Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area, 98-100 [2012-31535]
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Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices
Technology (the National Coordinator)
for the testing of EHR technology to the
2014 Edition EHR certification criteria
under the ONC HIT Certification
Program. The approved test tools and
test procedures are identified on the
ONC Web site at: https://
www.healthit.gov/policy-researchersimplementers/2014-edition-final-testmethod.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
FOR FURTHER INFORMATION CONTACT:
HHS gives notice of a
determination concerning a petition to
add a class of employees from the
United Nuclear Corporation in
Hematite, Missouri, to the Special
Exposure Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7384q. On
December 7, 2012, the Secretary of HHS
determined that the following class of
employees does not meet the statutory
criteria for addition to the SEC as
authorized under EEOICPA:
SUMMARY:
All site employees who worked in any area
of the United Nuclear Corporation—
Hematite, Missouri, site from January 1,
1958, through December 31, 1973, and the
residual period January 1, 1974, through July
31, 2006.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 1–
877–222–7570. Information requests can
also be submitted by email to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2012–31215 Filed 12–31–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Availability: Test Tools and
Test Procedures Approved by the
National Coordinator for the ONC HIT
Certification Program
Carol Bean, Director, Office of
Certification, Office of the National
Coordinator for Health Information
Technology, 202–690–7151.
On
January 7, 2011, the Department of
Health and Human Services issued a
final rule establishing a permanent
certification program for the purposes of
testing and certifying health information
technology (‘‘Establishment of the
Permanent Certification Program for
Health Information Technology,’’ 76 FR
1262) (Permanent Certification Program
final rule). The permanent certification
program was renamed the ‘‘ONC HIT
Certification Program’’ in a final rule
published on September 4, 2012 (77 FR
54163) (‘‘2014 Edition EHR Certification
Criteria final rule’’). In the preamble of
the Permanent Certification Program
final rule, we stated that when the
National Coordinator had approved test
tools and test procedures for
certification criteria adopted by the
Secretary ONC would publish a notice
of availability in the Federal Register
and identify the approved test tools and
test procedures on the ONC Web site. In
the 2014 Edition EHR Certification
Criteria final rule the Secretary adopted
the 2014 Edition EHR certification
criteria. The National Coordinator has
approved test tools and test procedures
for testing EHR technology to the 2014
Edition EHR certification criteria under
the ONC HIT Certification Program.
These approved test tools and test
procedures are identified on the ONC
Web site at: https://www.healthit.gov/
policy-researchers-implementers/2014edition-final-test-method.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 300jj–11.
Office of the National
Coordinator for Health Information
Technology (ONC), Department of
Health and Human Services.
ACTION: Notice.
Dated: December 19, 2012.
Farzad Mostashari M.D.,
National Coordinator for Health Information
Technology.
This notice announces the
availability of test tools and test
procedures approved by the National
Coordinator for Health Information
BILLING CODE 4150–45–P
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AGENCY:
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1456–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:
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
March 4, 2013.
ADDRESSES: In commenting, please refer
to file code CMS–1456–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 instructions under the ‘‘More Search
Options’’ tab.
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–1456–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: Department of
Health and Human Services, Attention:
CMS–1456–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 ONLY to the
following addresses:
SUMMARY:
E:\FR\FM\02JAN1.SGM
02JAN1
Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices
tkelley on DSK3SPTVN1PROD with
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.
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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 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/or
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 assure 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
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99
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 § 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 § 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: Bolivar Medical
Center in Cleveland, Mississippi, is
requesting a waiver to work with:
Mississippi Organ Recovery Agency,
4400 Lakeland Drive, Flowood, MS
39232.
The Hospital’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)
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100
Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices
Dated: December 19, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–31535 Filed 12–31–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0523]
Guidance for Industry and Food and
Drug Administration Staff; Refuse To
Accept Policy for 510(k)s; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
I. Background
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Refuse to Accept Policy for 510(k)s.’’
The purpose of this document is to
explain the procedures and criteria FDA
intends to use in determining whether
a 510(k) submission is administratively
complete, which determines whether it
should be accepted for substantive
review and clearance. This guidance is
applicable to 510(k)s reviewed in the
Center for Devices and Radiological
Health (CDRH) and the Center for
Biologics Evaluation and Research
(CBER).
