Statement of Alan S. Kliger, M.D., President, Renal Physicians Association, Rockville, Maryland

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

June 26, 2007

Mr. Chairman and Members of the Subcommittee-

My name is Alan Kliger.  I am a kidney specialist, a Clinical Professor of Medicine at Yale University School of Medicine, and I am Chairman of the Department of Medicine at the Hospital of St. Raphael in New Haven, Connecticut.  I am an employee of a not-for-profit hospital, and am not in the employ of any pharmaceutical manufacturers or other commercial enterprises.

I am currently President of the Renal Physicians Association (RPA), 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.  In addition, I am the past president of the Forum of ESRD Networks, a national organization of regional networks under contract with CMS to promote and oversee quality improvement at dialysis and kidney transplant facilities, and to ensure access to care for all patients who need dialysis treatments.  

I want to begin by thanking you Mr. Chairman and Ranking Member Camp, first for your leadership on an issue that affects the lives of the millions of Americans suffering from kidney disease. Secondly, I want to thank you for giving me an opportunity to inform this discussion with some perspectives on the issue of anemia management that I believe have sometimes been overlooked—those of the front-line physicians who are actually treating patients suffering from kidney disease and kidney failure. 

This is a complex issue.  I know because for more than 15 years RPA has been directly involved in helping to develop evidence-based clinical practice guidelines, based on systematic reviews of the published evidence. In fact, I served on the steering committee of the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative, or KDOQI, which was charged with developing guidelines for dialysis patient care, including anemia management.  I also participated in the development of 16 clinical performance measures designed to measure what doctors actually do, give them feedback, and help them refine their practices to reflect what works best.  The dividends we saw from that effort included an improvement in the quality of care as well as documented evidence of better adherence to practice guidelines.

Clinical Practice Guidelines and Physician Prescribing Autonomy

RPA believes that clinical practice guidelines in renal care, like those in other medical disciplines, should be evaluated on the basis of the strength of evidence, an assessment of harms and benefits, and should benefit from robust physician and other multidisciplinary input and review.  Guidelines developed with these considerations in mind can only enhance the delivery of high quality patient care and help ensure kidney patient safety.  RPA also believes that the current body of literature in the area of anemia management fulfills these criteria, and forms a solid foundation for public policy making efforts such as the Centers for Medicare and Medicaid Services (CMS) EPO Monitoring Policy (EMP).  Further, it is our opinion that the CHOIR and CREATE studies published in the New England Journal of Medicine last year, once subjected to the full measure of robust scientific review, will likely represent an important addition to this already significant body of literature, and should be considered thoughtfully and thoroughly by care providers and policymakers.

However, it is important to remember that clinical practice guidelines are just that: guidelines, not required protocols.  Because every patient is unique, when it comes to ESA dosing, each patient must be considered individually—not in the aggregate.  Clinical decisions and prescription choices must be made one patient at a time—based on what options provide that patient with the best outcomes possible. 

The most important determining factor in the care of the patient, above all, should be the physician’s clinical judgment considered in the context of the physician-patient relationship.  We believe that it is of paramount importance to maintain the physician's autonomy and ability to exercise clinical judgment in prescribing for the individual patient.  Decisions for the individual may be different than practice guidelines advise because of individual clinical evaluation and specific patient needs, taking into account a wide range of factors, including the age of the patient and the severity of kidney disease.  This is a fundamental and well-recognized clinical principle in medicine, and it is mandatory that it be maintained and protected.  RPA believes the CMS’ EPO Monitoring Policy accounts for such use of the physician’s clinical judgment.

Recent studies warn that kidney failure patients should not have high blood counts, noting that a group of patients with high blood counts in general carried a higher risk than patients with lower blood counts.  But my experience with one of my patients shows how patient-centered care sometimes should deviate from guideline-advised care. I have a 52-year-old patient who is in kidney failure. When his blood count is less than 36 percent, he feels tired and washed out and experiences chest pain. When EPO raises his blood count to 38 percent, he feels like a healthy man; he functions better and feels more productive.  The differences are so prominent to him that he tells me what his blood count is before I have a chance to measure it.  For this particular patient, a higher blood count is what he needs in order to function normally. My patient knows that the recent studies warn about the long-term side effects of these higher blood counts, but he also knows he needs these levels to function normally. His choice and mine for enough EPO to maintain higher blood counts is the right choice.

RPA believes that in the recent discourse on national coverage of EPO, the critical issue of variability of individual patient response to EPO dose has been understated.  As we have noted in correspondence to CMS, attempts to assess or quantify individual sensitivities (i.e. responsiveness) to EPO at a narrow level have not been successful.  Therefore, there is no single, predictable response to a given dose of EPO, a fact that accounts for the wide range in individual responses to treatment.  As a result, in the aggregate it is physiologically not rational to tailor a normal distribution of patient responses to a payment limit: such a paradigm cannot be successful in delivering optimal treatment with sophisticated agents to complicated patients.  Payment limits structured in this fashion place emphasis on the wrong arm of therapy: emphasis should be placed rather on reducing the number of patients with low hematocrits/hemoglobins (<30%/10 gm/dL).  At the same time, Medicare coverage policy should strive to maintain levels in all patients >11 gm/dL, given the ample data disclosing the adverse short and long-term effects to patients with persistent anemia.  Simply put, overemphasis on monitoring patients at the upper end of the range should not create problems for patients at the lower end, and RPA believes that the current CMS EPO Monitoring Policy strives to avoid such problems in the broad Medicare ESRD beneficiary population. 

Misperceptions Regarding EPO Reimbursement

Finally, RPA would also like to take this opportunity to dispel some common misperceptions regarding reimbursement for erythropoietin.  There have been articles in both the mainstream and medical trade press implying that nephrologists have a financial incentive to prescribe higher doses of erythropoietin to ESRD patients.  This is simply not true.  Nephrologists prescribe EPO based on their clinical judgment of what will optimize the individual patient’s hemoglobin level.  Moreover, it is the dialysis facility that receives reimbursement for EPO prescribed to ESRD patients, not the nephrologist.  Any inference that the nephrologist will personally benefit from prescribing higher doses of EPO, or any drug, to ESRD patients is flat wrong. 

Conclusion

In conclusion, RPA supports the use of clinical practice guidelines in the development of protocols enhancing the delivery of high quality patient care, but believes they must be considered in the context of the physician’s clinical judgment.  RPA believes that physician prescribing autonomy must be maintained, and that the variability in ESRD patient hemoglobin levels must be taken into account in the development of national coverage policy for EPO.

As always, RPA stands ready to serve as a resource as the Committee works to ensure the best possible health outcomes and quality of life for Medicare beneficiaries with ESRD.