Introduction
On January 31, 2020, then-Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a declaration of the COVID-19 Public Health Emergency (PHE).[i] This enabled the administration, including the Centers for Medicare and Medicaid Services (CMS), to temporarily modify or waive certain Medicare requirements to help beneficiaries access care.[ii] Certain “waivers” or “flexibilities” directly impacted the operations of Medicare Advantage Organizations, Part D sponsors, and Medicare-Medicaid Plans.
While the PHE has been extended multiple times, the Department of Health and Human Services (HHS) currently plans for the PHE to expire at the end of the day on May 11, 2023. Many (but not all) of the PHE flexibilities enacted by CMS will expire simultaneously. [iii],[iv] Select PHE flexibilities and their anticipated impacts on Medicare managed care organizations are described below.
Flexibilities: Temporary CMS Policy of Relaxed Enforcement
Flexibility: Vaccinations
| Origin | Coronavirus Aid, Relief, and Economic Security (CARES) Act and Inflation Reduction Act |
| Background | During the PHE, Medicare beneficiaries had access to COVID-19 vaccinations and the administration thereof without cost-sharing.[x] |
| Anticipated Changes | Individuals with Medicare coverage will continue to have access to COVID-19 vaccinations without cost-sharing after the end of the PHE.[xi] Members of Medicare Advantage plans will not face out-of-pocket costs for COVID-19 vaccinations if the vaccinations are provided by in-network providers. |
| Anticipated Date of Changes | NA |
| Compliance Matters | Organizations will need to continue to provide in-network coverage of COVID-19 vaccinations and administration thereof without cost-sharing.[xii] See “General Best Practices.” |
Flexibility: Over-The-Counter Tests
| Origin | Original Medicare[xiii] |
| Background | During the PHE, CMS has provided Medicare beneficiaries access to free over-the-counter COVID-19 tests. |
| Anticipated Changes | According to CMS, “[c]urrent access to free over-the-counter COVID-19 tests will end with the end of the PHE. However, some Medicare Advantage plans may continue to provide coverage as a supplemental benefit.”[xiv] |
| Anticipated Date of Changes | PHE Expiration: EOD on May 11, 2023. |
| Compliance Matters | Work with actuarial and benefit staff to determine whether the plan will continue to provide coverage of COVID-19 tests as a supplemental benefit. If the plan elects to offer such supplemental benefits, ensure that such benefits are reflected in the plan’s benefit package submitted and approved by CMS. Notify enrollees, as needed, of benefit package changes, as required. Drive marketing and communications efforts to ensure any such notifications are developed and disseminated. “Per CMS regulations at § 422.111(d)(3), CMS expects MA organizations and MMPs to notify all enrollees at least 30 days before the effective date of any plan changes.”[xv] Drive coordination among actuarial, product development, and/or claims adjudication staff to ensure any needed cost-sharing and/or supplemental provisions are implemented. Conduct focused testing of claims adjudication logic to ensure that cost-sharing is appropriately applied. As noted below, organizations should anticipate an increase in the influx of appeals and grievances. This may necessitate increasing staff resources and providing “refresher” training. |
Flexibility: Diagnostic Laboratory Tests
| Origin | The Families First Coronavirus Response Act and the CARES Act |
| Background | “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, [their] administration, and specified testing-related services furnished on or after March 18, 2020, and during the applicable emergency period.”[xvi] |
| Anticipated Changes | After the expiration of the PHE, members of 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.[xvii] |
| Anticipated Date of Changes | PHE Expiration: EOD on May 11, 2023. |
| Compliance Matters | Drive coordination among actuarial, product development, and/or claims adjudication staff to ensure any needed cost-sharing and/or supplemental provisions are implemented. Conduct focused testing of claims adjudication logic to ensure that cost-sharing is appropriately applied. Drive marketing and communications staff efforts to ensure any required notifications to members are developed and disseminated. “Per CMS regulations at § 422.111(d)(3), CMS expects MA organizations and MMPs to notify all enrollees at least 30 days before the effective date of any plan changes.”[xviii] As noted below, organizations should anticipate an increase in the influx of appeals and grievances. This may necessitate increasing staff resources and providing “refresher” training. |
Flexibility: Oral Antiviral Treatments for COVID-19
