures due 63067 through 63068), we finalized at
Revised Blueprints submitted under to prioritizing the care of COVID–19 § 414.1400(b)(3)(v)(D) that beginning
§ 600.125(c) will not be subject to the patients. with the 2021 performance period,
public comment requirements under We believe that clinicians who are on QCDRs are required to collect data on a
§ 600.115(c), as we have determined that the frontlines taking care of COVID–19 QCDR measure, appropriate to the
the existence of unforeseen cases should not be burdened with measure type, prior to submitting the
circumstances resulting from the PHE having to submit data to a QCDR for QCDR measure for CMS consideration
for the COVID–19 pandemic warrants an purposes of QCDR measure assessment during the self-nomination period. For
exception to the normal public notice (testing and data collection). In the reasons discussed in section II.R. of
procedures to expedite the certification consideration of clinicians’ limited this IFC, we are delaying the
of a revised Blueprint that implements resources and in an effort to reduce implementation of this policy by 1 year.
temporary changes to expand access to burden on clinicians and health care Specifically, we are amending
coverage. We have determined that it organizations that are responding to the § 414.1400(b)(3)(v)(D) to state that
would not be practical to solicit public COVID–19 pandemic, we are amending beginning with the 2022 performance
comment during the PHE for the the QCDR measure approval criteria period, QCDRs are required to collect
COVID–19 pandemic, and we recognize previously finalized in the CY 2020 PFS data on a QCDR measure, appropriate to
that there is a need to ensure consumers final rule (84 FR 63065 through 63068), the measure type, prior to submitting
have access to the care they need as specifically: (1) Completion of QCDR the QCDR measure for CMS
expeditiously as possible. Nonetheless, measure testing at § 414.1400(b)(3)(v)(C) consideration during the self-
we encourage states to seek public as discussed in section II.R.1. of this nomination period.
input, when appropriate, consistent IFC; and (2) collection of data on QCDR During this 1-year delay, we will
with applicable state requirements. measures at § 414.1400(b)(3)(v)(D) as continue to review QDCR measures as
If a state seeks to make a permanent, discussed in section II.R.2. of this IFC. in past years to ensure they are valid
significant change to its BHP, such as and identify performance gaps in the
1. Completion of QCDR Measure Testing area of measurement. As described in
permanently altering verification,
enrollment, or disenrollment policies, In the CY 2020 PFS final rule (84 FR the 2020 QCDR Measure Development
the state must follow the usual process 63065 through 63067), we finalized at Handbook,48 this process includes
for submission of a revised Blueprint § 414.1400(b)(3)(v)(C) that beginning vetting the measures to ensure they are
with a prospective effective date in with the 2021 performance period, all implementable and collectible, which
accordance with § 600.125(a). In QCDR measures must be fully includes an evaluation of the measure
addition, when seeking to make developed and tested, with complete and coding constructs (for example,
permanent, significant changes to its testing results at the clinician level, whether the measure is constructed as a
BHP, the state must continue to operate prior to submitting the QCDR measure ratio, proportional, or inverse measure).
under the terms of the existing certified at the time of self-nomination. For the Additionally, we will review the
Blueprint until HHS certifies the reasons discussed in section II.R. of this
revision. IFC, we are delaying the 46 See https://www.cms.gov/Medicare/Quality-
implementation of this policy by 1 year. Initiatives-Patient-Assessment-Instruments/
R. Merit-Based Incentive Payment Specifically, we are amending QualityInitiativesGenInfo/CMS-Quality-Strategy.
47 Available at https://qpp-cm-prod-
System (MIPS) Qualified Clinical Data § 414.1400(b)(3)(v)(C) to state that content.s3.amazonaws.com/uploads/580/
Registry (QCDR) Measure Approval beginning with the 2022 performance 2020%20Self-Nomination%20Toolkit
Criteria period, all QCDR measures must be %20for%20QCDRs%20%26%20Qualified
We have heard from third party fully developed and tested, with %20Registries.zip.
48 Available at https://qpp-cm-prod-content
intermediaries, specifically QCDRs, that complete testing results at the clinician .s3.amazonaws.com/uploads/580/2020%20Self-
due to the COVID–19 pandemic they level, prior to submitting the QCDR Nomination%20Toolkit%20for%20QCDRs%20%26
anticipate being unable to complete measure at the time of self-nomination. %20Qualified%20Registries.zip.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27595
evidence provided by the QCDR (for cannot be waived under the section T. Delay in the Compliance Date of
example, clinical studies and/or 1135 PHE waiver authority. Except as Certain Reporting Requirements
scientific journals) that would support expressly permitted by statute, we Adopted for IRFs, LTCHs, HHAs and
the need for measurement in lieu of remind physicians, practitioners and SNFs
insufficient data collection to suppliers that most items and services 1. Delay of the Compliance Date of the
demonstrate that there is a measurement must be reasonable and necessary for Transfer of Health (TOH) Information
gap. the diagnosis or treatment of an illness Quality Measures and Certain
S. Application of Certain National or injury or to improve the functioning Standardized Patient Assessment Data
Coverage Determination and Local of a malformed body member to be paid Elements (SPADEs) Adopted for the IRF
Coverage Determination Requirements under Part A or Part B of Title XVIII. QRP, LTCH QRP, and HH QRP
During the PHE for the COVID–19 Physicians, practitioners, and suppliers In the FY 2020 IRF PPS final rule (84
Pandemic are required to continue documenting FR 39100 through 39161), we adopted
National Coverage Determinations the medical necessity for all services. the TOH Information to Provider-Post-
(NCDs) are determinations by the Accordingly, the medical record must Acute Care and TOH Information to
Secretary with respect to whether or not be sufficient to support payment for the Patient-Post-Acute Care quality
a particular item or service is covered services billed (that is, the services were measures (collectively, the TOH
nationally under Title XVIII. Local actually provided, were provided at the Information Measures) beginning with
Coverage Determinations (LCDs) are level billed, and were medically the FY 2022 IRF QRP and finalized that
determinations by a Medicare necessary). IRFs would be required to collect data
Administrative Contractor (MAC) with on both measures beginning with
respect to whether or not a particular 2. Enforcement Discretion of Clinical patients discharged on or after October
item or service is covered under section Indications for Additional LCDs 1, 2020. We also adopted standardized
1862(a)(1)(A) of the Act in the particular patient assessment data elements
In the March 31st COVID–19 IFC, we
MAC’s geographical areas. Articles are (SPADEs) for six categories that IRFs
finalized on an interim basis that we
often published alongside LCDs and must report for patients beginning with
contain coding or other guidelines that will not enforce the clinical indications the FY 2022 IRF QRP, with data
complement an LCD. NCDs and LCDs for coverage across respiratory, home collection beginning with admissions
contain clinical conditions a patient anticoagulation management and and discharges (except for the hearing,
must meet to qualify for coverage of the infusion pump NCDs and LCDs vision, race and ethnicity SPADEs,
item or service. (including articles) allowing for more which would be collected for
In section II.U. of the March 31st flexibility for practitioners to care for admissions only) on October 1, 2020 (84
COVID–19 IFC, we finalized on an their patients. This enforcement FR 39114 through 84 FR 39149). In the
interim basis that to the extent an NCD discretion will only apply during the FY 2020 Inpatient Prospective Payment
or LCD (including articles) would PHE for the COVID–19 pandemic. System (IPPS)/Long-Term Care Hospital
otherwise require a face-to-face or in- In this IFC, we are finalizing on an (LTCH) PPS final rule (84 FR 42526
person encounter or other implied face- interim basis that we will not enforce through 84 FR 84534), we adopted the
to-face services, those requirements same two measures and SPADEs for
the clinical indications for therapeutic
would not apply during the PHE for the reporting by LTCHs beginning with FY
continuous glucose monitors in LCDs.
COVID–19 pandemic. Additionally, we 2022 LTCH QRP with data collection
finalized on an interim basis that we For example, we will not enforce the
beginning with patients discharged on
will not enforce the clinical indications current clinical indications restricting
October 1, 2020 and data collection on
for coverage across respiratory, home the type of diabetes that a beneficiary the SPADEs beginning with admissions
anticoagulation management and must have or relating to the and discharges (except for the hearing,
infusion pump NCDs and LCDs demonstrated need for frequent blood vision, race, and ethnicity SPADEs,
(including articles) allowing for glucose testing in order to permit which would be collected for
flexibility for practitioners to care for COVID–19 infected patients with admissions only) on October 1, 2020.
their patients. This section provides diabetes to receive a Medicare covered In the CY 2020 HH PPS final rule (84
clarification and expands upon section therapeutic continuous glucose monitor. FR 60557 through 60610), we also
II.U. of the March 31st COVID–19 IFC. This discretion is intended to permit adopted these measures for reporting by
COVID–19 patients to more closely HHAs in the CY 2022 HH QRP
1. Applicability of Reasonable and beginning with patients discharged or
monitor their glucose levels given that
Necessary Requirement for Covered transferred January 1, 2021 and data
Items and Services they are at risk for unpredictable
impacts of the infection on their glucose collection on the SPADEs beginning
Some external stakeholders appear to levels and health. The use of therapeutic with the start of care, resumption of
be misinterpreting statements that CMS continuous glucose monitors may allow care, and discharges (except for the
made in the March 31st COVID–19 IFC patients to proactively treat their hearing, vision, race, and ethnicity
as waiving medical necessity diabetes and prevent the need for SPADEs, which would be collected at
requirements; there are now questions the start of care only) on January 1,
hospital-based diabetic care.
as to whether items and services can be 2021.
Practitioners will also have greater
furnished or ordered without reason The current assessment instruments
during the PHE for the COVID–19 flexibility to allow more of their diabetic
that IRFs, LTCHs, and HHAs use to
pandemic. We note there is nothing in patients to better monitor their glucose submit data to meet the requirements of
guidance or the March 31st COVID–19 and adjust insulin doses from home by their respective QRPs do not include the
IFC, that could be interpreted to using a therapeutic continuous glucose data elements that these providers need
permanently or temporarily waive the monitor. This enforcement discretion to report the TOH Information Measures
reasonable and necessary statutory will only apply during the PHE for the or the SPADEs that we previously
requirement, which is expressed in COVID–19 pandemic. finalized for data collection beginning
section 1862(a)(1)(A) of the Act and either October 1, 2020 for IRFs and
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27596 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
LTCHs or January 1, 2021 for HHAs. We on these measures beginning with does not include the data elements that
have developed updated assessment patients discharged on October 1, 2021. are needed to report the TOH
instruments that include these new data We will also require IRFs and LTCHs to Information Measures and the SPADEs
elements, and under our current begin collecting data on the SPADEs for that we previously finalized for data
implementation timeline, we would be admissions and discharges (except for collection beginning October 1, 2020.
in the process of training providers on the hearing, vision, race, and ethnicity We previously released a draft version
how to operationalize them. Each of SPADEs, which would be collected for of the updated MDS 3.0 v1.18.1 that
these providers would also be in the admissions only) on October 1st of the includes these new data elements, and
process of training their staffs on how to year that is at least 1 full fiscal year after under our current implementation
use the updated versions, as well as the end of the COVID–19 PHE. HHAs timeline, we would be in the process of
working with their vendors to make will be required to use OASIS–E to training providers on how to
programming changes necessary to begin collecting data on the two TOH operationalize them. Each of these
implement them timely. However, we Information Measures beginning with providers would also be in the process
want to provide maximum flexibilities discharges and transfers on January 1st of training their staffs on how to use the
for these providers to respond to the of the year that is at least 1 full calendar updated versions, as well as working
public health threats posed by the year after the end of the COVID–19 PHE. with their vendors to make
COVID–19 PHE, and to reduce the For example, if the COVID–19 PHE ends programming changes necessary to
burden in administrative efforts on September 20, 2020, HHAs will be timely implement them. However, as we
associated with attending training, required to begin collecting data on previously noted in a March 19, 2020
training their staffs and working with those measures beginning with patients notice posted on our website 49
their vendors to incorporate the updated discharged or transferred on January 1, stakeholders have expressed concerns
assessment instruments into their 2022. We will also require HHAs to that the length of our planned
operations. Accordingly, we are begin collecting data on the SPADEs implementation period is too short for
delaying the release of updated versions beginning with the start of care, SNFs to properly educate their staffs on
of the IRF Patient Assessment resumption of care, and discharges how to operationalize the updated MDS
Instrument (IRF–PAI), LTCH Continuity (except for the hearing, vision, race, and given that the updated version did not
Assessment Record and Evaluation Data ethnicity SPADEs, which would be adequately address the needs of states
Set (LTCH CARE Data Set), and HHA’s collected at the start of care only) on that use the instrument for payment and
Outcome and Assessment Information January 1st of the year that is at least 1 to report data. For these reasons, we
Set (OASIS) Instrument to reduce the full calendar year after the end of the stated that we were delaying the release
burden that these providers would COVID–19 PHE. of the updated version of the MDS. This
otherwise incur as a result of being We believe that these delays will give delay will enable SNFs to continue
required to incorporate the updated IRFs, LTCHs, and HHAs enough time to using the current version of the MDS,
versions into their operations before operationalize the updated versions of with which they are already familiar.
October 1, 2020 (for IRFs and LTCHs) or their respective assessment instruments, Our delay of the release of the
January 1, 2021 (for HHAs). This delay including taking any necessary training updated version of the MDS 3.0 v1.18.1
will enable these providers to continue and ensuring that their vendors can will impact the ability of SNFs to collect
using the current versions of their make appropriate programming updates. and report data on the two TOH
We plan to release the drafts of the new Information Measures and SPADEs.
assessment instruments, with which
instruments again for these programs Accordingly, in this IFC, we are
they are already familiar. The current
shortly after the COVID–19 PHE ends to delaying the compliance dates for the
version of the IRF–PAI has been in use
provide ample time for training and any collection and reporting of these
since October 1, 2019 (IRF–PAI v. 3.0).
vendor programming. measures and SPADEs. Although we did
The current version of the LTCH CARE
not originally delay the release of the
Data Set has also been in use since 2. Delay in the Compliance Date of the
updated version of the MDS because of
October 1, 2019 (LTCH CARE Data Set Transfer of Health Information Measures
the COVID–19 PHE, we believe that this
v. 4.00). The current version of the and Certain SPADEs Adopted for the
PHE is appropriate to take into
OASIS Instrument has been in use since SNF QRP
consideration when determining when
January 1, 2019 (OASIS–D). In the FY 2020 SNF PPS final rule (84 it will be feasible to release the updated
This delay of the updated assessment FR 38755 through 84 FR 38764), we version, and when it will likewise be
instruments will impact the ability of adopted the TOH quality measures feasible to require SNFs to begin to
IRFs, LTCHs and HHAs to collect and beginning with the FY 2022 SNF QRP report the new quality measure and
report data on the two TOH Information and finalized that SNFs would be SPADEs data.
Measures and SPADEs under their required to collect data on both Therefore, we will require SNFs to
respective QRPs. Accordingly, in this measures beginning with patients begin collecting data on the two TOH
IFC, we are delaying the compliance discharged on October 1, 2020. We also Information Measures beginning with
dates for the collection and reporting of adopted SPADEs for six categories that discharges on October 1st of the year
these TOH Information Measures and SNFs must report for patients beginning that is at least 2 full fiscal years after the
SPADEs. Specifically, we will require with the FY 2022 SNF QRP, with data end of the COVID–19 PHE. For example,
IRFs to use IRF–PAI V4.0 and LTCHs to collection for patients discharged if the COVID–19 PHE ends on
use LTCH CARE Data Set V5.0 to begin October 1, 2020 for admissions and September, 20, 2020, SNFs will be
collecting data on the two TOH discharges (except for the hearing, required to begin collecting data on
Information Measures beginning with vision, race, and ethnicity SPADEs, these measures beginning with patients
discharges on October 1st of the year which would be collected for discharged on October 1, 2022. We will
that is at least 1 full fiscal year after the admissions only).
end of the COVID–19 PHE. For example, The current version of the Minimum 49 https://www.cms.gov/Medicare/Quality-
if the COVID–19 PHE ends on Data Set (MDS), MDS 3.0 v1.17.1, that Initiatives-Patient-Assessment-Instruments/
NursingHomeQualityInits/Skilled-Nursing-Facility-
September 20, 2020, IRFs and LTCHs SNFs use to submit data in order to Quality-Reporting-Program/SNF-Quality-Reporting-
will be required to begin collecting data meet the requirements of the SNF QRP Program-Spotlights-and-Announcements.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27597
also require SNFs to begin collecting calculated without use of the excepted all hospitals in a region or locale, we
data on the SPADEs beginning with quality data. will communicate this decision through
admissions and discharges (except for Based on our previously finalized routine communication channels to
the hearing, vision, race, and ethnicity policy, a hospital must submit the hospitals, vendors, and Quality
SPADEs, which would be collected for Hospital VBP Program ECE request form Improvement Organizations (QIOs),
admissions only) on October 1st of the (OMB control #0938–1022), including including but not limited to issuing
year that is at least 2 full fiscal years any available evidence of the impact of memos, emails, and notices on the
after the end of the COVID–19 PHE. the extraordinary circumstances on the public QualityNet website (see https://
Although this delay is longer than the hospital’s quality measure performance, www.qualitynet.org). This policy will
delay we are adopting for IRFs, LTCHs within 90 calendar days of the date on more closely align the Hospital VBP
and HHAs, we believe that the which the natural disaster or other Program ECE policy with the ECE policy
additional delay for SNFs is appropriate extraordinary circumstance occurred (78 adopted for other quality reporting and
because it will give us enough time to FR 50706). VBP programs, including the Hospital
work with stakeholders to ensure that We continue to recognize that Inpatient Quality Reporting, Hospital
their concerns are addressed while also unforeseen extraordinary circumstances, Outpatient Quality Reporting, Inpatient
allowing SNFs a reasonable amount of such as the current PHE for COVID–19, Psychiatric Facility Quality Reporting,
time to complete required training, train could substantially affect the ability of Ambulatory Surgical Center Quality
their staffs, and work with their vendors hospitals to perform under the Hospital Reporting, PPS-Exempt Cancer Hospital
to make necessary programming VBP Program at the same level at which Quality Reporting, Hospital-Acquired
updates. Shortly after the COVID–19 they might otherwise have performed if Condition Reduction, and Hospital
PHE ends, we plan to work with the natural disaster or extraordinary Readmissions Reduction Programs. If
stakeholders to develop a mutually circumstance had not occurred. We also we grant an ECE to hospitals located in
agreeable timeline for releasing the continue to acknowledge that using an entire region or locale under this
updated MDS 3.0 v1.18.1 that provides quality measure data from these periods revised policy and, as a result of
sufficient time for SNFs to incorporate to generate the Hospital VBP Program granting that ECE, one or more hospitals
the updated version into their TPS might substantially impact the located in that region or locale does not
operations. value-based incentive payment amount report the minimum number of cases
that the hospital would otherwise and measures required to enable us to
U. Update to the Hospital Value-Based receive. Further, we believe that during calculate a TPS for that hospital for the
Purchasing (VBP) Program an extraordinary circumstance that applicable program year, the hospital
Extraordinary Circumstance Exception affects an entire geographic region or will be excluded from the Hospital VBP
(ECE) Policy locale, which could include the entire Program for the applicable program
In the FY 2014 IPPS/LTCH final rule United States (such as the COVID–19 year. We refer readers to the FY 2020
(78 FR 50704 through 50707), we PHE), the requirement for hospitals to IPPS/LTCH PPS final rule (84 FR 42399
finalized a disaster/extraordinary submit individual ECE request forms through 42400) for the minimum
circumstance exception (ECE) policy for along with supporting evidence to CMS number of measures and cases that we
the Hospital VBP Program. The intent of within 90 days of the date the currently require hospitals to report to
the Hospital VBP ECE policy is to extraordinary circumstance occurred receive a TPS for a program year under
mitigate any adverse impact on quality could be overly burdensome for the Hospital VBP Program.
performance as a direct result of hospitals by requiring additional A hospital that does not report the
unforeseen extraordinary circumstances administrative actions from hospital minimum number of cases or measures
outside of the hospital’s control and the personnel, who may need to focus on for a program year will not receive a 2
resulting impact on their value-based care delivery and related priorities percent reduction to its base operating
incentive payment amounts. during and subsequent to the DRG payment amount for each
Under the current policy and upon a extraordinary circumstance. discharge in the applicable program
hospital’s request, we will consider Therefore, we believe it is necessary year, and will also not be eligible to
providing an exception from the to update the Hospital VBP Program’s receive any value-based incentive
Hospital VBP Program requirements to ECE policy to include the ability for us payments for the applicable program
hospitals affected by natural disasters or to grant exceptions to hospitals located year.
other extraordinary circumstances (78 in entire regions or locales, which could In accordance with this updated
FR 50704 through 50706). Specifically, include the entire United States, policy and consistent with the ECE
in the FY 2014 IPPS/LTCH final rule, without a request where we determine guidance we issued on March 22, 2020
we stated that we interpreted the that the extraordinary circumstance has and March 27, 2020,50 we are granting
minimum number of cases and affected the entire region or locale. an ECE with respect to the COVID–19
measures requirement in sections Accordingly, in this IFC, we are PHE to all hospitals participating in the
1886(o)(1)(C)(ii)(III) and (IV) of the Act modifying the Hospital VBP Program’s Hospital VBP Program for the following
to not include any measures or cases for ECE policy to allow us to grant ECE reporting requirements:
which a hospital has submitted data exceptions to hospitals which have not • Hospitals will not be required to
during a performance period for which requested them when we determine that report National Healthcare Safety
the hospital has been granted a Hospital an extraordinary circumstance that is Network (NHSN) HAI measures and
VBP Program ECE. We also stated that, out of their control, such as an act of HCAHPS survey data for the following
if after the applicable quality measure nature (for example, a hurricane) or PHE quarters: October 1, 2019–December 31,
data from a performance period has (for example, the COVID–19 pandemic),
been excepted due to the granting of an affects an entire region or locale, in 50 https://www.cms.gov/newsroom/press-releases/
ECE, the hospital still reports the addition to retaining the individual ECE cms-announces-relief-clinicians-providers-
minimum number of cases and request policy. We are codifying this hospitals-and-facilities-participating-quality-
reporting, and https://www.cms.gov/files/
measures required for the program year, updated ECE policy at § 412.165(c) of document/guidance-memo-exceptions-and-
the hospital will still receive a Total our regulations. When we make the extensions-quality-reporting-and-value-based-
Performance Score (TPS) that has been determination to grant an exception to purchasing-programs.pdf%20.
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27598 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
2019 (Q4 2019), January 1, 2020–March identifying whether the patient has the results are considered in the overall
31, 2020 (Q1 2020), and April 1, 2020– antibodies specific to the SARS-CoV–2 management of the patient.
June 30, 2020 (Q2 2020). However, virus. Patients who have these In circumstances outside of the
hospitals can optionally submit part or antibodies may have developed an COVID–19 PHE, we would ordinarily
all of these data by the posted immune response to SARS-CoV–2 use the NCD process to establish a
submission deadlines on the HVBP indicating recent or prior infection, and benefit category and establish that an
QualityNet site (available at https:// therefore, potentially may not be at item or service is reasonable and
www.qualitynet.org/inpatient/iqr/ immediate risk for re-infection. It is necessary under section 1862(a)(1)(A) of
participation). We refer readers to the expected that patients have been the Act. The NCD process is established
March 27 guidance memo for more infected with COVID–19 who either had in section 1862(l) of the Act and
information on the HAI and HCAHPS characteristic symptoms and were not requires the Secretary to make a
measures in that are included in the tested or had minor or non-specific proposed decision available to the
Hospital-Acquired Condition Reduction symptoms and did not seek testing. An public for 30 days of public comment
Program. FDA-authorized serology test that followed by issuing a final decision not
• We will exclude qualifying claims detects antibodies to SARS-CoV–2, the later than 60 days after the close of the
data from the mortality, complications, virus that causes COVID–19, may comment period. Given the need to
and Medicare Spending per Beneficiary potentially aid in identifying patients establish timely and uniform national
measures for the following quarters: who have had an immune response to coverage that is relevant during the PHE
January 1, 2020–March 31, 2020 (Q1 current or prior SARS-CoV–2 infection. for the COVID–19 pandemic, we have
2020) and April 1, 2020—June 30, 2020 Based on this information, we are determined that coverage for FDA-
(Q2 2020). finalizing on an interim basis that these authorized COVID–19 serology tests
We are granting these exceptions to FDA-authorized COVID–19 serology should be established in an interim final
assist hospitals while they direct their tests fall under the Medicare benefit manner through this IFC. Since we are
resources during the PHE related to category of diagnostic laboratory test not aware of any professional society
COVID–19 toward caring for their (section 1861(s)(3) of the Act). recommendations for confirmatory or
patients and ensuring the health and Therefore, these tests are coverable by repeat testing on the same sample, CMS
safety of patients and staff. We believe the Medicare program because they fall would expect to be billed once per
it is appropriate to except hospitals from under at least one Medicare benefit sample. Further, we would not expect
the requirement to report HAI measure category. This may not be an exhaustive such tests to be performed and billed
data, HCAHPS survey data, and claims- list of benefit categories as CMS did not unless clinically indicated.
based data for Q1 and Q2 2020 evaluate information about the test to We are finalizing on an interim basis,
discharges because the data collected identify additional benefit categories. that during the PHE for the COVID–19
during that period may be greatly pandemic, Medicare will cover FDA-
Having COVID–19 serology test
impacted by the hospital’s response to authorized COVID–19 serology tests as
results is useful to individual patients,
COVID–19. While hospitals will they are reasonable and necessary under
their practitioners, and their
continue to submit claims for section 1862(a)(1)(A) of the Act for
communities because it could change
reimbursement, we will not use beneficiaries with known current or
the decisions Medicare beneficiaries
discharge data from these quarters for known prior COVID–19 infection or
make for themselves and influences
measure calculations because we are suspected current or suspected past
practitioner management of the
concerned that these claims data may COVID–19 infection. We are amending
beneficiaries’ medical treatment.
not be fully reflective of their quality or § 410.32 to reflect this determination of
If it can be determined that they are
cost of care. For the Q4 2019 HAI and coverage.
