Medicare and Medicaid Programs; Announcement of Applications From Two Hospitals Requesting Waivers for Organ Procurement Service Areas, 29323-29325 [07-2441]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices
Dated: May 16, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 07–2578 Filed 5–24–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10207]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Physician SelfReferral Exceptions for Electronic
Prescribing and Electronic Health
Records (CMS–1303–F); Form Number:
CMS–10207 (OMB#: 0938–1009); Use:
Section 101 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
directs the Secretary to create an
exception to the physician self-referral
prohibition in section 1877 of the Act
for certain arrangements in which a
physician receives compensation in the
form of items or services (not including
cash or cash equivalents)
(‘‘nonmonetary remuneration’’) that is
necessary and used solely to receive and
transmit electronic prescription
information. In addition, using our
separate legal authority under section
1877(b)(4) of the Act, the regulation
jlentini on PROD1PC65 with NOTICES
AGENCY:
VerDate Aug<31>2005
17:34 May 24, 2007
Jkt 211001
CMS–1303–F (71 FR 45140) created a
separate regulatory exception for certain
arrangements involving the provision of
nonmonetary remuneration in the form
of electronic health records software or
information technology and training
services necessary and used
predominantly to create, maintain,
transmit, or receive electronic health
records. These exceptions are consistent
with the President’s goal of achieving
widespread adoption of interoperable
electronic health records to improve the
quality and efficiency of health care
while maintaining the levels of security
and privacy that consumers expect.
The conditions for both exceptions
require that arrangements for the items
and services provided must be set forth
in a written agreement, be signed by the
parties involved, specify the items or
services being provided and the cost of
those items or services, and cover all of
the electronic prescribing and/or
electronic health records technology to
be provided by the donating entity. We
have suggested that, instead of one
master agreement that is updated with
each new donation, the parties may
choose to create a specific new contract
and then reference other agreements or
cross-reference a master list of
agreements.
The requirements associated with the
exception for electronic prescribing
items and services are limited to
donations made by hospitals to
members of their medical staffs; by
group practices to their physician
members; and by PDP sponsors and MA
organizations to prescribing physicians.
The requirements associated with the
exception for electronic health records
software or information technology and
training services include donations by
entities furnishing DHS to physicians.
The paperwork burden is the creation
and execution of the written
agreements. The burden associated with
the written agreement requirement is
the time and effort necessary for
documentation of the agreement
between the parties, including the
signatures of the parties. Frequency:
Recordkeeping and Reporting—On
occasion; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
27,440; Total Annual Responses:
54,730; Total Annual Hours: 17,545.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
29323
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on July 24, 2007.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—B, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: May 21, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–10097 Filed 5–24–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1274–NC]
Medicare and Medicaid Programs;
Announcement of Applications From
Two Hospitals Requesting Waivers for
Organ Procurement Service Areas
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
SUMMARY: This notice announces two
hospitals’ requests 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 for each hospital.
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 24, 2007.
ADDRESSES: In commenting, please refer
to file code CMS–1274–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 https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
E:\FR\FM\25MYN1.SGM
25MYN1
jlentini on PROD1PC65 with NOTICES
29324
Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices
open comment period.’’ (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–1274–
NC, P.O. Box 8017, Baltimore, MD
21244–8017.
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–1274–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 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 proposed notice to assist
us in fully considering the issues. You
can assist us by referencing the file code
CMS–1274–C 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
VerDate Aug<31>2005
17:34 May 24, 2007
Jkt 211001
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all electronic
comments received before the close of
the comment period on the public Web
site as soon as possible after they have
been received: https://www.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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
[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 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 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, according to section
1138(a)(1)(C) 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)(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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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 42 CFR 486.308(e) and (f).
II. Waiver Request Procedures
[If you choose to comment on issues in this
section, please include the caption ‘‘Waiver
Request Procedures’’ at the beginning of your
comments.]
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
E:\FR\FM\25MYN1.SGM
25MYN1
Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices
hospitals. We will then make a final
determination on the waiver request and
notify the hospitals and the designated
and requested OPOs.
III. Hospital Waiver Request
[If you choose to comment on issues in this
section, please include the caption ‘‘Hospital
Waiver Request’’ at the beginning of your
comments.]
As permitted by 42 CFR 486.308(e),
the following two hospitals are
requesting waivers 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.
