CMS Issues Interim Final Rule with Comment on Access and Payment for COVID-19 Treatments

The Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment (IFC) which seeks to implement provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act on access to and payment for COVD-19 treatments. A large part of the rule focuses on requiring any future FDA-approved COVID-19 vaccine to be provided at no cost to beneficiaries enrolled in Medicare and Medicare Advantage. While the rule also has a no-cost vaccine provision for Medicaid, it would only apply for the duration of the public health emergency. The decision to renew the public health emergency declaration lays with the Secretary of Health and Human Services, who can only renew it for 90 days at a time.

Specific to Medicaid, the rule also provides further guidance and flexibility to states around maintaining Medicaid beneficiary enrollment while receiving the temporary increase in federal funding through FMAP as provided in the Families First Coronavirus Response Act (FFCRA).

For the convenience of our members who have been following policy discussions surrounding the development of a COVID-19 vaccine, below is the excerpt of the CMS fact sheet that focuses on Medicaid vaccine coverage. Before our members dive into that text, we note for broader context that a vaccine does not yet exist; this article by Politico Pulse highlights some challenges around vaccine production. The article also highlights a vaccine allocation planning tool “developed by Ariadne Labs and the nonprofit Surgo Foundation, [aimed] at helping state and local leaders plan for distributing a coronavirus vaccine.”

As announced by CMS:

“Under Section 6008 of the Families First Coronavirus Response Act (FFCRA), states’ and territories’ Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). The FMAP increase is available through the end of the quarter in which the COVID-19 PHE ends. To receive that increase, section 6008(4) of the FFCRA establishes a condition that a state must cover COVID-19 vaccines and their administration for Medicaid enrollees without cost sharing.  However, CMS has not interpreted section 6008(b)(4) of the FFCRA to require that state Medicaid programs cover the services described in that provision for individuals whose Medicaid eligibility is limited by statute or under existing section 1115 demonstration authority to only a narrow range of benefits that would not otherwise include these services (e.g., groups that receive Medicaid coverage only for COVID-19 testing, family planning or Tuberculosis-related treatment services).

The condition at section 6008(b)(4) of the FFCRA does not apply to the Children’s Health Insurance Program (CHIP). In CHIP, separate CHIPs cover Advisory Committee on Immunization Practices (ACIP)-recommended vaccines and their administration for all children under age 19 with no cost sharing. Coverage of uninsured pregnant women in a separate CHIP program is optional. Currently, the states that cover pregnant women in a separate CHIP program include all ACIP-recommended vaccines with no cost sharing in this coverage. However, current CMS interpretation is that this vaccine coverage is not required.

However, if provided under a state’s separate CHIP program include all ACIP-recommended vaccines with no cost sharing in this coverage; however, this vaccine coverage is not required. The condition at section 6008(b)(4) of the FFCRA also does not apply to the BHP. Minnesota and New York are the only states that currently operate a BHP. BHP coverage includes benefits in at least the ten essential health benefits described in section 1302(b) of the PPACA and must comply with the Exchange’s cost-sharing protections, which includes providing all ACIP-recommended vaccines without cost sharing.

After the conditions in FFCRA section 6008 are no longer in effect in a state, the state Medicaid program must cover administration of COVID-19 vaccines recommended by the ACIP for several populations:

• All Medicaid-enrolled children under the age of 21 eligible for the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit;
• Any adult populations who receive coverage through Alternative Benefit Plans (ABPs), including the PPACA adult expansion population; and
• Adults in states electing to receive a one percentage point FMAP increase for offering such vaccines and their administration under the preventive services benefit pursuant to section 1905(b) of the Social Security Act.

Other adult beneficiaries may be covered at state option for the COVID-19 vaccine administration after the requirements in FFCRA section 6008 are no longer in effect in a state. In separate CHIPs, vaccine coverage is the same during and after the PHE.

In BHP, vaccine coverage is largely the same during and outside of the public health emergency. However, during the COVID-19 public health emergency, plans must provide coverage for and must not impose any cost-sharing for “qualifying coronavirus preventive services,” including a COVID vaccine, regardless of whether the vaccine is delivered by an in-network or out-of-network provider. 

The COVID-19 Claims Reimbursement program administered by HRSA may cover COVID-19 treatment, including the administration of vaccines, for limited-benefit beneficiaries.  In addition, a state might have the option, subject to federal approval, to propose or amend a section 1115 demonstration to include this coverage for a group that would not otherwise be entitled to receive it under the statute or under current section 1115 authority.”

Understanding vaccine costs outside of Medicaid: Anna Merlan of Vice explains how health insurers are trying to avoid the mandate that they cover the cost of Covid-19 tests.