Medicare and Medicaid Programs; Solicitation for Proposals for the Frontier Community Health Integration Project Demonstration, 6594-6596 [2014-02062]
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mstockstill on DSK4VPTVN1PROD with NOTICES
6594
Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices
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VerDate Mar<15>2010
20:14 Feb 03, 2014
Jkt 232001
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write ‘‘FTC Generic Clearance ICR,
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The FTC Act and other laws that the
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permitted by the Privacy Act, in the
Commission’s privacy policy, at https://
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David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2014–02216 Filed 2–3–14; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5511–N]
Medicare and Medicaid Programs;
Solicitation for Proposals for the
Frontier Community Health Integration
Project Demonstration
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice provides eligible
entities with the information necessary
to apply for participation in the Frontier
Community Health Integration Project
(FCHIP) demonstration. The
demonstration is designed to better
integrate the delivery of acute care,
extended care and other health care
services, and improve access to care for
Medicare and Medicaid beneficiaries
residing in very sparsely populated
areas. A competitive application process
will be used to select eligible entities for
participation in this demonstration. The
demonstration is planned for up to 3
years.
SUMMARY:
Applications will be considered
timely if we receive them on or before
5 p.m., eastern standard time (E.S.T.) on
May 5, 2014.
ADDRESSES: Mail one unbound original
and two copies to: Centers for Medicare
& Medicaid Services, Attention: Steven
Johnson, 7500 Security Boulevard, Mail
Stop: WB–06–05, Baltimore, Maryland
21244–1850.
In addition, an email copy in MS
Word or PDF must be sent to: FCHIP@
cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Steven Johnson, (410) 786–3332 or
FCHIP@cms.hhs.gov.
DATES:
E:\FR\FM\04FEN1.SGM
04FEN1
Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices
Please
refer to file code CMS–5511–N on the
application. Applicants are required to
submit one unbound original and two
copies to the address listed in the
ADDRESSES section of this notice. In
addition, an email copy in MS Word or
PDF must be sent to: FCHIP@
cms.hhs.gov. Because of staffing and
resource limitations, we cannot accept
applications by facsimile (FAX)
transmission. Applications postmarked
after the closing date, or postmarked on
or before the closing date but not
received in time, will be considered
late.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
A. Legislative Authority
Section 123 of the Medicare
Improvements for Patients and
Providers Act of 2008, (MIPPA) (Pub. L.
110–275) as amended by section 3126 of
the Patient Protection and Affordable
Care Act (Pub. L. 111–148), authorizes
a demonstration project on community
health integration models in certain
rural counties to develop and test new
models for the delivery of health care
services to better integrate the delivery
of acute care, extended care and other
health care services, and improve access
to care for Medicare and Medicaid
beneficiaries residing in very sparsely
populated areas.
The authorizing legislation defines
distinct roles for this demonstration for
the Centers for Medicare & Medicaid
Services (CMS) and the Health
Resources and Services Administration
(HRSA) in developing and
implementing this project. HRSA was
charged with awarding grants to eligible
entities for the purpose of technical
assistance and informing the Secretary
of the Department of Health and Human
Services (Secretary) on the specific
needs of frontier communities, while
CMS is to conduct a demonstration
testing alternative reimbursement and
administrative strategies.
This demonstration is commonly
known as the Frontier Community
Health Integration Project (FCHIP). CMS
is hereby requesting applications for
participation in this demonstration from
eligible entities as defined in Section
123(d)(1)(B) of MIPPA. CMS interprets
the eligible entity definition as meaning
critical access hospitals (CAHs) that
receive funding through the Rural
Hospital Flexibility Program. The
statute limits the Demonstration to no
more than 4 States; it also restricts
eligibility to CAHs within States with at
least 65 percent of counties with 6 or
less persons per square mile. With
respect to these requirements, CMS is
VerDate Mar<15>2010
20:14 Feb 03, 2014
Jkt 232001
limiting applications to CAHs in Alaska,
Montana, Nevada, North Dakota, and
Wyoming.
