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State of IndianaRFP 18-061

Substance Use Disorder 1115 Waiver Assessment RFPAttachment H – Scope of Work

1. Overview

Section 1115 Medicaid waivers through the Centers for Medicare and Medicaid Services (CMS) are intended to be research and demonstration programs that are evaluated to provide federal and state policymakers with information on the impact of changes implemented through waivers. Indiana’s new substance use disorder (SUD) section 1115(a) demonstration provides the authority for the State to reimburse for limited residential and inpatient stays within institutions for mental disease (IMDs). Indiana is utilizing this opportunity to strengthen its covered SUD benefits with the inclusion of Addiction Recovery Management Services (ARMS). Indiana is also using this opportunity to align its state regulations around the American Society of Addiction Medicine (ASAM) Patient Placement Criteria. This waiver has been approved for three demonstration years, and the demonstration became effective on February 1st, 2018. As an extension of the Healthy Indiana Plan (HIP) demonstration waiver, the SUD demonstration will technically take place within Demonstration Years (DYs) 4 (February 2018-January 2019), 5 (February 2019 – January 2020), and 6 (February 2020-January 2021) of the 1115 waiver. All HIP related activities shall be considered out-of-scope for this project.

In developing the 1115 SUD waiver demonstration, the State is striving to achieve five comprehensive goals, which are set forth in the 1115 waiver (see Attachment I, Bidder’s Library). They are as follows:

(1) Expanded SUD treatment options for all Indiana Medicaid members;

(2) Reduced readmission rates for SUD treatment;

(3) Reduced usage of the emergency room for SUD treatment;

(4) Promotion of the entire continuum of SUD treatment options; and

(5) Strengthened consistency with prior authorization determinations for SUD services.

Further, CMS is interested in States pursuing an 1115 SUD waiver to meet the following six milestones:

(1) Access to critical levels of care for SUD treatment;

(2) Use of evidence-based SUD-specific patient placement criteria;

(3) Use of nationally recognized SUD-specific program standards to set provider qualifications for residential treatment facilities;

(4) Sufficient provider capacity at critical levels of care, including medication assisted treatment for opioid use disorder (OUD);

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(5) Implementation of comprehensive treatment and prevention strategies to address opioid abuse and OUD; and

(6) Improved care coordination and transition between levels of care.

2. Evaluation Overview

The State intends to evaluate the 1115 SUD demonstration waiver to determine its overall impact on Indiana Medicaid and its members. The evaluation must include components that are needed to satisfy the Centers for Medicare and Medicaid Services (CMS) requirements for evaluation of an 1115 waiver, as outlined in the CMS Special Terms and Conditions (STCs) for the SUD waiver (see Attachment I, Bidder’s Library). The evaluation will determine if Indiana is making sufficient progress on the five goals the State is seeking to achieve and the six major milestones as provided by CMS.

2.1 Respondent Experience

Respondents shall demonstrate experience evaluating statewide healthcare delivery programs, programs authorized through the United States Department of Health and Human Services (HHS), and/or documented equivalent experience.

2.2 Communications and Meetings

The contractor shall:

(a) Facilitate an in-person kick off meeting with FSSA. Contractor shall include all project staff at the kick off meeting and provide a detailed agenda and meeting summary.

(b) Assign a project manager who will provide direct point of contact and engage in day-to-day communication with the State.

(c) Provide progress reports on any evaluation activity monthly, or as often as FSSA requests.

(d) Meet monthly with FSSA, or as often as FSSA requests, to discuss process, progress, barriers, and any other related issues proposed by FSSA or the Contractor related to evaluation activities. If agreed upon in advance by FSSA, specific meetings may take place via telephone or video conferencing.

(e) Designate key staff to meet with FSSA staff as delineated in Section 2.6.

(f) Facilitate and record minutes of all meetings with FSSA staff.

(g) If requested by FSSA, following the submission of any deliverable to FSSA, provide an oral presentation and accompanying PowerPoint file to FSSA or other stakeholders regarding its review and any recommendations. Relevant members of the Contractor team, including the Program Director and Project Manager, shall be present. Contractor shall submit a PowerPoint presentation three business days prior to the meeting and submit a final electronic copy to FSSA within two business days of the meeting.

