[Federal Register Volume 72, Number 71 (Friday, April 13, 2007)]
[Notices]
[Pages 18658-18659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10227, CMS-1561 and 1561A, CMS-2728, CMS-
10221, CMS-R-290, and CMS-R-26]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.
    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) 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: Existing collection in 
use without an OMB Control Number; Title of Information Collection: 
PACE State Plan Amendment Pre-print; Form Number: CMS-10227 
(OMB: 0938-New); Use: The Balanced Budget Act of 1997 created 
section 1934 of the Social Security Act that established the Program 
for the All-Inclusive Care for the Elderly (PACE). The legislation 
established the PACE program as a Medicaid State plan option serving 
the frail and elderly in the home and community. In accordance with the 
rule published in the November 24, 1999 Federal Register (64 FR 66271), 
if a State elects to offer PACE as an optional Medicaid benefit, it 
must complete a State Plan Amendment described as Enclosures 
3, 4, 5, 6 and 7. In State Medicaid Director letters dated 
March 23, 1998 and November 9, 2000, CMS advised States that it had 
provided a suggested pre-print and supplemental pages for a State to 
express its intention to elect PACE as an option to its State plans. As 
pre-print packet Enclosures 3-7 were suggested and not 
required, CMS did not believe at the time that a suggested form 
required clearance from OMB. The PACE regulation 42 CFR part 460 was 
first published in the Federal Register as an interim final rule on 
November 24, 1999. The final PACE rule was published on December 8, 
2006. CMS is seeking OMB approval to use Enclosures 3, 4, 5, 6 
and 7. The information is used by CMS to affirm that the State elects 
to offer PACE an optional State plan service and the specifications of 
eligibility, payment and enrollment for the program; Frequency: 
Reporting--Once; Affected Public: State, Local or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 56 possible 
responses but we have only received 20 thus far; Total Annual Hours: 
1,120.
    2. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Health Insurance Benefit Agreement and Supporting Regulations at 42 CFR 
489; Form Numbers: CMS-1561 and 1561A (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 
1561A are essential for CMS to ensure that applicants are in compliance 
with the requirements. Applicants will be required to sign the 
completed form and provide operational information to CMS to assure 
that they continue to meet the requirements after approval; Frequency: 
Reporting--Other: all new applicants must complete; Affected Public: 
State, Local or Tribal Governments, Business or Other for profit and 
Not-for-profit institutions; Number of Respondents: 3300; Total

[[Page 18659]]

Annual Responses: 3300; Total Annual Hours: 275.
    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.
    4. 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.
    5. 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.
    6. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Information Collection Requirements (ICRs) Contained in the Clinical 
Laboratory Improvement Amendments (CLIA) Regulations 42 CFR part 
493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 
493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493.1252, 439.1253, 
493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 
493.1273, 493.1274, 493.1278, 493.1283, 493.1289, 493.1291, and 
493.1299; Form Numbers: CMS-R-26 (OMB: 0938-0612); Use: The 
ICRs referenced in 42 CFR part 493 outline the requirements necessary 
to determine an entity's complicance with CLIA. CLIA requires 
laboratories that perform testing on human beings to meet performance 
requirements (quality standards) in order to be certified by the 
Department of Health and Human Services (HHS). HHS conducts inspections 
to determine a laboratory's compliance with CLIA requirements. CLIA 
implements the certificate, laboratory standards and inspection 
requirements; Frequency: Reporting--As needed; Affected Public: State, 
Local or Tribal Governments, Federal Government, Business or Other for 
profit and Not-for-profit institutions; Number of Respondents: 168,688; 
Total Annual Responses: 756,241; Total Annual Hours: 11,363,680.
    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.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received at the address below, 
no later than 5 p.m. on June 12, 2007.
    CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development--A, Attention: Melissa Musotto, 
Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    Dated: April 6, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E7-6990 Filed 4-12-07; 8:45 am]
BILLING CODE 4120-01-P