The authorizing legislation mandates
that the project last for 3 years. The law
authorizes waiver of such provisions of
the Medicare and Medicaid programs as
are necessary to conduct the
demonstration project. The authorizing
legislation also requires the
demonstration to be budget neutral, that
is, to be structured such that Medicare
expenditures under the demonstration
do not to exceed the amount which the
Secretary estimates would have been
paid if the demonstration project were
not implemented. This notice references
CMS’s request for proposals for the
FCHIP demonstration, which sets forth
project guidelines, conditions of
participation, payment methodology,
and application instructions.
The FCHIP demonstration is designed
to improve access to certain services,
the delivery of which is often not
feasible at low volumes under current
Medicare reimbursement but if
integrated into the local delivery
system, would lead to improved
outcomes and greater efficiency in
health care service delivery. Integration
of services is intended as an
intervention that is directed by the
various providers serving the
community so that the specific health
care needs of residents are addressed in
appropriate settings—either inpatient,
outpatient, or at home. The desired
outcome is to increase access to health
care services, with the objective of
supporting certain services so as to
allow them to be financially feasible
given the low patient volumes of a
remote and sparsely populated area.
Another objective is to decrease the
number of avoidable hospital
admissions, readmissions, and
avoidable transfers to tertiary facilities,
such that there is no net increase in
Medicare spending for the affected
population. To address the goal of
increasing access with no net cost
increase, we have identified four types
of services for which this demonstration
will provide financial support, and
promote community health
integration—these are: Nursing facility
care within the CAH, telemedicine,
ambulance, and home health. We have
selected these services on the basis of
research and literature review.
Applicants should identify additional
services of one or more of these types,
beyond what is currently available.
Applicants must address the need for
these services, including how they
enhance patient care options and the
ability of beneficiaries to remain in their
communities; and how quality of these
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
6595
services will be maintained, to assure
care can safely be provided locally. We
will also work in the development
process of this project with State
Medicaid agencies on their proposals for
Medicaid-specific reimbursement
mechanisms to support access to
community-based health care services.
B. FCHIP Applications
In keeping with the authorizing
legislation in section 123 of MIPPA,
entities that meet the eligibility
requirements will be able to apply for
the demonstration. Specifically, an
eligible entity must be located in either
Alaska, Montana, Nevada, North Dakota,
or Wyoming although CMS will select
no more than 4 States to participate in
the demonstration. Each entity in its
application will be required to describe
a proposal to enhance health-related
services so as to complement those
currently provided within the
community and reimbursed by
Medicare, Medicaid, or other third-party
payers. The applicant must describe an
integrated system of services and
explain how these will better serve the
community’s health-related needs.
An entity applying for the
demonstration will be required to
demonstrate linkages (either ownership
or contractual) with the providers of the
identified additional services, such as
nursing home, telemedicine, home
health agency, or ambulance service.
Specifically, to be approved for payment
of telemedicine services under the
demonstration’s payment methodology,
the applicant must demonstrate
effective arrangements with distant site
specialists who will participate in
telemedicine linkages with providers
within the communities. In addition, to
be approved for ambulance services, the
applicants must show transfer
arrangements with essential providers.
Each applicant will be asked to
submit an analysis of how its proposed
project will be budget neutral and/or
achieve cost savings. This will include
projections of the number of patients
that will gain access to services within
the community that are supported by
the demonstration, the cost of these
services, and the resulting cost savings
from averting transfers to out-of-area
hospitals and/or avoidable
hospitalizations. The applicant will be
evaluated on the plausibility of this
analysis, the ability to support
projections with clinical evidence and
the sensitivity of cost outcomes to the
stated assumptions of change in services
and patient behavior.
Interested and eligible parties can
obtain complete solicitation and
supporting information on the CMS
E:\FR\FM\04FEN1.SGM
04FEN1
6596
Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices
Web site at: https://innovation.cms.gov/
initiatives/. Paper copies can
be obtained by writing to Steven
Johnson at the address listed in the
ADDRESSES section of this notice.
