The EACH/PIC Coalition submitted comments to CMS on the 15 drugs selected for the Medicare Negotiation Program for IPAY 2028. The comments provided input on evaluating therapeutic alternatives, protecting patient access to medications, and ensuring CMS addresses patient-reported obstacles to care.
The comments stated:
“As CMS evaluates the selected drugs and therapeutic alternatives, we emphasize that for many patients, particularly those living with chronic and complex conditions, therapeutic alternatives are not interchangeable. Our updated Patient Experience Survey found that treatment value is highly individualized and among those who tried multiple treatments, over 80 percent described their medication as valuable. Many of these patients also emphasized their treatment’s unique value to them, rather than general effectiveness. Among 60 patients with rheumatoid arthritis, for example, 82 percent of them cycled through multiple medications and 49 percent had comorbidities that affected their treatment choice. These findings reinforce that drugs within the same therapeutic class often serve distinct clinical needs across patients.”
“As CMS implements the IPAY 2026 negotiated prices, we urge regulators to actively monitor formulary placement, tiering, and utilization management practices for negotiated drugs. Further, CMS should publicly report on patterns of prior authorization, step therapy, and coverage denials affecting selected products. We also urge CMS to establish mechanisms for patients and providers to report access disruptions linked to negotiation implementation. Oversight should not be limited to initial rollout; ongoing monitoring will be critical to ensuring that negotiated prices do not inadvertently trigger downstream restrictions that undermine patient access.”
“We share CMS’s goal of improving prescription drug affordability for Medicare beneficiaries. As the agency advances IPAY 2028 it is essential that implementation be accompanied by vigilant oversight of plan behavior and a sustained focus on patient-reported access challenges.”
“We respectfully request that CMS prioritize continuity of care, guard against non-medical switching, closely monitor utilization management practices, and use patient-reported data to evaluate the real-world impact of the negotiation program. EACH and PIC stand ready to share additional survey findings, facilitate patient engagement opportunities, and serve as a resource as CMS continues this work.”