[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Notices]
[Pages 9562-9563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1332-NC]


Medicare and Medicaid Programs; Announcement of an Application 
From a Hospital Requesting a Waiver From Its Designated Organ 
Procurement Service Area

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with comment period.

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SUMMARY: This notice announces a hospital's request for a waiver from 
entering into an agreement with its designated organ procurement 
organization (OPO), 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 the 
requested waiver.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on April 25, 2006.

ADDRESSES: In commenting, please refer to file code CMS-1332-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. 
(Attachments should be in Microsoft Word, WordPerfect, or Excel; 
however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-1332-NC, P.O. Box 8015, Baltimore, MD 21244-8015.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-1332-NC, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    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:
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this notice to assist us in considering whether we 
should grant the requested waiver. You can assist us by referencing the 
file code CMS-1332-NC and the specific ``issue identifier'' that 
precedes the section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. CMS posts all electronic 
comments received before the close of the comment period on its public 
Web site as soon as possible after they have been received. Hard copy 
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 Boulevard, 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 1-800-
743-3951.

I. Background

    Organ Procurement Organizations (OPOs) are not-for-profit 
organizations that recover human organs from potential donors in 
hospitals and distribute them to transplant centers throughout the 
country. Qualified OPOs are designated by the Centers for Medicare & 
Medicaid Services (CMS) to recover 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 transplantation, 
according to section 1138(a) of the Social Security Act (the Act), and 
our regulations at 42 CFR 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 with its designated OPO to identify potential donors 
only within its service area.
    However, section 1138(a)(2) of the Act provides that a hospital may 
obtain a waiver of the above 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

[[Page 9563]]

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 to offer interested parties an opportunity to comment in writing, 
during the 60-day public comment period.
    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 42 CFR 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 a waiver request, 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 request 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 request and notify the hospital, the 
designated OPO, and the requested OPO.

III. Hospital Waiver Request

    As permitted by 42 CFR 486.316(e), Piedmont Healthcare Systems of 
Rock Hill, South Carolina has requested a waiver in order to enter into 
an agreement with an alternative, out-of-area OPO. Piedmont Healthcare 
Systems is requesting a waiver to work with: LifePoint, 4200 Faber 
Place Drive, Charleston, SC 29105.
    Piedmont Healthcare System's designated OPO is: LifeShare of the 
Carolinas, 5000-D Airport Center Parkway, Charlotte, NC 28208.
    Piedmont Healthcare Systems must continue to work with its 
designated OPO while we complete our review.

IV. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
    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 those requirements is currently approved under OMB 
0938-0688, and HCFA-R-13, Conditions of Coverage for Organ Procurement 
Organizations, with an expiration date of February 28, 2007.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble.

VI. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 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). This notice 
does not reach the economic threshold and thus is not considered a 
major rule.
    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 small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$6 million to $29 million in any 1 year. Individuals and States are not 
included in the definition of a small entity. We are not preparing an 
analysis for the RFA because we have determined that this rule will not 
have a significant economic impact on a substantial number of small 
entities.
    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 603 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 Core-Based 
Statistical Area and Metropolitan Statistical Area and has fewer than 
100 beds. We are not preparing an analysis for section 1102(b) of the 
Act because we have determined that 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 whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. That threshold 
level is currently approximately $120 million. This notice will have no 
consequential effect on State, local, or tribal governments 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. Since this notice does not impose any costs on State or 
local governments, the requirements of E.O. 13132 are not applicable.

    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: February 9, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-1646 Filed 2-23-06; 8:45 am]
BILLING CODE 4120-01-P