| Origin | Emergency Use Authorization (EUA) |
| Background | “CMS has permitted Part D sponsors to pay pharmacy claims for dispensing fees [federal government]-procured [EUA] oral antiviral drugs for the 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 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 [federal government]-procured product remains available.”[xix] |
| Anticipated Changes | “There is no change in [Original] Medicare coverage of treatments for those exposed to COVID-19 once the PHE ends, and in cases where cost sharing and deductibles apply now, they will continue to apply. Generally, the end of the COVID-19 PHE does not change access to oral antivirals, such as Paxlovid and Lagevrio.”[xx] While Medicare Advantage plans must cover treatments that Original Medicare covers, “they may require the [member] to see a provider who is in [their] network and may have different cost sharing than [Original] Medicare.”[xxi] |
| Anticipated Date of Changes | NA; the exhaustion of products procured by the federal government will likely result in further changes, but an end date is not currently clear. |
| Compliance Matters | Organizations should continue to provide coverage of oral antiviral treatments in accordance with current protocols. |
Flexibility: Part D “Refill-Too-Soon” Edits and Maximum Day Supply
| Origin | Blanket Waiver |
| Background | “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.” [xxii] |
| Anticipated Changes | The requirements described above will no longer apply after the COVID-19 PHE expires. |
| Anticipated Date of Changes | PHE Expiration: EOD on May 11, 2023. |
| Compliance Matters | Organizations should reevaluate any claim edits that were relaxed due to the PHE and determine whether recalibration in alignment with pre-PHE protocols is necessary and implement accordingly. Because plan members may now be accustomed to receiving greater supplies of their drugs, organizations should anticipate an increase in the influx of appeals and grievances; this may necessitate increasing staff resources and providing “refresher” training. Care management staff should also be prepared for greater interaction with plan members who require assistance filling prescriptions. |
Flexibility: Medicare Appeals
| Origin | Blanket Waiver |
| Background | During the COVID-19 PHE, CMS has allowed Medicare Advantage and Part D plans (as well as the attendant Independent Review Entities) to allow extensions for filing appeals. Regulations allow an MA 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 the late filing of a request for reconsideration. CMS has also allowed Medicare Advantage and Part D plans to process appeals with incomplete Appointment of Representation (“AOR”) forms.[xxxiii] |
| Anticipated Changes | Regarding the processing of appeals with incomplete AOR forms: This flexibility will no longer apply. Regarding extensions for filing appeals: When the PHE ends, these flexibilities will continue to apply consistent with existing authority, and requests for appeals must meet the existing regulatory requirements. |
| Anticipated Date of Changes | Regarding the processing of appeals with incomplete AOR forms: PHE Expiration: EOD on May 11, 2023. Regarding extensions for filing appeals: NA. |
| Compliance Matters | If applicable, organizations should resume enforcement of the requirement to provide complete AOR forms. In addition to implementing necessary system changes, organizations should consider retraining staff, increasing oversight of representative-submitted appeals to ensure appropriate adjudication, and preparing resources for any additional outreach needed to obtain AOR forms. |
General Best Practices
In addition to the compliance standards described above, organizations should consider taking steps to maximize compliance program effectiveness and reduce the likelihood of noncompliance repercussions (such as regulatory enforcement). Organizations should:
- Review applicable policies and procedures to ensure content is updated to align with changes resulting from the conclusion of the PHE.
- Increase focused oversight via internal monitoring activities, particularly in relation to customer service/call center operations, claims adjudication, and care management.
- Increase the frequency and/or expand the scope of internal auditing activities.
- Proactively provide education to network providers about changes, particularly in relation to benefit offerings.
- Reexamine existing regulatory requirements in each operational area (e.g., appeals) to ensure that no conflicts exist with operations implemented during the PHE in response to CMS flexibilities.
- Continue to monitor HPMS memoranda and other CMS communication channels for further sub-regulatory guidance related to the conclusion of the PHE.
