Department of Health & Human Services

Centers for Medicare & Medicaid Services

7500 Security Boulevard, Mail Stop S3-02-01

Baltimore, Maryland 21244-1850


Office of Clinical Standards and Quality


Thomas F. Parker, M.D.

100 Highland Park Village

Suite 200

Dallas, TX  75205


Dear Dr. Parker:


I want to thank you for your thoughtful and considerate letter of June 5, 2009, addressed to Nancy-Ann DeParle at the White House and me at the Centers for Medicare & Medicaid Services (CMS).  As you know, this letter outlined some of the imperatives to reform the delivery of care to U.S. ESRD patients, focused on simultaneously improving patient outcomes as well as increasing efficiency and value. CMS appreciates the summary and recommendations that you have submitted from the April 2009, international conference in Boston titled ESRD: State of the Art and Charting the Challenges for the Future. Many of the findings of this conference have been known for years and, for a number of reasons, have yet to be successfully addressed. CMS would agree that now is a good time for us all to attempt to address the conference findings, as well as many others not articulated in your letter.


Some additional issues include:


  1. The U.S. healthcare system spends more per capita on healthcare than any other nation in the world, often with quality outcomes far inferior to other developed nations. This is true of ESRD care. While some aspects of our payment and reimbursement system contribute to this, other factors are involved, including failure to follow evidence-based guidelines, lag in adoption of health information technology, inability and reluctance to measure and hold accountable quality and efficiency at the individual provider level, etc.  Focusing on payment system reform alone won’t correct these other factors.


  1. There is disagreement, often due to a lack of sufficient evidence, for many of the proposed clinical interventions and initiatives that patients, providers and suppliers sometimes raise as solutions to ESRD treatment shortcomings. Any major changes we consider in the ESRD treatment and payment arena should, as a general rule, be based on sound, documented evidence, not opinion.


  1. The epidemic of Chronic Kidney Disease (CKD), still largely unrecognized by most Americans, must be included in any discussion of ESRD challenges. If we do nothing more to prevent the estimated 25 million Americans with CKD from progressing to ESRD, the financial and delivery system burden will be overwhelmed, reducing any hope of achieving the goals your letter raise. In addition, for those patients who inevitably progress to ESRD, the management of their transition from stage 2-4 CKD to stage 5 will be critical.


  1. Addressing the many issues facing CKD and ESRD care in the U.S. will involve not just consideration of potential regulatory and administrative remedies that CMS might be able to implement, but also identification of issues that are beyond CMS/HHS authority and that would require statutory changes through standard legislative channels. Furthermore, there are many improvements that ESRD providers, patients and suppliers, as well as pharmaceutical and device manufacturers,  might be able to achieve independent of statutory, regulatory, or administrative changes at the federal level, and are simply part of expected, “good” healthcare by providers and “responsibility” that patients should take. Finally, other payers have a role in addressing these issues.


As a next step, I would suggest that we arrange a preliminary discussion of the issues you’ve raised, either by teleconference, or in person. I plan to call you about this, and my Administrative Assistant, Shanterri Brown-Jones, will be in touch with your office(s) to set this up and coordinate the logistics, including who should participate in ongoing discussions. It will be important to assure that all stakeholders have an opportunity to participate in any such discussions over time, including beneficiaries and their advocates. As you know, there are a number of proposed payment rules currently in the active public comment phase and we are about to go into the rulemaking process for Section 153(b): ESRD Bundled Payment Reform, in the near future. Any discussions about specific payment changes need to be limited during rulemaking, but there are numerous issues outlined in your letter that we can preliminarily address.


One last issue, the address that you used to send me your letter is not a CMS address, but a private residence in Baltimore. Would you please correct the address in any database or listings that might contain it to 7500 Security Boulevard, S3-02-01, Baltimore, MD  21244-1850.


I want to thank you again for raising these important issues pertaining to CKD and ESRD and look forward to working with you and others on these matters. If you have any questions, or if I can be of assistance at any time, please do not hesitate to contact me.  I am also sending this response to the co-signer of your letter.






Barry M. Straube, M.D.

CMS Chief Medical Officer

Director, Office of Clinical Standards and Quality

Centers for Medicare & Medicaid Services


CC:      Nancy-Ann DeParle



(published on RenalWEB with permission from Tom F. Parker, MD on August 28, 2009)

This is also available as a WORD document.

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