Creation/Revision Date: February 23, 2011
February 3, 2011
Louis Jacques, MD
Director, Coverage Analysis Group
Office of Clinical Standards and Quality,
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re: Technical Assessment for MEDCAC Review of the Impact of Erythropoiesis Stimulating Agents (ESA) Use on Renal Transplant Survival
Dear Dr. Jacques,
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease.
We are writing to offer comments on the Technical Assessment developed for the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on the impact of ESA use on renal transplant survival, as well as to offer our perspective on the process more broadly.
Technical Assessment and MEDCAC Process
RPA believes that the CMS/AHRQ contractor for the technical assessment (TA), the University of Connecticut/Hartford Hospital Evidence-based Practice Center (EPC), made every effort to specifically answer the questions presented to it by CMS/AHRQ. However, it is also our belief that the scope of the questions was so narrowly defined that the broader, truer picture of the impact of ESA use in the care of Medicare beneficiaries and other patients with chronic kidney disease (CKD), both on dialysis and not on dialysis, is obscured. For example, the inclusion and exclusion criteria governing the studies included in the TA included studies predating the era of ESA use that seem to be of limited or little relevance, while excluding more recent literature on large segments of the CKD patient population that would have substantively informed the Committee’s deliberations. Thus, while we believe that while the TA contractor fulfilled its charge in a technical sense, the broader mission of compiling data in an effort to benefit Medicare beneficiaries was not fulfilled.
Further, to our knowledge the TA contractors were never asked to review data on the impact of ESAs on CKD patients prior to transplantation, where the benefit of ESA use may be most discernable. Instead, the TA contractors reviewed studies of patients who had never been transfused in that era when transfusions were used to increase the likelihood of success, rather than review studies of those patients where use of transfusion as an intervention had resulted in high panel reactive antibodies (PRA), increased sensitization, and thus these patients becoming poor candidates for transplantation. As a result, we believe that the TA ultimately resulted in an inaccurate portrayal of the impact and downstream effect of the use of transfusions on the CKD patient population in its entirety.
In addition to our concerns regarding the structure and implementation of the TA, RPA also believes that other issues contributed to an overall process that was less than optimal. For example, it is our belief that the MEDCAC deliberations would have benefitted from presentations and other active participation by representatives from the United Network for Organ Sharing (UNOS) and the United States Renal Data System (USRDS). Both organizations play a critically important role in the policy development process for the CKD patient and transplant patient populations, and would have been able to offer an invaluable perspective on issues surrounding transfusions, sensitization, and renal graft survival in these patient populations. Developing an agenda with a knowledge and expertise gap of this nature does not benefit the process, or ultimately, edicare beneficiaries that may be affected by the MEDCAC’s work.
RPA General Perspective
As stated in previous communications with FDA, CMS, AHRQ, and other federal health policymaking agencies, RPA is acutely sensitive to the challenges and difficulties presented in developing policy affecting the Medicare program and its beneficiaries. Balancing among separate agencies patient safety and drug efficacy considerations, the fiduciary responsibilities of ensuring that the Medicare Trust Fund is appropriately administered, and the evidence development and evaluation process is a monumental task, and the collaborative efforts of all the federal agencies working on these issues is to be commended.
In this spirit of collaboration, RPA urges all federal policymakers assessing the evidence and reviewing coverage policies for ESAs to proceed with all due deliberation. RPA shares the safety concerns associated with ESA prescriptions that result in high Hgb levels or very high ESA doses, and we recognize the necessity of monitoring Medicare program expenditures in an era of extreme financial constraint.
However, we also strongly believe that further curtailing the availability of ESAs to the CKD patient population, for both dialysis patients and those not on dialysis, would represent a drastic step backward in terms of patient care. RPA’s membership consists of nephrologists and other nephrology practitioners who provide care to CKD patients every day, and as such we are profoundly cognizant of the beneficial impact of ESA use in the anemia management of CKD patients.
Finally, we remind the relevant federal health policymakers that transplantation is the optimal (and most cost-effective) method of renal replacement therapy. Accordingly, every effort must be made to facilitate the CKD patient’s path to transplantation, and we believe that access to appropriate use of ESAs is a crucially important component of that journey.
As always, we welcome the opportunity to work collaboratively with all federal agencies in their efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to our federal policymaking partners in their future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at firstname.lastname@example.org.
Edward R. Jones, M.D.
Don Berwick, MD, Administrator, CMS
Marilyn Tavenner, Chief Operating Officer, Office of the Administrator, CMS
Dennis Wagner, Acting Director, Office of Clinical Standards and Quality, CMS
James Rollins, MD, PhD, Director, Division of Items and Devices, CAG, CMS