[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Notices]
[Page 34468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12054]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-290, CMS-10221, and CMS-2728]


Agency Information Collection Activities: Submission for OMB 
Review; 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), 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 function; (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: Medicare Program: 
Process for Making National Coverage Determinations; Form Number: CMS-
R-290 (OMB: 0938-0776); Use: On September 26, 2003 (68 FR 
55634), we published a notice that described how we revised the process 
we use to make Medicare coverage decisions including decisions 
regarding whether new technology and services can be covered. In 
accordance with section IV.B of the aforementioned notice, CMS' Revised 
Process for Making National Coverage Determinations, we require an 
individual or entity to make a formal request for a national coverage 
determination. Upon receipt of a formal request and adequate supporting 
documentation, we will make a determination based on the evidence 
presented, to cover the device or service or not to cover the device or 
service where it is not supported by the medical evidence. We are 
resubmitting this information collection request (ICR) to the Office of 
Management and Budget as an extension of the currently approved 
collection. We have not made any material modifications to the ICR 
since the last submission. Frequency: Recordkeeping and Reporting--On 
occasion; Affected Public: Business or other-for-profit, Not-for-profit 
institutions; Number of Respondents: 200; Total Annual Responses: 200; 
Total Annual Hours: 8,000.
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Worksheet for Recording Results of Medicare 
Site Visits of Independent Diagnostic Testing Facilities (IDTFs) Form; 
Form Number: CMS-10221 (OMB: 0938-New); Use: Prior to 
enrolling in Medicare, independent diagnostic testing facilities 
(IDTFs) must undergo a site visit as required under 42 CFR 410.33. The 
purpose of the site visit is to ensure that the IDTF is in compliance 
with the provisions of 42 CFR 410.33, as well as all other applicable 
Federal, State and local laws and regulations. It is also used to 
verify the information the IDTF furnished on its CMS-855B enrollment 
application.
    Section 410.33 contains a significant number of standards that 
IDTFs must meet in order to enroll in Medicare. Compliance with the 
standards further ensures that only qualified and legitimate IDTFs can 
bill Medicare. This is especially important in light of concerns about 
recent fraudulent activity by some IDTFs. We are submitting the 
``Worksheet for Recording Results of Medicare Site Visits of 
Independent Diagnostic Testing Facilities (IDTFs),'' for OMB approval. 
The purpose of this document is to ensure that the individuals 
performing IDTF site visits take into account both new and existing 
IDTF standards in a consistent fashion. Frequency: Reporting--On 
occasion; Affected Public: Business or other-for-profit, Not-for-profit 
institutions; Number of Respondents: 2,000; Total Annual Responses: 
2,000; Total Annual Hours: 4,000.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: End Stage Renal 
Disease Medical Evidence Report Medicare Entitlement and/or Patient 
Registration; Form Number: CMS-2728 (OMB: 0938-0046); Use: The 
End Stage Renal Disease Medical Evidence (CMS-2728) is completed for 
all ESRD patients either by the first treatment facility or by a 
Medicare-approved ESRD facility when it is determined by a physician 
that the patient's condition has reached that stage of renal impairment 
that a regular course of kidney dialysis or a kidney transplant is 
necessary to maintain life.
    The data reported on the CMS-2728 is used by the Federal 
Government, ESRD Networks, treatment facilities, researchers and others 
to monitor and assess the quality and type of care provided to end 
stage renal beneficiaries. The data collection captures the specific 
medical information required to determine the Medicare medical 
eligibility of End Stage Renal Disease claimants. It also collects data 
for research and policy on this population. Frequency: Reporting--Once; 
Affected Public: Individuals or households, Business or other-for-
profit, Not-for-profit institutions; Number of Respondents: 100,000; 
Total Annual Responses: 100,000; Total Annual Hours: 75,000.
    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/PaperworkReductionActof1995, 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 or faxed within 30 days of this notice 
directly to the OMB desk officer: OMB Human Resources and Housing 
Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 
10235, Washington, DC 20503, Fax Number: (202) 395-6974.

    Dated: June 14, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E7-12054 Filed 6-21-07; 8:45 am]
BILLING CODE 4120-01-P