[Federal Register Volume 66, Number 150 (Friday, August 3, 2001)]
[Notices]
[Pages 40706-40708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1193-NC]


Medicare and Medicaid Programs; Announcement of Applications From 
Hospitals Requesting Waivers for Organ Procurement Service Areas

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

ACTION: Notice with comment period.

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SUMMARY: This notice announces three applications that we have received 
from hospitals requesting waivers from entering into agreements with 
their designated organ procurement organizations (OPOs), 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 these waivers.

COMMENT DATE: We will consider comments if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on October 
2, 2001.

ADDRESSES: In commenting, please refer to file code CMS-1193-NC. 
Because of staffing and resource limitations, we cannot accept comments 
by facsimile (FAX) transmission. Mail written comments (one original 
and three copies) to the following address only: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-1193-NC, P.O. Box 8010, Baltimore, MD 21244-8010.
    To ensure that mailed comments are received in time for us to 
consider them, please allow for possible delays in delivering them.
    If you prefer, you may deliver your written comments (one original 
and three copies) to one of the following addresses: Room 443-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201, or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    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: Inspection of Public Comments: 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 Blvd., 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 (410) 786-9994.

I. Background

    Organ Procurement Organizations (OPOs) are not-for-profit 
organizations that collect human organs from hospitals and distribute 
them to transplant centers around the country. Qualified OPOs are 
designated by the Centers for Medicare & Medicaid Services (CMS) to 
collect organs in CMS-defined exclusive geographic service areas, 
according to section 371(b)(1)(E) of the Public Health Service Act (42 
U.S.C. 273(b)(1)(E)) 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

[[Page 40707]]

1138(a) of the Social Security Act (the Act), and our regulations at 
Sec. 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 that particular designated OPO.
    However, section 1138(a)(2) of the Act provides that a hospital may 
obtain a waiver of these 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 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 offer 
interested parties an opportunity to comment in writing for 60 days, 
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 Sec. 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 the waiver requests, 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 requests 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 requests and notify the affected hospitals 
and OPOs.

III. Hospital Waiver Requests

    As permitted by Sec. 486.316(e), three hospitals have requested 
waivers in order to enter into agreements with alternative, out-of-area 
OPOs. The listing below indicates the name of the facility, the city 
and State of the facility, the requested OPO, and the currently 
designated area OPO. This request is not a result of a governmental 
change; therefore, the exception under Sec. 486.316(g) does not apply 
to these three hospitals. These hospitals must continue to work with 
their designated OPOs until the completion of our review.

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       Name of facility                  City                  State          Requested OPO      Designated OPO
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Portage Health System.........  Hancock...............  MI                  MIOP               WIWU
Trace Regional Hospital.......  Houston...............  MS                  MSOP               TNMS
SCCI Hospital.................  Lima..................  OH                  OHLP               OHLC
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IV. Keys to the OPO Codes

    The keys to the acronyms used in the listings to identify OPOs and 
their addresses are as follows:

MIOP
    ORGAN PROCUREMENT AGENCY OF MICHIGAN
    2203 Platt Road
    Ann Arbor, Michigan 48104
MSOP
    MISSISSIPPI ORGAN RECOVERY AGENCY, INC.
    12 River Bend Place
    Suite B
    Jackson, Mississippi 39208
TNMS
    MID-SOUTH TRANSPLANT FOUNDATION
    910 Madison Avenue
    Suite 1002
    Memphis, Tennessee 38103
WIWU
    UNIVERSITY OF WISCONSIN OPO
    University of Wisconsin Hospitals and Clinics
    600 Highland Avenue
    Madison, Wisconsin 53792
OHLP
    LIFELINE OF OHIO
    770 Kinnear Road
    Suite 200
    Columbus, Ohio 43212
OHLC
    LIFE CONNECTION OF OHIO
    40 Wyoming Street
    Dayton, Ohio 45409

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection requirement 
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires that we solicit comment on the following 
issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques or other forms of information technology.
    Section 486.316 sets forth the requirements for a Medicare or 
Medicaid participating hospital to request a waiver permitting the 
hospital to have an agreement with an OPO other than the OPO designated 
for the service area in which the hospital is located. The burden 
associated with these requirements is currently approved under OMB 
0938-0688, HCFA-R-13, Conditions of Coverage for Organ

[[Page 40708]]

Procurement Organizations, with an expiration date of November 30, 
2001.

    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: July 20, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-19438 Filed 8-2-01; 8:45 am]
BILLING CODE 4120-01-P