title: Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare.
abstract: OBJECTIVE
  In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect.
  
  
  OBJECTIVE
  To assess the effects of the changes in reimbursement policy and the ESA drug label on patients who underwent incident hemodialysis.
  
  
  METHODS
  For this retrospective cohort study, patients 66 years or older who had undergone incident hemodialysis, and were enrolled in Medicare parts A, B, or D for at least 12 months prior to hemodialysis initiation between January 1, 2008, and December 31, 2013, were recruited from hemodialysis centers across the United States. Patients were divided into 2 cohorts based on their date of hemodialysis initiation and followed: January 1, 2008, to December 31, 2009, for the prepolicy cohort and July 1, 2011, to June 30, 2013, for the postpolicy cohort, with the exclusion of January 1, 2010, to June 30, 2011, as a transition period.
  
  
  METHODS
  Changes in CMS reimbursement policy for dialysis and the FDA label for ESAs.
  
  
  METHODS
  Major adverse cardiovascular events (MACEs), including acute myocardial infarction (AMI), stroke, and all-cause mortality; hospitalized congestive heart failure (H-CHF); venous thromboembolism; and red blood cell transfusions. Secondary outcomes included evaluating effects on black and other patient subgroups.
  
  
  RESULTS
  Baseline characteristics of the 69 718 incident hemodialysis patients were similar between cohorts. Compared with the prepolicy period, the risk of MACE, death, H-CHF, and venous thromboembolism were similar in the postpolicy period, and the risk of stroke decreased (hazard ratio [HR], 0.77; 95% CI, 0.64-0.93; P = .01); the use of ESAs also decreased, and the rate of blood transfusions increased (HR, 1.09; 95% CI, 1.07-1.12; P < .001). In the post-postpolicy period, black patients had a significant reduction in risk of MACE (HR, 0.82; 95% CI, 0.73-0.92; P < .001) and all-cause mortality (HR, 0.82; 95% CI, 0.73-0.93; P = .002).
  
  
  CONCLUSIONS
  After the bundling policy and ESA labeling changes in 2011, the risks of MACE and death for patients 66 years or older and covered by fee-for-service Medicare who had undergone incident hemodialysis did not change; the risk of stroke was reduced, and the rate of blood transfusions modestly increased. Black patients had substantial reductions in the risks of MACE and death.
authors: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Cunlin
authors: C
authors: Wang
authors: Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Robert
authors: R
authors: Kane
authors: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Mark
authors: M
authors: Levenson
authors: Centers for Medicare & Medicaid Services, Washington, DC.
authors: Jeffrey
authors: J
authors: Kelman
authors: Acumen LLC, Burlingame, California.
authors: Michael
authors: M
authors: Wernecke
authors: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Joo-Yeon
authors: JY
authors: Lee
authors: Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Steven
authors: S
authors: Kozlowski
authors: Acumen LLC, Burlingame, California.
authors: Carmen
authors: C
authors: Dekmezian
authors: Center for Device and Radiologic Health, Food and Drug Administration, Silver Spring, Maryland.
authors: Zhiwei
authors: Z
authors: Zhang
authors: Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Aliza
authors: A
authors: Thompson
authors: Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Kimberly
authors: K
authors: Smith
authors: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Yu-Te
authors: YT
authors: Wu
authors: Acumen LLC, Burlingame, California.
authors: Yuqin
authors: Y
authors: Wei
authors: Acumen LLC, Burlingame, California.
authors: Yoganand
authors: Y
authors: Chillarige
authors: Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: Qin
authors: Q
authors: Ryan
authors: Centers for Medicare & Medicaid Services, Washington, DC.
authors: Chris
authors: C
authors: Worrall
authors: Acumen LLC, Burlingame, California.
authors: Thomas E
authors: TE
authors: MaCurdy
authors: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors: David J
authors: DJ
authors: Graham
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044383:Black People / Q000706:statistics & numerical data; D001803:Blood Transfusion / Q000706:statistics & numerical data; D014487:Centers for Medicare and Medicaid Services, U.S. / Q000191:economics / Q000458:organization & administration*; D015331:Cohort Studies; D004348:Drug Labeling; D018588:Fee-for-Service Plans; D005260:Female; D018166:Health Care Reform; D006397:Hematinics / Q000008:administration & dosage* / Q000191:economics; D006801:Humans; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy*; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D012051:Reimbursement Mechanisms / Q000191:economics / Q000458:organization & administration*; D012052:Reimbursement, Incentive / Q000191:economics; D006435:Renal Dialysis; D012189:Retrospective Studies; D020521:Stroke / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D044465:White People / Q000706:statistics & numerical data; D001741:Black or African American
chemical_list: D006397:Hematinics