Ppr Int D698C32Bf004E0Fe Teaching Hospitals Teaching Physicians And Medical Residents Pdf - Ppr Int D698C32Bf004E0Fe Teaching Hospitals.
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A CMS fact sheet, Teaching Hospitals, Teaching Physicians and Medical Residents: CMS Flexibilities to Fight COVID-19, with pages dated 11/6/2023, on Medicare and Medicaid flexibilities used during the COVID-19 Public Health Emergency (PHE). It describes a three-phase CMS review of PHE waivers and flexibilities to prepare the health care system for operation after the PHE. On COVID-19 vaccines, it recalls the October 28, 2020 Interim Final Rule and states that CMS will continue to pay approximately $40 per dose for administering the vaccines in most outpatient settings, moving to approximately $30 per dose from January 1 of the year after the EUA declaration ends. It also sets out an additional payment of approximately $36 per dose for administering the vaccine in the patient's home.
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Teaching Hospitals, Teaching Physicians and Medical Residents: 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.
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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
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 that
the PHE ends. 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 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.
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More information: COVID-19 vaccine toolkits
• Providers
o Payment
o Billing
o Coding
• Health & Drug Plans
• State Medicaid programs
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 if 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:
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• 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.
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.
Medicare 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:
https://www.cms.gov/COVIDOTCtestsProvider. This program will end at the end of the COVID-
19 public health emergency.
Workforce
• Application of Teaching Physician Regulations: Under current rules, Medicare payment
is made for services furnished by a teaching physician involving residents only if the
physician is physically present for the key portion of the service or procedure, and
immediately available to furnish services during the entire procedure, where applicable.
During the COVID-19 PHE, teaching physicians may use audio/video real time
communications technology to interact with the resident through virtual means, which
would meet the requirement that they be present for the key portion of the service,
including when the teaching physician involves the resident in furnishing Medicare
Telehealth services. 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
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involving teaching physicians and residents further through our rulemaking process.
These flexibilities do 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.
• Teaching physicians involving residents in providing care at certain primary care centers
can provide the necessary direction, management, and review for services furnished by
up to four residents at a time using audio/video real-time communications technology.
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.
During the PHE, teaching physicians can oversee and bill for an expanded scope of care
furnished by up to four residents at a time in certain primary care centers, including all
levels of an office/outpatient evaluation and management (E/M) visit, telephone E/M,
care management, and communication technology-based services. After the PHE,
teaching physicians cannot bill for levels 4-5 of an office/outpatient evaluation and
management (E/M) visit furnished by residents in these primary care centers in any
location.
• Resident Moonlighting: Under our permanent policy, Medicare considers the services of
residents that are not related to their approved graduate medical education programs
and performed in the outpatient department or the emergency department of a
hospital as the resident’s separately billable physicians’ services. Medicare also
considers the services of residents that are not related to their approved GME programs
and furnished to inpatients of a hospital in which they have their training program as
separately billable physicians’ services. This is unchanged and will continue after the
PHE.
• Counting of Resident Time at Alternate Locations: Existing regulations have specific rules
on when a hospital may count a resident for purposes of Medicare direct graduate
medical education (DGME) payments or indirect medical education (IME) payments.
Normally, if the resident is performing activities within the scope of his/her approved
program in his/her own home, or a patient’s home, the hospital may not count the
resident. During the COVID-19 PHE, a hospital that is paying the resident’s salary and
fringe benefits for the time that the resident is at home or in a patient’s home, but
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performing duties within the scope of the approved residency program and meeting
appropriate physician supervision requirements, could claim that resident for IME and
DGME purposes. This allowed medical residents to perform their duties in alternative
locations, including their own home or a patient’s home, as long as such activities meet
appropriate physician supervision requirements. When the COVID-19 PHE ends, a
hospital may not count a resident for purposes of Medicare DGME payments or IME
payments if the resident is performing activities within the scope of his/her approved
program in his/her own home, or a patient’s home.
