MOM NOFO Final 2019 0206_v2.pdf

U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services

Center for Medicare and Medicaid Innovation

Maternal Opioid Misuse Model

Notice of Funding Opportunity Type: New

Funding Opportunity Type: Cooperative Agreement

Notice of Funding Opportunity Number: CMS-2A2-20-001

CFDA: 93.687

Notice of Funding Opportunity Posting Date: February 8, 2019

Applicable Dates:

Letter of Intent to Apply Due Date: N/A

Electronic Application Due Date: May 6, 2019

3:00 PM Eastern U.S. Time

Anticipated Issuance Notice(s) of Award: November 6, 2019

Anticipated Period of Performance: 5 Years

Table of Contents Executive Summary

A. Program Description

A1. Purpose

A2. Authority

Waiver Authority

A3. Background

A3.1 Model Overview

A3.2 Model Goals

A.4. Program Requirements

A.4.1 Medicaid and CHIP Authorities

A.4.2. Key Terms

A.4.3 Model Performance Periods and Associated Funding Structure

A.4.4 MOM Model Services and Care-Delivery Structure

A.4.5 Application Sections

A.4.6 Application Submission Requirements

A.5 Technical Assistance and Information for Prospective Applicants

B. Federal Award Information

B1. Total Funding

B2. Award Amount

B3. Anticipated Award Date

B4. Period of Performance

B5. Number of Awards

B6. Type of Award

C. Eligibility Information

C1. Eligible Applicants (select all that apply)

C2. Cost Sharing or Matching

C3. Letter of Intent

C4. Ineligibility Criteria

C5. Single Application Requirement

C6. Continued Eligibility Requirements

C7. EIN, DUNS, and SAM Regulations

D. Application and Submission Information

D1. Address to Request Application Package (select one)

D2. Content and Form of Application Submission

D3. Unique Entity Identifier and System for Award Management (SAM)

D4. Submission Dates and Times

D5. Intergovernmental Review

D6. Cost Restrictions

D7. Mandatory Disclosure

E. Application Review Information

E.1. Application Review Criteria

E2. Review and Selection Process (select one)

E3. Federal Awardee Performance Integrity Information System (FAPIIS)

F. Federal Award Administration Information

F1. Federal Award Notices

F2. Administrative and National Policy Requirements

F3. Terms and Conditions

F4. Cooperative Agreement Terms and Conditions of Award

F.5. Reporting

F.5.1. Financial Reports

F.5.2. Monitoring

F.5.3. Evaluation

F.5.4. Learning System Participation

G. CMS Contacts

G1. Programmatic and Administrative Questions

Appendix A. Guidance for Preparing a Budget Request and Narrative

Appendix B. Application and Submission Information

EIN, DUNS, AND SAM REQUIREMENTS (ALL APPLICATIONS)

APPLICATION MATERIALS AND INSTRUCTIONS TO APPLY VIA GRANTS.GOV (COMPETITIVE

APPLICATIONS)

Appendix C. Application Check-Off List Required Contents

Required Contents

Appendix D. Business Assessment of Applicant Organization

Appendix E. Review and Selection Process

Appendix F. Program Duplication Assessment Questionnaire

Appendix G. Illustrative Medicaid Services for Pregnant and Postpartum Women and Their Infants

Appendix H. Glossary Appendix I. References Appendix J. 504 Compliance…

Executive Summary

The Maternal Opioid Misuse (MOM) model provides funding opportunities for selected state Medicaid agencies to test whether payments that support evidence-based, coordinated care delivery for pregnant and postpartum women with opioid use disorder (OUD) and their infants can reduce Medicaid and Children’s Health Insurance Program (CHIP) expenditures, and improve the quality of care for this population of Medicaid and CHIP beneficiaries.

Pregnancy, a time during which women may be more engaged in their own care due to more regular interactions with the healthcare system, provides a key opportunity for focused impact on health care outcomes for pregnant women and their infants within the context of the broader opioid crisis. The MOM model will test payment and care-delivery innovation to improve outcomes and reduce costs for pregnant and postpartum Medicaid beneficiaries with OUD and their infants.

