05-5917. Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs); 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 6086). In that rule, we proposed to establish new conditions for coverage for organ procurement organizations (OPOs), including multiple new outcome and process performance measures based on donor potential and other related factors in each service area of qualified OPOs. We are proposing new standards with the goal of improving OPO performance and increasing organ donation. The comment period is extended for 60 days.

DATES:

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

ADDRESSES:

In commenting, please refer to file code CMS-3064-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-3064-P, P.O. Box 8015, Baltimore, MD 21244-8015.

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 [phone] 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:

Marcia Newton, [phone].

SUPPLEMENTARY INFORMATION:

On February 4, 2005, we published a proposed rule in the Federal Register (70 FR 6086) that would establish new conditions for coverage for organ procurement organizations (OPOs), including multiple new outcome and process performance measures based on donor potential and other related factors in each service area of qualified OPOs.

The proposed rule includes comprehensive conditions for coverage for OPOs that would replace the OPO existing conditions for coverage. The proposed rule contains multiple new technical, structural, and performance requirements, including new procedures for re-certification of OPOs and new outcome performance measures based on organ donor potential. 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.

Authority: Sections 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-g, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C. 273).

(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.