[Federal Register: February 4, 2008 (Volume 73, Number 23)]
[Proposed Rules]
[Page 6451-6452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe08-11]
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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.
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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