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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10267, CMS-10137, CMS-10237, CMS-R-240, CMS-10316 and CMS-10305]

# AGENCY:

Centers for Medicare & Medicaid Services.

In compliance with the requirement of section 3506I(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:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     QualityNet Identity Management System (QIMS) Account Form;                     *Use:*                     The QualityNet Identity Management System (QIMS) account registration form must be completed by any new persons needing access to Consolidated Renal Operations in a Web Enabled Network (CROWNWeb.) The 8,561 existing accounts owners will not have to reregister for new user accounts. The CROWNWeb user community is composed of CMS employees, ESRD Network Organization staff and dialysis facilities staff. The CROWNWeb system is the system used as the collection point of data necessary for entitlement of ESRD patients to Medicare benefits and Federal Government monitoring and assessing of quality and type of care provided to renal patients. The data collected in QIMS will provide the necessary security measures for creating and maintaining active CROWNWeb user accounts and collection of audit trail information required by the CMS Information Security Officers (ISSO).                     *Form Number:*                     CMS-10267 (OMB#: 0938-1050);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     7,439; Total                    *Annual Responses:*                     7,439;                     *Total Annual Hours:*                     3,720. (For policy questions regarding this collection contact Michelle Tucker at 410-786-0376. For all other issues call 410-786-1326.                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Application for Prescription Drug Plans (PDP); Application for Medicare Advantage Prescription Drug (MA-PD); Application for Cost Plans to Offer Qualified Prescription Drug Coverage; Application for Employer Group Waiver Plans to Offer Prescription Drug Coverage; Service Area Expansion Application for Prescription Drug Coverage;                     *Use:*                     The Applications for Part D sponsors to offer qualified prescription drug coverage are completed by entities seeking approval to offer Part D benefits under the Medicare Prescription Drug Benefit                           ( print page 57036)                        program established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D of the Social Security Act.                

Effective January 1, 2006, the Part D program established an optional prescription drug benefit for individuals who are entitled to Medicare Part A or enrolled in Part B. In general, coverage for the prescription drug benefit is provided through PDPs that offer drug-only coverage, or through MA organizations that offer integrated prescription drug and health care coverage (MA-PD plans). PDPs must offer a basic drug benefit. Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer either a basic benefit or may offer broader coverage for no additional cost. Medicare Advantage Private Fee for Service Plans (MA-PFFS) may choose to offer a Part D benefit. Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Plans may also provide a Part D benefit. If any of the contracting organizations meet basic requirements, they may also offer supplemental benefits through enhanced alternative coverage for an additional premium.

                    The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, PACE, and EGWP applicants. The collected information will be used by CMS to: (1) ensure that applicants meet CMS requirements, (2) support the determination of contract awards.                     *Form Number:*                     CMS-10137 (OMB#: 0938-0936);                     *Frequency:*                     Once;                     *Affected Public:*                     Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     295; Total                    *Annual Responses:*                     295;                     *Total Annual Hours:*                     3,576. (For policy questions regarding this collection contact Linda Anders at 410-786-0459. For all other issues call 410-786-1326.)                

                    3.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Part C Medicare Advantage Application and 1876 Cost Plan Expansion Application;                     *Use:*                     The Balanced Budget Act of 1997 (BBA) established a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act) which provided for a Medicare+Choice (M+C) program. Under section 1851(a)(1) of the Act, every individual entitled to Medicare Part A and enrolled under Part B, except for most individuals with end-stage renal disease (ESRD), could elect to receive benefits either through the Original Medicare Program or an M+C plan, if one was offered where he or she lived. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to the provisions of Medicare Part C, governing what is now called the Medicare Advantage (MA) program (formerly Medicare+Choice) Organizations wishing to provide healthcare services under MA and/or MA-PD plans must complete an application, file a bid, and receive final approval from CMS. Existing MA plans may expand their contracted area by completing the Service Area Expansion (SAE) application. Any current Cost Plan Contractor that wants to expand its Medicare cost-based contract with CMS under Section 1876 of the Act, as amended by the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) and subsequent legislation can complete the application.                     *Form Number:*                     CMS-10237 (OMB#: 0938-0935);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     870; Total                    *Annual Responses:*                     870;                     *Total Annual Hours:*                     15,696. (For policy questions regarding this collection contact Letticia Ramsey at 410-786-5262. For all other issues call 410-786-1326.)                