The MOM model leverages Center for Medicare and Medicaid Innovation authorities and state flexibility to address the fragmented care that the model’s focus population currently receives. The Centers for Medicare & Medicaid Services (CMS) will provide support for model awardees to design and implement state-specific interventions through funding for infrastructure and capacity development and, potentially,

1) a one-year, transitional period of care delivery, and 2) achievement of quality milestones. During the model’s five-year performance period, responsibility for funding the care-delivery innovation will transition to each state, with the ultimate goal of sustaining successful payment and care-delivery strategies through incorporation into each state’s Medicaid programs.

Item Description

HHS Awarding Agency Centers for Medicare & Medicaid Services

CMS Awarding Center Center for Medicare and Medicaid Innovation

Notice of Funding Opportunity Title Maternal Opioid Misuse Model

Authorization Section 1115A(b) of the Social Security Act (the Act) as added by Section 3021 of the Patient Protection and Affordable Care Act (P.L. 111-148)

Funding Opportunity Type New

Funding Opportunity Number CMS-2A2-20-001

Type of Award Cooperative Agreement

Catalog of Federal Domestic Assistance 93.687

Letter of Intent to Apply Due Date (if applicable)

Application Due Date & Time

May 6, 2019 3:00 PM Eastern U.S. Time

Anticipated Issuance Notice(s) of Award November 6, 2019

Anticipated Period of Performance

January 1, 2020 – December 31, 2024

Anticipated Total Available Funding $64,560,000 pending availability of funds

Estimated Number of Awards Up to Twelve (12)

A. Program Description A1. Purpose

CMS, through its Center for Medicare and Medicaid Innovation (Innovation Center), seeks applications to the MOM model: a state-driven payment and service delivery model that aims to improve quality and reduce spending for pregnant and postpartum Medicaid and CHIP beneficiaries with OUD and their infants.

The needs of this population are best served through coordinated and integrated physical and behavioral health care, including access to medication assisted treatment (MAT), and through appropriate linkages to community services. The MOM model will test whether funding states to develop and implement interventions that deliver evidence-based, coordinated care and referrals to community or other support services will improve beneficiary outcomes while reducing Medicaid expenditures. The model further addresses existing gaps by supporting state development of coverage and payment strategies that will sustain beneficiary access to high-quality, coordinated care during and after the model performance period.

CMS will award, through a competitive process, renewable one-year cooperative agreements to up to 12 successful applicants. The model will run for a five-year period. The parameters for the model are described in this Notice of Funding Opportunity announcement (NOFO).

A2. Authority The authority for the MOM model is section 1115A of the Social Security Act (the Act). Section 1115A of the Act authorizes the Secretary of the Department of Health and Human Services to test innovative payment and service delivery models to reduce Medicare, Medicaid, or CHIP expenditures while preserving or enhancing the quality of care.

Waiver Authority Under section 1115A(d)(1) of the Act, the Secretary of Health and Human Services may waive such requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii), and 1934 (other than subsections (b)(1)(A) and (c)(5) of such section) as may be necessary solely for purposes of carrying out section 1115A with respect to testing models described in section 1115A(b). For this model and consistent with this standard, the Secretary may consider issuing waivers of certain fraud and abuse provisions in sections 1128A, 1128B, and 1877 of the SSA.

Waivers are not being issued in this document; waivers, if any, would be set forth in separately issued documentation. Thus, notwithstanding any other provision of this NOFO, all awardees, subawardees, and all other relevant individuals or entities must comply with all applicable laws and regulations, except as explicitly provided in any such separately documented waiver issued pursuant to section 1115A(d)(1) specifically for the MOM model. Any such waiver would apply solely to the MOM model and could differ in scope or design from waivers granted for other programs or models.

