Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
Summary
A CMS fact sheet, Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19. It states that at the beginning of the COVID-19 Public Health Emergency CMS used emergency waiver authorities and regulatory authorities to enable flexibilities, and that CMS developed a cross-cutting initiative to reestablish health and safety standards and other requirements at the eventual end of the emergency. It describes a review in three concurrent phases and notes that the fact sheet focuses on Medicare and Medicaid flexibilities only. It then covers COVID-19 vaccines, stating that on October 28, 2020 CMS released an Interim Final Rule with comment period on Medicare Part B coding and payment for COVID-19 vaccines and their administration.
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Cite this document
“Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19.”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/ppr-int-0b72cc9b10888f7f-physicians-and-other-clinicians-pdf-1b8207e87a/
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Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19
At the beginning of the COVID-19 Public Health Emergency (PHE), CMS used emergency waiver
authorities and various regulatory authorities to enable flexibilities so providers could rapidly
respond to people impacted by COVID-19. CMS developed a cross-cutting initiative to use a
comprehensive, streamlined approach to reestablish certain health and safety standards and
other financial and program requirements at the eventual end of the COVID-19 public health
emergency.
This CMS cross-cutting initiative focused on evaluating CMS-issued PHE waivers and flexibilities
to prepare the health care system for operation after the PHE. This review happened in three
concurrent phases:
1. CMS assessed the need for continuing certain waivers based on the current phase of the
PHE. Since the beginning of the PHE, CMS has both added and terminated flexibilities and
waivers as needed. In doing so, CMS considered the impacts on communities — including
underserved communities — and the potential barriers and opportunities that the
flexibilities may address.
2. CMS assessed which flexibilities would be most useful in a future PHE, such as natural and
man-made disasters and other emergencies, to ensure a rapid response to future
emergencies, both locally and nationally, or to address the unique needs of communities
that may experience barriers to accessing health care.
3. CMS is continuing to collaborate with federal partners and the health care industry to
ensure that the health care system is holistically prepared for addressing future
emergencies.
As CMS identified barriers and opportunities for improvement, the needs of each person and
community served were considered and assessed with a health equity lens to ensure our
analysis, stakeholder engagement, and policy decisions account for health equity impacts on
members of underserved communities and health care professionals disproportionately serving
these communities.
Please note: This fact sheet focuses on Medicare and Medicaid flexibilities only.
COVID-19 Vaccines
On October 28, 2020, CMS released an Interim Final Rule with comment period (IFC)
announcing that Medicare Part B would establish coding and payment rates for COVID-19
vaccines and their administration as preventive vaccines, without cost-sharing, as soon as the
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Food and Drug Administration (FDA) authorized or approved the product through an
Emergency Use Authorization (EUA) or Biologics License Application (BLA). The IFC also
implemented provisions of the CARES Act to ensure swift coverage of COVID-19 vaccines by
private health insurance plans participating in the Health Insurance Marketplace, without cost
sharing, from both in- and out-of-network providers, during the course of the public health
emergency (PHE).
Payment After the End of the PHE
CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in
most outpatient settings for Medicare beneficiaries through the end of the calendar year in
which the Secretary ends the EUA declaration for drugs and biologicals with respect to COVID-
19. The EUA declaration is distinct from, and not dependent on, the PHE for COVID-19.
Effective January 1 of the year following the year in which the EUA declaration ends, CMS will
set the payment rate for administering COVID-19 vaccines to align with the payment rate for
administering other Medicare Part B preventive vaccines, that is, approximately $30 per dose.
Additional Payment for Administering the Vaccine in the Patient’s Home
In calendar year 2023, CMS will pay approximately $36 in addition to the standard
administration amount (approximately $40 per dose) to administer COVID-19 vaccines in the
home for certain Medicare patients. For vaccines requiring multiple doses, this payment applies
for each dose in the series, including any additional or booster doses. We also geographically
adjust the additional amount and administration rate based on where you administer the
vaccine. Starting January 1, 2023, we’ll also annually update the additional in-home payment
rate for administering the COVID-19 vaccine to reflect changes in costs related to administering
preventive vaccines.
Additional Payment for Administering the Vaccine in the Patient’s Home After the End of the
PHE
We’ll continue to pay a total payment of approximately $76 per dose to administer COVID-19
vaccines in the home for certain Medicare patients through calendar year 2023. The additional
payment is not affected by the end of the PHE.
More information: COVID-19 vaccine toolkits
• Providers
o Payment
o Billing
o Coding
• Health & Drug Plans
• State Medicaid programs
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COVID-19 Monoclonal Antibodies
There are currently no COVID-19 monoclonal antibodies approved or authorized for use
against the dominant strains of COVID-19 in the United States.
The FDA issued emergency use authorizations (EUA) for monoclonal antibody therapies used
for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive
COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or
hospitalization. The FDA also issued an EUA for a monoclonal antibody product used as a pre-
exposure prophylaxis of COVID-19 in adults and pediatric patients with certain conditions.
During the EUA declaration for drugs and biologicals with respect to COVID-19, CMS covers and
pays for these infusions or injections the same way it covers and pays for COVID-19 vaccines
when furnished consistent with the EUA. There’s also no beneficiary cost sharing and no
deductible for COVID-19 monoclonal antibody products when providers administer them. In the
event these products become approved or authorized for use, they will continue to be covered
and paid under the Medicare Part B preventive vaccine benefit until the end of the calendar
year in which the Secretary ends the EUA declaration. This coverage and payment will continue
even after the PHE ends.
CMS doesn’t pay for the COVID-19 monoclonal antibody product when a health care setting has
received it for free. If a health care setting purchased the product from the manufacturer,
Medicare pays the reasonable cost or 95% of the average wholesale price.
