On September 29, 2023, a significant legal development occurred that could affect how health insurance carriers and group health plans handle manufacturer coupons for prescription drugs. The District Court for the District of Columbia vacated a rule issued by the Department of Health and Human Services (HHS) that allowed, but did not mandate, the inclusion of manufacturer coupons in calculating the cost-sharing for health plans. In this blog post, we’ll explore the background of this issue, the 2019 HHS rule, and the subsequent legal decisions that have led to this recent development.

HHS’s 2019 Rule

In 2019, HHS issued a rule to clarify this matter. The rule stated that plans were not required to count the value of manufacturer coupons toward a participant’s out-of-pocket maximum if a medically appropriate generic drug was available. However, the rule left some ambiguity, suggesting that if no generic equivalent was available, plans might have to include these coupons in cost-sharing calculations. This posed a dilemma, especially for qualified high deductible health plans (HDHPs) compatible with health savings accounts (HSAs). Including coupons in the deductible calculation could disqualify participants from making or receiving HSA contributions.

Departments’ Non-Enforcement Position

Recognizing the HDHP/HSA conflict, the Departments of Labor, Treasury, and HHS issued FAQ Part 40, stating they wouldn’t enforce penalties against health plans that excluded the value of manufacturer coupons from out-of-pocket maximum calculations, even when there was no generic equivalent available. This non-enforcement stance remained in place until further guidance was provided.

HHS’s May 2020 Rule

In May 2020, HHS published the Notice of Benefit and Payment Parameters 2021 (NBPP 2021), which offered further clarification on the counting of manufacturer support, including coupons, in out-of-pocket maximums. This rule allowed health insurance carriers and group health plans to include financial support from drug manufacturers, but it was not a requirement. It depended on state law and the discretion of the health plans.

Recent Court Decision

The recent decision by the District Court for the District of Columbia has now vacated the 2020 HHS rule. As a result, HHS has been directed to reconsider the regulations in light of the court’s ruling.

If you want to dive deeper into the details of this development and its implications, you can download the full PDF from the source where this information was obtained. Please visit the original website for more comprehensive information on this evolving issue.

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