Comment on CMS-2026-2080-0001

Research!America appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' proposal to treat fixed dose combination products as the same qualifying single-source drug under the Medicare Drug Price Negotiation Program. Our organization is a nonprofit alliance that advocates for science, discovery, and innovation to achieve better health for all. Recognizing the complexity of this issue, we believe it is critical to avoid unintentionally discouraging research that responds to patients' lived experience with disease. Biomedical innovation is not measured solely by discovering new therapeutic mechanisms. It also includes research that makes effective treatments more accessible, more convenient, and less disruptive to patients' lives. It is important to encourage innovation that not only helps people live longer but also helps them live better while receiving treatment. For many patients, particularly those undergoing treatment for cancer and other serious illnesses, the difference between spending several hours receiving an intravenous infusion and receiving a treatment through a brief subcutaneous injection is profound. Such innovations can reduce time away from work and family, lessen travel burdens, decrease dependence on infusion centers, reduce the need for implanted ports and their associated risks, and improve the overall treatment experience. They may also expand access to care, particularly for patients in rural or medically underserved communities. These advances are the result of substantial research, clinical development, and regulatory review. They represent deliberate scientific efforts to improve not only whether a therapy works, but also how patients experience that therapy. Research!America is concerned that the proposed policy could signal that these types of innovations are unimportant and not worthy of investment, to the detriment of patients. As CMS considers its final policy, we encourage the agency to ensure that Medicare policy appropriately recognizes innovations that make treatment more accessible, more convenient, less burdensome, and better aligned with patients' lives. Doing so will advance the shared goals of better health and a more effective healthcare system. Thank you for the opportunity to provide these comments.