ESRD: State of the Art and Charting the Challenges for the Future

 

April 23-26, 2009

 

 

Co-Chairs

Thomas F. Parker III, MD

Theodore I. Steinman, MD, FACP

 

Steering Committee

William M. Bennett, MD

Allan J. Collins, MD, FACP

Richard J. Cronin, MD

Francis L. Delmonico, MD

Raymond Hakim, MD, PhD

William L. Henrich, MD, MACP

Alan Hull, MD

Prof. Dr. Norbert Lameire

J. Michael Lazarus, MD

Edmund Lowrie, MD

Allen R. Nissenson, MD, FACP

Prof. Dr. med Eberhard Ritz

Richard Glassock, MD  ex-officio



100 Highland Park Village

Suite 200

Dallas, TX 75205

 

 

Nancy-Ann DeParle

Counselor to the President

Director of the White House Office of Health Reform

The White House

1600 Pennsylvania Avenue, NW

Washington, DC 20500

 

 

Barry Straube, MD

Director and Chief Clinical Officer

Office of Clinical Standards and Quality

Centers for Medicare and Medical Services

1 West Hill Street

Balitimore, MD 21230

 


June 5, 2009

Dear Ms. DeParle and Dr. Straube:

ESRD: State of the Art and Charting the Challenges for the Future:  Harvard Medical School Department of Continuing Education and Beth Israel Deaconess Medical Center were the host organizations for this 4-day conference held in Boston, April 23-26, 2009.  With this letter, we ask that you consider the conclusions and recommendations of the conference, to gain the greatest value and outcomes for patients with kidney failure, given the enormity of the quality issues primarily and, further, the costs and prevalence of kidney failure.

The conclusions of this seminal conference are that substantial changes in the delivery and financing of care are required to improve patient outcomes for the end-stage renal disease (ESRD) population. All in attendance – organizers, faculty and attendees – concur that a pathway for this to happen can be established.  Patients have been receiving “adequate” but not optimal treatment. Small incremental improvements in the most important clinical outcomes for patients with kidney failure are no longer acceptable.  

 

As background, the American Society of Nephrology, European Dialysis and Transplant Association/European Renal Association, International Society of Nephrology, National Kidney Foundation, and the Renal Physicians Association endorsed this meeting, co-chaired by Drs. Theodore I. Steinman and Tom F. Parker III.  (As societies, they have not endorsed nor seen this letter.  Copies have been sent to each.)

 

An international Steering Committee, as listed on the letterhead, developed the program, the purpose of which was:

  • To examine trends since the hallmark 1989 Dallas Morbidity and Mortality Conference (Published: American Journal of Kidney Disease, May, 1990), which pointed out the shortcomings in patient survival and care.  Have there been improvements since this meeting?  If not, why not?
  • To examine medical and non-medical factors that influence ESRD care today.   (Examples of non-medical factors are health care reform proposals, payors, regulations, guidelines, technical advances and specific dialysis industry issues.)
  • To develop a pathway for the delivery of care over the next five years and beyond.

 

The emphasis for the presentations was depth, candor and controversy by examining the entire dialysis delivery process in the context of outcomes.  The following paragraphs present the salient conclusions derived from faculty presentations, question and answer periods, and consensus developed by the Steering Committee.  The full proceedings of the conference will be published in a forthcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN). 

 

Over the 20 years since the Dallas conference progress has been slowly incremental.  Thousands of lives have been saved through advancements, but the facts remain:

  • Mortality exceeds 20% per year
  • At a cost of $34,000,000,000
  • With less than 20% of patients rehabilitated
  • And hospital costs per year exceed $20,000 per patient. 

 

We are capable of doing better than our present system of delivery of care.

