[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31122-31123]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my08-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1550-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), 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 July 29, 2008.
ADDRESSES: In commenting, please refer to file code CMS-1550-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-1550-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-1550-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.
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, 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 Sec. 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,
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 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 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 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
[[Page 31123]]
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 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), Magnolia Regional Health Center
of Corinth, Mississippi 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. Magnolia Regional
Health Center is requesting a waiver to work with: Mississippi Organ
Recovery Agency, 12 River Bend Place, Suite B, Jackson, MS 39232.
Magnolia Regional Health Center's Designated OPO is: Mid-South
Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 302,
Memphis, TN 38018.
(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: May 21, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-12117 Filed 5-29-08; 8:45 am]
BILLING CODE 4120-01-P