Creation/Revision Date: April 18, 2011
April 13, 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: Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N)
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 Proposed Decision Memo (PDM) on ESA use in chronic kidney disease (CKD) patients referenced above. RPA supports CMS’ decision to not issue a national coverage determination (NCD) in this area. We believe this is a reasonable and prudent policy decision that reflects current clinical evidence and appropriately balances our mutually shared patient safety concerns with the imperative to provide the most effective patient care possible. Our comments will first discuss the evidence cited in the PDM via the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) process and how we believe it offers an incomplete portrayal of the current impact of ESA use in kidney patient care. We will also outline why we believe that the Agency’s proposal to not issue an NCD is the right decision.
Evidence Cited in PDM and MEDCAC
While RPA commends CMS for reaching what we believe is the correct conclusion in not issuing an NCD, we continue to be concerned that the evidence and literature outlined in the PDM maintains its focus on the narrowly defined segment of data that emanated from MEDCAC Technical Assessment (TA). Without completely restating our comments on the TA, in short, we noted that: (1) the parameters for the TA were structured such that dated literature of seemingly little relevance could be included, while more recent and relevant evidence pertaining to CKD care was excluded; (2) the negative impact of transfusions on potential candidates for transplantation was undervalued if not dismissed; and (3) the MEDCAC process in general did not allow for participation by key relevant knowledge centers such as the United Network for Organ Sharing (UNOS) and the United States Renal Data System (USRDS). As stated in many communications RPA has submitted to CMS and predecessor agencies over the last 30 years, we are extremely sympathetic to the competing priorities that must be balanced in Medicare coverage policy development; however, in this instance, it is our belief that the process was less than optimal.
RPA Support of CMS Proposal
RPA believes that CMS’ proposal to not issue an NCD is appropriate, based on our view that the present policy status quo represents the correct policy for the current point in time. Over the past 15 years there have been a number of policy revisions and advances in clinical literature and understanding that have shaped and informed where the kidney care community is today. These include but are not limited to; (1) the Hematocrit Measurement Audit (HMA) of 1997; (2) the EPO Monitoring Policy (EMP) of 2004; (3) the CHOIR and CREATE studies of 2007-2009 that shed light on cardiac-related safety concerns for patients at high hemoglobin levels (targeting Hb at 13 Gm/dL and achieving Hb over 12 by use of ESAs for both dialysis and pre-dialysis CKD patients); and (4) the implementation of the ESRD Prospective Payment System (PPS) in 2011. The cumulative impact of these events has been or is expected to be reduced use of ESA therapy, particularly in patients near the higher end of the 10-12 Hb range. These circumstances form the basis of our opinion that the current policy strikes the right balance between addressing patient safety concerns and preserving access for CKD patients to the substantial benefits of ESA therapy. It is also RPA’s belief that alignment of ESA coverage policy with the recent decision of the Food and Drug Administration’s Cardiovascular and Renal Drug Advisory Committee (CRDAC) to not recommend a label change would avoid unnecessary confusion for practitioners, local carriers, and other stakeholders.
Finally, RPA urges CMS to continue to preserve the ability of doctors and patients to consider together the risks and benefits of ESAs, and to make individualized patient care decisions about ESAs or other therapies one at a time at the bedside. Appropriate interactions of this nature would incorporate not only the physician’s clinical expertise but also the patient’s preferences, perceptions, and resulting quality of life. An effective process for determining appropriate administration of ESAs to kidney patients must include a discussion of the risks and benefits of ESA therapy.
As always, we welcome the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to CMS in its 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.
Ruben L. Velez, M.D.