II. Collection of Information
Requirements
The information collection
requirements associated with this notice
are subject to the Paperwork Reduction
Act of 1995; however, the information
collection requirements are currently
approved under the information
collection request associated with OMB
control number 0938–0880 entitled
‘‘Medicare Waiver Demonstration
Applicant.’’ Applicants must submit the
Medicare Waiver Demonstration
Application to be considered for this
program.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: August 20, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–02062 Filed 1–31–14; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0053]
Designation of High-Risk Foods for
Tracing; Request for Comments and
for Scientific Data and Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
The Food and Drug
Administration (‘‘FDA’’ or ‘‘we’’) is
announcing the opening of a docket to
obtain comments and scientific data and
information that will help us to
implement the section of the FDA Food
Safety Modernization Act (FSMA) that
requires FDA to designate high-risk
foods. We are providing an opportunity
for interested parties to submit
comments and scientific data and
information that will help us develop
our process for implementing this
provision.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Submit electronic or written
comments and scientific data and
information by April 7, 2014.
ADDRESSES: You may submit comments
and scientific data and information,
DATES:
VerDate Mar<15>2010
20:14 Feb 03, 2014
Jkt 232001
identified by Docket No. FDA–2014–N–
0053, by any of the following methods:
Electronic Submissions
Submit electronic comments and
scientific data and information in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments
and scientific data and information.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2014–N–0053 for this
notice. All comments and scientific data
and information received may be posted
without change to
https://www.regulations.gov, including
any personal information provided. For
additional information on submitting
comments and scientific data and
information, see the ‘‘Comments’’
heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to
read background documents or
comments and scientific data and
information received, go to
https://www.regulations.gov and insert
the docket number found in brackets in
the heading of this document into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sherri Dennis, Center for Food Safety
and Applied Nutrition (HFS–005), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1914.
SUPPLEMENTARY INFORMATION:
I. Background
A. FDA Food Safety Modernization Act
Provision Requiring Designation of
High-Risk Foods
On January 4, 2011, the President
signed the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353) into law. Section 204 of FSMA
requires, among other things, the
designation of high-risk foods.
Specifically, section 204(d)(2)(A) of
FSMA requires FDA to designate highrisk foods for which additional
recordkeeping requirements are
appropriate and necessary to protect the
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
public health, and to do so not later
than 1 year after the date of enactment
of FSMA (and thereafter, if necessary).
Section 204(d)(2)(B) requires FDA to
publish the list of high-risk foods on the
Internet Web site of FDA at the time
when FDA issues final rules to establish
the additional recordkeeping
requirements for high-risk foods.
Section 204(d)(2)(A) of FSMA
specifically states that the designation of
high-risk foods must be based on the: (1)
Known safety risks of a particular food,
including the history and severity of
foodborne illness outbreaks attributed to
such food, taking into consideration
foodborne illness data collected by the
Centers for Disease Control and
Prevention; (2) likelihood that a
particular food has a high potential risk
for microbiological or chemical
contamination or would support the
growth of pathogenic microorganisms
due to the nature of the food or the
processes used to produce such food; (3)
point in the manufacturing process of
the food where contamination is most
likely to occur; (4) likelihood of
contamination and steps taken during
the manufacturing process to reduce the
possibility of contamination; (5)
likelihood that consuming a particular
food will result in a foodborne illness
due to contamination of the food; and
(6) likely or known severity, including
health and economic impacts, of a
foodborne illness attributed to a
particular food.
Through this notice, we are
establishing a docket to provide an
opportunity for interested parties to
provide comments and scientific data
and information that will help us refine
our draft approach to identifying highrisk foods, as required by section
204(d)(2) of FSMA. Section I.B
summarizes our tentative draft approach
for the review and evaluation of data to
designate high-risk foods. Attached as a
reference to this notice is a draft
approach document in which we
describe the process and methodology
we are considering using for designating
high-risk foods. After reviewing
comments received in response to this
notice on the draft approach described
here, we plan to further revise the
approach as necessary. We also
anticipate that the approach will be
reviewed by scientific experts (‘‘peer
reviewed’’).
