[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Notices]
[Pages 11687-11688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6089]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-1013-NC]


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

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

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: This notice announces an additional application that HCFA has 
received from a hospital requesting waiver from dealing with its 
designated organ procurement organization (OPO) in accordance with 
section 1138(a)(2) of the Act. 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, no later than 5 p.m. on May 11, 
1998.

ADDRESSES: Mail written comments (one original and three copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-1013-NC, PO 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 HCFA-1013-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(a)(1)(A) 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) 
(Pub. L. 103-432) amended section 1138 of the Act to require that 
effective January 1, 1996, a hospital must notify the organ procurement 
organization 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 
donations; 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

[[Page 11688]]

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). The 
regulations further specify that a hospital may continue to operate 
under its existing agreement with an out-of-area OPO while HCFA is 
processing the waiver request.

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 Request

    As allowed under Sec. 483.316(d), the following hospital has 
requested a waiver to have an agreement with an alternative, out-of-
area OPO, as a result of changes in its designated OPO due to the 
latest redesignation of OPO service areas. The listing includes the 
name of the facility, the city and State location of the facility, the 
requested OPO, and the currently designated area OPO. The hospital has 
submitted a timely waiver request and may work on an interim basis with 
the requested out-of-area OPO, pending receipt of public comments and 
our final determination.

----------------------------------------------------------------------------------------------------------------
        Name of facility                City                State            Requested OPO      Designated OPO  
----------------------------------------------------------------------------------------------------------------
Baptist Memorial Hospital--      New Albany........  MS.................  TNMS..............  MSOP.             
 Union County.                                                                                                  
----------------------------------------------------------------------------------------------------------------

IV. Keys to the OPO Codes

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

MSOP--MISSISSIPPI ORGAN RECOVERY AGENCY, 12 River Bend Place, Jackson, 
MS 39208
TNMS--MID-SOUTH TRANSPLANTATION FOUNDATION, 956 Court Avenue, Memphis, 
TN 38163.

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 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 a designated OPO 
other than the OPO designated for its service area currently are 
approved by OMB.

    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; and Program No. 93.774, and No. 
93.778, Medical Assistance Program)

    Dated: February 27, 1998.
Kathleen A. Buto,
Acting Director, Center for Health Plans and Providers, Health Care 
Financing Administration.
[FR Doc. 98-6089 Filed 3-9-98; 8:45 am]
BILLING CODE 4120-01-P