HCAHPS data, the exception is being immune, these patients would possibly
granted because the April and May 2020 not be at risk for contracting COVID–19 W. Modification to Medicare Provider
data submission deadlines for those data and not be risking the health of their Enrollment Provision Concerning
fall during the COVID–19 PHE, and we communities if they travel outside of Certification of Home Health Services
believe it is important to reduce the data their home as they would not spread
COVID–19. Among the biggest risks to 1. Background—Provider Enrollment
collection and reporting burden so that
hospitals can direct their resources the community are patients with Section 1866(j)(1)(A) of the Act
toward responding to the COVID–19 COVID–19 infection who have not requires the Secretary to establish a
PHE. We continue to closely monitor developed symptoms or had minor non- process for the enrollment of providers
and analyze the impact that the COVID– specific symptoms, yet are infectious.51 and suppliers in the Medicare program.
19 PHE has on the HVBP program, and Beneficiaries who are negative for The overarching purpose of the
if necessary, will communicate any COVID–19 antibodies through serology enrollment process is to help ensure
other exceptions and/or extensions that testing may need to take more that providers and suppliers that seek to
we believe are appropriate for the preventive measures to reduce their bill the Medicare program for services or
Hospital VBP Program through routine personal risk of infection as some items furnished to Medicare
communication channels to hospitals, persons, based on age and other factors, beneficiaries are qualified to do so
vendors, and QIOs, including but not are at higher risk of serious illness or under federal and state laws.
limited to issuing memos, emails, and death from the disease. Further, a The applicable provider enrollment
notices on the public QualityNet practitioner should discuss the results regulations are largely, though not
website (see https:// of the serology test with the beneficiary exclusively, contained in part 424,
www.qualitynet.org). to ensure that the beneficiary subpart P (currently §§ 424.500 through
understands the results of the test and 424.570). Several of our previous
V. COVID–19 Serology Testing provider enrollment rulemaking efforts
51 Wei WE, Li Z, Chiew CJ, Yong SE, Toh MP, Lee
A blood-based serology test can be have focused on strengthening existing
VJ. Presymptomatic Transmission of SARS-CoV–
used to detect whether a patient may 2—Singapore, January 23–March 16, 2020. MMWR
enrollment procedures and eliminating
have previously been infected with the Morb Mortal Wkly Rep 2020;69:411–415. DOI: existing vulnerabilities; in other words,
virus that causes COVID–19 by http://dx.doi.org/10.15585/mmwr.mm6914e1. the objectives have been to enhance our
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27599
ability to: (1) Conduct strict screening rulemaking. Consequently, we are necessary change to better align issuer
activities; (2) take prompt action against revising § 424.507(b)(1) to include billing with the statutory requirements
problematic providers and suppliers; ordering/certifying physicians, PAs, specified in section 1303 of the Patient
and (3) implement important safeguards NPs, and CNSs as individuals who can Protection and Affordable Care Act,
against improper Medicare payments. certify the need for home health which requires non-Hyde abortion
Yet we believe that the current COVID– services. We note that, for reasons services be treated differently from other
19 PHE requires us to undertake similar to those related to our other covered services. Specifically, requiring
provider enrollment rulemaking for a modifications to Medicare rules separate billing for coverage of non-
different reason; specifically, the need concerning the certification and Hyde abortion services better aligns
to help providers and suppliers provision of home health services, this with Congress’s intent for QHP issuers
concentrate their resources on treating change to § 424.507 is final and to collect two distinct premium
those beneficiaries affected by COVID– applicable to services provided on or payments for coverage of these services,
19. Therefore, as discussed in section after March 1, 2020. We will review and one for the coverage of non-Hyde
III. of this IFC, ‘‘Waiver of Proposed respond to any comments thereon in the abortion services, and one for coverage
Rulemaking,’’ we believe the urgency of CY 2021 HH PPS final rule or in another of all other services covered under a
this COVID–19 PHE constitutes good future rule. QHP.
cause to waive the normal notice-and- Under the separate billing policy
X. Health Insurance Issuer Standards finalized in the 2019 Program Integrity
comment process under the
Under the Affordable Care Act, Rule at § 156.280(e)(2)(ii), issuers of
Administrative Procedure Act and
Including Standards Related to individual market QHPs are required to
statute. Accordingly, this IFC contains
Exchanges: Separate Billing and begin separately billing policy holders
an important revision to part 424,
Segregation of Funds for Abortion for the portion of the policy holder’s
subpart P that will give providers and
Services premium attributable to non-Hyde
suppliers certain flexibilities in their
activities during the existing COVID–19 In light of these extraordinary abortion services, as specified by the
PHE. circumstances and the immediate need regulation, on or before the QHP issuer’s
for qualified health plan (QHP) issuers first billing cycle following June 27,
2. Certification of Home Health to devote resources to respond to the 2020.
Services—Revision to § 424.507 COVID–19 PHE, we are revising 45 CFR To address the risk of coverage
Currently, § 424.507(b)(1) contains 156.280(e)(2)(ii) to delay terminations related to failure on the
certain payment requirements for implementation of the separate billing part of policy holders to pay the
covered Part A or Part B home health policy for 60 days from the effective separately billed amount for coverage of
services. Specifically, and consistent date we finalized in the ‘‘Patient non-Hyde abortion services, we
with section 6405(b) of the Patient Protection and Affordable Care Act; determined that HHS would exercise
Protection and Affordable Care Act Exchange Program Integrity’’ final rule enforcement discretion in two scenarios
(which amended sections 1814(a)(2) and (84 FR 71674) (‘‘2019 Program Integrity related to policy holder nonpayment of
1835(a)(2) of the Act), to receive Rule’’).52 Under this 60-day extension, the separate bill for coverage of non-
payment for such services, the QHP issuers must comply with the Hyde abortion services. Under the first
provider’s claim must meet all of the separate billing policy finalized at scenario, we explained that HHS will
following requirements: § 156.280(e)(2)(ii) beginning on or before not take enforcement action against a
• The ordering/certifying physician the QHP issuer’s first billing cycle QHP issuer that adopts and implements
must be identified by his or her legal following August 26, 2020. a policy, applied uniformly to all its
name and National Provider Identifier To better align QHP issuer billing for QHP enrollees, under which an issuer
(NPI) on the claim. coverage of non-Hyde abortion services does not place an enrollee into a grace
• The ordering/certifying physician with the separate payment requirement period and does not terminate QHP
must be enrolled in Medicare in an in section 1303 of the Patient Protection coverage based solely on the policy
approved status or have validly opted- and Affordable Care Act,53 we finalized holder’s failure to pay the separate
out of the Medicare program. a policy in the 2019 Program Integrity payment for coverage of non-Hyde
However, and as previously Rule requiring issuers of individual abortion services. We further explained
mentioned in this IFC, section 3708 of market QHPs offering coverage of non- that the QHP issuer would: (1) Be
the CARES Act made several important Hyde abortion services to separately bill prohibited from using any federal funds
amendments to sections 1814(a)(2) and policy holders for the portion of their for coverage of non-Hyde abortion
1835(a)(2) of the Act (as well as other premium attributable to coverage of services; (2) be required to collect the
related sections of the statute). One non-Hyde abortion services. We premium for the non-Hyde abortion
amendment was that NPs, CNSs, and explained in the 2019 Program Integrity coverage; and (3) not be able to relieve
PAs (as those terms are defined in Rule that separately billing policy the policy holder of the duty to pay the
section 1861(aa)(5) of the Act) working holders in this manner for coverage of amount of premium attributable to
in accordance with state law may also non-Hyde abortion services is a coverage for non-Hyde abortion
certify the need for home health services. We explained that this
services. Section 3708(f) of the CARES 52 A typographical error in the date in the enforcement posture would take effect
Act authorizes us to promulgate an regulation text promulgated in the 2019 Program upon the effective date of the separate
interim final rule, if necessary, to Integrity Rule was corrected on January 17, 2020. billing requirements on June 27, 2020.
implement the provisions in section 85 FR 2888. Under the second scenario, we
53 The Patient Protection and Affordable Care Act
3708 by the statutory deadline. Further, (Pub. L. 111–148) was enacted on March 23, 2010.
explained that HHS will not take
given the need for flexibility in the The Health Care and Education Reconciliation Act enforcement action against QHP issuers
provision of health care services in the of 2010 (Pub. L. 111–152), which amended and that, on or after the effective date of the
COVID–19 PHE, we believe it is revised several provisions of the Patient Protection final rule (February 25, 2020), modify
and Affordable Care Act, was enacted on March 30,
appropriate to implement these 2010. In this IFC, we refer to the two statutes
the benefits of a plan either at the time
statutory changes in this IFC, rather collectively as the ‘‘Patient Protection and of enrollment or during a plan year to
than through notice-and-comment Affordable Care Act’’. effectively allow enrollees to opt out of
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27600 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
coverage of non-Hyde abortion services the immediate need for QHP issuers to response. We believe extending the
by not paying the separate bill for such divert resources to responding to the deadline 60 days for QHP issuers and
services, resulting in an enrollee COVID–19 PHE, we are revising Exchanges to comply with the separate
effectively having a modified plan that § 156.280(e)(2)(ii) to delay billing policy is appropriate, so that
does not cover non-Hyde abortion implementation of the separate billing they may adequately respond to the
services. policy for 60 days. Under this 60-day COVID–19 PHE and divert resources to
We also stated in the 2019 Program delay, QHP issuers must comply with address the COVID–19 PHE that may
Integrity rule that, for those State the separate billing policy finalized at otherwise have been used for timely
Exchanges and QHP issuers that may § 156.280(e)(2)(ii) beginning on or before compliance with the separate billing
face uncommon or unexpected the QHP issuer’s first billing cycle policy.
impediments to timely compliance, following August 26, 2020. Although the 2019 Program Integrity
HHS would consider extending We acknowledge that a particular Rule provides an existing framework for
enforcement discretion to an Exchange QHP issuer’s or Exchange’s ability to HHS to exercise its enforcement
or QHP issuer that fails to timely comply with the separate billing policy discretion in connection with QHP
comply with the separate billing policy by the extended deadline of August 26, issuers and Exchanges unable to timely
as required under the final rule, if we 2020, may depend on the particular comply with the separate billing policy
find that the Exchange or QHP issuer impact the COVID–19 PHE has on the based on the circumstances of the
attempted in good faith to timely meet resources, systems, and operations of particular Exchange or QHP issuer,
the requirements. However, we noted that QHP issuer or Exchange. We also based on reports from a number of QHP
that HHS would be unlikely to exercise acknowledge that the timeline for how issuers and Exchanges, we have
such discretion for an Exchange or QHP long the COVID–19 PHE continues to concluded that handling requests for
issuer that fails to meet the separate impact QHP issuers and Exchanges is additional time to come into compliance
billing requirements after more than 1 uncertain, and therefore, QHP issuers on a case-by-case basis is not an
year following publication of the 2019 and Exchanges may be confronted with efficient mechanism to address these
Program Integrity Rule. additional unexpected impediments to requests and does not adequately
We have received a number of timely compliance past the 60-day delay acknowledge the shared burden that the
requests from QHP issuers requesting we are finalizing in this IFC. HHS will COVID–19 PHE is placing on QHP
that HHS exercise its enforcement still consider exercising its enforcement issuers and Exchanges. We believe that
discretion for delayed implementation discretion in connection with an the COVID–19 PHE is an unexpected
in light of the heightened burden QHP Exchange or QHP issuer that fails to impediment to timely compliance with
issuers are experiencing related to timely comply with the separate billing the separate billing policy for all QHP
addressing the COVID–19 PHE. QHP policy on or before the first billing cycle issuers and Exchanges alike. As a
issuers explained in their requests to following August 26, 2020, if HHS finds consequence, we have determined that
HHS that the dedication of numerous that the Exchange or QHP issuer it is appropriate to extend the deadline
cross-functional resources in response attempted in good faith to timely meet for compliance 60 days through this
to the COVID–19 PHE has led to an the requirements. We do not anticipate IFC, and to codify this change in the
overall reduction in resources available that HHS would exercise such Federal Register.54
for other initiatives, such as preparatory discretion for an Exchange or QHP As previously noted, we finalized in
arrangements to timely implement the issuer that fails to meet the separate the 2019 Program Integrity Rule that
separate billing policy. QHP issuers billing requirements after more than 1 HHS would exercise enforcement
further explained how the already year following publication of the 2019 discretion in two scenarios related to
existing challenges to timely Program Integrity Rule or more than 6 policy holder nonpayment of the
compliance with the separate billing months after the end of the COVID–19 separate bill. We note that the extension
policy pose an even greater obstacle PHE, whichever comes later. However, for compliance we are finalizing here
when considered in conjunction with we emphasize that QHP issuers and only impacts the first of those scenarios,
the mounting demands on QHP issuers Exchanges should make good faith by delaying when this enforcement
in responding to the COVID–19 PHE. efforts to fully comply by the extended posture becomes available by 60 days.
We are also aware that for many QHP deadline of the first billing cycle As previously stated, HHS will not take
issuers, some, if not all, of their daily following August 26, 2020. We believe enforcement action against a QHP issuer
work is being accomplished while staff the 60-day delay will sufficiently that adopts and implements a policy,
is working remotely, adding yet another alleviate burden on resources in the applied uniformly to all its QHP
barrier to timely compliance. short-term, as well as provide sufficient enrollees, under which an issuer does
We believe that despite timely QHP time for QHP issuers and Exchanges, not place an enrollee into a grace period
initiation of planning for compliance such that responding to the COVID–19 and does not terminate QHP coverage
with the separate billing policy, there PHE and timely compliance with the based solely on the policy holder’s
are circumstances outside of the control separate billing policy are both
of QHP issuers, due to the COVID–19 practical. As a consequence, we do not 54 In light of the ongoing litigation challenging the
PHE, that make timely compliance with anticipate formally extending the separate billing policy and the delayed briefing
schedule for this litigation, delaying
the separate billing policy impractical compliance deadline again. implementation of the separate billing policy by 60
by the deadline, on or before the first As QHP issuers and Exchanges work days would also be justified, as the 60-day delay
billing cycle following June 27, 2020. to respond to the COVID–19 PHE, and provides the court additional time to resolve the
Moreover, we believe it is imprudent to implement and establish policies to issues before compliance with the separate billing
provision is required and offers regulated parties
require QHP issuers to devote resources ensure access to COVID–19-related care more certainty before dedicating limited resources
to timely compliance with the separate for enrollees, HHS is working to assess to the necessary changes during this PHE. This
billing policy when these resources can and extend regulatory flexibility to QHP extension is also consistent with the representations
instead be directed towards addressing issuers, Exchanges, and other health made by the federal government to the federal court
in lawsuits challenging the separate billing policy
the immediate needs associated with the industry stakeholders, where doing so in response to requests that HHS delay
COVID–19 PHE. Therefore, in light of may enable these stakeholders to divert implementation of the separate billing policy in
these extraordinary circumstances and existing resources to the COVID–19 PHE light of COVID–19.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27601
failure to pay the separate payment for implementing regulations at 42 CFR part specified above at a frequency specified
coverage of non-Hyde abortion services. 483, subpart B. by the Secretary, but no less than
This enforcement posture will now take Sections 1819(d)(3) and 1919(d)(3) of weekly to the Center for Disease Control
effect on the earliest date on which QHP the Act explicitly require that LTC and Prevention’s (CDC) National
issuers will need to begin complying facilities develop and maintain an Healthcare Safety Network (NHSN)
with the separate billing requirements, infection control program that is (OMB Control Number 0920–1290).
August 26, 2020. We are not making any designed, constructed, equipped, and Furthermore, we note that the
additional revisions to the separate maintained in a manner to protect the information reported will be shared
billing provisions finalized in the 2019 health and safety of residents, with CMS and we will retain and
Program Integrity Rule other than personnel, and the general public. In publicly report this information to
extending the date for compliance with addition, sections 1819(d)(4)(B) and support protecting the health and safety
the separate billing policy by 60 days. 1919(d)(4)(B) of the Act explicitly of residents, personnel, and the general
When explaining our rationale for the authorize the Secretary to issue any public, in accordance with sections
implementation deadline of the first regulations he deems necessary to 1819(d)(3)(B) and 1919(d)(3) of the Act.
billing cycle following June 27, 2020 in protect the health and safety of The Freedom of Information Act (FOIA)
the 2019 Program Integrity Rule, we residents. Infection prevention and (found in Title 5 of the United States
expressed the importance of QHP control is a primary goal of initiatives Code, section 552) provides that, upon
issuers implementing the separate taking place in LTC facilities during the request from any person, a Federal
billing policy changes at the earliest COVID–19 PHE. Under the explicit agency must release any agency record
date feasible to better align QHP issuer instructions of Congress, existing unless that record falls within one of the
billing of non-Hyde abortion services regulations at § 483.80 require facilities nine statutory exemptions and three
with the separate payment requirement to, among other things, establish and exclusions (see https://www.foia.gov/
in section 1303 of the Patient Protection maintain an infection prevention and faq.html for detailed information).
control program (IPCP) designed to Further, FOIA requires that agencies
and Affordable Care Act. Although
provide a safe, sanitary, and comfortable make available for public inspection
expeditious implementation of this
environment and to help prevent the copies of records, that because of the
policy continues to be important, we
development and transmission of nature of their subject matter, the
believe the impact of the COVID–19
communicable diseases and infections. agency determines the records have
PHE on QHP issuer and Exchange
Furthermore, current § 483.80(a)(2) become or are likely to become the
operations has shifted the date by which
requires facilities to have written subject of subsequent requests for
it is operationally and administratively
standards, policies, and procedures for substantially the same information. We
feasible to require QHP issuers to timely
the program, which among other things, have received, and expect to continue to
comply with the separate billing policy.
must include a system of surveillance receive, COVID–19 related FOIA
We acknowledge that extending the date designed to identify possible
for compliance by 60 days also delays requests. These requirements will
communicable diseases or infections support our efforts to proactively inform
the added transparency the separate before they can spread to other persons
billing policy would provide for policy interested parties and ensure that the
in the facility and when and to whom most complete information on COVID–
holders related to whether QHPs cover possible incidents of communicable
non-Hyde abortion services. However, 19 cases is available. The new reporting
disease or infections should be reported. requirements at § 483.80(g)(1) and (2) do
we believe the delay in increasing In an effort to support surveillance of
transparency and better aligning QHP not relieve LTC facilities of the
COVID–19 cases, we are revising the
issuer billing with the separate payment obligation to continue to comply with
requirements to establish explicit
requirement in section 1303 of the § 483.80(a)(2)(ii), which requires
reporting requirements for confirmed or
Patient Protection and Affordable Care facilities to report possible incidents of
suspected cases. Specifically, we are
Act is outweighed by the immediate communicable disease and infections.
revising our requirements by adding a
need for QHP issuers and Exchanges to This includes complying with state and
new provision at § 483.80(g)(1), to
divert resources to respond to the local reporting requirements for COVID–
require facilities to electronically report
current COVID–19 PHE. 19.
information about COVID–19 in a
standardized format specified by the At § 483.80(g)(3), we are adding a new
Y. Requirement for Facilities To Report
Secretary. The report includes, but is provision to require facilities to inform
Nursing Home Residents and Staff
not limited to, information on: residents, their representatives, and
Infections, Potential Infections, and
Suspected and confirmed COVID–19 families of those residing in facilities of
Deaths Related to COVID–19
infections among residents and staff, confirmed or suspected COVID–19 cases
Under sections 1866 and 1902 of the including residents previously treated in the facility among residents and staff.
Act, providers of services seeking to for COVID–19; total deaths and COVID– This reporting requirement supports the
participate in the Medicare or Medicaid 19 deaths among residents and staff; overall health and safety of residents by
program, or both, must enter into an personal protective equipment and hand ensuring they are informed participants
agreement with the Secretary or the hygiene supplies in the facility; in the care that they receive as well as
state Medicaid agency, as appropriate. ventilator capacity and supplies providing assurances of the mitigating
Long-term care (LTC) facilities seeking available in the facility; resident beds steps the facility is taking to prevent and
to be Medicare and Medicaid providers and census; access to COVID–19 testing control the spread of COVID–19.
of services must be certified as meeting while the resident is in the facility; Facilities must inform residents, their
federal participation requirements. LTC staffing shortages; and other information representatives, and families by 5 p.m.
facilities include SNFs for Medicare and specified by the Secretary. This the next calendar day following the
NFs for Medicaid. The federal information will be used to monitor occurrence of either: A single confirmed
participation requirements for SNFs, trends in infection rates, and inform infection of COVID–19; or three or more
NFs, and dually certified facilities, are public health policies. residents or staff with new-onset of
set forth in sections 1819 and 1919 of In addition, at § 483.80(g)(2), facilities respiratory symptoms that occur within
the Act and codified in the are required to provide the information 72 hours of each other. Also, cumulative
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27602 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
updates to residents, their public interest, because time is of the deleting services from the telehealth list
representatives, and families must be essence in informing residents, their as is required under section
provided at least weekly by 5 p.m. the families, and the general public of the 1834(m)(4)(F)(ii) of the Act.
next calendar day following the incidence of COVID–19; such In the March 31st COVID–19 IFC (85
subsequent occurrence of either: Each information will assist public health FR 19232–19253), we added a number
time a confirmed infection of COVID–19 officials in detecting outbreaks and of services to the Medicare telehealth
is identified; or whenever three or more saving lives. list on an interim final basis for the
residents or staff with new onset of The applicability date for duration of the PHE for the COVID–19
respiratory symptoms occur within 72 § 483.80(g)(1) through (3)(iii) is the date pandemic. While we believe that we
hours of each other. This information of the publication of this rule (that is, have already added the vast majority of
must be reported in accordance with the effective date as noted in the DATES services that it would appropriate to add
existing privacy regulations and statute, section of this notice). to the Medicare telehealth list for
and must not include Personally purposes of the PHE for the COVID–19
Z. Time Used for Level Selection for
Identifiable Information (PII). Facilities pandemic, it is possible that we might
Office/Outpatient Evaluation and
must include information on mitigating identify other services that would be
Management Services Furnished Via
actions implemented to prevent or appropriate additions to the telehealth
Medicare Telehealth
reduce the risk of transmission, list, taking into consideration infection
including if normal operations in the In the March 31st COVID–19 IFC (85 control, patient safety, and other public
nursing home will be altered such as FR 19268 through 19269), for the health concerns resulting from the
restrictions or limitations to visitation or duration of the PHE for the COVID–19 COVID–19 PHE. Due to the urgency of
group activities. For purposes of this pandemic, we revised our policy to minimizing unnecessary contact
reporting requirement, facilities are not specify that the office/outpatient E/M between beneficiaries and practitioners,
expected to make individual telephone level selection for office/outpatient E/M we believe that, for purposes of the PHE
calls. Instead, facilities can utilize services when furnished via telehealth for the COVID–19 pandemic, we should
communication mechanisms that make can be based on MDM or time, with modify the process we established for
this information easily available to all time defined as all of the time adding or deleting services from the
residents, their representatives, and associated with the E/M on the day of Medicare telehealth services list under
families, such as paper notification, the encounter. We stated that currently our regulation at § 410.78(f) to allow for
listservs, website postings, and/or there are typical times associated with an expedited process during the PHE
recorded telephone messages. the office/outpatient E/M visits, and that that does not involve notice and
These reporting requirements along those times are what should be met for comment rulemaking. Therefore, for the
with public reporting of the data purposes of level selection. We stated duration of the PHE for the COVID–19
support our responsibility to protect and that typical times associated with the pandemic, we are revising our
ensure the health and safety of residents office/outpatient E/M visits were regulation at § 410.78(f) to specify that,
by enforcing the standards required to available as a public use file at https:// during a PHE, as defined in § 400.200 of
help each resident attain or maintain www.cms.gov/Medicare/Medicare-Fee- this chapter, we will use a subregulatory
their highest level of well-being. As for-Service-Payment/ process to modify the services included
noted, sections 1819(d)(3)(B) and PhysicianFeeSched/PFS-Federal- on the Medicare telehealth list.
1919(d)(3) of the Act requires that a Regulation-Notices-Items/CMS-1715-F. While we are not codifying a specific
facility must establish an infection Members of the physician community process to be in effect during the PHE
control program that is designed, have brought to our attention that the for the COVID–19 pandemic, we note
constructed, equipped, and maintained policy announced in the March 31st that we could add services to the
in a manner to protect the health and COVID–19 IFC relies on typical times Medicare telehealth list on a
safety of residents, personnel, and the listed in our public use file even when subregulatory basis by posting new
general public. We believe that these those times do not align with the typical services to the web listing of telehealth
reporting requirements are necessary for times included in the office/outpatient services when the agency receives a
CMS to monitor whether individual E/M code descriptors. We agree that request to add (or identifies through
nursing homes are appropriately discrepancies between times can be internal review) a service that can be
tracking, responding, and mitigating the confusing. We believe that, because the furnished in full, as described by the
spread and impact of COVID–19 on our times are being used for the purpose of relevant code, by a distant site
most vulnerable citizens, personnel who choosing which level of office/ practitioner to a beneficiary in a manner
care for them, and the general public. outpatient E/M CPT code to bill, the that is similar to the in-person service.
