Oct, 30, 2020

Ensuring Access to the COVID-19 Vaccine for Adult Medicaid Enrollees: A Roadmap for States

Allison Orris and Julian Polaris, Manatt Health

Update — October 30, 2020:

On October 28, the Department of Health and Human Services – along with the Departments of Labor and the Treasury – released an interim final rule with comment regarding vaccine coverage and administration. With respect to Medicaid vaccine administration, the rule simply reiterates the coverage rules described below. States interested in more details – including potential strategies to fill gaps in coverage that may arise after the end of the coronavirus public health emergency – can find additional detail about coverage and reimbursement of COVID-19 vaccines, vaccine administration, and cost-sharing in a toolkit for states. The toolkit also describes vaccine coverage under the Children’s Health Insurance Program (CHIP) and the Basic Health Plan (BHP). With respect to the BHP, the October 28interim final rule clarifies that during the PHE, BHP plans must provide coverage for vaccines – without cost-sharing – regardless of whether the vaccine is delivered by an in-network or out-of-network provider. After the PHE, vaccine coverage is required for BHP enrollees, but plans could charge cost-sharing for out-of-network providers.

Original Post — October 19, 2020:

With several COVID‑19 vaccine candidates now in late-stage clinical trials, state officials are hard at work planning their vaccine distribution strategies in accordance with federal guidelines. A key element for states to consider is the extent to which various health care payers will cover the costs of vaccine administration.[1] This question is particularly complex with respect to the Medicaid program, which contains a patchwork of vaccine coverage requirements that vary across eligibility groups.

Under the Families First Coronavirus Response Act (FFCRA), states that accept the 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP) must, for the duration of the federal public health emergency (PHE), cover all COVID‑19 vaccines without cost sharing for all Medicaid enrollees.[2] The PHE may expire long before states reach their goal of comprehensive community immunization, however. After the PHE, certain adult Medicaid enrollees may face cost-sharing obligations or lack coverage for COVID‑19 vaccines, depending on how a state Medicaid program defines coverage for preventive services in its state plan.

This expert perspective provides a roadmap for states to assess their vaccine coverage policies in Medicaid and, if necessary, to close any coverage gaps that might otherwise inhibit vaccine uptake during a crucial period of mass immunization.[3] The concluding section discusses the possibility of congressional action that may alter the federal landscape for Medicaid vaccine coverage.

Medicaid Vaccine Coverage Requirements Vary by Eligibility Group

States that accept enhanced FMAP under FFCRA must cover COVID‑19 vaccines for all Medicaid-enrolled populations during the federal PHE period, as noted above. Even without FFCRA’s coverage guarantee, however, federal law requires comprehensive vaccine coverage for Medicaid enrollees under the age of 21, as well as adults covered under the Affordable Care Act (ACA) Medicaid expansion. As explained below, these populations are entitled to coverage of all vaccines that have been recommended by the Advisory Committee on Immunization Practices (ACIP), a body within the Centers for Disease Control and Prevention (CDC) that issues evidence-based guidelines about which vaccines should be administered to which populations. ACIP is expected to promptly issue guidelines for any COVID‑19 vaccine that receives FDA authorization. But since federal law does not require comprehensive vaccine coverage for non-expansion adults enrolled in Medicaid, an ACIP recommendation will not guarantee coverage for these individuals once the PHE ends. Vaccine coverage is an optional benefit for this population, and so COVID-19 vaccine coverage for non-expansion adults will vary from state to state post-PHE. The Table below summarizes the different vaccine coverage requirements that apply to each of these eligibility groups.