• Graduate Medical Education (GME) Residents’ Training in Other Hospitals: During the
COVID-19 PHE, a teaching hospital that sends residents to other hospitals has been able
to continue to claim those residents in the teaching hospital’s IME and DGME FTE
resident counts, if certain requirements are met. Those requirements include that 1) the
teaching hospital sends the resident to the other hospital in response to the COVID-19
pandemic; 2) the time spent by the resident training at the other hospital is in lieu of
time that would have been spent training at the sending hospital; and 3) the time that
the resident spent training immediately prior to and/or subsequent to the time frame
that the COVID-19 PHE has been in effect has been included in the FTE count for the
sending hospital. Moreover, the presence of residents in non-teaching hospitals has not
triggered establishment of IME and/or DGME FTE resident caps at those non-teaching
hospitals. Specifically, for DGME, the presence of residents in non-teaching hospitals has
not triggered establishment of PRAs at those non-teaching hospitals. When the COVID-
19 PHE ends, a teaching hospital that sends residents to other hospitals cannot claim
those residents in its IME and DGME FTE resident counts. Also, when the COVID-19 PHE
ends, the presence of residents in non-teaching hospitals will trigger establishment of
IME and/or DGME FTE resident caps at those non-teaching hospitals (and for DGME, it
will trigger establishment of PRAs at those non-teaching hospitals).
• GME Affiliation Agreements Extended Deadline: Due to the COVID-19 Public Health
Emergency (PHE), under the authority of section 1135(b)(5) of the Social Security Act
(the Act), CMS waived the July 1 submission deadline, under 42 CFR 413.79(f)(1) for new
Medicare GME affiliation agreements, and the June 30 deadline, under the May 12,
1998 Health Care Financing Administration Final Rule (63 FR 26318, 26339, 26341) for
amendments of existing Medicare GME affiliation agreements. That is, during the
COVID-19 PHE, instead of requiring that new Medicare GME affiliation agreements be
submitted to CMS and the MACs by July 1, 2020 (for the academic year starting July 1,
2020), and that amendments to Medicare GME affiliation agreements be submitted to
CMS and the MACs by June 30, 2020 (for the academic year ending June 30, 2020), CMS
allowed hospitals to submit new and/or amended Medicare GME affiliation agreements
as applicable to CMS and the MACs by January 1, 2021. Similarly, CMS allowed hospitals to
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submit new Medicare GME affiliation agreements by January 1, 2022 (for the academic year
starting July 1, 2021) and allowed hospitals to submit amended Medicare GME affiliation
agreements by January 1, 2022 (for the academic year ending June 30, 2021). CMS did not
modify subsequent deadlines for hospitals to submit new and/or amended Medicare
GME affiliation agreements (as applicable), to CMS and the MACs, and returned to the
otherwise applicable July 1 and June 30 deadlines.
• IME Payments Held Harmless for Temporary Increase in Beds: During the COVID-19 PHE,
CMS has held teaching hospitals harmless from a reduction in IME payments due to
beds temporarily added during the COVID-19 PHE, by not considering such beds when
determining IME payments. When the COVID-19 PHE ends, any added beds will be
considered in determining the hospital’s IME payments.
• Inpatient Psychiatric Facilities (IPFs) and Inpatient Rehabilitation Facilities (IRFs)
Teaching Status Adjustment Payments: To ensure that teaching IPFs and IRFs can
alleviate bed capacity issues by taking patients from the inpatient acute care hospitals
without being penalized by lower teaching status adjustments, we have been freezing
the IPFs’ and IRFs’ teaching status adjustment payments at their values prior to the PHE.
For the duration of the COVID-19 PHE, a teaching IPF’s and a teaching IRF’s teaching
status adjustment payments have been the same as they were on the day before the
COVID-19 PHE was declared. When the COVID-19 PHE ends, any change to a teaching
IPF’s or a teaching IRF's average daily census will be considered in determining its
teaching status adjustment payments.
• Sterile Compounding: CMS has been waiving hospital sterile compounding requirements
to allow used face masks to be removed and retained in the compounding area to be re-
donned and reused during the same work shift in the compounding area only. This
conserves scarce face mask supplies. CMS has not been reviewing the use and storage
of facemasks under these requirements. This waiver will end at the conclusion of the
COVID-19 PHE.
• Medical Staff Requirements: CMS has been waiving the Medical Staff requirements at 42
CFR §482.22(a)(1)-(4) to allow for physicians, whose privileges would have expired, to
continue practicing at the hospital and for new physicians to be able to practice in the
hospital, before full medical staff/governing body review and approval, to address
workforce concerns related to COVID-19. This waiver will end at the conclusion of the
COVID-19 PHE.
• Physician services: CMS has been waiving 482.12(c)(1)-(2) and §482.12(c)(4), which
require that Medicare patients be under the care of a physician and that a physician be
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on call at all times. This allows hospitals to use other practitioners, such as physician’s
assistants and nurse practitioners, to the fullest extent possible. These waivers have
been implemented while remaining consistent with a state’s emergency preparedness
or pandemic plan. These waivers will end at the conclusion of the COVID-19 PHE.
