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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:

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                               ( print 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                         *Paperwork@cms.hhs.gov,*                         or call the                               ( print 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