A3. Background The Acting Secretary of the Department of Health and Human Services (HHS) declared on October 26, 2017 that the opioid crisis is a nationwide public health emergency..i,ii Opioid misuse has devastating consequences for individuals, families, caregivers, states, and communities. The impact of this crisis is significant for CMS beneficiaries, who have higher rates of opioid overdose deaths and opioid misuse-related healthcare utilization relative to the privately insured.iii,iv,v Pregnant and postpartum Medicaid beneficiaries and their infants are at particular and growing risk of harm. Substance use is now a leading cause of maternal mortality; Medicaid is the primary payer for more than 75% of maternal hospital stays related to substance use disorders; and Medicaid pays for 80% of the $1.5 billion annual cost of caring for infants exposed in utero to substances such as opioids.vi

Despite the significant and costly burden of opioid misuse in pregnancy, numerous barriers remain to delivering well-coordinated, high-quality care that improves outcomes for pregnant and postpartum women with OUD. This lack of coordination is especially problematic for a population that faces numerous multifaceted challenges, including intense stigma, in accessing health care and non-clinical social supports.

First, there is a critical lack of coordination and integration among providers caring for pregnant and postpartum women with OUD across practice settings. Second, while Medicaid affords states the flexibility to cover most needed services for pregnant and postpartum women with OUD, coverage varies widely across states and may impact access to evidence-based care.1 Third, access to substance use disorder treatment for Medicaid beneficiaries is limited because providers do not universally accept Medicaid coverage or treat pregnant and postpartum women. Finally, there is a shortage of substance use treatment and maternity care providers for pregnant and postpartum women with OUD, particularly in rural areas, where the opioid crisis is magnified.

While there is an array of ongoing federal activity to address opioid misuse among different segments of the U.S. population, existing care fragmentation and coverage variation affecting pregnant and postpartum Medicaid beneficiaries represents a critical opportunity for a payment innovation that catalyzes care transformation for this group of women.

The Innovation Center has developed the MOM model in alignment with the Administration, HHS, and other CMS initiatives responding to the unfolding public health crisis. To optimize outcomes, pregnant and postpartum women with OUD need not only consistent prenatal care and treatment for OUD, including access to MAT – delivered by a multidisciplinary team of providers – but also prompt referral to community-based services such as housing, outreach services2, and supported employment 3. Under the

1 For example, state policies may limit access to freestanding birth centers, which have been shown to improve birth outcomes for mothers and infants. See “Final Evaluation Report: Strong Start for Mothers and Newborns - Enhanced Prenatal Care Models,” Vols. 1-2 and Findings-At-A-Glance available at https://innovation.cms.gov/initiatives/strong-start/.

2 “Outreach services” would include identifying and enrolling eligible beneficiaries in coverage and providing l inkages to model services.

3 Defined at 42 C.F.R. 440.180(c)(2)(iii)(C) as “any combination of special supervisory services, training, transportation, and adaptive equipment that the State demonstrates are essential for persons to engage in paid employment and that are not normally required for nondisabled persons engaged in competitive employment.”

https://innovation.cms.gov/initiatives/strong-start/ https://innovation.cms.gov/initiatives/strong-start/

MOM model, awardees will develop and implement strategies that transform a fragmented system of care in order to improve health outcomes and reduce Medicaid expenditures associated with treating pregnant and postpartum women with OUD.

A3.1 Model Overview State Medicaid agencies (referred to as “states”) will partner with one or more local or regional entities associated with clinical delivery sites (such entity referred to as a “care-delivery partner”) to design and implement an intervention that coordinates and delivers physical and behavioral healthcare services – along with appropriate coordination, beneficiary engagement, and referrals to community or other support services – for the model population. Applicants may propose to implement the model on a statewide basis or in a clearly-defined sub-state geography. In addition to a detailed description of its proposed intervention, each applicant must propose a Coverage and Payment Strategy that addresses how it will assume responsibility for funding care-delivery during the model performance period (as applicable) and that sets out a sustainable coverage plan that will allow members of the model population to access coordination, engagement, and referrals services after they are no longer enrolled in the model. States that use CHIP funding to provide health coverage to pregnant women may include pregnant CHIP beneficiaries in their proposed model population. This strategy should leverage available Medicaid and CHIP authorities as necessary, including State Plan Amendments (SPAs) and waivers. While the MOM model does not preclude collaboration between states considering whether to apply to the model: 1) each state must submit its own application; 2) each application will be evaluated individually based on the criteria set forth in the NOFO; and, 3) each awardee will be independently responsible for meeting all requirements set forth in its individualized cooperative agreement.

