[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Notices]
[Pages 56227-56229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20089]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-359/CMS-360, CMS-10706, CMS-10725 and CMS 
10728]


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

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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.

[[Page 56228]]


DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by October 13, 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: Extension of a currently 
approved information collection; Title of Information Collection: 
Comprehensive Outpatient Rehabilitation Facility (CORF) Certification 
and Survey Forms; Use: The form CMS-359 is an application for health 
care providers that seek to participate in the Medicare program as a 
Comprehensive Outpatient Rehabilitation Facility (CORF). The form 
initiates the process for facilities to become certified as a CORF and 
it provides the CMS Location and State Survey Agency (SA) staff 
identifying information regarding the applicant that is stored in the 
Automated Survey Processing Environment (ASPEN) system.
    The form CMS-360 is a survey tool used by the SAs to record 
information in order to determine a provider's compliance with the CORF 
Conditions of Participation (COPs) and to report this information to 
the Federal government. The form includes basic information on the COP 
requirements, check boxes to indicate the level of compliance, and a 
section for recording notes. CMS has the responsibility and authority 
for certification decisions which are based on provider compliance with 
the COPs and this form supports this process. Form Number: CMS-359/360 
(OMB control number: 0938-0267); Frequency: Occasionally; Affected 
Public: Private Sector (Business or other for-profits); Number of 
Respondents: 49 Number of Responses: 8; Total Annual Hours: 74. (For 
questions regarding this collection contact Caroline Gallaher (410)786-
8705.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Generic 
Clearance for the Center for Clinical Standards and Quality IT Product 
and Support Teams; Use: The Health Information Technology for Economic 
and Clinical Health (HITECH) Act is part of the American Reinvestment 
and Recovery Act (ARRA) of 2009. As noted in the HITECH Act, CMS is 
responsible for defining ``meaningful use'' of certified electronic 
health record (EHR) technology and developing incentive payment 
programs for Medicare and Medicaid providers. CMS is continually 
implementing and updating information systems as legislation and 
requirements change. To support this initiative, CCSQ IT Product and 
Support Teams (CIPST) must have the capacity for engagement with users 
in an ongoing variety of research, discovery, and validation activities 
to create and refine systems that do not place an undue burden on users 
and instead are efficient, usable, and desirable.
    The Center for Clinical Standards and Quality (CCSQ) is responsible 
for administering appropriate information systems so that the public 
can submit healthcare-related information. While beneficiaries 
ultimately benefit, the primary users of (CIPST) are healthcare 
facility employees and contractors. They are responsible for the 
collection and submission of appropriate beneficiary data to CMS to 
receive merit-based compensation.
    The generic clearance will allow a 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 information systems that serve CMS 
audiences. CMS implements human-centered methods and activities for the 
improvement of policies, services, and products. As information systems 
and technologies are developed or improved upon, they can be tested and 
evaluated for end-user feedback regarding utility, usability, and 
desirability. The overall goal is to apply a human-centered engagement 
model to maximize the extent to which CMS CIPST product teams can 
gather ongoing feedback from consumers. Feedback helps engineers and 
designers arrive at better solutions, therefore minimizing the burden 
on consumers and meeting their needs and goals.
    The activities under this clearance involve voluntary engagement 
with target CIPST users to receive design and research feedback. 
Voluntary end-users from samples of self-selected customers, as well as 
convenience 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 is for use in both quantitative and qualitative groups 
collecting data related to human-computer interactions with information 
system development. We will use the findings to create the highest 
possible public benefit. Form Number: CMS-10706 (OMB control number: 
0938-NEW); Frequency: Occasionally; Affected Public: Individuals and 
Private Sector (Business or other for-profit and Not-for-profit 
institutions); Number of Respondents: 11,476; Total Annual Responses: 
11,476; Total Annual Hours: 4,957. (For policy questions regarding this 
collection contact Stephanie Ray at 410-786-0971).
    3. Type of Information Collection Request: New information 
collection; Title of Information Collection: Pharmacy Benefit Manager 
Transparency; Use: The Patient Protection and Affordable Care Act (Pub. 
L. 111-148) and the Health Care and Education Reconciliation Act of 
2010 (Pub. L. 111-152) (collectively, the Patient Protection and 
Affordable Care Act (PPACA)) were signed into law in 2010. The PPACA 
established competitive private health insurance markets, called 
Marketplaces or Exchanges, which give millions of Americans and small 
businesses access to qualified health plans (QHPs), including stand-
alone dental plans

[[Page 56229]]

(SADPs)--private health and dental insurance plans that are certified 
as meeting certain standards. The PPACA added section 1150A of the 
Social Security Act, which requires pharmacy benefit managers (PBMs) to 
report prescription benefit information to the Department of Health and 
Human Services (HHS). PBMs are third-party administrators of 
prescription programs for a variety of types of health plans, including 
QHPs. The Centers for Medicare and Medicaid Services (CMS) files this 
information collection request (ICR) in connection with the 
prescription benefit information that PBMs must provide to HHS under 
section 1150A. The burden estimate for this ICR reflects the time and 
effort for PBMs to submit the information regarding PBMs and 
prescription drugs. Form Number: CMS-10725 (OMB control number: 0938-
NEW); Frequency: Annually; Affected Public: Private Sector (business or 
other for-profits), Number of Respondents: 40; Number of Responses: 
275. Total Annual Hours: 1,400. For questions regarding this collection 
contact Ken Buerger at 410-786-1190.
    4. Type of Information Collection Request: New Collection; Title of 
Information Collection: Value in Opioid Use Disorder Treatment 
Demonstration; Use: Value in Opioid Use Disorder Treatment (Value in 
Treatment) is a 4-year demonstration program authorized under section 
1866F of the Social Security Act (Act), which was added by section 6042 
of the Substance Use-Disorder Prevention that Promotes Opioid Recovery 
and Treatment for Patients and Communities Act (SUPPORT Act). The 
purpose of Value in Treatment, as stated in the statute, is to 
``increase access of applicable beneficiaries to opioid use disorder 
treatment services, improve physical and mental health outcomes for 
such beneficiaries, and to the extent possible, reduce Medicare program 
expenditures.'' As required by statute, Value in Treatment will be 
implemented no later than January 1, 2021.
    Section 1866F(c)(1)(A)(ii) specifies that individuals and entities 
must apply for and be selected to participate in the Value in Treatment 
demonstration pursuant to an application and selection process 
established by the Secretary. Section 1866F(c)(2)(B)(iii) specifies 
that in order to receive CMF and performance-based incentive payments 
under the Value in Treatment program, each participant shall report 
data necessary to: Monitor and evaluate the Value in Treatment program; 
determine if criteria are met; and determine the performance-based 
incentive payment. Form Number: CMS-10728 (OMB control number: 0938-
New); Frequency: Yearly; Affected Public: Individuals and Households; 
Number of Respondents: 12,096; Total Annual Responses: 12,096; Total 
Annual Hours: 1,285. (For policy questions regarding this collection 
contact Rebecca VanAmburg at 410-786-0524.)

    Dated: September 8, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-20089 Filed 9-10-20; 8:45 am]
BILLING CODE 4120-01-P