[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50919-50920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-1047-NC]


Medicare and Medicaid Programs; Announcement of Additional 
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: This notice announces two additional applications that HCFA 
has received from hospitals requesting waivers from entering into 
agreements with their designated organ procurement organizations (OPOs) 
in accordance with section 1138(a)(2) of the Social Security Act. It 
supplements notices published in the Federal Register on January 19, 
1996, May 17, 1996, November 8, 1996, April 21, 1997, and September 17, 
1997, that announced hospital waiver requests received by us. 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 
November 23, 1998.

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-1047-NC, P.O. Box 7517, 
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 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, 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-1047-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, May 17, 1996, November 8, 1996, and April 21, 
1997, and September 17, 1997, we published notices in the Federal 
Register (61 FR 1389, 61 FR 24941, 61 FR 57876, 62 FR 19326, and 62 FR 
48872) that announced applications that HCFA had received from 
hospitals requesting waivers from entering into agreements 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 five notices. Section 1138(a)(1)(A)(iii) of the Act 
provides that a hospital must notify the designated OPO (for the 
service area in which it is located), as defined under section 
1138(a)(3)(B) of the Act, of potential organ donors. Under section 
1138(a)(1)(C) of the Act, the hospital must have an agreement to 
identify potential donors only with that designated OPO.
    Section 1138(a)(2) of the Act provides that the hospital may obtain 
a waiver from the Secretary of these requirements. A waiver allows the 
hospital to have an agreement with an OPO other than the designated OPO 
if conditions specified in section 1138(a)(2)(A) of the Act are met.
    Section 1138(a)(2)(A) further states that in granting a waiver, the 
Secretary must determine that such a 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 
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 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

[[Page 50920]]

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 a now out-of-
area OPO while we are processing the waiver request submitted in 
accordance with Sec. 486.316(d).

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 
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 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. Additional Hospital Waiver Requests

    As allowed under Sec. 486.316(e), each of the following two 
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 requested OPO, and 
the currently designated area OPO. The exception under Sec. 486.316(g) 
does not apply to these two hospitals, so these hospitals may not work 
with the requested OPOs rather than the designated OPOs until the 
completion of our review.

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         Name of facility                  City                State          Requested OPO      Designated OPO
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Jennie Stuart Medical Center.....  Hopkinsville........  KY                 KYDA               TNDS
Medical University of S.C........  Charleston..........  SC                 GALL               SCOP
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IV. Keys to the OPO Codes

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

KYDA  KENTUCKY ORGAN DONOR AFFILIATES, 106 East Broadway, Louisville, 
KY 40202
TNDS  TENNESSEE DONOR SERVICE, 1714 Hayes Street, Nashville, TN 37203
GALL  LIFELINK OF GEORGIA, 3715 Northside Parkway, 100 Northcreek, 
Suite 300, Atlanta, GA 30327
SCOP  SOUTH CAROLINA ORGAN PROCUREMENT AGENCY, 1064 Gardner Road, Suite 
105, Charleston, SC 29407.

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.
    Section 486.316 Designation of one OPO for each service area:
    In summary, Sec. 486.316 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 are 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-1047-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: Sec. 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: September 8, 1998.
Robert A. Berenson,
Director, Center for Health Plans and Providers, Health Care Financing 
Administration.
[FR Doc. 98-25403 Filed 9-22-98; 8:45 am]
BILLING CODE 4120-01-P