                    4.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Prospective Payments for Hospital Outpatient Service and Supporting Regulations is 42 CFR 413.65;                     *Use:*                     Section 1833(t) of the Social Security Act (the Act) requires the Secretary to establish a prospective payment system (PPS) for hospital outpatient services. Successful implementation of an outpatient PPS requires that CMS distinguish facilities or organizations that function as departments of hospitals from those that are freestanding, so that CMS can determine which services should be paid under the outpatient prospective payment system (OPPS), the clinical laboratory fee schedule, or other payment provisions applicable to services furnished to hospital outpatients.                

                    CMS will use the information from sections 413.65(b)(3) and (c) to determine whether a facility or organization acquired by a main provider should be treated as provider-based for Medicare certification, coverage, and payment purposes or whether a main provider has had a material change in its relationship to a provider-based facility or organization that affects the provider-based status of the facility or organization. In addition, section 1866(b)(2) of the Act authorizes hospitals and other providers to impose deductible and coinsurance charges for facility services, but does not allow such charges by facilities or organizations which are not provider-based. Implementation of this provision requires that CMS have information from the required reports, so it can determine which facilities are provider-based.                     *Form Number:*                     CMS-R-240 (OMB#: 0938-0798);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Business or other for-profits and Not-for-profit institutions;                     *Number of Respondents:*                     905;                     *Total Annual Responses:*                     500,405;                     *Total Annual Hours:*                     26,563 (For policy questions regarding this collection contact Daniel Schroder at 410-786-7452. For all other issues call 410-786-1326.)                

                    5.                     *Type of Information Collection Request:*                     New collection;                     *Title of Information Collection:*                     Medicare Prescription Drug Plan (PDP) and Medicare Advantage Prescription Drug Plan (MA-PD) Disenrollment Reasons Survey;                     *Use:*                     The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires the collection and reporting performance data for Part D prescription drug plans. Specifically, the MMA under section 1860D-4 (Beneficiary Protections for Qualified Prescription Drug Coverage) requires CMS to conduct consumer satisfaction surveys regarding PDPs and MA-PDs. CMS will use the survey to obtain information regarding beneficiaries' reasons for disenrolling from their chosen Part D plan, and their expectations relative to provided benefits and services. Determining the reasons for disenrollment from Part D plans will provide important information regarding potential dissatisfaction with some aspect of the plan, such as access, service, cost, quality of care, or the benefits provided. This information can be used by CMS to improve the design and functioning of the Part D program.                     *Form Number:*                     CMS-10316 (OMB#: 0938-New);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Individuals and households;                     *Number of Respondents:*                     120,000;                     *Total Annual Responses:*                     120,000;                     *Total Annual Hours:*                     34,800. (For policy questions regarding this collection contact Phyllis Nagy at 410-786-6646. For all other issues call 410-786-1326.)                

                    6.                     *Type of Information Collection Request:*                     New collection;                     *Title of Information Collection:*                     Medicare Part C and Part D Data Validation (42 CFR 422.516g and 423.514g);                     *Use:*                     Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to the Centers for                           ( print page 57037)                        Medicare & Medicaid Services on a variety of measures. In order for the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, CMS is developing reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards will provide a review process for Medicare Advantage Organizations (MAOs), Cost Plans, and Part D sponsors to use to conduct data validation checks on their reported Part C and Part D data.                     *Form Number:*                     CMS-10305 (OMB#: 0938-NEW);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Business or other for-profit;                     *Number of Respondents:*                     634;                     *Total Annual Responses:*                     634;                     *Total Annual Hours:*                     237,127. (For policy questions regarding this collection contact Terry Lied at 410-786-8973. 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 E-mail 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 October 18, 2010. 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 13, 2010.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2010-23160 Filed 9-16-10; 8:45 am]

BILLING CODE 4120-01-P