The Centers for Medicare and Medicaid Services (CMS) issued a Proposed Rule on June 19, 2020, that, if implemented as written, would present challenges to pharmaceutical manufacturers that offer co-pay assistance programs. The Proposed Rule addresses the impact that PBM co-pay accumulator adjustment programs have on co-pay assistance programs and their exclusion from the best price determination.

As written in 42 CFR § 447.505(c)(8) through (12) – Determination of best price, manufacturer-sponsored co-pay assistance programs, coupons, and rebates are excluded from best price computation “to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other entity does not receive any price concession.” With the advent of co-pay accumulator adjustment programs in recent years, the full value of the co-pay assistance program may no longer go to the patient as the PBM and health plan sponsor take advantage of these funds.

The Proposed Rule would place full responsibility on pharmaceutical manufacturers to ensure that co-pay assistance program benefits are provided entirely to the patient. CMS is “proposing to revise the determination of best price § 447.505 to add a requirement that manufacturers ensure that the benefits of their assistance programs as provided at § 447.505(c)(8) through (12) are provided entirely to the consumer.” CMS further states that “We believe manufacturers have the ability to establish coverage criteria around their manufacturer assistance programs to ensure the benefit goes exclusively to the consumer or patient.”

While manufacturers can establish program eligibility criteria, there is not currently a reliable method by which manufacturers can ensure in all cases that the assistance they offer is applied exclusively to the benefit of the patient. Determination of how the value of manufacturer assistance funds is accounted for is made solely by the health plan sponsor.

Simply put, the Proposed Rule would require manufacturers to include the value of co-pay assistance programs in best price if the program was utilized by a patient covered under a health plan and coupon payments were subject to a co-pay accumulator adjustment program.

CMS has allowed for a 30-day comment period on this proposal which ends July 20, 2020.

TrialCard will be submitting comments to CMS and we are encouraging our manufacturer partners as well as patient advocacy groups to also take part. Additionally, TrialCard is preparing various courses of action that we will make available to our clients depending on if and how the rule is ultimately published.

Rick Fry, Senior Vice President, Commercial Solutions