[Federal Register Volume 69, Number 94 (Friday, May 14, 2004)]
[Notices]
[Pages 26841-26842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10989]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10110, CMS-102-105, CMS-R-216, CMS-10047 and 
CMS-18F5]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & 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 & 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;

[[Page 26842]]

(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: 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.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: CLIA Budget 
Workload Reports and Supporting Regulations Contained in 42 CFR 
493.1-.2001; Form No.: CMS-102-105 (OMB 0938-0599); Use: 
Information collected will be used by CMS in determining the amount of 
Federal Reimbursement for compliance surveys. Use of the information 
includes program evaluation, audit, budget formulation and budget 
approval; Frequency: Quarterly and Annually; Affected Public: State, 
Local, or Tribal Government; Number of Respondents: 50; Total Annual 
Responses: 50; Total Annual Hours: 4,500.
    3. 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.
    4. 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.
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Application for 
Hospital Insurance and Supporting Regulations in 42 CFR 406.7; Form 
No.: CMS-18F5 (OMB 0938-0251); Use: The CMS-18F5 is used to 
establish entitlement to Hospital Insurance and Supplementary Medical 
Insurance for beneficiaries entitled under Title XVIII of the Social 
Security Act. The HCFA-18F5-SP is included in this renewal. (The Agency 
name change on the Spanish language form has not been done because 
there is still stock on hand.); Frequency: On occasion; Affected 
Public: Individuals or Households, Business or other for-profit, Not-
for-profit institutions, Farms, Federal Government, and State, Local or 
Tribal Gov.; Number or Respondents: 50,000; Total Annual Responses: 
50,000; Total Annual Hours: 12,500.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS's 
Web Site address at http://cms.hhs.gov/regulations/pra/default.asp, 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 60 days of this notice directly to the CMS Paperwork Clearance 
Officer designated at the following address: CMS, Office of Strategic 
Operations and Regulatory Affairs, Division of Regulations Development 
and Issuances, Attention: Melissa Musotto, Room C5-14-03, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850.

    Dated: May 6, 2004.
John P. Burke, III,
Paperwork Reduction Act Team Leader, Office of Strategic Operations and 
Strategic Affairs, Division of Regulations Development and Issuances.
[FR Doc. 04-10989 Filed 5-13-04; 8:45 am]
BILLING CODE 4120-03-P