[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11040-11043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-304/304a, CMS-368/CMS-R-144, CMS-R-308, CMS-
10151, CMS-10199, CMS-R-13, and CMS-10279]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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

[[Page 11041]]

collection techniques or other forms of information technology to 
minimize the information collection burden.

DATES: Comments must be received by April 18, 2017.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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 [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

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CMS-304/304a......................  Reconciliation of State Invoice and
                                     Prior Quarter Adjustment Statement.
CMS-368/CMS-R-144.................  Medicaid Drug Rebate Program Forms.
CMS-R-308.........................  State Children's Health Insurance
                                     Program and Supporting Regulations.
CMS-10151.........................  Data Collection for Medicare
                                     Beneficiaries Receiving Implantable
                                     Cardioverter-Defibrillators for
                                     Primary Prevention of Sudden
                                     Cardiac Death.
CMS-10199.........................  Data Collection for Medicare
                                     Facilities Performing Carotid
                                     Artery Stenting with Embolic
                                     Protection in Patients at High Risk
                                     for Carotid Endarterectomy.
CMS-R-13..........................  Conditions of Coverage for Organ
                                     Procurement Organizations and
                                     Supporting Regulations ate
                                     Children's Health Insurance Program
                                     and Supporting Regulations.
CMS-10279.........................  Ambulatory Surgical Center
                                     Conditions for Coverage.
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    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Reconciliation of 
State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304 
(Reconciliation of State Invoice) is used by manufacturers to respond 
to the state's rebate invoice for current quarter utilization. Form 
CMS-304a (Prior Quarter Adjustment Statement) is required only in those 
instances where a change to the original rebate data submittal is 
necessary. Form Number: CMS-304 and -304a (OMB control number: 0938-
0676); Frequency: Quarterly; Affected Public: Business or other for-
profits; Number of Respondents: 1,037; Total Annual Responses: 4,148; 
Total Annual Hours: 187,880. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program Forms; Use: We develop the rebate amount per drug unit 
from information supplied by the drug manufacturers and distributes 
these data to the states. States then must report quarterly to the drug 
manufacturers and report to us the total number of units of each dosage 
form/strength of their covered outpatient drugs reimbursed during a 
quarter and the rebate amount to be refunded. This report is due within 
60 days of the end of each calendar quarter. The information in the 
report is based on claims paid by the state Medicaid agency during a 
calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required 
from states quarterly to report utilization for any drugs paid for 
during that quarter. Form CMS-368 (Administrative Data) is required 
only in those instances where a change to the original data submittal 
is necessary. Form Number: CMS-368 and -R-144 (OMB control number: 
0938-0582); Frequency: Quarterly; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 56; Total Annual Responses: 
224; Total Annual Hours: 12,101. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: State Children's 
Health Insurance Program and Supporting Regulations; Use: States must 
submit title XXI plans and amendments for approval by the Secretary. We 
use the plan and its subsequent amendments to determine if the state 
has met the requirements of title XXI. Information provided in the 
state plan, state plan amendments, and from the other information we 
are collecting will be used by advocacy groups, beneficiaries, 
applicants, other governmental agencies, providers groups, research 
organizations, health care corporations, health care consultants. 
States will use the information collected to assess state plan 
performance, health outcomes and an evaluation of the amount of 
substitution of private coverage that occurs as a result of the 
subsidies and the effect of the subsidies on access to coverage. Form 
Number: CMS-R-308 (OMB control number: 0938-0841);

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Frequency: Yearly, Once, and Occasionally; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 56; Total Annual 
Responses: 28,294,596; Total Annual Hours: 1,473,885. (For policy 
questions regarding this collection contact Amy Lutzky at 410-786-
0721).
    4. 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.)
    5. Type of Information Collection Request: Extension 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 >= 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 (OMB control number: 
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 Sarah Fulton at 410-786-
2749.)
    6. 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.)
    7. 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.)


[[Page 11043]]


    Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-03234 Filed 2-16-17; 8:45 am]
 BILLING CODE 4120-01-P