International comparisons to assess effects of payment and regulatory changes in the United States on anemia practice in patients on hemodialysis: The dialysis outcomes and practice patterns study

Journal of the American Society of Nephrology

Volumn 27, Issue 7, 2016, Pages 2205-2215

  Fuller, Douglas S ^a   Bieber, Brian A ^a   Pisoni, Ronald L ^a   Li, Yun ^b   Morgenstern, Hal ^c   Akizawa, Tadao ^d   Jacobson, Stefan H ^e   Locatelli, Francesco ^f   Port, Friedrich K ^a   Robinson, Bruce M ^a,c  

^a ARBOR RESEARCH COLLABORATIVE FOR HEALTH   (United States)

^b UNIVERSITY OF MICHIGAN SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^d SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e DANDERYD HOSPITAL   (Sweden)

^f A MANZONI HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; HEMOGLOBIN; IRON; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN;

AGED; ANEMIA; ARTICLE; BLACK PERSON; COMPARATIVE STUDY; DRUG DOSE REDUCTION; FEMALE; GERMANY; HEMODIALYSIS; HEMODIALYSIS PATIENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; ITALY; JAPAN; MAJOR CLINICAL STUDY; MALE; PRESCRIPTION; PRIORITY JOURNAL; REIMBURSEMENT; SPAIN; UNITED KINGDOM; UNITED STATES; CLINICAL PRACTICE; CLINICAL TRIAL; ECONOMICS; EUROPE; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT;

AGED; ANEMIA; EUROPE; FEMALE; HEMATINICS; HUMANS; JAPAN; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PRACTICE PATTERNS, PHYSICIANS'; REIMBURSEMENT MECHANISMS; RENAL DIALYSIS; UNITED STATES;

EID: 85014640056     PISSN: 10466673     EISSN: 15333450     Source Type: Journal    
DOI: 10.1681/asn.2015060673     Document Type: Article

References (48)

