Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service Area, 49679-49681 [E8-18970]
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Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
information from a supplier that tells us
who it is, whether it meets certain
qualifications to be a health care
supplier, where it renders its services or
supplies, the identity of the owners of
the enrolling entity, and information
necessary to establish the correct claims
payment.
Form Number: CMS–855S (OMB#
0938–New);
Frequency: Yearly;
Affected Public: Business or other forprofits and not-for-profit institutions;
Number of Respondents: 126,134;
Total Annual Responses: 126,134;
Total Annual Hours: 149,234.
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
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 by the OMB desk officer at
the address below, no later than 5 p.m.
on September 22, 2008.
OMB Human Resources and Housing
Branch, Attention: OMB Desk Officer,
New Executive Office Building, Room
10235, Washington, DC 20503, Fax
Number: (202) 395–6974.
Dated: August 14, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–19393 Filed 8–21–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–179]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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.
jlentini on PROD1PC65 with NOTICES
AGENCY:
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
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: Revision of a currently
approved collection; Title of
Information Collection: Transmittal and
Notice of Approval of State Plan
Material and Medicaid State Plan—Base
Plan, Attachments and Supplemental
Pages and Supporting Regulations in 42
CFR 430.10–430.20 and 440.167; Use:
The Medicaid State base plan pages and
attachments are documents utilized by
State and territorial agencies which
have the responsibility for
administering the Medicaid program.
The Medicaid State plan is comprised of
‘‘pages’’ and organized by subject matter
which includes Medicaid eligibility
services, payment for services, and
general, financial and personnel
administration. When States seek to
change selected pages of their State
plans, the page(s) are transmitted to
CMS for review and approval by the
CMS Central and Regional Offices prior
to amending its State plan. Form
Number: CMS–179 (OMB# 0938–0193);
Frequency: Once and as needed;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 4,681;
Total Annual Hours: 9,271.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by October 21, 2008:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
49679
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: August 14, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–19395 Filed 8–21–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1417–NC]
Medicare and Medicaid Programs;
Announcement of Applications From
Hospitals Requesting Waiver for Organ
Procurement Service Area
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
SUMMARY: This notice announces three
hospitals’ requests for a waiver from
entering into an agreement with their
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 waivers.
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
October 21, 2008.
ADDRESSES: In commenting, please refer
to file code CMS–1417–NC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ and enter the filecode to
find the document accepting comments.
E:\FR\FM\22AUN1.SGM
22AUN1
jlentini on PROD1PC65 with NOTICES
49680
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
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–1417–
NC, P.O. Box 8016, Baltimore, MD
21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1417–NC, Mail Stop C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to either of the
following addresses.
a. Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
the CMS drop slots located in the main
lobby of the building. A stamp-in clock
is available for persons wishing to retain
a proof of filing by stamping in and
retaining an extra copy of the comments
being filed.)
b. 7500 Security Boulevard,
Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
FOR FURTHER INFORMATION CONTACT:
Mark A. Horney, (410) 786–4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
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 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, 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
§ 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
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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 § 486.308(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program
Memorandum (Transmittal No. A–95–
11) detailing the waiver process and
discussing the information that
hospitals must provide in requesting a
waiver. We indicated that upon receipt
of a waiver request, we would publish
a Federal Register notice to solicit
public comments, as required by section
1138(a)(2)(D) of the Act.
According to these requirements, we
will review the request and comments
received. During the review process, we
may consult on an as-needed basis with
the Public Health Service’s Division of
Transplantation, the United Network for
Organ Sharing, and our regional offices.
If necessary, we may request additional
clarifying information from the applying
hospital or others. We will then make a
final determination on the waiver
request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Requests
As permitted by § 486.308(e), the
following three hospitals have requested
waivers to work with and OPO other
than the designated OPO for its area:
Northern Dutchess Hospital of
Rhinebeck, New York has requested a
waiver in order to enter into an
agreement with a designated OPO other
than the OPO designated for the service
area in which the hospital is located.
Northern Dutchess Hospital is
requesting a waiver to work with: Center
for Donation & Transplant, 218 Great
Oak Boulevard, Albany, NY 12204.
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
Dutchess Hospital’s Designated OPO
is: New York Organ Donor Network, 132
West 31st Street, 11th Floor, New York,
NY 10001.
Methodist University Hospital of
Memphis, Tennessee has requested a
waiver in order to enter into an
agreement with a designated OPO other
than the OPO designated for the service
area in which the hospital is located.
Methodist University Hospital is
requesting a waiver to work with:
Tennessee Donor Services, 1600 Hayes
Street, Nashville, Tennessee 37203.
Methodist University Hospital’s
Designated OPO is: Mid-South
Transplant Foundation, Inc., 8001
Centerview Parkway, Suite 302,
Memphis, Tennessee 38018.
Le Bonheur Children’s Medical Center
of Memphis, Tennessee has requested a
waiver in order to enter into an
agreement with a designated OPO other
than the OPO designated for the service
area in which the hospital is located. Le
Bonheur Children’s Medical Center is
requesting a waiver to work with:
Tennessee Donor Services, 1600 Hayes
Street, Nashville, Tennessee 37203.
Methodist University Hospital’s
Designated OPO is: Mid-South
Transplant Foundation, Inc., 8001
Centerview Parkway, Suite 302,
Memphis, Tennessee 38018.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; Program No. 93.774, Medicare—
Supplementary Medical Insurance, and
Program No. 93.778, Medical Assistance
Program)
Dated: August 8, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–18970 Filed 8–21–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[CMS–2899–PN]
Medicare and Medicaid Programs;
Application by the Accreditation
Commission for Health Care for
Continued Deeming Authority for
Home Health Agencies
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Proposed notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This proposed notice
acknowledges the receipt of a deeming
application from the Accreditation
Commission for Health Care (ACHC) for
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
continued recognition as a national
accrediting organization for home health
agencies (HHAs) that wish to participate
in the Medicare or Medicaid programs.