MOM model funds may not be used to supplant or duplicate existing resources that cover the costs of Medicaid-covered services or administrative expenses. Rather, model funds are intended to support the development and long-term sustainability of the model intervention. These strategies may include but are not limited to: developing needed Medicaid Special Terms and Conditions (STCs) or SPAs; increasing provider capacity in the geographic area; establishing data-reporting infrastructure; strengthening collaborative relationships among providers; developing telemedicine resources; designing an optimal state Coverage and Payment Strategy; and, continuing service-delivery transformation.

A3.2 Model Goals

The model seeks improved quality of care, reduced expenditures, and improved health outcomes for pregnant and postpartum Medicaid beneficiaries with OUD and their infants, as well as sustained care transformation across participating geographies. Over the life of the model, each state is expected to fully implement successful payment and care-delivery strategies to ensure sustainability, with the ultimate goal of incorporating them into their Medicaid programs using existing Medicaid authorities. The results of this model test will also support other states and communities in implementing evidence-based payment and care-delivery strategies to better serve this population.

A.4. Program Requirements

A.4.1 Medicaid and CHIP Authorities

CMS expects that awardees will use available Medicaid and CHIP authorities as necessary to support model implementation. Individual states may need to work with CMS to request new authorities. Each MOM model applicant should incorporate a description of the Medicaid and CHIP authorities that it proposes to use to implement the model (see A.4.6., Application Submission Requirements), including authorities currently in place as well as authorities the applicant would request if their application were successful.

Information included in a MOM model application will be used solely for the purpose of application review and does not represent a formal request for a State Plan Amendment, waiver, or demonstration approval on the part of the state; nor a commitment to approval on the part of CMS. Rather, for successful applications, the identification of current and planned Medicaid authorities will help support state and federal planning efforts related to transitioning the financing of the care models from Innovation Center cooperative agreement-based funding to funding through the state Medicaid program, in compliance with applicable Medicaid statutory and regulatory requirements. During the Pre-Implementation Period of the model, each awardee will work with the Innovation Center and the Center for Medicaid and CHIP Services (CMCS) to refine and finalize the concepts detailed in its proposed implementation plan (see F.5.2., Table D, Operational Milestones).

A.4.2. Key Terms

The following key terms will be used throughout this NOFO (these and additional terms are defined in Appendix H., Glossary):

State Medicaid Agency: CMS will award funding to the state Medicaid agency, referred to throughout this NOFO as the “state, “applicant,” or “awardee,” and including state Medicaid agencies for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. As an awardee, each state will be responsible for receipt and management of award funding in accordance with the model terms and conditions and applicable federal grant laws, and accountable for meeting all requirements set out in the Terms and Conditions of Award.

Care-Delivery Partner: Each state applicant must engage one or more care-delivery partners to develop the model application and, if the state is selected as an awardee, to implement the model. A care-delivery partner must be a health system or payer, such as a Medicaid managed care plan (MCP), that is associated with a clinical delivery site. Each state will be responsible for working with its care-delivery partner(s) to:

identify, engage, and retain beneficiaries, participating providers, and clinical delivery sites in the model;

design and implement an intervention that ensures that Medicaid-covered services and model services are delivered to beneficiaries in a coordinated fashion; and ensure participation by all model partners, including the awardee, care-delivery partner, clinical delivery site providers and staff, patients and other relevant individuals or entities, in model evaluation. Although a state can work with more than one local or regional care-delivery partner to serve multiple regions or counties, only one award will be issued per state.

Model Population: The MOM model population will consist of pregnant and postpartum Medicaid and CHIP beneficiaries with OUD who reside in the awardee state. A state may include pregnant women covered by CHIP in the model population. If an awardee proposes to implement the model on a sub-state basis, the state may propose to limit eligibility based on residence in the sub-state model service area, subject to applicable Medicaid and CHIP statutory and regulatory requirements. An individual will be eligible to receive model services if she is pregnant, has OUD, and is eligible for and enrolled in Medicaid. A beneficiary will be considered enrolled in the model when she has been screened for and diagnosed with OUD, has an established initial treatment plan for OUD, and has provided the necessary consent and authorization documents to allow for information-sharing among providers and plans.

