E8-2051. Medicare and Medicaid Programs; Conditions for Coverage for End Stage Renal Disease Facilities-Extension of Timeline for Publication of Final Rule

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Extension of timeline for publication of final rule.

SUMMARY:

This notice announces an extension of the timeline for publication of the “Medicare and Medicaid Programs; Conditions for Coverage for End Stage Renal Disease Facilities” final rule. This notice is issued in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires that a notice be published in the Federal Register if a final regulation, due to exceptional circumstances, will take longer to publish than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and scope of public comments warrants the extension of the timeline for publication.

DATES:

As of February 4, 2008, CMMS announces a delay in the timeline for publication of final rulemaking.

FOR FURTHER INFORMATION CONTACT:

Lynn Riley, [phone]. Lauren Oviatt, [phone].

SUPPLEMENTARY INFORMATION:

 

I. Background

On February 4, 2005, we published in the Federal Register a proposed rule (70 FR 6184), that would establish new certification requirements for Medicare coverage of dialysis facilities. The proposed revisions would reflect advances in dialysis technology and standard care practices that have developed since the requirements were last revised in their entirety in 1976.

II. Notice of Continuation

This notice announces an extension of the timeline for publication of a final rule responding to comments on the above proposed rule. Section 1871(a)(3)(B) of the Act requires the Secretary to publish Medicare final regulations no later than 3 years after the publication date of the proposed rule. To meet this 3-year timeframe, the final rule would have to be published by February 4, 2008.

Section 1871(a)(3)(B) also provides that under “exceptional circumstances,” the Secretary may extend the initial targeted publication date of a final regulation. The Secretary is required, prior to the regulation's previously established proposed publication date, to provide public notice of this extension in the Federal Register, including a brief explanation of the justification for the variation.

This notice extends the timeline based on the following exceptional circumstances, which we believe, justify such an extension. We are not able to meet the 3-year timeline for publication of the final rule due to the complexity of the rule and the large number of public comments we received.

We received a large volume of timely comments on the proposed rule. The commenters presented extremely complex and detailed policy and legal issues, which require extensive consultation, review, and analysis. Also, the development of the final rule requires collaboration among other government agencies, including the Centers for Disease Control and Prevention and other agencies under the Department of Health and Human Services. We note that extensive coordination has been needed to ensure that these provisions follow guidelines and rules of all affected administrative agencies.

In addition, this final rule is extremely comprehensive because it updates and revises 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. Therefore, the incorporation of these updates has required extensive time, outreach, and collaboration to ensure that the final rule's provisions are consistent with technological and scientific advancement in the provision of dialysis services.

We believe that an extension of the publication timeline is necessary and appropriate to ensure that we are able to address all of the comments and issues raised in response to the February 4, 2005 proposed rule. Therefore, this notice extends the timeline for publication of the final rule until February 4, 2009.

Authority: Section 1871 of the Social Security Act (42 U.S.C. 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: January 31, 2008.

Ann Agnew,

Executive Secretary to the Department.