Children and young adults under the age of 21 are entitled to receive ACIP-recommended vaccines without cost sharing as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.[4] This same set of vaccines must be provided as part of the “well child” benefit in the Children’s Health Insurance Program (CHIP).[5] The federal government bears certain costs related to vaccine purchase and distribution through the Vaccines for Children (VFC) Program, but Medicaid and CHIP programs remain responsible for covering the cost of vaccine administration.[6]

Adults covered under the ACA Medicaid expansion receive an Alternative Benefit Plan that must include the same essential health benefits (EHB) as commercial plans offered on the Marketplace. The EHB standard includes coverage, without cost sharing, for all ACIP-recommended vaccines and certain other preventive services.[7]

For non-expansion adults enrolled in Medicaid—including mandatory and optional parents, pregnant women, and individuals who are elderly or disabled—vaccine coverage is an optional benefit. Each state may decide which vaccines to cover and whether cost sharing will apply.[8] To incentivize broad coverage, section 4106 of the ACA offered a one percentage point FMAP increase with respect to preventive services (including ACIP-recommended vaccines), but only for states that cover all federallyrecommended preventive services with no cost sharing.[9] Notwithstanding this FMAP incentive, a study published earlier this year in the Journal of the American Medical Association found that less than half of surveyed Medicaid programs covered all ACIP-recommended adult vaccines.  Vaccines also can be covered when furnished by a participating provider under certain Medicaid mandatory benefits that are available to all beneficiaries, depending on how those services are defined in the state plan (e.g., at state option, inpatient and outpatient hospital services, physician services, Federally Qualified Health Center Services could be defined to include vaccine administration). [10]

Table.   Federal Requirements for Coverage of COVID‑19 Vaccine, Without Cost Sharing, During and After the Federal Public Health Emergency (PHE)

Ensuring COVID‑19 Vaccine Coverage for Non-Expansion Adults

When FFCRA’s coverage mandate expires following the termination of the PHE, non-expansion adults may not have coverage for a COVID‑19 vaccine unless their state’s Medicaid program provides for such coverage. As states develop their COVID-19 vaccine distribution strategies, they may wish to review their current Medicaid vaccine coverage policies and, if necessary, submit a state plan amendment (SPA) to ensure that non-expansion adults have access to the COVID-19 vaccine. [12] Extending coverage will eliminate the cost of obtaining a vaccine as a barrier to widespread COVID‑19 immunization. States may also want to review their cost-sharing policies to further promote access by aligning cost-sharing policies across adult eligibility groups.

Some states already cover all ACIP-recommended vaccines for all Medicaid populations with no cost sharing.In states that have adopted this approach, an ACIP recommendation for a COVID‑19 vaccine will trigger coverage for all Medicaid enrollees, including non-expansion adults. A 2013 Colorado SPA, for example, provides coverage without cost sharing for all “approved vaccines and their administration recommended by [ACIP].” Colorado’s “coverage and billing codes will be updated to comply” with any newly issued ACIP guidelines. Hawaii submitted a similar SPA in 2014, and expressly noted that this revision aligned coverage of preventive services across the expansion and non-expansion adult populations.

Certain states provide coverage on a vaccine-by-vaccine basis and/or impose cost sharing on vaccine administration. To enhance access to immunization services, these states might consider amending their state plan to achieve one or more of the following aims:

  • Cover, without cost sharing, all COVID‑19 vaccines recommended by ACIP
  • Cover all ACIP-recommended vaccines without cost sharing
  • Cover all federally recommended preventive services without cost sharing, thereby qualifying for an FMAP enhancement under ACA section 4106

Congress Could Require or Incentivize Vaccine Coverage

A recent meeting of the Medicaid and CHIP Payment and Access Commission (MACPAC) included a session on strategies to enhance vaccine coverage for adult Medicaid enrollees (for all vaccines, not just related to COVID-19). The Commission expressed interest in studying, and perhaps recommending, one or more of the following policies, some of which would address the gaps described above, and all of which would likely require congressional action:

  • Mandate that states cover all ACIP-recommended vaccines without cost sharing, consistent with existing requirements for the ACA expansion population
  • Reduce state costs related to vaccine coverage by, for example:
    • Increasing the FMAP enhancement under ACA section 4106 for states that cover all federally recommended preventive services (currently, the FMAP increase is one percentage point)
    • Including vaccines in the Medicaid Drug Rebate Program and/or the 340B Drug Pricing Program
  • Establish an adult immunization program modeled on the VFC, thereby ensuring that all Medicaid-covered adults (and perhaps all uninsured adults) may receive ACIP-recommended vaccines regardless of ability to pay

Legislation along these lines may alter the financing structure for Medicaid vaccine coverage in a manner that favors comprehensive vaccine coverage. It is not clear whether or when Congress might take up any such proposal, however. In the interim, states can take the steps outlined above to ensure ready access to COVID‑19 vaccines for all Medicaid enrollees.