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(h) If requested by FSSA, assist FSSA in responding to any questions from CMS, the health plans, or other stakeholders, about any deliverable.

(i) Request the permission and approval of FSSA before any data or reports related to the evaluation are released. FSSA shall pre-approve all requests for use of its data. Research, including that needed for the evaluation components of this plan and any research using FSSA data above and beyond that contracted by the State, shall be approved by FSSA prior to commencement. The Contractor shall agree to submit to FSSA a copy of all findings, articles, and any other similar documents that are developed using the Indiana FSSA data, within thirty days of completion. The Contractor agrees that no data concerning the SUD waiver will be disclosed by the Contractor or published in a format that identifies FSSA without the written permission of the State.

2.3 Activities

Evaluation activities include the following:

(a) Refine research questions identified.

(b) Create testable hypotheses and measurable performance measures related to research questions.

(c) Conduct appropriate background research and literature review.

(d) Calculate statistically significant population size and sample selection criteria.

(e) Develop data collection methods and tools.

(f) Collect, verify, and validate relevant data.

(g) Establish a complete analysis and interpretation process.

(h) Develop reports and other deliverables.

2.4 Deliverables

The Contractor shall propose and come to an agreement with FSSA on a set of timelines for the completion of the required deliverables. Estimated timelines are provided in Section 2.5 based on the STCs and a demonstration start date of February 1st, 2018. If agreement cannot be reached, due dates shall be set by FSSA in the best interest of the State. The Contractor shall utilize any and all dates as indicated in the 1115 SUD demonstration STCs. The Contractor’s timely receipt of data is required to meet deliverable due dates. The Contractor shall not be penalized for performance delays caused by delays in receipt of data.

2.4.1 Evaluation Design

2.4.1.1 Draft Evaluation Design

The State must submit to CMS for approval, within 180 days of February 1st, 2018, a draft evaluation design. FSSA has commenced development of an initial

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evaluation design and intends to have a draft outline or skeleton of the evaluation design structure by the time the Contractor begins work. However, the evaluation design will be a key responsibility of the Contractor. Respondents shall describe a proposed evaluation design, including proposed Domains of Focus (Section 2.4.1.1.a) and Measures (Section 2.4.1.1.b) in their Technical Proposal, and the awarded Contractor shall work with the State to develop and finalize the draft evaluation design before submission to CMS. The draft evaluation design must be approved by the State prior to submission to CMS.

At a minimum, the draft design must include a discussion of the goals, objectives, and specific testable hypotheses. The design should be described in sufficient detail to determine that it is scientifically rigorous. The data strategy must be thoroughly documented.

The design should describe how the evaluation and reporting will be developed and maintained to assure its scientific rigor and completion. In summary, the demonstration evaluation will meet all standards of leading academic institutions and peer-reviewed academic journal, as appropriate for each aspect of the evaluation, including standards for the evaluation design, conduct, interpretation, and reporting of findings.

The design, including the budget and adequacy of approach, is subject to CMS approval. The budget and approach must be adequate to support the scale and rigor reflected within the 1115 SUD STCs.

2.4.1.1.a. Domains of Focus

The Contractor, with approval from FSSA, must propose at least one research question that it will investigate within each of the domains listed below. The Contractor shall propose questions to FSSA and work with FSSA to further refine them until FSSA provides final approval. The questions should relate to the following goals:

Increased rates of identification, initiation, and engagement in treatment;

Increased adherence to and retention in treatment; Reductions in overdose deaths, particularly those due to opioids; Reduced utilization of emergency departments and inpatient

hospital settings for treatment where the utilization is preventable or medically inappropriate through improved access to other continuum of care services;

Fewer readmissions to the same or higher level of care where the readmission is preventable or medically inappropriate; and

Improved access to care for physical health conditions among beneficiaries.

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The following are examples of hypotheses that can be considered in the development of the evaluation and design:

The 1115 SUD waiver will increase access to SUD treatment options to Indiana Medicaid members.

