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Agency Information Collection Activities: Submission for OMB Review; Comment Request

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Centers for Medicare and 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 and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration (HCFA), 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 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: New collection; Title of Information Collection: In-Center Hemodialysis CAHPS Survey (Note: Significant modifications were made to this information collection since the publication of the 60-day FR notice. The title of this information collection was also changed from End Stage Renal Disease Hemodialysis Patient Experience of Care (CAHPS) Survey since its publication.; Form No.: CMS-10105 (OMB #0938-NEW; Use: The In-Center Hemodialysis CAHPS Survey follows CMS CAHPS efforts in other provider areas (Managed Care, FFS, hospital), and is intended to provide CMS with a picture of the experience of this vulnerable population who receive life sustaining dialysis therapy approximately three times per week from dialysis facilities. A variety of patient satisfaction surveys are already conducted regularly by a many dialysis organizations (although the majority of instruments have not been tested) and this tool would provide the ESRD community with a tested, standardized survey instrument that facilities could use for quality improvement and comparative purposes. It will provide information for consumer choice, data that facilities can use for internal quality improvement and external benchmarking against other facilities, and finally, information that CMS can use for public reporting and monitoring purposes.; Frequency: Recordkeeping; Affected Public: Individuals or Households; Number of Respondents: 3,000; Total Annual Responses: 3,000; Total Annual Hours: 1,500.

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Health Insurance Benefit Agreement and Supporting Regulations in 42 CFR Section 489 and 491; Form No.: CMS-1561 (OMB #0938-0832); Use: Applicants to the Medicare program are required to agree to provide services in accordance with Federal requirements. The CMS-1561 and CMS-1561A are essential for CMS to ensure that applicants are in compliance with the requirements. Applicants are required to sign the completed forms and provide operational information to CMS to assure that they continue to meet the requirements after approval; Frequency: Other: as needed; Affected Public: Business or other for-profit, Not-for-profit institutions, and State, Local or Tribal Government; Number of Respondents: 3,300; Total Annual Responses: 3,300; Total Annual Hours: 175.

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) data for Medicare Part B Drugs and Biologicals and Supporting Regulations; Form No.: CMS-10110 (OMB #0938-0921); Use: This information collection implements the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 that require instructions to manufacturers on the submission of average sales price (ASP) data on Medicare Part B drugs to the Centers for Medicare and Medicaid Services (CMS). This form is the tool used by manufacturers to submit the required data.; Frequency: Quarterly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 120; Total Annual Responses: 480; Total Annual Hours: 15,360.

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Procedures for Advisory Opinions Concerning Physician Referrals and Supporting Regulations in 42 CFR Sections 411.370 through 411.389; Form No.: CMS-R-216 (OMB #0938-0714); Use: A request must include a complete description of the situation that is subject of the advisory opinion and must include copies of all relevant documents (or relevant portions), such as financial statements, contracts, leases, employment agreements and court documents. The submission must include the identities and addresses of all known actual and potential parties to the arrangement. A request for an advisory opinion is purely voluntary. The facts will relate to business plans and the requestor will already have collected and analyzed all or most of the information we will need to review the request; Frequency: On occasion; Affected Public: Not-for-profit institutions, Individuals or Households, and Business or other for-profit; Number or Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 2,000. Start Printed Page 44013

5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships and Supporting Regulations in 42 CFR, Sections 411.352 through 411.361; Form No.: CMS-10047 (OMB #0938-0846); Use: The final rule (HCFA-1809) incorporated into regulations the provisions in paragraphs (a), (b), (c), (d), and (h) of section 1877 of the Social Security Act. Under section 1877, if a physician or a member of a physician's immediate family has a financial relationship with a health care entity, the physician may not refer Medicare patients to that entity for the furnishing of 11 designated health services, unless an exception applies. In addition, section 1877 prohibits an entity from presenting or causing to be presented a Medicare claim or bill to any individual, third party payer, or other entity for designated health services furnished under a prohibited referral. Also, Medicare does not pay for a designated health service furnished under a prohibited referral.; Frequency: Annually and Other: whenever financial arrangements between entities that furnish designated health services and physicians change.; Affected Public: Business or other for-profit, Not-for-profit institutions, and Individuals or Households; Number or Respondents: 62,824; Total Annual Responses: 62,824; Total Annual Hours: 1,561,633.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at​regulations/​pra/​, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to, or call the Reports Clearance Office on (410) 786-1326. Written comments and recommendations for the proposed information collections must be mailed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Christopher Martin, New Executive Office Building, Room 10235, Washington, DC 20503.

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Dated: July 14, 2004.

John P. Burke, III,

Paperwork Reduction Act Team Leader, CMS Reports Clearance Officer, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances.

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[FR Doc. 04-16661 Filed 7-22-04; 8:45 am]