title: Managing oral phosphate binder medication expenditures within the Medicare bundled end-stage renal disease prospective payment system: economic implications for large U.S. dialysis organizations.
abstract: BACKGROUND
  From January 2016, payment for oral-only renal medications (including phosphate binders and cinacalcet) was expected to be included in the new Medicare bundled end-stage renal disease (ESRD) prospective payment system (PPS). The implementation of the ESRD PPS has generated concern within the nephrology community because of the potential for inadequate funding and the impact on patient quality of care.
  
  
  OBJECTIVE
  To estimate the potential economic impact of the new Medicare bundled ESRD PPS reimbursement from the perspective of a large dialysis organization in the United States.
  
  
  METHODS
  We developed an interactive budget impact model to evaluate the potential economic implications of Medicare payment changes to large dialysis organizations treating patients with ESRD who are receiving phosphate binders. In this analysis, we focused on the budget impact of the intended 2016 integration of oral renal drugs, specifically oral phosphate binders, into the PPS. We also utilized the model to explore the budgetary impact of a variety of potential shifts in phosphate binder market shares under the bundled PPS from 2013 to 2016.
  
  
  RESULTS
  The base model predicts that phosphate binder costs will increase to $34.48 per dialysis session in 2016, with estimated U.S. total costs for phosphate binders of over $682 million. Based on these estimates, a projected Medicare PPS $33.44 reimbursement rate for coverage of all oral-only renal medications (i.e., phosphate binders and cinacalcet) would be insufficient to cover these costs. A potential renal drugs and services budget shortfall for large dialysis organizations of almost $346 million was projected.
  
  
  CONCLUSIONS
  Our findings suggest that large dialysis organizations will be challenged to manage phosphate binder expenditures within the planned Medicare bundled rate structure. As a result, large dialysis organizations may have to make treatment choices in light of potential inadequate funding, which could have important implications for the quality of care for patients with ESRD.
authors.affiliation: University of Florida College of Pharmacy, Dept. of Pharmaceutical Outcomes Policy, 1225 Center Dr., HPNP 3325, Gainesville, FL 32610. hpark@cop.ufl.edu.
authors.forename: Haesuk
authors.initials: H
authors.lastname: Park
authors.forename: Karen L
authors.initials: KL
authors.lastname: Rascati
authors.forename: Michael S
authors.initials: MS
authors.lastname: Keith
mesh_terms: D000284:Administration, Oral; D002017:Budgets; D002614:Chelating Agents / Q000008:administration & dosage* / Q000191:economics; D006801:Humans; D007676:Kidney Failure, Chronic / Q000191:economics / Q000628:therapy*; D006278:Medicare; D018803:Models, Economic; D010710:Phosphates / Q000097:blood; D011445:Prospective Payment System / Q000191:economics*; D011787:Quality of Health Care; D006435:Renal Dialysis / Q000191:economics / Q000379:methods*; D014481:United States
chemical_list: D002614:Chelating Agents; D010710:Phosphates