Federal Register / Vol. 76, No. 245 / Wednesday, December 21, 2011 / Notices 79193 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule (PDF file, 450 KB. PDF Help) 

relating to the listing and operation of 

PSOs. Section 3.108(d) of the Patient 

Safety Rule requires AHRQ to provide 

public notice when it removes an 

organization from the list of federally 

approved PSOs. AHRQ has accepted a 

notification from The Georgia Hospital 

Association Research and Education 

Foundation Patient Safety Organization 

(GHA–PSO), PSO number P0057, which 

is a component entity of the Georgia 

Hospital Association Research and 

Education Foundation, to voluntarily 

relinquish its status as a PSO. 

Accordingly, The Georgia Hospital 

Association Research and Education 

Foundation Patient Safety Organization 

(GHA–PSO) was delisted effective at 

12:00 Midnight ET (2400) on December 

6, 2011. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.gov/ 

index.html. 

Dated: December 14, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–32579 Filed 12–20–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5048–N] 

Medicare Program; Independence at 

Home Demonstration Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice creates a new 

demonstration program for chronically 

ill Medicare beneficiaries to test a 

payment incentive and service delivery 

system that utilizes physician and nurse 

practitioner directed home-based 

primary care teams aimed at improving 

health outcomes and reducing 

expenditures, beginning December 21, 

2011. 

DATES: Effective Date: This notice is 

effective on December 21, 2011. 

Application Deadline: February 6, 

2012 at 5 p.m., Eastern Standard Time 

(E.S.T.). 

FOR FURTHER INFORMATION CONTACT: 

Linda Colantino (410) 786–3343. 

Jennifer Brown (410) 786–4036. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 3024 of the Patient Protection 

and Affordable Care Act of 2010 (the 

Affordable Care Act) (Pub. L. 111–148, 

enacted on March 23, 2010), amends 

title XVIII of the Social Security Act (the 

Act) by establishing the Independence 

at Home (IAH) Demonstration. 

The IAH Demonstration will test a 

service delivery model that utilizes 

physician and nurse practitioner 

directed primary care teams to provide 

services to high cost, chronically ill 

Medicare beneficiaries in their homes. 

Participating practices will be 

accountable for providing 

comprehensive, coordinated, 

continuous, and accessible care to highneed populations at home and 

coordinate health care across all 

treatment settings. Participating 

practices may share in savings under the 

demonstration if specified quality 

measures and savings targets are 

achieved. 

II. Provisions of the Notice 

We are seeking interested practices 

that can provide home-based primary 

care to Medicare beneficiaries for 

purposes of this demonstration. We 

anticipate that a wide variety of 

interested practices may be eligible to 

apply to the IAH Demonstration. The 

participants in the Demonstration will 

be multidisciplinary teams composed of 

various members such as physicians, 

nurse practitioners, physician assistants, 

pharmacists, social workers, and other 

supporting staff. The practices must be 

led by physicians or nurse practitioners 

and must have experience providing 

home-based primary care to patients 

with multiple chronic illnesses. These 

practices will also be organized, at least 

in part, for the purpose of providing 

physician services. Qualifying practices 

may share in savings. Providers cannot 

be participating in section 1899 of the 

Act, the Medicare Shared Savings 

Program, or other Medicare shared 

savings programs at the time of the 

Demonstration. 

Each participating practice must 

provide services to at least 200 

applicable beneficiaries during each 

year of the demonstration. A practice’s 

enrollment may vary over each year but 

must reach at least an average of 200 

applicable beneficiaries during the first 

year and not drop below that average for 

the remainder of the demonstration. 

There are three options available for 

practices to apply for the 

Demonstration. Practices may apply as a 

sole legal entity, consortium, or become 

a part of a national pool. These three 

options are for the purpose of 

establishing expenditure targets and 

determining incentive payments. 

Practices must enroll all existing 

patients meeting beneficiary eligibility 

criteria. 

Participating practices will make inhome visits tailored to an individual 

patient’s needs. Each practice must be 

available 24 hours per day, 7 days a 

week to carry out plans of care. 

Practices must use electronic health 

information systems, remote 

monitoring, and mobile diagnostic 

technology. 

Applicable beneficiaries are defined 

as Medicare fee-for-service (FFS) 

patients, who have at least 2 chronic 

illnesses, need assistance with 2 or more 

functional dependencies requiring the 

assistance of another person, have had 

a nonelective hospital admission within 

the last 12 months, and have received 

acute or subacute rehabilitation services 

within the last 12 months. Beneficiaries 

to be included in the Demonstration 

must be entitled to Medicare part A and 

enrolled in Medicare part B, not 

enrolled in a Medicare Advantage plan 

or a Program for All-Inclusive Care for 

the Elderly, and cannot be enrolled in 

a practice that is part of the Medicare 

Shared Savings Program or other 

program that shares Medicare savings. 

