Medicare and Medicaid Programs; Announcement of an Application From a Hospital Seeking To Enter Into an Agreement With a Different Organ Procurement Organization, 44972-44973 [2010-18370]
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Federal Register / Vol. 75, No. 146 / Friday, July 30, 2010 / Notices
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
srobinson on DSKHWCL6B1PROD with NOTICES
Section 401(a) of the Children’s
Health Insurance Program
Reauthorization Act of 2009 (Pub. L.
111–3) (CHIPRA), added section 1139A
to the Social Security Act (the Act).
Section 1139A(a)(6), as added by section
(401)(a), requires the Secretary to report
to the Congress by January 1, 2011, and
every 3 years thereafter, on the status of
the following factors that influence the
quality of care given to children under
the Medicaid and Children’s Health
Insurance Program.
• The duration and stability of health
insurance coverage for children under
titles XIX and XXI of the Social Security
Act.
• The quality of care provided under
titles XIX and XXI for:
+ Preventive health care services.
+ Health care for acute conditions.
+ Chronic health care.
+ Health services to ameliorate the
effects of physical and mental
conditions and to aid in the growth
and development of infants, young
children, school-age children, and
adolescents with special health care
needs.
• The quality of children’s health care
under titles XIX and XXI, across the
various domains of quality, including:
+ Clinical quality.
+ Health care safety.
+ Family experience with health care.
+ Health care in the most integrated
setting.
+ Elimination of racial, ethnic, and
socio-economic disparities in health
and health care.
• The status of voluntary reporting by
States under titles XIX and XXI,
utilizing the initial core quality
measurement set. Based on the
assessment of these factors affecting the
quality of care given to children under
titles XIX and XXI, the Secretary is also
required to make any recommendations
for legislative changes that are needed to
improve the quality of care provided to
children under titles XIX and XXI,
including recommendations for quality
reporting by the States.
II. Solicitation of Comments
We request public comments for
consideration in the formulation of
legislative changes to be recommended
by the Secretary, including
requirements for the process and
VerDate Mar<15>2010
16:29 Jul 29, 2010
Jkt 220001
content of quality reporting by the
States. We request that these suggestions
address the dimensions of quality and
the subject areas listed above.
III. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
Dated: July 19, 2010.
Marilyn Tavenner,
Principal Deputy Administrator, Centers for
Medicare & Medicaid Services.
[FR Doc. 2010–18140 Filed 7–29–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1579–NC]
Medicare and Medicaid Programs;
Announcement of an Application From
a Hospital Seeking To Enter Into an
Agreement With a Different Organ
Procurement Organization
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
AGENCY:
A hospital that had
previously been granted a waiver under
section 1138(a)(2) of the Social Security
Act (the Act), has requested to enter into
an agreement with a different Organ
Procurement Organization (OPO). This
notice requests comments from
hospitals, OPOs, and the general public
for our consideration in determining
whether we should grant the request.
We are particularly interested in
information and material that will help
determine whether the change is likely
to increase organ donation and will
ensure equitable treatment for patients
in both affected OPO service areas.
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
September 28, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–1579–NC. Because of
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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–1579–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–1579–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 before the close
of the comment period to either of 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,
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
E:\FR\FM\30JYN1.SGM
30JYN1
Federal Register / Vol. 75, No. 146 / Friday, July 30, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
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 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
VerDate Mar<15>2010
16:29 Jul 29, 2010
Jkt 220001
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 comment
period beginning on the publication
date of the notice in the Federal
Register.
On June 11, 2010, we published a
Federal Register notice (75 FR 33313)
that established a public process for
hospitals that had previously been
granted a waiver under section
1138(a)(2) of the Act. Under the notice,
a hospital may request approval to work
with a different OPO.
II. Procedures for Requesting a Change
in OPOs
For hospitals that had previously been
granted a waiver request under section
1138(a)(2) of the Act but are now
seeking to enter into an agreement with
a different OPO, the hospital may file a
request, by letter, to CMS containing the
information set forth in the June 11,
2010 notice (75 FR 33313). Upon receipt
of a request, we publish a Federal
Register notice to solicit public
comments, modeled after the
procedures set forth in section
1138(a)(2)(D) of the Act.
