Federal Register / Vol. 76, No. 191 / Monday, October 3, 2011 / Notices 61103 

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 

http://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 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: 

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-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 perbeneficiary-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. 

SUMMARY: 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 


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