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.

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 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).