Beneficiary Engagement: A beneficiary who is enrolled in the model and has received a physical or behavioral healthcare service, as defined in this NOFO, in a given calendar month, is considered engaged in the MOM model in that calendar month. A beneficiary who is enrolled in the model but has not received a physical or behavioral healthcare service, as defined in this NOFO, in a given calendar month is considered disengaged from the MOM model in that calendar month. An awardee’s eligibility to access Transition Funding, if available, varies based on a beneficiary’s engagement status (see B.2, Award Amount).

Model Intervention: Each awardee must design and implement a model intervention that delivers comprehensive physical and behavioral healthcare services in key categories of care to its model population and that provides coordination of services, beneficiary engagement, and referrals for necessary community or other support services. Additional information about required services is set out below in A.4.4., MOM Model Services and Care Structure. Each awardee must provide a plan for the provision of care by a multi-disciplinary team of healthcare professionals across a variety of settings, which may include co-located providers. The intervention may be implemented statewide or in a clearly defined sub-state geography and may build on but may not supplant or duplicate existing efforts.

Coverage and Payment Strategy: Each awardee must develop and implement a realistic, actionable, and sustainable Coverage and Payment Strategy. The Strategy must explain how the awardee will fund model services and establish coverage policies that ensure that members of the model population have access to such services, i.e., intake, assessment, creation of a treatment plan and coordination, engagement, and referral services. Each state has the flexibility to propose a Coverage and Payment Strategy tailored to the needs of its population and proposed service area, and the parameters of its State Plan, but is expected to consider State Plan Amendments and program waivers as necessary. The Coverage and Payment Strategy must be fully implemented by Year 3 of the model, but applicants will be expected to propose strategies that will sustain model interventions after the end of the model performance period.

Postpartum Period: Postpartum continuity of care is critical to success of the model, including maintaining both maternal and infant well-being as well as combatting the risk of relapse for women with OUD during the postpartum period. At a minimum, each awardee must ensure that members of its model population can access services throughout the postpartum period through the end of the month in which the 60-day period (beginning on the last day of her pregnancy) ends, as required by 42 U.S.C. 1396(a)(e)(5). Each applicant must address care for its model population during the postpartum period in its Coverage and Payment Strategy. Each applicant also has the opportunity to earn additional points toward its overall application score based on the proposed scope of services in its strategies, duration of extended access to these services, and overall long-term sustainability of its postpartum plans.

A.4.3 Model Performance Periods and Associated Funding Structure

Each state and its care-delivery partner(s) will implement the model during three distinct model performance periods: the Pre-Implementation Period (Year 1); Transition Period (Year 2); and Full Implementation Periods (Years 3, 4, and 5).

Table A sets out a non-exhaustive list of potential state and care-delivery partner activities during each model performance period. (Note that each care-delivery partner will perform its duties pursuant to its independent agreement with the awardee.)

Table A. Potential State and Care-Delivery Partner Activities by Model Period

State Care-Delivery Partners Pre- Implementation Period (Year 1)

• Develop state Coverage and Payment Strategy

• Develop related demonstration Special Terms and Conditions waiver or SPA submissions

• Work with CMCS to ensure necessary authorities are or will be in place to operate model in implementation period

• Develop and prepare to operationalize care-delivery model

• Strengthen provider collaborations

• Increase providers’ capacity in geographic area

State Care-Delivery Partners

• Ensure provision of usable claims and encounter data as necessary to operate and evaluate model

• Coordinate with care-delivery partners to support information-sharing, to the extent permitted by law

• Report required data to the Innovation Center in accordance with award

• Develop any needed telemedicine resources

• Establish data-reporting infrastructure

• Develop information-sharing system and processes

• Report required data to the Innovation Center in accordance with award

Transition Period (Year 2)

• Finalize a state Coverage and Payment Strategy

• Secure approval for related demonstrations, waivers or SPAs

• Coordinate with non-state partners to support information-sharing, to the extent permitted by law

• Report required data to the Innovation Center in accordance with award

• Implement care-delivery model, funded by section 1115A

• Report required data to the Innovation Center in accordance with award

Full Implementation Period (Years 3-5)

• Implement Coverage and Payment Strategy in Medicaid FFS, managed care, or other delivery system

• Innovation Center Transition Funding terminates; the state takes on financial responsibility for these services

• Report required data to the Innovation Center in accordance with award

• Implement care-delivery model, funded by state Medicaid and other sources identified in the Coverage and Payment Strategy

• Operate information-sharing system

• Report quality milestones

• Report required data to the

Innovation Center in accordance with award

These performance periods are associated with specific funding, described in more detail in Section B.2, Federal Award Information, Award Amount, Table B:

• Implementation Funding will be available annually during each year of the model to support infrastructure and capacity-building.

