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CMS Seeks to Make Eventual COVID-19 Vaccines Free for Nearly All Americans

As key providers of COVID-19 vaccines once approved, pharmacists should be aware of a proposed plan to make the immunization and associated costs free of charge for most recipients. Find out what CMS is proposed for Medicare, Medicaid, privately-insured and uninsured Americans.

WASHINGTON, DC – Any COVID-19 vaccine that receives Food and Drug Administration (FDA) authorization, either through an Emergency Use Authorization or licensed under a Biologics License Application, will be covered under Medicare as a preventive vaccine at no cost to beneficiaries, according to an Interim Final Rule with Comment Period (IFC) form the Centers for Medicare & Medicaid Services.

In another provision that would affect pharmacists, the IFC also implements provisions of the CARES Act designed to speed 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 public health emergency (PHE).

In addition to the plan to remove regulatory barriers and ensure consistent coverage and payment for the administration of an eventual vaccine, CMS released a set of toolkits for providers, states and insurers.

CMS also is increasing reimbursement for any new COVID-19 treatments that are approved or authorized by the FDA.

 “As Operation Warp Speed nears its goal of delivering the vaccine in record time, CMS is acting now to remove bureaucratic barriers while ensuring that states, providers and health plans have the information and direction they need to ensure broad vaccine access and coverage for all Americans, said CMS Administrator Seema Verma.

Hospital pharmacists will be interested in proposed additional hospital payments to support Medicare patients’ access to potentially life-saving COVID-19 therapies. While, under current rules, hospitals may qualify for additional outlier payments only when their costs for a particular patient exceed a certain threshold, under the IFC, hospitals would qualify for additional payments when they treat patients with innovative new products approved or authorized to treat COVID-19 to mitigate any losses even if they do not reach the current outlier threshold.

The IFC also alters reimbursement for outpatient hospital services for certain innovative treatments for COVID-19 that occur outside of bundled arrangements and are paid separately. In addition, CMS released information to prepare hospitals to bill for the outpatient administration of a monoclonal antibody product in the event one is approved under an emergency use authorization (EUA).

Other provisions in the IFC require that any provider who performs a COVID-19 diagnostic test post their cash prices online. Providers that are non-compliant could face civil monetary penalties.

As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine. Here are some details:

• Medicare beneficiaries will pay nothing for COVID-19 vaccines, and their copayment/coinsurance and deductible are waived. During 2020 and 2021, Medicare will pay directly for the COVID-19 vaccine and its administration for beneficiaries enrolled in Medical Advantage plans, which will not be responsible for reimbursing providers to administer the vaccine during this time. 
• Medicaid and CHIP agencies must provide vaccine administration with no cost sharing for most beneficiaries during the public health emergency. As for private health plans, CMS, along with the Departments of Labor and the Treasury, is requiring that most of them cover a recommended COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing.
• For Americans who are uninsured, providers will be able to be reimbursed for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).