 

The model of care developed and adopted by the “industry” over 30 years ago was an amalgamation of patient convenience, a minimal amount of science, an enormous need for dialysis care, and a Medicare payment methodology.  The ongoing payment system has propagated the current thrice weekly – approximately 3.5 to 4 hour model.  Since 1983, Medicare has controlled ESRD Part B costs with a composite rate system that is not tied to essential patient outcomes. Higher Part A costs result from a hospitalization rate that can be lowered.  New pharmaceuticals, enhanced technology, effective utilization of state of the art facilities and better trained caregivers offer only a vague hope that annualized mortality might be improved.  There is now data that changing the manner in which dialysis is delivered, plus just a few other outcome improvements, will result in vastly improved patient rehabilitation and longer quality of life survival.

 

During the conference, it was shown that only 14% of current morbidity and mortality could be accounted for by assessing the CMS mandated clinical performance measures that dialysis facilities report (albumin, Ca, P, Kt/V, PTH, hemoglobin, etc).  It was concluded that the system must address those issues that make the greatest difference in outcomes, not continue outmoded measurements that do not reflect quality of care.

 

There are two dominant issues that cause morbidity and mortality in the ESRD patient undergoing renal replacement therapy: cardiovascular disease and infection.   

 

Cardiovascular Disease

The data is convincing that left ventricular hypertrophy/increased mass index (LVH/LVMI) and congestive heart failure, resulting from fibrosis are the major culprits associated with premature death in the ESRD population.  Current conventional therapy does not sufficiently manage this issue.  Correction requires more hours of dialysis treatment, perhaps with a shorter duration between dialysis sessions to overcome volume issues.  Data from the Japanese ESRD population indicate that by decreasing the prevalence of LVMI by 50% in the dialysis population and reducing the incident rate to 10%, the annualized mortality rate in the US could conceivably be reduced by 50%. 

 

Infection

82% of all U.S. dialysis patients have their first treatment via a temporary or permanent catheter.   Use of a catheter for chronic dialysis access is higher here than in Europe and improved patient survival in Europe can be almost totally explained by increased catheter use in the U.S.  Catheters lead to an increase in infectious complications with subsequent hospitalizations, enormous costs, and increased death rate.  This is an iatrogenic epidemic.

 

Morbidity and mortality from infection is approaching that due to cardiovascular disease.    Reducing catheter use (and immunizing patients), along with observance of accepted facility infection control protocols, will create a major improvement in outcomes.

 

Early referral to a nephrologist does not appear to have significantly improved the incident catheter problem.  Nor are vascular surgeons aligned in solving this problem.  While the incidence of fistulas as the best access for dialysis patients has increased, the unintended consequence of the FistulaFirst initiative was to increase catheter placement at the expense of decreasing arterio-venous graft creation.

 

The conference concluded it is time to act now and much more assertively on the cardiovascular and infection complications in the ESRD population.

 

 

 Other factors emerged during the conference indicating a need to change models of RRT care:

  • While long-term outcomes have slowly improved, first year mortality has remained unchanged for the past 12 years.  (The KCP has just announced a program to bring attention to this issue.)  High mortality in the first 3 months can be significantly improved with attention to individual care needs such as rehabilitation, nutrition and adaptation to dialysis.  Noteworthy is that Medicare does not pay for services during the first 90 days – when the greatest morbidity is occurring.
  • The current formulas for prescribing and measuring the delivery of dialysis are insufficient.  The original premises on which both the concept and the mathematics are based are incorrect.  In addition, caregivers have relied on the formulaic approach rather than a full assessment of the individual patient.  One-size-fits-all approach has resulted in the “standard” dialysis prescription of thrice-weekly 3.-4 hour dialysis treatments, which is inadequate therapy.
  • The current usage of sodium modeling to gain sufficient volume removal in conventional dialysis needs reassessment.  The improper use of this is likely adding to salt loading and furthering cardiovascular disease.  More frequent or longer time on dialysis would lessen the need for this.  At the very least, the proper utilization of the technique needs oversight.
  • Sleep apnea, a major cause of morbidity and mortality, appears to be nearly epidemic among dialysis patients, regardless of the presence of obesity.  This, too, responds to lengthier dialysis with better volume control.
  • The inflammatory process is an ever-present phenomenon, but is likely enhanced by not using optimal water treatment in the dialysis process. Toxin exposure with our current AAMI water standards is too high in the U.S. as compared to Europe (where ultra pure water is used more commonly for dialysis).  Also, better control of volume shifts using the newer techniques of dialysis allows for modest abatement of the inflammatory process.  CMS is well aware of the problem with albumin and inflammation.  Albumin has been removed as a core indicator, apparently because it is difficult to “fix” in the milieu of inflammation.

