Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 60843 

the popHealth system related to 

meaningful use measures; and/or target 

patients with high disease burden in 

need of early intervention. 

Eligibility Rules for Participating in 

the Competition: To be eligible to win 

a prize under this challenge, an 

individual or entity: 

(1) Shall have registered to participate 

in the competition under the rules 

promulgated by Office of the National 

Coordinator for Health Information 

Technology; 

(2) Shall have complied with all the 

requirements under this section; 

(3) In the case of a private entity, shall 

be incorporated in and maintain a 

primary place of business in the United 

States, and in the case of an individual, 

whether participating singly or in a 

group, shall be a citizen or permanent 

resident of the United States; and 

(4) May not be a Federal entity or 

Federal employee acting within the 

scope of their employment. 

An individual or entity shall not be 

deemed ineligible because the 

individual or entity used Federal 

facilities or consulted with Federal 

employees during a competition if the 

facilities and employees are made 

available to all individuals and entities 

participating in the competition on an 

equitable basis. 

Registered participants shall be 

required to agree to assume any and all 

risks and waive claims against the 

Federal Government and its related 

entities, except in the case of willful 

misconduct, for any injury, death, 

damage, or loss of property, revenue, or 

profits, whether direct, indirect, or 

consequential, arising from their 

participation in a competition, whether 

the injury, death, damage, or loss arises 

through negligence or otherwise. 

Participants shall be required to 

obtain liability insurance or 

demonstrate financial responsibility, in 

amounts determined by the head of the 

Office of the National Coordinator for 

Health Information Technology, for 

claims by— 

(1) A third party for death, bodily 

injury, or property damage, or loss 

resulting from an activity carried out in 

connection with participation in a 

competition, with the Federal 

Government named as an additional 

insured under the registered 

participant’s insurance policy and 

registered participants agreeing to 

indemnify the Federal Government 

against third party claims for damages 

arising from or related to competition 

activities; and 

(2) the Federal Government for 

damage or loss to Government property 

resulting from such an activity. 

Participants must be teams of at least 

two people. 

All participants are required to 

provide written consent to the rules 

upon or before submitting an entry. 

DATES: 

• Submission Period Begins: 12:01 

a.m., EDT, September 26, 2011. 

• Submission Period Ends: 11:59 

p.m., EDT, February 3, 2012. 

Registration Process for Participants: 

To register for this challenge 

participants should: 

• Access the http:// 

www.challenge.gov Web site and search 

for the ‘‘popHealth Tools Development 

Challenge’’. 

• Access the ONC Investing in 

Innovation (i2) Challenge Web site at: 

Æ http://www.health2challenge.org/ 

category/onc/. 

Æ A registration link for the challenge 

can be found on the landing page under 

the challenge description. 

Amount of the Prize: 

• First Prize: $75,000. 

• Second Prize: $20,000. 

• Third Prize: $5,000. 

Awards may be subject to Federal 

income taxes and HHS will comply with 

IRS withholding and reporting 

requirements, where applicable. 

Basis Upon Which Winner Will Be 

Selected: 

The judging panel will make 

selections based upon the following 

criteria: 

1. Ability to integrate with popHealth 

system and build upon existing 

functionality. 

2. Impact on stakeholders. 

3. Usability and design. 

4. Creativity and Innovation. 

Additional Information: 

Ownership of intellectual property is 

determined by the following: 

• Each entrant retains title and full 

ownership in and to their submission. 

Entrants expressly reserve all 

intellectual property rights not 

expressly granted under the challenge 

agreement. 

• By participating in the challenge, 

each entrant hereby irrevocably grants 

to Sponsor and Administrator a limited, 

non-exclusive, royalty free, worldwide, 

license and right to reproduce, 

publically perform, publically display, 

and use the Submission to the extent 

necessary to administer the challenge, 

and to publically perform and 

publically display the Submission, 

including, without limitation, for 

advertising and promotional purposes 

relating to the challenge. 

Dated: September 26, 2011. 