1. Babitt JL, Lin HY: Mechanisms of anemia in CKD. J Am Soc Nephrol 23: 1631–1634, 2012
2. Pisoni RL, Bragg-Gresham JL, Young EW, Akizawa T, Asano Y, Locatelli F, Bommer J, Cruz JM, Kerr PG, Mendelssohn DC, Held PJ, Port FK: Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 44: 94–111, 2004
3. McFarlane PA, Pisoni RL, Eichleay MA, Wald R, Port FK, Mendelssohn D: International trends in erythropoietin use and hemoglobin levels in hemodialysis patients. Kidney Int 78: 215–223, 2010
4. Thamer M, Zhang Y, Lai D, Kshirsagar O, Cotter D: Influence of safety warnings on ESA prescribing among dialysis patients using an interrupted time series. BMC Nephrol 14: 172, 2013
5. Hirth RA: The organization and financing of kidney dialysis and transplant care in the United States of America. Int J Health Care Finance Econ 7: 301–318, 2007
6. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators: Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 355: 2085–2098, 2006
7. Drüeke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators: Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 355: 2071–2084, 2006
8. Pfeffer MA, Burdmann EA, Chen C-Y, Cooper ME, de Zeeuw D, Eckardt K-U, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R; TREAT Investigators: A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 361: 2019–2032, 2009
9. United States Congress, House Committee on Ways and Means, Subcommittee on Health: Hearing on Ensuring Kidney Patients Receive Safe and Appropriate Anemia Management Care [Electronic Resource]: Hearing before the Subcommittee on Health of the Committee on Ways and Means, US House of Representatives, One Hundred Tenth Congress, First Session, June 26, 2007. Available at: http://purl.access.gpo.gov/GPO/LPS122225. Accessed June 5, 2015
10. Saran R, Li Y, Robinson B, Ayanian J, Balkrishnan R, Bragg-Gresham J, Chen JT, Cope E, Gipson D, He K, Herman W, Heung M, Hirth RA, Jacobsen SS, Kalantar-Zadeh K, Kovesdy CP, Leichtman AB, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, O’Hare AM, Pisoni R, Plattner B, Port FK, Rao P, Rhee CM, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, Eggers PW, Agodoa LY, Abbott KC: US Renal Data System 2014 annual data report: Epidemiology of kidney disease in the United States. Am J Kidney Dis 66[Suppl 1]: S1–S305, 2015
11. US Government Accountability Office: End-Stage Renal Disease: Medicare Should Pay a Bundled Rate for All ESRD Items and Services, Washington, DC, US Government Accountability Office, 2007
12. Centers for Medicare & Medicaid Services (CMS); HHS: Medicare program; end-stage renal disease prospective payment system. Final rule. Fed Regist 75: 49029–49214, 2010
13. US Food and Drug Administration; US Department of Health and Human Services: FDA Drug Safety Communication: Modified Dosing Recommendations to Improve the Safe Use of Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease. Safety Announcement 6/24/2011. Available at: http://www.fda.gov/drugs/drugsafety/ucm259639.htm. Accessed June 15, 2015
14. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA: The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 339: 584–590, 1998
15. Coyne DW: The health-related quality of life was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial. Kidney Int 82: 235–241, 2012
16. Centers for Medicare & Medicaid Services (CMS); HHS: Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment, prosthetics, orthotics and supplies. Proposed rule. Fed Regist 76: 40498–40550, 2011
17. Centers for Medicare & Medicaid Services (CMS); HHS: Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies. Final rule. Fed Regist 76: 70228–70316, 2011
18. US Government Accountability Office: End-Stage Renal Disease: CMS Should Monitor Access to and Quality of Dialysis Care Promptly After Implementation of New Bundled Payment System, Washington, DC, US Government Accountability Office, 2010
19. American Society of Nephrology: ASN Comments on ESRD PPS and QIP Final Rule November 2010. Available at: http://www.asn-online.org/policy/webdocs/nov2010guidanceonfinalrule.pdf. Accessed August 7, 2014
20. Wish JB: Anemia management under a bundled payment policy for dialysis: A preview for the United States from Japan. Kidney Int 79: 265–267, 2011
21. Manns BJ, Tonelli M: The new FDA labeling for ESA–implications for patients and providers. Clin J Am Soc Nephrol 7: 348–353, 2012
22. Arbor Research Collaborative for Health: DOPPS Practice Monitor. Available at: http://www.dopps.org/DPM/Default.aspx. Accessed February 3, 2015
23. Kleophas W, Reichel H: International study of health care organization and financing: Development of renal replacement therapy in Germany. Int J Health Care Finance Econ 7: 185–200, 2007
24. Kleophas W, Karaboyas A, Li Y, Bommer J, Reichel H, Walter A, Icks A, Rump LC, Pisoni RL, Robinson BM, Port FK: Changes in dialysis treatment modalities during institution of flat rate reimbursement and quality assurance programs. Kidney Int 84: 578–584, 2013
25. Hasegawa T, Bragg-Gresham JL, Pisoni RL, Robinson BM, Fukuhara S, Akiba T, Saito A, Kurokawa K, Akizawa T: Changes in anemia management and hemoglobin levels following revision of a bundling policy to incorporate recombinant human erythropoietin. Kidney Int 79: 340–346, 2011