The information provided may be used times listed in the codes themselves We also note that any additional
to inform residents, families, and would be most appropriate for the services added using the revised process
communities of the status of COVID–19 purpose. Therefore, we are finalizing on would remain on the list only during
infections in their area. We believe that an interim basis, for the duration of the the PHE for the COVID–19 pandemic.
this action strengthens CMS’ response to PHE for the COVID–19 pandemic, that
BB. Payment for COVID–19 Specimen
the PHE for the COVID–19 pandemic, the typical times for purposes of level
Collection to Physicians, Nonphysician
and reaffirms our commitment to selection for an office/outpatient E/M
Practitioners and Hospitals
transparency and protecting the health are the times listed in the CPT code
and safety of nursing home residents. descriptor. In the March 31st COVID–19 IFC (85
As discussed in section III. of this IFC, FR 19256 through 19258), we changed
‘‘Waiver of Proposed Rulemaking’’, we AA. Updating the Medicare Telehealth Medicare payment policies for
believe the urgency of this COVID–19 List independent laboratories for specimen
PHE constitutes good cause to waive the In the CY 2002 PFS final rule with collection related to COVID–19 testing
normal notice-and-comment process comment period (64 FR 80041) we under certain circumstances.
under the Administrative Procedure Act amended regulations at § 410.78(f) to Specifically, under sections 1833(h)(3)
and section 1871(b)(2)(C) of the Act. state that PFS annual rulemaking would and 1834A(b)(5) of the Act, we
Waiving notice and comment is in the serve as the process for adding and established a policy for the duration of
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27603
the PHE for the COVID–19 pandemic to laboratory staff to collect specimens that payment is bundled into the
pay a nominal specimen collection fee from homebound individuals or non- payment rate for other services,
and associated travel allowance to hospital inpatients, the laboratory can including office and outpatient visits.
independent laboratories for collection bill Medicare for mileage in addition to Typically, collection of a specimen via
of specimens for COVID–19 clinical specimen collection. The travel codes nasal swab or other method during the
diagnostic laboratory testing from allow for payment either on a per provision of a service might be reported
beneficiaries who are homebound or mileage basis (P9603) or on a flat rate as part of (bundled with) an office/
inpatients not in a hospital. In that IFC, per trip basis (P9604). Payment of the outpatient E/M visit (CPT codes 99201–
we stated that Medicare-enrolled travel allowance is made only if a 99205, 99211–99215). In visits where a
independent laboratories can bill specimen collection fee is also payable. patient has face-to-face interaction with
Medicare for the specimen collection fee The travel allowance is intended to a billing professional with whom they
using one of the two new HCPCS codes cover the estimated travel costs of have an established relationship, these
effective March 1, 2020, HCPCS code collecting a specimen including the services are generally reported with a
G2023 (specimen collection for severe laboratory technician’s salary and travel level 2 through a level 5 visit (CPT
acute respiratory syndrome coronavirus expenses. codes 99212–99215). In cases where the
2 (SARS-CoV–2) (Coronavirus disease Unchecked spread of the coronavirus specimen is collected during a visit
[COVID–19]), any specimen source) and COVID–19 threatens to overwhelm where the face-to-face interaction only
HCPCS code G2024 (specimen healthcare resources in many areas of involves clinical staff of the billing
collection for severe acute respiratory the country. The coronavirus is very professional with whom the patient has
syndrome coronavirus 2 (SARS-CoV–2) contagious, spreading easily between an established relationship, these
(Coronavirus disease [COVID–19]), from people through communities largely services are generally reported using
an individual in a SNF or by a through droplet transmission. The CDC CPT code 99211. As noted previously,
laboratory on behalf of a HHA, any considers it more contagious than we referred to the PFS payment rate for
specimen source). influenza.55 Widespread diagnostic CPT code 99211 in establishing a
testing for COVID–19 is a critical payment amount under section
To establish a payment amount for
component of a public pandemic 1833(h)(3) of the Act for specimen
HCPCS code G2023 for the Clinical
response to support infection control collection for the COVID–19 tests
Laboratory Fee Schedule (CLFS) policy,
and proper treatment. Testing ensures described by G2023 (specimen
we looked to similar services in other
individuals with positive diagnoses can collection for severe acute respiratory
settings of care as a potential be aware of their own condition and
benchmark. In looking at other Medicare syndrome coronavirus 2 (SARS-CoV–2)
treatment they may need, and can (Coronavirus disease [COVID–19]), any
payment systems, we concluded that the isolate themselves to contain spreading.
PFS was the best source for assigning a specimen source)).
Testing on the scale that will be
payment amount since physicians and required to contain COVID–19 entails a During this PHE, we understand that
other practitioners often bill for services tremendous commitment of labor, some professional practices are
that involve specimen collection by equipment, and capital resources. collecting specimens for COVID–19
trained, non-institutional staff. Assessment and specimen collection to tests. In many cases, we expect that
Additionally, we stated that under the support widespread COVID–19 testing these services are appropriately paid as
PFS, a Level 1 established patient office will require extraordinary and resource- part of the visit codes described above.
visit (CPT code 99211) typically does intensive measures for infection control, Given the critical need for widespread
not require the presence of a physician such as providing masks and protective testing as part of the pandemic
or other qualified health care equipment to staff and, setting up response, we also expect that COVID–19
professional and the usual presenting significant physical space to avoid specimen collection may occur in
problem(s) are minimal and is typically additional spread when specimens are circumstances other than the typical
reported by physician practices when collected, among many other unique interaction between the patients and the
the patient only sees clinical office staff requirements. Recognizing the critical professionals or staff of these practices.
for services like acquiring a routine importance of expanding COVID–19 In our review of available HCPCS codes,
specimen sample. We also explained testing, in this IFC, we are providing we did not identify a code that would
that we considered establishing a higher additional payment for assessment and specifically describe the services that
payment amount that considered the COVID–19 specimen collection to would be furnished in the context of
Level 1 E/M visit plus the payment support testing by HOPDs, and large-scale dedicated testing operations
amount for CPT code 89220, Sputum physicians and other practitioners, to involving a physician or NPP,
obtaining specimen aerosol induced recognize the significant resources specifically, assessment of COVID–19
technique. However, as noted in the involved in safely collecting specimens symptoms and exposure, and specimen
March 31st COVID–19 IFC (85 FR from many beneficiaries during a collection for new patients. In
19257), we believe there are likely pandemic. The majority of ambulatory circumstances outside of the PHE, such
overlapping costs in staff time for these care in any community is furnished by a code would not be needed. We would
two services and the Level 1 office visit physicians and other practitioners in ordinarily expect physicians and NPPs
payment rate is adequate for HCPCS offices and HOPDs, and these are to establish a relationship with a patient
code G2023. The difference in payment natural locations for COVID–19 testing before their clinical staff could
for HCPCS code G2024 in comparison to in addition to laboratories. effectively assist in managing care
HCPCS code G2023 represents the When physicians and other incident to their services. However, in
statutory payment increase under practitioners collect specimens as part the context of the widespread testing
section 1834A(b)(5) of the Act for of their professional services Medicare that is necessary during this COVID–19
specimen collection when a sample is generally makes payment for the PHE, we believe it is important to
collected from an individual in a SNF services under the PFS, though often recognize such a service for new
or by a laboratory on behalf of an HHA. patients in addition to established
Under current CLFS policies, when an 55 https://www.cdc.gov/coronavirus/2019-ncov/ patients. In considering possible codes
independent laboratory sends skilled prevent-getting-sick/how-covid-spreads.html. for this purpose, we believe that CPT
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27604 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
code 99211 for a level 1 E/M visit, collection and testing for COVID–19 other qualified health care professional,
appropriately describes the required both at temporary expansion locations, for which the usual presenting
clinical staff and patient interaction. as well as original locations of the problem(s) are minimal and which is
However, billing for CPT code 99211is hospital. As with the physician office typically reported by physician
currently limited to patients with whom clinical staff, hospital clinical staff are practices when the patient only sees
the billing practitioner has an reviewing symptoms for patients clinical office staff. We further
established relationship. As discussed relative to CDC guidelines and obtaining established the payment for HCPCS
above, CPT code 99211 typically does specimen samples for laboratory testing. code G2023 for specimen collection
not involve interaction with physician As noted above, in our review of based on the resources required for CPT
or other qualified health care available HCPCS and CPT codes, we did code 99211. Currently the PFS pays a
professional and the usual presenting not identify a code that explicitly national unadjusted rate of $23.46 for
problem(s) are minimal. Thus, this CPT describes the exact services that CPT code 99211. APC 5731 Level 1
code typically is reported by a physician widespread testing efforts would Minor Procedures pays a national
or practitioner when the patient only require, assessment of symptoms and unadjusted rate of $22.98. Because these
sees clinical office staff for services like specimen collection. Such a uniquely payment amounts for APC 5731 Level 1
acquiring a routine specimen sample. auxiliary service would not normally be Minor Procedures approximates our best
Additionally, as previously noted, we needed. Typically, clinical staff services estimate of the resource cost for this
based our valuation of HCPCS code such as specimen collection are service, and because HCPCS code C9803
G2023 for specimen collection by included in a clinic or emergency room for a clinic visit dedicated to specimen
independent laboratories on CPT code visit or in other primary services collection is similar to other services in
99211. Therefore, for the duration of the furnished in the HOPD, such as APC 5731, we will assign HCPCS code
PHE, we will recognize physician and observation services or critical are C9803 to APC 5731 for the duration of
NPP use of CPT code 99211 for all services. However, during this COVID– the PHE. We established HCPCS code
patients, not just patients with whom 19 PHE, facilitating widespread testing C9803 only to meet the need of the PHE,
they have an established relationship, to requires recognizing such a service for and we expect to retire this code once
bill for a COVID–19 symptom and the standalone work hospitals are the PHE concludes.
exposure assessment and specimen undertaking to assess symptoms and Under the OPPS, we pay for HOPD
collection provided by clinical staff collect specimens form a significant services through separate payment or
incident to their services. number of patients. In light of the through packaged payment when the
For the duration of the COVID–19 tremendous need for testing created by service is integral, ancillary, supportive,
PHE, we are therefore finalizing on an this PHE and the resource needs to dependent, or adjunctive to the primary
interim basis that when the services provide extensive symptom assessment service or services provided in the
described by CPT code 99211 for a level for specimen collection, we are creating hospital outpatient setting during the
1 E/M visit are furnished for the a new E/M code solely to support same outpatient encounter and billed on
purpose of a COVID–19 assessment and COVID–19 testing for the PHE, HCPCS the same claim to the OPPS. The
specimen collection, the code can be code C9803 (Hospital outpatient clinic clinical staff services described by
billed for both new and established visit specimen collection for severe HCPCS code C9803 are services that are
patients. We believe this policy will acute respiratory syndrome coronavirus integral and ancillary to other primary
support expanded access to COVID–19 services, such as emergency room or
2 (sars-cov–2) (coronavirus disease
testing, and provide appropriate clinic visits, or even observation or
[covid–19]), any specimen source). We
payment for COVID–19 testing-related critical care services. We would not
believe this code is necessary to address
services furnished by physician and expect to make separate payment for a
the resource requirements hospitals face
other practitioners. This policy will clinic visit dedicated to specimen
in establishing broad community
allow physicians and practitioners to collection (HCPCS code C9803) when
diagnostic testing for COVID–19,
bill for services provided by clinical the hospital furnished other more
including the significant specimen
staff to assess symptoms and take significant services in the same
collection necessary to conduct that
specimens for COVID–19 laboratory encounter. We are assigning a status
testing.
testing for all patients, not just indicator of ‘‘Q1’’ to HCPCS code C9803
established patients. We note that a We will assign HCPCS code C9803 to indicating that this services will be
physician or practitioner cannot bill for APC 5731 Level 1 Minor Procedures. In conditionally packaged under the OPPS
services provided by auxiliary clinical assigning a service to an APC grouping, when billed with a separately payable
staff unless those staff meet all the section 1833(t)(2)(B) of the Act requires primary service in the same encounter.
requirements to furnish services that the groupings within the OPPS be The OPPS will only make separate
‘‘incident to’’ services, as described in comparable clinically and with respect payment to a hospital when HCPCS
42 CFR 410.26 and further described in to the use of resources. APC 5731 Level code C9803 is billed without another
section 60 of Chapter 15 Covered 1 Minor Procedures already contains primary covered hospital outpatient
Medical and other Health Services in many similar services to new HCPCS service. The OPPS also will make
the Medicare Benefit Policy Manual code C9803, including HCPCS code separate payment for CPT code C9803
100–02. We further note that we Q0091 (Obtaining screening pap smear) when it is billed with a clinical
adopted an interim final policy to and G0117 (Glaucoma Screening for diagnostic laboratory test with a status
permit the direct supervision high risk patients furnished by an indicator of ‘‘A’’ on Addendum B of the
requirement to be met through virtual optometrist or an ophthalmologist). OPPS.
presence of the supervising physician or Earlier in this section, we established Finally, section 6002(a) of the
practitioner using interactive audio and that clinical staff symptoms review and Families First Coronavirus Response
video technology for the duration of the specimen collection is similar to the Act (Pub. L. 116–127) amended section
PHE (85 FR 19245). services described by, a Level 1 1833 of the Act by adding a new
During this COVID–19 PHE, we established patient office visit (CPT paragraph (DD) to section (a)(1) and a
understand HOPDs also are engaging in code 99211), which typically does not new paragraph (11) to section (b) to
significant additional specimen require the presence of a physician or provide, respectively, that the payment
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27605
amount for a specified COVID–19 for purposes of COVID–19 testing. Cost- patient/caregiver during the month;
testing-related service for which sharing for this service will be waived each additional 20 minutes) and two
payment may be made under certain when all other requirements under self-measured blood pressure
outpatient payment provisions will be section 6002(a) of the Families First monitoring codes, CPT code 99473
100 percent of the payment amount Coronavirus Response Act are met. We (Self-measured blood pressure using a
otherwise recognized and that the are further creating a new code, CPT device validated for clinical accuracy;
deductible for such a service will not code C9803 under the OPPS for HOPDs patient education/training and device
apply. These amendments mean that to bill for a clinic visit dedicated to calibration) and CPT code 99474
there is no beneficiary cost-sharing specimen collection and adopting a (Separate self-measurements of two
(coinsurance and deductible amounts) policy to conditionally package readings one minute apart, twice daily
for COVID–19 testing-related services, payment for this code. The OPPS will over a 30-day period (minimum of 12
which is defined in new section make separate payment for HCPCS code readings), collection of data reported by
1833(cc) of the Act as, among other C9803 under the OPPS when no other the patient and/or caregiver to the
requirements, are medical visits in any primary service is furnished in the same physician or other qualified health care
of several categories of HCPCS E/M encounter. Cost-sharing for this service professional, with report of average
service codes, including office and other will be waived when all other systolic and diastolic pressures and
outpatient services, that results in an requirements under section 6002(a) of subsequent communication of a
order for or administration of a COVID– the Families First Coronavirus Response treatment plan to the patient).
19 clinical diagnostic laboratory test Act are met. As we stated in the March 31st
described in section COVID–19 IFC, we believe that RPM
CC. Payment for Remote Physiologic services support the CDC’s goal of
1852(a)(1)(B)(iv)(IV) of the Act and Monitoring (RPM) Services Furnished
relates to the furnishing or reducing human exposure to the novel
During the COVID–19 Public Health coronavirus while also increasing access
administration of such test or to the Emergency
evaluation of such individual for to care and improving patient outcomes.
purposes of determining the need of In the March 31st COVID–19 IFC, we RPM services could allow a patient with
such individual for such test. Because changed several policies related to an acute respiratory virus to monitor
physicians and other practitioners will payment for Remote Physiologic pulse and oxygen saturation levels using
be using the level 1 E/M code for Monitoring services under the PFS pulse oximetry. Nurses or other
during the COVID–19 PHE. We had auxiliary personnel, working with
established patients, CPT code 99211, to
previously finalized payment in the CY physicians, can check-in with the
conduct testing related visits, there will
2018 PFS final rule for CPT code 99091 patient and then using patient data,
not be beneficiary cost sharing when the
(Collection and interpretation of determine whether home treatment is
practitioner’s office bills for this service,
physiologic data digitally stored and/or safe, all the while reducing exposure
provided it results in an order for or
transmitted by the patient and/or risk and eliminating potentially
administration of a COVID–19 test.
caregiver to the physician or other unnecessary emergency department and
Similarly, because HOPDs will use
qualified health care professional, hospital visits. Based on these
HCPCS code C9803 to bill for a clinic
qualified by education, training, considerations, we established interim
visit for specimen collection, which we
licensure/regulation requiring a policies to eliminate as many
consider an E/M code in the office and minimum of 30 minutes of time). In the unnecessary obstacles as possible to
other outpatient services category of CY 2019 PFS final rule the following delivering these services as part of the
HCPCS codes, beneficiary cost sharing year, we finalized payment for CPT response to the pandemic. To that end,
will not apply for this service, provided codes 99453 (Remote monitoring of a combination of our permanent and
it results in an order for or physiologic parameter(s) (e.g., weight, interim policies for the duration of the
administration of a COVID–19 test and blood pressure, pulse oximetry, COVID–19 PHE allow RPM services to
meets other requirements of the law. We respiratory flow rate), initial; set-up and be furnished to new patients in addition
anticipate that a COVID–19 test will patient education on use of equipment), to established patients; with beneficiary
always be ordered or administered with 99454 (Remote monitoring of consent to be obtained at the time
HCPCS code C9803 because the physiologic parameter(s) (e.g., weight, services are furnished and by auxiliary
descriptor for this code includes blood pressure, pulse oximetry, personnel for physiologic monitoring of
specimen collection for COVID–19. respiratory flow rate), initial; device(s) patients with acute and/or chronic
In summary, in the March 31st supply with daily recording(s) or conditions; and under general
COVID–19 IFC, which created programmed alert(s) transmission, each supervision.
regulatory flexibilities to address the 30 days), and 99457 (Remote In recent weeks, we have been
COVID–19 PHE, we finalized two codes physiologic monitoring treatment notified by stakeholders that CPT
to recognize the unique resource costs of management services, clinical staff/ coding guidance states that the RPM
specimen collection in a way that physician/other qualified health care service described by CPT code 99454
retains the integrity of infection control professional time in a calendar month cannot be reported for monitoring of
during a pandemic: CPT codes G2023 requiring interactive communication fewer than 16 days during a 30-day
and G2024 for specimen collection for with the patient/caregiver during the period. In reviewing other RPM codes,
COVID–19 laboratory tests (85 FR month; first 20 minutes). Most recently, we also observed that CPT codes 99091,
19257). In this IFC, to further support in the CY 2020 PFS final rule (84 FR 99453, 99457, and 99458, also have 30-
widespread community testing for 62645 and 62646), we finalized a day reporting periods. Stakeholders
COVID–19, we are finalizing on an treatment management add-on code, have alerted CMS that while it is
interim basis that physicians and NPPs’ CPT code 99458 (Remote physiologic possible that remote physiologic
may use CPT code 99211 to bill for monitoring treatment management monitoring would be used to monitor a
services furnished incident to their services, clinical staff/physician/other patient with COVID–19 for 16 or more
professional services, for both new and qualified health care professional time days, many patients with COVID–19
established patients, when clinical staff in a calendar month requiring who need monitoring do not need to be
assess symptoms and collect specimens interactive communication with the monitored for as many as 16 days.
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27606 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Consequently, and for all of the same This 30-day delay in effective date can national emergency,60 beginning March
reasons we articulated for establishing be waived, however, if an agency finds 1, 2020. This declaration, along with the
the other policies supporting use of good cause to support an earlier Secretary’s January 30, 2020 declaration
RPM services as part of the pandemic effective date. Section 1871(e)(1)(B)(i) of of a PHE, conferred on the Secretary
response, for purposes of treating the Act also prohibits a substantive rule certain waiver authorities under section
suspected COVID–19 infections, we are from taking effect before the end of the 1135 of the Act. On March 13, 2020, the
establishing a policy on an interim final 30-day period beginning on the date the Secretary authorized waivers under
basis for the duration of the COVID–19 rule is issued or published. However, section 1135 of the Act, effective March
PHE to allow RPM monitoring services section 1871(e)(1)(B)(ii) of the Act 1, 2020.61 Ensuring the health and safety
to be reported to Medicare for periods permits a substantive rule to take effect of Medicare beneficiaries, Medicaid
of time that are fewer than 16 days of before 30 days if the Secretary finds that recipients, BHP enrollees, CHIP
30 days, but no less than 2 days, as long a waiver of the 30-day period is enrollees, and healthcare workers is of
as the other requirements for billing the necessary to comply with statutory primary importance. As this IFC directly
code are met. We are not proposing to requirements or that the 30-day delay supports that goal by offering healthcare
alter the payment for CPT codes 99454, would be contrary to the public interest. professionals flexibilities in furnishing
99453, 99091, 99457, and 99458 because Furthermore, section 1871(e)(1)(A)(ii) of services while combatting the COVID–
the overall resource costs for long-term 19 pandemic and ensuring that
the Act permits a substantive change in
monitoring for chronic conditions sufficient health care items and services
regulations, manual instructions,
assumed under the current valuation are available to meet the needs of
interpretive rules, statements of policy,
would appropriately reflect those for individuals enrolled in the Medicare,
or guidelines of general applicability
short-term monitoring for acute Medicaid, CHIP and BHP programs, it is
under Title XVIII of the Act to be
conditions in the context of COVID–19 critically important that we implement
disease and exposure risks. Payment for applied retroactively to items and this IFC as quickly as possible and for
CPT codes 99454, 99453, 99091, 99457, services furnished before the effective certain provisions, retroactive to either
and 99458 when monitoring lasts for date of the change if the failure to apply the start of the national emergency for
fewer than 16 days of 30 days, but no the change retroactively would be the COVID–19 pandemic, beginning on
less than 2 days, is limited to patients contrary to the public interest. Finally, March 1, 2020, or the start of the PHE
who have a suspected or confirmed the Congressional Review Act (CRA) for the COVID–19 pandemic on January
diagnosis of COVID–19. requires a delay in the effective date for 27, 2020. Not applying these revisions
major rules unless an agency finds good retroactive to either the start of the
III. Waiver of Proposed Rulemaking cause that notice and public procedure national emergency for the COVID–19
We ordinarily publish a notice of are impracticable, unnecessary, or pandemic, beginning on March 1, 2020,
proposed rulemaking in the Federal contrary to the public interest, in which or the start of the PHE for the COVID–
Register and invite public comment on case the rule shall take effect at such 19 pandemic on January 27, 2020 would
the proposed rule before the provisions time as the agency determines. 5 U.S.C. be contrary to the public interest of
of the rule take effect, in accordance 801(a)(3), 808(2). supporting necessary flexibilities during
with the Administrative Procedure Act On January 30, 2020, the International the entire PHE. As we are in the midst
(APA), 5 U.S.C. 553, and section 1871 Health Regulations Emergency of a PHE, we find good cause to waive
of the Act. Specifically, section 553(b) of Committee of the World Health notice and comment rulemaking as we
the APA requires the agency to publish Organization (WHO) declared the believe it would be impracticable and
a notice of the proposed rule in the outbreak of the 2019 Novel Coronavirus contrary to the public interest for us to
Federal Register that includes a (2019-nCoV) to be a Public Health undertake normal notice and comment
reference to the legal authority under Emergency of International Concern.56 rulemaking procedures, as that would
which the rule is proposed, and the delay giving healthcare providers the
On January 31, 2020, Health and Human
terms and substance of the proposed flexibilities to provide critical care. For
Services Secretary Alex M. Azar II
rule or a description of the subjects and the same reasons, because we cannot
determined that a PHE exists retroactive
issues involved. Section 553(c) further afford any delay in effectuating this IFC,
to January 27, 2020 57 under section 319
requires the agency to give interested we find good cause to waive the 30-day
parties the opportunity to participate in of the Public Health Service Act (42
U.S.C. 247d), in response to COVID–19), delay in the effective date and,
the rulemaking through public comment moreover, to make certain policies in
before the provisions of the rule take and on April 21, 2020, Secretary Azar
renewed, effective April 26, 2020, the this IFC applicable as of March 1,
effect. Similarly, section 1871(b)(1) of 2020—the date the President of the
the Act requires the Secretary to provide determination that a PHE exists.58 On
United States declared to be the
for notice of the proposed rule in the March 11, 2020, the WHO publicly
beginning of the national emergency
Federal Register and a period of not less declared COVID–19 to be a pandemic.59
concerning the COVID–19 pandemic, or,
than 60 days for public comment. On March 13, 2020, the President
if applicable, January 27, 2020, the date
Section 553(b)(B) and section declared that the COVID–19 pandemic
on which the PHE for the COVID–19
1871(b)(2)(C) of the Act authorize the in the United States constitutes a pandemic started.
agency to waive these procedures, In support of the imperative to
56 https://www.who.int/news-room/detail/30-01-
however, if the agency finds good cause contain and combat the virus in the
2020-statement-on-the-second-meeting-of-the-
that notice and comment procedures are international-health-regulations-(2005)-emergency- United States, this IFC will give health
impracticable, unnecessary, or contrary committee-regarding-the-outbreak-of-novel- care workers and hospitals additional
to the public interest and incorporates a coronavirus-(2019-ncov).
statement of the finding and its reasons 57 https://www.phe.gov/emergency/news/ 60 https://www.whitehouse.gov/presidential-
in the rule issued. healthactions/phe/Pages/2019-nCoV.aspx. actions/proclamation-declaring-national-
58 https://www.phe.gov/emergency/news/ emergency-concerning-novel-coronavirus-disease-
Section 553(d) ordinarily requires a
healthactions/phe/Pages/covid19-21apr2020.aspx. covid-19-outbreak/.
30-day delay in the effective date of a 59 https://www.who.int/dg/speeches/detail/who- 61 https://www.phe.gov/emergency/news/
final rule from the date of its director-general-s-opening-remarks-at-the-media- healthactions/section1135/Pages/covid19-
publication in the Federal Register. briefing-on-covid-19-11-march-2020. 13March20.aspx.