SUMMARY:
Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Refuse to Accept Policy for
510(k)s’’ to the Division of Small
Manufacturers, International and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8149. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
tkelley on DSK3SPTVN1PROD with
DATES:
VerDate Mar<15>2010
16:42 Dec 31, 2012
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Geeta Pamidimukkala, Center for
Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1564, Silver Spring, MD 20993–0002,
301–796–6453; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPLEMENTARY INFORMATION:
Jkt 229001
The purpose of the 510(k) acceptance
review is to make a threshold
determination whether a submission is
administratively complete, which
determines whether it should be
accepted for substantive review to reach
a determination regarding substantial
equivalence under section 513(i) of the
FD&C Act, 21 U.S.C. 360c(i). To find a
device substantially equivalent under
section 513(i) of the FD&C Act, FDA
must find that it has the same intended
use as the predicate device, and either:
(1) Has the same technological
characteristics as the predicate device,
or (2) has different technological
characteristics, as defined at section
513(i)(1)(B), and (3) the submission
contains information, including
appropriate clinical or scientific data if
necessary, that demonstrates the device
is as safe and effective as the predicate
and does not raise different questions of
safety and effectiveness from the
predicate.
The purpose of this document is to
explain the procedures and criteria FDA
intends to use in determining whether
a 510(k) submission is administratively
complete and should be accepted for
substantive review. This guidance
document provides updated information
to two existing guidance documents
entitled ‘‘Center for Devices and
Radiological Health’s Premarket
Notification (510(k)) Refuse to Accept
Policy’’ issued on June 30, 1993 and
‘‘510(k) Refuse to Accept Procedures,
510(k) Memorandum K94–1’’ issued on
May 20, 1994. Upon issuance as a final
guidance document, this guidance will
replace those documents.
To further focus the Agency’s review
resources on complete applications,
which will provide a more efficient
approach to ensuring that safe and
effective medical devices reach patients
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as quickly as possible, we have
modified the 1993 and 1994 guidances.
For example, we have modified the
510(k) Refuse to Accept (RTA) policy to
include an early review against specific
acceptance criteria and to inform the
submitter within the first 15 calendar
days of receipt of the submission if the
submission is administratively
complete, or if not, to identify the
missing element(s). In order to enhance
the consistency of our acceptance
decisions and to help submitters better
understand the types of information
FDA needs to conduct a substantive
review, this guidance, including the
checklists included in the appendices,
clarifies the necessary elements and
contents of a complete 510(k)
submission. These elements are
applicable to all devices reviewed
through the 510(k) notification process
in CDRH and CBER and have been
compiled into checklists for use by FDA
review staff.
In the Federal Register of August 13,
2012 (77 FR 48159), FDA announced the
availability of the draft guidance
document. Interested persons were
invited to comment by September 27,
2012. Eleven sets of comments were
received with multiple
recommendations pertaining to the
administrative processes and policies
regarding 510(k) acceptance decisions.
A number of commenters expressed
concern that the checklist questions
related to performance data implied that
FDA staff would need to conduct a level
of substantive review in order to
complete the checklist. FDA has revised
the language in these questions and
added further instructions to FDA staff
to more specifically state that only the
presence of the information is required
for acceptance, and that the adequacy of
the information should only be assessed
after acceptance and as part of the
substantive review.
Similar comments were received
regarding questions in the checklists
that identified an ‘‘analysis’’ or
‘‘discussion’’ as a criterion for
acceptance. Commenters were
concerned that FDA staff would be
assessing the adequacy of the ‘‘analysis’’
or ‘‘discussion’’ in order to complete the
checklist. These questions have also
been modified to explain more clearly
that the acceptance criterion requires
only that the ‘‘analysis’’ or ‘‘discussion’’
be present; the adequacy of this
information should be assessed during
the substantive review.
FDA received comments regarding
relevant prior submissions and how
prior FDA feedback relevant to
determining substantial equivalence has
been addressed in the submission under
E:\FR\FM\02JAN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 98-100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31535]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1456-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 March 4, 2013.
ADDRESSES: In commenting, please refer to file code CMS-1456-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 instructions under
the ``More Search Options'' tab.
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-1456-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: Department of Health and Human Services,
Attention: CMS-1456-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 ONLY to the following addresses:
[[Page 99]]
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/or 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 assure 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 Sec. 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: Bolivar Medical Center in Cleveland, Mississippi,
is requesting a waiver to work with: Mississippi Organ Recovery Agency,
4400 Lakeland Drive, Flowood, MS 39232.
The Hospital'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)
[[Page 100]]
Dated: December 19, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-31535 Filed 12-31-12; 8:45 am]
BILLING CODE 4120-01-P