26. Turenne MN, Cope EL, Porenta S, Mukhopadhyay P, Fuller DS, Pearson JM, Dahlerus C, Lantz B, Tentori F, Robinson BM: Has dialysis payment reform led to initial racial disparities in anemia and mineral metabolism management? J Am Soc Nephrol 26: 754–764, 2015
27. Gejyo F, Saito A, Akizawa T, Akiba T, Sakai T, Suzuki M, Nishi S, Tsubakihara Y, Hirakata H, Bessho M; Japanese Society for Dialysis Therapy: 2004 Japanese Society for Dialysis Therapy guidelines for renal anemia in chronic hemodialysis patients. Ther Apher Dial 8: 443–459, 2004
28. Tsubakihara Y, Nishi S, Akiba T, Hirakata H, Iseki K, Kubota M, Kuriyama S, Komatsu Y, Suzuki M, Nakai S, Hattori M, Babazono T, Hiramatsu M, Yamamoto H, Bessho M, Akizawa T: 2008 Japanese Society for Dialysis Therapy: Guidelines for renal anemia in chronic kidney disease. Ther Apher Dial 14: 240–275, 2010
29. Locatelli F, Aljama P, Bárány P, Canaud B, Carrera F, Eckardt KU, Hörl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S; European Best Practice Guidelines Working Group: Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 19[Suppl 2]: ii1–ii47, 2004
30. Locatelli F, Covic A, Eckardt KU, Wiecek A, Vanholder R; ERA-EDTA ERBP Advisory Board: Anaemia management in patients with chronic kidney disease: A position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant 24: 348–354, 2009
31. Locatelli F, Aljama P, Canaud B, Covic A, De Francisco A, Macdougall IC, Wiecek A, Vanholder R; Anaemia Working Group of European Renal Best Practice (ERBP): Target haemoglobin to aim for with erythropoiesis-stimulating agents: A position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. Nephrol Dial Transplant 25: 2846–2850, 2010
32. Kidney Disease Improving Global Outcomes: Kidney Disease Improving Global Outcomes clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl 2: 279–335, 2012
33. Locatelli F, Bárány P, Covic A, De Francisco A, Del Vecchio L, Goldsmith D, Hörl W, London G, Vanholder R, Van Biesen W; ERA-EDTA ERBP Advisory Board: Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: A European Renal Best Practice position statement. Nephrol Dial Transplant 28: 1346–1359, 2013
34. Vanholder R, Davenport A, Hannedouche T, Kooman J, Kribben A, Lameire N, Lonnemann G, Magner P, Mendelssohn D, Saggi SJ, Shaffer RN, Moe SM, Van Biesen W, van der Sande F, Mehrotra R; Dialysis Advisory Group of American Society of Nephrology: Reimbursement of dialysis: A comparison of seven countries. J Am Soc Nephrol 23: 1291–1298, 2012
35. Fuller DS, Pisoni RL, Bieber BA, Gillespie BW, Robinson BM: The DOPPS Practice Monitor for US dialysis care: Trends through December 2011. Am J Kidney Dis 61: 342–346, 2013
36. Whitman CB, Shreay S, Gitlin M, van Oijen MGH, Spiegel BMR: Clinical factors and the decision to transfuse chronic dialysis patients. Clin J Am Soc Nephrol 8: 1942–1951, 2013
37. Centers for Medicare and Medicaid Services (CMS): ESRD Payment Spotlight: ESRD Prospective Payment System (ESRD PPS) Overview of 2013 Claims-Based Monitoring Program. Available at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Spotlight.html. Accessed June 15, 2015
38. US Renal Data System: USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2013
39. Young EW, Goodkin DA, Mapes DL, Port FK, Keen ML, Chen K, Maroni BL, Wolfe RA, Held PJ: The Dialysis Outcomes and Practice Patterns Study (DOPPS): An international hemodialysis study. Kidney Int 57 [Suppl 74]: S74–S81, 2000
40. Pisoni RL, Gillespie BW, Dickinson DM, Chen K, Kutner MH, Wolfe RA: The Dialysis Outcomes and Practice Patterns Study (DOPPS): Design, data elements, and methodology. Am J Kidney Dis 44[Suppl 2]: 7–15, 2004
41. Robinson B, Fuller D, Zinsser D, Albert J, Gillespie B, Tentori F, Turenne M, Port F, Pisoni R: The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: Rationale and methods for an initiative to monitor the new US bundled dialysis payment system. Am J Kidney Dis 57: 822–831, 2011
42. ESRD Network 11: National 2010 and Trends Elab Report, 2011. Available at: http://www.esrdnet11.org/Elab/elab_national_2010_and_trends_report.pdf. Accessed November 8, 2011
43. Lea JP, Norris K, Agodoa L: The role of anemia management in improving outcomes for African-Americans with chronic kidney disease. Am J Nephrol 28: 732–743, 2008
44. Derebail VK, Lacson EK Jr., Kshirsagar AV, Key NS, Hogan SL, Hakim RM, Mooney A, Jani CM, Johnson C, Hu Y, Falk RJ, Lazarus JM: Sickle trait in African-American hemodialysis patients and higher erythropoiesis-stimulating agent dose. J Am Soc Nephrol 25: 819–826, 2014
45. Bock HA, Hirt-Minkowski P, Brünisholz M, Keusch G, Rey S, von Albertini B; Swiss EFIXNES trial investigators: Darbepoetin alpha in lower-than-equimolar doses maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta. Nephrol Dial Transplant 23: 301–308, 2008
46. Choi P, Farouk M, Manamley N, Addison J: Dose conversion ratio in hemodialysis patients switched from darbepoetin alfa to PEG-epoetin beta: AFFIRM study. Adv Ther 30: 1007–1017, 2013
47. Harrell FE Jr.: Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression, and Survival Analysis, New York, Springer, 2001
48. Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA; Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients: Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med 339: 578–583, 1998