Farzad Mostashari, 

National Coordinator for Health Information 

Technology. 

[FR Doc. 2011–25295 Filed 9–29–11; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–9042, CMS– 

10374, CMS–10385, CMS–10402 and CMS– 

10396] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Accelerated 

Payments and Supporting Regulations 

42 CFR, Section 412.116(f), 412.632(e), 

413.64(g), 413.350(d), and 484.245; Use: 

This information is used by the 

contractor to determine the provider’s 

eligibility for accelerated payments. If 

this information were not furnished 

with an accelerated payment request, 

the contractor would not be able to 

assess whether the provider’s financial 

difficulties justified the accelerated 

payment; Form Number: CMS–9042 

(OMB # 0938–0269); Frequency: Yearly; 

Affected Public: Private Sector; Business 

or other for-profit and not-for-profit 

institutions; Number of Respondents: 

37,804; Total Annual Responses: 945; 

Total Annual Hours: 473. (For policy 

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60844 Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 

questions regarding this collection 

contact Leonard Fisher at 410–786–4574 

TTY. For all other issues call 410–786– 

1326.) 

2. Type of Information Collection 

Request: New collection of information; 

Title of Information Collection: Training 

Needs Assessment, Evaluation/Survey— 

Question Compilation; Use: The intent 

of this information collection is to assist 

in the creation and enhancement of 

training for Federal and State health 

care surveyors and certification 

specialists. The purpose of the 

collection is to gather information for 

training needs assessment, training 

analysis, related demographic, 

psychographics and technographics to 

support the development and 

enhancement of training and training 

aids; Form Number: CMS–10374 (OMB 

# 0938–New); Frequency: Half-year (2 

per year); Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 2,161; Total Annual 

Responses: 4,322; Total Annual Hours: 

1,430. (For policy questions regarding 

this collection contact Etolia Biggs at 

410–786–8664. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Expedited 

Checklist: Medicaid Eligibility & 

Enrollment Systems—Advance Planning 

Document (E&E–APD); Use: Under 

sections 1903(a)(3)(A)(i) and 

1903(a)(3)(B) of the Social Security Act, 

CMS has issued new standards and 

conditions that must be met by States 

for Medicaid technology investments 

(including traditional claims processing 

systems, as well as eligibility systems) 

to be eligible for enhanced match 

funding. The Checklist will be 

submitted by States to the E&E APD 

National Coordinator for review and 

coordination in the Eligibility/ 

Enrollment Systems APD approval 

assignment. The information requested 

on the Checklist will be used to 

determine and approve enhanced FFP to 

States and to determine how States are 

complying with the seven standards and 

conditions; Form Number: CMS–10385 

(OMB#: 0938–1125); Frequency: 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 56; Total Annual 

Responses: 168; Total Annual Hours: 

204. (For policy questions regarding this 

collection contact Richard Friedman at 

410–786–4451. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Medicaid State 

Plan Preprint for Use by States When 

Implementing Section 6401 of the 

Patient Protection and Affordable Care 

Act under the Medicaid Program; Use: 

The Secretary, in consultation with the 

Department of Health of Human 

Services’ Office of the Inspector 

General, is required to establish 

procedures under which screening is 

conducted with respect to providers of 

medical or other items or services and 

suppliers under Medicare, Medicaid, 

and CHIP. The Secretary is also required 

to impose a fee on each institutional 

provider of medical or other items or 

services or supplier that would be used 

by the Secretary for program integrity 

efforts. States are required to comply 

with the process of screening providers 

and suppliers as established by the 

Secretary under 1866(j)(2) of the 

Affordable Care Act. The Office of 

General Counsel through guidance, is 

requiring that States use the Medicaid 

State Plan Preprint to assure CMS 

compliance with the law. CMS will use 

the information to review and approve 

the State plan. States would refer to the 

State plan on an as needed basis to 

manage and operate their Medicaid 

programs under Title XIX of the Social 

Security Act; Form Number: CMS– 

10402 (OMB # 0938–New); Frequency: 

Once; Affected Public: State, Local, or 

Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 56; Total Annual Hours: 14. 