While section 204(d)(2)(A) of FSMA
includes a statutory deadline within 1
year of the enactment of FSMA, FDA is
issuing this notice to solicit comments
and scientific data and information that
will help us refine our draft approach to
identifying high-risk foods. In section
II.B, there are a number of specific
E:\FR\FM\04FEN1.SGM
04FEN1
Agencies
[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6594-6596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02062]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-5511-N]
Medicare and Medicaid Programs; Solicitation for Proposals for
the Frontier Community Health Integration Project Demonstration
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice provides eligible entities with the information
necessary to apply for participation in the Frontier Community Health
Integration Project (FCHIP) demonstration. The demonstration is
designed to better integrate the delivery of acute care, extended care
and other health care services, and improve access to care for Medicare
and Medicaid beneficiaries residing in very sparsely populated areas. A
competitive application process will be used to select eligible
entities for participation in this demonstration. The demonstration is
planned for up to 3 years.
DATES: Applications will be considered timely if we receive them on or
before 5 p.m., eastern standard time (E.S.T.) on May 5, 2014.
ADDRESSES: Mail one unbound original and two copies to: Centers for
Medicare & Medicaid Services, Attention: Steven Johnson, 7500 Security
Boulevard, Mail Stop: WB-06-05, Baltimore, Maryland 21244-1850.
In addition, an email copy in MS Word or PDF must be sent to:
FCHIP@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Steven Johnson, (410) 786-3332 or
FCHIP@cms.hhs.gov.
[[Page 6595]]
SUPPLEMENTARY INFORMATION: Please refer to file code CMS-5511-N on the
application. Applicants are required to submit one unbound original and
two copies to the address listed in the ADDRESSES section of this
notice. In addition, an email copy in MS Word or PDF must be sent to:
FCHIP@cms.hhs.gov. Because of staffing and resource limitations, we
cannot accept applications by facsimile (FAX) transmission.
Applications postmarked after the closing date, or postmarked on or
before the closing date but not received in time, will be considered
late.
I. Background
A. Legislative Authority
Section 123 of the Medicare Improvements for Patients and Providers
Act of 2008, (MIPPA) (Pub. L. 110-275) as amended by section 3126 of
the Patient Protection and Affordable Care Act (Pub. L. 111-148),
authorizes a demonstration project on community health integration
models in certain rural counties to develop and test new models for the
delivery of health care services to better integrate the delivery of
acute care, extended care and other health care services, and improve
access to care for Medicare and Medicaid beneficiaries residing in very
sparsely populated areas.
The authorizing legislation defines distinct roles for this
demonstration for the Centers for Medicare & Medicaid Services (CMS)
and the Health Resources and Services Administration (HRSA) in
developing and implementing this project. HRSA was charged with
awarding grants to eligible entities for the purpose of technical
assistance and informing the Secretary of the Department of Health and
Human Services (Secretary) on the specific needs of frontier
communities, while CMS is to conduct a demonstration testing
alternative reimbursement and administrative strategies.
This demonstration is commonly known as the Frontier Community
Health Integration Project (FCHIP). CMS is hereby requesting
applications for participation in this demonstration from eligible
entities as defined in Section 123(d)(1)(B) of MIPPA. CMS interprets
the eligible entity definition as meaning critical access hospitals
(CAHs) that receive funding through the Rural Hospital Flexibility
Program. The statute limits the Demonstration to no more than 4 States;
it also restricts eligibility to CAHs within States with at least 65
percent of counties with 6 or less persons per square mile. With
respect to these requirements, CMS is limiting applications to CAHs in
Alaska, Montana, Nevada, North Dakota, and Wyoming.