More information: COVID-19 Monoclonal Antibodies
Payment After the End of the PHE
Effective January 1 of the year following the year in which the Secretary ends the EUA
declaration for drugs and biologicals with respect to COVID-19, CMS will pay for monoclonal
antibodies used for the treatment or for post-exposure prophylaxis of COVID-19:
• As we pay for biological products under Section 1847A of the Social Security Act.
• Through the applicable payment system, using the appropriate coding and payment
rates, similar to the way we pay for administering other complex biological products.
Monoclonal antibodies that are used for pre-exposure prophylaxis prevention of COVID-19 will
continue to be paid under the Part B preventive vaccine benefit if they meet applicable
coverage requirements.
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COVID-19 Oral Antivirals
The FDA issued an emergency use authorization (EUA) for oral antivirals for the treatment of
mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients.
Oral antivirals that are procured by the U.S. government (USG) and provided to pharmacies are
provided to patients at no cost. This process will continue while oral antivirals are being
procured by the USG.
Payment After the End of the PHE
Oral antivirals for COVID-19 that otherwise meet the statutory requirements for Part D
coverage at section 1860D-2(e) of the Social Security Act and are not procured by the US
government must be covered by Part D plans, as a formulary product or through the formulary
exception process. This applies to oral antivirals for COVID-19 with emergency use
authorization (EUA) under section 564 of the Federal Food, Drug and Cosmetic Act through
December 31, 2024, consistent with Section 4131 of the Consolidated Appropriations Act,2023
and any such products that receive FDA approval.
COVID-19 VEKLURYTM (remdesivir)
As of April 25, 2022, VEKLURYTM (remdesivir) is approved for the treatment of COVID-19. The
federal government didn’t purchase a supply of remdesivir. Medicare Part B provides payment
for the drug and its administration under the applicable Medicare Part B payment policy when a
facility or practitioner provides it in the outpatient setting, according to the FDA approval. In
most cases, the Medicare patient’s yearly Part B deductible and 20% co-insurance apply.
Coverage for Over-the-Counter COVID-19 Tests.
On April 4, 2022, Medicare implemented a demonstration program to allow people with
Medicare to receive up to eight tests per calendar month at no cost. This is the first time that
Medicare has covered an over-the-counter, self-administered, test. This new initiative enables
people with Medicare Part B, including those enrolled in a Medicare Advantage plan, to receive
tests at no cost from providers and suppliers who are eligible to participate. Pharmacies and
other health care providers interested in participating in this initiative can get more information
here. This program will end at the end of the COVID-19 public health emergency.
Medicare Telehealth
During the PHE, the Secretary has been using the waiver authority under section 1135 of the
Act to create flexibilities in the requirements of section 1834(m) of the Act and 42 CFR § 410.78
for use of interactive telecommunications systems to furnish telehealth services. This allows
clinicians to furnish more services to beneficiaries via telehealth so that they can take care of
their patients while mitigating the risk of the spread of the virus. During the public health
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emergency, all beneficiaries across the country have been able to receive Medicare telehealth
and other communications technology-based services wherever they are located. Additionally,
after the PHE ends, the Consolidated Appropriations Act, 2023 provides for an extension for
some of these flexibilities through December 31, 2024.
CMS has also been using these section 1135 waivers to create further PHE flexibilities to the
requirements of section 1834(m)(1) of the Act and 42 CFR § 410.78(a)(3) for the use of
interactive telecommunications systems to furnish telehealth services, to the extent they
require use of video technology, for certain services. This waiver allows the use of audio-only
equipment to furnish services described by the codes for audio-only telephone evaluation and
management services, and behavioral health counseling and educational services. Unless
provided otherwise, other services included on the Medicare Telehealth Services List must be
furnished using, at a minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site. Additionally, after the PHE
ends, the Consolidated Appropriations Act, 2023 extends availability of the telehealth
services that can be furnished using audio-only technology through December 31, 2024.
In the CY 2022 Physician Fee Schedule Rule, CMS revised the regulation at 42 CFR §
410.78(a)(3) to permit the use of audio-only equipment for telehealth services furnished to
patients in their homes under certain circumstances for purposes of diagnosis, evaluation, or
treatment of a mental health disorder (including substance use disorder). CMS has waived the
requirements of section 1834(m)(4)(E) of the Act and 42 CFR § 410.78 (b)(2), which specify the
types of practitioners who may bill for their services when furnished as Medicare telehealth
services from a distant site. The waiver of these requirements expands the types of health care
professionals who can furnish distant site telehealth services to include all those who are
eligible to bill Medicare for their professional services. As a result, a broader range of
practitioners, such as physical therapists, occupational therapists, and speech language
pathologists can use telehealth to provide many Medicare services. After the PHE ends, the
Consolidated Appropriations Act, 2023 provides for an extension for this flexibility through
December 31, 2024.
Additionally, we modified the process to add services to the Medicare Telehealth Services List
during the PHE, allowing us to consider adding appropriate services on a sub-regulatory basis,
as they were requested, as practitioners were actively learning how to use telehealth. A
complete list of all Medicare telehealth services can be found here:
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
After the PHE ends, we will resume consideration of changes to the Medicare Telehealth
Services List exclusively through notice and comment rulemaking.
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To reduce exposure risk, during the PHE and for an extended period of time for many services,
the following have been added to the Medicare Telehealth Services List:
• Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285).
• Initial and Subsequent Observation and Observation Discharge Day Management (CPT
codes 99217- 99220; CPT codes 99224- 99226; CPT codes 99234- 99236 – note: CPT
codes 99218-99219 have since been consolidated into inpatient observation Evaluation
& Management services).
• Initial Hospital Care and Hospital Discharge Day Management (CPT codes 99221-99223;
CPT codes 99238- 99239).
• Initial Nursing Facility Visits, All Levels (Low, Moderate, and High Complexity) and
Nursing Facility Discharge Day Management (CPT codes 99304-99306; CPT codes 99315-
99316; HCPCS code G9685).
