[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68332-68333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10570 and CMS-10437]


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

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 November 27, 2020.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 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. 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 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:

[[Page 68333]]

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.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Generic Social 
Marketing & Consumer Testing Research; Use: The purpose of this 
submission is to extend the approval of the generic clearance for a 
program of consumer research aimed at a broad audience of those 
affected by CMS programs including Medicare, Medicaid, Children's 
Health Insurance Program (CHIP), and health insurance exchanges. This 
program extends strategic efforts to reach and tailor communications to 
beneficiaries, caregivers, providers, stakeholders, and any other 
audiences that would support the Agency in improving the functioning of 
the health care system, improve patient care and outcomes, and reduce 
costs without sacrificing quality of care. The information collected 
will be used to create a streamlined and proactive process for 
collection of data and utilizing the feedback on service delivery for 
continuous improvement of communication activities aimed at diverse CMS 
audiences.
    The generic clearance will allow rapid response to inform CMS 
initiatives using a mixture of qualitative and quantitative consumer 
research strategies (including formative research studies and 
methodological tests) to improve communication with key CMS audiences. 
As new information resources and persuasive technologies are developed, 
they can be tested and evaluated for beneficiary response to the 
materials and delivery channels. Results will inform communication 
development and information architecture as well as allow for 
continuous quality improvement. The overall goal is to maximize the 
extent to which consumers have access to useful sources of CMS program 
information in a form that can help them make the most of their 
benefits and options
    The activities under this clearance involve social marketing and 
consumer research using samples of self-selected customers, as well as 
convenience samples, and quota samples, with respondents selected 
either to cover a broad range of customers or to include specific 
characteristics related to certain products or services. All collection 
of information under this clearance will utilize a subset of items 
drawn from a core collection of customizable items referred to as the 
Social Marketing and Consumer Testing Item Bank. This item bank is 
designed to establish a set of pre-approved generic question that can 
be drawn upon to allow for the rapid turn-around consumer testing 
required for us to communicate more effectively with our audiences. The 
questions in the item bank are divided into two major categories. One 
set focuses on characteristics of individuals and is intended primarily 
for participant screening and for use in structured quantitative on-
line or telephone surveys. The other set is less structured and is 
designed for use in qualitative one-on-one and small group discussions 
or collecting information related to subjective impressions of test 
materials. Results will be compiled and disseminated so that future 
communication can be informed by the testing results. We will use the 
findings to create the greatest possible public benefit. Form Number: 
CMS-10437 (OMB control number: 0938-1247); Frequency: Yearly; Affected 
Public: Individuals; Number of Respondents: 7,732; Number of Responses: 
61,992; Total Annual Hours: 26,588. (For policy questions regarding 
this collection contact Sabreet Kang Rajeev at 410-786-5616.)

    Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-23890 Filed 10-27-20; 8:45 am]
BILLING CODE 4120-01-P