[Federal Register: November 22, 2002 (Volume 67, Number 226)]
[Notices]
[Page 70435-70437]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no02-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1241-NC]
RIN 0938-AM37
Medicare and Medicaid Programs; Announcement of Applications From
Hospitals Requesting Waivers for Organ Procurement Service Areas
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
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SUMMARY: This notice announces three 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.
COMMENT DATE: We will consider comments if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on January
21, 2003.
ADDRESSES: In commenting, please refer to file code CMS-1241-NC.
Because of staffing and resource limitations, we cannot accept comments
by facsimile (FAX) transmission. Mail written comments (one original
and three copies) to the following address only: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-1241-NC, PO Box 8010, Baltimore, MD 21244-8010.
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 (one original
and three copies) to one of the following addresses:
Room 443-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 mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and could be considered late.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: Comments received timely will be
available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at the
headquarters of the Centers for Medicare & Medicaid Services, 7500
Security Blvd., Baltimore, Maryland 21244, Monday through Friday of
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view
public comments, phone (410) 786-9994.
I. Background
Organ Procurement Organizations (OPOs) are not-for-profit
organizations that collect human organs from
[[Page 70436]]
hospitals and distribute them to transplant centers around the country.
Qualified OPOs are designated by the Centers for Medicare & Medicaid
Services (CMS) to collect organs in CMS-defined exclusive geographic
service areas, according to section 371(b)(1)(F) of the Public Health
Service Act (42 U.S.C. 273(b)(1)(F)) and our regulations at 42 CFR
486.307. Once an OPO has been designated for an area, hospitals in that
area that participate in Medicare and Medicaid are required to work
with that OPO in providing organs for transplant, according to section
1138(a) of the Social Security Act (the Act), and our regulations at
Sec. 482.45.
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)
of potential organ donors. Under section 1138(a)(1)(C) of the Act,
every participating hospital must have an agreement to identify
potential donors only with that particular designated OPO.
However, section 1138(a)(2) of the Act provides that a hospital may
obtain a waiver of these requirements from the Secretary under certain
specified conditions. A waiver allows the hospital to have an agreement
with an OPO, other than the one initially designated by CMS, if the
hospital meets certain conditions specified in section 1138(a)(2) of
the Act. In addition, the Secretary may review additional criteria
described in section 1138(a)(2)(B) of the Act to evaluate the
hospital's request for a waiver.
Section 1138(a)(2)(A) of the Act 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 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 for 60 days,
beginning on the publication date in the Federal Register.
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 Sec. 486.316(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) detailing the waiver process and discussing 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.
According to these requirements, 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. Hospital Waiver Requests
As permitted by Sec. 486.316(e), three hospitals have requested
waivers in order to enter into agreements with alternative, out-of-area
OPOs. The listing below indicates the name of the facility, the city
and State of the facility, the requested OPO, and the currently
designated area OPO. These hospitals must continue to work with their
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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Pontotoc Health Services........ Pontotoc........... MS MSOP TNMS
Clay County Medical Center...... West Point......... MS MSOP TNMS
Iuca Hospital................... Iuca............... MS MSOP TNMS
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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:
MSOP--Mississippi Organ Recovery Agency, Inc., 12 River Bend Place,
Jackson, Mississippi 39208
TNMS--Mid-South Transplant Foundation, Inc., 910 Madison Avenue, Suite
1002, Memphis, Tennessee 38103
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:
[sbull] The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
[sbull] The accuracy of our estimate of the information collection
burden.
[sbull] The quality, utility, and clarity of the information to be
collected.
[sbull] Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques or other forms of information technology.
Section 486.316 sets forth 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 is currently approved under OMB
0938-0688, HCFA-R-13, Conditions of Coverage for Organ Procurement
Organizations, with an expiration date of February 28,2003.
VI. Regulatory Impact Statement
We have examined the impacts of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded
[[Page 70437]]
Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We have determined that this is not a major rule because it does not
impose an economically significant impact on covered entities or the
Medicare program.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Individuals and States are not included in the definition of a small
entity. This notice will not result in a significant impact on small
businesses because the notice simply announces three applications we
have received from hospitals requesting waivers from entering into
agreements with their designated OPOs.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. This notice will not have
a significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This notice will not result in an impact of
$110 million or more on the governments mentioned or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have reviewed this notice under these requirements and
have determined that it will not impose substantial direct requirement
costs on State or local governments.
We are not preparing analyses for either the RFA or section 1102(b)
of the Act because we have determined, and we certify, that this notice
will not have a significant economic impact on the operations of a
substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
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: November 18, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-29796 Filed 11-21-02; 8:45 am]
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