The 1115 SUD waiver will increase provider enrollment for SUD treatment for Indiana Medicaid members.

The 1115 SUD waiver will reduce readmission rates to emergency departments and inpatient hospital settings for Indiana Medicaid members who have had a previous admission for substance abuse treatment.

The 1115 SUD waiver will increase the percentage of Indiana Medicaid members affected by substance abuse who seek treatment for substance abuse.

The 1115 SUD waiver will promote the entire continuum of SUD treatment options.

2.4.1.1.b. Measures

The draft evaluation design must discuss the outcome measures that shall be used in evaluating the impact of the demonstration during the period of approval, including:

A description of each outcome measure selected, including clearly defined numerators and denominators, and National Quality Forum (NQF) numbers (as applicable).

Identifying the measure steward organization responsible for providing the required measure information for the measure, making any necessary updates to the measure, and informing stakeholders about any changes made to the measures.

The baseline value for each measure and the method by which the baselines were established.

The sampling methodology for assessing these outcomes including the margin of error, confidence level and response distribution, and sample size.

2.4.1.1.c. Sources of Measures

Measure sets could include CMS’s Core Set of Health Care Quality Measures for Children in Medicaid and CHIP, Consumer Assessment of Health Care Providers and Systems (CAHPS), the Initial Core Set of Health Care Quality Measures for Medicaid-Eligible Adults and/or measures endorsed by the National Quality Forum (NQF).

2.4.1.1.d. Evaluation Requirements

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The demonstration evaluation will meet the prevailing standards of scientific evaluation and academic rigor, as appropriate and feasible for each aspect of the evaluation, including standards for the evaluation design, conduct, and interpretation and reporting of findings. In addition, the evaluation design plan will include a description of how the effects of the demonstration will be isolated from those other changes occurring in the state at the same time through the use of comparison or control groups, regarding significant aspects of the demonstration.

The demonstration evaluation will use the best available data; use controls and adjustments for and reporting of the limitations of data and their effects on results; and discuss the generalizability of results.

2.4.1.2 Final Evaluation Design and Implementation

CMS shall provide comments on the draft evaluation strategy. The Contractor shall work with the State to finalize the evaluation design, and the State shall submit a final design to CMS within 60 days of receipt of CMS’s comments. If CMS has any additional comments, the Contractor will be required to update the report. This process will continue until CMS approves the final evaluation design. The State must implement the evaluation design and submit its progress in each of the quarterly and annual progress reports.

2.4.2 Quarterly Monitoring Reports

The Contractor shall draft three quarterly progress reports for each demonstration year (4-6) for the State, under the direction from FSSA staff, with the exception of DY4 when the Contractor will only be responsible for two quarterly reports. Due to the timing of the procurement, the first quarterly report in DY4 will be completed by FSSA. The quarterly reports will cover the first, second, and third quarter of each demonstration year. Quarter four of each demonstration year will be covered in the Annual Report (see Section 2.4.3).

A draft of the quarterly progress report should be submitted to the State no later than 30 days following the end of each demonstration quarter. After the submission of a draft, the Contractor shall work with the State to edit and finalize the report. The State is required to submit monitoring reports in a format agreed upon by both CMS and the State no later than 60 days following the end of each demonstration quarter. The quarterly reports shall include:

Any policy or administrative difficulties in operating the demonstration, as well as key challenges, underlying causes of challenges, how challenges are being addressed, key achievements, and to what conditions and efforts successes can be attributed;

Key performance metrics that examine outcomes of care, quality and cost of care, and access to care. The inventory of performance metrics required to be reported

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on a quarterly basis will be provided to the Contractor by the State as set forth in the required, CMS-approved Monitoring Plan;

Financial performance of the demonstration, including an updated budget neutrality workbook and quarterly expenditures associated with the populations affected by the demonstration, which will be provided by the State; and

Any results of the demonstration to date per the evaluation hypotheses.