• Anesthesia services: CMS has been waiving the requirements, at 42 CFR 482.52(a)(5),42
CFR 485.639(c)(2) and 42 CFR 416.42 (b)(2), that a certified registered nurse anesthetist
(CRNA) is under the supervision of a physician. CRNA supervision has been at the
discretion of the hospital or Ambulatory Surgical Center (ASC) and state law. This waiver
applies to hospitals, CAHs, and ASCs. These waivers allow CRNAs to function to the
fullest extent of their licensure and has been implemented while remaining consistent
with a state or pandemic/emergency plan. This will expire at the end of the COVID-19
public health emergency.
• Respiratory care services: We have been waiving the requirement at 42 CFR 482.57(b)(1)
that hospitals designate, in writing, the personnel qualified to perform specific
respiratory care procedures and the amount of supervision required for personnel to
carry out specific procedures. This flexibility has been implemented while remaining
consistent with a state or pandemic/emergency plan. Not being required to designate
these professionals in writing allows qualified professionals to operate to the fullest
extent of their licensure and training in providing patient care for respiratory illnesses.
This will expire at the end of the COVID-19 public health emergency.
• CAH Personnel qualifications: CMS has been waiving the minimum personnel
qualifications for clinical nurse specialist, nurse practitioners, and physician assistants
described at 42 CFR 485.604(a)(2), 42 CFR 485.604(b)(1)-(3), and 42 C.F.R 485.604(c)(1)-
(3). Clinical Nurse Specialists, Nurse Practitioners, and Physician Assistants still have to
meet state requirements for licensure and scope of practice, but not additional federal
requirements that may exceed state requirements. This gives states and facilities more
flexibility in using clinicians in these roles to meet increased demand. These flexibilities
have been implemented while remaining consistent with a state or
pandemic/emergency plan. This will expire at the end of the COVID-19 public health
emergency.
• CAH staff licensure: CMS has been deferring to staff licensure, certification, or
registration to state law by waiving the requirement at 42 CFR 485.608(d) that staff of
the CAH be licensed, certified, or registered in accordance with applicable federal, state,
and local laws and regulations. The CAH and its staff must still be in compliance with
applicable federal, state and local laws and regulations, and all patient care must be
furnished in compliance with state and local laws and regulations. This waiver defers all
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licensure, certification, and registration requirements for CAH staff to the state, which
adds flexibility where federal requirements are more stringent. This flexibility has been
implemented while consistent with a state or pandemic/emergency plan. CMS will end
this waiver at the conclusion of the COVID-19 PHE.
CMS Hospitals Without Walls (Temporary Expansion Sites)
• Hospitals Able to Provide Inpatient Care in Temporary Expansion Sites: As part of the
CMS Hospital Without Walls initiative, during the PHE hospitals could provide hospital
services in other health care facilities and sites not otherwise considered to be part of a
health care facility, or set up temporary expansion sites to help address the urgent need
to increase capacity to care for patients. During the PHE, CMS provided additional
flexibilities for hospitals to create surge capacity by allowing them to provide room and
board, nursing, and other hospital services at remote locations or sites not considered
part of a health care facility, such as hotels or community facilities. This flexibility allows
hospitals to separate COVID-19 positive patients from other non-COVID-19 patients to
help efforts around infection control and preservation of personal protective equipment
(PPE). For example, for the duration of the PHE, CMS allowed hospitals to screen
patients at offsite locations and furnish inpatient and outpatient services at temporary
expansion sites. Hospitals have still been expected to control and oversee the services
provided at an alternative location. When the COVID-19 PHE ends, hospitals will be
required to provide services to patients within their hospital departments.
• Relaxing Conditions of Participation. Under an additional initiative, CMS has been
relaxing certain conditions of participation (CoPs) for hospital operations to maximize
hospitals' ability to focus on patient care. The same initiative has also allowed currently
enrolled ambulatory surgical centers (ASCs) to temporarily enroll as hospitals and to
provide hospital services to help address the urgent need to increase hospital capacity
to take care of patients. Other interested entities, such as independent freestanding
emergency departments IFEDs), could pursue enrolling as an ASC and then pursue
converting their enrollment to hospital during the PHE. As of December 1, 2021, no new
ASC or new IFED requests to temporarily enroll as hospitals have been accepted. Refer
to https://www.cms.gov/files/document/qso-22-03-asc-hospital.pdf for more
information. When the PHE ends, ASCs can only be paid under the ASC payment
system for services on the ASC Covered Procedures List. When the COVID-19 PHE
ends, IFEDs cannot bill Medicare for services as their temporary Medicare certification
would end.