[i] Administration for Strategic Preparedness and Response. Determination That A Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus (January 31, 2020).
[ii] CMS. Coronavirus Waivers and Flexibilities (updated February 23, 2023).
[iii] CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023) and What Do I need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency (February 27, 2023).
[iv] The federal PHE for COVID-19 declared by former Secretary Azar under Section 319 of the Public Health Service Act is different from the COVID-19 National Emergency declared by the Trump Administration in 2020. President Biden signed a bill to end the latter on April 10, 2023. [CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023). See also H.J.Res.7 - Relating to a national emergency declared by the President on March 13, 2020, available at https://www.congress.gov/bill/118th-congress/house-joint-resolution/7.] “[T]he end of the COVID-19 National Emergency does not impact current operations at HHS, and it does not impact the planned May 11, 2023 expiration of the federal PHE for COVID-19 or any associated unwinding plans.” [CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023). See also Current Emergencies, available at https://www.cms.gov/about-cms/agency-information/emergency/epro/current-emergencies/current-emergencies-page.]
[v] “Due to the public health emergency posed by COVID-19 and the urgent need to ensure access to health care items and services covered by MA, Part D and Medicare-Medicaid plans, particularly in light of isolation and social distancing measures that are necessary to contain the spread of COVID-19, CMS is exercising its enforcement discretion to adopt a temporary policy of relaxed enforcement in connection with the policies discussed in this memo under the conditions outlined herein.” CMS HPMS Memorandum: Information Related to Coronavirus Disease 2019 – COVID 19 (April 21, 2020; rev. from March 10, 2020).
[vi] CMS HPMS Memorandum: Coronavirus Disease 2019 (COVID-19) Related Exercise of Enforcement Discretion Ending May 11, 2023 (March 24, 2023).
[vii] CMS HPMS Memoranda: Coronavirus Disease 2019 (COVID-19) Permissive Actions Extended in Contract Year 2022 (January 14, 2022) and Contract Year 2021 Coronavirus Disease 2019 (COVID-19) Permissive Actions FAQ (December 28, 2020).
[viii] CMS HPMS Memorandum: Coronavirus Disease 2019 (COVID-19) Related Exercise of Enforcement Discretion Ending May 11, 2023 (March 24, 2023).
[ix] CMS HPMS Memorandum: Coronavirus Disease 2019 (COVID-19) Related Exercise of Enforcement Discretion Ending May 11, 2023 (March 24, 2023).
[x] CMS. Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19 (February 24, 2023) and Toolkit on COVID-19 Vaccine: Health Insurance Issuers and Medicare Advantage Plans (updated April 6, 2022).
[xi] CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023); What Do I need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency (February 27, 2023); and Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap (February 9, 2023).
[xii] CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023).
[xiii] “Medicare covers up to 8 over-the-counter (OTC) COVID-19 tests from any participating pharmacy or health care provider for each calendar month until the COVID-19 public health emergency ends… If you’re in a Medicare Advantage Plan, you'll get this benefit through Original Medicare, not your plan.” CMS. Coronavirus Disease 2019 (COVID-19) Diagnostic Laboratory Tests (undated).
[xiv] CMS. What Do I need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency (February 27, 2023).
[xv] CMS. HPMS Memorandum: Coronavirus Disease 2019 (COVID-19) Related Exercise of Enforcement Discretion Ending May 11, 2023 (March 24, 2023).
[xvi] CMS. Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19 (February 24, 2023).
[xvii] CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023) and What Do I need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency (February 27, 2023).
[xviii] CMS. HPMS Memorandum: Coronavirus Disease 2019 (COVID-19) Related Exercise of Enforcement Discretion Ending May 11, 2023 (March 24, 2023).
[xix] CMS. Medicare Advantage and Part D Plans: CMS Flexibilities to Fight COVID-19 (February 24, 2023).
[xx] CMS. What Do I need to Know? CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency (February 27, 2023).
[xxi] CMS. Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (issued April 27, 2023).
[xxii] CMS. COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (updated October 13, 2022).
[xxiii] CMS. COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (updated October 13, 2022).
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