Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

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

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

          - [Document Identifier: CMS-10001, CMS-10009, CMS-10167, and CMS-10062]

# 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:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     HIPAA Nondiscrimination Provisions (Regulation HCFA 2022-IFC);                     *Form                               ( print page 72304)                            Number:*                     CMS-10001 (OMB#: 0938-827);                     *Use:*                     The provisions of Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are designed to make it easier for people to access health care coverage; to reduce the limitations that can be put on the coverage; and to make it more difficult for issuers to terminate the coverage. Title I provisions are divided into group and individual market protections. The group provisions apply to employment-related group health plans and to the issuers who sell insurance in connection with group health plans. Section 2702 of the Public Health Service Act (PHS Act) (the HIPAA nondiscrimination provisions) establish rules generally prohibiting group health plans and group health insurance issuers from discriminating against individual participants or beneficiaries based on any health factor of such participants or beneficiaries.;                     *Frequency:*                     Third party disclosure, Reporting—Annually;                     *Affected Public:*                     Business or other-for-profit, Individuals or Households, Not-for-profit institutions, Federal government, and State, Local, or Tribal Government;                     *Number of Respondents:*                     18;                     *Total Annual Responses:*                     18;                     *Total Annual Hours:*                     194.                

                    2.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     HIPAA Nondiscrimination Provisions (Regulation HCFA 2078-P);                     *Form Number:*                     CMS-10009 (OMB#: 0938-819);                     *Use:*                     The provisions of Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are designed to make it easier for people to access health care coverage, to reduce the limitations that can be put on the coverage, and to make it more difficult for issuers to terminate the coverage. Title I provisions are divided into group and individual market protections. The group provisions apply to employment-related group health plans and to the issuers who sell insurance in connection with group health plans. Section 2702 of the Public Health Service Act (PHS Act—the HIPAA nondiscrimination provisions) establish rules generally prohibiting group health plans and group health insurance issuers from discriminating against individual participants or beneficiaries based on any health factor of such participants or beneficiaries.;                     *Frequency:*                     Third party disclosure, Reporting—Annually;                     *Affected Public:*                     Business or other-for-profit, Individuals or Households, Not-for-profit institutions, Federal government, and State, Local, or Tribal Government;                     *Number of Respondents:*                     2600;                     *Total Annual Responses:*                     2600;                     *Total Annual Hours:*                     100.                

                    3.                     *Type of Information Collection Request:*                     New collection;                     *Title of Information Collection:*                     Competitive Acquisition Program (CAP) for Medicare Part B Drugs: CAP Physician Election Agreement;                     *Form Number:*                     CMS-10167 (OMB#: 0938-NEW);                     *Use:*                     Beginning in 2006, physicians will have a choice between acquiring and billing for Part B covered drugs under the Average Sales Price (ASP) drug payment methodology or electing to receive these drugs from vendors/suppliers selected for the CAP through a competitive bidding process. The provisions for this new payment system are described in the proposed rule entitled, “Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B,” that published March 4, 2005 (70 FR 10746), the interim final rule entitled, “Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B,” that published July 6, 2005 (70 FR 39022), and the final rule entitled, “Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006,” that published on November 21, 2005. Competitive bidding is seen as a means of using the dynamics of the marketplace to provide incentives for suppliers to provide reasonably priced products and services of high quality in an efficient manner. The CAP's objectives include the following: 1) to provide an alternative method for physicians to obtain Part B drugs to administer to Medicare beneficiaries; and 2) to reduce drug acquisition and billing burdens for physicians;                     *Frequency:*                     Reporting—Annually;                     *Affected Public:*                     Business or other-for-profit;                     *Number of Respondents:*                     10,000;                     *Total Annual Responses:*                     10,000;                     *Total Annual Hours:*                     20,000.                

                    4.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Collection of Diagnostic Data from Medicare Advantage Organizations for Risk Adjusted Payments Supporting Regulations 42 CFR Part 422 Subparts F and G and 42 CFR Part 423 Subparts F and G;                     *Form Number:*                     CMS-10062 (OMB#: 0938-0878);                     *Use:*                     Under the Medicare Prescription Drug Benefit, Improvement and Modernization Act of 2003 (MMA), the Congress restructured the M+C program into the Medicare Advantage (MA) program, Part C, and added an outpatient prescription drug benefit, Part D. In accordance with mandates in these laws, the Secretary of the Department of Health and Human Services must implement health status risk adjustment, a payment methodology for Parts C and D that takes into account the health status of plan enrollees. CMS collects inpatient and outpatient data. Part C data is collected using the CMS-HCC (hierarchical condition category) model. Part D data will be collected using the CMS Rx-HCC model. The Rx-HCC model is different from the CMS-HCC model primarily in that it predicts plan liability for drug costs instead of medical/surgical costs for service under Parts A and B. CMS will use the data to make risk adjusted payment under Parts C and D. MA plans, Medicare Advantage Prescription Drug (MA-PD) plans, and stand-alone Prescription Drug Plans (PDP's) will use the data to develop their Parts C and D bids.;                     *Frequency:*                     Reporting—Quarterly;                     *Affected Public:*                     Business or other-for-profit and Not-for-profit institutions;                     *Number of Respondents:*                     505;                     *Total Annual Responses:*                     14,091,370;                     *Total Annual Hours:*                     8,351.                

                    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/​regulations/​pra/​*, 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 at the address below, no later than 5 p.m. on January 31, 2006.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: November 17, 2005.

Michelle Shortt,

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

[FR Doc. 05-23414 Filed 12-01-05; 8:45 am]

BILLING CODE 4120-01-P