[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