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27607
flexibility to respond to the virus and assessments via communication have been affected by an extraordinary
continue caring for patients while technology. circumstance, including the COVID–19
minimizing exposure to COVID–19. In addition, we are allowing states PHE, without requiring that each
CDC guidelines are clear that public that operate a BHP to seek certification affected hospital individually submit an
exposure greatly increases the overall of temporary BHP Blueprint revisions to ECE request form.
risk to public health and they stress the make significant changes directly tied to Additionally, immediate
importance of containment and the PHE for the COVID–19 pandemic implementation of section 3712 of the
mitigation strategies to minimize public and that increase access to necessary CARES Act is necessary to provide
exposure and the spread of COVID–19. services without delay or other barriers prompt relief, as intended by the CARES
As of April 26th 2020, the CDC reports (such as cost sharing) during the Act, in the form of higher Medicare
957,875 cases of COVID–19 in the duration of the PHE for the COVID–19 payments to suppliers of DME in certain
United States and 53,922 deaths.62 pandemic. areas to ensure beneficiary access to
Individuals such as healthcare workers We are modifying the methodology to necessary medical equipment and
who come in close contact with those determine IME payments teaching supplies during the PHE.
infected with COVID–19 are at an hospitals so that temporary increases in
The COVID–19 pandemic PHE has
elevated risk of contracting the disease. available beds or bed capacity during
created a lack of predictability for many
To minimize these risks, the CDC has the PHE for the COVID–19 pandemic
ACOs participating in the Shared
urged healthcare professionals to make will not lower teaching hospitals’ IME
Savings Program regarding the impact of
every effort to distance themselves from payments or impact provider-based RHC
expenditure and utilization changes on
those who are potentially sick with payments for those RHCs who are not
financial benchmarks and performance
COVID–19 by using modalities such as currently subject to the national
year expenditures, and for those under
telephonic interviews, text monitoring payment limit. We are also
implementing temporary policies to performance-based risk, the potential
systems, or video conference.63 As the liability for shared losses, as well as
healthcare community works to allow teaching hospitals to claim, in
their resident FTE counts, residents that disrupting population health activities
establish and implement infection as clinicians, care coordinators and
prevention and control practices, we are teaching hospitals send to other
hospitals to respond to the PHE financial and other resources are
also working to revise and implement diverted to address immediate acute
regulations that function in concert with associated with COVID, which will
allow teaching hospitals to maintain care needs. ACOs and other program
those healthcare community infection stakeholders have advocated that there
prevention and treatment practices. GME payments and will not trigger
establishment of FTE counts or PRA is an urgent need to address these
This IFC offers flexibilities in certain caps at non-teaching receiving hospitals. concerns because ACOs need to make
Medicare, Medicaid, and BHP Likewise, we are adopting a policy to participation decisions for PY 2020 and
regulations that support measures to hold, for the duration of the COVID–19 PY 2021 soon and may choose to
combat the COVID–19 pandemic and PHE, IRF and IPF average daily census terminate their participation in the
safeguard all interests by protecting numbers at their values prior to the Shared Savings Program on or before the
healthcare providers and vulnerable COVID–19 PHE, so that IRF and IPF June 30, 2020 deadline, rather than face
beneficiaries. The provisions of this IFC teaching status adjustment payments do the potential of pro-rated shared losses
better enable and facilitate physicians not decrease during the pandemic. We for PY 2020 if the PHE does not extend
and other clinicians, to focus on caring are implementing various flexibilities for the entire year and if the existing
for these beneficiaries during this PHE for IRFs in this IFC so that IRFs may policies under the Shared Savings
for the COVID–19 pandemic and utilize their excess bed capacity to care Program do not adequately mitigate
minimize their own risks to COVID–19 for patients to alleviate capacity issues liability for shared losses. We believe it
exposure. in acute care hospitals during the is vital to the stability of the Shared
Furthermore, we are also adopting an COVID–19 pandemic. Specifically, IRFs Savings Program to encourage
extraordinary circumstances relocation will still be required to meet continued participation by ACOs by
exception policy for on-campus and requirements for IRF payment for adjusting program policies as necessary
excepted off-campus PBDs of hospitals patients who receive regular IRF care. to address the impact of the COVID–19
that relocate in response to the PHE, as However, for those patients who are pandemic, including by offering certain
well as describing the hospital cared for in an IRF solely to alleviate flexibilities in program participation
outpatient services and CMHC that can acute care hospital bed capacity, IRFs options to currently participating ACOs
to be furnished in temporary expansion will not have to comply with some and addressing potential distortions in
locations of a hospital (including the regulations governing documentation, expenditures resulting from the COVID–
patient’s home). therapy requirements, and other policies 19 pandemic. The changes included in
We are also establishing a national to maximize time spent on patient care this IFC will help to ensure a more
coverage policy under Medicare Part B during this pandemic. equitable comparison between ACOs’
for COVID–19 antibody diagnostic tests We are also making changes to the expenditures for PY 2020 and their
in order to ensure patients and Medicare regulations to revise payment updated historical benchmarks and that
practitioners have clinically relevant rates for certain DME and enteral ACOs are not rewarded or penalized for
information to allow for ongoing health nutrients, supplies, and equipment as having higher/lower COVID–19 spread
monitoring and isolation, as part of implementation of section 3712 in their assigned beneficiary
appropriate. of the CARES Act. We are also populations which, in turn, will help to
We are allowing Opioid Treatment increasing flexibilities for hospitals protect ACOs from owing excessive
Programs (OTPs) to furnish periodic participating in the Hospital VBP shared losses and the Medicare Trust
Program by expanding the Extraordinary Funds from paying out windfall shared
62 https://www.cdc.gov/coronavirus/2019-ncov/
Circumstances Exceptions (ECE) policy savings. For these reasons and the
cases-updates/cases-in-us.html. so that we can grant an ECE to hospitals reasons set forth in section II.L. of this
63 https://www.cdc.gov/coronavirus/2019-ncov/ within an entire region or locale, IFC, we find good cause to waive notice
php/guidance-evaluating-pui.html. including the entire United States, that and comment procedures for the
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27608 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
regulatory changes being made to the Medicare requirement for a physician or Finally, we are adding a new
Shared Savings Program in this IFC. other practitioner’s order for COVID–19 paragraph (g) to § 483.80, to require
Furthermore, changes effectuated in testing and certain related testing, as facilities to report information on
this rule to broaden the scope of well as allowing increased flexibilities COVID–19 incidence among residents
practitioners who may order home regarding documentation requirements and staff in LTC facilities to the CDC,
health services and expand the for such tests, during the COVID–19 without a previous opportunity for
availability of Medicaid coverage for PHE. public comment. We believe we have
certain laboratory testing during a PHE We are also allowing flexibilities to good cause to waive the normal notice-
and subsequent periods of active HHAs in the HHVBP Model by aligning and-comment process under the
surveillance are being made to HHVBP Model data submission Administrative Procedure Act and
maximize beneficiary access to needed requirements with any exceptions or section 1871(b)(2)(C) of the Act, because
services and minimize the transmission extensions granted for purposes of the acting immediately to provide
of the disease, which is of critical HH QRP during the PHE for the COVID– information to the CDC and the public
importance in the current PHE. 19 pandemic, as well as a policy for can help control the spread of the virus.
Additionally, during the PHE for the granting exceptions to the New Waiving notice and comment is in the
COVID–19 pandemic, we are adding Measures data reporting requirements public interest, because time is of the
flexibility for teaching physicians, under the HHVBP Model during the essence in informing residents, their
NPPs, PTs, OTs, SLPs, and others in PHE for the COVID–19 pandemic. families, and the general public of the
supervision, documentation, and other In addition, we are delaying the incidence of COVID–19 in the LTC
requirements of the Medicare program compliance dates for collecting and facility population; such information
that could impact the availability and reporting the TOH Information to will assist public health officials in
efficiency of care to ensure an adequate Provider-Post-Acute Care and TOH detecting outbreaks and saving lives.
number of clinicians are able to furnish Information to Patient-Post-Acute Care As noted in this IFC, it is critical in
critical services and tests. quality measures and certain emergencies and disaster situations to
Section 3708 of the CARES Act is respond as efficiently and effectively as
standardized patient assessment data
applicable to Medicare and Medicaid possible to address immediate public
with respect to six categories by IRFs,
and allows a home health patient to be health needs; as such, we may extend
LTCHs, and HHAs under, respectively,
under the care of a NP or CNS or a PA flexibilities in this IFC for future
the IRF QRP, LTCH QRP, and HH QRP.
and allows such practitioner to: (1) national emergencies, public health
Order home health services; (2) Additionally, in regard to the Quality
emergencies, or disasters. We welcome
establish and periodically review a plan Payment Program, due to the PHE, we
comments on whether some of these
of care for home health services; and (3) are amending § 414.1400(b)(3)(v)(C) and
flexibilities should be extended to
certify and re-certify that the patient is (D) to delay the implementation of these
future situations.
eligible for home health services. policies by 1 year. Both QCDR measure We believe it would be impracticable
Currently, these functions can only be approval criteria necessitate QCDRs and contrary to the public interest for us
paid for by Medicare when performed collecting data from clinicians in order to undertake normal notice and
by physicians. However, these changes to assess the measure, and we anticipate comment procedures and to thereby
are not effective until CMS implements that QCDRs may be unable to collect, delay the effective date of this IFC. We
the changes in regulation, and pursuant and clinicians unable to submit, data on find good cause to waive notice of
to section 3708(f) of the CARES Act, QCDR measures due to prioritizing the proposed rulemaking under the APA, 5
may be implemented by an IFC. care of COVID–19 patients. U.S.C. 553(b)(B), and section
Implementing all of the conforming We are also revising § 156.280(e)(2)(ii) 1871(b)(2)(C) of the Act. For those same
regulations changes in this IFC are to delay implementation of the separate reasons, as authorized by section 808(2)
needed to implement section 3708 of billing policy for 60 days from the date of the CRA, we find it is impracticable
the CARES Act, and will allow us to finalized in the 2019 Program Integrity and contrary to the public interest not
meet the statutorily-required 6-month Rule (84 FR 71674). Under this 60-day to waive the delay in effective date of
timeframe for implementation, but also extension, QHP issuers must comply this IFC under section 801 of the CRA.
allows us to act as expediently as with the separate billing policy finalized We therefore find there is good cause to
possible to implement this new at § 156.280(e)(2)(ii) beginning on or waive the CRA’s delay in effective date
flexibility during the current PHE for before the QHP issuer’s first billing pursuant to section 808(2) of the CRA.
the COVID–19 pandemic. cycle following August 26, 2020. We Furthermore, as noted above, the
We are also permitting flexibility with believe extending the deadline 60 days President declared that the COVID–19
respect to the administration of COVID– for QHP issuers and Exchanges to outbreak in the United States
19 tests for purposes of Medicaid comply with the separate billing policy constituted a national emergency
coverage, both during the COVID–19 is appropriate so that they may beginning March 1, 2020. In addition,
PHE and any subsequent periods of adequately respond to the current the Secretary’s declaration of a PHE for
active surveillance, to allow for national PHE and divert resources to the COVID–19 pandemic took effect on
continued surveillance as part of address COVID–19 that may otherwise January 27, 2020. To ensure the
strategies to detect recurrence of the have been used for timely compliance availability of the measures we are
virus in individuals and populations to with the separate billing policy. taking to address the COVID–19
prevent further spread of the disease. Therefore, the 60-day delayed pandemic, we believe it is vital that
These flexibilities related to Medicaid implementation for QHP issuers subject many of the Medicare policies in this
laboratory coverage, which are urgently to the separate billing policy is effective IFC apply starting either with the first
needed during the COVID–19 PHE, will immediately, such that QHP issuers are day of the national emergency or the
also apply during future PHEs resulting required to begin complying with the start of the PHE for the COVID–19
from outbreaks of communicable separate billing policy finalized at pandemic, as applicable. It is also
disease and any subsequent period of § 156.280(e)(2)(ii) beginning on or before important to ensure that health care
active surveillance. We are amending the first billing cycle following August providers that acted expeditiously to
Medicare regulations to remove the 26, 2020. implement appropriate physical and
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27609
operational changes to their practices to of benefits and make Medicaid coverage • The need for the information
adapt to emergency conditions, even in of home health services more available, collection and its usefulness in carrying
the absence of changes in our policies the amendments to § 440.70 will take out the proper functions of our agency.
to address them, are not disadvantaged effect on the same date as the Medicare • The accuracy of our estimate of the
relative to other health care providers, regulations implementing section 3708 information collection burden.
and will not be discouraged from taking of the CARES Act, March 1, 2020. We • The quality, utility, and clarity of
similar appropriate actions in the future. are providing a 60-day public comment the information to be collected.
Specifically, in this IFC we have period for this IFC as specified in the • Recommendations to minimize the
concentrated on increasing providers’ DATES section of this document.
information collection burden on the
ability to furnish services at temporary affected public, including automated
In this IFC, we are also delaying the collection techniques.
expansion locations, including the date by which SNFs must start
patient’s home, that is a PBD of the We are soliciting public comment for
collecting and reporting data on the the following sections of this document
hospital or an expanded CMHC to limit TOH Information to Provider–Post-
the need for patients to receive care in that contain information collection
Acute Care and TOH Information to requirements (ICRs):
the hospital itself, which could
Patient–Post-Acute Care quality
unnecessarily expose the patients or A. ICRs Regarding Rules Relating to
measures and standardized patient
providers to the pandemic contagion. Separate Billing and Segregation of
assessment data elements (SPADEs)
For example, hospital staff can now Funds for Abortion Services (§ 156.280)
with respect to six categories for the
remotely furnish psychotherapy to the This IFC does not impose any
SNF QRP. We are delaying these
beneficiary in their home, as long as the additional information collection
requirements because in response to
beneficiary is a registered outpatient of burden under the PRA, and does not
stakeholder concerns, we have delayed
the hospital and the patient’s home is contain any information collection
the release of an updated version of the
made provider-based to the hospital. It activities beyond the information
Minimum Data Set (MDS) that would
is critical this provision be retroactive to collection currently awaiting approval
have included the data elements that
the first day of the national emergency by OMB under the control number:
SNFs need to report these two quality
in order to ensure providers’ have the 0938–1358 (Billing and Collection of the
necessary flexibilities to provide measures and SPADEs. In the absence of
a vehicle to report these data, SNFs Separate Payment for Certain Abortion
services at temporary expansion Services (CMS–10681)).
locations and to ensure beneficiaries cannot report them beginning with
October 1, 2020 admissions and Based on 2020 QHP certification data
continue to receive critical services, in the Federally-facilitated Exchanges
while limiting their exposure to the discharges. We have taken the COVID–
19 PHE into consideration in selecting (FFEs) and State-based Exchanges on
pandemic contagion. Both March 1, the Federal Platform (SBE–FPs), in the
2020, and January 27, 2020, precede the a new compliance date, which will be
on October 1st of the year that is at least 2019 Program Integrity Rule (84 FR
date of publication of this IFC in the 71674), we estimated that 23 QHP
Federal Register, which means that two fiscal years after the PHE ends.
issuers will offer a total of 338 plans
certain Medicare provisions of this rule We find the notice-and-comment with coverage of non-Hyde abortion
have a retroactive effect. However, procedure impracticable because SNFs services in 9 FFE and SBE–FP states. We
section 1871(e)(1)(A)(ii) of the Act cannot comply with the reporting also estimated that in the 12 State
permits the Secretary to issue a rule for requirements for the two quality Exchanges that will operate their own
the Medicare program with retroactive measures and SPADEs until CMS technology platforms in 2020, 71 QHP
effect if the failure to do so would be releases the updated MDS and SNFs issuers will offer a total of
contrary to the public interest. As we have had an opportunity to become approximately 1,129 plans that include
have explained above, we believe it familiar with the updated version. Also, coverage for non-Hyde abortions
would be contrary to the public interest this IFC does not impose any additional services. Three of those State Exchanges
not to implement certain Medicare requirements, but rather delays the perform premium billing and payment
provisions of this IFC as soon as we are compliance date for collecting and processing, while the other 9 have their
authorized to do so under the authority reporting the two quality measures and issuers perform premium billing and
of section 1871(e)(1)(A)(ii) of the Act, SPADEs. Therefore, we find good cause payment processing. In total, we
that is, retroactively to either the start of to waive notice-and-comment estimated that there will be 94 QHP
the national emergency or the PHE for procedures and to issue this IFC without issuers offering a total of 1,467 plans
the COVID–19 pandemic, as applicable. a delay of effective date. (representing approximately 32 percent
Accordingly, the provisions in this IFC of individual market, on-Exchange
IV. Collection of Information
have retroactive applicability to March plans) covering non-Hyde abortion
Requirements
1, 2020, or January 27, 2020, unless services across 21 states in plan year
otherwise noted. Under the Paperwork Reduction Act 2020. With the 60-day delay, we
Separately, in light of the urgent need of 1995, we are required to provide 30- continue to believe the one-time burden
to provide the flexibilities under new day notice in the Federal Register and QHP issuers will incur to complete the
paragraph (d) in § 440.30 during the solicit public comment before a necessary technical build to implement
COVID–19 PHE, and because this collection of information requirement is the changes for the separate billing
provision will ease restrictions under submitted to the Office of Management policy will be incurred primarily in
existing law and make Medicaid and Budget (OMB) for review and 2020. Therefore, we are unable to
coverage of testing more available, this approval. In order to fairly evaluate quantify any additional cost or savings
provision will also be effective on whether an information collection related to the one-time technical build
March 1, 2020. Similarly, in light of the should be approved by OMB, section that would be attributable to this rule.
urgent need to provide the flexibilities 3506(c)(2)(A) of the Paperwork In the 2019 Program Integrity Rule,
in the amendments to § 440.70 during Reduction Act of 1995 (PRA) requires we estimated that each issuer and State
the COVID–19 PHE, and because they that we solicit comment on the Exchange performing premium billing
will increase flexibility in the delivery following issues: and payment processing will incur
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27610 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
ongoing annual costs, such as those that most, if not all, PBDs that relocate same CCN, original PBD address, and
related to identifying impacted during the COVID–19 PHE will relocate justification) for multiple sites as
enrollees, ensuring billing accuracy, back to their original location prior to, deemed appropriate by the hospital. We
reconciliation, quality assurance, or soon after, the COVID–19 PHE believe a Medical and Health Services
printing, recordkeeping, and document concludes. Manager will develop and submit the
retention. The total burden for each In place of the process adopted in the relocation request to the CMS Regional
issuer and State Exchange performing CY 2017 OPPS/ASC final rule with Office. These employees have an
premium billing and payment comment period (81 FR 79704 through average hourly wage rate of $55.35
processing was estimated to be 24,120 79705) and included in the existing based on the May 2019 Bureau of Labor
hours with an equivalent cost of $1.07 subregulatory guidance under which and Statistics’ Occupation Employment
million. Delaying the implementation of off-campus PBDs can apply for an Statistics. (Citation: BLS code 11–9111,
the deadline for the separate billing extraordinary circumstance relocation website for May 2019 data here:
policies by 60 days will result in a exception, all hospitals that relocate >https://www.bls.gov/oes/current/
reduction in this burden. We estimate excepted on- or off-campus PBDs to off- oes119111.htm<).
that the burden for each issuer and State campus locations in response to the We estimate 450 total submissions
Exchange performing premium billing COVID–19 PHE should notify their CMS (one per hospital) × 0.25 hours per
and payment processing will be reduced Regional Office by email of their submission = 113 total burden hours
by 4,020 hours with an equivalent cost hospital’s CCN; the address of the associated with this requirement and a
reduction of approximately $177,629 in current PBD; the address(es) of the total labor cost of $6,257 (113 hours ×
2020. For all 97 issuers and State relocated PBD(s); the date which they $55.37/hr).
Exchanges performing premium billing began furnishing services at the new The information collection
and payment processing, the total PBD(s); a brief justification for the requirements in this section associated
reduction in burden in 2020 will be relocation and the role of the relocation with § 419.48 have been submitted to
389,940 hours with an equivalent cost in the hospital’s response to COVID–19; OMB for emergency review and
reduction of approximately $17.4 and an attestation that the relocation is approval in accordance with the
million. not inconsistent with their state’s implementing regulations of the PRA at
In addition, we estimated that issuers emergency preparedness or pandemic 5 CFR 1320.13.
and State Exchanges performing plan. We expect hospitals to include in
premium billing and payment their justification for the relocation why C. ICRs Regarding Changes to § 424.507
processing will need to print and send the new PBD location (including As previously explained, under
approximately 1.82 million separate instances where the relocation is to the section 3708 of the CARES Act, we are
paper bills per month in 2020, incurring patient’s home) is appropriate for revising § 424.507(b)(1) to allow NPs,
monthly costs of approximately furnishing covered outpatient items and CNSs, and PAs to certify the need for
$91,200. Delaying the implementation services. To the extent that a hospital home health services. This, in turn,
of the deadline for the separate billing may relocate to an off-campus PBD that would require these three NPP types to
policies by 60 days will reduce the cost otherwise is the patient’s home, only be enrolled in or opted-out of Medicare
of printing separate bills in 2020 by one relocation request during the to certify such services. The following
approximately $182,400. COVID–19 PHE is necessary. discusses our burden estimates for this
The revised burden estimates will be We estimate that 450 hospitals will requirement.
included in the next submission of the request the temporary extraordinary Based on internal data from our
information collection to OMB. circumstances exception for one or more Provider Enrollment, Chain, and
excepted PBDs during the PHE. There Ownership System (PECOS), we
B. ICRs Regarding Temporary
are roughly 500 hospitals as identified generally estimate that approximately:
Extraordinary Circumstances Policy for
by a unique CMS Certification Number • 5,000 currently unenrolled or non-
Relocating Excepted Provider-Based
(CCN) in the states of New York, New opted out NPs, CNSs, and PAs will elect
Departments During the COVID–19 PHE
Jersey, Michigan, Washington, to enroll in or opt-out of Medicare solely
In section II.E. of this IFC, for Massachusetts, and Louisiana. These for the purpose of certifying home
purposes of enabling greater hospital states have some of the counties with health services. We believe they will do
flexibility, and, in particular, enabling the highest per-capita incidence of so in the first year following the
hospitals to rapidly develop temporary COVID–19, and we estimate that effective date of this IFC.
expansion sites for patient care, we are roughly 50 percent of the hospitals in • 1,000 new NPs, CNSs, and PAs each
temporarily adopting an expanded those states will apply for an exception year will enroll in or opt-out of
version of the extraordinary (roughly 250 hospitals) due to their Medicare for the same purpose.
circumstances relocation policy during need to relocate an on-campus or Physicians and practitioners complete
the COVID–19 PHE to include on- excepted off-campus PBD in response to the Form CMS–855O (Medicare
campus PBDs that relocate off-campus the PHE. In the remaining states, we Enrollment Application—Registration
during the COVID–19 PHE for the believe a smaller percent of hospitals in for Eligible Ordering and Referring
purposes of addressing the COVID–19 each state may also apply for the Physicians and Non-Physician
pandemic. We note that this temporary exception—resulting in a total of 450 Practitioners) if they are enrolling in
extraordinary circumstances policy is hospitals. Medicare not to obtain Medicare billing
time-limited to the PHE for COVID–19 We estimate that it will take each privileges but strictly to order, refer, or
to enable short-term hospital relocation hospital 15 minutes to complete and certify certain Medicare items and
of excepted off-campus and on-campus submit the request to the CMS Regional services. The information collection for
departments to improve access to care Office. We believe that all hospitals will Form CMS–855O is currently approved
for patients during this time. The submit a maximum of one relocation under OMB control number 0938–1135
temporary extraordinary circumstances request email (even though the request with an expiration date of December 31,
relocation policy established here will may include more than one location) 2021.
end following the end of the PHE for the and this request can include some of the According to the most recent wage
COVID–19 pandemic, and we anticipate same information (for example, the data provided by the Bureau of Labor
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27611
Statistics (BLS) for May 2019 (see http:// approval criteria necessitate QCDRs report information related to confirmed
www.bls.gov/oes/current/oes_ collecting data from clinicians in order or suspected COVID–19 cases in a
nat.htm#43-0000), the mean hourly to assess the measure, and we anticipate standardized format and frequency
wage for the general category of ‘‘Health that QCDRs may be unable to collect, specified by the Secretary, but no less
Diagnosing and Treating Practitioners, and clinicians unable to submit, data on frequent than weekly. This information
All Others’’ is $49.26. With fringe QCDR measures due to prioritizing the will be reported to the CDC’s National
benefits and overhead, the per hour rate care of COVID–19 patients. Because Healthcare Safety Network (NHSN). As
are $98.52. We also project that, on these policies are not modifying the of April 14, 2020, there are
average, it takes individuals approval criteria for QCDR measures but approximately 15,446 LTC facilities
approximately .5 hours to complete and are instead amending the timeline for
listed in the CMS Nursing Home
submit the Form CMS–855O or an opt- implementation of previously finalized
Compare database. As CMS will require
out affidavit. policies, we are not making any changes
Given the foregoing, we estimate a to our previously approved burden these facilities to participate in data
first-year burden of 3,000 hours (0.5 hr estimates. collection and reporting, we estimate
× (5,000 + 1,000)) at a cost of $295,560. that 95% of these facilities will report
The annual burden in Year 2 and in E. ICRs for the Hospital Value-Based COVID–19 case data.
