[Federal Register Volume 73, Number 120 (Friday, June 20, 2008)]
[Notices]
[Pages 35141-35142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13821]



[[Page 35141]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1812-NC]


Medicare and Medicaid Programs; Announcement of an Application 
From a 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: This notice announces a hospital's request for a waiver from 
entering into an agreement with its designated organ procurement 
organization (OPO).
    This notice requests comments from OPOs and the general public for 
our consideration in determining whether we should grant the requested 
waiver.

DATE: Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on August 19, 2008.

ADDRESSES: In commenting, please refer to file code CMS-1812-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 specific 
issues in this regulation to http://www.regulations.gov. Follow the 
instructions for ``Comment or Submission'' and enter the filecode to 
find the document accepting comments.
    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-1812-NC, P.O. Box 8016, Baltimore, MD 21244-8016.
    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-1812-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 either of the following addresses.
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Washington, DC 20201.
    (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.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    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.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.

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. OPOs are certified by the Centers for Medicare & Medicaid 
Services (CMS) to recover or procure organs in CMS-defined exclusive 
designated service areas (DSAs), 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 486.303 through 486.308. Once an OPO has been 
designated for a DSA, hospitals and critical access hospitals (CAHs) in 
that DSA that participate in Medicare and Medicaid are required to work 
with that OPO in procuring organs for transplant, according 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 or 
CAH must notify the designated OPO (for the DSA 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 
or CAH may obtain from the Secretary a waiver of the above requirements 
under certain specified conditions. A waiver allows the hospital to 
have an agreement with an OPO other than the one designated by CMS for 
the DSA in which the hospital or CAH is located, 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 before making a final determination on the waiver

[[Page 35142]]

applicability offer interested parties an opportunity to comment in 
writing during the 60-day period beginning on the date the notice is 
published 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 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 and the 
designated and requested OPOs.

III. Hospital Waiver Request

    As permitted by Sec.  486.308(e), McCullough-Hyde Memorial Hospital 
of Oxford, Ohio has requested a waiver in order to enter into an 
agreement with a designated OPO other than the OPO designated for the 
DSA in which the hospital is located. McCullough-Hyde Memorial Hospital 
is requesting a waiver to work with: LifeConnection of Ohio, 40 Wyoming 
Street, Dayton, OH 45409.
McCullough-Hyde Memorial Hospital's Designated OPO is: LifeCenter Organ 
Donor Network, 2925 Vernon Place, Suite 300, Cincinnati, OH 45219.

(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: June 9, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E8-13821 Filed 6-19-08; 8:45 am]
BILLING CODE 4120-01-P