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Clin J Am Soc Nephrol 2: 209-210, 2007
© 2007 American Society of Nephrology
doi: 10.2215/CJN.00260107
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Commentaries in Response to Controversies in Nephrology

Translating Guidelines into Policy

Robert J. Rubin*, and Daniel N. Mendelson{dagger}

* Georgetown University School of Medicine, Division of Nephrology and Hypertension, Washington, DC; and {dagger} Avalere Health and the Fuqua School of Business, Duke University, Durham, North Carolina

Address correspondence to: Dr. Robert J. Rubin, Georgetown University, 7901 Springer Road, Bethesda, MD 20817. Phone: 301-229-1341; Fax: 301-229-2846; E-mail: rjrmd{at}comcast.net


   Introduction
Top
 Introduction
Disclosures
 References
 
The use of and payment for erythropoietin-stimulating agents (ESA) has become a source of controversy in the nephrology and policy communities, as evidenced by the recent series of articles in CJASN and other journals (1–7), a high-profile Ways and Means Committee hearing last December, and a recent Government Accountability Office study on bundling payment for ESRD services (8). The drama of these deliberations was illustrated when Chairman Bill Thomas told Medicare officials, "You seriously need to consider that your payment policy is killing people." At the core of this debate is concern that current Medicare payment policy, based on "tainted" guidelines, inappropriately stimulates overuse of ESA, thereby harming patients and increasing Medicare costs.

Some historical context is needed to understand that the current policy is in fact a good faith attempt by Medicare officials to promote optimal therapy. In 1994, Medicare began the Clinical Performance Measures (CPM) Project to measure and improve patient outcomes, and designated anemia as a CPM. Aligning clinical and economic incentives produced remarkable results. The percentage of patients with hemoglobin ≤11 g/dl has decreased to 17% from 57% in 1997. Currently only 6% of dialysis patients have hemoglobin ≤10 g/dl. Conversely, the mean hemoglobin was 12.0 g/dl in 2004 (9). These numbers are collected from every dialysis unit and monitored by the networks. The clear message articulated through the policy is a desire to maintain hemoglobin at ≥11 g/dl.

It is important to understand that these numbers are "snapshots" not "movies" of patient hemoglobin. A recent study showed that, when followed for 6 mo, the mean hemoglobin is indistinguishable from the population mean regardless of whether the starting hemoglobin was <11 g/dl, 11 g/dl to <12.5 g/dl or ≥12.5 g/dl (10). A recent analysis of the Fresenius Medical Care (FMC-NA) database shows that of 21.6% ("snapshot") of patients that start with hemoglobin >13 g/dl, only 2.6% ("movie") still have hemoglobin >13 g/dl after 3 mo (11). The Centers for Medicare and Medicaid Services (CMS) Erythropoietin Monitoring Policy recognizes this and urges physicians to implement a dose reduction of ESA as hemoglobin approaches 12 g/dl. Consequently, it is critical for CMS to allow payment in such cases.

The Erythropoietin Monitoring Policy has "right-censored" the hemoglobin distribution curve through economic penalties for hemoglobin ≥13 without dose reduction. This has effectively shifted the curve to the left. Data from both DaVita (11) and FMC-NA (personal communication with Kent Thiry, CEO DaVita, Inc., November 16, 2006) show an increase in the proportion of patients with hemoglobin <11 g/dl (1.5 to 2.5%) and an even smaller change in the number of patients with hemoglobin >13 g/dl. It is important to remember that the lower limit of hemoglobin recommended by the Kidney Disease Outcomes Quality Initiative is 11 g/dl and is evidenced-based (12).

It appears that CMS, with input from industry and the nephrology community, seems to have gotten it about right. Further "right-censoring" of the curve will increase the number of beneficiaries with hemoglobin <11 g/dl, and the cycling data suggest that very few people exhibit hemoglobin >13 g/dl for very long. Given the importance of this policy, further monitoring and research is clearly needed, but current evidence does not support dramatic changes.


   Disclosures
Top
 Introduction
 Disclosures
References
 
R.R. is or has recently been a paid consultant to Amgen, Fresenius, DaVita, and the Centers for Medicare and Medicaid Services. In addition, he is the co-chair of the congressionally mandated advisory committee on bundling of ESRD services. D.M. is president of Avalere Health, which has provided advisory services on ESRD to Amgen, the Centers for Medicare and Medicaid Services, and various managed-care companies.


   Acknowledgments
 
We would like to thank DaVita and FMC-NA for their willingness to share their data with us.


   Footnotes
 
Published online ahead of print. Publication date available at www.cjasn.org.


   References
Top
 Introduction
 Disclosures
 References
 

  1. Narins RG, Bennett WM: Patient care guidelines: Problems and solutions. Clin J Am Soc Nephrol2 :1 –2,2007[CrossRef]
  2. Coyne DW: Influence of industry on renal guideline development. Clin J Am Soc Nephrol2 :3 –7,2007[CrossRef]
  3. Van Wyck D, Eckardt K-U, Uhlig K, Rocco M, Levin A: Appraisal of evidence and control of bias in the Kidney Disease Outcomes Quality Initiative guideline development process. Clin J Am Soc Nephrol2 :8 –10,2007[CrossRef]
  4. Coyne DW: Practice recommendations based on low, very low, and missing evidence. Clin J Am Soc Nephrol2 :11 –12,2007[CrossRef]
  5. Van Wyck D, Eckardt K-U, Uhlig K, Rocco M, Levin A: Response to "Influence of Industry on Renal Guideline Development." Clin J Am Soc Nephrol2 :13 –14,2007[CrossRef]
  6. Steinbrook R: Medicare and erythropoietin. N Engl J Med356 :4 –6,2007[Free Full Text]
  7. Steinbrook R: Haemoglobin concentrations in chronic kidney disease. Lancet368 :2191 –2193,2006[CrossRef][Medline]
  8. Report to the Chairman, Committee on Ways and Means, House of Representatives: End-stage renal disease: Bundling of Medicare’s payment for drugs with payment for all ESRD services would promote efficiency and clinical flexibility. Washington, DC: Government Accountability Office, November 2006. (GAO-07-77) Available at http://www.gao.gov/cgi-bin/getrpt?GAO-07-77. Accessed January 12,2007
  9. Centers for Medicare & Medicaid Services: 2005 Annual Report, End Stage Renal Disease. Clinical Performance Measures Project. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards & Quality, Baltimore, Maryland,2005 , pp34 –39
  10. Ebben JP, Gilbertson DT, Foley RN, Collins AJ: Hemoglobin level variability: Associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol1 :1205 –1210,2006[CrossRef]
  11. Ofsthun NJ, Lazarus, JM: Impact of the change in CMS billing rules for erythropoietin on hemoglobin outcomes in dialysis patients. Blood Purif25 :31 –35,2007 Avaiable at: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=96394&Ausgabe=232307&ProduktNr=223997&filename=96394.pdf. Accessed January 18,2007[CrossRef][Medline]
  12. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis47 :S11 –S145,2006[CrossRef][Medline]




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