[Federal Register Volume 62, Number 180 (Wednesday, September 17, 1997)]
[Notices]
[Pages 48872-48873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24644]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[BPD-898-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 six additional applications that HCFA 
has received from hospitals requesting waivers from dealing with their 
designated organ procurement organizations (OPOs) in accordance with 
section 1138(a)(2) of the Act. It supplements notices published in the 
Federal Register on January 19, 1996, May 17, 1996, November 8, 1996, 
and April 21, 1997, that announced hospital waiver requests received by 
HCFA. This notice requests comments from OPOs and the general public 
for our consideration in determining whether these waivers should be 
granted. This notice also makes a technical correction to two of the 
listings in the April 21, 1997 notice.

DATES: Written comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5:00 p.m. on 
November 17 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-898-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.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code BPD-898-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. Honey, (410) 786-4554.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 19, 1996, May 17, 1996, November 8, 1996, and April 21, 
1997, we published notices in the Federal Register (61 FR 1389, 61 FR 
24941, 61 FR 57876, and 62 FR 19326) 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 four notices. Section 1138(a)(1)(A)(iii) of 
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) 
(Pub. L. 103-432) amended section 1138 of the Act to require that 
effective January 1, 1996, a hospital must notify the OPO designated 
for the service area in which it is located of potential organ donors 
(sections 1138(a)(1)(A)(iii) and (a)(3)(B) of the Act). The hospital 
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 (section 
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.
    Regulations at 42 CFR 486.316(d) provide that if HCFA changes 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 will use to evaluate the waiver in these 
cases are the same as that described above under section 1138(a)(2)(A) 
of the Act and incorporated in 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 HCFA 
is processing the waiver request.
    Earlier this year HCFA redesignated all OPO service areas as a 
result of the 2-year recertification process required under the statute 
and regulations at Sec. 486.304(e)(2).

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 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 the HCFA Central Office, 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 Requests

    As allowed under Sec. 486.316(e), the following six hospitals have 
requested waivers to have an agreement with an alternative, out-of-area 
OPO, as a result of changes in their designated OPOs due to the 
redesignation of OPO service areas earlier this year. The listing 
includes the name of the facility, the city and State location of the 
facility, the

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requested OPO, and the currently designated area OPO. These hospitals 
have submitted timely waiver requests and may work with the requested 
OPO rather than the designated OPO pending our review.

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         Name of facility                  City               State          Requested OPO      Designated OPO  
----------------------------------------------------------------------------------------------------------------
Alamance Regional Medical Center.  Burlington.........  NC                 NCNC               NCBG              
Bullhead Community Hospital......  Bullhead City......  AZ                 AZOB               NVLV              
Cooley Dickinson Hospital Inc....  Northhampton.......  MA                 MAOB               CTHH              
Ohio Valley Medical Center.......  Wheeling...........  WV                 PATF               OHLP              
Reynolds Memorial Hospital.......  Glen Dale..........  WV                 PATF               OHLP              
Wheeling Hospital................  Wheeling...........  WV                 PATF               OHLP              
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IV. Technical Correction

    In the April 21, 1997, notice with comment period at 62 FR 19328, 
in the first chart, the listings of the OPO codes of the requested and 
designated OPOs for Crestline Memorial Hospital and River Valley Health 
System were inadvertently reversed. The corrected entries for these 
hospitals read as follows:

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         Name of facility                  City               State          Requested OPO      Designated OPO  
----------------------------------------------------------------------------------------------------------------
River Valley Health System.......  Ironton............  OH                 OHLP               KYDA              
Crestline Memorial Hospital......  Crestline..........  OH                 OHLP               OHLC              
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V. Keys to the OPO Codes

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

AZOB--DONOR NETWORK OF ARIZONA, 3877 North Seventh Street, Phoenix, AZ 
85014
CTHH--NORTHEAST OPO AND TISSUE BANK, Hartford Hospital, 80 Seymour 
Street, Hartford, CT 06102-5037
KYDA--KENTUCKY ORGAN DONOR AFFILIATES, 105 East Broadway, Louisville, 
KY 40202
MAOB--NEW ENGLAND ORGAN BANK, INC., One Gateway Center, Newton, MA 
02158
NCBG--CAROLINA LIFE CARE, North Carolina Baptist Hospitals, Medical 
Center Boulevard, Winston-Salem, NC 27157
NCNC--CAROLINA ORGAN PROCUREMENT, 702 Johns Hopkins Drive, Greenville, 
NC 27834
NVLV--NEVADA DONOR NETWORK, 4580 Southeastern Avenue, Suite 33, Las 
Vegas, NV 89119
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
PATF--CENTER FOR ORGAN RECOVERY AND EDUCATION, 204 Sigma Drive, RIDC 
Park, Pittsburgh, PA 15238.

VI. 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 to be 
collected.
    The information collection requirement and the burden associated 
with requiring a Medicare or Medicaid participating hospital to have an 
agreement with the OPO designated for its area or to submit a waiver 
request to HCFA for approval to have an agreement with an OPO other 
than the OPO designated for its service area currently are approved 
under OMB approval number 0938-0688 (HCFA-R-13), with an expiration 
date of November 30, 1997.

    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: September 2, 1997.
Bruce M. Fried,
Director, Center for Health Plans and Providers, Health Care Financing 
Administration.
[FR Doc. 97-24644 Filed 9-16-97; 8:45 am]
BILLING CODE 4120-01-P