[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]
[[Page 48872]]
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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
[[Page 48873]]
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
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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
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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