Institute for Orthopeadic Surgery is
requesting a waiver to work with:
LifeLine of Ohio, 770 Kinnear Road,
Columbus, OH 43212.
Institute for Orthopeadic Surgery’s
Designated OPO is: LifeConnection of
Ohio, 40 Wyoming Street, Dayton, OH
45409.
Trinity at Terrace Park Medical Center
is requesting a waiver to work with:
Iowa Donor Network, 550 Madison
Avenue, North Liberty, IA 52317.
Trinity at Terrace Park Medical
Center’s designated OPO is: Gift of Hope
Organ and Tissue Donor Network, 660
N. Industrial Drive, Elmhurst, IL 60126.
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: May 11, 2007
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 07–2441 Filed 5–18–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
jlentini on PROD1PC65 with NOTICES
[CMS–3181–PN]
Medicare Program; Application by the
American Diabetes Association (ADA)
for Continued Recognition as a
National Accreditation Program for
Accrediting Entities To Furnish
Outpatient Diabetes Self-Management
Training
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
VerDate Aug<31>2005
17:34 May 24, 2007
Jkt 211001
SUMMARY: This proposed notice
announces the receipt of an application
from the American Diabetes Association
(ADA) for continued recognition as a
national accreditation program for
accrediting entities that wish to furnish
outpatient diabetes self-management
training to Medicare beneficiaries.
Section 1865(b)(3) of the Social Security
Act (the Act) requires that we publish a
notice identifying the national
accreditation body making the request,
describing the nature of the request, and
providing at least a 30-day public
comment period.
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
June 25, 2007.
ADDRESSES: In commenting, please refer
to file code CMS–3181–PN. 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 https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (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–3181–
PN, P.O. Box 8017, Baltimore, MD
21244–8017.
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–3181–PN, 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
29325
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 FURTHER INFORMATION CONTACT: Joan
A. Brooks, (410) 786–5526.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this proposed notice to assist
us in fully considering the issues. You
can assist us by referencing the file code
CMS–3181–PN 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. We post 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: https://www.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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
[If you choose to comment on issues in this
section, please include the caption
‘‘Background’’ at the beginning of your
comments.]
Under the Medicare program, eligible
beneficiaries may receive outpatient
diabetes self-management training when
ordered by the physician or qualified
non-physician practitioner treating the
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29323-29325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1274-NC]
Medicare and Medicaid Programs; Announcement of Applications From
Two Hospitals Requesting Waivers for Organ Procurement Service Areas
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: This notice announces two hospitals' requests 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 for each hospital.
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 24, 2007.
ADDRESSES: In commenting, please refer to file code CMS-1274-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 https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
[[Page 29324]]
open comment period.'' (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-1274-NC, P.O. Box 8017, Baltimore, MD 21244-8017.
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-1274-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 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 proposed notice to
assist us in fully considering the issues. You can assist us by
referencing the file code CMS-1274-C 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. We post all electronic
comments received before the close of the comment period on the public
Web site as soon as possible after they have been received: https://
www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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
[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 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 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,
according to section 1138(a)(1)(C) 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)(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 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 42 CFR 486.308(e) and (f).
II. Waiver Request Procedures
[If you choose to comment on issues in this section, please include
the caption ``Waiver Request Procedures'' at the beginning of your
comments.]
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
[[Page 29325]]
hospitals. We will then make a final determination on the waiver
request and notify the hospitals and the designated and requested OPOs.
III. Hospital Waiver Request
[If you choose to comment on issues in this section, please include
the caption ``Hospital Waiver Request'' at the beginning of your
comments.]
As permitted by 42 CFR 486.308(e), the following two hospitals are
requesting waivers 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.
Institute for Orthopeadic Surgery is requesting a waiver to work
with: LifeLine of Ohio, 770 Kinnear Road, Columbus, OH 43212.
Institute for Orthopeadic Surgery's Designated OPO is:
LifeConnection of Ohio, 40 Wyoming Street, Dayton, OH 45409.
Trinity at Terrace Park Medical Center is requesting a waiver to
work with: Iowa Donor Network, 550 Madison Avenue, North Liberty, IA
52317.
Trinity at Terrace Park Medical Center's designated OPO is: Gift of
Hope Organ and Tissue Donor Network, 660 N. Industrial Drive, Elmhurst,
IL 60126.
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: May 11, 2007
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 07-2441 Filed 5-18-07; 8:45 am]
BILLING CODE 4120-01-P