[1] Vaccine coverage has two components: (1) reimbursement for the vaccine itself (which the provider may have purchased in advance, unless vaccine supply is furnished free of charge by a government program); and (2) reimbursement for the service of administering the vaccine. A vaccine recipient’s health plan may cover one or both of those costs.

[2] Like the enhanced FMAP, the vaccine coverage requirement lasts until the end of the calendar quarter in which the PHE expires. FFCRA § 6008(b)(4). Based on the current PHE end date of January 20, 2021, the vaccine coverage requirement will expire on March 31, 2021 unless the PHE is renewed. (For additional discussion of the various federal flexibilities that are linked to the PHE, see this SHVS resource.) The FFCRA coverage requirement does not apply to groups covered solely using state funds, such as immigrant populations for whom states are unable to claim a federal match. In addition, the vaccine coverage requirement may not apply to the optional Medicaid eligibility group created under FFCRA, which allows states to cover COVID‑19 testing for uninsured individuals during the PHE. Social Security Act § 1902(a)(10) (as amended by FFCRA § 6004(a)(3)). In the “Heroes 2.0” bill, House Democrats sought to amend this optional eligibility group by expressly adding coverage for COVID‑19 vaccines.

[3] The Health Resources & Services Administration (HRSA) has indicated that the COVID‑19 Program for the Uninsured will reimburse providers for costs related to the administration of an FDA-authorized vaccine—in addition to COVID‑19 testing and treatment—to an individual who is uninsured. Consistent with HRSA’s prior guidance regarding treatment services, it appears that an individual with public or private health coverage will be deemed “uninsured” for purposes of the HRSA program if the individual lacks specific coverage for the COVID-19 vaccine.

[4] 42 C.F.R. § 441.56; CMS COVID‑19 Coverage Guidance.

[5] 42 C.F.R. §§ 457.410(b)(2), 457.520(b)(4); CMS COVID‑19 Coverage Guidance.

[6] As described in section 1928 of the Social Security Act, the federal government pays for the cost of acquiring and distributing vaccines to participating VFC providers, who must offer the vaccine free of charge to eligible children under the age of 18, including children who are Medicaid-eligible, uninsured, or American Indian or Alaska Native. The CDC has clarified that the VFC includes children enrolled in a Medicaid-expansion CHIP program, but not children enrolled in a separate CHIP program. Although VFC providers are permitted to charge vaccine recipients a fee for vaccine administration, this fee is covered for VFC-eligible children who are enrolled in Medicaid or CHIP.

[7] 42 C.F.R. § 440.347; 45 C.F.R. § 147.130.

[8] Certain Medicaid beneficiaries are only eligible for limited benefits, such as individuals enrolled in family planning-only coverage or tuberculosis coverage; vaccine coverage is not available to these beneficiaries even as an optional benefit. Instead, vaccine administration will be covered by the Provider Relief Fund program administered by the Health Resources and Services Administration.

[9] ACA § 4106; SMD 13-002. The increased FMAP applies with respect to both fee-for-service and managed care programs. In addition to ACIP-recommended vaccines, the federally recommended preventive services include any service assigned a grade of “A” or “B” by the United States Preventive Services Task Force (USPSTF), as well as certain prescribed services for the “reduction of physical or mental disability and restoration of an individual to the best possible functional level.”

[10] The a toolkit for states that CMS released alongside its October 28 interim final rule with comment includes more information about how to pursue these options.

[11] States may impose cost sharing on vaccines administered to 19 and 20 year-olds who are not enrolled in an ABP.

[12] Vaccine coverage is typically defined under the “preventive services” benefit in Attachment 3.1-A of the Medicaid state plan. A state seeking to expand vaccine coverage should consider a standard SPA rather than a COVID‑19 Disaster Relief SPA. Because Disaster Relief SPAs expire automatically at the end of the PHE, they cannot be used to ensure vaccine coverage after the PHE.