[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Notices]
[Pages 1811-1813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-1062-NC]
RIN 0938-AJ32


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

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice with comment period.

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SUMMARY: This notice announces additional applications that we have 
received from hospitals requesting waivers from entering into 
agreements with their designated organ procurement organizations 
(OPOs). Section 1138(a)(2) of the Social Security Act allows the 
Secretary of the Department of Health and Human Services to grant 
waivers to hospitals that want to enter into an agreement with a 
specific OPO that is not the designated OPO for the hospital's service 
area. This notice also requests comments from OPOs and the general 
public for our consideration in determining whether these waivers 
should be granted.

DATES: Comments will be considered if we receive them at the 
appropriate address no later than 5 p.m. on March 15, 1999.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-1062-NC, P.O. Box 26676, 
Baltimore, MD 21244-0517.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses: Room 443-G, Hubert H. 
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, 
or Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    Comments may also be submitted electronically to the following e-
mail address: [email protected]. E-mail comments must include the 
full name, postal address, and affiliation (if applicable) of the 
sender and must be submitted to the referenced address to be 
considered. All comments must be incorporated in the e-mail message 
because we may not be able to access attachments.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-1062-NC. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 443-G of 
the Department's offices at 200 Independence Avenue, SW., Washington, 
DC, Monday through Friday from 8:30 a.m. to 5 p.m. (phone: (202) 690-
7890).

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1138(a)(1)(A)(iii) of the Social Security Act (the Act) 
provides that a participating hospital must notify its designated organ 
procurement organization (OPO) of potential organ donors. The 
designated OPO, as defined under section 1138(a)(3)(B) of the Act, is 
determined by the service area in which the hospital is located. Under 
section 1138(a)(1)(C) of the Act, the hospital must have an agreement 
to identify potential organ donors only to that designated OPO.
    Section 1138(a)(2) of the Act provides that a participating 
hospital may obtain a waiver of these requirements from the Secretary 
of the Department of Health and Human Services (the Secretary). A 
waiver allows the hospital to have an agreement with an OPO other than 
its designated OPO if conditions specified in section 1138(a)(2)(A) of 
the Act are met.
    Section 1138(a)(2)(A) states that in granting a waiver, the 
Secretary must determine that such a waiver--
     Is expected to increase organ donation; and
     Will ensure equitable treatment of patients referred for 
transplants within the service area served by the hospital's 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

[[Page 1812]]

that the Secretary may consider, among other factors:
     Cost effectiveness.
     Improvements in quality.
     Whether there has been any change in a hospital's 
designated OPO service area due to the changes made on or after 
December 28, 1992, in definition of metropolitan statistical areas.
     The length and continuity of a hospital's relationship 
with the OPO other than the 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, within 60 days of the published notice.
    The regulations at 42 CFR 486.316(d) provide that if we change the 
OPO designated for an area, hospitals located in that area must enter 
into agreements with the newly designated OPO or submit a request for a 
waiver within 30 days of notice of the change in designation. The 
criteria that the Secretary uses to evaluate the waiver in these cases 
are the same as those described above under section 1138(a)(2)(A) of 
the Act and have been incorporated into the regulations at 
Sec. 486.316(e).
    Section 486.316(g) further specifies that a hospital may continue 
to operate under its existing agreement with an out-of-area OPO while 
we are processing the waiver request submitted in accordance with 
Sec. 486.316(d).
    In accordance with section 1138(a)(2)(D) of the Act, this notice 
announces applications from hospitals requesting waivers from entering 
into agreements with their designated OPOs. This notice supplements 
previous notices announcing OPO waivers published on January 19, 1996, 
May 17, 1996, November 8, 1996, April 21, 1997, September 17, 1997, and 
September 23, 1998 (61 FR 1389, 61 FR 24941, 61 FR 57876, 62 FR 19326, 
62 FR 48872, and 63 FR 50919).

II. Waiver Request Procedures

    In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) that was supplied to each hospital. This Program Memorandum 
detailed the waiver process and discussed 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.
    We will review the requests and the 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 allowed under Sec. 486.316(e), each of the following hospitals 
has requested a waiver to have an agreement with an alternative, out-
of-area OPO. This listing includes the name of the facility requesting 
a waiver, the city and state of the facility, the requested OPO, and 
the currently designated area OPO.

