[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Pages 52236-52238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24236]


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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

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

[[Page 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-for-profit 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 employer-sponsored 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-for-profit 
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-by-case 
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) in-person 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 E-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to [email protected], or call the

[[Page 52238]]

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