[Federal Register Volume 73, Number 23 (Monday, February 4, 2008)]
[Proposed Rules]
[Pages 6451-6452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2051]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 400, 405, 410, 412, 413, 414, 488, and 494

[CMS-3818-RCN]
RIN 0938-AG82


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.

[[Page 6452]]


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

FOR FURTHER INFORMATION CONTACT: Lynn Riley, (410) 786-1286. Lauren 
Oviatt, (410) 786-4683.

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.
 [FR Doc. E8-2051 Filed 2-1-08; 8:45 am]
BILLING CODE 4120-01-P