[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 44012-44013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10105, CMS-1561, CMS-10110, CMS-R-216 and 
CMS-10047]


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

AGENCY: 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.

[[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 http://www.cms.hhs.gov/regulations/pra/, or e-mail your 
request, including your address, phone number, OMB number, and CMS 
document identifier, to [email protected], 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.

    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.
[FR Doc. 04-16661 Filed 7-22-04; 8:45 am]
BILLING CODE 4120-03-P