[Federal Register: May 14, 2004 (Volume 69, Number 94)]
[Notices]
[Page 26841-26842]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my04-49]
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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 Paperwork@hcfa.gov, 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