• Transition Funding will be available during the Transition Period only to support intake, assessment, and the creation of a treatment plan (once per pregnancy per beneficiary) and coordination, engagement, and referral activities (ongoing for up to 12 months) not otherwise covered by Medicaid.

Model funds may not be used to supplant or duplicate existing funding sources. The state must assume these costs in alignment with its Coverage and Payment Strategy by Year 3.

• Milestone Funding will be available during the Full Implementation Period based on each awardee’s demonstrated performance on pre-determined quality milestones.

Award amounts will vary based on the variations in healthcare costs in the awardee geography and the needs demonstrated by each applicant in its responses to this NOFO. For example, the amount of Transition Funding would take into account existing coverage of coordination, engagement, and referral activities in an applicant’s State Plan. Figure 1 sets out MOM Model Periods and Associated Funding.

Figure 1. MOM Model Performance Periods and Associated 1115A Funding to States

A.4.4 MOM Model Services and Care-Delivery Structure

An awardee’s model population must have access to a combination of physical and behavioral healthcare services, billed as usual to Medicaid, in addition to intake, assessment, and creation of a treatment plan and coordination, engagement, and referral services (see Appendix H, Glossary). Coordination, engagement, and referrals not covered by Medicaid (but not the care itself) will be supported by model funding in the Transition Period (Year 2) only.

Each awardee must ensure that its model population has access to evidence-based OUD treatment consistent with current clinical guidelines. CMS recognizes that clinical guidelines may change during the course of the model. An awardee that wishes to change the services that it makes available to its model population in response to changes in clinical guidance must obtain prior written approval from CMS. Each awardee must fund payment for all coordination, engagement, and referral services based on their coverage and payment strategies during the Full Implementation Period (Years Three through Five). Model funds may not be used to cover the cost of any Medicaid-covered service at any time during the model.

Figure 2 illustrates the MOM model care-delivery structure. As the figure shows, the MOM model would encompass care from the prenatal through the postpartum period. Within this structure, covered clinical and behavioral healthcare services would be billed as usual to Medicaid, including well-woman care, OUD treatment, prenatal and postpartum care, labor and delivery, and infant care (including NICU stays). Figure 2 also highlights the patient intake, assessment, treatment planning, coordination, engagement, and referral services that would be paid for through MOM model Transition Funding in Year 2 of the model. In Years 3-5, all of the services included in the care-delivery model are expected to be covered through the state Medicaid program.

Transition Period Year 2

Full Implementation Period Years 3, 4, and 5

• Annual Implementation Funding

• Transition Funding (Restricted and not guaranteed)

• Milestone Funding (Restricted and not guaranteed)

Pre-Implementation Period Year 1

Figure 2. MOM Model Care-Delivery Structure

A.4.4.1 Physical and Behavioral Healthcare Services

Awardees will be responsible for ensuring that beneficiaries participating in the model can access a set of essential physical and behavioral healthcare services in each of the categories below. These services, would be billed as usual to Medicaid and include:

• Physical health care: MAT for OUD, maternity care, and relevant primary care services; and

• Behavioral health care: mental health and other appropriate addiction services beyond MAT.

A.4.4.2 Coordination, Engagement, and Referral Services

The model will also require awardees to coordinate care, engage beneficiaries, and provide referrals for community and other support services. These additional model components will complement the current set of Medicaid-covered services to meet the model population’s comprehensive needs, including referrals for health-related social needs. Each state will have flexibility in defining the specific set of services that satisfy the following five components:

• Comprehensive care management;

• Care coordination;

• Health promotion;

• Individual and family support; and,

• Referral to community/support services (see Appendix H).

