Medicare Program; Comprehensive Primary Care Initiative, 61103 [2011-25356]
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Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices
of comprehensive, accountable primary
care supported by multiple payers. We
are seeking to collaborate with other
payers in select markets and with
approximately 75 primary care practices
in each market over the course of this
4-year initiative. This solicitation is
directed to public and private health
care payers who will respond
individually to the Innovation Center.
Once payers and markets have been
selected, primary care practices will be
recruited and selected in those markets.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5508–N]
Medicare Program; Comprehensive
Primary Care Initiative
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces a
solicitation for health care payer
organizations to participate in the
Comprehensive Primary Care initiative
(CPC), a multipayer model designed to
improve primary care.
DATES: Letter of Intent Submission
Deadlines: Interested organizations must
submit a nonbinding letter of intent
(LOI), which includes an Excel
document identifying preliminary
markets of interest by November 15,
2011 using the LOI template provided
on the Innovation Center Web site at
https://www.innovation.cms.gov/.
Application Submission Deadline:
Applications must be received through
an online portal, on or before 5 p.m.,
Eastern Standard Time (E.S.T) on
January 17, 2012. We reserve the right
to request additional information from
applicants in order to assess their
applications.
SUMMARY:
Letters of Intent should be
submitted electronically in PDF format
via encrypted e-mail to the following email address by the applicable date
specified in the DATES section of this
notice: CPCi@cms.hhs.gov. Letters of
Intent will only be accepted via e-mail.
Applications will only be accepted via
the online application portal.
FOR FURTHER INFORMATION CONTACT:
CPCi@cms.hhs.gov for questions
regarding the aspects of the
Comprehensive Primary Care initiative
or the application process.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
The Centers for Medicare & Medicaid
Services (CMS) are committed to the
three-part aim of better health, better
health care, and lower per-capita costs
for Medicare, Medicaid and Children’s
Health Insurance Program (CHIP)
beneficiaries. One potential mechanism
for achieving this goal is to support
practice redesign in primary care
through payment reform.
The Center for Medicare & Medicaid
Innovation (Innovation Center) is
seeking to strengthen free-standing
primary care capacity by testing a model
VerDate Mar<15>2010
16:42 Sep 30, 2011
Jkt 223001
II. Provisions of the Notice
Consistent with its authority under
section 1115A of the Social Security Act
(the Act) as added by section 3021 of the
Affordable Care Act, to test innovative
payment and service delivery models
that reduce spending under Medicare,
Medicaid or CHIP, while preserving or
enhancing the quality of care, the
Innovation Center aims to achieve the
following goals through the
implementation of the Comprehensive
Primary Care (CPC) initiative:
• To collaborate with other payers on
aligned strategies to support the
delivery of comprehensive primary care
services provided by practices
participating in the initiative (as
described in Section D of the
solicitation).
• To test whether a set of
comprehensive primary care functions,
coupled with payment reform, use of
data to guide improvement, and
meaningful use of health information
technology can achieve the three-part
aim of better care, improved health and
reduced costs that could ultimately be
adopted by Medicare and Medicaid
programs.
We will pay a per-beneficiary-permonth care management payment to
each participating primary care
practices for comprehensive primary
care services that the practice provides
to its Medicare fee-for-service
beneficiaries We will offer an
opportunity for participating practices
to share in savings in years 2 through 4
of the program if the market in which
the practice participates experiences
reductions in its reductions in its total
health system costs (a described in
Section F of the solicitation). Each payer
applying for this initiative will propose
a strategy that is aligned with the
Innovation Center’s approach to
supporting comprehensive primary care.
Learning systems will support
participating practices throughout the
initiative. Payer selection criteria are
described in section II of the
Solicitation.
To the extent that States apply, the
Innovation Center will also pay a per-
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
61103
beneficiary-per-month care management
payment to primary care on behalf of
Medicaid fee-forservice beneficiaries;
shared savings will not be a part of the
payment methodology for Medicaid feefor–service.
III. Collection of Information
Requirements
Section 1115A(d)(3)of the Act
specifies that the requirements of the
Paperwork Reduction Act of 1995 do
not apply with respect to the testing and
evaluation of payment and service
delivery models or the expansion of
these models under section 1115A of
the Act.
Authority: Section 1115A of the Social
Security Act.
