Medicare Proposes Using National Kidney Foundation Standards For ESRD Treatment
This article was originally published in The Pink Sheet Daily
Executive Summary
CMS' proposed rule on end-stage renal disease conditions for coverage suggests facility-wide standards using NKF Disease Outcomes Quality Initiative clinical practice guidelines. Medicare adoption of the K/DOQI guidelines could be a positive for manufacturers of ESRD therapies.
|
The Centers for Medicare & Medicaid Services is proposing to adopt clinical practice guidelines developed by the National Kidney Foundation for end-stage renal disease. CMS will publish a proposed rule for Medicare end-stage renal disease conditions for coverage in the Federal Register Feb. 4. The agency will have a 90-day comment period for the rule. "The preamble to the proposed rule includes a detailed discussion regarding the possible use of minimum facility-wide standards with a request for public comment regarding whether to immediately adopt certain widely-accepted [NKF Disease Outcomes Quality Initiative] clinical practice guidelines as minimum facility-wide standards," CMS said. "The proposed regulation is applicable to over 4,700 Medicare-approved renal dialysis facilities and over 325,000 patients with chronic kidney disease," CMS noted. Medicare's adoption of the K/DOQI guidelines could be a positive for manufacturers of ESRD drugs. Amgen uses the K/DOQI guidelines as part of its marketing strategy for the chronic kidney disease therapy Sensipar (cinalcalcet). Shire, which markets Fosrenol (lanthanum) for reduction of serum phosphate in ESRD patients, noted that the aggressive K/DOQI guidelines give physicians an opportunity to reassess patients' therapy (1 (Also see "Shire's Fosrenol Marketing Campaign Will Follow Adderall Model" - Pink Sheet, 6 Jan, 2005.)). - Elizabeth Walker |