2.4.3 Annual Monitoring Reports

The Contractor shall draft one annual monitoring report for each demonstration year describing the State’s progress during the demonstration year, under the direction from FSSA staff. A draft of the annual monitoring report should be submitted to the State no later than 45 days following the end of the demonstration year. After submission of a draft, the Contractor shall work with the State to edit and finalize the report. The State is required to submit the annual monitoring reports in a format agreed upon by both CMS and the State no later than 90 days following the end of each demonstration year. The annual monitoring reports must include all items included in each quarterly monitoring report as well as summative information about quarter four of the demonstration year, summarized to reflect the operations and activities throughout the demonstration year.

2.4.4 Mid-Point Assessment

The Contractor shall be required to conduct an independent mid-point assessment of the demonstration. The Mid-Point Assessment shall be focused on the State’s progress as articulated in the 1115 waiver implementation plan and monitoring protocol. The assessment will include an examination of progress toward meeting each milestone and timeframe as approved under the 1115 SUD Implementation Plan. The assessment will also include a determination of factors that affected achievement on the milestones and performance measure gap closure percentage points to date, as well as a determination of selected factors likely to affect future performance in meeting milestones and targets not yet met. For any milestone at risk for not being met, the Contractor will provide recommendations to FSSA for adjustments to the 1115 SUD Implementation Plan. The Midpoint Assessment must also include an assessment of budget neutrality.

The Contractor will work with all key stakeholders, including the health plans, SUD treatment providers, members, and FSSA in the development, planning, and conducting of the assessment. The Contractor will provide a summary report to FSSA that includes the methodologies used for examining progress and assessing risk, the limitations of the methodologies, all conclusions drawn up through this point of the demonstration, and any recommendations for FSSA to consider. Once completed and approved, the State will submit a copy of the report to CMS. If CMS has any additional comments, the Contractor will be required to update the report. This process will continue until CMS approves the final Mid-Point Assessment report.

The demonstration began on February 1, 2018. The Mid-Point Assessment must be completed between August 1, 2019 and January 1, 2020. The summary report should be

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provided to the State by January 15, 2020. After submission of the draft, the Contractor shall work with the State to edit and finalize the report. This report will be finalized and submitted to CMS by January 31, 2020.

2.4.5 Interim Evaluation

2.4.5.1 Draft Interim Evaluation Report

The Contractor shall draft an Interim Evaluation Report for the State, under the direction of FSSA staff. The Interim Evaluation Report shall align with and follow the CMS approved evaluation design and discuss and present findings. All outcome measures identified in evaluating the impact of the demonstration must be reported on. The report shall provide contextualize outcomes based upon baseline data and/or a comparison group. Any additional information related to the goals, objectives, and hypotheses discussed in the evaluation design shall also be included.

The draft Interim Evaluation Report is due to CMS upon submission of the waiver’s renewal or one (1) year prior to the end of the demonstration. The draft Interim Evaluation Report will be approved by the State before it is submitted to CMS.

2.4.5.2 Final Interim Evaluation Report

The Contractor shall work with the State to complete a final Interim Evaluation Report within sixty (60) days after receiving CMS comments on the draft Interim Evaluation Report. If CMS has any additional comments, the Contractor will be required to update the report. This process will continue until CMS approves the final Interim Evaluation Report.

2.4.6 Summative Evaluation Report

2.4.6.1 Draft Summative Evaluation Report

The Contractor shall draft a Summative Evaluation Report for the State, under the direction of FSSA staff. The Summative Evaluation Report will discuss the following information:

Basic information on the demonstration, including the issues that the State is trying to address with the SUD waiver

Evaluation questions and hypotheses An overview of the research that was conducted to evaluate the SUD

waiver The strengths and weaknesses of the study design, data sources, and

analyses Quantitative and qualitative results to show whether and to what degree

the evaluation questions and hypotheses of the demonstration were achieved

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General conclusions about the SUD waiver Recommendations and policy implications

The draft Summative Evaluation Report is due to CMS within eighteen (18) months of the end of the approval period. The draft Summative Evaluation Report will be approved by the State before it is submitted to CMS.

2.4.6.2 Final Summative Evaluation Report

The Contractor shall work with the State to complete a final Summative Evaluation Report within sixty (60) days after receiving CMS comments on the draft Summative Evaluation Report. If CMS has any additional comments, the Contractor will be required to update the report. This process will continue until CMS approves the final Summative Evaluation Report.

