August 25, 2015

Andrew Slavitt, Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue SW
Washington, D.C. 20201

Dear Mr. Slavitt,

Dialysis Patient Citizens (DPC) appreciates the opportunity to provide the Centers for Medicare and Medicaid Services (CMS) with comments on the proposed payment rule for the Medicare End Stage Renal Disease (ESRD) program. As America’s largest patient-led organization representing dialysis patients, DPC’s membership consists of more than 28,000 dialysis and pre-dialysis patients and their families. We seek to ensure the patient point of view is considered by policy makers.

Dialysis patients are prescribed an average of 4-5 oral medications in addition to those that are infused. Most dialysis patients also suffer comorbidities beyond their kidney failure. As such, our population has a strong interest in ensuring access to prescription drugs, their generic equivalents, and biosimilars.

We are concerned that this proposed rule, in grouping all biosimilars tied to a single reference product together under a single J-Code and paying them all the amount, would create a disincentive to invest in this crucial area of medicine. It does not account for the potentially significant differences among each biosimilar and therefore could erode the market that is needed to spur competition in this area. Without competition, patients may not have sufficient access to biosimilars in a range of therapeutic areas.

We urge you to carefully examine the information submitted on this topic and the potential implications of this proposal, and issue a final rule that ensures patients’ long-term access to biosmilars.

Thank you again for your consideration of our comments and concerns. If you have any questions or would like additional information, please do not hesitate to contact me.

Hrant Jamgochian, J.D., LL.M. Executive Director