The authorizing legislation mandates that the project last for 3
years. The law authorizes waiver of such provisions of the Medicare and
Medicaid programs as are necessary to conduct the demonstration
project. The authorizing legislation also requires the demonstration to
be budget neutral, that is, to be structured such that Medicare
expenditures under the demonstration do not to exceed the amount which
the Secretary estimates would have been paid if the demonstration
project were not implemented. This notice references CMS's request for
proposals for the FCHIP demonstration, which sets forth project
guidelines, conditions of participation, payment methodology, and
application instructions.
The FCHIP demonstration is designed to improve access to certain
services, the delivery of which is often not feasible at low volumes
under current Medicare reimbursement but if integrated into the local
delivery system, would lead to improved outcomes and greater efficiency
in health care service delivery. Integration of services is intended as
an intervention that is directed by the various providers serving the
community so that the specific health care needs of residents are
addressed in appropriate settings--either inpatient, outpatient, or at
home. The desired outcome is to increase access to health care
services, with the objective of supporting certain services so as to
allow them to be financially feasible given the low patient volumes of
a remote and sparsely populated area. Another objective is to decrease
the number of avoidable hospital admissions, readmissions, and
avoidable transfers to tertiary facilities, such that there is no net
increase in Medicare spending for the affected population. To address
the goal of increasing access with no net cost increase, we have
identified four types of services for which this demonstration will
provide financial support, and promote community health integration--
these are: Nursing facility care within the CAH, telemedicine,
ambulance, and home health. We have selected these services on the
basis of research and literature review. Applicants should identify
additional services of one or more of these types, beyond what is
currently available. Applicants must address the need for these
services, including how they enhance patient care options and the
ability of beneficiaries to remain in their communities; and how
quality of these services will be maintained, to assure care can safely
be provided locally. We will also work in the development process of
this project with State Medicaid agencies on their proposals for
Medicaid-specific reimbursement mechanisms to support access to
community-based health care services.
B. FCHIP Applications
In keeping with the authorizing legislation in section 123 of
MIPPA, entities that meet the eligibility requirements will be able to
apply for the demonstration. Specifically, an eligible entity must be
located in either Alaska, Montana, Nevada, North Dakota, or Wyoming
although CMS will select no more than 4 States to participate in the
demonstration. Each entity in its application will be required to
describe a proposal to enhance health-related services so as to
complement those currently provided within the community and reimbursed
by Medicare, Medicaid, or other third-party payers. The applicant must
describe an integrated system of services and explain how these will
better serve the community's health-related needs.
An entity applying for the demonstration will be required to
demonstrate linkages (either ownership or contractual) with the
providers of the identified additional services, such as nursing home,
telemedicine, home health agency, or ambulance service. Specifically,
to be approved for payment of telemedicine services under the
demonstration's payment methodology, the applicant must demonstrate
effective arrangements with distant site specialists who will
participate in telemedicine linkages with providers within the
communities. In addition, to be approved for ambulance services, the
applicants must show transfer arrangements with essential providers.
Each applicant will be asked to submit an analysis of how its
proposed project will be budget neutral and/or achieve cost savings.
This will include projections of the number of patients that will gain
access to services within the community that are supported by the
demonstration, the cost of these services, and the resulting cost
savings from averting transfers to out-of-area hospitals and/or
avoidable hospitalizations. The applicant will be evaluated on the
plausibility of this analysis, the ability to support projections with
clinical evidence and the sensitivity of cost outcomes to the stated
assumptions of change in services and patient behavior.
Interested and eligible parties can obtain complete solicitation
and supporting information on the CMS
[[Page 6596]]
Web site at: https://innovation.cms.gov/initiatives/. Paper
copies can be obtained by writing to Steven Johnson at the address
listed in the ADDRESSES section of this notice.
II. Collection of Information Requirements
The information collection requirements associated with this notice
are subject to the Paperwork Reduction Act of 1995; however, the
information collection requirements are currently approved under the
information collection request associated with OMB control number 0938-
0880 entitled ``Medicare Waiver Demonstration Applicant.'' Applicants
must submit the Medicare Waiver Demonstration Application to be
considered for this program.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: August 20, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-02062 Filed 1-31-14; 4:15 pm]
BILLING CODE 4120-01-P