AHA submits comments on CMS draft guidance for Medicare drug price negotiation; AHA criticizes retrospective refund process, urges adoption of prospective approach consistent with 340B statutory requirements

In a letter submitted July 2 to the Centers for Medicare & Medicaid Services on guidance for the Medicare Drug Price Negotiation Program, the AHA expressed concern about the agency’s proposal to retrospectively effectuate the policy.

The AHA called CMS’ retrospective refund process “complex, burdensome and would be operationally unworkable,” and could unwillingly cause providers to pursue rebates and 340B discounts from drug manufacturers instead of requiring them to make lower negotiated prices available upfront. The AHA urged CMS to finalize a prospective process that aligns with the Health Resources and Services Administration’s historic interpretation of the 340B statutory requirements and balances the interests of Medicare patients, dispensing entities and manufacturers under the program.