[Federal Register: August 26, 2005 (Volume 70, Number 165)]
[Notices]
[Page 50372-50373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au05-99]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1309-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. 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 October 25, 2005.
ADDRESSES: In commenting, please refer to file code CMS-1309-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/regulations/ecomments.
(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-1309-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-1309-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 with comment
period to assist us in fully considering issues and developing
policies. You can assist us by referencing the file code CMS-1309-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
[If you choose to comment on issues in this section, please include the
caption ``BACKGROUND'' at the beginning of your comments.]
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 transplant,
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 to identify potential donors only with its designated
OPO.
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
[[Page 50373]]
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 (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 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 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 and the
designated and requested OPOs.
III. Hospital Waiver Request
As permitted by 42 CFR 486.316(e), Rockford Health System of
Rockford, Illinois has requested a waiver in order to enter into an
agreement with an alternative, out-of-area OPO. Rockford Health System
is requesting a waiver to work with: University of Wisconsin OPO,
University of Wisconsin Hospital and Clinic, 600 Highland Avenue,
Madison, Wisconsin 53792. Rockford Health System's designated OPO is:
Gift of Hope Organ and Tissue Donor Network, 660 North Industrial
Drive, Elmhurst, Il 60126-1520. Rockford Health System must continue to
work with its designated OPO until the completion of our review.
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: August 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-16796 Filed 8-25-05; 8:45 am]
BILLING CODE 4120-01-P