AHA shares concerns on data exchange provision under drug price negotiation program

The AHA May 1 expressed concerns (LINK) to the Centers for Medicare & Medicaid Services about the payment process established under the Medicare Drug Price Negotiation Program, explaining ways it undermines the purpose of the 340B Drug Pricing Program. The Medicare Transaction Facilitator is intended to support data and payment exchanges among dispensing entities, plan sponsors and drug companies to implement drug discounts. However, CMS will only require dispensing entities, and not drug manufacturers, to participate in the payment module overseen by the MTF. This would allow drug manufacturers to establish their own payment systems outside of the MTF, making agency oversight more challenging. Additionally, CMS would let drug manufacturers make required discounted prices available retrospectively, which could jeopardize patient access to critical medications.

The AHA said the retrospective process established by the prior administration to effectuate the maximum fair price for selected drugs undermines congressional intent and frustrates the agency’s stated goals of lowering drug prices for patients and providers. The process is “complex, overly burdensome and operationally unworkable, particularly with respect to the critical 340B Drug Pricing Program,” AHA wrote. “By allowing drug manufacturers to deny upfront access to the MFP or the 340B price and force dispensing entities to participate in a retrospective process designed by the manufacturers themselves, this process unfairly disadvantages patients and the providers who serve them, in favor of drug manufacturers whose pricing practices necessitated legislative intervention in the first place.”

The AHA called for CMS to finalize a process ensuring efficient and prospective access to the MFP and 340B price for all dispensing entities furnishing selected drugs to eligible patients, as well as strict accountability measures to ensure drug manufacturer compliance with applicable laws. The AHA also urged CMS to require drug company participation in the MTF payment module and to disallow drug companies from unilaterally changing alternative payment arrangements after approval by CMS.