CMS releases plan for COVID-19 vaccines and treatments

Oct. 29, 2020

The U.S. Centers for Medicare & Medicaid Services (CMS) released a comprehensive plan to facilitate access to COVID-19 vaccines and treatments, according to a press release from the agency.

To do this, CMS released an Interim Final Rule with Comment Period (IFC), which establishes that any vaccine receiving U.S. 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).

In anticipation of the availability of new COVID-19 treatments, the IFC also establishes additional Medicare payments to hospitals to support seniors’ access to these COVID-19 therapies.  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.

Under this 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 they may experience from making these therapies available, even if they do not reach the current outlier threshold. The IFC also makes changes to reimbursement for outpatient hospital services to ensure payment 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 EUA.

This rule also allows states to employ a broad range of strategies, based on local needs, to appropriately manage their Medicaid program costs. The guidance and flexibility provided to states in the IFC will help them maintain Medicaid beneficiary enrollment while receiving the temporary increase in federal funding in the Families First Coronavirus Response Act (FFCRA), CMS said.

CMS said it also is taking continued steps to ensure that price transparency extends to COVID-19 testing during the PHE. 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 may 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.

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