GenIC #57 (New): Section 1115 Substance Use Disorder (SUD) Demonstration: Monitoring Reports Documents and Templates

Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions (CMS-10398)

SUD Monitoring Protocol Template Instructions (version 4)

GenIC #57 (New): Section 1115 Substance Use Disorder (SUD) Demonstration: Monitoring Reports Documents and Templates

OMB: 0938-1148

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Medicaid Section 1115 SUD Demonstration

Monitoring Protocol Template Instructions



Medicaid and CHIP State Plan, Waiver, and Program Submissions


PRA Disclosure Statement - This information is being collected to assist the Centers for Medicare & Medicaid Services in program monitoring of Medicaid Section 1115 Substance Use Disorder Demonstrations. This mandatory information collection (42 CFR 431.428) will be used to support more efficient, timely and accurate review of states’ SUD 1115 demonstrations monitoring reports submissions to support consistency of monitoring and evaluation of SUD 1115 Demonstrations, increase in reporting accuracy, and reduce timeframes required for monitoring and evaluation. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to the extent of the law. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. The OMB control number for this project is 0938-1148 (CMS-10398 #57). Public reporting burden for this collection of information is estimated to average 20 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.








Instructions for Using the SUD Monitoring Protocol Template

The state should use this template to develop its SUD monitoring protocol, which should describe the state’s monitoring plans for the SUD demonstration and be submitted to CMS within 150 days of demonstration approval as described in the Special Terms and Conditions (STCs).


Note: If the state’s SUD demonstration is part of a comprehensive demonstration, CMS will work with the state to ensure there is not duplication in the reporting requirements for different components of the demonstration. For example, CMS may work with the state to avoid duplication in the following areas: select metrics within Part A (SUD Metrics Workbook) and select reporting topics within Part B (for example, SUD Demonstrations Operations and Policy, Budget Neutrality, SUD Demonstration and Evaluation Update, Other SUD Demonstration Reporting, and Notable State Achievements and/or Innovations).



The state’s SUD monitoring protocol will consist of two parts:



  1. Part A (SUD Metrics Workbook) is an Excel file in which the state will identify the metrics it plans to report. The template that the state received contains the draft set of CMS-provided SUD metrics. The state should review the CMS-provided metrics listed in the Monitoring Protocol tab of the SUD Metrics Workbook and the accompanying CMS-provided metrics technical specifications [to be shared with states as soon as available]. After reviewing these materials, the state should identify the metrics it plans to report (all required metrics, any recommended metrics, and any additional state-identified metrics), and complete the Monitoring Protocol tab as follows:

  • State-identified metrics. If the state identifies any metrics for reporting other than those provided by CMS, the state should add rows for each state-identified metric to the relevant reporting topic within the Monitoring Protocol tab.



NOTE: Any metric additions to the Monitoring Protocol tab should be added after row 58. After the Protocol has been approved, these additions will also need to be made on the Metrics report tab.



    • Health IT metrics. The state is expected to identify metrics to measure progress on its SUD health IT plan. For each key health IT question listed below, the state is required to select at least one metric from the list of sample metrics in Table 1, or identify its own metrics.



Key Health IT Questions

Sample Metrics

  1. How is information technology being used to slow down the rate of growth of individuals identified with SUD?

  • e-prescribing of controlled substances

    • Sample Process Measure: Number of eRx dispensed.

  • PDMP checking by provider types (prescribers, dispensers)

    • Sample Process Measure: Number of PDMP users, number of checks.

  • Leveraging PDMP-EHR and/or HIE integration, including possible use of Single Sign on (SSO)

    • Sample Process Measure: Number of SSO connections live.

  • SBIRT/surveys – electronic

    • Sample Process Measure: Number of surveys dispensed, completed

  • Project ECHO – provider training on pain management.

    • Sample Process Measure: Number of training sessions held.

  • Onboarding EMS to HIE and/or PDMP (dependent upon state’s PDMP access policies)

    • Sample Process Measure: Number of connections live.

  • Emergency room HIT/E capabilities to check PDMP/HIE

    • Sample Process Measure: Number of connections live.

  • Connecting jails/criminal justice

    • Sample Process Measure: Number of connections live.

  • Connecting housing data sources for identification, eligibility for housing assistance

  • Sample Process Measure: Number of connections live.

  1. How is information technology being used to treat effectively individuals identified with SUD?

  • eReferral/eConsult – closed loop referral services for consultation and/or follow up services

    • Sample Process Measure: Number of referrals and/or consultations and completed services.

  • Access to additional services using Provider/Resource directory - connecting primary care to SUD service offerings

    • Sample Process Measure: # of providers and resources managed in provider/resource directory; accuracy of information; frequency of information update.

  • Consent Management / Inter-Intra State e-Consent capture and use –

    • # of individuals for whom consent to disclose or access information per state policy (both covered and non-covered 42CFR Part 2 and HIPPA) has been obtained and captured.

