[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70435-70437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29796]


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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]
BILLING CODE 4120-01-P