[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Pages 43198-43200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-1055-NC]


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

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. 
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 
requests comments from OPOs and the general public for our 
consideration in determining whether these waivers should be granted.

COMMENT DATE: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on October 
8, 1999.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health

[[Page 43199]]

and Human Services, Attention: HCFA-1055-NC, P.O. Box 9016, Baltimore, 
MD 21244-9016.
    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.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-1055-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 
with only that designated OPO to identify potential organ donors.
    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 
the designated OPO if the 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 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 
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 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 service area due to the 
changes made on or after December 28, 1992, in definition of 
metropolitan statistical areas (MSAs); and (4) 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 process its waiver request it submitted in accordance 
with Sec. 486.316(d).
    This notice supplements previous notices announcing OPO waivers 
published in the Federal Register on January 19, 1996 (61 FR 1389), May 
17, 1996 (61 FR 24941), November 8, 1996 (61 FR 57876), April 21, 1997 
(62 FR 19326), September 17, 1997 (62 FR 48872), September 23, 1998 (63 
FR 50919), and January 12, 1999 (64 FR 1811).

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 comments received. During the 
review process, we may consult, on an as-needed basis, with the Health 
Resources and Services Administration's Division of Transplantation; 
the Organ Procurement and Transplantation Network Contractor, 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. The listing includes the name of the facility, the city 
and state of the facility, the currently designated area OPO and the 
requested OPO.

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        Name of facility                  City                State          Designated  OPO     Requested  OPO
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Keweenaw Memorial Hospital......  Laurium............  MI                  WIWU                MIOP
Jefferson Memorial Hospital.....  Ranson.............  WV                  DCTC                VAOP
Dickinson County Healthcare       Iron Mountain......  MI                  WIWU                MIOP
 System.
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    The following two 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. These waivers will only be effective upon 
completion of our review if the provider meets the requirement of 
Sec. 486.316 (e).

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        Name of facility                  City                State          Designated  OPO     Requested  OPO
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Fairview Hospital...............  Great Barrington...  MA                  MAOB                NYAP
Elko General Hospital...........  Elko...............  NV                  NVLV                UTOP
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[[Page 43200]]

IV. Key to the OPO Codes

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

DCTC--WASHINGTON REGIONAL TRANSPLANT CONSORTIUM, 8110 Gatehouse Road, 
Suite 101 W, Falls Church, VA 22042
MAOB--NEW ENGLAND ORGAN BANK, One Gateway Center, Newton, MA 02458
MIOP--ORGAN PROCUREMENT AGENCY OF MICHIGAN, 2203 Platt Road, Ann Arbor, 
MI 48104
NVLV--NEVADA DONOR NETWORK, 4850 Southeastern Avenue, Suite 33, Las 
Vegas, NV 89119
NYAP--CENTER FOR DONATION AND TRANSPLANT, 218 Great Oaks Blvd., Albany, 
NY 12203
UTOP--INTERMOUNTAIN ORGAN PROCUREMENT AGENCY, 230 South 500 East, Suite 
290, Salt Lake City, UT 84102
VAOP--VIRGINIA ORGAN PROCUREMENT AGENCY, 1527 Houguenot Road, 
Midlothian, VA 23113
WIWU--UNIVERSITY OF WISCONSIN OPO, University of Wisconsin Hospitals 
and Clinics, 600 Highland Avenue, Madison, Wisconsin 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 following issue 
for the information collection requirements 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 qualify for 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. 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 
recordkeeping 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-1055-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: August 2, 1999.
Robert A. Berenson,
Director, Center for Health Plans and Providers, Health Care Financing 
Administration.
[FR Doc. 99-20403 Filed 8-6-99; 8:45 am]
BILLING CODE 4120-01-P