[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Notices]
[Pages 59274-59275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1825-NC]


Medicare and Medicaid Programs; Announcement of Application from 
Hospital Requesting Waiver for Organ Procurement Service Area

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

ACTION: Notice with comment period.

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SUMMARY: A hospital has requested a waiver of statutory requirements 
that would otherwise require the hospital to enter into an agreement 
with its designated Organ Procurement Organization (OPO). The request 
was made in accordance with section 1138(a)(2) of the Social Security 
Act (the Act). This notice requests comments from OPOs and the general 
public for our consideration in determining whether we should grant the 
requested waiver.

DATES: Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on November 26, 2010.

ADDRESSES: In commenting, please refer to file code CMS-1825-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions under 
the ``More Search Options'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1825-NC, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    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 to 
the following address ONLY: Department of Health and Human Services, 
Attention: CMS-1825-NC, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to one of the following addresses 
prior to the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey 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.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously 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:
    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. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also 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 are responsible for the procurement, preservation, 
and transport of transplantable organs to transplant centers throughout 
the country. Qualified OPOs are designated by the Centers for Medicare 
& Medicaid Services (CMS) to recover or procure organs in CMS-defined 
exclusive geographic service areas, pursuant to section 371(b)(1) of 
the Public Health Service Act (42 U.S.C. 273(b)(1) and our regulations 
at 42 CFR 486.306. Once an OPO has been designated for an area, 
hospitals in that area that participate in Medicare and Medicaid are 
required to

[[Page 59275]]

work with that OPO in providing organs for transplant, pursuant to 
section 1138(a)(1)(C) 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 its designated OPO.
    However, section 1138(a)(2)(A) 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)(A) 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; 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 
received from a hospital within 30 days of receiving the application, 
and to offer interested parties an opportunity to comment in writing 
during the 60-day period 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.  486.308(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 
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 Health Resources and Services Administration'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 and the designated and requested OPOs.

III. Hospital Waiver Requests

    As permitted by Sec.  486.308(e), the following hospital has 
requested a waiver in order to enter into an agreement with a 
designated OPO other than the OPO designated for the service area in 
which the hospital is located: Highland District Hospital (Medicare 
provider number 36-1332), of Hillsboro, Ohio, is requesting a waiver to 
work with LifeCenter Organ Donor Network, 615 Elsinore Place, Suite 
400, Cincinnatti, Ohio 45202.
    The Hospital's Designated OPO is: Lifeline of Ohio Organ 
Procurment, 770 Kinnear Road, Suite 200, Columbus, Ohio 43212.

(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 21, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-24101 Filed 9-24-10; 8:45 am]
BILLING CODE 4120-01-P