Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area, 19269-19271 [2013-07343]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices
by the Secretary, HHS, advising the
Secretary on whether there is a class of
employees at any Department of Energy
facility who were exposed to radiation
but for whom it is not feasible to
estimate their radiation dose, and on
whether there is a reasonable likelihood
that such radiation doses may have
endangered the health of members of
this class. The Subcommittee on
Procedures Review was established to
aid the ABRWH in carrying out its duty
to advise the Secretary, HHS, on dose
reconstructions. The Subcommittee on
Procedures Review is responsible for
overseeing, tracking, and participating
in the reviews of all procedures used in
the dose reconstruction process by the
NIOSH Division of Compensation
Analysis and Support (DCAS) and its
dose reconstruction contractor.
Matters To Be Discussed: The agenda
for the Subcommittee meeting includes
discussion of the following ORAU and
DCAS procedures: OTIB–0055
(‘‘Conversion from NCRP Report 38
Neutron Quality Factors to ICRP Pub.
60’’), Program Evaluation Report (PER)0005 (‘‘Misinterpreted Application of
the External Dose Factor {Hanford}’’),
PER 014 (‘‘Construction Trades
Workers’’), PER 017 (‘‘Evaluation of
Incomplete Internal Dose Records from
Idaho, Argonne-East and Argonne-West
National Laboratories’’), PER 020
(‘‘Blockson Technical Basis
Document’’), PER 029 (‘‘Hanford TBD
Revision’’), PER 031 (‘‘Y–12 TBD
Revisions’’), PER 037 (‘‘Ames TBD
Revision’’), PER 038 (‘‘Hooker
Electrochemical TBD Revision’’),
ORAUT–PROC–0044 (‘‘Special
Exposure Cohort’’); DCAS Report 0053
(‘‘Stratified Co-Worker Sets’’); and a
continuation of the comment-resolution
process for other dose reconstruction
procedures under review by the
Subcommittee.
The agenda is subject to change as
priorities dictate.
In the event an individual wishes to
provide comments, written comments
may be submitted. Any written
comments received will be provided at
the meeting and should be submitted to
the contact person below in advance of
the meeting.
Contact Person for More Information:
Theodore Katz, Designated Federal
Official, NIOSH, CDC, 1600 Clifton
Road, Mailstop E–20, Atlanta Georgia
30333, Telephone (513) 533–6800, Toll
Free 1 (800) CDC–INFO, email
dcas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
VerDate Mar<15>2010
17:34 Mar 28, 2013
Jkt 229001
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2013–07367 Filed 3–28–13; 8:45 am]
BILLING CODE 4163–18–P
19269
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1457–NC]
Medicare and Medicaid Programs;
Announcement of Application From a
Hospital Requesting Waiver for Organ
Procurement Service Area
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
Notice of Cancellation: This
document corrects a notice that was
published in the Federal Register on
March 21, 2013 (78 FR 06434),
announcing a teleconference that would
include the initial review, discussion,
and evaluation of applications received
in response to ‘‘Indoor Environment of
Low-Income Renovated Multifamily
Housing in the Western Region of the
United States (U01), Funding
Opportunity Announcement EH–13–
001.’’ This meeting is canceled.
Notice will be provided if the meeting
is rescheduled in accordance with
section 10(a)(2) of the Federal Advisory
Committee Act (Pub.L. 92–463).
Contact Person for More Information:
J. Felix Rogers, Ph.D., M.P.H., Scientific
Review Officer, National Center for
Injury Prevention and Control, CDC,
4770 Buford Highway, NE., Mailstop
F63, Atlanta, Georgia 30341, Telephone:
(770) 488–4334.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2013–07366 Filed 3–28–13; 8:45 am]
BILLING CODE 4163–18–P
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SUMMARY: A hospital has requested a
waiver of statutory requirements that
would otherwise require the hospital to
enter into an agreement with its
designated Organ Procurement
Organization (OPO). The request was
made 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
May 28, 2013.
ADDRESSES: In commenting, refer to file
code CMS–1457–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 https://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–1457–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–1457–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments to a regulations
staff member ONLY to the following
addresses:
E:\FR\FM\29MRN1.SGM
29MRN1
19270
Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices
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.)
mstockstill on DSK4VPTVN1PROD with NOTICES
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, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously 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:
Patricia Taft, (410) 786–4561.
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: https://
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
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17:34 Mar 28, 2013
Jkt 229001
that are responsible for the
procurement, preservation, and
transport of 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 CMSdefined 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 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 only with its
designated OPO to identify potential
donors.
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
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the application, and to offer interested
parties an opportunity to submit
comments during the 60-day comment
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 § 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 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 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 waiver
request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Request
As permitted by 42 CFR 486.308(e),
the following hospital has requested a
waiver to enter into an agreement with
a designated OPO other than the OPO
designated for the service area in which
the hospital is located:
Southern Ocean Medical Center in
Manahawkin, New Jersey, is requesting
a waiver to work with: New Jersey
Sharing Network, 691 Central Avenue,
New Providence, NJ 07974.
