[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36099-36100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10199, CMS-R-247, and CMS-R-38]


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) 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: Data Collection for Medicare Facilities 
Performing Carotid Artery Stenting with Embolic Protection in Patients 
at High Risk for Carotid Endarterectomy; Use: CMS provides coverage for 
carotid artery stenting (CAS) with embolic protection for patients at 
high risk for carotid endarterectomy and who also have symptomatic 
carotid artery stenosis between 50% and 70% or have asymptomatic 
carotid artery stenosis >= 80% in accordance with the Category B IDE 
clinical trials regulation (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1, or in accordance with 
the National Coverage Determination on CAS post approval studies 
(Medicare NCD Manual 20.7). Accordingly, CMS considers coverage for CAS 
reasonable and necessary {section 1862 (A)(1)(a) of the Social Security 
Act{time} . However, evidence for use of CAS with embolic protection 
for patients at high risk for carotid endarterectomy and who also have 
symptomatic carotid artery stenosis >= 70% who are not enrolled in a 
study or trial is less compelling. To encourage responsible and 
appropriate use of CAS with embolic protection, CMS issued a Decision 
Memo for Carotid Artery Stenting on March 17, 2005, indicating that CAS 
with embolic protection for patients at high risk for carotid 
endarterectomy and who also have symptomatic carotid artery stenosis >= 
70% will be covered only if performed in facilities that have been 
determined to be competent. In accordance with this criteria CMS 
considers coverage for CAS reasonable and necessary {section 
1862(A)(1)(a) of the Social Security Act{time} . Form Number: CMS-10199 
(OMB: 0938-NEW); Frequency: Reporting--On occasion; Affected 
Public: Business or other for-profit, Not-for-profit institutions; 
Number of Respondents: 1,000; Total Annual Responses: 1,000; Total 
Annual Hours: 500.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Expanded Coverage 
for Diabetes Outpatient Self-Management Training Services and 
Supporting Regulations Contained in 42 CFR 410.141, 410.142, 410.143, 
410.144, 410.145, 410.146, 414.63; Use: According to the National 
Health and Nutrition Examination Survey (NHANES), as many as 18.7 
percent of Americans over age 65 are at risk for developing diabetes. 
The goals in the management of diabetes are to achieve normal metabolic 
control and reduce the risk of micro- and macro-vascular complications. 
Numerous epidemiologic and interventional studies point to the 
necessity of maintaining good glycemic control to reduce the risk of 
the complications of diabetes. In expanding the Medicare program to 
include diabetes outpatient self-management training services, the 
Congress intended to empower Medicare beneficiaries with diabetes to 
better manage and control their conditions. The Conference Report 
indicates that the conferees believed that ``this provision will 
provide significant Medicare savings over time due to reduced 
hospitalizations and complications arising from diabetes.'' (H.R. Conf. 
Rep. No. 105-217, at 701 (1997)). Form Number: CMS-R-247 (OMB: 
0938-0818); Frequency: Recordkeeping and Reporting--On occasion; 
Affected Public: Business or other for-profit institutions; Number of 
Respondents: 2,008; Total Annual Responses: 8,032; Total Annual Hours: 
88,519.
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Conditions of 
Certification for Rural Health Clinics and Supporting Regulations in 42 
CFR 491.9, 491.10, 491.11; Use: The Rural Health Clinic (RHC) 
conditions of participation are based on criteria prescribed in law and 
are designed to ensure that each facility has a properly trained staff 
to provide appropriate care and to assure a safe physical environment 
for patients. The Centers for Medicare and Medicaid Services (CMS) uses 
these conditions of participation to certify RHCs wishing to 
participate in the Medicare program. These requirements are similar in 
intent to standards developed by industry organizations such as the 
Joint Commission on Accreditation of Hospitals, and the National League 
of Nursing/American Public Association and merely reflect accepted 
standards of management and care to which rural health clinics must 
adhere. Form Number: CMS-R-38 (OMB: 0938-0334); Frequency: 
Recordkeeping and Reporting--Annually and upon initial application for 
Medicare approval; Affected Public: Business or other for-profit and 
Not-for-profit institutions; Number of Respondents: 3,674; Total

[[Page 36100]]

Annual Responses: 3,674; Total Annual Hours: 8,816.
    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 August 22, 2006.
    CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development--B, Attention: William N. Parham, 
III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.

    Dated: June 14, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E6-9842 Filed 6-22-06; 8:45 am]
BILLING CODE 4120-01-P