New CMS Rule Creates Disincentive for Drug Makers To Offer Copay Assistance


The Centers for Medicare and Medicaid Services (CMS) proposed a new rule that could prevent drug makers from offering copay assistances to patients in need. The new rule acknowledges that health insurers, rather than patients, benefit from copay accumulator programs. However, CMS’s new proposed rule states that if a health plan implements a copay accumulator program, then the value of any copay assistance received by the health plan will be counted toward the Medicaid Best Price calculation. The Medicaid Best Price rule requires drug makers to give Medicaid programs the best price among nearly all purchasers.

Under current regulation, copay assistance is excluded from the calculation of Medicaid Best Price based on the assumption that the patient, and not the health plan, is receiving the assistance. However, CMS’s proposed rule states that if a private health plan imposes a copay accumulator, then any copay assistance benefits the health plan and not the patient. Therefore, the value of the copay assistance will be taken into account when calculating Medicaid Best Price for that drug. It puts the burden on the drug manufacturer to negotiate with the PBM to ensure that all the value from the patient assistance goes to the patient, a difficult feat especially since CMS recently released the Notice of Benefit and Payment Parameter for 2021 (NBPP 2021) final rule. NBPP 2021 explicitly states that health plans are permitted to implement copay accumulator programs. If drug manufacturers cannot get health plans to abandon copay accumulator programs, then the drug manufacturers may choose not to offer copay assistance to patients in need rather than allow copay assistance to count toward Medicaid Best Price. Given that copay accumulators already make it hard for patients to afford their medication, this new rule could have a significantly detrimental impact on patient access to medications. Comments on the rule are due July 20, 2020.

Read the full rule here.


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