  1. How is information technology being used to effectively monitor “recovery” supports and services for individuals identified with SUD?

  • Care management/recovery – shared care plan accessibility across care team

    • Sample Process Measure: Creation of statewide functionalities for possible use by care team members (e.g., Direct secure messaging for sharing behavioral health treatment data with proper consent).

  • Connecting corrections systems to care delivery systems for incarcerated individual release to community

    • Sample Process Measure: Number of connections live.

  • Individuals connected to alternative therapies from other community based resources for pain management or general therapy/treatment

    • Sample Process Measure: Number of clinicians with list of community resources that individuals can be referred to in an e-directory.

    • Sample Process Measure: # of providers and resources on a community list that can be provided to clinicians to SUD treating providers for the purpose of individual referrals in an e-directory.

    • Sample Process Measure: tracking Medication-assisted treatment (MAT) (use of medications with counseling and behavioral therapies to treat substance use disorders and prevent opioid overdose.



  • Plans to report metrics. The column “State Will Report” identifies whether the state plans to report each metric. The state should mark Y or N to indicate whether it will include each metric in its reporting.

  • Standard information on CMS-provided metrics. The following columns of the Monitoring Protocol tab contain standard information on CMS-provided metrics:

    • Reporting priority*

    • Number (#)*

    • Metric Name*

    • Metric Definition*

    • Data Source*

    • Measurement Period*

    • Reporting Frequency*

The columns marked with an asterisk (*) above cannot be altered by the state, other than for state-identified metrics (described below).



  • Standard information on state-identified metrics. For state-identified reporting metrics, including health IT-related metrics, the state should populate the following columns consistently according to the below guidance:

    • Reporting priority: The state should populate this column as “state-identified” for all state-identified metrics except health IT, which are listed as “required.”

    • Number (#): The state should number each state-identified metric according to the following numbering convention: S.1, S.2, S.3, etc.

The state should populate the remaining columns to provide a similar level of detail to the CMS-provided metrics:

    • Metric Name

    • Metric Definition

    • Data Source

    • Measurement Period

    • Reporting Frequency

If the state proposes to add state-identified metrics, please ensure that these modifications are described in the column entitled “Explanation of any deviations from the technical specifications.”



  • Baseline, target, and goals. As described in the STCs, for each metric, the state must provide a baseline, a target to be achieved by the end of the demonstration, and an annual goal for closing the gap between baseline and target (expressed as percentage points where applicable). Results from demonstration year one (to be submitted in the state’s first annual monitoring report) will be used for baselines. Targets should reflect directional targets (e.g., increase, decrease), rather than values and be benchmarked against performance in best practice settings. The state should provide this information in columns:

    • Baseline Reporting Period (MM/DD/YY—MM/DD/YY)

    • Annual Goal

    • Overall Demonstration Target

  • Alignment with CMS-provided technical specifications. The state should attest that planned reporting matches the CMS-provided technical specifications for each CMS-provided metric, using the column named “Attest that planned reporting matches the CMS-provided specification (Y/N).” For metrics where reporting does not match the CMS-provided specifications, describe these deviations in the provided column. Deviations include reporting on fewer subpopulations than those outlined in the technical specifications.

  • Initial reporting date. In the column “Quarter in which reporting will begin”, the state should note the first report in which each metric will appear (for example, DY1, Q3). For any metrics for which the state will not begin reporting immediately (in the next expected quarterly or annual report), the state should use the column entitled “Explanation of any plans to phase in reporting over time” to describe and justify plans to phase in the metric reporting.



  1. Part B (SUD Monitoring Protocol Template) is a Word document containing three narrative reporting sections:

    • 1. The Transmittal Title Page is a brief form that the state should complete as part of the SUD Monitoring Protocol. The state will submit this form as the title page of all Monitoring Reports. The content of this transmittal table should stay consistent over time.

    • 2. The Proposed Modifications to SUD Narrative Information on Implementation table is a companion to Part B, Section 3 of the SUD Monitoring Report Template (Narrative Information on Implementation). The state should review the information requested in the SUD Monitoring Report Template Section 3 and identify any modifications the state would like to make in its reporting on each topic, including any potential challenges to reporting the requested information. In the Proposed Modifications to SUD Narrative Information on Implementation table in Section 2 of the monitoring protocol template, the state should describe each proposed modification and summarize the reasoning for this modification. The state should then mark the appropriate check box confirming that it will report the narrative information as planned, either with no modifications or with the exception of any modifications described in the table.

    • 3. Acknowledgement of Budget Neutrality reporting- The Budget Neutrality Workbook will be provided by the state’s project officer. To complete Section 3, the state should review the workbook and select the appropriate check box to indicate that the state will provide budget neutrality reporting as requested.

    • 4. The SUD Demonstration Monitoring Reporting Schedule should present the state’s schedule for submitting quarterly and annual monitoring reports for the duration of the SUD demonstration, in accordance with the reporting requirements in the state’s STCs.





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