Long-Term Care Hospitals & Extended Neoplastic Disease Care Hospitals: CMS Flexibilities to Fight COVID-19
Summary
This is a CMS fact sheet on flexibilities for Long-Term Care Hospitals and Extended Neoplastic Disease Care Hospitals during the COVID-19 public health emergency (PHE). It states that CMS evaluated PHE waivers and flexibilities in three concurrent phases to prepare the health care system for operation after the PHE. It says that after the end of the PHE, CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in most outpatient settings through the end of the calendar year in which the Secretary ends the EUA declaration. It adds that a waiver of provider enrollment site visits for moderate and high-risk providers and suppliers terminated on 07-06-2020.
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“Long-Term Care Hospitals & Extended Neoplastic Disease Care Hospitals: CMS Flexibilities to Fight COVID-19.”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/cms-long-term-care-hospitals-extended-neoplastic-disease-care-hospitals-pdf-www-cms-gov-e339258074/
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Long-Term Care Hospitals & Extended Neoplastic Disease Care
Hospitals: 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 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 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 purchases 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 that the PHE ends, 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 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 and
authorization. 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.
Site Neutral Payment Rate Provisions
• Site Neutral Payment Rate Provisions: As required by section 3711(b) of the CARES Act,
during the Public Health Emergency (PHE) due to COVID-19, certain provisions of section
1886(m)(6) of the Social Security Act were waived relating to certain site neutral
payment rate provisions for long-term care hospitals (LTCHs).
o Section 3711(b)(1) of the CARES Act waived the payment adjustment under section
1886(m)(6)(C)(ii) of the Act for LTCHs that do not have a discharge payment
percentage (DPP) for the period that is at least 50% during the COVID-19 PHE period.
For the purposes of calculating an LTCH’s DPP, all admissions during the COVID-19
PHE period were counted in the numerator of the calculation. In other words, LTCH
cases that were admitted during the COVID-19 PHE period were counted as
discharges paid the LTCH PPS standard Federal payment rate. At the end of the
COVID-19 PHE, the payment adjustment under section 1886(m)(6)(C)(ii) of the Act is
applied for LTCHs that do not have a DPP for the period that is at least 50%.
Section 3711(b)(2) of the CARES Act provides a waiver of the application of the site-
neutral payment rate under section 1886(m)(6)(A)(i) of the Act for those LTCH
admissions that are in response to the public health emergency and occur during the
COVID-19 public health emergency (PHE) period. Under this provision, all LTCH cases
admitted during the COVID-19 public health emergency period (that is, admissions
occurring on or after January 27, 2020 through the duration of the COVID-19 PHE)
were paid the relatively higher LTCH PPS standard Federal rate. When the COVID-19
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PHE ends, all LTCH admissions, except those that meet the requirements for
exclusion from the site-neutral rate, are subject to the site-neutral payment rate
under section 1886(m)(6)(A)(i) of the Act.
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.
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
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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.
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.
• Care for Patients in Extended Neoplastic Disease Care Hospitals: For the duration of
the public health emergency, CMS issued a program participation requirement waiver
to extended neoplastic disease care hospitals to exclude inpatient stays where the
hospital admits or discharges patients in order to meet the demands of the
emergency from the greater than 20-day average length of stay requirement, which
allows these facilities to be excluded from the hospital inpatient prospective payment
system and paid an adjusted payment for Medicare inpatient operating and capital-
related costs under the reasonable cost-based reimbursement rules. At the end of
the COVID-19 PHE, Extended Neoplastic Disease Care Hospitals must comply with the
20-day average length of stay requirement at § 412.23(i)(1).
• COVID-19 Accelerated and Advance Payments (CAAP): For the most up to date
information related to the CAAP Program, please visit
https://www.cms.gov/medicare/covid-19-accelerated-and-advance-payments
• 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:
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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 wanted 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.
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
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reconsideration. When the COVID-19 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 COVID-19
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
information that is available (42 CFR 422.562 and 42 CFR 423.562). When the COVID-19
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.
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Cost Reporting
• 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.
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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