• Cardiac Care Services (CPT codes 93797-93798, CPT code 93750).
• Critical Care Services (CPT codes 99291-99292).
• Domiciliary, Rest Home, or Custodial Care Services, New and Established patients (CPT
codes 99324- 99328; CPT codes 99336-99337 — CPT codes 99334 and 99335 were
added permanently).
• ESRD Services (CPT code 90953; CPT code 90956; CPT code 90959; CPT code 90962).
• Eye Examinations (CPT code 92002; CPT code 92004; CPT code 92012; CPT code 92014).
• Home Visits, New and Established Patient, All levels (CPT codes 99341- 99345; CPT
codes 99349; CPT code 99350 — CPT codes 99347 and 99348 were added permanently).
• Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468-
99469; CPT codes 99471-99473; CPT codes 99475- 99476; CPT codes 99479-99480).
• Initial and Continuing Intensive Care Services (CPT code 99477-99478).
• Care Planning for Patients with Cognitive Impairment (CPT code 99483 was added
permanently).
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• Group and Individual Psychotherapy (CPT code 90875; CPT code 90901; CPT codes
96110-96121; CPT code 96125; CPT code 96127; CPT codes 96036-96039; CPT code
96158; CPT codes 96170-96171; CPT codes 97129-97130; CPT codes 97150-97158; CPT
code 0362T; CPT code 0373T; HCPCS code G0410; HCPCS codes G0422-G0423 — CPT
code 90853 was added permanently).
• Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes
96136-96139).
• Neurostimulator Services (CPT codes 95970-95972; CPT codes 95983-95984).
• Rehabilitation — Pulmonary and Cardiac (CPT codes 94625-94626; CPT code 94664).
• Speech and Hearing Services (CPT code 92508; CPT code 92526; CPT code 92550; CPT
code 92552; CPT code 92553; CPT codes 92555-92557; CPT code 92563; CPT code
92565; CPT code 92567; CPT code 92568; CPT code 92570; CPT code 92587; CPT codes
92601-92604; CPT codes 92607-92610; CPT codes 92625-92627; CPT code 96105; CPT
code 96110; CPT codes 96112-96113; CPT code S9152).
• Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-
97168; CPT codes 97110, 97112, 97116, 97530, 97535, 97537, 97542, 97763, 97750,
97755, 97760, 97761, 98960-98962, 92521-92524, 92507).
• Radiation Treatment Management Services (CPT code 77427).
• Ventilation Services (CPT codes 94002-94005).
• Prolonged Outpatient Office Visit (HCPCS code G2212)
• Telephone E/M (CPT codes 99441-99443).
These services will remain on the Medicare Telehealth Services List and will be available through
the end of CY 2023, and we anticipate addressing updates to the Medicare Telehealth Services List for
CY 2024 and beyond through our established processes as part of the CY 2024 Physician Fee Schedule
proposed and final rules.
Remote Evaluations, Virtual Check-Ins & E-Visits
• Medicare pays for e-visits, which are brief communication services with practitioners,
professionals, clinicians, and providers via a number of communication technology
modalities, including synchronous discussion over a telephone or exchange of
information through video or image. During the PHE, clinicians can provide remote
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evaluation of patient video/images and virtual check-in services (HCPCS codes G2010
and G2012 for physicians and G2251 and G2252 are for non-physician practitioners) to
both new and established patients. After the end of the PHE, these services may only be
provided to established patients.
• In addition to physicians and other non-physician practitioners, during the PHE, licensed
clinical social workers, clinical psychologists, physical therapists, occupational therapists,
and speech language pathologists can provide e-visits. E-visits are non-face-to-face
communications with the practitioner using online patient portals. (CPT codes 99421-
99423 for physicians and CPT codes 98970-98972 for qualified non-physician
practitioners).
This policy was made permanent in the CY 2021 PFS Final Rule.
Telephone Evaluation, Management/Assessment and Management Services, and Behavioral
Health and Education Services
• During the PHE, a broad range of clinicians, including physicians, have been able to
provide certain services by telephone to their patients.
• Medicare payment for the telephone evaluation and management visits (CPT codes
99441-99443) is equivalent to the Medicare payment for office/outpatient visits with
established patients effective March 1, 2020. After the PHE ends, the Consolidated
Appropriations Act, 2023 provides for an extension for this flexibility through
December 31, 2024.
• When clinicians have furnished an evaluation and management (E/M) service that
otherwise would have been reported as an in-person or telehealth visit, using audio-
only technology, practitioners have been able to bill using these telephone E/M codes
provided that it is appropriate to furnish the service using audio-only technology and all
of the required elements in the applicable telephone E/M code (99441-99443)
description are met.
• Using section 1135 waiver authority, CMS has been allowing many behavioral health
and education services to be furnished via telehealth using audio-only communications.
The full Medicare Telehealth Services List notes which services are eligible to be
furnished via audio-only technology, including the telephone evaluation and
management visits: https://www.cms.gov/Medicare/Medicare-General-
Information/Telehealth/Telehealth-Codes.
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After the PHE ends, the Consolidated Appropriations Act, 2023 extends availability of the
telehealth services that can be furnished using audio-only technology through December 31,
2024.
In the CY 2022 Physician Fee Schedule Rule, CMS revised the regulation at 42 CFR § 410.78(a)(3)
to permit the use of audio-only equipment permanent policy for telehealth services furnished
to patients in their homes under certain circumstances for purposes of diagnosis, evaluation, or
treatment of a mental health disorder (including a substance use disorder).
Remote Physiologic Monitoring
• Using the waiver authority under section 1135 of the Act during the PHE, we have
permitted clinicians to bill for remote physiologic monitoring (RPM) services furnished
to both new and established patients, and to patients with both acute and chronic
conditions. When the PHE ends, clinicians must once again have an established
relationship with the patient prior to providing RPM services. However, we will
continue to allow RPM services to be furnished to patients with both acute and chronic
conditions (pre-PHE, an initiating visit was required before RPM services could be
billed).