2.5 Deliverables Timeline and Schedule

The following tables detail when each deliverable will be due during each contract year. The timeline provided is based upon the 1115 waiver approval received by FSSA on February 1, 2018 and a contract for this Scope of Work beginning around May 1, 2018. Deadlines are subject to change based upon CMS requirements and the contract start date. Therefore, the State may update the timeline during contract preparation with the awarded Contractor.

Note in the following tables if a deadline is scheduled to occur on a weekend or State holiday based on the general criteria set for in Section 2.4, the deadline has been moved to the next Business Day (indicated by “*”).

2.5.1 Contract Year One (est. May 2018-April 2019)

Deliverable

Contractor Deadline for Submission to State

(“Contractor Deadline”)

State Deadline for Submission to CMS

2.4.1.1 Draft Evaluation Design June 15, 2018 July 31, 2018

2.4.1.2 Final Evaluation Design 30 days after receiving CMS written feedback

60 days after receiving CMS written feedback

2.4.2 DY 4 Quarterly Monitoring Report 2

August 30, 2018 October 1, 2018*


November 30, 2018 December 31, 2018*

2.4.3 DY 4 Annual Monitoring Report (**split across two contract years)

March 18, 2019* See Contract Year Two Table

Note: Due to the timing of the procurement, DY 4 Quarterly Monitoring Report 1 will be completed by FSSA.

2.5.2. Contract Year Two (est. May 2019-April 2020)

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Deliverable

Contractor Deadline for Submission to State



2.4.3 DY 4 Annual Monitoring Report (**split across two contract years)

See Contract Year One Table

May 2, 2019


May 30, 2019 July 1, 2019*


August 30, 2019 September 30, 2019*


December 2, 2019* January 2, 2020

2.4.5.1 Draft Interim Evaluation Report

December 15, 2019 January 31, 2020

2.4.5.2. Final Interim Evaluation Report

30 days after receiving CMS feedback

60 days after receiving CMS feedback

2.4.4 Mid-Point Assessment January 15, 2020 January 31, 20202.4.3 DY 5 Annual Report March 16, 2020 April 30, 2020 (leap

year)

2.5.3 Contract Year Three (est. May 2020-April 2021)

Deliverable

Contractor Deadline for Delivery to State




June 1, 2020* July 1, 2020


August 31, 2020* September 30, 2020


November 30, 2020 December 30, 2020

2.4.3 DY 6 Annual Monitoring Report(**split across two contract years)

March 17, 2021 See Contract Year 4 Table

2.5.4 Contract Year Four (est. May 2021-April 2022)

Deliverable




2.4.3 DY 6 Annual Monitoring See Contract Year 3 May 3, 2021*

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Report Table

2.5.5 Contract Year Five (est. May 2022-April 2023)

Deliverable




2.4.6.1 Draft Summative Evaluation Report

May 1, 2022 July 31, 2022

2.4.6.2 Final Summative Evaluation Report



2.6 Key Staff

The Contractor should submit a staffing plan with position qualifications to FSSA to ensure completion of all required deliverables. FSSA shall conduct an annual review of the Contractor’s staffing plan to determine whether any changes in the personnel or number of staff are required to complete the deliverables. FSSA shall have final approval of any replacement personnel proposed following contract activation or any time during the contract. These positions include, but are not limited to, the following:

Project Director Project Manager Data Manager Statistician

2.7 Accessing State Databases

The Contractor will be required to work with the State’s technical team to receive access to various State databases. The Contractor must be willing to sign a Data Use Agreement with the State and be able to transfer the data in a way which meets the Health Insurance Portability and Accountability Act (HIPAA) requirements for the transfer of sensitive data.

