The end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023, presents both regulatory and business risks for Medicare Advantage (MA) plans as some (but not all) emergency declarations and regulatory flexibilities also come to an end. This article summarizes the major MA requirements and flexibilities related to the COVID-19 pandemic and addresses whether they will end along with the PHE. MA plans should monitor the changes to requirements and flexibilities, evaluate the potential impact on beneficiaries, and consider whether operational adjustments or targeted beneficiary communications are appropriate to help mitigate any potential impacts.
The era of the COVID-19 pandemic is approaching its official end. The Biden Administration plans to end the national emergency for COVID-19, declared under Section 201 of the National Emergencies Act, and the public health emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service Act, on May 11, 2023.
These emergency declarations have been in place since March 2020. They enabled the US Department of Health and Human Services (HHS) and its operating divisions to waive or modify certain requirements for Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). In some instances, HHS linked its exercise of enforcement or programmatic discretion to the declarations. Congress later enacted legislation that imposed new requirements or provided HHS with additional flexibilities tied to the declarations (See generally Families First Coronavirus Response Act; Coronavirus Aid, Relief, and Economic Security Act (CARES); American Rescue Plan Act of 2021; Inflation Reduction Act of 2022; Consolidated Appropriations Act, 2023 (CAA)).
HHS and the Centers for Medicare & Medicaid Services (CMS) implemented new requirements and waived or modified others for the Medicare Advantage (MA) program. For example, MA plans received increased flexibility to waive cost-sharing for COVID-19 treatments and prior authorization for certain services. Most of those changes promise to end with the PHE.
The end of the PHE presents both regulatory and business risks for MA plans. MA plans that overlook the end of the PHE may suddenly find themselves out of compliance with program requirements. At the same time, a return to pre-pandemic requirements may increase plan costs and produce unintended economic and clinical consequences for enrollees.
This article summarizes the major MA requirements and flexibilities related to the COVID-19 pandemic and addresses whether they will end along with the PHE. MA plans should monitor the changes to requirements and flexibilities, evaluate the potential impact on beneficiaries, and consider whether operational adjustments or targeted beneficiary communications are appropriate to help mitigate any potential impacts.
The COVID-19 Determinations and Declarations
In January 2020, Secretary of Health and Human Services Alex M. Azar II determined that the PHE existed. In March 2020, President Trump declared a national emergency under the National Emergencies Act and made an emergency determination under the Stafford Act.
Section 319 of the Public Health Service Act authorizes the Secretary of Health and Human Services to determine that a PHE exists if the Secretary determines that (1) a disease or disorder presents a PHE, or (2) a PHE, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. The determination lapses in 90 days unless the Secretary renews it.
The determination enables the Secretary to exercise additional legal and regulatory authorities to respond to the PHE. The authorities include Section 1135 of the Social Security Act, which empowers the Secretary to waive statutory and regulatory requirements for Medicare, Medicaid and CHIP. For the COVID-19 pandemic, the Secretary delegated the authority to prescribe the scope of the waiver to the CMS administrator.
The Secretary has renewed the PHE for COVID-19 many times since March 2020. The most recent renewal was in February 2023. The PHE is set to lapse on May 11, 2023.
Key COVID-19 Requirements and Flexibilities for MA Plans
HHS issued its roadmap for the transition from the PHE on February 9, 2023. The roadmap addresses many specific actions and initiatives, such as expanding access to telehealth services, providing support for mental health and substance use disorder treatment, and improving data collection and analysis to better track COVID-19 and other public health threats.
CMS issued a corresponding fact sheet on February 27, 2023. The fact sheet addresses the agency’s approach to COVID-19 flexibilities going forward. On April 27, 2023, CMS issued a list of frequently asked questions regarding the CMS waivers, flexibilities and the end of the PHE addressing all programs, including Medicare, Medicaid, CHIP and private insurance.
The following table summarizes the anticipated dispositions of key flexibilities for MA plans:
COVID-19 vaccinations are currently covered under Medicare Part B and Part D without cost sharing. MA plans must pay for the vaccine and its administration for beneficiaries enrolled in their plans. Provider payment rates are determined by the contract between the MA plan and the provider when such a contract is in place and may or may not include additional payments for at-home COVID-19 vaccinations.
Does not expire. The US Food and Drug Administration’s emergency use authorizations for COVID-19 vaccines (and treatments and tests) will remain effective after the PHE ends on May 11, 2023.
COVID-19 vaccines will continue to be covered under Part B and Part D. MA beneficiaries will pay nothing for a COVID-19 vaccination if they receive their vaccinations from an in-network provider.
Coverage of Testing and Testing-Related Services for COVID-19
MA plans are not permitted to charge cost sharing for clinical laboratory tests for the detection of COVID-19, the administration of such tests and specified COVID-19 testing-related services. MA plans also may not impose any prior authorization or other utilization management requirements with respect to the coverage of COVID-19 testing and its administration.