Dated: September 27, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–25356 Filed 9–28–11; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0689]
Draft Guidance for Industry and Food
and Drug Administration Staff; De
Novo Classification Process
(Evaluation of Automatic Class III
Designation); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation).’’ The purpose of this
document is to provide guidance to FDA
staff and industry on the process for the
submission and review of petitions
submitted under the Federal Food,
Drug, and Cosmetic Act (FD&C Act),
also known as the de novo classification
process. FDA is issuing this draft
guidance to provide updated
recommendations for efficient
interaction with FDA, including what
information to submit, when seeking a
path to market for a novel device via the
de novo process. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
SUMMARY:
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Page 61103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25356]
[[Page 61103]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-5508-N]
Medicare Program; Comprehensive Primary Care Initiative
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a solicitation for health care payer
organizations to participate in the Comprehensive Primary Care
initiative (CPC), a multipayer model designed to improve primary care.
DATES: Letter of Intent Submission Deadlines: Interested organizations
must submit a nonbinding letter of intent (LOI), which includes an
Excel document identifying preliminary markets of interest by November
15, 2011 using the LOI template provided on the Innovation Center Web
site at https://www.innovation.cms.gov/.
Application Submission Deadline: Applications must be received
through an online portal, on or before 5 p.m., Eastern Standard Time
(E.S.T) on January 17, 2012. We reserve the right to request additional
information from applicants in order to assess their applications.
ADDRESSES: Letters of Intent should be submitted electronically in PDF
format via encrypted e-mail to the following e-mail address by the
applicable date specified in the DATES section of this notice:
CPCi@cms.hhs.gov. Letters of Intent will only be accepted via e-mail.
Applications will only be accepted via the online application portal.
FOR FURTHER INFORMATION CONTACT: CPCi@cms.hhs.gov for questions
regarding the aspects of the Comprehensive Primary Care initiative or
the application process.
SUPPLEMENTARY INFORMATION:
I. Background
The Centers for Medicare & Medicaid Services (CMS) are committed to
the three-part aim of better health, better health care, and lower per-
capita costs for Medicare, Medicaid and Children's Health Insurance
Program (CHIP) beneficiaries. One potential mechanism for achieving
this goal is to support practice redesign in primary care through
payment reform.
The Center for Medicare & Medicaid Innovation (Innovation Center)
is seeking to strengthen free-standing primary care capacity by testing
a model of comprehensive, accountable primary care supported by
multiple payers. We are seeking to collaborate with other payers in
select markets and with approximately 75 primary care practices in each
market over the course of this 4-year initiative. This solicitation is
directed to public and private health care payers who will respond
individually to the Innovation Center. Once payers and markets have
been selected, primary care practices will be recruited and selected in
those markets.
II. Provisions of the Notice
Consistent with its authority under section 1115A of the Social
Security Act (the Act) as added by section 3021 of the Affordable Care
Act, to test innovative payment and service delivery models that reduce
spending under Medicare, Medicaid or CHIP, while preserving or
enhancing the quality of care, the Innovation Center aims to achieve
the following goals through the implementation of the Comprehensive
Primary Care (CPC) initiative:
To collaborate with other payers on aligned strategies to
support the delivery of comprehensive primary care services provided by
practices participating in the initiative (as described in Section D of
the solicitation).
To test whether a set of comprehensive primary care
functions, coupled with payment reform, use of data to guide
improvement, and meaningful use of health information technology can
achieve the three-part aim of better care, improved health and reduced
costs that could ultimately be adopted by Medicare and Medicaid
programs.
We will pay a per-beneficiary-per-month care management payment to
each participating primary care practices for comprehensive primary
care services that the practice provides to its Medicare fee-for-
service beneficiaries We will offer an opportunity for participating
practices to share in savings in years 2 through 4 of the program if
the market in which the practice participates experiences reductions in
its reductions in its total health system costs (a described in Section
F of the solicitation). Each payer applying for this initiative will
propose a strategy that is aligned with the Innovation Center's
approach to supporting comprehensive primary care. Learning systems
will support participating practices throughout the initiative. Payer
selection criteria are described in section II of the Solicitation.
To the extent that States apply, the Innovation Center will also
pay a per-beneficiary-per-month care management payment to primary care
on behalf of Medicaid fee-forservice beneficiaries; shared savings will
not be a part of the payment methodology for Medicaid fee-for-service.
III. Collection of Information Requirements
Section 1115A(d)(3)of the Act specifies that the requirements of
the Paperwork Reduction Act of 1995 do not apply with respect to the
testing and evaluation of payment and service delivery models or the
expansion of these models under section 1115A of the Act.
Authority: Section 1115A of the Social Security Act.
Dated: September 27, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-25356 Filed 9-28-11; 11:15 am]
BILLING CODE 4120-01-P