[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44012-44013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-70]
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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 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 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