[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10367-10369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10398 #57]


Medicaid and Children's Health Insurance Program (CHIP) Generic 
Information Collection Activities: Proposed Collection; Comment Request

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

ACTION: Notice.

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SUMMARY: On May 28, 2010, the Office of Management and Budget (OMB) 
issued Paperwork Reduction Act (PRA) guidance related to the 
``generic'' clearance process. Generally, this is an expedited process 
by which agencies may obtain OMB's approval of

[[Page 10368]]

collection of information requests that are ``usually voluntary, low-
burden, and uncontroversial collections,'' do not raise any substantive 
or policy issues, and do not require policy or methodological review. 
The process requires the submission of an overarching plan that defines 
the scope of the individual collections that would fall under its 
umbrella. On October 23, 2011, OMB approved our initial request to use 
the generic clearance process under control number 0938-1148 (CMS-
10398). It was last approved on April 26, 2021, via the standard PRA 
process which included the publication of 60- and 30-day Federal 
Register notices. The scope of the April 2021 umbrella accounts for 
Medicaid and CHIP State plan amendments, waivers, demonstrations, and 
reporting. This Federal Register notice seeks public comment on one or 
more of our collection of information requests that we believe are 
generic and fall within the scope of the umbrella. Interested persons 
are invited to submit 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 March 10, 2022.

ADDRESSES: When commenting, please reference the applicable form number 
(see below) and the OMB control number (0938-1148). 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: CMS-10398 (#74)/OMB 
control number: 0938-1148, 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 
access CMS' website at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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

SUPPLEMENTARY INFORMATION: Following is a summary of the use and burden 
associated with the subject information collection(s). More detailed 
information can be found in the collection's supporting statement and 
associated materials (see ADDRESSES).

Generic Information Collection

    1. Title of Information Collection: Medicaid Section 1115 Substance 
Use Disorder (SUD) Demonstration: Monitoring Reports Documents and 
Templates; Type of Information Collection Request: Revision of a 
currently approved collection; Use: On November 1, 2017, CMS released a 
letter #17-003 to all state Medicaid Directors announcing new 
directions on how CMS would like to work with states on section 1115(a) 
demonstrations to improve access to and quality of treatment for 
Medicaid beneficiaries as part of a Department-wide effort to combat 
the ongoing opioid crisis. The letter also announced that CMS is now 
offering a more flexible, streamlined approach to accelerate states' 
ability to respond to the national opioid crisis while enhancing 
states' monitoring and reporting of the impact of any changes 
implemented through these demonstrations.
    Medicaid Section 1115 demonstration monitoring and evaluation 
Special Terms and Conditions (STC), and the letter #17-003, make clear 
that CMS remains committed to ensuring state accountability for the 
health and well-being of Medicaid enrollees and that monitoring and 
evaluation are important for understanding the outcomes and impacts of 
approaches to Medicaid SUD demonstrations. For this purpose, CMS is 
undertaking efforts to help states monitor the elements of these 
demonstrations, while giving them the flexibility to adapt to changing 
conditions in their states. States with approved SUD demonstrations are 
required to develop implementation and monitoring plans, including 
monitoring metrics, a monitoring protocol, and regular monitoring 
reports describing their implementation progress.
    In addition, the STCs for these section 1115 demonstrations address 
that states are required to submit in their regular monitoring reports, 
information on milestones and performance measures that they elected to 
represent key indicators of progress toward meeting the goals for the 
demonstrations.
    Furthermore, to improve the quality and efficiency of the reporting 
requirements for SUD demonstrations, CMS in conjunction with state 
advisory groups developed a set of standardized monitoring tools for 
states to use for their regular reporting, including:
     The Medicaid section 1115 SUD demonstration monitoring 
protocol template (this is a one-time submission);
     The Medicaid section 1115 SUD demonstration monitoring 
protocol workbook (this is a one-time submission);
     The Medicaid section 1115 SUD demonstration monitoring 
report template, and;
     The Medicaid Section 1115 SUD demonstration monitoring 
report workbook.
    As specified in official 1115 policy communications to states:
    In accordance with 42 CFR 431.428 states must submit all post-
approval deliverables as stipulated by CMS and within the timeframes 
outlined within the STCs for the specific Medicaid 1115 State 
Demonstration.
    The State Medicaid Director Letter, #17-003, entitled, Strategies 
Addressing the Opioid Epidemic, provides a framework for SUD 
demonstrations under Medicaid Section 1115 Authority. This letter 
indicates that a state's application should confirm its commitment to 
assuring the necessary resources to support robust monitoring protocol 
and evaluation, and that the state will provide an implementation plan 
subject to CMS approval. The letter further states that information 
about the specific measures and reporting will be detailed in a 
monitoring protocol agreed upon by CMS and the state after approval of 
the demonstration which will demonstrate progress toward meeting the 
goals for this demonstration initiative.
    In addition, the STCs for the Medicaid section 1115 SUD 
demonstrations require that approved states submit an SUD 
implementation plan subject to CMS approval, and an SUD monitoring 
protocol to be developed in cooperation with CMS and which is subject 
to CMS approval. The SUD monitoring protocol, reporting templates, and 
associated monitoring metrics flow down from the OMB-approved SUD 
implementation plan, which aligns with the goals and objectives of the 
demonstration as expressed in SMDL #17-003.
    The STCs also require approved states to submit three quarterly and 
one annual monitoring reports consistent with the elements provided in 
42 CFR

[[Page 10369]]

431.428 and in accordance with a framework to be provided by CMS. The 
STCs also provide that the monitoring framework be subject to change as 
monitoring systems are developed and evolve, and that states are 
required to report in a structured manner that supports federal 
tracking and analysis.
    In this 2022 information collection request, we have revised the 
following monitoring tools:
     Monitoring protocol tools:
    [cir] Monitoring protocol workbook (updated to Version 6.0)
    [cir] Monitoring protocol template (updated to Version 4.0)
     Monitoring report tools:
    [cir] Monitoring report template (updated to Version 4.0)
    [cir] Monitoring report workbook (updated to Version 6.0)
    This 2022 release incorporates updated guidance on reporting 
metrics, narrative information, and other clarifications. This release 
also reflects modifications to align with the Medicaid Section 1115 
Substance Use Disorder Demonstrations: Technical Specifications for 
Monitoring Metrics Manual Version 4.0 (released September 2021).
    In addition, this release incorporates updated functionality in the 
Performance Metrics Database & Analytics (PMDA) system aimed to 
automate aspects of reporting and customize tools to ease state burden. 
Updated functionality includes:
     Auto-population of certain fields within the monitoring 
report tools in alignment with the state's CMS-approved monitoring 
protocol.
     Reporting flagged items early in the process to reduce 
resubmission and allow CMS to engage with the state faster and on a 
more detailed level.
     Ensuring the latest version of the monitoring tools are 
utilized by sending an email notification to all designated 
demonstration contacts when customized monitoring report tools are 
available.
    Form Number: CMS-10398 (#57) (OMB control number: 0938-1148); 
Frequency: Once, yearly, and quarterly; Affected Public: State, Local, 
or Tribal Governments; Number of Respondents: 35; Total Annual 
Responses: 596; Total Annual Hours: 6,394. For policy questions 
regarding this collection contact: Danielle Daly at 410-786-0897.

    Dated: February 18, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2022-03936 Filed 2-23-22; 8:45 am]
BILLING CODE 4120-01-P