CMS-10294.Appendix B (8-23-10)

APPENDIX B
FEDERAL REGISTER NOTICE

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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,

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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]
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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
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
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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

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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

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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

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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
[email protected], or call the

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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]
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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
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

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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
[email protected], 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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
[email protected].

Proposed Project

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]

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

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Agency for Healthcare Research and
Quality Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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 [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

‘‘Medical Expenditure Panel Survey
(MEPS) Household Component and the
MEPS Medical Provider Component
Through 2012’’

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