[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56710-56711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22329]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10199 and CMS-10266]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

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

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the 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.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by October 15, 2013:

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs Attention: CMS Desk 
Officer Fax Number: (202) 395-6974 OR Email: OIRA_submission@omb.eop.gov To obtain copies of a supporting statement and 
any related forms for the proposed collection(s) summarized in this 
notice, you may make your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT:  Reports Clearance Office at (410) 
786-1326

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal Agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Reinstatement without 
change of a previously approved 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: We provide 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 percent and 70 percent or have asymptomatic carotid 
artery stenosis = 80 percent 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, we consider coverage for CAS 
reasonable and necessary (section 1862 (A)(1)(a) of the Social Security 
Act). However, evidence for use of CAS with embolic protection for 
patients with high risk for carotid endarterectomy and who also have 
symptomatic carotid artery stenosis = 70 percent who are not 
enrolled in a study or trial is less compelling. To encourage 
responsible and appropriate use of CAS with embolic protection, we 
issued a Decision Memo for Carotid Artery Stenting on March 17, 2005, 
indicating that CAS with embolic protection for symptomatic carotid 
artery stenosis = 70 percent will be covered only if 
performed in facilities that have been determined to be competent in 
performing the evaluation, procedure and follow-up necessary to ensure 
optimal patient outcomes. In accordance with this criteria, we consider 
coverage for CAS reasonable and necessary (section 1862 (A)(1)(a) of 
the Social Security Act). Form Number: CMS-10199 (OCN: 0938-1011); 
Frequency: Yearly; Affected Public: Business or other for-profit and 
Not-for-profit institutions; Number of Respondents: 1,000; Total Annual 
Responses: 1,000; Total Annual Hours: 500. (For policy questions 
regarding this collection contact Lori Ashby at 410-786-6322.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Conditions of Participation: Requirements for Approval and 
Reapproval of Transplant Centers to Perform Organ Transplants; Use: The 
Conditions of Participation and accompanying requirements specified in 
the regulations are used by our surveyors as a basis for determining 
whether a transplant center qualifies for approval or re-approval under 
Medicare.

[[Page 56711]]

We, along with the healthcare industry, believe that the availability 
to the facility of the type of records and general content of records 
is standard medical practice and is necessary in order to ensure the 
well-being and safety of patients and professional treatment 
accountability. Form Number: CMS-10266 (OCN: 0938-1069); Frequency: 
Yearly; Affected Public: Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 226; Total Annual 
Responses: 528; Total Annual Hours: 2,523. (For policy questions 
regarding this collection contact Diane Corning at 410-786-8486.)

    Dated: September 10, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-22329 Filed 9-12-13; 8:45 am]
BILLING CODE 4120-01-P