• Current CPT coding guidance states that the RPM services described by CPT codes 99453
and 99454 cannot be reported when fewer than 16 days of data are collected. During
the PHE, we used section 1135 waiver authority to allow clinicians to bill CPT codes
99453 and 99454 when as few as two days of data were collected if the patient was
diagnosed with, or was suspected of having, COVID-19 and as long as all other billing
requirements of the codes were met. When the PHE ends, clinicians must only bill for
these services when at least 16 days of data have been collected.
Removal of Frequency Limitations on Certain Medicare Telehealth Services
Using section 1135 waiver authority, on an interim basis during the PHE, we removed the
frequency restrictions for the following listed codes furnished via Medicare telehealth. These
restrictions were established through rulemaking and implemented through systems edits.
• A subsequent inpatient visit could be furnished via Medicare telehealth, without the
limitation that the telehealth visit is once every three days (CPT codes 99231-99233).
• A subsequent skilled nursing facility visit could be furnished via Medicare telehealth,
without the limitation that the telehealth visit is once every 14 days (CPT codes 99307-
99310).
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• Critical care consult codes could be furnished to a Medicare beneficiary by telehealth,
without the limitation that the telehealth visit is once per day (HCPCS codes G0508-
G0509).
We have received a number of inquiries from interested parties regarding temporarily
continuing our suspension of these frequency limitations beyond the end of the PHE,
specifically our requirement that CPT codes 99231-99233 may only be furnished via Medicare
telehealth once every 3 days, and our requirement that CPT codes 99307-99309 may only be
furnished via Medicare telehealth once every 14 days. We are exercising enforcement
discretion and will not consider these frequency limitations through December 31, 2023, as we
anticipate considering our policy further through our rulemaking process.
Other Medicare Telemedicine and Remote Patient Care
o Medicare patients with end-stage renal disease (ESRD) who are on home dialysis must
receive a face-to-face visit, without the use of telehealth, at least monthly in the case of
the initial three months of home dialysis and at least once every three consecutive
months after the initial three months. We used section 1135 waiver authority during the
PHE to allow these visits to be furnished as telehealth services. This will expire at the
end of the COVID-19 public health emergency.
o To the extent that a National Coverage Determination (NCD) or Local Coverage
Determination (LCD) would otherwise require an in-person, face-to-face visit for
evaluations and assessments, we used section 1135 waiver authority to remove those
requirements so that these services can be furnished via telehealth during the public
health emergency. This will expire at the end of the COVID-19 public health
emergency.
o As a flexibility for the COVID-19 PHE, annual beneficiary consent for virtual check-ins
may be obtained at the same time as the services are furnished for both new and
established patients. Post PHE—virtual check-ins may only be furnished to established
patients.
o The flexibility to obtain annual beneficiary consent for virtual check-ins at the time of
service was made permanent in the CY 2021 PFS Final Rule. At the end of the PHE,
virtual check-ins may only be furnished to established patients.
o Physician visits: Using the waiver authority under section 1135 of the Act during the
PHE, CMS created flexibilities allowing physicians and non-physician practitioners during
the PHE to perform in-person visits for nursing home residents and allow visits to be
conducted, as appropriate, via telehealth options. When the PHE ends, physicians will
be required to conduct any federally required in-person visits. However, there remains
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flexibility in some of our regulations that allows physicians to delegate visits to other
practitioners, as long as they are doing so in accordance with state law. (This waiver
was terminated on 05-07-2022 per QSO-22-15-NH&NLTC&LSC.)
o Opioid Treatment Programs (OTPs): During the PHE, patient counseling and therapy
services have been provided by telephone in cases where two-way interactive audio-
video communication technology is not available to the beneficiary, and all other
applicable requirements are met. This flexibility has been made permanent for OTPs in
the CY 2022 PFS final rule. During the PHE, periodic assessments have been conducted
via two-way interactive audio-video communication technology and may have been
provided by telephone, only in cases where the beneficiary has not had access to two-
way interactive audio-video communication technology and all other applicable
requirements have been met. In the CY 2023 PFS final rule, we extended the flexibility
for OTPs to furnish periodic assessments via audio-only (telephone) interactions under
certain circumstances through the end of 2023.
Workforce
• Medicare Physician Supervision Requirements: CMS has temporarily modified the
regulatory definition of direct supervision, which requires the supervising physician or
practitioner to be “immediately available” to furnish assistance and direction during the
service, to include “virtual presence” of the supervising clinician through the use of real-
time audio and video technology. This flexibility is currently set to return to pre-PHE
rules at the end of the calendar year that the PHE ends.
• Supervision Requirements for Non-Surgical Extended Duration Therapeutic Services:
During the PHE, direct supervision has not been required at the initiation of non-surgical
extended duration therapeutic services provided in hospital outpatient departments
and critical access hospitals. Instead, a general level of supervision could be provided for
the entire duration of these services, so the supervising physician or practitioner has not
been required to be immediately available. In the CY 2021 OPPS/ASC final rule, CMS
made this provision permanent, so after the PHE ends, this policy will stay in effect (85
FR 85866).
• Medicare Physician Supervision and Auxiliary Personnel: The physician could have
entered into a contractual arrangement that meets the definition of auxiliary personnel
at 42 CFR § 410.26, including with staff of another provider/supplier types, such as a
home health agency (defined under § 1861(o) of the Act) or a qualified home infusion
therapy supplier (defined under § 1861(iii)(3)(D)), or entities that furnish ambulance
services, which can provide the staff and technology necessary to provide care that,
ordinarily, would have been provided incident to a physician’s service (including services
that are allowed to be performed via telehealth). In such instances, the
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provider/supplier would have sought payment for any services provided by auxiliary
personnel from the billing practitioner and would not have submitted claims to
Medicare for such services.
