Reed Smith Client Alerts

HHS recently issued guidance in FAQs part 50 regarding implementation of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), providing clarity on (1) the mandatory timeline for payors to offer cost-sharing protections for administration of the COVID-19 vaccine, and (2) guidelines for health plan incentive programs that encourage vaccination. This alert provides a brief overview of the FAQs and an analysis of their impact on payors.

Cost-sharing protections apply immediately upon vaccine-related approvals

Under the CARES Act, health insurance issuers and non-grandfathered group health plans must cover qualifying coronavirus preventive services without cost-sharing requirements. 1 The definition of “qualifying coronavirus preventative services” includes immunizations that have been recommended by the Advisory Committee on Immunization Practices (ACIP) and for which the Centers for Disease Control and Prevention (CDC) has adopted the recommendation. Such immunizations become entitled to cost-sharing protections 15 business days following the CDC’s adoption. 2

ACIP has issued several vaccine-related recommendations over the course of the pandemic, and a question arose regarding the effective dates of cost-sharing requirements applicable to the various vaccine approvals. In previous FAQs, the regulators indicated that the cost-sharing requirements become effective 15 business days after each vaccine-specific recommendation and adoption. 3 For example, the cost-sharing requirements regarding administration of the Pfizer vaccine to individuals aged 16+ would have become effective 15 business days after the December 11, 2020, Emergency Use Authorization (EUA).

However, in FAQs part 50, the regulators clarified that the applicable effective date for all vaccine-related cost-sharing requirements was ACIP’s December 12, 2020 recommendation (which the CDC adopted the same day) for vaccination with any COVID-19 vaccine within the scope of an EUA or Biologics License Application (BLA). 4 In effect, this means that payors must cover COVID-19 vaccines and their administration without cost sharing immediately once the particular vaccine becomes authorized under an EUA or approved under a BLA. This extends to any EUA or BLA amendment – including those regarding boosters, additional doses, and expansions to age demographics.

The vaccine authorization and approval landscape is rapidly changing, and payors must ensure that they can pivot quickly to integrate new requirements into their claim adjudication and appeal processes immediately upon EUA or BLA adoption or amendment. In addition to the heightened public scrutiny on insurance coverage of vaccines, failure to comply with the CARES Act creates ongoing regulatory and litigation risk. Given the conflicting guidance on this particular timing issue regulators will only enforce it prospectively. However members could potentially pursue causes of action related to past delays applying cost-sharing protections to vaccine administration. Payors should consider educating grievance and appeal personnel regarding this issue to reduce litigation exposure related to ongoing appeals.