Under these procedures, we will
review the request and 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
44973
hospital or others. We will then make a
final determination on the request to
change the OPO and notify the hospital
and the OPOs involved.
III. Hospital Requests To Change OPOs
As permitted by the June 11, 2010
notice (75 FR 33313), the following
hospital has requested to work with an
OPO other than the OPO it had been
designated to work through based on a
previous waiver request:
OSF St. Anthony Medical Center of
Rockford, Illinois, Provider Number 14–
0233, is requesting to work with: Gift of
Hope Organ & Tissue Donor Network,
425 Spring Lake Drive, Itasca, IL 60143.
OSF St. Anthony Medical Center has
an existing waiver to work with: UW
Health Organ Procurement
Organization, 450 Science Drive, Suite
220, Madison, WI 53711.
(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: July 21, 2010.
Marilyn Tavenner
Principal Deputy Administrator and Chief
Operating Officer, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–18370 Filed 7–29–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0260]
Report: A New Approach to Targeting
Inspection Resources and Identifying
Patterns of Adulteration: The
Reportable Food Registry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a report entitled ‘‘A New
Approach to Targeting Inspection
Resources and Identifying Patterns of
Adulteration: The Reportable Food
Registry.’’ The report presents FDA’s
experience with the Reportable Food
Registry (RFR or the Registry) from the
opening of the Reportable Food
electronic portal on September 8, 2009,
until March 31, 2010.
ADDRESSES: Submit written requests for
single copies of the report to the Office
of Food Defense, Communication and
Emergency Response (HFS–005), Center
for Food Safety and Applied Nutrition,
SUMMARY:
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[Federal Register Volume 75, Number 146 (Friday, July 30, 2010)]
[Notices]
[Pages 44972-44973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1579-NC]
Medicare and Medicaid Programs; Announcement of an Application
From a Hospital Seeking To Enter Into an Agreement With a Different
Organ Procurement Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: A hospital that had previously been granted a waiver under
section 1138(a)(2) of the Social Security Act (the Act), has requested
to enter into an agreement with a different Organ Procurement
Organization (OPO). This notice requests comments from hospitals, OPOs,
and the general public for our consideration in determining whether we
should grant the request. We are particularly interested in information
and material that will help determine whether the change is likely to
increase organ donation and will ensure equitable treatment for
patients in both affected OPO service areas.
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 September 28, 2010.
ADDRESSES: In commenting, please refer to file code CMS-1579-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-1579-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-1579-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 before the close of the comment period
to either of 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,
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
[[Page 44973]]
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 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 comment period beginning on the publication date of
the notice in the Federal Register.
On June 11, 2010, we published a Federal Register notice (75 FR
33313) that established a public process for hospitals that had
previously been granted a waiver under section 1138(a)(2) of the Act.
Under the notice, a hospital may request approval to work with a
different OPO.
II. Procedures for Requesting a Change in OPOs
For hospitals that had previously been granted a waiver request
under section 1138(a)(2) of the Act but are now seeking to enter into
an agreement with a different OPO, the hospital may file a request, by
letter, to CMS containing the information set forth in the June 11,
2010 notice (75 FR 33313). Upon receipt of a request, we publish a
Federal Register notice to solicit public comments, modeled after the
procedures set forth in section 1138(a)(2)(D) of the Act.
Under these procedures, we will review the request and 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 request to change the OPO and notify the
hospital and the OPOs involved.
III. Hospital Requests To Change OPOs
As permitted by the June 11, 2010 notice (75 FR 33313), the
following hospital has requested to work with an OPO other than the OPO
it had been designated to work through based on a previous waiver
request:
OSF St. Anthony Medical Center of Rockford, Illinois, Provider
Number 14-0233, is requesting to work with: Gift of Hope Organ & Tissue
Donor Network, 425 Spring Lake Drive, Itasca, IL 60143.
OSF St. Anthony Medical Center has an existing waiver to work with:
UW Health Organ Procurement Organization, 450 Science Drive, Suite 220,
Madison, WI 53711.
(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: July 21, 2010.
Marilyn Tavenner
Principal Deputy Administrator and Chief Operating Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2010-18370 Filed 7-29-10; 8:45 am]
BILLING CODE 4120-01-P