• Obtaining Beneficiary Consent: CMS requires that beneficiaries must grant
consent to receive care management services furnished by auxiliary personnel
before the start of the service. Since the start of the PHE, there have been many
flexibilities regarding how this consent is obtained. Under current regulations,
some of these flexibilities will expire at the end of the calendar year that the PHE
ends. However, CMS may consider these policies in notice and comment
rulemaking. For further information on obtaining consent for CCM, refer to pg. 5
of the FAQ available at: https://www.cms.gov/files/document/chronic-care-
management-faqs.pdf.
• Medicare Nonphysician Practitioners: We created the flexibility at 42 CFR § 410.32(b),
on an interim basis during the PHE, to allow nurse practitioners (NPs), clinical nurse
specialists (CNSs), certified nurse-midwives (CNMs), and physician assistants (PAs) to
supervise diagnostic tests as authorized under state law and licensure. These
practitioners continue the required statutory relationships with supervising or
collaborating physicians. In the CY 2021 PFS final rule, CMS made these flexibilities
permanent and added certified registered nurse anesthetists (CRNAs) to the above list
of nonphysician practitioners allowed to supervise diagnostic tests as authorized under
state law and licensure (85 FR 84590-84592).
• Physical Therapists and Occupational Therapists: The treating physical or occupational
therapist who develops, or is responsible for, the maintenance program or plan has
been able to delegate the performance of the related maintenance therapy services to a
therapy assistant when clinically appropriate. This has freed up the therapist to furnish
other needed services during the PHE requiring their evaluative and assessment skills.
This flexibility has been made permanent via CY 2021 rulemaking, allowing physical and
occupational therapists to delegate maintenance therapy services to their therapy
assistants as clinically appropriate in the same manner that rehabilitation services are
delegated.
• Pharmacists: We have been allowing pharmacists, as well as other health care
professionals who are authorized to order lab tests under the state scope of practice
and other relevant laws, to order COVID-19 tests for Medicare beneficiaries during the
PHE. This does not mean that these pharmacists and other health care professionals
have been able to enroll in the Medicare program to furnish and bill for services they
furnish to beneficiaries; rather, it has allowed Medicare to pay for tests that they order.
This will expire at the end of the COVID-19 public health emergency.
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• Teaching Physicians: During the PHE, services furnished by a resident in a teaching
setting could be billed by a teaching physician who is present during the key portion of
the service. If the training setting is located outside of a metropolitan statistical area
(MSA), the teaching physician could have a virtual presence through audio/video real-
time technology. During the PHE, this virtual presence of the teaching physician is
allowed for all teaching settings. Under the so-called primary care exception at section
415.174, a teaching physician may bill for certain services when they direct and review
the care furnished by up to four residents at a time. For all teaching settings during the
PHE, teaching physicians may direct care and review services each resident provides
during or at once after each visit virtually. After the PHE, CMS is exercising enforcement
discretion to allow teaching physicians in all teaching settings to be present virtually,
through audio/video real-time communications technology, for purposes of billing
under the PFS for services they furnish involving resident physicians. We are exercising
this enforcement discretion through December 31, 2023, as we anticipate considering
our policy for services involving teaching physicians and residents further through our
rulemaking process. This policy does not apply in the case of surgical, high risk,
interventional, or other complex procedures, services performed through an endoscope,
and anesthesia services. This allows teaching hospitals to maximize their workforce to
safely take care of patients.
• Hospital Services: CMS has waived requirements at § 482.12(c)(1)-(2) and (4) that
Medicare patients in the hospital must be under the care of a physician. This has
allowed hospitals to use other practitioners, such as physician assistants and nurse
practitioners, to the fullest extent possible. This waiver is required to be implemented in
accordance with a state’s emergency preparedness or pandemic plan and will expire at
the end of the COVID-19 public health emergency.
• National coverage determinations (NCDs) and Local Coverage Determinations (LCDs): To
the extent NCDs and LCDs require a specific practitioner type or physician specialty to
furnish or supervise a service, during the PHE, the Chief Medical Officer or equivalent of
a hospital or facility has had the authority to make those staffing decisions. This waiver
ends upon the conclusion of the PHE.
• CMS has exercised enforcement discretion and has not enforced the current clinical
indications in LCDs for therapeutic continuous glucose monitors during this public health
emergency. This change is intended to permit more COVID-19 patients with diabetes to
better monitor their glucose and adjust insulin doses from home. This will expire at the
end of the COVID-19 public health emergency.
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• Practitioner Locations: During the PHE, CMS has waived the Medicare requirement that
a physician or non-physician practitioner must be licensed in the state in which they are
practicing if the physician or practitioner 1) is enrolled as such in the Medicare program,
2) has a valid license to practice in the state reflected in their Medicare enrollment, 3) is
furnishing services — whether in person or via telehealth — in a state in which the
emergency is occurring in order to contribute to relief efforts in his or her professional
capacity, and 4) is not affirmatively excluded from practice in the state or any other
state that is part of the section 1135 emergency area. A physician or non-physician
practitioner could seek an 1135-based licensure waiver from CMS by contacting the
provider enrollment hotline for the Medicare Administrative Contractor that serviced
their geographic area. This waiver did not have the effect of waiving state or local
licensure requirements or any requirement specified by the state or a local government
as a condition for waiving its licensure requirements. We originally implemented the
waiver out of an abundance of caution; however, it turned out that regulations that
existed before the PHE allowed for a deferral to state law.
