[Federal Register Volume 61, Number 13 (Friday, January 19, 1996)]
[Notices]
[Pages 1389-1390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-644]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-854-NC]


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

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

ACTION: Notice with comment period.

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SUMMARY: In accordance with the Social Security Amendments of 1994, 
this notice announces applications received from hospitals requesting 
waivers from dealing with their designated area organ procurement 
organizations (OPOs). Effective January 1, 1996, a hospital is required 
to have an agreement with the OPO designated for the area in which it 
is located unless granted a waiver to have an agreement with an 
alternative OPO. This notice requests comments from OPOs and the 
general public for consideration by us in determining whether such a 
waiver should be granted.

DATES: Written comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on March 
19, 1996.

ADDRESSES: Mail written comments (one original and three copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: BPD-854-NC, P.O. Box 7517, 
Baltimore, MD 21244-0517.

[[Page 1390]]

    If you prefer, you may deliver your written comments (one original 
and three copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Washington, DC 20201, or
Room C5-09-26, 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 BPD-854-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 309-G of 
the Department's offices at 200 Independence Avenue SW., Washington, 
DC, on Monday through Friday of each week 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 of the Social Security Act (the Act) provides that a 
hospital or rural primary care hospital that participates in the 
Medicare or Medicaid programs must establish written protocols for the 
identification of potential organ donors. Section 155 of the Social 
Security Amendments of 1994 (SSA '94) (Public Law 103-432) amended 
section 1138 of the Act to require that effective January 1, 1996, a 
hospital may have an agreement concerning organ procurement only with 
its designated Organ Procurement Organization (OPO) unless it obtains a 
waiver from the Secretary that would allow the hospital to have an 
agreement with a different OPO. This section also provides that any 
hospital that had an agreement with an out-of-area OPO on the date of 
enactment, October 31, 1994, must submit a waiver request to the 
Secretary by January 1, 1996, if it wishes to retain the agreement. The 
existing agreement would remain in effect pending the Secretary's 
determination.
    The law further states that in granting a waiver for an out-of-area 
agreement, the Secretary must determine that such a waiver: (1) Would 
be expected to increase donation; and (2) will assure equitable 
treatment of patients referred for transplants within the service area 
served by the designated OPO and within the service area served by the 
out-of-area OPO. In making a waiver determination, 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 definition of metropolitan 
statistical areas (MSA); and (4) the length and continuity of a 
hospital's relationship with the out-of-area OPO. Under section 
1138(a)(2)(D) of the Act, the Secretary is required to publish a notice 
of any waiver applications within 30 days of receiving the application 
and offer interested parties an opportunity to comment in writing 
within 60 days of the published notice.

II. Hospital Requests for Waiver

    In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) that has been supplied to each hospital. This Program Memorandum 
detailed the waiver process and discussed the information that may be 
provided by hospitals requesting a waiver. As required by law, we 
indicated that upon receipt of the waiver requests, we would publish a 
notice to solicit comments.
    Upon receipt of the comments, we will review the request and 
comments received. During the review process, we may consult on an as 
needed basis with parties other than those that submitted comments 
including the Public Health Service's Division of Transplantation, the 
United Network for Organ Sharing, and HCFA regional offices. If 
necessary, we may also request additional clarifying information from 
the applying hospital. It should be noted that there is no time limit 
upon which we must complete our review. We then will make a 
determination on the waiver requests and notify the affected hospitals 
and OPOs.

III. Hospitals Requesting Waivers

    To date, we have received waiver applications from the following 
hospitals:

Hospital Name: West Florida Regional Medical Center
City & State: Pensacola, FL
Requested OPO: Alabama Organ Center
City & State: Birmingham, AL
Designated OPO: University of Florida
City & State: Gainesville, FL

Hospital Name: Singing River Hospital System
City & State: Pascagoula, MS
Requested OPO: Alabama Organ Center
City & State: Birmingham, AL
Designated OPO: Mississippi Organ Recovery Agency
City & State: Jackson, MS

Hospital Name: Jefferson Memorial Hospital
City & State: Ranson, WV
Requested OPO: Virginia's Organ Procurement Agency
City & State: Midlothian, VA
Designated OPO: Center Organ Recovery & Education
City & State: Pittsburgh, PA

Hospital Name: City Hospital
City & State: Martinsburg, WV
Requested OPO: Virginia's Organ Procurement Agency
City & State: Midlothian, VA
Designated OPO: Center Organ Recovery & Education
City & State: Pittsburgh, PA

Hospital Name: Princeton Community Hospital
City & State: Princeton, WV
Requested OPO: Virginia's Organ Procurement Agency
City & State: Midlothian, VA
Designated OPO: Center Organ Recovery & Education
City & State: Pittsburgh, PA

Hospital Name: Fort Walton Beach Medical Center
City & State: Ft. Walton Beach, FL
Requested OPO: Alabama Organ Center
City & State: Birmingham, AL
Designated OPO: University of Florida
City & State: Gainesville, FL

Hospital Name: Baylor Medical Center at Grapevine
City & State: Grapevine, TX
Requested OPO: Southwest Organ Bank
City & State: Dallas, TX
Designated OPO: Life Gift Organ Donation Center
City & State: Houston, TX

Hospital Name: St. Joseph Regional Health Center
City & State: Bryan, TX
Requested OPO: Southwest Organ Bank
City & State: Dallas, TX
Designated OPO: Life Gift Organ Donation Center
City & State: Houston, TX

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

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

    Dated: November 30, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 96-644 Filed 1-17-96; 8:45 am]
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