(For policy questions regarding this 

collection contact Richard Friedman. at 

410–786–4451. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Medication 

Therapy Management Program 

Improvements—Standardized Format. 

Use: The Medicare Modernization Act 

of 2003 (MMA) under title 42 CFR Part 

423, Subpart D, established the 

requirements that Part D sponsors must 

meet with regard to medication therapy 

management (MTM) programs. 

Beginning in 2010, sponsors must offer 

an interactive, person-to-person 

comprehensive medication review 

(CMR) by a pharmacist or other 

qualified provider at least annually. A 

CMR is a review of a beneficiary’s 

medications, including prescription and 

over-the-counter (OTC) medications, 

herbal therapies, and dietary 

supplements, which is intended to aid 

in assessing medication therapy and 

optimizing patient outcomes. Sponsors 

must summarize the CMR and provide 

an individualized written or printed 

summary to the beneficiary. The burden 

associated with the time and effort 

necessary for Part D sponsors to conduct 

CMRs with written summaries was 

estimated previously under OMB 

Control Number 0938–0964 as 937,500 

hours with total labor cost of $112.5 

million. 

The Affordable Care Act (ACA) under 

Section 10328 specifies that the 

Secretary, in consultation with relevant 

stakeholders, develop a standardized 

format for the action plan and written or 

printed summary that are given to 

beneficiaries as a result of their CMRs. 

The standardized format will replace 

whatever formats Part D sponsors are 

using for their written CMR summaries 

and action plans prior to 2013. 

Beginning in January, 2013, Part D 

sponsors will collect information 

required by the new standardized 

format, and provide that information to 

Medicare beneficiaries after their CMRs 

on forms that comply with the 

requirements specified by CMS for the 

standardized format. The use of the 

standardized format will increase the 

burden associated with providing the 

CMRs with written summaries and 

action plans as described in this 

submission. The use of the standardized 

format will support a uniform and 

consistent level of MTMP 

communications with beneficiaries, 

improve the ability of beneficiaries to 

understand and manage their 

medications safely and effectively, and 

support improved healthcare outcomes 

and lower overall healthcare costs. The 

final standardized format will be posted 

in the 2013 Call Letter for 

implementation by Part D sponsors in 

January 2013. Form Number: CMS– 

10396 (OCN: 0938–New); Frequency: 

Yearly; Affected Public: Private Sector— 

Business or other For-profits; Number of 

Respondents: 673; Number of 

Responses: 1,875,000; Total Annual 

Hours: 1,179,894. (For policy questions 

regarding this collection, contact Gary 

Wirth at 410–786–3997. For all other 

issues call (410) 786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments for the proposed information 

collections must be received by the 

OMB desk officer at the address below, 

no later than 5 p.m. on October 31, 

2011. 

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Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 60845 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: September 27, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–25271 Filed 9–29–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10241, CMS– 

10412, CMS–R–263, CMS–R–262, CMS– 

10142 and CMS–855(O)] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Survey of Retail 

Prices: Payment and Utilization Rates, 

and Performance Rankings; Use: CMS 

will develop a National Average Drug 

Acquisition Cost (NADAC) for States to 

consider when developing 

reimbursement methodology. The 

NADAC is a new pricing benchmark 

that will be based on the national 

average costs that pharmacies pay to 

acquire Medicaid covered outpatient 

drugs. It is intended to provide States 

with a more accurate reference price to 

base reimbursement for prescription 

drugs and will be based on drug 

acquisition costs collected directly from 

pharmacies through a nationwide 

survey process. This survey will be 

conducted on a monthly basis to ensure 

that the NADAC reference file remains 

current and up-to-date. A NADAC 

Survey Request for Information has been 

developed to send to random 

pharmacies for voluntary completion. 

