Updated Guidance on Drug Manufacturers’ Coupons – Enforcement Delay

Author: Cindy Niesen, Associate Director: Research & Compliance, Hays Companies

Last week, the US Departments of Health and Human Services (HHS), Treasury and Labor jointly issued an FAQ stating that for 2020 they will not enforce new guidelines (which were incorporated into HHS’s Notice of Benefit and Payment Parameters for 2020) regarding drug manufacturers’ assistance (coupons or copay assistance programs).

Under the NBPP, to the extent consistent with state law, health plans would be required to count drug manufacturers’ direct assistance toward member out-of-pocket expenses for medically-appropriate brand name drugs, or in cases where there is no generic equivalent.

The enforcement delay is intended to give the Agencies more time to issue updated guidance that better aligns with existing rules that prohibit individuals with first-dollar health coverage (before satisfying the minimum HDHP deductible) from contributing to HSAs.

This new guidance also leaves open the states’ authority to pass new statutes, or enforce existing laws, that may prohibit or limit reductions in member out-of-pocket expenses from copay assistance plans.

For now, employers may continue operating or implement new copay accumulator plans, at least until 2021.

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