On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine.
The IFR governs any vaccine that is licensed by FDA under a Biologics License Application (BLA), or, significantly, receives an Emergency Use Authorization (EUA) from the Agency. While the CARES Act obligates Medicare to cover the costs of a vaccine formally approved through the BLA process, the Act does not explicitly provide for coverage of a vaccine that is alternatively authorized by FDA under an EUA. In implementing this IFR, however, CMS reasoned that an EUA is tantamount to a BLA based partly on the rigors of the process, as well as Congress’ intent to extend no-cost, rapid access to a vaccine – particularly with respect to seniors, a large population considered at high-risk to the effects of COVID-19 and which makes up the vast majority of Medicare beneficiaries.
Under the IFR, providers would be prohibited from charging for the administration of a vaccine as a condition for receiving it free from the federal government. In addition to eliminating cost, the wide-ranging IFR’s overarching goal is to remove administrative barriers and reduce potential delays to patient access to a vaccine. As such, the IFR also endeavors to create flexibilities:
- For states maintaining Medicaid enrollment during the COVID‑19 public health emergency; and
- In the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 public health emergency.
Significantly, the IFR also provides:
- Enhanced Medicare payments for new COVID-19 treatments;
- Price transparency for COVID-19 tests; and
- An extension of Performance Year 5 for the Comprehensive Care for Joint Replacement model.
The IFR utilizes Section 3713 of the CARES Act in order to add FDA-authorized or approved vaccines to the list of preventative vaccines covered under Medicare Part B. In addition to covering the costs of administration, the IFR also eliminates any copayment/coinsurance or deductible.
The IFR extends the same coverage of costs to Medicare Advantage (MA) participants by paying directly for the administration of a vaccine to beneficiaries enrolled in MA plans. MA plans will directly cover the costs of administration for providers who administer the vaccine to MA beneficiaries during calendar years 2020 and 2021. Similar to traditional Medicare enrollees, any copayment/coinsurance and deductibles will be waived for MA beneficiaries.
As part of the IFR, CMS announced Medicare payment rates for single-dose and multi-dose immunizations, which can be adjusted in light of practical geographic considerations related to cost. Additionally, CMS intends to announce coding instructions through program memoranda as expediently as possible once FDA authorizes or approves a vaccine.
Medicaid Beneficiaries and the Uninsured
The IFR generally requires state Medicaid programs to provide vaccine administration at no cost to most beneficiaries. The IFR does so by invoking the Families First Coronavirus Response Act (FFCRA), Section 6008 of which ties a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage for the duration of the COVID-19 public health emergency. That increase in funding is conditional on states covering the costs of a vaccine and its administration for Medicaid enrollees without cost sharing during the duration of the public health emergency, with additional flexibility after its expiration. While the IFR supports this general principle it is not absolute and we thus encourage stakeholders in Medicaid and CHIP programs to consult the IFR directly to ensure compliance.
As for the uninsured, under the IFR providers will be able to seek reimbursement for administration of a vaccine through the FFCRA Relief Fund and the Provider Relief Fund, as managed by the Health Resources and Services Administration. While the lion’s share of the $175 billion appropriated to the Provider Relief Fun via the CARES Act and Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA) has already been spent, the FFCRA Relief Fund is intended to make available an additional $2 billion through a combination of FFCRA and PPPHCEA funds.
The IFR became effective on November 2, 2020, even though it will not be published in the Federal Register until November 6, 2020. CMS will accept comments on the IFR if they are submitted on or before 5:00 PM EST on January 4, 2021.