We will establish a practice-specific 

spending target derived from claims, 

based on expected Medicare FFS 

utilization for each of the beneficiaries 

in the practices in the absence of the 

Demonstration. Annual spending targets 

will be calculated for each participating 

practice at the end of each performance 

year. The spending target will be 

derived from a base expenditure amount 

equal to the average payments under 

Medicare Part A and Part B. Savings 

will be calculated as the difference 

between each practice’s spending target 

and actual costs. Practices will also be 

required to meet quality performance 

standards in order to share in any 

savings. Under this 3-year 

demonstration, IAH providers will 

continue to bill and be paid standard 

Medicare FFS reimbursement. 

Applicants must submit completed 

applications following the format 

outlined in the Demonstration 

application instructions in order to be 

considered for review by CMS. 

Applications not received in this format 

will not be considered for review. 

For the Project Application and 

specific details regarding the IAH 

Demonstration, please refer to the CMS 

Web site at http://www.cms.gov/ 


sroberts on DSK5SPTVN1PROD with NOTICES
79194 Federal Register / Vol. 76, No. 245 / Wednesday, December 21, 2011 / Notices 

DemoProjectsEvalRpts/downloads/ 

IAH_FactSheet.pdf 

Please refer to file code [CMS–5048– 

N] on the Application. Applicants must 

submit at least 1 electronic copy on CD– 

ROM of the Application and are 

required to submit a paper version of 

the Application with an original 

signature. Because of staffing and 

resource limitations, we cannot accept 

applicationss by facsimile (FAX) 

transmission. Hard copies and 

electronic copies must be identical. 

Applications for practices applying to 

the IAH Demonstration will be 

considered timely if they are received 

on or before 5 p.m., Eastern Standard 

Time (E.S.T.) on the date listed in the 

DATES section of this notice. 

III. Collection of Information 

Requirements 

Accordance to section 3024 of the 

Affordable Care Act this notice 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). 

Authority: Section 3024 of the Affordable 

Care Act. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medicare— 

Supplementary Medical Insurance Program) 

Dated: September 9, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–32568 Filed 12–20–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0902] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

Product Labeling: Medication Guide 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

regulations requiring the distribution of 

patient labeling, called Medications 

Guides, for certain products that pose a 

serious and significant public health 

concern requiring distribution of FDAapproved patient medication. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 21, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, (301) 

796–7651, 

juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collections of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumption used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Prescription Drug Product Labeling; 

Medication Guide Requirements (OMB 

Control Number 0910–0393)—Extension 

FDA regulations require the 

distribution of patient labeling, called 

Medication Guides, for certain 

prescription human drug and biological 

products used primarily on an 

outpatient basis that pose a serious and 

significant public health concern 

requiring distribution of FDA-approved 

patient medication information. These 

Medication Guides inform patients 

about the most important information 

they should know about these products 

in order to use them safely and 

effectively. Included is information such 

as the drug’s approved uses, 

contraindications, adverse drug 

reactions, and cautions for specific 

populations, with a focus on why the 

particular product requires a Medication 

Guide. These regulations are intended to 

improve the public health by providing 

information necessary for patients to use 

certain medication safely and 

effectively. 

The regulations contain the following 

reporting requirements that are subject 

to the PRA. The estimates for the burden 

hours imposed by the following 

regulations are listed in table 1 of this 

document: 

• 21 CFR 208.20—Applicants must 

submit draft Medication Guides for FDA 

approval according to the prescribed 

content and format. 

• 21 CFR 208.24(e)—Each authorized 

dispenser of a prescription drug product 

for which a Medication Guide is 

required, when dispensing the product 

to a patient or to a patient’s agent, must 

provide a Medication Guide directly to 

each patient unless an exemption 

applies under 21 CFR 208.26. 

• 21 CFR 208.26 (a)—Requests may 

be submitted for exemption or deferral 

from particular Medication Guide 

content or format requirements. 

• 21 CFR 314.70(b)(3)(ii) and 21 CFR 

601.12(f)—Application holders must 

submit changes to Medication Guides to 

FDA for prior approval as supplements 

to their applications. 

FDA estimates the burden of this 

collection of information as follows: 


sroberts on DSK5SPTVN1PROD with NOTICES