[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Notices]
[Pages 50372-50373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1309-NC]


Medicare and Medicaid Programs; Announcement of an Application 
From a Hospital Requesting Waiver for Organ Procurement Service Area

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

ACTION: Notice with comment period.

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SUMMARY: This notice announces a hospital's request for a waiver from 
entering into an agreement with its designated organ procurement 
organization (OPO), in accordance with section 1138(a)(2) of the Social 
Security Act. This notice requests comments from OPOs and the general 
public for our consideration in determining whether we should grant the 
requested waiver.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 25, 2005.

ADDRESSES: In commenting, please refer to file code CMS-1309-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four 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 regular 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-1309-NC, 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 express or overnight mail. You may send 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-1309-NC, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. 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 information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on all issues set forth in this notice with comment 
period to assist us in fully considering issues and developing 
policies. You can assist us by referencing the file code CMS-1309-NC 
and the specific ``issue identifier'' that precedes the section on 
which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. CMS posts all electronic 
comments received before the close of the comment period on its public 
Web site as soon as possible after they have been received. Hard copy 
comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, at the headquarters of the Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.

I. Background

[If you choose to comment on issues in this section, please include the 
caption ``BACKGROUND'' at the beginning of your comments.]

    Organ Procurement Organizations (OPOs) are not-for-profit 
organizations that recover human organs from potential donors in 
hospitals and distribute them to transplant centers throughout the 
country. Qualified OPOs are designated by the Centers for Medicare & 
Medicaid Services (CMS) to recover organs in CMS-defined exclusive 
geographic service areas, according to section 371(b)(1)(F) of the 
Public Health Service Act (42 U.S.C. 273(b)(1)(F)) and our regulations 
at 42 CFR 486.307. Once an OPO has been designated for an area, 
hospitals in that area that participate in Medicare and Medicaid are 
required to work with that OPO in providing organs for transplant, 
according to section 1138(a) of the Social Security Act (the Act), and 
our regulations at 42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act 
provides that a hospital must notify the designated OPO (for the 
service area in which it is located) of potential organ donors. Under 
section 1138(a)(1)(C) of the Act, every participating hospital must 
have an agreement to identify potential donors only with its designated 
OPO.
    However, section 1138(a)(2) of the Act provides that a hospital may 
obtain a waiver of the above requirements from the Secretary under 
certain specified conditions. A waiver allows the hospital to have an 
agreement with an OPO other than the one initially designated by CMS, 
if the hospital meets certain conditions specified in section 
1138(a)(2) of the Act. In addition, the Secretary may review additional 
criteria described in section 1138(a)(2)(B) of the Act to evaluate the 
hospital's request for a waiver.
    Section 1138(a)(2)(A) of the Act states that in granting a waiver, 
the Secretary must determine that the waiver: (1) Is expected to 
increase organ donations; and (2) will ensure equitable treatment

[[Page 50373]]

of patients referred for transplants within the service area served by 
the designated OPO and within the service area served by the OPO with 
which the hospital seeks to enter into an agreement under the waiver. 
In making a waiver determination, section 1138(a)(2)(B) of the Act 
provides that the Secretary may consider, among other factors: (1) 
Cost-effectiveness; (2) improvements in quality; (3) whether there has 
been any change in a hospital's designated OPO due to the changes made 
in definitions for metropolitan statistical areas (MSAs); and (4) the 
length and continuity of a hospital's relationship with an OPO other 
than the hospital's designated OPO. Under section 1138(a)(2)(D) of the 
Act, the Secretary is required to publish a notice of any waiver 
application within 30 days of receiving the application, and to offer 
interested parties an opportunity to comment in writing during the 60-
day period beginning on the publication date in the Federal Register.
    The criteria that the Secretary uses to evaluate the waiver in 
these cases are the same as those described above under sections 
1138(a)(2)(A) and (B) of the Act and have been incorporated into the 
regulations at 42 CFR 486.316(e) and (f).

II. Waiver Request Procedures

    In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) detailing the waiver process and discussing the information that 
hospitals must provide in requesting a waiver. We indicated that upon 
receipt of a waiver request, we would publish a Federal Register notice 
to solicit public comments, as required by section 1138(a)(2)(D) of the 
Act.
    According to these requirements, we will review the request and 
comments received. During the review process, we may consult on an as-
needed basis with the Public Health Service's Division of 
Transplantation, the United Network for Organ Sharing, and our regional 
offices. If necessary, we may request additional clarifying information 
from the applying hospital or others. We will then make a final 
determination on the waiver request and notify the hospital and the 
designated and requested OPOs.

III. Hospital Waiver Request

    As permitted by 42 CFR 486.316(e), Rockford Health System of 
Rockford, Illinois has requested a waiver in order to enter into an 
agreement with an alternative, out-of-area OPO. Rockford Health System 
is requesting a waiver to work with: University of Wisconsin OPO, 
University of Wisconsin Hospital and Clinic, 600 Highland Avenue, 
Madison, Wisconsin 53792. Rockford Health System's designated OPO is: 
Gift of Hope Organ and Tissue Donor Network, 660 North Industrial 
Drive, Elmhurst, Il 60126-1520. Rockford Health System must continue to 
work with its designated OPO until the completion of our review.

    Authority: Section 1138 of the Social Security Act (42 U.S.C. 
1320b-8).

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

    Dated: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-16796 Filed 8-25-05; 8:45 am]
BILLING CODE 4120-01-P