 

The nephrology community has reacted to the meeting with unusual attention.  The World Congress of Nephrology in Milan requested a two-hour synopsis of the conference.  The American Society of Nephrology Annual Meeting will have 2 hours devoted to a summary.  In addition to the CJASN publication, articles have appeared in Nephrology New and Issues, on the website RenalWeb.  Numerous requests for presentations have been received. 

 

Stakeholders need to provide our patients with optimal care.  It is time to adapt the care to the science and insist that the payment system acknowledge that a process established long in the past is currently not in the best interest of our patients.  Substituting longer, daily or nocturnal dialysis, performed at home or in-center, with greater attention to cardiovascular disease, infection and a-v access is the roadmap for major improvement in care.  The current reimbursement-delivery of care model does not acknowledge this need sufficiently.

 

In 2011, a “bundling” payment system will be in place. We strongly urge that the best science be factored into the new payment model, with the emphasis being on patient rehabilitation and treatments that enhance improved survival. Continuation of our current formula for reimbursement does a disservice to the patient with ESRD. 

 

Specifically, we need to discuss the following:

  • Develop a program wherein catheters constitute less than 10% of access use after 90 days of treatment and less than 30% of incident patients.
  • Address first year hospitalizations and mortality with support of programs that have demonstrated improved results, especially the first 90 days, a time of greatest morbidity and mortality and during which Medicare does not provide payment.
  • Address those modalities of dialysis that ameliorate cardiovascular disease rather than contribute, such as longer, more frequent therapies, whether in-center or at home.

 

We are requesting that CMS and the current administration address the reimbursement-clinical model of care for patients with kidney failure.  It is essential for all of us to provide these patients the benefit of the best science and maximize the care they deserve.  We believe that our mission is aligned with yours - to offer optimal care with the greatest value.  (Though financial models have not been developed within the clinical parameters being discussed, it is highly likely that these will be budget neutral if the impact on Medicare Parts A and B are analyzed.)

 

The Steering Committee and faculty are available to work with the CMS to establish and facilitate change. We request an opportunity to discuss with you how best to make the changes along with other stakeholders to deliver cost-effective and quality compassionate care.

 

On behalf of the over 500,000 patients with kidney failure and of the 110,000 who develop it each year, we have to join forces to provide optimal care, If we do not pay attention, together, who will?

 

Speaking for those who attended and contributed to the conference, and for the Steering Committee, we thank you for your consideration and look forward to hearing from you.

 

Sincerely,

 

The Steering Committee

 

 

Please address all correspondence to:

Tom F. Parker, III MD

Theodore I. Steinman, MD

100 Highland Park Village

Suite 200

Dallas, TX  75205

 

Phone: 214 295 3345

Fax: 214 295 3346

Email: tfparker3rd@aol.com

 

Copies:

National Institutes of Health (NIDDK/DKUHD): Robert Star, MD

United States House of Representatives Health Sub-Committees

United States Senate Health Sub-Committees

Kidney Care Partners

American Society of Nephrology

National Kidney Foundation

American Association of Kidney Patients

American Nephrology Nurses Association

Renal Physicians Association

American Kidney Fund

Sponsors of the Meeting who are not members of the KCP

Kidney Care Quality Alliance (KCQA)

Network Forum

Drew E. Altman, Ph.D.

Stuart H. Altman, Ph.D.

 

Note:  Dr. Andrew Narva of NIDDK/DKUHD provided consultation and advice during the formative phases of the program development.  He has not participated in the conclusions and recommendations of the Steering Committee.


 

 

 

 

Note:  The design of the logo indicates the stylized kidney with a circle of arrows indicating the lack of major progress in patient outcomes over the past 30 years.  The arrow coming out of the constricted box is the hope and plan to move beyond this history and begin to make a real difference.