• Off Site Patient Screening: CMS has been waiving the enforcement of section 1867(a) of
the Social Security Act (the Emergency Medical Treatment and Labor Act, or EMTALA).
This has been allowing hospitals, psychiatric hospitals, and critical access hospitals
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(CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the
spread of COVID-19, while consistent with the state emergency preparedness or
pandemic plan. This waiver will terminate at the end of the COVID-19 PHE.
• Expanded Ability for Hospitals to Offer Long-term Care Services (Swing Beds) for Patients
Who do not Require Acute Care but do Meet the Skilled Nursing Facility (SNF) Level of
Care Criteria as Set Forth at 42 CFR 409.31: Under section 1135(b)(1) of the Act, CMS
has been waiving the requirements at 42 CFR 482.58, “Special Requirements for hospital
providers of long-term care services (swing beds)” subsections (a)(1)-(4) “Eligibility” to
allow hospitals to establish SNF swing beds payable under the SNF prospective payment
system (PPS) to provide additional options for hospitals with patients who no longer
require acute care, but are unable to find placement in a SNF.
In order to qualify for this waiver, hospitals must have:
o Not used SNF swing beds for acute level care.
o Complied with all other hospital conditions of participation and those SNF provisions
set out at 42 CFR 482.58(b) to the extent not waived.
o Been consistent with the state’s emergency preparedness or pandemic plan.
Hospitals must call the CMS Medicare Administrative Contractor (MAC) enrollment
hotline to add swing-bed services. The hospital must attest to CMS that:
o They have made a good faith effort to exhaust all other options.
o There are no skilled nursing facilities within the hospital’s catchment area that under
normal circumstances would have accepted SNF transfers, but are currently not
willing to accept or able to take patients because of the COVID-19 public health
emergency (PHE).
o The hospital meets all waiver eligibility requirements.
o They have a plan to discharge patients as soon as practicable, when a SNF bed
becomes available, or when the PHE ends, whichever is earlier.
This waiver applies to all Medicare enrolled hospitals (except psychiatric and long-term
care hospitals that need to provide post-hospital SNF level swing-bed services for non-
acute care patients in hospitals) consistent with the state’s emergency preparedness or
pandemic plan. The hospital shall not bill for SNF PPS payment using swing beds when
patients require acute level care or continued acute care at any time while this waiver is
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in effect. This waiver is permissible for swing bed admissions during the COVID-19 PHE
with an understanding that the hospital must have a plan to discharge swing bed
patients as soon as practicable, when a SNF bed becomes available, or when the PHE
ends, whichever is earlier. This waiver will terminate at the end of the COVID-19 PHE.
• Paperwork Requirements: CMS has been waiving certain specific paperwork
requirements only for hospitals that are considered to be impacted by a widespread
outbreak of COVID-19. This allows hospitals to establish COVID-19 specific areas. This
waiver will terminate at the end of the PHE. Hospitals that are located in a state that has
widespread confirmed cases would not be required to meet the following requirements:
o 42 CFR §482.13(d)(2) with respect to timeframes in providing a copy of a medical
record.
o 42 CFR §482.13(h) related to patient visitation, including the requirement to have
written policies and procedures on visitation of patients who are in COVID-19
isolation and quarantine processes.
o 42 CFR §482.13(e)(1)(ii) regarding seclusion.
• Physical Environment: CMS has been waiving certain physical environment requirements
under the Medicare conditions of participation at 42 CFR §482.41 and 42 CFR §485.623
to allow for increased flexibilities for surge capacity and patient quarantine at hospitals,
psychiatric hospitals, and critical access hospitals (CAH) as a result of COVID-19. CMS has
been permitting facility and non-facility space that is not normally used for patient care
to be utilized for patient care or quarantine, provided the location is approved by the
state (ensuring that safety and comfort for patients and staff are sufficiently addressed)
and is consistent with the state’s emergency preparedness or pandemic plan. This
allows for increased capacity and promotes appropriate cohorting of COVID-19 patients.
States are still subject to obligations under the integration mandate of the Americans
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with Disabilities Act, to avoid subjecting persons with disabilities to unjustified
institutionalization or segregation1. This waiver will terminate at the end of the COVID-
19 PHE.
• Critical Access Hospital Length of Stay: CMS has been waiving the Medicare
requirements that Critical Access Hospitals (CAHs) limit the number of beds to 25 and
that the length of stay be limited to 96 hours under the Medicare conditions of
participation regarding number of beds and length of stay at 42 CFR §485.620. This will
expire at the end of the COVID-19 public health emergency.