Year 3 is 500 hours (0.5 hr × 1,000) at Purchasing (VBP) Program
We have estimated that the COVID–19
a cost of $49,260. This results in a total In section II.U. of this IFC, we are LTC facility forms will take an average
burden of 4,000 hours (3,000 hr + 500 updating the Extraordinary of 55 minutes to complete weekly,
hr + 500 hr) at a cost of $394,080. When Circumstance Exception (ECE) policy knowing that the reporting burden
averaged over the typical 3-year OMB for the Hospital VBP Program to allow includes surveillance and data entry.
approval period, we estimate an annual us to grant exceptions to hospitals
We further estimate that LTC facility
burden of 1,333 hours (4,000 hr/3) at a which have not requested them when
users will report these data on a weekly
cost of $131,360 ($394,080/3). we determine that an extraordinary
circumstance, such as PHE, including basis. The Module allows retrospective
The information collection
requirements in this section associated the current PHE for COVID–19, affects data collected from previous dates to be
with § 424.507 have been submitted to an entire region or locale. In a situation entered. Because OMB PRA approval is
OMB for emergency review and where we are granting such an requested for 180 days, the total number
approval in accordance with the exception for an entire region or locale, of responses per respondent is 26. This
implementing regulations of the PRA at hospitals are not required to complete burden will be submitted under the ICR
5 CFR 1320.13. any forms or submit any additional titled National Healthcare Safety
information, therefore the program does Network (NHSN) Patient Impact Module
D. ICRs for Merit-Based Incentive
not anticipate any change in burden for Coronavirus (COVID–19)
Payment System (MIPS) Qualified
associated with this IFC. Surveillance in Healthcare Facilities
Clinical Data Registry (QCDR) Measure
(OMB Control Number 0920–1290).
Approval Criteria § 414.1400 F. ICRs for COVID–19 Reporting in
Nursing Homes Details of this burden can be found in
In section II.R. of this IFC, we are Table 1.
amending § 414.1400(b)(3)(v)(C) and (D) We are revising the regulations by
to delay the implementation of these adding a provision at § 483.80(g) to
policies by 1 year. Both QCDR measure require LTC facilities to electronically
TABLE 1—BURDEN AND RESPONSES
Average
Number Total
Number of burden per Total burden Hourly wage
Type of respondent Form name responses per respondent
respondents response (in hrs.) rate
respondent costs
(in hrs.)
LTCF personnel ..... COVID–19 Module, Long-Term Care 9,782 26 15/60 63,583 $50.91 $3,237,011
Facility: Staff and Personnel Impact
form.
Business and finan- COVID–19 Module, Long-Term Care 2,446 26 15/60 15,899 37.56 597,166
cial operations Facility: Staff and Personnel Impact
occupations. form.
State and local COVID–19 Module, Long-Term Care 2,446 26 15/60 15,899 40.21 639,299
health depart- Facility: Staff and Personnel Impact
ment occupations. form.
LTCF personnel ..... COVID–19 Module, Long-Term Care 9,782 26 20/60 84,777 50.91 4,315,997
Facility: Resident Impact and Facility
Capacity form.
Business and finan- COVID–19 Module, Long-Term Care 2,446 26 20/60 21,199 37.56 796,234
cial operations Facility: Resident Impact and Facility
occupations. Capacity form.
State and local COVID–19 Module, Long-Term Care 2,446 26 20/60 21,199 40.21 852,412
health depart- Facility: Resident Impact and Facility
ment occupations. Capacity form.
LTCF personnel ..... COVID–19 Module, Long-Term Care 9,782 26 5/60 21,194 50.91 1,078,987
Facility: Ventilator Capacity & Sup-
plies form.
Business and finan- COVID–19 Module, Long-Term Care 2,446 26 5/60 5,300 37.56 199,068
cial operations Facility: Ventilator Capacity & Sup-
occupations. plies form.
State and local COVID–19 Module, Long-Term Care 2,446 26 5/60 5,300 40.21 213,113
health depart- Facility: Ventilator Capacity & Sup-
ment occupations. plies form.
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27612 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
TABLE 1—BURDEN AND RESPONSES—Continued
Average
Number Total
Number of burden per Total burden Hourly wage
Type of respondent Form name responses per respondent
respondents response (in hrs.) rate
respondent costs
(in hrs.)
LTCF personnel .....COVID–19 Module, Long-Term Care 9,782 26 15/60 63,583 50.91 3,237,011
Facility: Supplies & Personal Protec-
tive Equipment form.
Business and finan- COVID–19 Module, Long-Term Care 2,446 26 15/60 15,899 37.56 597,166
cial operations Facility: Supplies & Personal Protec-
occupations. tive Equipment form.
State and local COVID–19 Module, Long-Term Care 2,446 26 15/60 15,899 40.21 639,299
health depart- Facility: Supplies & Personal Protec-
ment occupations. tive Equipment form.
Total ............... ............................................................... ........................ ........................ ........................ 349,731 ........................ 16,402,763
V. Response to Comments suppliers. These policies will likely beneficiaries. The changes to the BHP
Because of the large number of public minimize exposure risks to patients, regulations to allow states to submit a
comments we normally receive on clinicians and the general public. revised Blueprint retroactive to the start
Federal Register documents, we are not The flexibilities available to hospitals of the PHE for the COVID–19 pandemic
and CMHCs to furnish certain will eliminate some burdens on states
able to acknowledge or respond to them
outpatient services remotely will allow and will help ensure enrollees’
individually. We will consider all
more of these services to be furnished in increased access to coverage during the
comments we receive by the date and
a manner that reduces the exposure risk PHE for the COVID–19 pandemic.
time specified in the DATES section of
to patients, hospital staff, and The temporary increase to certain
this preamble, and, when we proceed
physicians. To the extent that hospitals DME payment rates, as required by
with a subsequent document, we will
use these flexibilities to care for patients section 3712 of the CARES Act, will
respond to the comments in the
who would have otherwise received increase Medicare expenditures as well
preamble to that document.
care in more traditional hospital as beneficiary cost-sharing. Moreover, it
VI. Regulatory Impact Analysis settings, they likely would not result in is possible that the other flexibilities
any significant change in aggregate and changes contained within this IFC
A. Statement of Need Medicare payments for hospital would increase aggregate Medicare or
Throughout this IFC, we discuss services. Medicaid services. Improvements in
several changes to payment and The policy to exclude temporarily both provider and/or patient health are
coverage policies intended to allow added surge capacity beds when intended benefits of this IFC. For
health care providers maximum determining a teaching hospital’s IME example, if the protections against
flexibility to minimize the spread of payments, may increase costs relative to exposure risk, such as teaching
COVID–19 among Medicare and those that would otherwise been physicians remotely reviewing visits
Medicaid beneficiaries, health care incurred under current policies during furnished by residents, are effective,
personnel, and the community at large, the PHE for COVID–19; however, we providers may maintain their own
and increase capacity to address the estimate that there will not be a health and thus be available to furnish
needs of their patients. The flexibilities significant change in aggregate Medicare more services overall.
and changes contained within this IFC IME payments relative to current
are responsive to this developing policies absent the PHE for COVID–19. B. Overall Impact
pandemic emergency and to recent A similar policy will also allow RHCs We have examined the impacts of this
legislation that gives us additional that are provider-based to a hospital to rule as required by Executive Order
authority. Given the potentially maintain their payment amounts levels 12866 on Regulatory Planning and
catastrophic impact to public health, it if the hospital temporarily adds Review (September 30, 1993), Executive
is difficult to estimate the economic additional beds, which would otherwise Order 13563 on Improving Regulation
impact of the spread of COVID–19 disqualify them. Likewise, we are and Regulatory Review (January 18,
under current payment rules compared adopting a policy to maintain IRF and 2011), the Regulatory Flexibility Act
to the rules issued in this IFC. IPF average daily census numbers so (RFA) (September 19, 1980, Pub. L. 96–
We believe that the needs of Medicare that IRF and IPF teaching status 354), section 1102(b) of the Act, section
and Medicaid beneficiaries suffering adjustment payments do not decrease 202 of the Unfunded Mandates Reform
from COVID–19 will likely test the during the pandemic. Act of 1995 (March 22, 1995; Pub. L.
capacity of the health care system over The changes to Medicare and 104–4), Executive Order 13132 on
the coming months. Our policies Medicaid regulations to expand the Federalism (August 4, 1999), the
implemented in this IFC will provide scope of the practitioners who may Congressional Review Act (5 U.S.C.
flexibilities, during the PHE for COVID– order home health services are 804(2)), and Executive Order 13771 on
19, to physicians and other anticipated to eliminate some burdens Reducing Regulation and Controlling
practitioners, home health and hospice on practitioners and beneficiaries. Regulatory Costs (January 30, 2017).
providers, FQHCs, RHCs, hospitals, Similarly, the changes to Medicaid’s Executive Orders 12866 and 13563
critical access hospitals, CMHCs, IRFs, regulations to expand the circumstances direct agencies to assess all costs and
IPFs LTCHs, skilled clinical under which certain laboratory tests can benefits of available regulatory
laboratories, providers of the laboratory be covered during a PHE and alternatives and, if regulation is
testing benefit in Medicaid, Opioid subsequent periods of active necessary, to select regulatory
Treatment Programs (OTPs), Shared surveillance are anticipated to eliminate approaches that maximize net benefits
Savings Program ACOs, and DMEPOS some burdens on providers and (including potential economic,
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27613
environmental, public health and safety this threshold will be reached by the practitioners. We anticipate that these
effects, distributive impacts, and provisions in this IFC. changes could possibly result in higher
equity). Section 3(f) of Executive Order In addition, section 1102(b) of the Act Medicare expenditures because,
12866 defines a ‘‘significant regulatory requires us to prepare a regulatory although the changes primarily modify
action’’ as an action that is likely to impact analysis if a rule may have a supervision requirements, without a
result in a rule: (1) Having an annual significant impact on the operations of corresponding change in payment rate,
effect on the economy of $100 million a substantial number of small rural the added flexibility could result in a
or more in any 1 year, or adversely and hospitals. This analysis must conform to higher volume of services. We anticipate
materially affecting a sector of the the provisions of section 604 of the that the changes will allow the same
economy, productivity, competition, RFA. For purposes of section 1102(b) of services that were occurring before the
jobs, the environment, public health or the Act, we define a small rural hospital PHE to continue during the PHE;
safety, or state, local or tribal as a hospital that is located outside of however, expenditures could increase if
governments or communities (also a metropolitan statistical area and has additional services are furnished. To the
referred to as ‘‘economically fewer than 100 beds. This IFC will not extent that expenditures increased due
significant’’); (2) creating a serious have a significant impact on the to increases in service volume, this
inconsistency or otherwise interfering operations of a substantial number of would represent a cost to the Federal
with an action taken or planned by small rural hospitals. Government.
another agency; (3) materially altering Executive Order 13132 establishes 3. Modified Requirements for Ordering
the budgetary impacts of entitlement certain requirements that an agency COVID–19 Diagnostic Laboratory Tests
grants, user fees, or loan programs or the must meet when it issues a proposed
rights and obligations of recipients rule that imposes substantial direct Section II.C. of this IFC implements a
thereof; or (4) raising novel legal or requirement costs on state and local policy to allow Medicare beneficiaries
policy issues arising out of legal governments, preempts state law, or to get COVID–19 and other related
mandates, the President’s priorities, or otherwise has Federalism implications. testing during the COVID–19 PHE
the principles set forth in the Executive This IFC does not have a substantial without requiring the order of the
Order. direct cost impact on state or local treating physician or practitioner, and
Executive Order 12866 and other laws governments, preempt state law, or instead allowing the testing to be
and Executive Orders require economic otherwise have federalism implications. ordered by any healthcare professional
analysis of the effects of proposed and who is authorized to do so under
C. Detailed Economic Analysis of the applicable state law. We do not
final (including interim final) rules.64 Provisions of the IFC
The Office of Management and Budget anticipate that this change will affect
has designated this rulemaking as 1. Reporting Under the Home Health overall Medicare expenditures over time
‘‘economically significant’’ under E.O. Value-Based Purchasing Model for CY because we expect that the change
12866 and also major under the 2020 During the COVID–19 Public would accelerate the timing of COVID–
Congressional Review Act. Health Emergency 19 testing that would otherwise have
This IFC’s designation under occurred over a longer timeframe.
Section II.A. of this IFC implements a
Executive Order 13771, titled Reducing policy to align HHVBP Model data 4. Opioid Treatment Programs—
Regulation and Controlling Regulatory submission requirements with any Furnishing Periodic Assessments via
Costs (82 FR 9339), which was issued exceptions or extensions granted for Communication Technology
on January 30, 2017, will be informed purposes of the HH QRP during the PHE Section II.D. of this IFC implements a
by public comments received. for the COVID–19 pandemic, as well as change to allow periodic assessments
The RFA requires agencies to analyze a policy for granting exceptions to the furnished by OTPs to be furnished via
options for regulatory relief of small New Measures data reporting two-way interactive audio-video
entities, if a rule has a significant impact requirements under the HHVBP Model communication technology, and in
on a substantial number of small during the PHE for the COVID–19 cases where beneficiaries do not have
entities. The great majority of hospitals pandemic. We do not anticipate a access to two-way audio/video
and most other health care providers change to Medicare expenditures as a communications technology, to allow
and suppliers are small entities, either result of this policy. However, we periodic assessments to be furnished
by being nonprofit organizations or by expect reduced burden on providers. using audio-only telephone calls rather
meeting the SBA definition of a small than via two-way interactive audio-
business (having revenues of less than 2. Scope of Practice
video communication technology,
$8.0 million to $41.5 million in any 1 Section II.B. of this IFC implements provided all other applicable
year). Individuals and states are not several policies to temporarily add requirements are met. This change will
included in the definition of a small flexibility for certain nonphysician not result in an increase in Medicare
entity. As its measure of significant healthcare professionals in supervision, expenditures because the add-on
economic impact on a substantial documentation and other requirements payment for these services was available
number of small entities, HHS uses an of the Medicare program that could prior to the PHE for COVID–19 and
adverse change in revenue of more than impact the availability and efficiency of because this change only provides OTPs
3 to 5 percent. We do not believe that care. As discussed in section II.B. of this additional flexibilities regarding the
IFC, several states have sought to manner in which they furnish these
64 Section 202 of the Unfunded Mandates Reform
increase pharmacist capacity by relaxing services during the pandemic.
Act of 1995 (UMRA) (Pub. L. 104–04, enacted on
March 22, 1995) also requires that agencies assess
supervision requirements during the
PHE for COVID–19. We expect that, 5. Treatment of Certain Relocating
anticipated costs and benefits before issuing any
rule whose mandates require spending in any 1 year especially when coupled with policies Provider-Based Departments During the
of $100 million in 1995 dollars, updated annually adopted by states, the temporary PHE
for inflation. In 2020, that amount is approximately
$156 million. This IFC does not mandate, on an
flexibility and clarification we provide Section II.E. of this IFC adopts a
unfunded basis, any requirements for State, local, in this IFC will increase capacity for temporary extraordinary circumstances
or tribal governments, or for the private sector. pharmacists and other healthcare relocation exception policy for on-
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27614 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
campus and excepted off-campus PBDs adjustment payments at their values The increase is a result of paying a
that relocate off-campus in response to prior to the COVID–19 PHE. This will blend of 75 percent of the fully adjusted
the PHE that permits the PBDs that mitigate changes in teaching adjustment payment rates and 25 percent of the
relocate to continue to be paid under the payments relative to their levels before unadjusted payment rates and is
OPPS. This policy could drive slightly the COVID–19 PHE. To the extent that estimated to increase affected rates on
higher spending during the PHE than teaching adjustment payments did average 33%. However, the estimated
would otherwise occur, but generally it change, the changes would represent a Medicare gross benefit cost against the
would maintain current payment rates transfer between IPFs or IRFs and the FY 2021 President’s Budget baseline is
to on-campus and excepted off-campus Federal Government (with an increase $140 million dollars. It would represent
PBDs in the event of a temporary in payments being a transfer from the a transfer from the Federal Government
relocation due to the PHE for COVID– Federal Government to IPFs or IRFs, and to DMEPOS suppliers and a transfer
19. These policies would be time vice versa). from beneficiaries to the Federal
limited and we do not believe they This section also implements a policy Government. This change may also
would result in higher use of services; to allow, for the duration of the COVID– affect the federal financial participation
rather they would allow services 19 PHE, teaching hospitals to claim, limit for DMEPOS items and services
furnished by these relocated towards their resident FTE counts, furnished to Medicaid beneficiaries, but
departments to continue to be paid at residents that teaching hospitals send to we are unable to quantify the effect.
the higher rate under the OPPS, rather other hospitals to respond to the PHE 10. Care Planning for Medicare Home
than at the lower PFS-equivalent rate if associated with COVID. To the extent Health Services
these excepted PBDs relocated off- that hospitals are not sending or
campus outside of the PHE and were not Section II.J. of this IFC implements
accepting residents because of our
granted an extraordinary circumstances conforming regulations text changes
current regulations, and those residents
relocation exception. required by section 3708 of the CARES
continue to train at the home teaching
Overall there would be minimal Act. We believe that section 3708 of the
hospitals, allowing the residents to train CARES Act will have a negligible
change in the types of patients treated elsewhere is budget neutral. The
under these policies compared to the impact on Medicare expenditures. NPPs
hospitals would continue to get paid the generally work in collaboration with or
absence of these policy changes. To the
same GME payments that they would under the supervision of a physician;
extent that Medicare expenditures
have received if the residents had therefore, utilization is unlikely to
increased, it would represent a transfer
continued to train at the home hospitals. change substantially as a result of the
from the Federal Government to
No other hospitals would receive CARES Act. In areas where NPPs are
hospitals paid under the OPPS.
additional GME payments for that able to act independently under their
6. Furnishing Hospital Outpatient resident training. state scopes of practice and where
Services Remotely physicians are scarce, there may be a
8. Rural Health Clinics
Section II.F. of this IFC discusses slight increase in utilization; however,
flexibilities under which certain Section II.H. of this IFC implements a we are unable to quantify the impact.
outpatient services, including PHP policy that excludes temporarily added Although the majority of states require
services furnished by a hospital or surge capacity beds from a hospital’s physician collaboration for these NPPs,
CMHC in the beneficiary’s home, can be bed count for the purposes of we note that even in states that allow
furnished remotely during the PHE for determining whether a RHC that is independent practice authority, many of
COVID–19. These changes will not provider-based to that hospital is subject these practitioners continue to work in
result in higher costs because they only to a per-visit national payment limit. We a practice environment (inpatient
provide flexibility for providers to do not anticipate that this policy would facility or outpatient or physician’s
continue to furnish these services increase the number of RHCs that would office) that includes a physician.
during the pandemic. not be subject to the payment limit;
rather, it would ensure those RHCs who 11. CARES Act Waiver of the ‘‘3-Hour
7. Medical Education were not subject to the limit prior to the Rule’’ and Modification of IRF Coverage
Section II.G. of this IFC implements a PHE maintain that status. This policy and Classification Requirements for
policy that excludes temporarily added could increase costs relative to the Freestanding IRF Hospitals for the PHE
surge capacity beds when determining a baseline of current payment rules and During the COVID–19 Pandemic
teaching hospital’s IME payments. This the PHE, but will mitigate changes in Section II.K. of this IFC amends
policy could increase costs relative to costs relative to their levels before the section § 412.622(a)(3)(ii) (commonly
the baseline IME payments that would COVID–19 PHE. To the extent payments referred to as the ‘‘3-hour rule’’) to
be established under current payment to RHCs increased, it would represent a address the waiver required by section
rules if teaching hospitals temporarily transfer from the Federal Government to 3711(a) of the CARES Act during the
add beds given the COVID–19 PHE, but RHCs. emergency period described in section
will mitigate changes in IME payments 1135(g)(1)(B) of the Act and amends
9. DME Interim Pricing in the CARES
relative to their levels before the § 412.29(d), (e), (h), and (i) and
Act
COVID–19 PHE. To the extent that IME § 412.622(a)(3), (4), and (5) to add an
payments do change, the changes in Section II.I. of this IFC implements exception for patients admitted solely
payments would represent a transfer the temporary increase to certain DME for care furnished to patients in an IRF
between teaching hospitals and the payment rates, as required by section solely to relieve acute care hospital
Federal Government (that is, an increase 3712 of the CARES Act. Section 3712 of capacity in a state (or region, as
in payments would be a transfer from the CARES Act increases Medicare applicable) that is experiencing a surge
the Federal Government to teaching expenditures, as well as beneficiary during the PHE. We expect that the
hospitals, and vice versa). cost-sharing by increasing Medicare waiver required by the CARES Act will
This section also implements a policy payment rates for certain DMEPOS increase Medicare expenditures because
to hold, for the duration of the COVID– items furnished in non-rural and it will increase the volume of patients
19 PHE, IRF and IPF teaching status contiguous non-competitively bid areas. admitted to IRFs and paid for under the
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27615
IRF PPS. However, we do not expect This would represent a significant performance-based risk in the face of
that the other changes to § 412.29(d), (e), increase in the program’s attrition rate, elevated uncertainty. The net effect of
(h), and (i) and § 412.622(a)(3), (4), and which was 16 percent in 2019 and has offering this flexibility is estimated to be
(5) for freestanding IRF hospitals will been 11 percent on average.65 Further, a $60 million reduction in federal
increase the IRF volume of cases beyond based on a recent National Association spending, with the reduction ranging
the increases that will already be of ACOs (NAACOS) survey, 56 percent from $0 to $170 million.
expected to occur as a result of the of risk-based ACOs may leave the In modeling the impact of forgoing the
CARES Act. Moreover, these changes program due to concerns about having application cycle for a January 1, 2021
are likely to minimize exposure risks to to pay shared losses in 2020 because of agreement start date, we considered a
patients, clinicians, and the general costs incurred in treating COVID–19.66 combination of factors. Not offering an
public. To the extent that Medicare A key new flexibility is the allowance application cycle for a 2021 start date
expenditures increase, it would for ACOs in the last performance year of helps to mitigate any complexity arising
represent a transfer from the Federal their current agreement period (mainly from the use of 2020 as a benchmark
Government to IRFs. Track 1 ACOs and Track 1+ Model year, when expenditures for 2020 could
ACOs) to elect to extend their agreement be extremely unusual given the COVID–
12. Shared Savings Program 19 pandemic and the related disruption
period by an additional performance
Changes to the Shared Savings year in 2021. The anticipated resulting to normal health care utilization. In
Program as described in section II.L. of increase in retention of existing ACOs particular, forgoing a January 1, 2021
this IFC are estimated to reduce program that would have otherwise been agreement start date prevents 2020
spending relative to a status quo unlikely to renew in the face of serving as benchmark year 3, which is
baseline by preventing COVID–19- pandemic uncertainty is estimated to most heavily weighted in the case of
related treatment costs from causing lower net program spending (that is, ACOs entering a first agreement period
highly variable and uncertain increase federal savings) by $100 (§ 425.601(a)(7)).
distortions in the calculation of shared million (ranging from $90 to $120 In addition, maintaining an
savings and shared losses for individual million) despite potential increases in application cycle for a January 1, 2021
ACOs and by offering flexibilities that shared savings payments to certain start date could result in a scenario
are expected to help retain ACO ACOs that will benefit from the where only a small number of
participation in the face of broader additional year under their existing organizations are able to devote
uncertainties from the historic agreement period for which the ACO’s resources to applying to participate (or
disruption caused by the COVID–19 historical benchmark is established, renew their participation) in the Shared
pandemic. In modeling the impacts of adjusted, updated, and reset (as Savings Program given the impact of the
these changes, we used ACO applicable) according to the COVID–19 pandemic on their
performance data from performance methodologies specified in §§ 425.602 operations and the challenges facing
year 2018 to simulate 2020 performance, and 425.603. providers and suppliers. There is a
and included assumptions for variation Another important new flexibility particular risk that the unusual
in COVID–19 spending and a decline in allows certain ACOs to temporarily circumstances surrounding the COVID–
elective services and the deferral of freeze their position along the BASIC 19 pandemic could result in selective
other services. In modeling the impact track’s glide path, which will allow participation by only those ACOs that
of these changes, we considered the some ACOs to avoid transitioning to a find their historical benchmark, for
following: higher level of performance-based risk whatever reason, would provide for
• Based on a typical year, we for performance year 2021. This large windfall shared savings payments
assumed up to a 20 percent reduction in flexibility is also estimated to decrease over a 5-year agreement period.
expenditures for 2020 because of a program spending (increase federal Therefore, forgoing the application cycle
decline in elective services and the savings) mainly by reducing the chance for a January 1, 2021 start date is
deferral of other services, and we that risk-averse ACOs would drop out of estimated to mitigate such selective
assumed increases in expenditures due the Shared Savings Program rather than participation and therefore reduce
to COVID–19 inpatient treatment and transition to a higher level of program spending by $150 million (with
related spending. We estimate that this the reduction estimate ranging from $0
performance-based risk for performance
variation in COVID–19 related spending to $410 million).
year 2021. For example, ACOs opting to
would roughly double the standard The most significant impact is
remain in Level B instead of
deviation in gross measured savings and estimated to result from the new policy
transitioning to Level C or higher risk
losses (expressed as a percentage of to adjust certain Shared Savings
and reward (such as Level E, which
benchmark) that would have been Program calculations to remove Parts A
qualifies as an Advanced APM) for
determined across all ACOs and B expenditures for episodes of care
performance year 2021 would in effect
participating in PY 2020. for treatment of COVID–19. Failing to
accept a lower savings sharing rate (and
• Absent flexibilities to encourage remove this spending would likely
their participating ACO providers/
continued participation (by allowing a create highly variable shared savings
suppliers would forgo potential
voluntary 1-year extension for ACOs and shared losses results for individual
incentive payments from qualifying as
whose agreement periods expire on ACOs that happen to have over-
participating in an Advanced APM) in representation or under-representation
December 31, 2020, and allowing ACOs
exchange for elimination of of COVID–19-related hospitalizations in
to maintain participation at the same
level of the BASIC track’s glide path for 65 Verma S. Number of ACOs Taking Downside
their assigned beneficiary population.