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       Name of facility                City             State          Designated  OPO         Requested  OPO
----------------------------------------------------------------------------------------------------------------
The Kings Daughter Hospital...  Greenville.......  MS              TNMS                    MSOP
Delta Regional Medical Center.  Greenville.......  MS              TNMS                    MSOP
Oktibbeha County Hospital.....  Starkville.......  MS              TNMS                    MSOP
Greenwood Leflore Hospital....  Greenwood........  MS              TNMS                    MSOP
Grenada Lake Medical Center...  Grenada..........  MS              TNMS                    MSOP
North Mississippi Medical       Tupelo...........  MS              TNMS                    MSOP
 Center.
Gilmore Memorial Hospital.....  Amory............  MS              TNMS                    MSOP
Genesee Mercy Healthcare......  Batavia..........  NY              NYFL                    NYWN
Baraga County Memorial          L'Anse...........  MI              WIUW                    MIOP
 Hospital.
Grand View Hospital...........  Ironwood.........  MI              WIUW                    MIOP
Bell Memorial.................  Ishpeming........  MI              WIUW                    MIOP
Iron County Community           Crystal Falls....  MI              WIUW                    MIOP
 Hospitals.
St. Mary's Hospital...........  Superior.........  WI              MNOP                    WIUW
Affinity Health Systems.......  Oshkosh..........  WI              WIUW                    WISE
New London Family Medical       New London.......  WI              WIUW                    WISE
 Center.
Calumet Medical Center........  Chilton..........  WI              WIUW                    WISE
Culpeper Memorial Hospital....  Culpeper.........  VA              DCTC                    VAOP
Warren Memorial Hospital......  Front Royal......  VA              DCTC                    VAOP
City Hospital.................  Martinsburg......  WV              DCTC                    VAOP
Mary Washington Hospital......  Fredericksburg...  VA              DCTC                    VAOP
----------------------------------------------------------------------------------------------------------------

    The following three hospitals have requested a waiver under 
Sec. 486.316(e) for a reason unrelated to a change in the designated 
service area of an OPO. Accordingly, these waivers will only be 
effective upon completion of our review.

----------------------------------------------------------------------------------------------------------------
       Name of facility                City             State          Designated  OPO         Requested  OPO
----------------------------------------------------------------------------------------------------------------
Mansfield Hospital............  Mansfield........  OH              OHLC                    OHLP
Shelby Hospital...............  Shelby...........  OH              OHLC                    OHLP
Fletcher Allen................  Burlington.......  VT              MAOB                    NYAP
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[[Page 1813]]

IV. Key to the OPO Codes

    The key to the acronyms used in the listings to identify OPOs and 
their addresses is as follows:

DCTC--Washington Regional Transplant Consortium, 8110 Gateway Road, 
Suite 101 W, Falls Church, VA 22042
MAOB--New England Organ Bank, One Gateway Center, Newton, MA 02158
MIOP--Organ Procurement Agency of Michigan, 2203 Platt Road, Ann Arbor, 
MI 48104
MNOP--Lifesource, Upper Midwest Organ Procurement Organization Inc., 
2550 University Avenue West, Suite 315 South, St. Paul, MN 55114-1904
MSOP--Mississippi Organ Recovery Agency, Inc., 12 River Bend Place, 
Suite B, Jackson, MS 39208
NYAP--OPO of Albany Medical College, 47 Scotland Avenue, AP8, Albany, 
NY 12208
NYFL--Finger Lakes Donor Recovery Network, Corporate Woods of Brighton, 
Building 120, Suite 180, Rochester, NY 14623
NYWN--Upstate New York Transplant Services, Inc., 165 Genesee Street, 
Suite 103, Buffalo, NY 14209
OHLC--Life Connection of Ohio, 1545 Holland Road, Suite C, Maumee, OH 
43537
OHLP--Lifeline of Ohio, 770 Kinnear Road, Suite 200, Columbus, OH 43212
TNMS--Mid-South Transplant Foundation, 956 Court Avenue, Memphis, TN 
38163
VAOP--Virginia Organ Procurement Agency, 1527 Huguenot Road, 
Midlothian, VA 23113
WISE--Wisconsin Donor Network, Froedtert Memorial Lutheran Hospital 
9200 West Wisconsin Avenue, Milwaukee, WI 53226
WIUW--University of Wisconsin OPO, University of Wisconsin Hospital and 
Clinics, 600 Highland Avenue, Madison, WI 53792

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.
    Therefore, we are soliciting public comment on the information 
collection requirements for the issue described below.
    Designation of one OPO for each service area:
    Section 486.316(e) states the requirements for a Medicare or 
Medicaid participating hospital to request a waiver permitting the 
hospital to have an agreement with a designated OPO other than the OPO 
designated for the service area in which the hospital is located. 
However, the burden associated with these requirements is currently 
approved under OMB 0938-0688, HCFA-R-13, Conditions of Coverage for 
Organ Procurement Organizations, with an expiration date of November 
30, 1999.
    If you comment on any of these information collection and record 
keeping requirements, please mail copies directly to the following:

Health Care Financing Administration, Office of Information Services, 
Security and Standards Groups, Division of HCFA Enterprise Standards, 
Attention: Louis Blank, HCFA-1062-NC, Room N2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Attention: Allison Eydt, HCFA Desk Officer, Room 10235, New 
Executive Office Building, Washington, DC 20503.

    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: January 5, 1999.
Robert A. Berenson,
Director, Center for Health Plans and Providers, Health Care Financing 
Administration.
[FR Doc. 99-630 Filed 1-11-99; 8:45 am]
BILLING CODE 4120-01-P