Prescription Drug Manufacturer Coupon Values May Be Excluded for Determining Annual Cost-Sharing Limits, for Now

The Department of Labor (DOL), Health and Human Services (HHS), and Internal Revenue Service (IRS) jointly released an FAQ on August 26, 2019, that explain whether health plans should be including drug manufacturers’ coupons in determining the annual cost-sharing limits under the Affordable Care Act (ACA). HHS regulations that announced the 2020 benefit and payment parameters (including the maximum annual cost-sharing limits) indicated that plans and insurers may exclude the value of drug manufacturers’ coupons when determining the annual cost-sharing limits when a medically appropriate generic equivalent is available. This applies for plan years beginning on or after January 1, 2020.

Feedback received following the release of these regulations was that this provision implies that such coupon amounts must be counted toward the annual cost-sharing limit in any other circumstance, and that a requirement like this could lead to a conflict with the certain rules for high deductible health plans (HDHP) and the establishment of health savings accounts (HSA). IRS guidance surrounding HSA’s provide that drug manufacturer coupons would not affect an individual’s HSA eligibility as long as the plan did not apply the value of the coupon towards their deductible.

Since plan sponsors and insurers may not be able to comply with both the impending HHS rules and the existing IRS regulations simultaneously, the agencies jointly intend to address this conflict in the HHS regulations that announce the 2021 benefit and payment parameters. Until then, enforcement action will not be initiated in cases where a health plan excludes the value of drug manufacturers’ coupons from the annual limitation on cost sharing, including in circumstances in which there is no medically appropriate generic equivalent available.