• CAH Status and location: CMS has been waiving the requirement at 485.610(b) that the
CAH be located in a rural area or an area being treated as rural, allowing the CAHs
flexibility in the establishment of surge site locations. Waiving the requirement at
485.610(e) regarding off-campus and co-location requirements allows the CAH flexibility
in establishing off-site locations. In an effort to facilitate the establishment of CAHs
without walls, these waivers remove restrictions on CAHs regarding their rural location
and their location relative to other hospitals and CAHs. These flexibilities have been
implemented while consistent with state or emergency or pandemic plan. CMS will end
this waiver at the conclusion of the COVID-19 PHE.
• Housing Acute Care Patients in Excluded Distinct Part Units: During the PHE, CMS has
been waiving requirements to allow acute care hospitals to house acute care inpatients
in excluded distinct part units, where the distinct part unit’s beds are appropriate for
acute care inpatients. The Inpatient Prospective Payment System (IPPS) hospital bill for
the care and annotate the patient’s medical record to indicate the patient is an acute
care inpatient being housed in the excluded unit because of capacity issues related to
the disaster or emergency. At the end of the PHE, acute care hospitals cannot bill for
acute care inpatients housed in excluded distinct part units.
• Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital:
During the PHE, CMS has been waiving requirements to allow acute care hospitals with
²Please note that consistent with the integration mandate of Title II of the ADA and the Olmstead vs LC decision, states are
obligated to offer/provide discharge planning and/or case management/transition services, as appropriate, to individuals who
are removed from their Medicaid home- and community-based services under these authorities during the course of the public
health emergency, as well as to individuals with disabilities who may require these services in order to avoid unjustified
institutionalization or segregation. Transition services/case management and/or discharge planning would be provided to
facilitate these individuals in their return to the community when their condition and public health circumstances permit.
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excluded distinct part inpatient psychiatric units that, as a result of a disaster or
emergency, need to relocate inpatients from the excluded distinct part psychiatric unit
to an acute care bed and unit. The hospital should continue to bill for inpatient
psychiatric services under the Inpatient Psychiatric Facility Prospective Payment System
(IPF PPS) for such patients and annotate the medical record to indicate the patient is a
psychiatric inpatient being cared for in an acute care bed because of capacity or other
exigent circumstances related to the COVID-19 Public Health emergency. This waiver
could be utilized where the hospital’s acute care beds are appropriate for psychiatric
patients and the staff and environment are conducive to safe care. For psychiatric
patients, this includes assessment of the acute care bed and unit location to ensure
those patients at risk of harm to self and others are safely cared for. At the end of the
PHE, inpatients receiving psychiatric services paid under the IPF PPS and furnished by
the excluded distinct part psychiatric unit of an acute care hospital cannot be housed
in an acute care bed and unit.
• Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a
Hospital: During the PHE, CMS has been waiving requirements to allow acute care
hospitals with excluded distinct part inpatient rehabilitation units that, as a result of a
disaster or emergency, need to relocate inpatients from the excluded distinct part
rehabilitation unit to an acute care bed and unit. The hospital should continue to bill for
inpatient rehabilitation services under the Inpatient Rehabilitation Facility Prospective
Payment System for such patients and annotate the medical record to indicate the
patient is a rehabilitation inpatient being cared for in an acute care bed because of
capacity or other exigent circumstances related to the disaster or emergency. This
waiver could be utilized where the hospital’s acute care beds are appropriate for
providing care to rehabilitation patients and such patients continue to receive intensive
rehabilitation services. At the end of the PHE, inpatients receiving rehabilitation
services paid under the IRF PPS and furnished by the excluded distinct part
rehabilitation unit of an acute care hospital cannot be housed in an acute care bed
and unit.
• Telemedicine: CMS has been waiving the provisions related to telemedicine for hospitals
and CAHs at 42 CFR 482.12(a)(8)-(9) and 42 CFR 485.616(c), making it easier for
telemedicine services to be furnished to the hospital's patients through an agreement
with an off-site hospital. This allows for increased access to necessary care for hospital
and CAH patients, including access to specialty care. CMS will end this waiver at the
conclusion of the COVID-19 PHE.
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
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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.
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
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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.
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.
• Verbal Orders: CMS has been waiving the requirements of 42 CFR §482.23, §482.24 and
§485.635(d)(3) to allow for additional flexibilities related to verbal orders where read-
back verification is still required but authentication may occur later than 48 hours. This
allows for more efficient treatment of patients in a surge situation. CMS will end this
waiver at the conclusion of the PHE.
