52236 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 

its oversight review, ORI found that 

Norma Couvertier, former Research 

Assistant II, APT Foundation in New 

Haven, Connecticut, engaged in research 

misconduct in research supported by 

National Institute of Drug Abuse 

(NIDA), National Institutes of Health 

(NIH), award R37 DA015969. 

Specifically, ORI found that Ms. 

Couvertier engaged in research 

misconduct by falsifying and fabricating 

data that were reported on Participant 

Urine Monitoring and Breathalyzer 

Result Forms (CRFs) completed by the 

Respondent for thirty two (32) of the 

enrolled study participants in the 

computer Based Training in Cognitive 

Behavioral Therapy (CBT4CBT) research 

study. A total of 253 alcohol 

breathalyzer (BALS) results were 

recorded for the 32 participants as being 

0.000 indicating no alcohol detected, 

rather than the code 999 used when no 

breathalyzer test was done. 

ORI also found that Ms. Couvetier, on 

253 occasions, with 32 different study 

participants, falsified alcohol 

breathalyzer test results and knowingly 

and consistently entered a false negative 

test (indicated by 0.000) rather than 

identifying the result as a missing data 

collection (indicated by code 999). 

ORI acknowledges Ms. Couvetier’s 

verbal admissions and willingness to 

cooperate and assist during the APT 

Foundation’s investigation. 

Ms. Couvertier has entered into a 

Voluntary Settlement Agreement in 

which she has voluntarily agreed, for a 

period of three (3) years, beginning on 

September 18, 2009: 

(1) To exclude herself from serving in 

any advisory capacity to the U.S. Public 

Health Service (PHS), including but not 

limited to service on any PHS advisory 

committee, board, and/or peer review 

committee, or as a consultant; 

(2) that any institution that submits an 

application for PHS support for a 

research project on which the 

Respondent’s participation is proposed 

or that uses her in any capacity on PHSsupported research or that submits a 

report of PHS-funded research in which 

she is involved must concurrently 

submit a plan for supervision of her 

duties to ORI. The supervisory plan 

must be designed to ensure the integrity 

of her research contribution. 

Respondent agreed that she will not 

participate in any PHS-supported 

research until such a supervisory plan is 

approved by ORI. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852. (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. E9–24392 Filed 10–8–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10142, CMS–R– 

262, CMS–10300, CMS–10298 and CMS– 

10294] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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: CY 2011 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans are required to 

submit an actuarial pricing ‘‘bid’’ for 

each plan offered to Medicare 

beneficiaries for approval CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. 

CMS reviews and analyzes the 

information provided on the Bid Pricing 

Tool. Ultimately, CMS decides whether 

to approve the plan pricing (i.e., 

payment and premium) proposed by 

each organization. Refer to the 

supporting document attachment ‘‘C’’ 

for a list of changes. Form Number: 

CMS–10142 (OMB#: 0938–0944); 

Frequency: Reporting—Yearly; Affected 

Public: Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 550; Total Annual 

Responses: 6,050; Total Annual Hours: 

42,350. (For policy questions regarding 

this collection contact Diane Spitalnic at 

410–786–5745. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2011 Plan 

Benefit Package (PBP) Software and 

Formulary Submission Use: Under the 

Medicare Modernization Act (MMA), 

Medicare Advantage (MA) and 

Prescription Drug Plan (PDP) 

organizations are required to submit 

plan benefit packages for all Medicare 

beneficiaries residing in their service 

area. The plan benefit package 

submission consists of the PBP software, 

formulary file, and supporting 

documentation, as necessary. MA and 

PDP organizations use the PBP software 

to describe their organization’s plan 

benefit packages, including information 

on premiums, cost sharing, 

authorization rules, and supplemental 

benefits. They also generate a formulary 

to describe their list of drugs, including 

information on prior authorization, step 

therapy, tiering, and quantity limits. 

