OPINION

Substantial Clinical Improvement: Optimizing CMS Guidelines For New Products

A checklist of CMS potential outcomes to demonstrate substantial clinical improvement.

Meet The Experts

 

Michael Anger, MD, FACP, FASN
Senior Vice President and Chief Medical Officer, Renal Therapies Group, Fresenius Medical Care North America Chief Medical Officer, Frenova Renal Research

References

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  2. Deo A, Schmid CH, Earley A, et al. Loss to analysis in randomized controlled trials in CKD. Am J Kidney Dis 2011 Sept;58(3):349-55. doi: 10.1053/j.ajkd.2011.04.023.
  3. Palmer SC, Sciancalepore M, Strippoli GF. Trial quality in nephrology: how are we measuring up? Am J Kidney Dis 2011 Sep;58(3):335-7. doi: 10.1053/j.ajkd.2011.06.006.
  4. Centers for Medicare and Medicaid Services. Medicare program: End-Stage Renal Disease Prospective Payment System, payment for renal dialysis services furnished to individuals with acute kidney injury, and End-Stage Renal Disease Quality Incentive Program. Fact sheet, Nov. 2, 2020. https://www.cms.gov/newsroom/fact-sheets/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-renal-dialysis-services.
  5. Wetmore JB, Gilbertson DT, Liu J, Collins AJ. Improving outcome in patients receiving dialysis: the PEER Kidney Care Initiative. Clin J Am Soc Nephrol 2016 Jul 7;11(7):1297-1304. doi: 10.2215/CJN.12981215.