Coverage of Life-Saving COVID-19 Vaccines & Therapeutics

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

On October 28, 2020, CMS released a comprehensive plan with proactive measures to remove regulatory barriers and ensure consistent coverage and payment for the administration of an eventual vaccine for millions of Americans. CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine once it is available.  These resources are designed to increase the number of providers that can administer the vaccine, ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID-19 treatments that are approved or authorized by the FDA. 

The goal of this plan is to ensure all Americans, including the nation’s seniors, have access to the coronavirus disease 2019 (COVID-19) vaccine at no cost when it becomes available.  To that end, CMS released an Interim Final Rule with Comment Period (CMS-9912-IFC … 241 pages) that establishes 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.  The IFC also implements provisions of the CARES Act that ensure swift coverage of a COVID-19 vaccine by most private health insurance plans without cost sharing from both in and out-of-network providers during the course of the public health emergency (PHE).  The IFC is scheduled to display at the Federal Register as soon as possible with an immediate effective date, and a 30-day comment period.

Along with these regulatory changes, CMS is issuing three toolkits aimed at state Medicaid agencies, providers who will administer the vaccine, and health insurance plans. Together, these toolkits will help ensure the health care system is prepared to successfully administer a safe and effective vaccine by addressing issues related to access, billing and payment, and coverage.

Additional information on this IFC can be found in the Fact Sheet.

The COVID-19 vaccine resources for providers, health plans and State Medicaid programs can be found here.   A link to CMS-9912-IFC is also found on this webpage.   The toolkits are also located on this webpage:

The FAQs on billing for therapeutics can be found here.  This is the 152-page FAQ document that is a work in progress.  You’ll recognize it once you navigate to that website.  The FAQ document was last updated on October 28, 2020 with this information.