Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area, 26432-26434 [2014-10641]
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26432
Federal Register / Vol. 79, No. 89 / Thursday, May 8, 2014 / Notices
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.
emcdonald on DSK67QTVN1PROD with NOTICES
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
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
VerDate Mar<15>2010
16:18 May 07, 2014
Jkt 232001
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 of the Department of
Health and Human Services (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 § 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.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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:
Mount Grant General Hospital,
Hawthorne, Nevada, is requesting a
waiver to work with: California
Transplant Donor Network, 1000
Broadway, Suite 600, Oakland,
California 94607–4099.
The Hospital’s Designated OPO is:
Nevada Donor Network, 2061 E Sahara
Ave., Las Vegas, Nevada 89104.
IV. Collection of Information
Requirement
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 Public Comments
We will consider all comments we
receive by the date and time specified
in the DATES section of this preamble.
Dated: May 2, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–10624 Filed 5–7–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1617–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.
AGENCY:
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 79, No. 89 / Thursday, May 8, 2014 / Notices
ACTION:
Notice with comment period.
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
July 7, 2014.
ADDRESSES: In commenting, refer to file
code CMS–1617–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–1617–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–1617–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:
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
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:18 May 07, 2014
Jkt 232001
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 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
26433
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 of the Department of
Health and Human Services (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 § 486.308(e) and (f).
E:\FR\FM\08MYN1.SGM
08MYN1
26434
Federal Register / Vol. 79, No. 89 / Thursday, May 8, 2014 / Notices
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
In accordance with § 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:
Carson Valley Medical Center,
Gardnerville, Nevada, is requesting a
waiver to work with: California
Transplant Donor Network, 1000
Broadway, Suite 600, Oakland,
California 94607–4099.
The Hospital’s Designated OPO is:
Nevada Donor Network, 2061 E. Sahara
Ave., Las Vegas, Nevada 89104.
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).
emcdonald on DSK67QTVN1PROD with NOTICES
V. Response to Public Comments
We will consider all comments we
receive by the date and time specified
in the DATES section of this preamble.
Dated: May 2, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–10641 Filed 5–7–14; 8:45 am]
BILLING CODE 4120–01–P
VerDate Mar<15>2010
16:18 May 07, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1601]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Custom Device
Exemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 9,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Custom Device Exemption’’. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Custom Device Exemption—(OMB
Control Number 0910–NEW)
I. Background
The custom device exemption is set
forth at section 520(b)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(b)(2)(B)).
A custom device is in a narrow category
of device that, by virtue of the rarity of
the patient’s medical condition or
physician’s special need the device is
designed to treat, it would be
impractical for the device to comply
with premarket review regulations and
performance standards.
Effective July 9, 2012, the Food and
Drug Administration Safety and
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Innovation Act (FDASIA) implemented
changes to the custom device exemption
contained in section 520(b) of the FD&C
Act. The new provision amended the
existing custom device exemption and
introduced new concepts and
procedures for custom devices, such as:
• Devices created or modified in
order to comply with the order of an
individual physician or dentist;
• the potential for multiple units of a
device type (limited to no more than
five units per year) qualifying for the
custom device exemption; and
• annual reporting requirements by
the manufacturer to FDA about devices
manufactured and distributed under
section 520(b) of the FD&C Act.
Under FDASIA, ‘‘devices’’ that qualify
for the custom device exemption
contained in section 520(b) of the FD&C
Act were clarified to include no more
than ‘‘five units per year of a particular
device type’’ that otherwise meet all the
requirements necessary to qualify for
the custom device exemption.
The guidance also provides draft
definitions of terms used in the custom
device exemption, explains how FDA
plans to interpret the concept of ‘‘five
units per year of a particular device
type’’ in section 520(b)(2)(B) of the
FD&C Act, describes what information
manufacturers should submit in a
custom device annual report (annual
report) to FDA, and provides guidance
on how to submit an annual report for
devices distributed under the custom
device exemption.
On November 19, 2012, FDA
published a notice requesting comments
in the Federal Register (77 FR 69488),
requesting that stakeholders submit
information on and examples of
appropriate use of the custom device
exemption for assistance in drafting this
guidance based on specific questions
asked in the notice. FDA has reviewed
all the comments from the notice and
has taken them into consideration for
this draft guidance.
II. Significance of Guidance
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 custom device exemption. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26432-26434]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10641]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1617-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.
[[Page 26433]]
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 July 7, 2014.
ADDRESSES: In commenting, refer to file code CMS-1617-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-1617-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-1617-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:
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 of the
Department of Health and Human Services (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).
[[Page 26434]]
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
In accordance with 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:
Carson Valley Medical Center, Gardnerville, Nevada, is requesting a
waiver to work with: California Transplant Donor Network, 1000
Broadway, Suite 600, Oakland, California 94607-4099.
The Hospital's Designated OPO is: Nevada Donor Network, 2061 E.
Sahara Ave., Las Vegas, Nevada 89104.
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 Public Comments
We will consider all comments we receive by the date and time
specified in the DATES section of this preamble.
Dated: May 2, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-10641 Filed 5-7-14; 8:45 am]
BILLING CODE 4120-01-P