• Reporting Requirements: CMS has been waiving reporting requirements at §482.13(g)
(1)(i)-(ii), which require hospitals to report patients in an intensive care unit whose
death is caused by their disease process, but who required soft wrist restraints to
prevent pulling tubes/IVs, may be reported later than close of business next business
day, provided any death where the restraint may have contributed is continued to be
reported within standard time limits. Due to current hospital surge, we are waiving this
requirement to ensure that hospitals are focusing on increased care demands and
patient care. CMS will end this waiver at the conclusion of the PHE.
• Limit Discharge Planning for Hospital and CAHs: To allow hospitals and CAHs more time
to focus on increasing care demands, discharge planning has focused on ensuring that
patients are discharged to an appropriate setting with the necessary medical
information and goals of care. CMS has been waiving detailed regulatory requirements
to provide information regarding discharge planning, as outlined in 42 CFR
§482.43(a)(8), §482.61(e), and 485.642(a)(8). The hospital, psychiatric hospital, and CAH
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must assist patients, their families, or the patient's representative in selecting a post-
acute care provider by using and sharing data that includes, but is not limited to, home
health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF),
and long-term care hospital (LTCH) data on quality measures and data on resource use
measures. The hospital must ensure that the post-acute care data on quality measures
and data on resource use measures is relevant and applicable to the patient's goals of
care and treatment preferences. During this public health emergency, a hospital may
not be able to assist patients in using quality measures and data to select a nursing
home or home health agency, but must still work with families to ensure that the
patient discharge is to a post-acute care provider that is able to meet the patient’s care
needs. CMS will end this waiver at the conclusion of the PHE.
• Modify Discharge Planning for Hospitals: Patients must continue to be discharged to an
appropriate setting with the necessary medical information and goals of care. To
address the COVID-19 pandemic, CMS has been waiving certain requirements related to
hospital discharge planning for post-acute care services at 42 CFR §482.43(c), so as to
expedite the safe discharge and movement of patients among care settings, and to be
responsive to fluid situations in various areas of the country. CMS has been waiving
certain requirements for those patients discharged home and referred for HHA services,
or for those patients transferred to a SNF for post-hospital extended care services, or
transferred to an IRF or LTCH for specialized hospital services. For example, a patient
may not be able to receive a comprehensive list of nursing homes in the geographic
area, but must still be discharged to a nursing home that is available to provide the care
that is need by the patient. CMS will end this waiver at the conclusion of the PHE.
• Medical Records: CMS has been waiving 42 CFR §482.24(a) through (c), which cover the
subjects of the organization and staffing of the medical records department,
requirements for the form and content of the medical record, and record retention
requirements. CMS has been waiving these requirements under 42 CFR
§482.24(c)(4)(viii) and §485.638(a)(4)(iii) related to medical records to allow flexibility in
completion of medical records within 30 days following discharge and for CAHs that all
medical records must be promptly completed. This flexibility has allowed clinicians to
focus on the patient care at the bedside during the pandemic. CMS will end this waiver
at the conclusion of the PHE.
• Flexibility in Patient Self Determination Act Requirements (Advance Directives): CMS has
been waiving the requirements at section 1902(a)(58) and 1902(w)(1)(A) for Medicaid,
1852(i) (for Medicare Advantage), and 1866(f) and 42 CFR 489.102 for Medicare, which
require hospitals and CAHs to provide information about their advance directive policies
to patients. We are waiving this requirement to allow for staff to more efficiently deliver
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care to a larger number of patients. This waiver will terminate at the end of the COVID-
19 PHE.
• Extension for Inpatient Prospective Payment System (IPPS) Wage Index Occupational Mix
Survey Submission: CMS collects data every three years on the occupational mix of
employees for each short-term, acute care hospital participating in the Medicare
program. During the PHE, CMS granted an extension for data submission for hospitals
nationwide affected by COVID-19 until August 3, 2020. Due to continued COVID related
concerns from hospitals about meeting that deadline, CMS further extended this
deadline to September 3, 2020. Hospitals could submit their occupational mix surveys
along with complete supporting documentation to their MACs by no later than
September 3, 2020. Hospitals could then submit revisions to their occupational mix
surveys to their MACs, if needed, by no later than September 10, 2020. The next
collection of the wage index occupational mix survey data (based on 2022 data) is
expected to be collected in Summer 2023.