CMS will review the proposed set of services to ensure that each applicant will provide services in each of the five components. See Appendix G for an illustrative list of services for this population across categories (physical and behavioral health care, coordination, engagement, and referral services).

A.4.4.3 Recommended Optional Partners (Not Required)

Each state and its care-delivery partners may consider engaging and coordinating with entities other than clinical delivery sites in order to promote model goals and address the comprehensive needs of the model’s population. Such recommended partnerships could include the following entity types:

• Single State Agency for substance abuse services

• State and/or local public health agencies

• Child welfare agencies

• Justice system components, including problem-solving courts focused on family, substance use, and juvenile issues

• Civil legal aid organizations

• State or regional perinatal quality collaboratives

• Local government entities

• Area hospitals

• Local academic institutions and researchers

• Homeless and other temporary shelters

• Professional organizations

• National/local branches of advocacy organizations

• Home visiting programs

• Early intervention services

• Early care and education programs

A.4.5 Application Sections

Applicants for the MOM Model must submit a Model Implementation Plan, Model Impact Analysis, completed Model Budget Narrative, and Program Duplication Questionnaire. Model application sections are as follows:

- Model Context

A.4.6.1 Statement of the Problem and Gap Analysis A.4.6.2 Characteristics of the Proposed Model Service Area and Model Population

- Model Implementation Plan A.4.6.3 Intervention Design A.4.6.4 Coverage and Payment Strategy A 4.6.5 Sustainability Plan

- A.4.6.6 Memorandum/a of Understanding

- Data-Sharing, Reporting, and Evaluation Plan

A 4.6.7 Data-Sharing Capacity and Plan A 4.6.8 Reporting Plan A.4.6.9 Evaluation Plan

- Model Impact Analysis A 4.6.10 Impact on Quality of Care A 4.6.11 Cost Savings Projection

- A.4.6.12 Organizational Capacity of Applicant and Care-Delivery Partner

- A.4.6.13 Model Budget Narrative

- A.4.6.14 Program Duplication Assessment

A.4.6 Application Submission Requirements

MOM model applicants must address the following areas in their applications. CMS reserves the right to request that an applicant revise or otherwise modify its proposal and budget based on CMS recommendations.

Model Context

The applicant should use this section to describe the current state of care for pregnant and postpartum women with OUD within the proposed model service area.

A.4.6.1 Statement of the Problem and Gap Analysis Applicants must provide a narrative that identifies the current process(es) for identifying and treating pregnant and postpartum women with OUD in the proposed model service area. The Statement of the Problem should include a Gap Analysis that identifies the gaps in providing, funding, and ensuring access to comprehensive physical and behavioral health care for this population; and, explain how participating in the model will address these gaps.

A.4.6.2 Characteristics of Proposed Model Service Area and Model Population Applicants must clearly identify the geographic area(s) in which they propose to implement the model.

Descriptions could include ZIP codes; identification of political subdivisions such as counties, parishes, or cities; census tracts; any other unit that will unambiguously specify the boundaries of the geographic focus area; or, whether the model service area will include all political subdivisions within the state. Any applicant that proposes to conduct the model test in one or more sub-state regions must include a justification for focusing on such particular sub-state region(s). An applicant that proposes to conduct the model test on a sub-state basis must indicate whether eligibility for model services will be limited to beneficiaries who reside in the sub-state region(s), to the extent permitted by Medicaid and CHIP requirements.

The applicant must provide information about the population of pregnant and postpartum women residing in the proposed model service area using the following data points:

1. Number and percentage of births in the proposed geographic service area(s) covered by Medicaid and

CHIP, by age and ZIP code for years 2016-2018. Note that if an applicant does not have data for one or more years in this required range, it should provide an explanation and, if possible, a proxy in the form of the most recent year that is available.