performance year 2021) and an Risk Doubles Under ‘Pathways To Success’. Health At baseline, such variability would
adjustment to certain program Affairs. January 10, 2020. Available at https:// likely produce windfall payments to
calculations to remove payment www.healthaffairs.org/do/10.1377/ certain ACOs while causing other ACOs
amounts for episodes of care for hblog20200110.9101/full/. with significant exposure to COVID–19
66 NAACOS, Survey Shows ACOs’ Concerns
treatment of COVID–19, we project that About the Effect of COVID–19. Available at https://
in their assigned beneficiary
up to 30 percent of all ACOs would www.naacos.com/assets/docs/pdf/2020/ populations to potentially leave the
elect to discontinue their participation. SurveyReportACO-EffectsCOVID19-04132020.pdf. Shared Savings Program. Excluding
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27616 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
expenditures for these episodes of care and practitioners as well as real changes 14. Payment for Audio-Only Telephone
for treatment of COVID–19 from the in resource use. At this time, we are Evaluation and Management Services
specified financial calculations under unable to separately estimate transfers Section II.N. of this IFC increases
the Shared Savings Program is and real changes in resource use. payment rates, for the duration of the
anticipated to reduce program spending As shown Table 2, the net change in PHE for COVID–19, for telephone E/M
by $1,110 million (reduction estimate expenditures to the Federal Government visits to match payment rates under the
ranging from $560 to $1,710 million) associated with the Shared Savings PFS for office/outpatient visits with
mainly by preventing windfall Program policies in this IFC is estimated established patients. We expect that
payments of shared savings to ACOs at ¥$1.1 billion for performance year these increases in payment rates will
favored by such extreme variation. 2020, ¥$0.13 billion for performance
By reducing program spending (even not result in higher aggregate Medicare
year 2021, ¥$0.05 billion for expenditures as long as these telephone
at the low-magnitude end of the range
performance years 2022 and 2023, and E/M visits fully substitute during the
of uncertainty), this change to exclude
¥$0.04 billion for performance years pandemic for in-person or telehealth E/
payment amounts for episodes of care
2024 and 2025. We present the M visits that otherwise would have
for treatment of COVID–19 necessarily
estimates as undiscounted streams over occurred. Absent the increase in
satisfies the requirement under section
6 performance years rather than payment rates, it is unlikely that
1899(i)(3)(B) of the Act that program
spending not exceed spending that annualized streams because we estimate telephone E/M visits would have served
would have occurred under a that more than 75 percent of the total as an alternative for in-person or
hypothetical version of the program that change will accrue to performance year telehealth E/M visits to the same extent
would not have utilized flexibilities 2020. as could occur with the increase in
allowed under section 1899(i)(3) of the payment rates. However, it is also
Act. The adjustments to expenditure TABLE 2—ESTIMATED NET SAVINGS TO possible that this provision would
and revenue calculations to mitigate the MEDICARE PROGRAM FROM SHARED increase aggregate Medicare payments.
impact of COVID–19 that require the use SAVINGS PROGRAM POLICIES For example, if the protections against
of our authority under section 1899(i)(3) exposure risk are effective, physicians
of the Act will only lower anticipated Performance may maintain their own health and thus
Net change in expenditures
program spending further below the year be available to furnish more services
hypothetical baseline compared to what overall. Improvements in the health of
2020 ............... ¥$1.11 billion. patients and physicians are intended
we have determined in previous 2021 ............... ¥$0.13 billion.
rulemaking to meet the requirements of benefits of this provision. If additional
2022 ............... ¥$0.05 billion.
section 1899(i)(3)(B) of the Act.67 2023 ............... ¥$0.05 billion. services are furnished, Medicare
Therefore, we believe that the 2024 ............... ¥$0.04 billion. expenditures will increase, resulting in
adjustments to remove payment 2025 ............... ¥$0.04 billion. a cost to the Federal Government.
amounts for episodes of care for 15. Flexibility for Medicaid Laboratory
Note: Performance years co-occur with cal-
treatment of COVID–19 from the endar years. Negative values reflect a reduc- Services
calculation of performance year tion in federal net cost. Net change in expend-
expenditures, updates to the historical itures includes both changes in real resource Section II.O. of this IFC implements
benchmark, and ACO participants’ use and transfers between the Federal Gov- revisions to the Medicaid laboratory
ernment and ACOs and Medicare-enrolled benefit at § 440.30 to provide states with
Medicare FFS revenue used to suppliers, providers, and practitioners.
determine the loss sharing limit in the flexibility to provide Medicaid coverage
two-sided models of the BASIC track, 13. Additional Flexibility Under the for laboratory tests and X-ray services
meet the requirements for use of our Teaching Physician Regulations that may not meet certain requirements
authority under section 1899(i)(3) of the in § 440.30(a) or (b) (such as the
Act. Section II.M. of this IFC discusses requirement that tests be furnished in an
In total, the changes to the Shared changes to allow teaching physicians to office or similar facility) during periods
Savings Program described in this IFC review the services furnished by of a PHE resulting from an outbreak of
are estimated to reduce program residents, as required under the primary communicable disease and during any
spending by $1.43 billion over the 2020 care exception rules, remotely through subsequent periods of active
to 2025 period (ranging from a reduction virtual means via interactive surveillance. The purpose of such
of $790 million to $2.12 billion), with telecommunications technology during laboratory and X-ray services must be to
most of the reduction ($1.11 billion) the PHE for COVID–19. This change will diagnose or detect SARS–CoV–2,
attributable to performance year 2020. give teaching physicians additional antibodies to SARS–CoV–2, COVID–19,
Table 2 provides our best estimate, flexibilities to direct the care furnished or the communicable disease named in
net of shared savings payments to by residents remotely to minimize the PHE or its causes, and the deviation
ACOs, of the change in resource use and exposure risks to patients, clinicians, from the requirements in § 440.30 (a) or
transfers between the Federal and the general public; and there would (b) must be intended to avoid
Government and ACOs and ACO be no change in Medicare payment rates transmission of the communicable
providers/suppliers as a result of the or change in the types of patients treated disease. This change is not estimated to
changes to the Shared Savings Program under this policy compared to the have a significant impact on federal
included in this IFC. The change in absence of this policy change. Aggregate expenditures for the Medicaid program.
expenditures is classified as a net Medicare expenditures could increase if
the changes allow residents to furnish 16. Improving Care Planning for
change in expenditures because it is a Medicaid Home Health Services
mix of transfers between the Federal more services with remote supervision
Government and ACOs and other from teaching physicians. To the extent Section II.P. of this IFC implements
Medicare-enrolled providers, suppliers, that Medicare expenditures increase revisions to the Medicaid home health
because residents furnish more services, benefit at § 440.70 to expand the scope
67 See for example, 81 FR 38011 and 38012, and this change will represent a cost to the of practitioners who may order home
83 FR 68060. Federal Government. health services. This change is not
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27617
estimated to have a significant impact 20. Delay in the Compliance Date of dependent on the availability of testing,
on federal expenditures for the Policies Adopted for the IRF QRP, LTCH the price of the test and the length of the
Medicaid program. QRP, HH QRP and SNF QRP PHE. While the tests are new and have
Section II.T. of this IFC delays certain not previously been covered by
17. Basic Health Program (BHP) Medicare it is possible that some of the
Blueprint Revisions reporting requirements for policies
cost of furnishing the test will be offset.
adopted for the IRF QRP, LTCH QRP,
Section II.Q. of this IFC provides As a result of serology testing there may
HH QRP, and SNF QRP. We do not
flexibility to states that operate a BHP to be patients identified as not having had
anticipate any economic impact as a
seek certification of temporary revisions an immune response to COVID–19. If
result of the delay.
these patients take preventive measures
that make significant changes to their
21. Update to the Hospital Value-Based to reduce their risk of infection as a
respective Blueprint that are directly
Purchasing (VBP) Program result of this information then they may
tied to the PHE for the COVID–19
Extraordinary Circumstance Exception avoid COVID–19 infections, related
pandemic and increase access to
Policy hospitalizations and additional costs to
coverage. A state operating a BHP can Medicare.
seek to apply these revisions Section II.U. of this IFC updates the
retroactively to the start of the PHE for Hospital VBP Program’s ECE policy to 23. Certification of Home Health
the COVID–19 pandemic. Such more closely align that policy with the Services—Revision to § 424.507
revisions would expire at the end of the ECE policies of CMS’ other hospital In section II.W. of this IFC, we discuss
PHE, or a reasonable later date as QRP and VBP program, and to also the provision to allow certain NPPs the
certified by HHS. This change is not provide more flexibility to hospitals ability to certify a patient’s need for
estimated to have a significant impact confronted with unforeseen home health services. Previously only
on federal expenditures for the BHP. extraordinary circumstances beyond physicians were eligible to certify the
their control. Under the current policy, need for home health under Medicare.
18. Merit-Based Incentive Payment a hospital must submit the Hospital VBP The majority of NPPs are likely already
System (MIPS) Qualified Clinical Data Program ECE request form, including enrolled in the Medicare program and
Registry (QCDR) Measure Approval any available evidence of the impact of will not need to take any additional
Criteria the extraordinary circumstances on the enrollment actions. However, we
hospital’s quality measure performance, estimate that approximately 5,000
Section II.R. of this IFC amends
within 90 calendar days of the date on currently unenrolled or non-opted out
§ 414.1400(b)(3)(v)(C) and (D) to delay
which the natural disaster or other NPs, CNSs, and PAs will elect to enroll
the implementation of these policies by
extraordinary circumstance occurred (78 in or opt-out of Medicare solely for the
1 year. Both QCDR measure approval
FR 50706). We are retaining this policy purpose of certifying home health
criteria necessitate QCDRs collecting as well as introducing a new policy that
data from clinicians in order to assess services. We believe they will do so in
allows us to grant an ECE to hospitals the first year following the effective date
the measure, and we anticipate that affected by an extraordinary
QCDRs may be unable to collect, and of this IFC; moreover, 1,000 new NPs,
circumstance, such as the COVID–19 CNSs, and PAs each year will enroll in
clinicians unable to submit, data on PHE, within an entire region or locale
QCDR measures due to prioritizing the or opt-out of Medicare for the same
without requiring that each affected purpose.
care of COVID–19 patients. This delay hospital individually submit an ECE
will not affect reporting burden for request form. 24. Separate Billing and Segregation of
QDCRs or clinicians; therefore, there is The existing individual ECE request Funds for Abortion Services
no expected impact. form policy is accounted for in the In light of the immediate need for
19. Application of Certain National currently approved Hospital Inpatient QHP issuers and Exchanges to divert
Coverage Determination and Local Reporting PRA package, OMB control resources to responding to COVID–19,
Coverage Determination Requirements #0938–1022. There are no changes to we are delaying implementation of the
During the PHE for the COVID–19 the individual ECE request form policy separate billing policy for 60 days as
Pandemic and therefore no changes to the burden discussed in section II.X. of this IFC.
associated with the HVBP program. Under this 60-day extension, QHP
Section II.S.2. of this IFC exercises The updated policy that allows CMS issuers must comply with the separate
enforcement discretion for LCDs related to grant exceptions for entire regions, billing policies finalized at
to clinical indications for therapeutic including the entire United States, § 156.280(e)(2)(ii) beginning on or before
continuous glucose monitors. This during an extraordinary circumstance, their first billing cycle following August
policy may temporarily allow additional does not require hospitals to submit any 26, 2020. We estimate that delaying the
beneficiaries to be covered by Medicare documentation: Therefore, we do not implementation deadline for the
for home use of therapeutic continuous anticipate any change in burden or costs separate billing policies by 60 days will
glucose monitors during the PHE for the for the Hospital VBP Program based on not result in substantial changes to the
COVID–19 pandemic including diabetic the changes to the ECE policy set forth one-time implementation costs as
patients with COVID–19 infections. in this IFC. estimated in the 2019 Program Integrity
While this should be a small and final rule. Some issuers and State
temporary increase in the use of 22. COVID–19 Serology Testing Exchanges may have already sent
therapeutic continuous glucose Section II.V. of this IFC provides for notices to enrollees informing them of
monitors it is possible that this increase national coverage of COVID–19 FDA- the separate billing and payment
will be offset by a reduction in authorized serology tests for certain requirements and may now have to send
hospitalizations. Additionally, patients Medicare beneficiaries during the PHE additional notices to inform them of the
using therapeutic continuous glucose for the COVID–19 pandemic. It is change. In such cases, the reduction in
monitors may be able to reduce their use unclear to what extent this test will ongoing costs will be lower. We request
of other diabetic testing supplies which increase Medicare expenditures. The comment that would allow for
could also contribute to offsetting costs. cost to Medicare will be primarily refinement of the upfront and ongoing
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27618 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
cost savings estimates. Reduction in reduction in burden in 2020 will be 28. Payment for COVID–19 Specimen
costs directly related to printing and approximately 337,793 hours with an Collection to Physicians, Nonphysician
sending of separate bills for issuers and equivalent cost savings of Practitioners and Hospitals
State Exchanges that perform premium approximately $4.2 million.
billing and payment processing have Section II.BB. of this IFC describes a
25. Requirement for Facilities To Report policy to make assessment and
been discussed previously in the
‘‘Collection of Requirements’’ section of Nursing Home Residents and Staff specimen collection for COVID–19
this IFC. Infections, Potential Infections, and testing payable under the Medicare PFS
In the 2019 Program Integrity final Deaths Related to COVID–19 and conditionally packaged under the
rule, we estimated that issuers and State OPPS for the duration of the PHE for
Section II.Y. of this IFC revises the
Exchanges that perform premium billing COVID–19. Because these services were
infection prevention and control
and payment processing will each incur not previously payable under the
requirements for LTC facilities to more
ongoing annual costs of approximately Medicare PFS or conditionally packaged
effectively respond to the specific
$1 million associated with activities under the OPPS, Medicare expenditures
challenges posed by the COVID–19
such as processing and reconciling will increase, representing a cost to the
pandemic. Specifically, we are adding
separate payments, support for enrollees Federal Government. However, on net
provisions to require facilities to
who enter grace period for non- we estimate that greater testing
electronically report information related
payments, customer service, outreach combined with proper public health
to confirmed or suspected COVID–19
and compliance. Delaying the practices of physical distancing and
cases in a standardized format and
implementation by 60 days will reduce isolation for exposed or infected
frequency specified by the Secretary and
these ongoing costs by approximately individuals would result in fewer
requiring facilities to inform residents
$16.2 million for all 94 issuers and 3 COVID–19 infections and consequently,
and their representatives of confirmed
State Exchanges that perform premium this policy would reduce expenditures
or suspected COVID–19 cases in the
billing and payment processing. We also for the treatment of Medicare
facility among residents and staff. As
estimated that each of the 12 State beneficiaries with COVID–19, which
discussed in the Collection of
Exchanges will incur ongoing annual would be a benefit to the Federal
Information section, we expect a burden
costs associated with increased Government.
increase of $16,402,763 attributed to the
customer service, outreach, and CDC’s NHSN collection (OMB Control 29. Payment for Remote Physiologic
compliance, estimated to be #0920–1290). Monitoring (RPM) Services Furnished
approximately $200,000 for the 6
During the COVID–19 PHE
months in 2020. The 60-day delay in 26. Time Used for Level Selection for
implementation will reduce these Office/Outpatient Evaluation and Section II.CC. of this IFC describes a
ongoing costs in 2020 by approximately Management Services Furnished Via policy, for the duration of the PHE for
$0.8 million for all 12 Exchanges. In Medicare Telehealth COVID–19, to allow the RPM
addition, we estimated that the FFEs monitoring service to be reported to
will incur ongoing costs of Section II.Z. of this IFC implements a
Medicare for periods of time that are
approximately $400,000 for the 6 policy that for the duration of the PHE
fewer than 16 days of 30 days, as long
months in 2020. The delay in for the COVID–19 pandemic, the typical
as the other requirements for billing the
implementation will reduce the ongoing times for purposes of level selection for
code are met. To the extent that this
costs in 2020 by approximately an office/outpatient E/M service
increases volume of the RPM
$133,333. furnished via telehealth are the times
monitoring service, this policy would
Consumers will also experience a listed in the CPT code descriptor. We do
increase Medicare expenditures,
reduction in burden. In the 2019 not anticipate a change to Medicare
resulting in a cost to the Federal
Program Integrity final rule, we expenditures as a result of this policy.
Government.
estimated that issuers and State 27. Updating the Medicare Telehealth
Exchanges performing premium billing D. Accounting Statement
List
and payment processing will be 1. Medicare Program
required to send a separate bill to Section II.AA. of this IFC revises the
approximately 2 million policy holders process during the PHE for COVID–19 As required by OMB Circular A–4
and that consumers will incur a burden by which CMS could add services to the (available at https://
of 5 minutes per month after the initial Medicare telehealth list and that www.whitehouse.gov/sites/
month to read and understand the services added through the process whitehouse.gov/files/omb/circulars/A4/
separate bill. Delaying the would remain on the Medicare a-4.pdf), in the following Table 3, we
implementation by 60 days will result telehealth list during the PHE for have prepared an accounting statement
in a burden reduction of 10 minutes (at COVID–19. This section does not add showing the classification of the
a cost of $12.37 per hour) in 2020 for any services to the Medicare telehealth expenditures associated with the
each consumer. For approximately 2 list. Therefore, we do not anticipate a provisions of this IFC as they relate to
million policyholders, the total change to Medicare expenditures. the Medicare program.
TABLE 3—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS
Units
Category Estimates Discount rate Period covered
Year dollar (%) (CY)
Transfers:
Annualized Monetized ($million/year) ....................................... ¥269.6 2019 7 2020–2025
¥250.8 2019 3 2020–2025
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27619
TABLE 3—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS—Continued
Units
Category Estimates Discount rate Period covered
Year dollar (%) (CY)
From Whom to Whom .............................................................. Reduced transfer from Federal Government to ACOs and Medicare-enrolled
suppliers, providers, and practitioners.
List of Subjects 42 CFR Part 600 certification’’ and adding in its place the
Administration practice and phrase ‘‘the certification’’.
42 CFR Part 409
procedure, Health care, Health ■ 4. Section 409.43 is amended—
Health facilities, Medicare. insurance, Intergovernmental relations, ■ a. By revising paragraphs (a)
Penalties, Reporting and recordkeeping introductory text and (a)(1);
42 CFR Part 410 ■ b. In paragraph (b), by removing the
requirements.
Diseases, Health facilities, Health phrases ‘‘physician’s orders’’ and
professions, Laboratories, Medicare, 45 CFR Part 156 ‘‘physician order’’ and adding in its
Reporting and recordkeeping Administrative practice and place the phrases ‘‘physician or allowed
requirements, Rural areas, X-rays. procedure, Advertising, Advisory practitioner’s orders’’ and ‘‘physician or
committees, Brokers, Conflict of allowed practitioner order’’,
42 CFR Part 412 respectively;
interests, Consumer protection, Grant
Administrative practice and programs—health, Grants ■ c. In the paragraph (c) subject heading
procedure, Health facilities, Medicare, administration, Health care, Health by removing the word ‘‘Physician’’ and
Puerto Rico, Reporting and insurance, Health maintenance in paragraph (c)(1) introductory text by
recordkeeping requirements. organization (HMO), Health records, removing the term ‘‘physician’’ and
Hospitals, Indians, Individuals with adding in its place the phrase
42 CFR Part 413 ‘‘Physician or allowed practitioner’’ and
disabilities, Intergovernmental relations,
Diseases, Health facilities, Medicare, Loan programs—health, Medicaid, ‘‘physician or allowed practitioner’’,
Puerto Rico, Reporting and Organization and functions respectively;
recordkeeping requirements. (Government agencies), Prescription ■ d. In paragraph (c)(1)(i) introductory
drugs, Public assistance programs, text by removing the phrase
42 CFR Part 414 ‘‘physician’s verbal order’’ and adding
Reporting and recordkeeping
Administrative practice and requirements, Sunshine Act, Technical in its place the phrase ‘‘physician or
procedure, Biologics, Diseases, Drugs, assistance, Women, Youth. allowed practitioner’s orders’’; and
■ e. In paragraphs (d), (e)(1)
Health facilities, Health professions, For the reasons set forth in the
Medicare, Reporting and recordkeeping introductory text, (e)(2), and (f) by
preamble, the Centers for Medicare & removing the term ‘‘physician’’ and
requirements. Medicaid Services amends 42 CFR adding in its place the phrase
42 CFR Part 415 chapter IV, and the Department of ‘‘physician or allowed practitioner’’.
Health and Human Services amends 45 The revisions read as follows:
Health facilities, Health professions, CFR part 156, as set forth below:
Medicare, Reporting and recordkeeping § 409.43 Plan of care requirements.
requirements. Title 42
(a) Contents. An individualized plan
42 CFR Part 424 PART 409—HOSPITAL INSURANCE of care must be established and
BENEFITS periodically reviewed by the certifying
Emergency medical services, Health physician or allowed practitioner, as
facilities, Health professions, Medicare. ■ 1. The authority citation for part 409 defined at § 484.2 of this chapter.
42 CFR Part 425 continues to read as follows: (1) The HHA must be acting upon a
Authority: 42 U.S.C. 1302 and 1395hh. plan of care that meets the requirements
Administrative practice and of this section for HHA services to be
procedure, Health facilities, Health § 409.41 [Amended] covered.
professions, Medicare, Reporting and ■ 2. Section 409.41 is amended in * * * * *
recordkeeping requirements. paragraph (b) by removing the phrase ■ 5. Section 409.44 is amended—
42 CFR Part 440 ‘‘The physician certification’’ and ■ a. By revising paragraph (c)(1)
adding in its place the phrase ‘‘The introductory text;
Grant programs—health, Medicaid. certification’’. ■ b. In paragraphs (c)(1)(i),
42 CFR Part 483 (c)(2)(i)(D)(1), and (c)(2)(i)(F)(3) by
§ 409.42 [Amended] removing the term ‘‘physician’’ and
Grant programs—health, Health ■ 3. Section 409.42 is amended— adding in its place the term ‘‘physician
facilities, Health professions, Health ■ a. In the paragraph (b), subject or allowed practitioner’’;
records, Medicaid, Medicare, Nursing heading and text, and in paragraph (c) ■ c. In paragraphs (c)(2)(iii)(A), by
homes, Nutrition, Reporting and introductory text by removing the removing the term ‘‘physician’s’’ and
recordkeeping requirements, Safety. phrase ‘‘a physician’’ and adding in its adding in its place the term ‘‘physician’s
42 CFR Part 484 place the phrase ‘‘a physician or or allowed practitioner’s’’; and
allowed practitioner, as defined at ■ d. In paragraph (c)(2)(iv) introductory
Health facilities, Health professions, § 484.2 of this chapter’’. text by removing the term ‘‘physician’’
Medicare, Reporting and recordkeeping ■ b. In paragraph (c) introductory text and adding in its place the term
requirements. by removing the phrase ‘‘the physician ‘‘physician or allowed practitioner’’.
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27620 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
The revision reads as follows: section, all diagnostic x-ray tests, (B) Furnished under the general
diagnostic laboratory tests’’; supervision of a physician, clinical
§ 409.44 Skilled services requirements. ■ b. By adding paragraph (a)(3); psychologist, or during the Public
* * * * * ■ c. By revising paragraphs (b)(1) and Health Emergency, as defined in
(c) * * * (b)(2)(iii)(B); § 400.200 of this chapter, for the
(1) Speech-language pathology ■ d. By adding paragraph (b)(2)(viii); COVID–19 pandemic, by a nurse
services and physical or occupational ■ e. By revising paragraph (b)(3) practitioner, clinical nurse specialist,
therapy services must relate directly and introductory text; physician assistant or a certified nurse-
specifically to a treatment regimen ■ f. By revising paragraph (d)(2)(i) and midwife, to the extent that they are
(established by the physician or allowed paragraph(d)(2)(ii) introductory text; authorized to perform the tests under
practitioner) after any needed and applicable State law.
consultation with the qualified ■ g. By revising paragraph (d)(3)(i)
therapist, that is designed to treat the * * * * *
introductory text. (viii) During the COVID–19 Public
beneficiary’s illness or injury. Services The revisions and additions read as Health Emergency as defined in
related to activities for the general follows: § 400.200 of this chapter, diagnostic
physical welfare of beneficiaries (for
§ 410.32 Diagnostic x-ray tests, diagnostic tests performed by a physician assistant
example, exercises to promote overall
laboratory tests, and other diagnostic tests: authorized to perform the tests under
fitness) do not constitute physical
Conditions. applicable State law.
therapy, occupational therapy, or
speech-language pathology services for (a) * * * * * * * *
Medicare purposes. To be covered by (3) Public Health Emergency (3) Levels of supervision. Except
Medicare, all of the requirements apply exception. During the Public Health where otherwise indicated, all
as follows: Emergency, as defined in § 400.200 of diagnostic x-ray and other diagnostic
this chapter, for the COVID–19 tests subject to this provision and
* * * * * payable under the physician fee
pandemic, the order of a physician or
§ 409.45 [Amended] NPP is not required for otherwise schedule must be furnished under at
covered diagnostic laboratory tests for least a general level of supervision as
■ 6. Section 409.45 is amended—
■ a. In paragraph (a) by removing the
COVID–19 and for otherwise covered defined in paragraph (b)(3)(i) of this
term ‘‘physician’’ and adding in its diagnostic laboratory tests for influenza section. In addition, some of these tests
place the phrase ‘‘physician or allowed virus or similar respiratory condition also require either direct or personal
practitioner’’. needed to obtain a final COVID–19 supervision as defined in paragraph
■ b. In paragraph (b)(1) introductory text diagnosis when performed in (b)(3)(ii) or (iii) of this section,
by removing the phrase ‘‘physician’s conjunction with COVID–19 diagnostic respectively. When direct or personal
order’’ and adding in its place the laboratory test in order to discount supervision is required, supervision at
phrases ‘‘physician or allowed influenza virus or related diagnosis. the specified level is required
practitioner’s orders’’; and FDA-authorized COVID–19 serology throughout the performance of the test.