• Modification of 60-day limit for Substitute Billing Arrangements (Locum Tenens): CMS has
modified the 60-day limit in section 1842(b)(6)(D)(iii) of the Social Security Act to allow a
physician or physical therapist to use the same substitute for the entire time he or she is
unavailable to provide services during the COVID-19 emergency, plus an additional period
of no more than 60 continuous days after the public health emergency expires. On the 61st
day after the public health emergency ends (or earlier if desired), the regular physician or
physical therapist must use a different substitute or return to work in his or her practice for
at least one day in order to reset the 60-day clock. The modified timetable applies to both
types of substitute billing arrangements under Medicare fee-for-service (i.e., reciprocal
billing arrangements and fee-for-time compensation arrangements, formerly known as
locum tenens).
Note: Under the Medicare statute, only 1) physicians and 2) physical therapists who
furnish outpatient physical therapy services in a health professional shortage area
(HPSA), a medically underserved area (MUA), or a rural area can receive Medicare fee-
for-service payment for services furnished by a substitute under a substitute billing
arrangement. In addition, Medicare can pay for services under a substitute billing
arrangement only when the regular physician or physical therapist is unavailable to
provide the services. Finally, as provided by law, a regular physician or physical therapist
who has been called or ordered to active duty as a member of a reserve component of
the U.S. armed forces may continue to use the same substitute for an unlimited time
even after the emergency ends.
• Provider Enrollment: During the PHE, CMS has established toll-free hotlines for
physicians, non-physician practitioners, and Part A certified providers and suppliers who
have established isolation facilities to enroll and receive temporary Medicare billing
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privileges. When the PHE ends, the hotlines will be shut down. Additionally, CMS has
provided the following flexibilities for provider enrollment:
o Screening requirements:
• Site Visits: CMS waived provider enrollment site visits for moderate and high-
risk providers/suppliers. (This waiver terminated on 07-06-2020 and CMS, in
accordance with 42 CFR §§ 424.517 and 424.518, resumed all provider
enrollment site visits.)
• Fingerprint-based criminal background checks: CMS waived the requirement
for fingerprint-based criminal background checks for 5% or greater owners of
newly enrolling high-risk categories of providers and suppliers (e.g., newly-
enrolling Home Health Agencies, DMEPOS suppliers, Medicare Diabetes
Prevention Programs, Opioid Treatment Programs). (This waiver terminated
on 10/31/2021 and CMS, in accordance with 42 CFR § 424.518, resumed
requesting fingerprints for all newly enrolling high-risk providers and
suppliers.)
o Application Fees: CMS waived the collection of application fees for institutional
providers who are initially enrolling, revalidating, or adding a new practice location.
(This waiver terminated on 10/31/2021 and CMS, in accordance with 42 CFR §
424.514, resumed collecting application fees.)
o Revalidation: CMS postponed all revalidation actions. This did not prevent a provider
who wants to submit a revalidation application from doing so; MACs processed
revalidation applications. (This waiver terminated on 10/31/2021 and CMS
resumed a phased-in approach to revalidation activities; revalidation letters began
being mailed again in November 2021 with due dates in early 2022.)
o Expedited Enrollment: CMS expedited any pending or new applications from
providers and suppliers, including physicians and non-physician practitioners
received on or after March 1, 2020. When the PHE ends, CMS will resume normal
application processing times.
o Opt-Out Enrollment: CMS allowed practitioners to cancel their opt-out status early
and enroll in Medicare to provide care to more patients. CMS also allowed MACs to
accept opt-out cancellation requests via email, fax, or phone call to the hotline. CMS
allowed a provider to submit an application (an 855-I or 855-R for example) to cancel
their opt-out. Providers were not required to submit a written notification to cancel
their opt-out status. When the PHE ends, this waiver will terminate and opted-out
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practitioners will not be able to cancel their opt-out statuses earlier than the
applicable regulation at 42 CFR § 405.445 allows for.
o Reporting Home Address: During the PHE, CMS allowed practitioners to render
telehealth services from their home without reporting their home address on their
Medicare enrollment while continuing to bill from their currently enrolled location.
Even though the PHE is anticipated to end on May 11, 2023, the waiver will continue
through December 31, 2024.
o State Licensure: During the PHE, CMS allowed licensed physicians and other
practitioners to bill Medicare for services provided outside of their state of
enrollment. CMS has determined that, when the PHE ends, CMS regulations will
continue to allow for a total deferral to state law. Thus, there is no CMS-based
requirement that a provider must be licensed in its state of enrollment.
• Student Documentation: In the CY 2020 Physician Fee Schedule (PFS) final rule, we
adopted simplified medical record documentation requirements for physicians and
certain nonphysician practitioners to allow the billing clinician to review and verify,
rather than re-document, information added to the medical record by any member of
the health care team. During the public health emergency, this principle has applied
across the spectrum of all Medicare-covered services, and has also applied to therapists
so that they may review and verify, rather than redocument, notes added to the medical
record by any other member of the health care team, including therapy or other
students. These simplified medical record documentation requirement policies were
finalized and will continue to be in effect after the PHE ends.
Medicare COVID-19 Diagnostic Testing and Reporting
• Price Transparency for COVID-19 Testing: In an Interim Final Rule with Comment Period
(IFC) issued October, 28, 2020, CMS implemented the CARES Act requirement that
providers of a diagnostic test for COVID-19 to make public the cash price for such tests
on their websites. Providers without websites have been required to provide price
information in writing within two business days upon request and on a sign posted
prominently at the location where the provider performs the COVID-19 diagnostic test,
if such location is accessible to the public. Noncompliance may result in civil monetary
penalties up to $300 per day. After the PHE, in accordance with the CARES Act, this
special price transparency requirement will terminate. Price transparency
requirements under other laws and regulations will continue to apply.
• COVID-19 Diagnostic Testing: During the PHE, CMS specified that the level one E/M visit
(CPT code 99211), which can ordinarily be billed only when clinical staff perform
services incident to the services of the billing physician or practitioner for an established
patient, can be billed when clinical staff assess a patient and collect a specimen for a
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COVID-19 diagnostic test for both new and established patients. After the PHE, the
usual requirements for billing the level 1 E/M visit (CPT code 99211) apply.