CMS proposes to add the survey to an 

existing collection, ‘‘Annual State 

Report and Annual State Performance 

Rankings.’’ The requirements and 

burden associated with the annual 

report/rankings are unaffected by this 

proposed action; Form Number: CMS– 

10241 (OCN: 0938–1041); Frequency: 

Biennially, Once; Affected Public: 

Private Sector; Business or other forprofits; Number of Respondents: 30,000; 

Total Annual Responses: 30,000; Total 

Annual Hours: 15,000. (For policy 

questions regarding this collection 

contact Lisa Ferrandi at 410–786–5445. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Section 1115 

Demonstration: Long Term Services and 

Supports and Other Service Models for 

Individuals with Disabilities and 

Chronic Conditions; Use: Section 1115 

of the Social Security Act provides the 

Secretary of Health and Human Services 

broad authority to authorize 

experimental, pilot, or demonstration 

projects likely to assist in promoting the 

objectives of the Medicaid statute. 

Flexibility under Section 1115 is 

sufficiently broad to allow states to test 

substantially new ideas of policy merit. 

States seeking interventions for 

individuals needing LTSS to lower 

costs, improve care and improve health 

can utilize the 1115 demonstration to 

test and deliver innovative services and 

approaches to better and more 

efficiently meet the needs of this 

population. Section 1115 

demonstrations provide a vehicle for 

innovations in both care delivery and 

payment methodologies. 

Demonstrations must be ‘‘budget 

neutral’’ over the life of the project, 

meaning they cannot be expected to cost 

the Federal government more than it 

would cost without the waiver. State 

Medicaid agencies are responsible for 

developing section 1115 demonstration 

applications and submitting them to 

CMS; Form Number: CMS–10412 (OCN: 

0938–New); Frequency: Once; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 2,240. (For policy 

questions regarding this collection 

contact Adrienne Delozer at 410–786– 

0278. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Site 

Investigation for Durable Medical 

Equipment (DME) Suppliers; Use: CMS 

is mandated to identify and implement 

measures to prevent fraud and abuse in 

the Medicare program. To meet this 

challenge, CMS has moved forward to 

improve the quality of the process for 

enrolling suppliers into the Medicare 

program by establishing a uniform 

application for enumerating suppliers of 

durable medical equipment, prosthetics, 

orthotics, and supplies (DMEPOS). 

Implementation of enhanced procedures 

for verifying the enrollment information 

has also improved the enrollment 

process. As part of this process, 

verification of compliance with supplier 

standards is necessary. The site 

investigation form has been used in the 

past to aid the Medicare contractor (the 

National Supplier Clearinghouse and/or 

its subcontractors) in verifying 

compliance with the required supplier 

standards found in 42 CFR 424.57(c). 

The primary function of the site 

investigation form is to provide a 

standardized, uniform tool to gather 

information from a DMEPOS supplier 

that tells us whether it meets certain 

qualifications to be a DMEPOS supplier 

(as found in 42 CFR 424.57(c)) and 

where it practices or renders its 

services. 

This site investigation form collects 

the same information as its predecessor, 

with the exception of one new yes/no 

question under the ‘‘Records and 

Telephone’’ section (question 11(a)) 

used to verify if the DMEPOS supplier 

maintains physician ordering/referring 

records for the supplies and/or services 

it renders to Medicare beneficiaries (if 

applicable). This information is required 

by Section 1833(q) of the Social Security 

Act which states that all physicians and 

non-physician practitioners that meet 

the definitions at section 1861(r) and 

1842(b)(18)(C) be uniquely identified for 

all claims for services that are ordered 

or referred. Other information collected 

on this site investigation remains 

unchanged, but has been reformatted for 

greater functionality. Form Number: 

CMS–R–263 (OCN: 0938–0749); 

Frequency: Once; Affected Public: 

Private Sector—Business or other forprofits and not-for-profit institutions; 

Number of Respondents: 30,000; Total 

Annual Responses: 30,000; Total 

Annual Hours: 15,000. (For policy 

questions regarding this collection 

contact Kimberly McPhillips at 410– 

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