Coverage for Life-Saving COVID-19 Vaccines & Therapeutics Ensured by CMS Two Weeks Before Election Day

The Centers for Medicare & Medicaid Services (CMS) is taking steps 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.

Today, the agency 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 available. Designed to increase the number of providers that can administer the vaccine, these resources 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.

To ensure broad access to a vaccine for America’s seniors, CMS 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.

Other important details:

  • 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 are also being implemented.
  • In anticipation of the availability of new COVID-19 treatments, additional Medicare hospital payment to support Medicare patients’ access to these potentially life-saving COVID-19 therapies will be made.In Medicare, hospitals are generally reimbursed a fixed payment amount for the services they provide during an inpatient stay, even if their costs exceed that amount.
  • Under current rules, hospitals may qualify for additional “outlier payments,” but only when their costs for a particular patient exceed a certain threshold.
  • Now, 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 they may experience from making these therapies available, even if they do not reach the current outlier threshold.
  • Changes will be made to outpatient hospital service reimbursement to ensure payment for certain innovative treatments for COVID-19 that occur outside of bundled arrangements and are paid separately.
  • Hospitals will prepare to bill for the outpatient administration of a monoclonal antibody product in the event one is approved under an emergency use authorization (EUA).
  • States will also be allowed to employ a broad range of strategies – based on local needs – to appropriately manage their Medicaid program costs.
  • CMS takes continued steps to ensure price transparency extends to COVID-19 testing.  Providers who perform COVID-19 diagnostic tests will be required to post cash prices online. Non-compliant could result in civil monetary penalties.

CMS Toolkits

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. These 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.

Medicare: Beneficiaries with Medicare pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.

Medicare Advantage (MA): For 2020 and 2021, Medicare will cover COVID-19 vaccine for beneficiaries enrolled in these plans and reimbursing providers will not be required. COVID-19 vaccines will be at no cost to beneficiaries and copayment/coinsurance and deductibles will be waived.

Medicaid: Vaccines for most beneficiaries must be provided with no cost sharing during the public health emergency. After the emergency period, depending on the population, states may evaluate cost sharing policies and be required to submit state plan amendments.

Private Plans: CMS, the Department of Labor, and the Department of Treasury are requiring that most private health plans and issuers cover a recommended COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing. The rule also provides that out-of-network rates cannot be unreasonably low, and references CMS’s reimbursement rates as a potential guideline for insurance companies.

The toolkits also address issues related to billing and payment.

Coverage

A condition of receiving free COVID-19 vaccines from the federal government will be that providers are prohibited from charging consumers for administration of the vaccine.

For those uninsured, providers can 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).

Medicare Payment

CMS also released new Medicare payment rates for COVID-19 vaccine administration. The Medicare payment rates will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of two or more doses, the initial dose(s) administration payment rate will be $16.94, and $28.39 for the administration of the final dose in the series. These rates will be geographically adjusted and recognize the costs involved in administering the vaccine.

CMS is encouraging state policymakers and other private insurance agencies to utilize the information on the Medicare reimbursement strategy to develop their vaccine administration payment plan in the Medicaid program, CHIP, the Basic Health Program (BHP), and private plans. Using the Medicare strategy as a model would allow states to match federal efforts in successfully administering the full vaccine to the most vulnerable populations.

This IFC (CMS-9912-IFC) will display with an immediate effective date and may be downloaded at: https://www.cms.gov/files/document/covid-vax-ifc-4.pdf

Additional information on this IFC can be found in the fact sheet here: https://www.cms.gov/newsroom/fact-sheets/fourth-covid-19-interim-final-rule-comment-period-ifc-4

The COVID-19 vaccine resources for providers, health plans and State Medicaid programs can be found here: https://www.cms.gov/covidvax

The FAQs on billing for therapeutics can be found here: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

Contact: CMS Media Relations: CMS Media Inquiries

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