The Hospital’s Designated OPO is:
Gift of Life Donor Program, 401 N 3rd
Street, Philadelphia, PA 19123.
IV. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C.35).
V. Response to Comments
We will consider all comments we
receive by the date and time specified
in the DATES section of this preamble,
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Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices
and, when we proceed with a
subsequent document, we will respond
to the comments in the preamble to that
document.
(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: March 25, 2013
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2013–07343 Filed 3–28–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369; (Formerly
Docket No. 2007D–0168)]
Draft Guidance for Industry on
Bioequivalence Recommendations for
Metronidazole Vaginal Gel; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Metronidazole
Vaginal Gel.’’ The guidance provides
specific recommendations on the design
of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for metronidazole
vaginal gel.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 28, 2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
VerDate Mar<15>2010
17:34 Mar 28, 2013
Jkt 229001
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
Andre, Center for Drug Evaluation and
Research (HFD–600), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9326.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311; FDA–2007–D–0433),
FDA announced the availability of a
guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific bioequivalence (BE)
recommendations available to the
public on FDA’s Web site at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that
guidance, FDA adopted this process as
a means to develop and disseminate
product-specific BE recommendations
and provide a meaningful opportunity
for the public to consider and comment
on those recommendations. This notice
announces the availability of draft BE
recommendations for metronidazole
vaginal gel.
New drug application 020208 for
MetroGel-Vaginal (metronidazole)
vaginal gel, 0.75%, was initially
approved by FDA in August 1992. On
October 31, 2006, FDA approved ANDA
077264 for a generic version of
MetroGel-Vaginal 0.75%
(metronidazole). FDA is now issuing a
draft guidance for industry on BE
recommendations for generic
metronidazole vaginal gel (Draft
Metronidazole Vaginal Gel BE
Recommendations).
In March 2006, Foley & Lardner LLP
(the petitioner) submitted a citizen
petition requesting that FDA require
that any ANDA referencing Metro-Gel
Vaginal meet certain conditions,
including conditions related to
demonstrating BE (Docket No. FDA–
2006–P–0080). FDA is reviewing the
issues raised in the petition. FDA will
consider any comments on the Draft
Metronidazole Vaginal Gel BE
Recommendations in responding to the
citizen petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for metronidazole vaginal gel. It
does not create or confer any rights for
or on any person and does not operate
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19271
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–07296 Filed 3–28–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
[Docket Number OIG–1302–N]
Special Fraud Alert: Physician-Owned
Entities
Office of Inspector General
(OIG), HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: This Special Fraud Alert
addresses physician-owned entities that
derive revenue from selling, or
arranging for the sale of, implantable
medical devices ordered by their
physician-owners for use in procedures
the physician-owners perform on their
own patients at hospitals or ambulatory
surgical centers (ASCs).
These regulations are effective
on March 29, 2013.
DATES:
FOR FURTHER INFORMATION CONTACT:
Patrice S. Drew, Department of Health
and Human Services, Office of Inspector
General, Congressional and Regulatory
Affairs, at (202) 619–1368.
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]]>Agencies
[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Notices]
[Pages 19269-19271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07343]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1457-NC]
Medicare and Medicaid Programs; Announcement of Application From
a Hospital Requesting Waiver for Organ Procurement Service Area
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: A hospital has requested a waiver of statutory requirements
that would otherwise require the hospital to enter into an agreement
with its designated Organ Procurement Organization (OPO). The request
was made 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 May 28, 2013.
ADDRESSES: In commenting, refer to file code CMS-1457-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 https://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-1457-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-1457-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments to a regulations staff member ONLY to
the following addresses:
[[Page 19270]]
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,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously 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: Patricia Taft, (410) 786-4561.
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: https://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 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 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 only with its
designated OPO to identify potential donors.
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 submit comments
during the 60-day comment 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
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 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 waiver request and notify the hospital and
the designated and requested OPOs.
III. Hospital Waiver Request
As permitted by 42 CFR 486.308(e), the following hospital has
requested a waiver to enter into an agreement with a designated OPO
other than the OPO designated for the service area in which the
hospital is located:
Southern Ocean Medical Center in Manahawkin, New Jersey, is
requesting a waiver to work with: New Jersey Sharing Network, 691
Central Avenue, New Providence, NJ 07974.
The Hospital's Designated OPO is: Gift of Life Donor Program, 401 N
3rd Street, Philadelphia, PA 19123.
IV. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C.35).
V. Response to Comments
We will consider all comments we receive by the date and time
specified in the DATES section of this preamble,
[[Page 19271]]
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
(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: March 25, 2013
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-07343 Filed 3-28-13; 8:45 am]
BILLING CODE 4120-01-P