Section 1865(b)(3)(A) of the Social
Security Act (the Act) requires that
within 60 days of receipt of an
organization’s complete application, we
publish a notice that identifies the
national accrediting body making the
request, describes the nature of the
request, and provides at least a 30-day
public comment period.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. d.s.t. on September 21,
2008.
In commenting, please refer
to file code CMS–2899–PN. 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 for ‘‘Comment or
Submission’’ and enter the file code to
find the document accepting comments.
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–
2899–PN, P.O. Box 8013, Baltimore,
MD 21244–8013.
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–
2899–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 either of the
following addresses:
a. Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey (HHH) Building is
not readily available to persons without
Federal Government identification,
commenters are encouraged to leave
ADDRESSES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
49681
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. 7500 Security Boulevard, Baltimore,
MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
‘‘SUPPLEMENTARY INFORMATION’’ section.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636;
Patricia Chmielewski, (410) 786–6899.
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
Under the Medicare program, eligible
beneficiaries may receive covered
services from a home health agency
(HHA) provided certain requirements
are met. Sections 1861(m) and (o), and
1891 of the Social Security Act (the Act)
authorize the Secretary to establish
distinct criteria for facilities seeking
designation as an HHA. Regulations
concerning provider agreements are at
42 CFR part 489 and those pertaining to
activities relating to the survey and
certification of facilities are at part 488.
The regulations at part 484 specify the
conditions that an HHA must meet in
order to participate in the Medicare
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Pages 49679-49681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1417-NC]
Medicare and Medicaid Programs; Announcement of Applications From
Hospitals Requesting Waiver for Organ Procurement Service Area
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: This notice announces three hospitals' requests for a waiver
from entering into an agreement with their 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 waivers.
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 October 21, 2008.
ADDRESSES: In commenting, please refer to file code CMS-1417-NC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.regulations.gov. Follow the
instructions for ``Comment or Submission'' and enter the filecode to
find the document accepting comments.
[[Page 49680]]
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-1417-NC, P.O. Box 8016, Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1417-NC, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to either of the following addresses.
a. Room 445-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: 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 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, 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 Sec. 486.306. Once an OPO has been designated for an area,
hospitals in that area that participate in Medicare and Medicaid are
required to work with that OPO in providing organs for transplant,
pursuant to section 1138(a)(1)(C) of the Social Security Act (the Act),
and our regulations at Sec. 482.45.
Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must
notify the designated OPO (for the service area in which it is located)
of potential organ donors. Under section 1138(a)(1)(C) of the Act,
every participating hospital must have an agreement to identify
potential donors only with its designated OPO.
However, section 1138(a)(2)(A) of the Act provides that a hospital
may obtain 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 comment in writing
during the 60-day period beginning on the publication date in the
Federal Register.
The criteria that the Secretary uses to evaluate the waiver in
these cases are the same as those described above under sections
1138(a)(2)(A) and (B) of the Act and have been incorporated into the
regulations at Sec. 486.308(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program Memorandum (Transmittal No. A-
95-11) detailing the waiver process and discussing the information that
hospitals must provide in requesting a waiver. We indicated that upon
receipt of a waiver request, we would publish a Federal Register notice
to solicit public comments, as required by section 1138(a)(2)(D) of the
Act.
According to these requirements, we will review the request and
comments received. During the review process, we may consult on an as-
needed basis with the Public Health Service's Division of
Transplantation, the United Network for Organ Sharing, and our regional
offices. If necessary, we may request additional clarifying information
from the applying hospital or others. We will then make a final
determination on the waiver request and notify the hospital and the
designated and requested OPOs.
III. Hospital Waiver Requests
As permitted by Sec. 486.308(e), the following three hospitals
have requested waivers to work with and OPO other than the designated
OPO for its area:
Northern Dutchess Hospital of Rhinebeck, New York has requested a
waiver in order to enter into an agreement with a designated OPO other
than the OPO designated for the service area in which the hospital is
located. Northern Dutchess Hospital is requesting a waiver to work
with: Center for Donation & Transplant, 218 Great Oak Boulevard,
Albany, NY 12204.
[[Page 49681]]
Dutchess Hospital's Designated OPO is: New York Organ Donor
Network, 132 West 31st Street, 11th Floor, New York, NY 10001.
Methodist University Hospital of Memphis, Tennessee has requested a
waiver in order to enter into an agreement with a designated OPO other
than the OPO designated for the service area in which the hospital is
located. Methodist University Hospital is requesting a waiver to work
with: Tennessee Donor Services, 1600 Hayes Street, Nashville, Tennessee
37203.
Methodist University Hospital's Designated OPO is: Mid-South
Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 302,
Memphis, Tennessee 38018.
Le Bonheur Children's Medical Center of Memphis, Tennessee has
requested a waiver in order to enter into an agreement with a
designated OPO other than the OPO designated for the service area in
which the hospital is located. Le Bonheur Children's Medical Center is
requesting a waiver to work with: Tennessee Donor Services, 1600 Hayes
Street, Nashville, Tennessee 37203.
Methodist University Hospital's Designated OPO is: Mid-South
Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 302,
Memphis, Tennessee 38018.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance, and Program No. 93.778, Medical
Assistance Program)
Dated: August 8, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-18970 Filed 8-21-08; 8:45 am]
BILLING CODE 4120-01-P
