[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Proposed Rules]
[Pages 15264-15265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5918]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 482, and 488

[CMS-3835-N]
RIN 0938-AH17


Medicare Program; Hospital Conditions of Participation: 
Requirements for Approval and Re-Approval of Transplant Centers To 
Perform Organ Transplants; Extension of Comment Period

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

ACTION: Notice of extension of comment period for proposed rule.

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SUMMARY: This notice extends the comment period for a proposed rule 
published in the Federal Register on February 4, 2005, (70 FR 6140). 
The proposed rule sets forth the requirements that heart, heart-lung, 
intestine, kidney, liver, lung, and pancreas transplant centers would 
be required to meet to participate as Medicare-approved transplant 
centers. These proposed revised requirements focus on an organ 
transplant center's ability to perform successful transplants and 
deliver quality patient care as evidenced by good outcomes and sound 
policies and procedures. We also proposed that approval, as determined 
by a center's compliance with the proposed data submission, outcome, 
and process requirements would be granted for 3 years. Every 3 years, 
approvals would be renewed for transplant centers that continue to meet 
these requirements. We proposed these revised requirements to ensure 
that transplant centers continually provide high-quality 
transplantation services in a safe and efficient manner. The comment 
period for the proposed rule is extended for 60 days.

DATES: The comment period is extended to 5 p.m. on June 6, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3835-P. Because 
of

[[Page 15265]]

staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By mail. You may mail written comments (one original and two 
copies) to the following address only: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Attention: CMS-3835-
P, P.O. Box 8013, Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.
    Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.

FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539.

SUPPLEMENTARY INFORMATION: On February 4, 2005 (70 FR 6140), we 
published a proposed rule in the Federal Register that set forth the 
requirements that heart, heart-lung, intestine, kidney, liver, lung, 
and pancreas transplant centers would be required to meet to 
participate as Medicare-approved transplant centers.
    The proposed rule set forth the first comprehensive hospital 
conditions of participation (CoPs) for transplant centers that perform 
organ transplants. The proposed rule contains multiple new technical, 
structural, and performance requirements, including new procedures for 
approval and re-approval of transplant centers and new outcome 
performance measures. Due to the large number of proposed new 
requirements and the technical nature of the proposed outcome 
performance measures, we are extending the comment period to ensure 
sufficient time for the public to review and comment on the proposed 
requirements. Therefore, we are extending the public comment period for 
an additional 60 days, until June 6, 2005. We believe the revised date 
will allow sufficient time for the public to provide comments.

    Authority: Sections 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302, 1395hh).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773, Medicare--Hospital Insurance 
Program; and No. 93.774, Medicare--Supplementary Medical Insurance 
Program)

    Dated: March 14, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: March 18, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-5918 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P