Additionally, CMS uses the PBP and 

formulary data to review and approve 

the plan benefit packages proposed by 

each MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. Based on 

operational changes and policy 

clarifications to the Medicare program 

and continued input and feedback by 

the industry, CMS has made the 

necessary changes to the plan benefit 

package submission. Refer to the 

supporting document ‘‘Appendix B’’ for 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 52237 

a list of changes. Form Number: CMS– 

R–262 (OMB#: 0938–0763); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profit and not-forprofit institutions; Number of 

Respondents: 475; Total Annual 

Responses: 4988; Total Annual Hours: 

12,113. (For policy questions regarding 

this collection contact Sara Walters at 

410–786–3330. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: State Plan 

Amendment Templates for Additional 

State Plan Option for Providing 

Premium Assistance under Title XIX 

and XXI; Use: Section 301 of the 

Children’s Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA), 

Public Law 111–3, adds Section 

2105(c)(10) of the Social Security Act 

effective April 1, 2009, to offer States a 

new option to provide premium 

assistance subsidies to enroll targeted 

low-income individuals under age 19, 

and their parents in qualified employersponsored coverage. To elect this 

option, a State Children’s Health 

Insurance Program agency will complete 

the template pages and submit it for 

approval as part of a State plan 

amendment. Form Number: CMS–10300 

(OMB#: 0938–New); Frequency: 

Reporting—Once and On occasion; 

Affected Public: State, Local or Tribal 

Government; Number of Respondents: 

51; Total Annual Responses: 51; Total 

Annual Hours: 255. (For policy 

questions regarding this collection 

contact Stacey Green at 410–786–6102. 

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

4. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Data Collection 

For Developing Outpatient Therapy 

Payment Alternatives (DOTPA) ; Use: In 

Section 545 of the Benefits 

Improvement and Protection Act (BIPA) 

of 2000, the Congress required the 

Secretary of the Department of Health 

and Human Services to report on the 

development of standardized 

assessment instruments for outpatient 

therapy. Currently, CMS does not 

collect these data. The purposes of this 

project are to identify, collect, and 

analyze therapy-related information tied 

to beneficiary need and the effectiveness 

of outpatient therapy services that is 

currently unavailable to CMS. The 

ultimate goal is to develop payment 

method alternatives to the current 

financial cap on Medicare outpatient 

therapy services. Form Number: CMS– 

10298 (OMB#: 0938–New); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profit and not-forprofit institutions; Number of 

Respondents: 190; Total Annual 

Responses: 38,632; Total Annual Hours: 

13,658. (For policy questions regarding 

this collection contact David Bott at 

410–786–0249. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Program 

Evaluation of the Eighth and Ninth 

Scope of Work Quality Improvement 

Organization Program; Use: The 

statutory authority for the Quality 

Improvement Organization (QIO) 

Program is found in Part B of Title XI 

of the Social Security Act, as amended 

by the Peer Review Improvement Act of 

1982. The Social Security Act 

established the Utilization and Quality 

Control Peer Review Organization 

Program, now known as the QIO 

Program. The statutory mission of the 

QIO Program, as set forth in Title 

XVIII—Health Insurance for the Aged 

and Disabled, Section 1862(g) of the 

Social Security Act—is to improve the 

effectiveness, efficiency, economy, and 

quality of services delivered to Medicare 

beneficiaries. The quality strategies of 

the Medicare QIO Program are carried 

out by specific QIO contractors working 

with health care providers in their state, 

territory, or the District of Columbia. 

The QIO contract contains a number of 

quality improvement initiatives that are 

authorized by various provisions in the 

Act. As a general matter, Section 1862(g) 

of the Act mandates that the secretary 

enter into contracts with QIOs for the 

purpose of determining that Medicare 

services are reasonable and medically 

necessary and for the purposes of 

promoting the effective, efficient, and 

economical delivery of health care 

services and of promoting the quality of 

the type of services for which payment 

may be made under Medicare. CMS 

interprets the term ‘‘promoting the 

quality of services’’ to involve more 

than QIOs reviewing care on a case-bycase basis, but to include a broad range 

of proactive initiatives that will promote 

higher quality. CMS has, for example, 

included in the SOW tasks in which the 

QIO will provide technical assistance to 

Medicare-participating providers and 

practitioners in order to help them 

improve the quality of the care they 

furnish to Medicare beneficiaries. 