3. Billing and Invoicing

The State intends to compensate the Contractor on a deliverable basis. Each deliverable will be priced by type in the cost proposal. Payments for the following deliverables will be paid when the deliverable is delivered to FSSA on-time, approved by FSSA, finalized, and sent to CMS:

Quarterly Monitoring Report Annual Monitoring Report

Further, payment for each of the following deliverables will be made in two increments as set forth in the Deliverable Payment Schedule Table below:

Evaluation Design and Implementation

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Mid-Point Assessment* Interim Evaluation Report Summative Evaluation Report

Table: Deliverable Payment Schedule

Milestone Achieved % of Total Deliverable DueDraft deliverable approved by the State and submitted to CMS*

40% of the deliverable’s contract amount will be paid

Final deliverable approved by CMS after incorporating CMS feedback*

60% of the deliverable’s contract amount will be paid.

*Note: For the Mid-Point Assessment, the first milestone will be achieved when the draft deliverable is approved by the State, at which time the Contractor will be paid 40% of the deliverable’s contract amount. The second milestone will be achieved when the deliverable is approved by CMS, at which time the Contractor will be paid 60% of the deliverable’s contract amount.

3.1 Timeliness Performance

As untimely completion of a deliverable has less value, the following Table lists the payments due to the Contractor for the Contractor’s untimely completion of a deliverable if the Contractor fails to complete and submit an acceptable deliverable by the respective deliverable’s Contractor Deadline set forth in Section 2.5. There will be an exception if the failure to complete the milestone can be attributed to the State's material delay or material failure to comply with its obligations.

Table: Deliverable Timeline Timeliness Performance

Untimely Delivery Measurement Payment Due to ContractorDelivery more than 2 business days after Contractor Deadline

(Deliverable Cost) – (A percentage, not to exceed 5%, of the Deliverable Cost, reasonably representing the decreased value provided to the State due to the late delivery)

Delivery for each week (5 business days) after the Contractor Deadline + 2 days

(Deliverable Cost) – (A percentage, not to exceed 5%, of the Deliverable Cost, reasonably representing the decreased value provided to the State due to the late delivery)

4. Corrective Action and Payment Withholds

It is the State’s primary goal to ensure that the Contractor is accountable for delivering services as defined and agreed to in the Contract. This includes, but is not limited to, performing all items described in the Scope of Work, completing all deliverables in a timely manner described

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in the Scope of Work, and generally performing to the satisfaction of the State. Failure to perform in a satisfactory manner may result in corrective actions and withholds described below.

It is the intent of FSSA to remedy any non-performance through specific remedies and a payment withholding protocol. In the event that the Contractor fails to meet requirements set forth in the Contract, the State will provide the Contractor with a written notice of non-compliance and may require any of the corrective actions or remedies discussed below. The State will provide written notice of non-compliance to the Contractor within thirty (30) calendar days of the State’s discovery of such non-compliance.

4.1 Corrective Actions

If the State determines that the Contractor is not performing to the satisfaction of the State, has not completed any deliverable in a satisfactory or timely manner, or upon written request by the State for any reason, the Contractor shall submit, within ten (10) business days of the occurrence or State request, a Corrective Action Plan (CAP). The nature of the corrective action(s) will depend upon the nature, severity, and duration of the deficiency and repeated nature. Severity shall be determined by the State, in its sole discretion.

At a minimum, the CAP shall address the causes of the deficiency, the impacts and the measures being taken and/or recommended to remedy the deficiency, and whether the solution is permanent or temporary. It must also include a schedule showing when the deficiency will be remedied, and for when the permanent solution will be implemented, if appropriate.

4.2 Payment Withholds

Beginning the month in which a CAP is required per the Corrective Actions paragraph above, the State may withhold 10% of the following deliverable’s invoice and all subsequent billing until the CAP is implemented. When the CAP is completed and the proposed remedy is implemented, all monies withheld shall be returned to the Contractor within 30 days. Should the CAP not be submitted as required or should the remedy not be implemented within the timeframe specified by the CAP, the monies will continue to be withheld until the ability to perform in a satisfactory manner is demonstrated to the sole discretion of the State. In addition, the State reserves the right to pursue appropriate legal recourse for damages it sustains as a result of this failure to perform.

The Contractor and the State shall schedule monthly meetings to discuss the Contractor’s performance. The Contractor is required to show satisfactory progress towards milestones and otherwise provide information that can be used to show that performance is satisfactory. Scheduling of review meetings shall be agreed upon mutually between Contractor and the State.

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