[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19734-19735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10151, CMS-10199, CMS-R-13, CMS-10279]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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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 the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and 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 May 30, 2017.

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) 395-5806 OR, Email: 
[email protected].
    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 Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

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. 
Comments submitted in response to the 60-day Federal Register Notice 
have been addressed in Appendix A of the ICR. 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 with 
change of a previously approved collection; Title of Information 
Collection: Data Collection for Medicare Beneficiaries Receiving 
Implantable Cardioverter-Defibrillators for Primary Prevention of 
Sudden Cardiac Death; Use: We provide coverage for implantable 
cardioverter-defibrillators (ICDs) for secondary prevention of sudden 
cardiac death based on extensive evidence showing that use of ICDs 
among patients with a certain set of physiologic conditions are 
effective. Accordingly, we consider coverage for ICDs reasonable and 
necessary under Section 1862(a)(1)(A) of the Social Security Act. 
However, evidence for use of ICDs for primary prevention of sudden 
cardiac death is less compelling for certain patients.
    To encourage responsible and appropriate use of ICDs, we issued a 
``Decision Memo for Implantable Defibrillators'' on January 27, 2005, 
indicating that ICDs will be covered for primary prevention of sudden 
cardiac death if the beneficiary is enrolled in either an FDA-approved 
category B IDE clinical trial (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1) or a qualifying 
prospective data collection system (either a practical clinical trial 
or prospective systematic data collection, which is sometimes referred 
to as a registry). Form Number: CMS-10151 (OMB control number: 0938-
0967); Frequency: Occasionally; Affected Public: Business or other for-
profits, Not-for-profit institutions; Number of Respondents: 1,600; 
Total Annual Responses: 80,000; Total Annual Hours: 20,000. (For policy 
questions regarding this collection contact JoAnna Baldwin at 410-786-
7205.)
    2. Type of Information Collection Request: Revision of a currently 
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 [gteqt]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 
[gteqt]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 [gteqt]70 percent will be 
covered only if performed in facilities that have been determined to be 
competent in

[[Page 19735]]

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 (OMB control number: 0938-
1011); Frequency: Yearly; Affected Public: Business or other for-profit 
and Not-for-profit institutions; Number of Respondents: 1,370; Total 
Annual Responses: 4,110; Total Annual Hours: 28,998. (For policy 
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Conditions of 
Coverage for Organ Procurement Organizations and Supporting 
Regulations; Use: Section 1138(b) of the Social Security Act, as added 
by section 9318 of the Omnibus Budget Reconciliation Act of 1986 (Pub. 
L. 99-509), sets forth the statutory qualifications and requirements 
that organ procurement organizations (OPOs) must meet in order for the 
costs of their services in procuring organs for transplant centers to 
be reimbursable under the Medicare and Medicaid programs. An OPO must 
be certified and designated by the Secretary as an OPO and must meet 
performance-related standards prescribed by the Secretary. The 
corresponding regulations are found at 42 CFR part 486 (Conditions for 
Coverage of Specialized Services Furnished by Suppliers) under subpart 
G (Requirements for Certification and Designation and Conditions for 
Coverage: Organ Procurement Organizations).
    Since each OPO has a monopoly on organ procurement within its 
designated service area (DSA), we must hold OPOs to high standards. 
Collection of this information is necessary for us to assess the 
effectiveness of each OPO and determine whether it should continue to 
be certified as an OPO and designated for a particular donation service 
area by the Secretary or replaced by an OPO that can more effectively 
procure organs within that DSA. Form Number: CMS-R-13 (OMB control 
number: 0938-0688); Frequency: Occasionally; Affected Public: Not-for-
profit institutions; Number of Respondents: 58; Total Annual Responses: 
58; Total Annual Hours: 13,546. (For policy questions regarding this 
collection contact Diane Corning at 410-786-8486.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Ambulatory 
Surgical Center Conditions for Coverage; Use: The Ambulatory Surgical 
Center (ASC) Conditions for Coverage (CfCs) focus on a patient-
centered, outcome-oriented, and transparent processes that promote 
quality patient care. The CfCs are designed to ensure that each 
facility has properly trained staff to provide the appropriate type and 
level of care for that facility and provide a safe physical environment 
for patients. The CfCs are used by Federal or state surveyors as a 
basis for determining whether an ASC qualifies for approval or re-
approval under Medicare. We, along with the healthcare industry, 
believe that the availability to the facility of the type of records 
and general content of records, which this regulation specifies, 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-10279 (OMB control number: 0938-1071); Frequency: 
Annual; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 5,500; Total Annual 
Responses: 5,500; Total Annual Hours: 209,000. (For policy questions 
regarding this collection contact Jacqueline Leach at 410-786-4282.)

    Dated: April 26, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-08738 Filed 4-27-17; 8:45 am]
BILLING CODE 4120-01-P