• Extension of Comprehensive Care for Joint Replacement (CJR) Model Year 5: In the IFC
issued October 28, 2020, CMS extended Performance Year (PY) five of the
Comprehensive Care for Joint Replacement (CJR) model an additional 6 months, so that
PY five ended September 30, 2021. To accommodate the extension of PY 5, CMS
performed a 12-month reconciliation period and a 9-month reconciliation period in PY
5. Further, the adjustment to the extreme and uncontrollable circumstances policy for
COVID-19, previously established in Medicare and Medicaid Programs: Policy and
Regulatory Revisions in Response to the COVID-19 Public Health Emergency IFC, expired
on March 31, 2021. Beginning on April 1, 2021 through the end of the model, the
extreme and uncontrollable circumstances policy for COVID-19 has been episode based,
where actual episode payments are capped at the quality adjusted target price for an
episode with actual episode payments that include a claim with a COVID-19 diagnosis
code. Lastly, to ensure that the model continues to include the same inpatient Lower
Extremity Joint Replacement (LEJR) procedures, despite the adoption of new MS-DRGs
521 and 522 to describe those procedures, CMS made a technical change, retroactive to
October 1, 2020, to include these new DRGs in the model. Questions about the CJR
model can be submitted via email at CJRSupport@cms.hhs.gov.
• Postponement of Application Deadline to the Medicare Geographic Classification Review
Board. Per requirements at section 1886(d)(10)(C)(ii) of the Social Security Act (the Act)
and 42 CFR 412.256(a)(2), September 1, 2020 was the deadline to submit an application
to the Medicare Geographic Classification Review Board (MGCRB) for FY 2022
reclassifications. These provisions require applications to be filed through OH CDMS
(https://www.cms.gov/Regulations-and-Guidance/Review-Boards/MGCRB/Electronic-
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Filing) not later than the first day of the 13-month period preceding the federal fiscal
year for which reclassification is requested.
Due to the COVID-19 Public Health Emergency (PHE), under the authority of section
1135(b)(5) of the Act, CMS postponed the September 1 deadline until 15 days after the
public display date of the FY 2021 IPPS/LTCH final rule by the Office of the Federal
Register.
CMS did not modify the respective September 1st deadlines for submission of
applications for FY 2023 or FY 2024 reclassifications to the MGCRB due to the COVID-19
PHE.
• Utilization review. CMS has been waiving these requirements at 42 CFR §482.1(a)(3) and
42 C.F.R §482.30 that require hospitals participating in Medicare and Medicaid to have a
utilization review plan that meets specified requirements. CMS has been waiving the
entire Utilization Review CoP at §482.30, which requires that a hospital must have a
utilization review (UR) plan with a UR committee that provides for review of services
furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of
the admission, duration of stay, and services provided. These flexibilities have been
implemented while remaining consistent with a state or pandemic/emergency
plan. Removing these administrative requirements allow hospitals to focus more
resources on providing direct patient care. CMS will end this waiver at the conclusion
of the PHE.
• Quality assessment and performance improvement program. CMS has been waiving
482.21(a)-(d) and (f), and 485.641(a), (b), and (d), which provide details on the scope of
the program, the incorporation and setting of priorities for the program’s performance
improvement activities, and integrated QAPI programs (for hospitals that are a part of a
hospital system). These flexibilities, which apply to both hospitals and CAHs, have been
implemented while remaining consistent with a state’s emergency preparedness or
pandemic plan. We expect any improvements to the plan to focus on the Public Health
Emergency. While this waiver decreases burden associated with the development of a
hospital or CAH QAPI program, the requirement that hospitals and CAHs maintain an
effective, ongoing, hospital-wide, data-driven quality assessment and performance
improvement program will remain. This waiver applies to both hospitals and CAHs. CMS
will end this waiver at the conclusion of the PHE.
• Nursing services: CMS has been waiving the provision at 42 CFR 482.23(b)(4), 42 CFR
482.23(b)(7), and 485.635(d)(4), which require the nursing staff to develop and keep
current a nursing care plan for each patient, and the provision that requires the hospital
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to have policies and procedures in place establishing which outpatient departments are
not required to have a registered nurse present. These waivers allow nurses increased
time to meet the clinical care needs of each patient and allow for the provision of
nursing care to an increased number of patients. In addition, we have expected that
hospitals would need relief for the provision of inpatient services and, as a result, the
requirement to establish nursing-related policies and procedures for outpatient
departments has been unnecessary. These flexibilities apply to both hospitals and CAHs,
and have been implemented while remaining consistent with a state or
pandemic/emergency plan. CMS will end this waiver at the conclusion of the PHE.
• Food and dietetic service: CMS has been waiving the requirement at 42 CFR 482.28(b)(3)
to have a current therapeutic diet manual approved by the dietitian and medical staff
readily available to all medical, nursing, and food service personnel. Such manuals have
not needed to be maintained at surge capacity sites. These flexibilities have been
implemented while remaining consistent with a state or pandemic/emergency plan.
