[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Notices]
[Page 36099-36100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-53]
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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 Paperwork@cms.hhs.gov, 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