• Physician or Practitioner Order for COVID-19 tests: In the COVID-19 Public Health
Emergency Interim Final Rule #3 (CMS-3401-IFC), we revised a previous policy that
covered multiple COVID-19 tests for an individual beneficiary without a physician or
other practitioner order. Medicare has been covering a beneficiary’s first COVID-19 test
without an order. Subsequent tests require a physician’s or other practitioner’s order.
This change has ensured that beneficiaries receive appropriate medical attention if they
feel they need multiple tests, and has reduced the risk of fraud. FDA requirements for
an order and state requirements around ordering diagnostic tests still applied. CMS also
removed certain documentation and recordkeeping requirements associated with
orders for COVID-19 diagnostic tests as these requirements would not be relevant in the
absence of an order. CMS still requires laboratories to furnish the results of COVID-19
tests to the beneficiary. Consistent and regular reporting of all testing results to local
officials is critical to public health management of the pandemic, so we would expect
any clinician or laboratory receiving results to report those results promptly, consistent
with state and local public health requirements, typically within 24 hours. After the PHE,
Medicare will require all COVID-19 and related testing that is performed by a
laboratory to be ordered by a physician or non-physician practitioner.
Reducing Administrative Burden
• “Stark Law” Waivers: The physician self-referral law (also known as the “Stark Law”) 1)
prohibits a physician from making referrals for certain designated health services
payable by Medicare to an entity with which he or she (or an immediate family
member) has a financial relationship, unless the requirements of an applicable
exception are satisfied; and 2) prohibits the entity from filing claims with Medicare (or
billing another individual, entity, or third party payer) for any improperly referred
designated health services. On March 30, 2020, CMS issued blanket waivers of certain
provisions of the Stark Law. These blanket waivers applied to financial relationships and
referrals that are related to the COVID-19 emergency. The remuneration and referrals
described in the blanket waivers must be solely related to COVID-19 purposes, as
defined in the blanket waiver document. During the PHE, CMS permitted certain
referrals and the submission of related claims that would otherwise violate the Stark
Law, if all requirements of the waivers were met. When the COVID-19 PHE ends, the
waivers will terminate and physicians and entities must immediately comply with all
provisions of the Stark Law.
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Flexibilities under the “Stark Law” waivers have included:
o Hospitals and other health care providers could pay above or below fair market
value for the personal services of a physician (or an immediate family member of a
physician), and parties could pay below fair market value to rent equipment or
purchase items or services. For example, a physician practice could rent or sell
needed equipment to a hospital at a price below what the practice could charge
another party. Or, a hospital could provide space on hospital grounds at no charge
to a physician who is willing to treat patients who sought care at the hospital but
were not appropriate for emergency department or inpatient care.
o Health care providers could support each other financially to ensure continuity of
health care operations. For example, a physician owner of a hospital could make a
personal loan to the hospital without charging interest at a fair market rate so that
the hospital could make payroll or pay its vendors.
o Hospitals could provide benefits to their medical staff, such as multiple daily meals,
laundry service to launder soiled personal clothing, or child care services while the
physicians were at the hospital and engaging in activities that benefited the hospital
and its patients.
o Health care providers could offer certain items and services that were solely related
to COVID-19 purposes (as defined in the waivers), even when the provision of the
items or services would exceed the annual non-monetary compensation cap. For
example, a home health agency could provide continuing medical education to
physicians in the community on the latest care protocols for homebound patients
with COVID-19, or a hospital could provide isolation shelter or meals to the family of
a physician who was exposed to the novel coronavirus while working in the
hospital’s emergency department.
o Physician-owned hospitals could temporarily increase the number of their licensed
beds, operating rooms, and procedure rooms, even though such expansion would
otherwise be prohibited under the Stark Law. For example, a physician-owned
hospital could temporarily convert observation beds to inpatient beds to
accommodate patient surge during the COVID-19 pandemic in the United States.
o Some of the restrictions regarding when a group practice could furnish medically
necessary designated health services (DHS) in a patient’s home were loosened. For
example, any physician in the group could order medically necessary DHS that were
furnished to a patient by one of the group’s technicians or nurses in the patient’s
home contemporaneously with a physician service that was furnished via telehealth
by the physician who ordered the DHS.
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o Group practices could furnish medically necessary MRIs, CT scans, or clinical
laboratory services from locations like mobile vans in parking lots that the group
practice rented on a part-time basis.
• National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) on
Respiratory Related Devices, Home Infusion Pumps and Home Anticoagulation Therapy:
CMS has not enforced clinical restrictions in certain NCDs and LCDs that otherwise
would have restricted coverage of these devices and services for COVID-19 patients
during the public health emergency. Clinicians have had more flexibility in determining
patient needs for respiratory related devices and equipment and the flexibility for more
patients to manage their treatments at home, but need to continue to document those
decisions in the medical record. The NCD enforcement discretion expires at the end of
the COVID-19 public health emergency.
• National Coverage Determination (NCD) on Oxygen and Oxygen Equipment. CMS issued
a National Coverage Determination (NCD) reconsideration in September 2021, during
the PHE, that permanently removes many of the barriers to the use of home oxygen and
oxygen equipment, thereby expanding Medicare oxygen coverage in the home. When
the PHE ends, these changes will remain. Examples of changes made in the new NCD
include allowing home oxygen coverage in beneficiaries with acute, short term need for
oxygen (e.g. individuals recovering from COVID or pneumonia). providing the ability for
individuals who do not exhibit hypoxemia (low level of oxygen in the blood) to access
home oxygen (e.g. individuals with cluster headaches) if their symptoms are improved
by oxygen therapy, and removing the requirement for the prior use of alternative
treatments before oxygen in the home can be used.