End of PHE
People enrolled in MA plans can continue to receive COVID-19 PCR and antigen tests when the test is covered by Medicare, but their cost-sharing may change when the PHE ends.
COVID-19 At-Home Testing
MA beneficiaries pay no cost sharing for COVID-19 at-home testing.
End of PHE
MA plans will no longer be required to offer free at-home tests; however, some plans may continue providing them as a supplemental benefit.
MA beneficiaries pay no cost sharing for certain COVID-19 treatments, including oral antiviral drugs (such as Paxlovid). Part D plans are encouraged to pay dispensing fees for these drugs that may be higher than usual.
This flexibility will continue following the end of the COVID-19 PHE while the US government-procured product remains available.
MA beneficiaries may face cost-sharing requirements for certain COVID-19 pharmaceutical treatments. Part D plans are required to cover oral antiviral treatments not procured by the US government even if they are only available through emergency use authorization until December 31, 2024. CAA, Pub. L. No. 117-328, § 4131 (2022).
MA plans have flexibility to waive certain requirements with regard to coverage and cost sharing during the PHE, and expand coverage beyond those telehealth benefits approved by CMS in the plan’s benefit package.
End of PHE
Special Requirements During a Disaster or Emergency
MA plans are required to do the following:
Cover services at out-of-network facilities that participate in Medicare
Waive requirements for gatekeeper referrals where applicable
Charge enrollees who are affected by the emergency and who receive care at out-of-network facilities no more than they would face if they had received care at an in-network facility.
Ends 30 days after the latest applicable end date of the PHE, national emergency or state disaster declaration (when multiple declarations apply to the same geographic area). See 42 C.F.R. § 422.100(m).
Extensions to File Appeal: CMS allows MA and Part D plans, as well as the Part C and Part D Independent Review Entities (IREs), to allow extensions to file appeals. Specifically, 42 C.F.R. 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.
Extensions to Adjudicate: 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 (i) the enrollee requests the extension; (ii) 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 (iii) the extension is justified due to extraordinary, exigent or other non-routine circumstances and is in the enrollee’s interest.
Process an Appeal with Incomplete Appointment of Representation Forms: MA and Part D plans, as well as the Part C and Part D IREs, are allowed to process an appeal even with incomplete Appointment of Representation forms.
Process Appeals with Incomplete Information: MA and Part D plans, as well as the Part C and Part D IREs, are allowed to process requests for appeal that don’t meet the required elements, but instead use information that is available.
Good Cause: MA and Part D plans, as well as the Part C and Part D IREs, are allowed to utilize all flexibilities available in the appeal process as if good cause requirements are satisfied.
End of PHE
Reductions in Cost-Sharing
CMS allows Medicare Advantage Organizations (MAOs) to waive or reduce enrollee cost-sharing for beneficiaries enrolled in their MA plans who are impacted by the outbreak where the waiver or reduction in cost-sharing is tied to the COVID-19 outbreak.
End of PHE
SNP Model of Care Compliance
MAOs may implement strategies that do not fully comply with their approved SNP model of care in order to provide care to enrollees while ensuring that enrollees and healthcare providers are also protected from the spread of COVID-19.
End of PHE
Additional or Expanded Benefit Offerings
CMS exercised enforcement discretion to allow MA plans to expand telehealth services and other mid-year benefit enhancements (beyond those included in their approved 2020, 2021 and 2022 bids describing covered benefits) when such mid-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.
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, if prior authorization or step therapy requirements have been satisfied, and if no safety edits otherwise limit the quantity or days’ supply. CARES Act, Pub. L. No. 116-136, § 3714 (2020).
End of PHE
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 prior authorization requirements at any time for other formulary drugs in order to facilitate access with less burden on beneficiaries, plans and providers.
End of PHE
“Refill-Too-Soon” Edits and Maximum Day Supply
Part D 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.
End of PHE
Home or Mail Delivery of Part D Drugs
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 situations when a disaster or emergency makes it difficult for enrollees to get to a retail pharmacy.
End of PHE
COVID-19 Oral Antivirals (Dispensing Fees)
Part D sponsors are permitted to pay pharmacy claims for dispensing fees of oral antiviral drugs for the treatment of COVID-19 without enrollee cost sharing, and report prescription drug events for the dispensing fee claims.
End of PHE
MA plans should continuously monitor updated guidance from CMS to stay informed about how these changes will impact them and other industry stakeholders.
MA plans should take several additional steps during the transition from the PHE, including the following:
Assess the impact: Review the waivers and flexibilities allowed during the PHE and assess the impact of their expiration on plan benefits, costs and health outcomes.
Adjust operations: Consider whether any operational, staffing or system changes are necessary for a smooth transition. Implement changes as appropriate.
Communicate with members: Promptly inform members about any changes in benefits, costs or operations that may impact them. Note how the changes may affect the options available to members in the future.
Communicate with providers: Promptly inform providers about any changes that may impact their ability to continue providing care to members.
By taking these steps, MA plans can help ensure a smooth transition for all stakeholders.