[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Notices]
[Pages 58092-58093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-1145-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 two additional applications that we have 
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. This 
notice requests comments from OPOs and the general public for our 
consideration in determining whether we should grant these waivers.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on November 27, 2000.

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-1145-NC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    To ensure that mailed comments are received in time for us to 
consider them, please allow for possible delays in delivering them.
    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 C5-16-03, 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-1145-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, 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(a)(1)(A)(iii) of the Social Security Act (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 the hospital meets conditions specified in section 
1138(a)(2)(A) of the Act. In addition, the Secretary may review 
additional criteria described in section 1138(a)(2)(B) of the Act to 
evaluate a hospital's waiver.
    Section 1138(a)(2)(A) further 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 
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 definitions for metropolitan statistical areas (MSAs); 
and (4) the length and continuity of a hospital's relationship with an 
OPO other than the hospital's 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 sections 1138(a)(2)(A) and 
(B) of the Act and have been incorporated into the regulations at 
Secs. 486.316(e) and (f). 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. This request is not a result of a 
governmental change; therefore, the exception under Sec. 486.316(g) 
does not apply to these two hospitals. Moreover, these hospitals may 
not work with the requested OPOs rather than the designated OPOs until 
the completion of our review.

[[Page 58093]]



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       Name of facility              City               State             Requested OPO        Designated OPO
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Copley Hospital..............  Morrisville....  VI                    NYAP                  MAOB
Mercy Memorial Hospital......  Urbana.........  OH                    OHLC                  OHLP
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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:

MAOB......................................  New England Organ Bank, One
                                             Gateway Center, Newton, MA
                                             02158.
NYAP......................................  Center for Donation and
                                             Transplant, 218 Great Oaks
                                             Blvd, Albany, NY 12203.
OHLC......................................  Life Connection of Ohio,
                                             1545 Holland Road, Suite C,
                                             Maumee, OH 43537-1694.
OHLP......................................  Lifeline of Ohio, 770
                                             Kinnear Road, Suite 200,
                                             Columbus, OH 43212.
 

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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, through the use of automated collection 
techniques or other forms of information technology.
    Section 486.316 states the requirements for a Medicare or Medicaid 
participating hospital to request a waiver permitting the hospital to 
have an agreement with an OPO other than the OPO designated for the 
service area in which the hospital is located. 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, 2001.

    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 31, 2000.
Robert A. Berenson,
Director, Center for Health Plans and Providers, Health Care Financing 
Administration.
[FR Doc. 00-24820 Filed 9-26-00; 8:45 am]
BILLING CODE 4120-01-P