[Federal Register Volume 75, Number 146 (Friday, July 30, 2010)]
[Notices]
[Pages 44972-44973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1579-NC]


Medicare and Medicaid Programs; Announcement of an Application 
From a Hospital Seeking To Enter Into an Agreement With a Different 
Organ Procurement Organization

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

ACTION: Notice with comment period.

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SUMMARY: A hospital that had previously been granted a waiver under 
section 1138(a)(2) of the Social Security Act (the Act), has requested 
to enter into an agreement with a different Organ Procurement 
Organization (OPO). This notice requests comments from hospitals, OPOs, 
and the general public for our consideration in determining whether we 
should grant the request. We are particularly interested in information 
and material that will help determine whether the change is likely to 
increase organ donation and will ensure equitable treatment for 
patients in both affected OPO service areas.

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 September 28, 2010.

ADDRESSES: In commenting, please refer to file code CMS-1579-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 ``Submit a 
comment'' instructions.
    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-1579-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: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1579-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 before the close of the comment period 
to either of the following addresses:
    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, 
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

[[Page 44973]]

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 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 comment period beginning on the publication date of 
the notice in the Federal Register.
    On June 11, 2010, we published a Federal Register notice (75 FR 
33313) that established a public process for hospitals that had 
previously been granted a waiver under section 1138(a)(2) of the Act. 
Under the notice, a hospital may request approval to work with a 
different OPO.

II. Procedures for Requesting a Change in OPOs

    For hospitals that had previously been granted a waiver request 
under section 1138(a)(2) of the Act but are now seeking to enter into 
an agreement with a different OPO, the hospital may file a request, by 
letter, to CMS containing the information set forth in the June 11, 
2010 notice (75 FR 33313). Upon receipt of a request, we publish a 
Federal Register notice to solicit public comments, modeled after the 
procedures set forth in section 1138(a)(2)(D) of the Act.
    Under these procedures, 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 request to change the OPO and notify the 
hospital and the OPOs involved.

III. Hospital Requests To Change OPOs

    As permitted by the June 11, 2010 notice (75 FR 33313), the 
following hospital has requested to work with an OPO other than the OPO 
it had been designated to work through based on a previous waiver 
request:
    OSF St. Anthony Medical Center of Rockford, Illinois, Provider 
Number 14-0233, is requesting to work with: Gift of Hope Organ & Tissue 
Donor Network, 425 Spring Lake Drive, Itasca, IL 60143.
    OSF St. Anthony Medical Center has an existing waiver to work with: 
UW Health Organ Procurement Organization, 450 Science Drive, Suite 220, 
Madison, WI 53711.

(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: July 21, 2010.
Marilyn Tavenner
Principal Deputy Administrator and Chief Operating Officer, Centers for 
Medicare & Medicaid Services.
[FR Doc. 2010-18370 Filed 7-29-10; 8:45 am]
BILLING CODE 4120-01-P