■ c. In paragraphs (b)(2)(i), (c)(1), and (g) tests are included as covered tests * * * * *
by removing the term ‘‘physician’’ and during the Public Health Emergency, as (d) * * *
add in its place the phrase ‘‘physician defined in § 400.20 of this chapter, for (2) * * *
or allowed practitioner’’. the COVID–19 pandemic, as they are (i) Ordering the service. Except for
reasonable and necessary under section tests described in paragraph (a)(3) of
§ 409.46 [Amended] 1862(a)(1)(A) of the Act for beneficiaries this section, the physician (or qualified
■ 7. Section 409.46 is amended in with known current or known prior nonphysician practitioner, as defined in
paragraph (a) by removing the term COVID–19 infection or suspected paragraph (a)(2) of this section), who
‘‘physician’’ and adding in its place the current or suspected prior COVID–19 orders the service must maintain
phrase ‘‘physician or allowed infection. documentation of medical necessity in
practitioner’’. (b) * * * the beneficiary’s medical record.
(1) Basic rule. Except as indicated in (ii) Submitting the claim. Except for
§ 409.48 [Amended] paragraph (b)(2) of this section, all tests described in paragraph (a)(3) of
■ 8. Section 409.48 is amended in diagnostic x-ray and other diagnostic this section, the entity submitting the
paragraph (c)(1) by removing the term tests covered under section 1861(s)(3) of claim must maintain the following
‘‘physician’’ and adding in its place the the Act and payable under the physician documentation:
phrase ‘‘physician or allowed fee schedule must be furnished under * * * * *
practitioner’’. the appropriate level of supervision by (3) * * *
a physician as defined in section 1861(r) (i) Documentation requirements.
PART 410—SUPPLEMENTARY of the Act or, during the Public Health Except for tests described in paragraph
MEDICAL INSURANCE (SMI) Emergency as defined in § 400.200 of (a)(3) introductory text, upon request by
BENEFITS this chapter, for the COVID–19 CMS, the entity submitting the claim
pandemic, by a nurse practitioner, must provide the following information:
■ 9. The authority citation for part 410 clinical nurse specialist, physician
continues to read as follows: * * * * *
assistant or a certified nurse-midwife to ■ 11. Section 410.67 is amended in
Authority: 42 U.S.C. 1302, 1395m, the extent that they are authorized to do paragraph (b)(7) by adding two
1395hh, 1395rr, and 1395ddd. so under applicable state law. Services sentences at the end to read as follows:
■ 10. Section 410.32 is amended— furnished without the required level of
■ a. In paragraph (a) introductory text by supervision are not reasonable and § 410.67 Medicare coverage and payment
removing the phrase ‘‘All diagnostic x- necessary (see § 411.15(k)(1) of this of Opioid use disorder treatment services
ray tests, diagnostic laboratory tests’’ chapter). furnished by Opioid treatment programs.
and adding in its place the phrase (2) * * * * * * * *
‘‘Except as otherwise provided in this (iii) * * * (b) * * *
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27621
(7) * * * During the Public Health medical history are reviewed to once per week to determine the
Emergency for the COVID–19 pandemic, determine whether the patient is likely appropriateness of treatment.
as defined in § 400.200 of this chapter, to benefit significantly from an intensive * * * * *
these periodic assessments can be inpatient hospital program. This ■ 15. Section 412.105 is amended by
furnished via two-way interactive procedure must ensure that the revising paragraphs (d)(1) and
audio-video communication technology, preadmission screening for each (f)(1)(iii)(A) to read as follows:
as clinically appropriate, and in Medicare Part A fee-for-Service patient
compliance with all other applicable is reviewed and approved by a § 412.105 Special treatment: Hospitals that
requirements. In cases where a rehabilitation physician prior to the incur indirect costs for graduate medical
beneficiary does not have access to two- patient’s admission to the IRF. education programs.
way audio-video communications * * * * *
technology, periodic assessments can be (e) Except for care furnished to
(d) * * *
furnished using audio-only telephone patients in a freestanding IRF hospital
(1) Step one. A factor representing the
calls rather than via two-way interactive solely to relieve acute care hospital
sum of 1.00 plus the hospital’s ratio of
audio-video communication technology capacity in a state (or region, as full-time equivalent residents to beds, as
if all other applicable requirements are applicable) that is experiencing a surge, determined under paragraph (a)(1) of
met. as defined in § 412.622 of this chapter, this section, excluding beds temporarily
* * * * * during the Public Health Emergency, as added during the time frame that the
defined in § 400.200 of this chapter, Public Health Emergency as defined in
■ 12. Section 410.78 is amended by
have in effect a procedure to ensure that § 400.200 of this chapter is in effect, is
revising paragraph (f) to read as follows:
patients receive close medical raised to an exponential power equal to
§ 410.78 Telehealth services. supervision, as evidenced by at least 3 the factor set forth in paragraph (c) of
* * * * * face-to-face visits per week by a licensed this section.
(f) Process for adding or deleting physician with specialized training and
* * * * *
services. Except as otherwise provided experience in inpatient rehabilitation to (f) * * *
in this paragraph, changes to the list of assess the patient both medically and (1) * * *
Medicare telehealth services are made functionally, as well as to modify the (iii)(A) Full-time equivalent status is
through the annual physician fee course of treatment as needed to based on the total time necessary to fill
schedule rulemaking process. During maximize the patient’s capacity to a residency slot. No individual may be
the Public Health Emergency for the benefit from the rehabilitation process counted as more than one full-time
COVID–19 pandemic, as defined in except that during the Public Health equivalent. If a resident is assigned to
§ 400.200 of this chapter, we will use a Emergency, as defined in § 400.200 of more than one hospital, the resident
subregulatory process to modify the this chapter, for the COVID–19 counts as a partial full-time equivalent
services included on the Medicare pandemic such visits may be conducted based on the proportion of time worked
telehealth list during the Public Health using telehealth services (as defined in in any areas of the hospital listed in
Emergency taking into consideration section 1834(m)(4)(F) of the Act). paragraph (f)(1)(ii) of this section to the
infection control, patient safety, and
* * * * * total time worked by the resident. A
other public health concerns resulting
(h) Except for care furnished to hospital cannot claim the time spent by
from the emergency. A list of the
patients in a freestanding IRF hospital residents training at another hospital,
services covered as telehealth services
under this section is available on the solely to relieve acute care hospital unless the exception provided at
CMS website. capacity in a state (or region, as § 413.78(i) of this chapter applies. A
applicable) that is experiencing a surge, part-time resident or one working in an
PART 412—PROSPECTIVE PAYMENT as defined in § 412.622 of this chapter, area of the hospital other than those
SYSTEMS FOR INPATIENT HOSPITAL listed under paragraph (f)(1)(ii) of this
during the Public Health Emergency, as
SERVICES section (such as a freestanding family
defined in § 400.200 of this chapter,
practice center or an excluded hospital
have a plan of treatment for each
■ 13. The authority citation for part 412 unit) would be counted as a partial full-
continues to read as follows: inpatient that is established, reviewed,
time equivalent based on the proportion
and revised as needed by a physician in
Authority: 42 U.S.C. 1302 and 1395hh. of time assigned to an area of the
consultation with other professional
hospital listed in paragraph (f)(1)(ii) of
■ 14. Section 412.29 is amended by personnel who provide services to the
this section, compared to the total time
revising paragraphs (d), (e), (h), and (i) patient.
necessary to fill a full-time residency
to read as follows: (i) Except for care furnished to slot.
§ 412.29 Classification criteria for payment patients in a freestanding IRF hospital * * * * *
under the inpatient rehabilitation facility solely to relieve acute care hospital
■ 16. Section 412.165 is amended by
prospective payment system. capacity in a state (or region, as
adding paragraph (c) to read as follows:
* * * * * applicable) that is experiencing a surge,
(d) Except for care furnished to as defined in § 412.622 of this chapter, § 412.165 Performance scoring under the
patients in a freestanding IRF hospital during the Public Health Emergency, as Hospital Value-Based Purchasing (VBP)
solely to relieve acute care hospital defined in § 400.200 of this chapter, use Program.
capacity in a state (or region, as a coordinated interdisciplinary team * * * * *
applicable) that is experiencing a surge, approach in the rehabilitation of each (c) Extraordinary circumstances
as defined in § 412.622 of this chapter, inpatient, as documented by the exception. (1) A hospital may request
during the Public Health Emergency, as periodic clinical entries made in the and CMS may grant exceptions to the
defined in § 400.200 of this chapter, patient’s medical record to note the Hospital VBP Program’s requirements
have in effect a preadmission screening patient’s status in relationship to goal under this section when there are
procedure under which each attainment and discharge plans, and certain extraordinary circumstances
prospective patient’s condition and that team conferences are held at least beyond the control of the hospital.
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27622 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
(2) A hospital may request an (ii) Except during the emergency described in paragraph (a)(4)(ii) of this
exception within 90 calendar days of period described in section section may count as one of the face-to-
the date that the extraordinary 1135(g)(1)(B) of the Act, generally face visits.
circumstances occurred by submitting a requires and can reasonably be expected (4) Documentation. Except for care
completed Extraordinary Circumstances to actively participate in, and benefit
furnished to patients in a freestanding
Request Form (available on the Hospital from, an intensive rehabilitation therapy
IRF hospital solely to relieve acute care
Value-Based Purchasing (HVBP) program. Under current industry
standards, this intensive rehabilitation hospital capacity in a state (or region, as
Program section of the QualityNet
website (QualityNet.org)), and any therapy program generally consists of at applicable) that is experiencing a surge
available evidence of the impact of the least 3 hours of therapy (physical during the Public Health Emergency, as
extraordinary circumstances on the therapy, occupational therapy, speech- defined in § 400.200 of this chapter, to
hospital’s quality measure performance. language pathology, or prosthetics/ document that each patient for whom
The form must be sent via secure file orthotics therapy) per day at least 5 days the IRF seeks payment is reasonably
transfer via the QualityNet Secure per week. In certain well-documented expected to meet all of the requirements
portal, secure fax, email, or cases, this intensive rehabilitation in paragraph (a)(3) of this section at the
conventional mail. therapy program might instead consist time of admission, the patient’s medical
(3) Following receipt of the request of at least 15 hours of intensive record at the IRF must contain the
form, CMS will provide a written rehabilitation therapy within a 7- following documentation—
acknowledgement using the contact consecutive-day period, beginning with * * * * *
information provided in the request, to the date of admission to the IRF. Benefit
from this intensive rehabilitation (5) Interdisciplinary team approach to
the CEO and any additional designated
therapy program is demonstrated by care. Except for care furnished to
personnel, notifying them that the
hospital’s request has been received, measurable improvement that will be of patients in a freestanding IRF hospital
and provide a written response to the practical value to the patient in solely to relieve acute care hospital
CEO and any additional designated improving the patient patient’s capacity in a state (or region, as
personnel using the contact information functional capacity or adaptation to applicable) that is experiencing a surge
provided in the request. impairments. The required therapy during the Public Health Emergency, as
(4) CMS may grant an exception to treatments must begin within 36 hours defined in § 400.200 of this chapter, in
one or more hospitals that have not from midnight of the day of admission order for an IRF claim to be considered
requested an exception if CMS to the IRF. reasonable and necessary under section
determines that an extraordinary (iii) Except for care furnished to 1862(a)(1) of the Act, the patient must
circumstance has affected an entire patients in a freestanding IRF hospital require an interdisciplinary team
region or locale, which may include the solely to relieve acute care hospital approach to care, as evidenced by
capacity in a state (or region, as
entire United States. CMS will notify documentation in the patients’ medical
applicable) that is experiencing a surge
hospitals that it has granted an record of weekly interdisciplinary team
during the Public Health Emergency, as
exception under this paragraph via meetings that meet all of the following
defined in § 400.200 of this chapter, is
multiple methods, which may include requirements—
sufficiently stable at the time of
memos, emails, and notices posted on * * * * *
admission to the IRF to be able to
the public QualityNet website (see
actively participate in the intensive (c) * * *
https://www.qualitynet.org).
rehabilitation therapy program that is
■ 17. Section 412.622 is amended— described in paragraph (a)(3)(ii) of this State (or region, as applicable) that is
■ a. By revising paragraphs (a)(3)(i) section. experiencing a surge means a state (or
through (iv), (a)(4) introductory text, (iv) Except for care furnished to region, as applicable) that is in phase 1
and (a)(5) introductory text; and patients in a freestanding IRF hospital of the President’s Guidelines for
■ b. In paragraph (c) by adding a solely to relieve acute care hospital Opening Up America Again (https://
definition for ‘‘State (or region, as capacity in a state (or region, as www.whitehouse.gov/openingamerica/),
applicable) that is experiencing a surge’’ applicable) that is experiencing a surge specifically, a state (or region, as
in alphabetical order. during the Public Health Emergency, as applicable) that satisfies all of the
The revisions and addition read as defined in § 400.200 of this chapter, following, as determined by applicable
follows: requires physician supervision by a state and local officials:
rehabilitation physician. The (i) All vulnerable individuals
§ 412.622 Basis of payment. requirement for medical supervision
(a) * * * continue to shelter in place.
means that the rehabilitation physician
(3) * * * must conduct face-to-face visits with the (ii) Individuals continue social
(i) Except for care furnished to patient at least 3 days per week distancing.
patients in a freestanding IRF hospital throughout the patient ’s stay in the IRF (iii) Individuals avoid socializing in
solely to relieve acute care hospital to assess the patient both medically and groups of more than 10.
capacity in a state (or region, as functionally, as well as to modify the
applicable) that is experiencing a surge course of treatment as needed to (iv) Non-essential travel is minimized.
during the Public Health Emergency, as maximize the patient’s capacity to (v) Visits to senior living facilities and
defined in § 400.200 of this chapter, benefit from the rehabilitation process hospitals are prohibited.
requires the active and ongoing except that during the Public Health (vi) Schools and organized youth
therapeutic intervention of multiple Emergency, as defined in § 400.200 of activities remain closed.
therapy disciplines (physical therapy, this chapter, for the COVID–19
occupational therapy, speech-language pandemic such visits may be conducted
pathology, or prosthetics/orthotics using telehealth services (as defined in
therapy), one of which must be physical section 1834(m)(4)(F) of the Act).The
or occupational therapy. post-admission physician evaluation
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27623
PART 413—PRINCIPLES OF PART 414—PAYMENT FOR PART B the 2021 performance period’’ and
REASONABLE COST MEDICAL AND OTHER HEALTH adding in its place the phrase
REIMBURSEMENT; PAYMENT FOR SERVICES ‘‘Beginning with the 2022 performance
END-STAGE RENAL DISEASE period’’.
SERVICES; PROSPECTIVELY ■ 20. The authority citation for part 414
DETERMINED PAYMENT RATES FOR continues to read as follows: PART 415—SERVICES FURNISHED BY
SKILLED NURSING FACILITIES; Authority: 42 U.S.C. 1302, 1395hh, and PHYSICIANS IN PROVIDERS,
PAYMENT FOR ACUTE KIDNEY 1395rr(b)(l). SUPERVISING PHYSICIANS IN
INJURY DIALYSIS TEACHING SETTINGS, AND
■ 21. Section 414.210 is amended by
RESIDENTS IN CERTAIN SETTINGS
revising paragraph (g)(9)(iii) and (iv)
■ 18. The authority citation for part 413 and adding paragraph (g)(9)(v) to read as ■ 23. The authority citation for part 415
continues to read as follows: follows: continues to read as follows:
Authority: 42 U.S.C. 1302, 1395d(d), § 414.210 General payment rules. Authority: 42 U.S.C. 1302 and 1395hh.
1395f(b), 1395g, 1395l(a), (i), and (n),
1395x(v), 1395hh, 1395rr, 1395tt, and * * * * * ■ 24. Section 415.172 is amended by
1395ww. (g) * * * revising paragraphs (a) introductory
(9) * * * text, (a)(2), and (b) to read as follows:
■ 19. Section 413.78 is amended by (iii) For items and services furnished
revising paragraph (b) and adding in rural areas and non-contiguous areas § 415.172 Physician fee schedule payment
paragraph (i) to read as follows: (Alaska, Hawaii, and U.S. territories) for services of teaching physicians.
§ 413.78 Direct GME payments: with dates of service from June 1, 2018 (a) General rule. If a resident
Determination of the total number of FTE through December 31, 2020 or through participates in a service furnished in a
residents. the duration of the emergency period teaching setting, physician fee schedule
* * * * * described in section 1135(g)(1)(B) of the payment is made only if a teaching
Act (42 U.S.C. 1320b–5(g)(1)(B)), physician is present during the key
(b) No individual may be counted as whichever is later, based on the fee portion of any service or procedure for
more than one FTE. A hospital cannot schedule amount for the area is equal to which payment is sought. During the
claim the time spent by residents 50 percent of the adjusted payment Public Health Emergency, as defined in
training at another hospital, except as amount established under this section § 400.200 of this chapter, for the
provided in paragraph (i) of this section. and 50 percent of the unadjusted fee COVID–19 pandemic, if a resident
Except as provided in paragraphs (c), schedule amount. participates in a service furnished in a
(d), and (e) of this section, if a resident (iv) For items and services furnished teaching setting, physician fee schedule
spends time in more than one hospital in areas other than rural or payment is made if a teaching physician
or in a nonprovider setting, the resident noncontiguous areas with dates of is present during the key portion of the
counts as partial FTE based on the service from June 1, 2018 through service using audio/video real-time
proportion of time worked at the March 5, 2020, based on the fee communications technology for any
hospital to the total time worked. A schedule amount for the area is equal to service or procedure for which payment
part-time resident counts as a partial 100 percent of the adjusted payment is sought.
FTE based on the proportion of amount established under this section. * * * * *
allowable time worked compared to the (v) For items and services furnished (2) In the case of evaluation and
total time necessary to fill a full-time in areas other than rural or management services, the teaching
internship or residency slot. noncontiguous areas with dates of physician must be present during the
* * * * * service from March 6, 2020, through the portion of the service that determines
(i) For the time frame that the Public remainder of the duration of the the level of service billed. (However, in
Health Emergency (as defined in emergency period described in section the case of evaluation and management
§ 400.200 of this chapter) associated 1135(g)(1)(B) of the Act (42 U.S.C. services furnished in hospital outpatient
with COVID–19 was in effect, a sending 1320b–5(g)(1)(B)), based on the fee departments and certain other
hospital can include FTE residents schedule amount for the area is equal to ambulatory settings, the requirements of
training at another hospital in its FTE 75 percent of the adjusted payment § 415.174 apply.) During the Public
count if all of the following conditions amount established under this section Health Emergency, as defined in
are met. and 25 percent of the unadjusted fee § 400.200 of this chapter, for the
schedule amount. For items and COVID–19 pandemic, the teaching
(1) The sending hospital sends the services furnished in areas other than
resident to the other hospital in physician may be present during the
rural or noncontiguous areas with dates portion of the service that determines
response to the COVID–19 pandemic. of service from the expiration date of the the level of service billed using audio/
(2) The time spent by the resident emergency period described in section video real-time communications
training at the other hospital is in lieu 1135(g)(1)(B) of the Act (42 U.S.C. technology. (However, in the case of
of time that would have been spent in 1320b–5(g)(1)(B)), through December 31, evaluation and management services
approved training at the sending 2020, based on the fee schedule amount furnished in hospital outpatient
hospital. for the area is equal to 100 percent of departments and certain other
(3) The time that the resident spent the adjusted payment amount ambulatory settings, the requirements of
training immediately prior to and/or established under this section. § 415.174 apply.)
subsequent to the time frame that the * * * * * (b) Documentation. Except for
Public Health Emergency (as defined in services furnished as set forth in
§ 400.200 of this chapter) associated § 414.1400 [Amended] §§ 415.174 (concerning an exception for
with COVID–19 was in effect is ■ 22. Section 414.1400 is amended in services furnished in hospital outpatient
included in the FTE count for the paragraphs (b)(3)(v)(C) and (D) by and certain other ambulatory settings),
sending hospital. removing the phrase ‘‘Beginning with 415.176 (concerning renal dialysis
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27624 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
services), and 415.184 (concerning and other diagnostic tests if the signature’’ and adding in its place the
psychiatric services), the medical interpretation is performed or reviewed phrase ‘‘physician or allowed
records must document the teaching by a physician other than a resident. practitioner’s signature’’;
physician was present at the time the During the Public Health Emergency, as ■ h. By revising paragraph (b)(2)(ii)(B);
service is furnished. The presence of the defined in § 400.200 of this chapter, for ■ i. In paragraphs (c)(1) introductory
teaching physician during procedures the COVID–19 pandemic, physician fee text by removing the phrase
and evaluation and management schedule payment may also be made for ‘‘physician’s medical records’’ and
services may be demonstrated by the the interpretation of diagnostic adding in its place the phrase
notes in the medical records made by radiology and other diagnostic tests if ‘‘physician or allowed practitioner’s
the physician or as provided in the interpretation is performed by a medical record’’;
§ 410.20(e) of this chapter. During the resident when the teaching physician is ■ j. In paragraph (c)(1)(i) by removing
Public Health Emergency, as defined in present through audio/video real-time the phrase ‘‘physician’s medical record’’
§ 400.200 of this chapter, for the communications technology. and adding in its place the phrase
COVID–19 pandemic, except for (b) [Reserved] ‘‘physician or allowed practitioner’s
services furnished as set forth in ■ 27. Section 415.184 is revised to read medical record’’;
§§ 415.174 (concerning an exception for as follows: ■ k. In paragraph (c)(1)(ii)(A) by
services furnished in hospital outpatient removing the term ‘‘physician’’ and
and certain other ambulatory settings), § 415.184 Psychiatric services. adding in its place the phrase
415.176 (concerning renal dialysis To qualify for physician fee schedule ‘‘physician or allowed practitioner’’;
services), and 415.184 (concerning payment for psychiatric services ■ l. In the paragraph (d) subject heading
psychiatric services), the medical furnished under an approved GME by removing the term ‘‘physician’’ and
records must document if the teaching program, the physician must meet the adding in its place the phrase
physician was physically present or if requirements of §§ 415.170 and 415.172, ‘‘physician or allowed practitioner’s’’;
the teaching physician was present including documentation, except that ■ m. In paragraph (d) introductory text
through audio/video real-time the requirement for the presence of the by removing the term ‘‘physician’’ and
communications technology at the time teaching physician during the service in adding in its place the phrase
the service is furnished. The presence of which a resident is involved may be met ‘‘physician or allowed practitioner’’;
the teaching physician during by observation of the service by use of and by removing the term ‘‘physician’s’’
procedures and evaluation and a one-way mirror, video equipment, or adding in its place the phrase
management services may be similar device. During the Public Health ‘‘physician or allowed practitioner’s’’;
demonstrated by the notes in the Emergency, as defined in § 400.200 of and
medical records made by the physician this chapter, for the COVID–19 ■ n. In paragraph (d)(1) by removing the
or as provided in § 410.20(e) of this pandemic, the requirement for the term ‘‘physician’’ each time it appears
chapter. presence of the teaching physician and adding in its place the phrase
* * * * * during the service in which a resident ‘‘physician or allowed practitioner’’.
is involved may be met by direct The revisions and addition read as
■ 25. Section 415.174 is amended by
supervision by audio/video real-time follows:
revising paragraph (b) and adding
paragraph (c) to read as follows: communications technology.
§ 424.22 Requirements for home health
PART 424—CONDITIONS FOR services.
§ 415.174 Exception: Evaluation and
management services furnished in certain MEDICARE PAYMENT Medicare Part A or Part B pays for
centers. home health services only if a physician
■ 28. The authority citation for part 424 or allowed practitioner as defined at
* * * * *
(b) Nothing in paragraph (a) of this continues to read as follows: § 484.2 of this chapter certifies and
section may be construed as providing Authority: 42 U.S.C. 1302 and 1395hh. recertifies the content specified in
a basis for the coverage of services not ■ 29. Section 424.22 is amended—
paragraphs (a)(1) and (b)(2) of this
determined to be covered under ■ a. By revising the introductory text; section, as appropriate.
