[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
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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
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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.
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Name of facility City State Designated OPO Requested OPO
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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