Additional authority for these activities 

appears in Section 1154(a)(8) of the Act, 

which requires that QIOs perform such 

duties and functions, assume such 

responsibilities, and comply with such 

other requirements as may be required 

by the Medicare statute. CMS regards 

survey activities as appropriate if they 

will directly benefit Medicare 

beneficiaries. In addition, Section 

1154(a)(10) of the Act specifically 

requires that the QIOs ‘‘coordinate 

activities, including information 

exchanges, which are consistent with 

economical and efficient operation of 

programs among appropriate public and 

private agencies or organizations, 

including other public or private review 

organizations as may be appropriate.’’ 

CMS regards this as specific authority 

for QIOs to coordinate and operate a 

broad range of collaborative and 

community activities among private and 

public entities, as long as the predicted 

outcome will directly benefit the 

Medicare program. 

The purpose of the study is to design 

and conduct an analysis evaluating the 

impact on national and regional health 

care processes and outcomes of the 

Ninth Scope of Work QIO Program. The 

QIO Program is national in scope and 

scale and affects the quality of 

healthcare of 43 million elderly and 

disabled Americans. CMS will conduct 

an impact and process analysis using 

data from multiple sources: (1) Primary 

data collected via in-depth interviews, 

focus groups, and surveys of QIOs, 

health care providers, and other 

stakeholders; (2) secondary data 

reported by QIOs through CMS systems; 

and (3) CMS administrative data. The 

findings will be presented in a final 

report as well as in other documents 

and reports suitable for publication in 

peer-review journals. This request 

relates to the following data collections: 

(1) Survey of QIO directors and theme 

leaders; (2) Survey of hospital QI 

directors and nursing home 

administrators; (3) focus groups with 

Medicare beneficiaries; and (4) inperson and telephone discussions with 

QIO staff, partner organizations, health 

care providers, and community health 

leaders. Form Number: CMS–10294 

(OMB# 0938–New); Frequency: 

Occasionally; Affected Public: Business 

or other for-profits, and Medicare 

beneficiaries; Number of Respondents: 

3,343; Total Annual Responses: 3,343; 

Total Annual Hours: 1,707. (For policy 

questions regarding this collection 

contact Robert Kambic at 410–786– 

1515. 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 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

52238 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by December 8, 2009: 

1. Electronically. You may submit 

your comments electronically to 

http://www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: October 1, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–24236 Filed 10–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10287] 

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: New collection; Title of 

Information Collection: Medicare 

Quality of Care Complaint Form; Use: In 

accordance with section 1154(a)(14) of 

the Social Security Act, Quality 

Improvement Organizations (QIOs) are 

required to conduct appropriate reviews 

of all written complaints submitted by 

beneficiaries concerning the quality of 

care received. The Medicare Quality of 

Care Complaint Form will be used by 

Medicare beneficiaries to submit quality 

of care complaints. This form will 

establish a standard form for all 

beneficiaries to utilize and ensure 

pertinent information is obtained by 

QIOs to effectively process these 

complaints. Form Number: CMS–10287 

(OMB#: 0938–New); Frequency: 

Reporting—On occasion; Affected 

Public: Individuals or Households; 

Number of Respondents: 3,500; Total 

Annual Responses: 3,500; Total Annual 

Hours: 583. (For policy questions 

regarding this collection contact Tom 

Kessler at 410–786–1991. 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 and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 9, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: October 1, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–24233 Filed 10–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (0MB) approve the proposed 

information collection project: ‘‘Medical 

Expenditure Panel Survey (MEPS) 

Household Component and the MEPS 

Medical Provider Component through 

2012.’’ In accordance with the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 

3506(c)(2)(A)), AHRQ invites the public 

to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on May 6, 2009 and allowed 60 

days for public comment. No comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. 

DATES: Comments on this notice must be 

received by November 9, 2009. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by email at OIRA_submissionomb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Medical Expenditure Panel Survey 

(MEPS) Household Component and the 

MEPS Medical Provider Component 

Through 2012’’ 

AHRQ seeks to renew the Medical 

Expenditure Panel Survey Household 

Component (MEPS–HC) and the MEPS 

Medical Provider Component (MEPS– 

MPC) through the year 2012. For over 

thirty years, the results of the MEPS and 

its predecessor surveys (the 1977 

National Medical Care Expenditure 

Survey, the 1980 National Medical Care 

Utilization and Expenditure Survey and 

mstockstill on DSKH9S0YB1PROD with NOTICES