Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19
Summary
A CMS document, Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19, with the date 05/10/2023 in its page footers. It describes a CMS cross-cutting initiative that evaluated public health emergency (PHE) waivers and flexibilities in three concurrent phases. It lists flexibilities including expanded benefits and telehealth under Medicare Advantage, waiver of prior authorization for Part D drugs, relaxed refill-too-soon edits allowing up to a 90-day supply under section 3714 of the CARES Act, and flexibilities in the appeal process. It says several of these continue for the duration of the COVID-19 PHE and ends with links to additional guidance.
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“Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19.”
Original at www.cms.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/medicare-advantage-and-part-d-plans-cms-flexibilities-to-fight-covid-1-35de7fe9d7/
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Medicare Advantage and Part D Plans:
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.
Reducing Administrative Burden
• Flexibility to Provide Expanded Benefits: CMS announced in guidance it is exercising
enforcement discretion to allow Medicare Advantage plans to expand telehealth
services and other mid-year benefit enhancements beyond those included in their
approved 2020, 2021, 2022, and 2023 bids describing covered benefits, when such mid-
05/10/2023 1
year benefit enhancements are provided in connection with the COVID-19 outbreak, are
beneficial to enrollees, and are provided uniformly to all similarly situated enrollees.
CMS will continue these flexibilities for the duration of the COVID-19 PHE.
• Prior Authorization for Part D Drugs: Part D Sponsors may waive prior authorization
requirements at any time that they otherwise would apply it to Part D drugs used to
treat or prevent COVID-19 if or when such drugs are identified. Part D Sponsors can also
choose to waive or relax PA requirements at any time for other formulary drugs in order
to facilitate access with less burden on beneficiaries, plans, and providers. This
flexibility will continue for the duration of the COVID-19 PHE.
• Part D “Refill-Too-Soon” Edits and Maximum Day Supply: Consistent with section 3714
of the CARES Act, during the public health emergency for COVID-19, Part D sponsors
must permit enrollees to obtain the total supply prescribed for a covered Part D drug up
to a 90-day supply in one fill or refill if requested by the enrollee, prior authorization or
step therapy requirements have been satisfied, and no safety edits otherwise limit the
quantity or days’ supply. Part D plan sponsors must relax their “refill-too-soon” edits.
Part D sponsors continue to have operational discretion as to how these edits are
relaxed, as long as access to Part D drugs is provided at the point of sale. For purposes of
section 3714 of the CARES Act, relaxed refill-too-soon edits are safety edits, and Part D
sponsors must not permit enrollees to obtain a single fill or refill that is inconsistent with
a safety edit. This requirement will end with the COVID-19 PHE.
• Home or Mail Delivery of Part D Drugs: In situations when a disaster or emergency
makes it difficult for enrollees to get to a retail pharmacy, or enrollees are actually
prohibited from going to a retail pharmacy (e.g., in a quarantine situation), Part D
sponsors have been permitted to voluntarily relax any plan-imposed policies that may
discourage certain methods of delivery, such as mail or home delivery, for retail
pharmacies that choose to offer these delivery services in these instances. This
flexibility will continue for the duration of the COVID-19 PHE.
• Audit Reviews: CMS temporarily reprioritized audit activity in 2020 under our oversight
discretion, returned to normal oversight activities in 2021, and continued providing
flexibility to audited organizations when needed.
COVID-19 Vaccines
• CMS reminds MA organizations that they must pay for the COVID-19 vaccine and its
administration (including approved booster doses), without cost-sharing in-network,
beginning January 1, 2022, for beneficiaries enrolled in their plans.
05/10/2023 2
COVID-19 Diagnostic Testing
• Coverage of Testing and Testing-Related Services for COVID-19: As a result of the
Families First Coronavirus Response Act and the CARES Act, Medicare Advantage
Organizations are not permitted to charge cost sharing for clinical laboratory tests for
the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19, the
administration of such tests, and specified COVID-19 testing-related services during the
period March 18, 2020, through the end of the COVID-19 public health emergency
declared by the Secretary under section 319 of the Public Health Service Act. In addition,
Medicare Advantage organizations may not impose any prior authorization or other
utilization management requirements with respect to the coverage of COVID diagnostic
tests, its administration and specified testing-related services furnished on or after
March 18, 2020, and during the applicable emergency period.
COVID-19 Oral Antivirals:
• The FDA issued an emergency use authorization (EUA) for oral antivirals for the
treatment of mild-to-moderate 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.
• CMS has permitted Part D sponsors to pay pharmacy claims for dispensing fees USG-
procured Emergency Use Authorization (EUA) oral antiviral drugs for treatment of
COVID-19 without enrollee cost- sharing, and report prescription drug events (PDEs) for
the dispensing fee claims. Additionally, the agency has strongly encouraged Part D
sponsors to pay dispensing fees to for these drugs that may be higher than a sponsor’s
usual negotiated dispensing fees, given the unique circumstances during the COVID-19
PHE. This flexibility will continue following the end of the COVID-19 PHE while USG-
procured product remains available.
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.
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
05/10/2023 3
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 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 COVID-19 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.
05/10/2023 4
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 and https://www.cms.gov/about-cms/emergency-preparedness-response-
operations/current-emergencies/coronavirus-waivers.
• Updated Guidance for Medicare Advantage Organizations can be found at:
https://www.cms.gov/files/document/updated-guidance-ma-and-part-d-plan-sponsors-
42120.pdf.
• COVID-related HPMS memos. MA and Part D plan guidance. Current emergencies |
CMS.
• HPMS memos on Part C and Part D programs are on this page under the “downloads”
section: https://www.cms.gov/medicare/health-
plans/healthplansgeninfo.https://www.cms.gov/medicare/health-
plans/healthplansgeninfo.
• Most recent memo:
https://www.cms.gov/files/document/extendedcovidflexibilitieshpmsmemo1142022.pd
f.
05/10/2023 5
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