CMS Announces New Plan to Cover COVID-19 Vaccine Under Medicare

The Trump Administration is slated to announce a plan, in the next few days, to cover the COVID-19 vaccine (when it is approved) under Medicare and Medicaid. According to the Centers for Medicare & Medicaid Services (CMS), it is Congress’s intent that Medicare beneficiaries have access to the vaccine once it is approved, free of cost sharing, to protect the most at-risk populations during the COVID-19 pandemic.

Congress attempted to mandate free COVID-19 vaccine coverage for all Americans in March with the CARES Act. According to the Trump Administration it is the intent that all Americans, including those receiving employer sponsored health insurance, receive the vaccine for free. However, certain hurdles are preventing Medicare and Medicaid beneficiaries from receiving the vaccine cost-free. Under the current rules, Medicare and Medicaid are not permitted to cover the cost of drugs authorized through emergency use protocols. Because this policy cannot be circumvented by Emergency Order, CMS, on October 28, 2020, released an Interim Final Rule with Comment Period (IFC) that established that any vaccine that receives Food and Drug Administration (FDA) authorization, either through an Emergency Use Authorization (EUA) or licensed under a Biologics License Application (BLA), will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. Under the IFC, Medicare would reimburse vaccine administration at a rate of $28.39 for single-dose vaccines. For vaccines requiring a series of doses, Medicare would reimburse $16.94 for the first dose and $28.30 for subsequent doses.

In March, the White House initiated Operation Warp Speed (OWS), a national program to accelerate the development and distribution of a COVID-19 vaccine as well as COVID-19 diagnostics and treatments. The program is a joint operation between the federal government, scientific organizations, and the private sector, with the goal being to produce and distribute 300 million doses of safe and effective COVID-19 vaccines by January 2021. OWS will identify and select the most promising vaccine and other treatment candidates and offer coordinated government support to encourage their development. The OWS program has already invested in more than 5 vaccine candidates that have reached Phase 3 clinical trials to produce as many vaccines as possible. Investing in the vaccine candidates as well as their production will reduce the time it takes for delivery when the vaccines are available. Despite the White House’s desire to expedite vaccine distribution, the FDA will not speed up their approval process and will make solely scientific-based decisions.

In early October, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) announced a partnership with CVS and Walgreens to offer and administer, at no cost, COVID-19 vaccines to individuals living and working in long term care facilities. While this will ensure that many high-risk Medicare beneficiaries and frontline workers have access to treatment, this is still a small percentage of the 60 million receiving Medicare services.

OWS is also developing a distribution plan for the potential vaccines, that will be distributed centrally in phases by the federal government, states, and other entities. The CDC is currently working with state and local health departments to address existing plans for distribution and administration of a COVID-19 vaccine. Initially, vaccines will likely be distributed to high risk populations, such as healthcare providers, nursing home residents and staff, as well as the elderly.

For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in Medicare and Medicaid policies. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.