February 5, 2008
By Claire Miley*
On February 4, 2008, the Centers for Medicare and Medicaid Services (CMS) issued a Notice extending until February 4, 2009, the publication of the final rule involving conditions for coverage for end stage renal disease (ESRD) facilities.
CMS published a proposed rule (70 Fed. Reg. 6184) on February 4, 2005, establishing new requirements for Medicare coverage of ESRD facilities. The proposed regulations reflected advances in dialysis technology and standard of care practices that have developed since the requirements were last revised in their entirety in 1976.
CMS is required to publish final regulations no later than three years after the publication date of the proposed rule. To meet this deadline, the final rule should have been published yesterday. However, under "exceptional circumstances" CMS may extend the initial targeted publication date by providing explanation. CMS indicates that it has received a large volume of timely filed comments on the proposed rule. The comments present "extremely complex and detailed policy and legal issues," according to CMS, which require extensive consultation, review, and analysis, including coordination among various government agencies.
The Notice indicates the final regulation will be extremely comprehensive because it will update and revise policies regarding infection control, water and dialysate quality, hemodialyzer re-use, self dialysis in the home, and clinical management of the dialysis patients' anemia management.
*We would like to thank Claire Miley (Bass Berry & Sims PLC, Nashville, TN) for providing this email alert.