In addition, there is no formal requirement for re-evaluation and retesting for those
who are hypoxemic, as long as the home oxygen is reasonable and necessary. For those
whose blood oxygen levels do not meet the definition of hypoxemia, the Medicare
statute requires that their attending physician must certify on the basis of a follow-up
test whether there is a medical need for the patient to continue to receive home
oxygen.
The NCD detailing this announcement can be found here:
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-
memo.aspx?proposed=N&ncaid=301
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• National Coverage Determinations (NCDs) for Percutaneous Left Atrial Appendage
Closure, Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve
Replacement and Ventricular Assist Devices: CMS has not enforced the procedural
volume requirements contained in these four NCDs for facilities and providers that,
prior to the public health emergency for COVID-19, met the volume requirements.
This enforcement discretion ensures that beneficiaries continue to have access to the
services covered under these NCDs. The NCD enforcement discretion expires at the
end of the COVID-19 public health emergency.
• Signature Requirements: CMS has been waiving signature and proof of delivery
requirements for Part B drugs and Durable Medical Equipment (DME) when a signature
cannot be obtained because of COVID-19. Suppliers should document in the medical
record the appropriate date of delivery and that a signature was not able to be obtained
because of COVID-19. After the PHE, signature and proof of delivery requirements will
be reinstated.
• Quality Payment Program (QPP) Merit-based Incentive Payment System (MIPS): MIPS
Automatic Extreme and Uncontrollable Circumstances’ (EUC) policy applied for
performance year 2021 — individual MIPS eligible clinicians who did not submit any
MIPS data by the deadline of March 31, 2022 will automatically have all four MIPS
performance categories reweighted to 0% and receive a neutral payment adjustment in
the 2023 payment year (this automatic policy does not apply to groups, virtual groups,
or Advanced Payment Model Entities). Groups and virtual groups had the option to
submit a MIPS EUC application requesting reweighting of one or more performance
categories due to the impact of the COVID-19 PHE, while APM entities had the option to
request reweighting for all performance categories.
At this time, the MIPS Automatic EUC policy is not being applied to all individual MIPS
eligible clinicians for the 2022 and 2023 performance years. However, individual
clinicians, groups, virtual groups, and APM entities have the option to submit a MIPS
EUC application and request reweighting. For more information related to the MIPS EUC
application visit: https://qpp.cms.gov/mips/exception-applications. CMS is continuing to
assess the implications of the pandemic to MIPS, and clinicians are encouraged to check
QPP.CMS.gov for updates.
• COVID-19 Accelerated and Advance Payments (CAAP): For more information related to
the CAAP Program, please visit https://www.cms.gov/medicare/covid-19-accelerated-
and-advance-payments.
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Medicare appeals in Traditional Medicare, Medicare Advantage (MA) and Part D
• During the PHE, CMS has been allowing Medicare Administrative Contractors (MACs)
and Qualified Independent Contractors (QICs) in the FFS program (42 CFR 405.942 and
42 CFR 405.962) and MA and Part D plans, as well as the Part C and Part D Independent
Review Entity (IREs) (42 CFR 422.582 and 42 CFR 423.582) to allow extensions to file an
appeal. Specifically, 42 CFR 422.582(c) and 42 CFR 423.582(c) allow a Part C or Part D
plan to extend the timeframe for filing a request if there is good cause for the late filing.
In addition, the Part D IRE may find good cause for late filing of a request for
reconsideration. When the PHE ends, these flexibilities will continue to apply
consistent with existing authority and requests for appeals must meet the existing
regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966), and the Part C and Part D IREs to waive requirements for
timeliness for requests for additional information to adjudicate appeals. In addition,
under applicable regulations, MA plans may extend the timeframe to adjudicate
organization determinations and reconsiderations for medical items and services (but
not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the
extension is justified and in the enrollee's interest due to the need for additional
medical evidence from a noncontract provider that may change an MA organization's
decision to deny an item or service; or, the extension is justified due to extraordinary,
exigent, or other non-routine circumstances and is in the enrollee's interest (42 CFR
422.568(b)(1)(i), 42 CFR 422.572(b)(1) and 42 CFR 422.590(f)(1)). When the PHE ends,
these flexibilities will continue to apply consistent with existing authority, and
requests for appeals must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR
405.910) and MA and Part D plans, as well as the Part C and Part D IREs, to process an
appeal even with incomplete Appointment of Representation forms (see 42 CFR 422.561
and 42 CFR 423.560 for definitions of “representative”). However, any communication
was sent only to the beneficiary. When the PHE ends, this flexibility will continue to
apply, consistent with existing guidance for the MACs and QIC in the FFS program. For
MA and Part D plans, as well as the Part C and Part D IREs, this flexibility will no longer
apply. The MA and Part D plans, as well as the Part C and D IREs, must process the
appeals based on regulatory requirements (42 CFR 422.582(f)-(g), 42 CFR 423.582(e)-(f),
42 CFR 422.592(d)-(e), and 42 CFR 423.600(g)-(h)).
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs,
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to process requests for appeal that don’t meet the required elements, but instead use
information that is available (42 CFR 422.562 and 42 CFR 423.562). When the PHE ends,
requests for appeals must meet the existing regulatory requirements.
• During the PHE, CMS has been allowing MACs and QICs in the FFS program (42 CFR 405.
950 and 42 CFR 405.966) and MA and Part D plans, as well as the Part C and Part D IREs,
to utilize all flexibilities available in the appeal process as if good cause requirements are
satisfied. When the PHE ends, these flexibilities may only be provided consistent with
existing regulatory authority.
Additional Guidance
• The Interim Final Rules and waivers can be found at: https://www.cms.gov/about-
cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-
waivers.
• CMS has released guidance to providers related to relaxed reporting requirements for
quality reporting programs at https://www.cms.gov/files/document/guidance-memo-
exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
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