[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Notices]
[Pages 51721-51722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10598 and CMS-10570]


Agency Information Collection Activities: Proposed Collection; 
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 (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 collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by October 20, 2020.

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' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Call the Reports Clearance Office at (410) 786-1326.

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

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).

CMS-10598 Generic Clearance for Evaluation of Stakeholder Training--
Health Insurance Marketplace and Market Stabilization Programs
CMS-10570 Appropriate Use Criteria (AUC) for Advanced Diagnostic 
Imaging Services

    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 information collection; Title of Information Collection: 
Generic Clearance for Evaluation of Stakeholder Training--Health 
Insurance Marketplace and Market Stabilization Programs; Use: CMS is 
strongly committed to providing appropriate education and technical 
outreach to States, issuers, self-insured group health plans and third-
party administrators

[[Page 51722]]

(TPA) participating in the Marketplace and/or market stabilization 
programs mandated by the ACA. CMS continues to engage with stakeholders 
in the Marketplace to obtain input through Satisfaction Surveys 
following Stakeholder Training events. The survey results will help to 
determine stakeholders' level of satisfaction with trainings, identify 
any issues with training and technical assistance delivery, clarify 
stakeholders' needs and preferences, and define best practices for 
training and technical assistance. CMS will continue to modify, enhance 
and develop forms for future years based on feedback from Stakeholders. 
Form Number: CMS-10598 (OMB control number: 0938-1331); Frequency: 
Occasionally; Affected Public: Private Sector; Number of Respondents: 
30,332; Number of Responses: 30,332; Total Annual Hours: 7,334. For 
questions regarding this collection contact Sonia Henderson at 301-492-
4320.
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging 
Services; Use: Section 218(b) of the Protecting Access to Medicare Act 
(PAMA) of 2014 amended the Medicare Part B statute by adding a new 
section 1834(q) of the Act entitled, ``Recognizing Appropriate Use 
Criteria for Certain Imaging Services,'' which directs the Secretary to 
establish a program to promote the use of AUC. This program is codified 
at 42 CFR 414.94. Evidence-based AUC for imaging can assist clinicians 
in selecting the imaging study that is most likely to improve health 
outcomes for patients based on their individual context. A provider-led 
entity (PLE) as defined in 42 CFR 414.94(b) is a national professional 
medical specialty society or other organization that is comprised 
primarily of providers or practitioners who, either within the 
organization or outside the organization, predominantly provide direct 
patient care. This program requires professionals ordering applicable 
imaging services as defined in Sec.  414.94(b) to consult with 
specified applicable AUC, which are criteria developed, endorsed or 
modified by a qualified PLE.
    The cornerstone of the PLE qualification process is for PLEs to 
demonstrate that they engage in a rigorous evidence-based process for 
developing, modifying, or endorsing AUC. Section 1834(q)(2)(B) 
specifies that the Secretary must consider whether AUC have stakeholder 
consensus, are scientifically valid and evidence-based, and are based 
on studies that are published and reviewable by stakeholders. In the 
2016 Physician Fee Schedule Final Rule with comment period (80 FR 
70886, November 16, 2015; see pages 71102-71116 and pages 71380-71382) 
we established a qualification process and requirements for qualified 
PLEs in order to ensure that the AUC development or endorsement 
processes used by a PLE result in high quality, evidence-based AUC in 
accordance with section 1834(q)(2)(B).
    In order to become and remain a qualified PLE, we require PLEs to 
demonstrate adherence to specific requirements when developing, 
modifying or endorsing AUC. To ensure that these requirements are met, 
we require PLEs to submit information demonstrating their adherence to 
these requirements. CMS qualifies those PLEs that demonstrate adherence 
to the requirements for a period of five years. Qualified PLEs are also 
required, during the 5th year after their most recent approval date, to 
ensure adherence has been maintained and to account for any changes in 
the entities' processes. Qualified PLEs must reapply every five years 
and must submit the applications by January 1 of the 5th year after the 
PLE's most recent approval date. Form Number: CMS-10570 (OMB control 
number: 0938-1288); Frequency: Occasionally; Affected Public: Private: 
Business or other for-profit and Not for-profit institutions; Number of 
Respondents: 10; Number of Responses: 10; Total Annual Hours: 150. (For 
policy questions regarding this collection, contact Heather Hostetler 
at 410-786-4515.)

    Dated: August 17, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-18337 Filed 8-20-20; 8:45 am]
BILLING CODE 4120-01-P