Medicare, such as routine physical ■ b. In paragraphs (a)(1) introductory (a) * * *
check-ups. text and (a)(1)(i), by removing the term (1) * * *
(c) During the Public Health ‘‘physician’’ each time it appears and (iii) A plan for furnishing the services
Emergency, as defined in § 400.200 of adding in its place the phrase has been established and will be or was
this chapter, for the COVID–19 ‘‘physician or allowed practitioner’’; periodically reviewed by a physician or
pandemic, the requirements in ■ c. In paragraph (a)(1)(i) by removing allowed practitioner and who is not
paragraph (a)(3) of this section for a the phrase ‘‘physician’s signature’’ each precluded from performing this function
teaching physician to direct the care and time it appears and adding in its place under paragraph (d) of this section.
then to review the services furnished by the phrase ‘‘physician or allowed (iv) The services will be or were
each resident during or immediately practitioner’s signature’’; furnished while the individual was
after each visit may be met using audio/ ■ d. By revising paragraph (a)(1)(iii) and under the care of a physician or allowed
video real-time communications (iv), (a)(1)(v) introductory text, and practitioner.
technology. (a)(1)(v)(A); (v) A face-to-face patient encounter,
■ e. By adding paragraph (a)(1)(v)(C); which is related to the primary reason
■ 26. Section 415.180 is revised to read
■ f. In paragraphs (a)(2), (b)(1) the patient requires home health
as follows:
introductory text, (b)(2) introductory services, occurred no more than 90 days
§ 415.180 Teaching setting requirements text, and (b)(2)(ii) introductory text, by prior to the home health start of care
for the interpretation of diagnostic removing the term ‘‘physician’’ and date or within 30 days of the start of the
radiology and other diagnostic tests. adding in its place the phrase home health care and was performed by
(a) General rule. Physician fee ‘‘physician or allowed practitioner’’; physician or non-physician practitioner
schedule payment is made for the ■ g. In paragraph (b)(2)(ii)(A) by defined in paragraph (a)(1)(v)(A) of this
interpretation of diagnostic radiology removing the phrase ‘‘physician’s section. The certifying physician or
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27625
certifying allowed practitioner must also physician or allowed practitioner must (c) * * *
document the date of the encounter as sign immediately following the (2) For the performance year starting
part of the certification. narrative in the addendum. on January 1, 2020, and for any
(A) The face-to-face encounter must * * * * * subsequent performance year that starts
be performed by one of the following: during the COVID–19 Public Health
■ 30. Section 424.507 is amended by
(1) The certifying physician (as Emergency defined in § 400.200, in
revising paragraph (b)(1) introductory
defined at § 484.2 of this chapter) or a determining beneficiary assignment, we
text to read as follows:
physician, with privileges, who cared use the primary care service codes
for the patient in an acute or post-acute § 424.507 Ordering covered items and identified in paragraph (c)(1) of this
care facility from which the patient was services for Medicare beneficiaries. section, and additional primary care
directly admitted to home health. * * * * * service codes as follows:
(2) The certifying nurse practitioner (b) * * * (i) CPT codes:
(as defined at § 484.2 of this chapter), (1) The ordering/certifying physician, (A) 99421, 99422, and 99423 (codes
certifying clinical nurse specialist (as or the ordering/certifying physician for online digital evaluation and
defined at § 484.2 of this chapter), or a management services).
assistant, nurse practitioner, or clinical
nurse practitioner or a clinical nurse (B) 99441, 99442, and 99443 (codes
nurse specialist working in accordance
specialist who is working in accordance for telephone evaluation and
with State law, must meet all of the management services).
with State law and in collaboration with following requirements: (ii) HCPCS codes:
a physician or in collaboration with an * * * * * (A) G2010 (code for remote evaluation
acute or post-acute care physician with of patient video/images).
privileges who cared for the patient in PART 425—MEDICARE SHARED (B) G2012 (code for virtual check-in).
the acute or post-acute care facility from SAVINGS PROGRAM ■ 34. Section 425.600 is amended by
which the patient was directly admitted
redesignating paragraph
to home health. ■ 31. The authority citation for part 425
(a)(4)(i)(B)(2)(iii) as paragraph
(3) A certified nurse midwife (as continues to read as follows:
(a)(4)(i)(B)(2)(iv) and adding new
defined in section 1861(gg) of the Act) Authority: 42 U.S.C. 1302, 1306, 1395hh, paragraph (a)(4)(i)(B)(2)(iii) to read as
as authorized by State law, under the and 1395jjj. follows:
supervision of a physician or under the ■ 32. Section 425.200 is amended by
supervision of an acute or post-acute revising paragraph (b)(3)(ii) to read as § 425.600 Selection of risk model.
care physician with privileges who follows: (a) * * *
cared for the patient in the acute or (4) * * *
post-acute care facility from which the § 425.200 Participation agreement with (i) * * *
patient was directly admitted to home CMS. (B) * * *
health. * * * * * (2) * * *
(4) A certifying physician assistant (as (b) * * * (iii) Exception for ACOs participating
defined at § 484.2 of this chapter) or a (3) * * * in the BASIC track’s glide path that elect
physician assistant under the (ii) The term of the participation to maintain their participation level for
supervision of a physician or under the agreement is 3 years, except as follows: performance year 2021. Prior to the
supervision of an acute or post-acute (A) For an ACO whose first agreement automatic advancement for performance
care physician with privileges who period in Track 1 began in 2014 or 2015, year 2021, an ACO that is participating
cared for the patient in the acute or in which case the term of the ACO’s in the BASIC track’s glide path for
post-acute care facility from which the initial agreement period under Track 1 performance year 2020 may elect to
patient was directly admitted to home (as described under § 425.604) may be remain in the same level of the BASIC
health. extended, at the ACO’s option, for an track’s glide path that it entered for the
additional year for a total of 4 2020 performance year, for performance
* * * * *
performance years if the conditions year 2021. For performance year 2022,
(C) The face-to-face patient encounter
specified in paragraph (e) of this section the ACO is automatically advanced to
must be performed by the certifying
the level of the BASIC track’s glide path
physician or allowed practitioner unless are met.
to which the ACO would have
the encounter is performed by: (B) For an ACO whose agreement
automatically advanced absent the
(1) A certified nurse midwife as period started on January 1, 2018, the
election to maintain its participation
described in paragraph (a)(1)(v)(A)(4) of term of the participation agreement is
level for performance year 2021, unless
this section. extended by 12 months if both of the
the ACO elects to transition to a higher
(2) A physician, physician assistant, following conditions are met:
level of risk and potential reward within
nurse practitioner, or clinical nurse (1) The ACO elects to extend the
the BASIC track’s glide path as provided
specialist with privileges who cared for participation agreement for a fourth
in § 425.226(a)(2)(i). A voluntary
the patient in the acute or post-acute performance year until December 31,
election by an ACO under this
facility from which the patient was 2021. paragraph must be made in the form and
directly admitted to home health and (2) The ACO’s election to extend its manner and by a deadline established
who is different from the certifying agreement period is made in the form by CMS.
practitioner. and manner and by a deadline
established by CMS. * * * * *
* * * * *
■ 35. Section 425.611 is added to read
(b) * * * * * * * *
as follows:
(2) * * * ■ 33. Section 425.400 is amended by
(ii) * * * adding paragraph (c)(2) to read as § 425.611 Adjustments to Shared Savings
(B) Exists as an addendum to the follows: Program calculations to address the
recertification form, in addition to the COVID–19 pandemic.
physician or allowed practitioner’s § 425.400 General. (a) General. This section describes
signature on the recertification form, the * * * * * adjustments CMS makes to Shared
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27626 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Savings Program calculations to address (B) Truncating expenditures for subsequent period of active surveillance
the impact of the COVID–19 pandemic. assignable beneficiaries in each county (as defined in this paragraph), Medicaid
(b) Episodes of care for treatment of for purposes of determining county fee- coverage is available for laboratory tests
COVID–19. (1) CMS identifies an for-service expenditures according to and X-ray services that do not meet
episode of care for treatment of COVID– §§ 425.601(c)(3) and 425.603(e)(3). conditions specified in paragraph (a) or
19 based on either of the following: (iii) Determining 5 percent of national (b) of this section, if the purpose of such
(i) Discharges for inpatient services per capita expenditures for Parts A and laboratory and X-ray services is to
eligible for the 20 percent adjustment B services under the original Medicare diagnose or detect SARS–CoV–2,
under section 1886(d)(4)(C) of the Act. fee-for-service program for assignable antibodies to SARS–CoV–2, COVID–19,
(ii) Discharges for acute care inpatient beneficiaries for purposes of capping the or the communicable disease named in
services for treatment of COVID–19 from regional adjustment to the ACO’s the Public Health Emergency or its
facilities that are not paid under the historical benchmark according to causes, and if the deviation from the
inpatient prospective payment system, § 425.601(a)(8)(ii)(C). conditions specified in paragraph (a) or
such as CAHs, when the date of (iv) Determining the flat dollar (b) of this section is intended to avoid
admission occurs within the Public equivalent of the projected absolute transmission of the communicable
Health Emergency as defined in amount of growth in national per capita disease. For purposes of this paragraph,
§ 400.200 of this chapter. expenditures for Parts A and B services a period of active surveillance is defined
(2) CMS defines the episode of care as under the original Medicare fee-for- as an outbreak of communicable disease
starting in the month in which the service program for assignable during which no approved treatment or
inpatient stay begins as identified by the beneficiaries, for purposes of updating vaccine is widely available, and it ends
admission date, all months during the the ACO’s historical benchmark on the date the Secretary terminates it,
inpatient stay, and the month following according to § 425.602(b)(2). or the date that is two incubation
the end of the inpatient stay as (v) Determining national growth rates periods after the last known case of the
indicated by the discharge date. that are used as part of the blended communicable disease, whichever is
(c) Applicability of adjustments. growth rates used to trend forward BY1 sooner. Additionally, during the Public
Notwithstanding any other provision in and BY2 expenditures to BY3 according Health Emergency defined in 42 CFR
this part, CMS adjusts the following to § 425.601(a)(5)(ii) and as part of the 400.200 or any future Public Health
Shared Savings Program calculations to blended growth rates used to trend the Emergency resulting from an outbreak of
exclude all Parts A and B fee-for-service benchmark and update the benchmark communicable disease, and during any
payment amounts for a beneficiary’s according to § 425.601(b)(2). subsequent period of active surveillance
episode of care for treatment of COVID– (3) Calculation of Medicare Parts A (as defined in this paragraph), Medicaid
19 as described in paragraph (b) of this and B fee-for-service revenue of ACO coverage is available for laboratory
section: participants for purposes of calculating processing of self-collected laboratory
(1) Calculation of Medicare Parts A the ACO’s loss recoupment limit under test systems that are authorized by the
the BASIC track as specified in FDA for home use, if available to
and B fee-for-service expenditures for an
§ 425.605(d). diagnose or detect SARS–CoV–2,
ACO’s assigned beneficiaries for all
(4) Calculation of total Medicare Parts antibodies to SARS–CoV–2, COVID–19,
purposes including the following:
A and B fee-for-service revenue of ACO or the communicable disease named in
Establishing, adjusting, updating, and
participants and total Medicare Parts A the Public Health Emergency or its
resetting the ACO’s historical
and B fee-for-service expenditures for causes, even if those self-collected tests
benchmark and determining
the ACO’s assigned beneficiaries for would not otherwise meet the
performance year expenditures.
purposes of identifying whether an ACO requirements of paragraph (a) or (b) of
(2) Calculation of fee-for-service
is a high revenue ACO or low revenue this section, provided that the self-
expenditures for assignable beneficiaries
ACO, as defined under § 425.20, and collection of the test is intended to
as used in determining county-level fee-
determining an ACO’s eligibility for avoid transmission of the communicable
for-service expenditures and national
participation options according to disease. If, pursuant to this paragraph, a
Medicare fee-for-service expenditures,
§ 425.600(d). laboratory processes a self-collected test
including the following calculations: (5) Calculation or recalculation of the system that is authorized by the FDA for
(i) Determining average county fee- amount of the ACO’s repayment home use, and the test system does not
for-service expenditures based on mechanism arrangement according to meet the conditions in paragraph (a) of
expenditures for the assignable § 425.204(f)(4). this section, the laboratory must notify
population of beneficiaries in each
the patient and the patient’s physician
county in the ACO’s regional service PART 440—SERVICES: GENERAL or other licensed non-physician
area according to §§ 425.601(c) and PROVISIONS practitioner (if known by the
425.603(e) for purposes of calculating
laboratory), of the results.
the ACO’s regional fee-for-service ■ 36. The authority citation for part 440
■ 38. Section 440.70 is amended—
expenditures. continues to read as follows:
■ a. By revising paragraph (a)(2);
(ii) Determining the 99th percentile of Authority: 42 U.S.C. 1302. ■ b. By adding paragraph (a)(3);
national Medicare fee-for-service ■ 37. Section 440.30 is amended by ■ c. By revising paragraph (b)(1)(ii);
expenditures for assignable beneficiaries adding paragraph (d) to read as follows: ■ d. In paragraph (b)(3)(iii), by removing
for purposes of the following: the phrase ‘‘for the period of the Public
(A) Truncating assigned beneficiary § 440.30 Other laboratory and X-ray Health Emergency,’’;
expenditures used in calculating services. ■ e. In paragraph (b)(3)(iv), by removing
benchmark expenditures under * * * * * the phrase ‘‘for the period of the Public
§§ 425.601(a)(4), 425.602(a)(4), and (d) During the Public Health Health Emergency,’’;
425.603(c)(4), and performance year Emergency defined in 42 CFR 400.200 ■ f. By revising paragraphs (f)
expenditures under §§ 425.604(a)(4), or any future Public Health Emergency introductory text and (f)(3)(i);
425.605(a)(3), 425.606(a)(4), and resulting from an outbreak of ■ g. In paragraph (f)(3)(ii) by removing
425.610(a)(4). communicable disease, and during any the phrase ‘‘working in collaboration
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27627
with the physician referenced in this section, to perform the face-to-face for Disease Control and Prevention’s
paragraph (a) of this section’’ and encounter independently, the non- National Healthcare Safety Network.
adding in its place the phrase ‘‘in physician practitioner must This information will be posted publicly
accordance with State law’’; communicate the clinical findings of by CMS to support protecting the health
■ h. In paragraph (f)(3)(iv) by removing that face-to-face encounter to the and safety of residents, personnel, and
the phrase ‘‘under the supervision of the ordering physician. Those clinical the general public.
physician referenced in paragraph (a) of findings must be incorporated into a (3) Inform residents, their
this section’’ and adding in its place the written or electronic document included representatives, and families of those
phrase ‘‘in accordance with State law’’; in the beneficiary’s medical record. residing in facilities by 5 p.m. the next
■ i. By adding paragraph (f)(3)(vi); * * * * * calendar day following the occurrence
■ j. By revising paragraphs (f)(4); (g)(1) No payment may be made for of either a single confirmed infection of
■ k. In paragraph (f)(5) introductory medical equipment, supplies, or COVID–19, or three or more residents or
text, by removing the phrase ‘‘the appliances referenced in paragraph staff with new-onset of respiratory
physician responsible’’ and adding in its (b)(3) of this section to the extent that symptoms occurring within 72 hours of
place the phrase ‘‘the practitioner a face-to-face encounter requirement each other. This information must—
responsible’’; and would apply as durable medical (i) Not include personally identifiable
■ l. By revising paragraph (g)(1). equipment (DME) under the Medicare information;
The revisions and addition read as program, unless a practitioner (ii) Include information on mitigating
follows: referenced in paragraph (a)(3) of this actions implemented to prevent or
section documents a face-to-face reduce the risk of transmission,
§ 440.70 Home health services. including if normal operations of the
encounter with the beneficiary
* * * * * facility will be altered; and
consistent with the requirements of
(a) * * * (iii) Include any cumulative updates
paragraph (f) of this section except as
(2) On orders written by a physician, for residents, their representatives, and
indicated in paragraph (g)(2) of this
nurse practitioner, clinical nurse families at least weekly or by 5 p.m. the
section.
specialist or physician assistant, next calendar day following the
working in accordance with State law, * * * * * subsequent occurrence of either: Each
as part of a written plan of care that the time a confirmed infection of COVID–19
PART 483—REQUIREMENTS FOR
ordering practitioner reviews every 60 is identified, or whenever three or more
STATES AND LONG TERM CARE
days for services described in (b)(1), (2), residents or staff with new onset of
FACILITIES
and (4) of this section; and respiratory symptoms occur within 72
(3) On his or her physician’s orders or ■ 39. The authority citation continues to hours of each other.
orders written by a licensed practitioner read as follows:
of the healing arts acting within the PART 484—HOME HEALTH SERVICES
scope of practice authorized under State Authority: 42 U.S.C. 1302, 1320a-7, 1395i,
1395hh and 1396r. ■ 41. The authority citation for part 484
law, as part of a written plan of care for
services described in paragraph (b)(3) of ■ 40. Section 483.80 is amended by is revised to read as follows:
this section. The plan of care must be adding paragraph (g) to read as follows: Authority: 42 U.S.C. 1302 and 1395hh.
reviewed by the ordering practitioner as § 483.80 Infection control. ■ 42. Section 484.2 is amended by—
specified in paragraph (b)(3)(iii) of this ■ a. Adding definitions for ‘‘Allowed
* * * * *
section. practitioner’’, ‘‘Clinical nurse
(g) COVID–19 reporting. The facility
(b) * * * specialist’’, ‘‘Nurse practitioner’’,
must—
(1) * * * ‘‘Physician’’, and ‘‘Physician assistant’’
(ii) Receives written orders from the (1) Electronically report information
about COVID–19 in a standardized in alphabetical order; and
patient’s practitioner as defined in (a)(2) ■ b. Revising the definitions of
of this section; format specified by the Secretary. This
report must include but is not limited ‘‘Summary report’’ and ‘‘Verbal order’’.
* * * * * to— The additions and revisions read as
(f) No payment may be made for (i) Suspected and confirmed COVID– follows:
services referenced in paragraphs (b)(1) 19 infections among residents and staff,
through (4) of this section, unless a § 484.2 Definitions.
including residents previously treated
practitioner referenced in paragraph * * * * *
for COVID–19;
(a)(2) of this section or for medical Allowed practitioner means a
(ii) Total deaths and COVID–19
equipment, a practitioner described in physician assistant, nurse practitioner,
deaths among residents and staff;
paragraph (a)(3) of this section or clinical nurse specialist as defined at
(iii) Personal protective equipment
documents that there was a face-to-face this part.
and hand hygiene supplies in the
encounter with the beneficiary that facility; * * * * *
meets the following requirements. (iv) Ventilator capacity and supplies Clinical nurse specialist means an
* * * * * in the facility; individual as defined at § 410.76(a) and
(3) * * * (v) Resident beds and census; (b) of this chapter, and who is working
(i) A physician; (vi) Access to COVID–19 testing while in collaboration with the physician as
* * * * * the resident is in the facility; defined at § 410.76(c)(3) of this chapter.
(vi) For medical equipment, supplies, (vii) Staffing shortages; and * * * * *
or appliances, a licensed practitioner of (viii) Other information specified by Nurse practitioner means an
the healing arts acting within the scope the Secretary. individual as defined at § 410.75(a) and
of practice authorized under state law. (2) Provide the information specified (b) of this chapter, and who is working
(4) If State law does not allow the in paragraph (g)(1) of this section at a in collaboration with the physician as
non-physician practitioner, as described frequency specified by the Secretary, defined at § 410.75(c)(3) of this chapter.
in paragraphs (f)(3)(ii) through (vi) of but no less than weekly to the Centers * * * * *
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27628 Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations
Physician is a doctor of medicine, of care that cannot be completed until § 484.80 [Amended]
osteopathy, or podiatric medicine, and after an evaluation visit, the physician ■ 47. Section 484.80 is amended in
who is not precluded from performing or allowed practitioner is consulted to paragraph (g)(2)(i) by removing the term
this function under paragraph (d) of this approve additions or modifications to ‘‘physician;’’ and adding in its place the
section. (A doctor of podiatric medicine the original plan. phrase ‘‘physician or allowed
may perform only plan of treatment (2) * * * practitioner;’’.
functions that are consistent with the (xvi) Any additional items the HHA or
functions he or she is authorized to physician or allowed practitioner may § 484.205 [Amended]
perform under State law.) choose to include. ■ 48. Section 484.205 is amended—
Physician assistant means an (b) Standard: Conformance with ■ a. In paragraphs (h)(1)(ii) by removing
individual as defined at § 410.74(a) and physician or allowed practitioner the term ‘‘physician’s’’ and adding in its
(c) of this chapter. orders. (1) Drugs, services, and place the phrase ‘‘physician or allowed
* * * * * treatments are administered only as practitioner’s’’;
Summary report means the ordered by a physician or allowed ■ b. In paragraphs (h)(1)(iii) and (h)(2)
compilation of the pertinent factors of a practitioner. introductory text by removing the term
patient’s clinical notes that is submitted (2) Influenza and pneumococcal ‘‘physician’’ and adding in its place the
to the patient’s physician, physician vaccines may be administered per phrase ‘‘physician or allowed
assistant, nurse practitioner, or clinical agency policy developed in consultation practitioner’’; and
nurse specialist. with a physician, physician assistant, ■ c. In paragraphs (i)(2)(i) and (j)(2)(i) by
* * * * * nurse practitioner, or clinical nurse removing the term ‘‘physician’s’’ and
Verbal order means a physician, specialist, and after an assessment of the adding in its place the phrase
physician assistant, nurse practitioner, patient to determine for ‘‘physician or allowed practitioner’s’’.
or clinical nurse specialist order that is contraindications.
(3) Verbal orders must be accepted § 484.235 [Amended]
spoken to appropriate personnel and
later put in writing for the purposes of only by personnel authorized to do so ■ 49. Section 484.235 is amended—
by applicable state laws and regulations ■ a. In paragraphs (a)(1) and (3) by
documenting as well as establishing or
revising the patient’s plan of care. and by the HHA’s internal policies. removing the term ‘‘physician’’ and
(4) When services are provided on the adding in its place the phrase
§ 484.50 [Amended] basis of a physician or allowed ‘‘physician or allowed practitioner’’;
practitioner’s verbal orders, a nurse ■ b. In paragraph (b)(1) by removing the
■ 43. Section 484.50 is amended in
acting in accordance with state phrase ‘‘assessment and physician
paragraphs (d)(1) and (3) by removing
licensure requirements, or other certification’’ and adding in its place the
the term ‘‘physician’’ and adding in its
qualified practitioner responsible for phrase ‘‘assessment and certification’’;
place the phrase ‘‘physician or allowed
furnishing or supervising the ordered and
practitioner’’.
services, in accordance with state law ■ c. In paragraph (b)(3) by removing the
§ 484.55 [Amended] and the HHA’s policies, must document term ‘‘physician’’ and adding in its
the orders in the patient’s clinical place the phrase ‘‘physician or allowed
■ 44. Section 484.55 is amended in
record, and sign, date, and time the practitioner’’.
paragraphs (a)(1), (b)(3) and (d)(2) by
removing the term ‘‘physician’’ and add orders. Verbal orders must be ■ 50. Section 484.315 is amended by
in its place the phrase ‘‘physician or authenticated and dated by the revising paragraph (b) to read as follows:
allowed practitioner’’. physician or allowed practitioner in
accordance with applicable state laws § 484.315 Data reporting for measures and
■ 45. Section 484.60 is amended— evaluation and the public reporting of
and regulations, as well as the HHA’s model data under the Home Health Value-
■ a. By revising paragraphs (a)(1),
internal policies. Based Purchasing (HHVBP) Model
(a)(2)(xvi), (b), and (c)(1); and (c) * * *
■ b. In paragraphs (c)(3)(i) and (ii) and * * * * *
(1) The individualized plan of care
(d)(1) and (2) by removing the term (b) Competing home health agencies
must be reviewed and revised by the
‘‘physicians’’ and adding in its place the in selected states will be required to
physician or allowed practitioner who is
phrase ‘‘physicians or allowed report information on New Measures, as
responsible for the home health plan of
practitioners’’. determined appropriate by the
care and the HHA as frequently as the
The revisions read as follows: Secretary, to CMS in the form, manner,
patient’s condition or needs require, but
and at a time specified by the Secretary,
§ 484.60 Condition of participation: Care no less frequently than once every 60
and subject to any exceptions or
planning, coordination of services, and days, beginning with the start of care
extensions CMS may grant to home
quality of care. date. The HHA must promptly alert the
health agencies for the Public Health
* * * * * relevant physician(s) or allowed
Emergency as defined in § 400.200 of
(a) * * * practitioner(s) to any changes in the
this chapter.
(1) Each patient must receive the patient’s condition or needs that suggest
that outcomes are not being achieved * * * * *
home health services that are written in
an individualized plan of care that and/or that the plan of care should be
PART 600—ADMINISTRATION,
identifies patient-specific measurable altered.
ELIGIBILITY, ESSENTIAL HEALTH
outcomes and goals, and which is * * * * * BENEFITS, PERFORMANCE
established, periodically reviewed, and STANDARDS, SERVICE DELIVERY
signed by a doctor of medicine, § 484.75 [Amended]
REQUIREMENTS, PREMIUM AND
osteopathy, or podiatry or allowed ■ 46. Section 484.75 is amended in the COST SHARING, ALLOTMENTS, AND
practitioner acting within the scope of introductory text and paragraph (b)(3) RECONCILIATION
his or her state license, certification, or by removing the term ‘‘physician’’ and
registration. If a physician or allowed adding in its place the phrase ■ 51. The authority citation for part 600
practitioner refers a patient under a plan ‘‘physician or allowed practitioner’’. continues to read as follows:
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Rules and Regulations 27629
Authority: Section 1331 of the Patient makes temporary significant changes to 18063, 18071, 18082, 26 U.S.C. 36B, and 31
Protection and Affordable Care Act of 2010 its BHP that are directly related to the U.S.C. 9701.
(Pub. L. 111–148, 124 Stat. 119), as amended Public Health Emergency and would ■ 54. Section 156.280 is amended by
by the Health Care and Education revising paragraph (e)(2)(ii) introductory
Reconciliation Act of 2010 (Pub. L. 111—152, increase enrollee access to coverage.
124 State. 1029). Such revised Blueprints may have an text to read as follows:
effective date retroactive to the first day § 156.280 Separate billing and segregation
■ 52. Section 600.125 is amended by
of the Public Health Emergency and of funds for abortion services.
revising paragraph (b) and adding
through the last day of the Public Health * * * * *
paragraph (c) to read as follows:
Emergency, or a later date if requested (e) * * *
§ 600.125 Revisions to a certified BHP by the state and certified by HHS. Such (2) * * *
Blueprint. revised Blueprints are not subject to the (ii) Beginning on or before the first
* * * * * public comment requirements under billing cycle following August 26, 2020,
(b) Continued operations. The state is § 600.115(c). to satisfy the obligation in paragraph
responsible for continuing to operate (e)(2)(i) of this section—
Title 45
under the terms of the existing certified * * * * *
Blueprint until and unless a revised PART 156—HEALTH INSURANCE
Blueprint that seeks to make significant Dated: April 24, 2020.
ISSUER STANDARDS UNDER THE Seema Verma,
change(s) is certified, except as
AFFORDABLE CARE ACT, INCLUDING Administrator, Centers for Medicare &
specified in paragraph (c) of this
STANDARDS RELATED TO Medicaid Services.
section.
EXCHANGES Dated: April 28, 2020.
(c) Public health emergency. For the
Public Health Emergency, as defined in Alex M. Azar II,
■ 53. The authority citation for part 156
§ 400.200 of this chapter, the State may Secretary, Department of Health and Human
submit to the Secretary for review and continues to read as follows: Services.
certification a revised Blueprint, in the Authority: 42 U.S.C. 18021–18024, 18031– [FR Doc. 2020–09608 Filed 5–1–20; 4:15 pm]
form and manner specified by HHS, that 18032, 18041–18042, 18044, 18054, 18061, BILLING CODE 4120–01–P
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