Removing these administrative requirements allow hospitals to focus more resources on
providing direct patient care. CMS will end this waiver at the conclusion of the PHE.
• Written policies and procedures for appraisal of emergencies at off campus hospital
departments: CMS has been waiving 482.12(f)(3) related to Emergency services, with
respect to the surge facility(ies) only, such that written policies and procedures for staff
to use when evaluating emergencies are not required for surge facilities. This removes
the burden on facilities to develop and establish additional policies and procedures at
their surge facilities or surge sites related to the assessment, initial treatment, and
referral of patients. These flexibilities have been implemented while remaining
consistent with a state’s emergency preparedness or pandemic plan. CMS will end this
waiver at the conclusion of the PHE.
• Emergency preparedness policies and procedures: CMS has been waiving 482.15(b) and
485.625(b), which require the hospital and CAH to develop and implement emergency
preparedness policies and procedures, and 482.15(c)(1)-(5) and 485.625(c)(1)-(5), which
require that the emergency preparedness communication plans for hospitals and CAHs
to contain specified elements with respect to the surge site. The requirement under the
communication plan requires hospitals and CAHs to have specific contact information
for staff, entities providing services under arrangement, patients' physicians, other
hospitals and CAHs, and volunteers. This has not been an expectation for a temporary
expansion site. These waivers remove the burden on facilities to establish these policies
and procedures for their surge facilities or surge sites. CMS will end these waivers at
the conclusion of the PHE.
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• Signature Requirements: CMS has been waiving signature and proof of delivery
requirements for Part B drugs and Durable Medical Equipment when a signature cannot
be obtained because of COVID-19. Suppliers have been documenting 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.
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.
• Providers that continue to experience the impacts of the PHE and require additional
time to file their cost report may submit a request to their MAC in accordance with
our regulation at 42 CFR 413.24 (f)(2)(ii). The MAC has the authority to grant up to a
60-day extension of the due date for filing a cost report if the provider's operations
are significantly adversely affected due to extraordinary circumstances over which
the provider has no control, such as the PHE.
• 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
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.)
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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
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.
When the PHE ends, 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.
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Payment for Innovative COVID-19 Therapies
Enhanced Payment for COVID-19 Therapies
• Enhanced Medicare Payments for New COVID-19 Treatments: Hospital Inpatient Stays: In
order to mitigate potential financial disincentives for hospitals to provide new COVID-19
treatments and to minimize any potential payment disruption immediately following the
end of the PHE, effective for discharges occurring on or after November 2, 2020, and
through the end of the FY in which the COVID-19 PHE ends, the Medicare program has
provided an enhanced payment for eligible inpatient cases that involve use of certain new
products authorized or approved to treat COVID-19 (86 FR 45162). The enhanced payment
is equal to the lesser of: 1) 65% of the operating outlier threshold for the claim; or 2) 65% of
the costs of the case beyond the operating Medicare payment (including the 20% add-on
payment under section 3710 of the CARES Act as applicable) for eligible cases.
• Separate Medicare Payment for New COVID-19 Treatments: Hospital Outpatient
Departments: To mitigate potential financial disincentives for hospitals to provide new
COVID-19 treatments in a hospital outpatient setting during the COVID-19 PHE, CMS has
excluded FDA-authorized or approved drugs and biologicals (including blood products)
authorized or approved to treat COVID-19 (and for which the FDA authorization or approval
does not limit use to the inpatient setting) from being packaged into the Comprehensive
Ambulatory Payment Classification (C-APC) payment when these treatments are billed on
the same claim as a primary C-APC service. Instead, Medicare has been paying for these
drugs and biologicals separately for the duration of the PHE. After the PHE, payment for
these treatments will be packaged into the payment for a C-APC when these services are
billed on the same outpatient claim.
COVID-19 Diagnostic Testing
• 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 are 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.
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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 Contractor (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, to
process requests for appeal that don’t meet the required elements, but instead use
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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 describe standards of practice and flexibilities within the
current regulations for hospitals (including critical access hospitals and psychiatric
hospitals) at https://www.cms.gov/files/document/qso-20-13-hospitalspdf.pdf-2.
• CMS guidance also addresses hospital flexibilities under the Emergency Medical
Treatment and Labor Act (EMTALA) to establish alternate testing and triage sites to
address the pandemic at https://www.cms.gov/files/document/qso-20-15-
hospitalcahemtala.pdf.
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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