[Federal Register Volume 61, Number 218 (Friday, November 8, 1996)]
[Notices]
[Pages 57876-57878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-879-NC]


Medicare and Medicaid Programs; Announcement of Additional 
Application From Hospital Requesting Waivers for Organ Procurement 
Service Area and Technical Correction

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

ACTION: Notice with comment period.

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SUMMARY: This notice announces an additional application which HCFA has 
received from a hospital requesting a waiver from dealing with its 
designated area organ procurement organization (OPO) in accordance with 
section 1138(a)(2) of the Social Security Act. It supplements notices 
published in the Federal Register on January 19, 1996 and May 17, 1996, 
that announced hospital waiver requests received by HCFA. 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 HCFA grants 
it a waiver to have an agreement with an alternative, out-of-area OPO. 
This notice requests comments from OPOs and the general public for our 
consideration 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,

[[Page 57877]]

no later than 5:00 p.m. on January 7, 1997.

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-879-NC, P.O. Box 7517, 
Baltimore, MD 21244-0517.
    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.

    Comments may also be submitted electronically to the following e-
mail address: [email protected]. E-mail comments must include the 
full name and address of the sender and must be submitted to the 
referenced addresss in order to be considered. All comments must be 
incorporated in the e-mail message because we may not be able to access 
attachments. Electronically submitted comments will be available for 
public inspection at the Independence Avenue address, below.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code BPD-879-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

    On January 19, 1996 and May 17, 1996, we published notices in the 
Federal Register (61 FR 1389 and 61 FR 24941) that announced 
applications which HCFA had received from hospitals requesting a waiver 
from dealing with their designated organ procurement organizations 
(OPOs) in accordance with section 1138 (a)(2) of the Social Security 
Act (the Act). This notice supplements these two notices and makes a 
technical correction to one of the groupings listed in the May 17, 1996 
notice.
    Section 1138 (a)(1)(A)(iii) 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 Act Amendments of 1994 (SSA '94) 
(Public Law 103-432) amended section 1138 of the Act to require that 
effective January 1, 1996, a hospital must notify the organ procurement 
organization (OPO) designated for the service area in which it is 
located of potential organ donors (sections 1138 (a)(1)(A)(iii) and 
(a)(1)(B) of the Act). It must also have an agreement to do so only 
with that designated OPO (sections 1138 (a)(1)(C) and (a)(3)(A)).
    The statute also provides that the hospital may obtain a waiver of 
these requirements from the Secretary. A waiver would allow the 
hospital to have an agreement with an ``out-of-area'' OPO (section 1138 
(a)(2)) if it meets conditions specified in the statute (sections 1138 
(a)(2)(A) (i) and (ii)).
    The law further states that in granting a waiver, 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 (section 1138 
(a)(2)(A)). 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 the definition of metropolitan 
statistical areas (MSAs); and (4) the length and continuity of a 
hospital's relationship with the out-of-area OPO (section 
1138(a)(2)(B)). 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. Section 155(a)(2) of SSA '94 provides that any hospital that 
had an agreement with an out-of-area OPO on the date of enactment of 
that legislation, October 31, 1994, may obtain a temporary or interim 
waiver of the requirements of sections 1138(a)(1)(A)(iii) and 
(a)(l)(C). The statute requires that the hospital must have submitted a 
waiver request to the Secretary by January 1, 1996. The statute 
specifically provides that the hospital's existing agreement with the 
out-of-area OPO would remain in effect pending the Secretary's final 
determination under section 1138(a)(2) as to whether the hospital 
should be granted a permanent waiver.
    For hospitals that do not meet these conditions, but that entered 
into agreements with out-of-area OPOs prior to January 1996, we have 
established a similar process. Under our section 1138(a)(2) authority 
to grant waivers if statutory conditions are met, we will make a 
preliminary determination as to whether the hospital's request meets 
the requirements of section 1138(a)(2)(A)(i) and (ii) based upon an 
initial review of its waiver request. If we determine that the hospital 
appears preliminarily to meet those standards, we will grant the 
hospital a temporary, interim waiver while we consider further the 
merits of the hospital's waiver request on a permanent basis. In the 
meantime, the hospital may continue its relationship with the OPO with 
which it has an agreement.

II. Waiver Request Procedures

    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. We indicated that upon 
receipt of the waiver requests, we would publish a Federal Register 
notice to solicit public comments, as required by law (section 
1138(a)(2)(D)).
    We will then review the requests and comments received. During the 
review process, we may consult on an as-needed basis with agencies 
outside HCFA, including the Public Health Service's Division of 
Transplantation, the United Network for Organ Sharing, and HCFA 
regional offices. If necessary, we may request additional clarifying 
information from the applying hospital or others. We then will make a 
final determination on the waiver requests and notify the affected 
hospitals and OPOs.

III. Additional Hospital Waiver Request

    This notice adds an additional hospital to the May 17, 1996 notice. 
We are adding the Hutcheson Medical Center, Inc. of Fort Oglethorpe, 
GA. The Hutcheson Medical Center currently designated area OPO is 
Tennessee Donor Services (TNDS), 1714 Hayes Street, Nashville, TN 
37203. The center's requested out-of-area OPO is Lifelink of Georgia 
(GALL), 3715 Northside Parkway, 100 Northcreek, Suite 300, Atlanta, GA 
30327.

IV. Technical Corrections

    In the May 17, 1996, notice with comment period on page 24943, in 
the Group I listing, we inadvertently carried the incorrect requested 
OPO code for

[[Page 57878]]

Mercy Hospital. The corrected entries for this hospital read as 
follows:

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        Name of facility                  City              State          Requested OPO        Designated OPO  
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Mercy Hospital..................  Willard............  OH............  OHLC................  OHLB               
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Key:                                                                                                            
OHLC Life Connection of Ohio, 1545 Holland Road, Suite C, Maumme, OH 43537.                                     
OHLB Lifebanc, 20600 Chagrin Blvd., Suite 350, Cleveland, OH 44122.                                             

    In the Group II listing, on page 24944, we inadvertently carried 
the incorrect code for the requested OPO and the designated OPO for New 
Milford Hospital. The corrected entries for this hospital read as 
follows:

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        Name of facility                  City              State          Requested OPO        Designated OPO  
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New Milford Hospital............  New Milford........  CT............  NYRT................  CTHH               
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Key:                                                                                                            
NYRT New York Regional Transplant Program, 475 Riverside Drive-Suite 1244, New York, NY 10115.                  
CTHH Northeast OPO and Tissue Bank, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102-5037.              

    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: September 20, 1996.
Thomas A. Ault,
Director, Bureau of Policy Development, Health Care Financing 
Administration.
[FR Doc. 96-28684 Filed 11-7-96; 8:45 am]
BILLING CODE 4120-01-P