Following the recent Emergency Use Authorizations ("EUAs") issued by the FDA for the Pfizer/BioNTech and Moderna COVID-19 vaccines, the Centers for Medicare & Medicaid Services ("CMS") issued payment allowances and effective dates for vaccines, antibodies and their administration during the Public Health Emergency ("PHE"). Payment and effective date information can be found on the CMS website here.

In short, CMS established payment rates for vaccine administration (first and second dose) and antibody infusion but not for the vaccine and antibody products themselves. CMS anticipates that, at least initially, providers will not incur a cost for the product and will update payment allowances at a later date. CMS reminds providers they "should not bill for the product if they received it for free."

Pursuant to the CARES Act, Medicare Part B coverage for COVID-19 vaccines and their administration will be available without beneficiary cost-sharing. Coverage for the vaccines is not available under Medicare Part D. Further, Medicare will pay for monoclonal antibody products to treat COVID-19, and their administration, also under Part B. During the PHE, Medicare will cover and pay for monoclonal antibody therapy, when furnished consistent with the EUA or approval, the same way it covers and pays for COVID-19 vaccines. According to CMS, "[t]his would allow a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract for this, to administer these treatments in accordance with the EUA." See Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction (Updated: December 3, 2020) here. Specifically for Skilled Nursing Facilities ("SNFs"), CMS will exercise enforcement discretion related to SNF consolidated billing rules and permit providers to bill directly and receive Medicare reimbursement for vaccines administered to SNF residents.

The Pfizer/BioNTech and Moderna COVID-19 vaccines have been authorized for administration under the FDA's EUA, which provides an expedited mechanism for permitting marketing of certain drugs, devices and biologics during a PHE. The vaccines have been purchased by the U.S. government, and distribution is being coordinated through the Centers for Disease Prevention and Control and local public health departments. Due to limitations in vaccine product, access to the vaccine has been prioritized based on epidemiological and public health considerations, with priority groups including health care workers with direct contact with COVID-19 patients in Phase 1a; other essential workers, including police and EMS, teachers, food, agricultural and grocery store staff, seniors over age 75 years and residents of SNFs in Phase 1b; and individuals age 65-74, those with underlying health concerns and workers in other essential industries such as transportation, telecommunications and food services in Phase 1c. Given variations between states, it is advisable to review each state's specific prioritization details as vaccination activities continue to move forward.

Practical Takeaways

Medicare coverage for COVD-19 vaccines and antibody therapy is available when furnished consistent with the EUA or other approval.

Providers should be familiar with billing and payment rules related to vaccine administration and products received for free.

Providers should monitor their state's vaccination priorities for details and information moving forward.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.