[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.)
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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