2. Description of current healthcare provider and treatment capacity, including information about

Medicaid beneficiary access to relevant providers and treatment facilities, within the proposed model service area for the types of care listed below. Applicants should use this section to identify the current capability of their provider networks, practices, and health systems to support coordinated care for the model population.

a.) Behavioral health care for pregnant and postpartum Medicaid beneficiaries with OUD; applicants should specifically describe availability of and access to MAT for Medicaid beneficiaries b.) Maternity care providers (prenatal, peripartum, and postpartum care) for Medicaid beneficiaries c.) Neonatal care for substance-exposed infants, including protocols for diagnosing and treating neonatal abstinence syndrome, for Medicaid beneficiaries

3. Description of opioid use among the model population within the proposed model service area, including the following data points for years 2016-2018:

a.) Number of opioid overdoses (fatal and non-fatal) among women ages 15-44 b.) Number of women enrolled in Medicaid between the ages of 15-44 who have been identified as having opioid use disorder (OUD) c.) Numbers of emergency department visits and hospital inpatient admissions for pregnant

Medicaid beneficiaries with and without substance use disorders d.) Total number of treatment admissions for pregnant Medicaid beneficiaries to facilities that are licensed or certified by the State substance use agency to provide substance use disorder treatment e.) Number of infants born with neonatal abstinence syndrome (NAS) in the proposed model service area f.) Number of Neonatal Intensive Care Unit (NICU) admissions associated with NAS, and total number of NICU admissions g.) Average length of stay (LOS) for infants admitted to the NICU with NAS or NOWS, and average NICU LOS for infants without NAS h.) At the discretion of the applicant, no more than three additional data points relevant to the impact of the opioid crisis on the model population within the proposed geographic service area.

Provision of any additional data provided in response to h.) Is optional and will count towards page limit for the Project Narrative.

If any of the data requested above are not available, the applicant should provide an explanation for why such data are not available and, if possible, a proxy for each missing data point. Note that each applicant must also provide a detailed plan for gathering and sharing critical data in the Model Implementation section below. Applicants should provide verifiable sources for all data points.

Model Implementation Plan

Applicants must submit information on their proposed Intervention Design and Coverage and Payment Strategy and a Sustainability Plan. Applicants must include all subsections of their implementation plan within their Project Narrative.

A.4.6.3 Intervention Design Applicants must provide a detailed description of their proposed model intervention. This description must identify the following elements:

1. Expected number of beneficiaries to be (a) screened for eligibility to enroll in the model and (b) and enrolled in each year of the model.

2. A clear statement indicating whether the applicant proposes to impose a maximum number of beneficiaries the model would serve at a given time. If so, the applicant must provide an explanation for why it believes an enrollment maximum is necessary; how the enrollment maximum will be designed and implemented (including the existing Medicaid authority that would permit a beneficiary cap, the number of enrollees who would be permitted to enroll over a specified time period, and a waitlist policy); and, how the applicant proposes to ensure access to usual care for Medicaid beneficiaries who seek model services if enrollment is closed due to the cap.

3. Strategy for identifying and enrolling individuals eligible for model services. This strategy should identify and describe all proposed points of entry for potential model enrollees and a plan for notifying beneficiaries when they have been enrolled in the model.

4. Plan for screening beneficiaries enrolled in the model to identify health-related social needs.

Applicants should identify a validated screening tool that the applicant will use to screen beneficiaries.

This tool must screen beneficiaries, at minimum, for unmet needs across the following six domains:

housing, food, transportation, utilities, interpersonal safety, and family and community support. The plan identified in response to this requirement should explain how the results of each screening will be integrated into the coordination, engagement, and referral activities detailed in the intervention design. (See Section F.5.2.2, Performance Milestones, for information about Milestone Funding separately associated with health-related social needs screening.)

5. Strategy for verifying beneficiary contacts during the course of the model, including a process for responding to CMS program audits of reported beneficiary contacts by the awardee and the care-delivery partner.

6. Description of the model’s proposed timeline for postpartum coverage, including the length of time after delivery model enrollees will be eligible for (a) Medicaid coverage and (b) model services. The applicant should use this section to explain how it will ensure that all beneficiaries who participate in the model will continue to have access to critical physical and behavioral healthcare services following delivery, including beneficiaries who are no longer eligible for Medicaid or model services. (Note that applicants must set out their proposed Coverage and Payment strategy in A.4.6.6, including a postpartum plan that meets minimum statutory requirements. Applicants have the opportunity to earn additional points based on access to services, duration of coverage, and sustainability of postpartum plans.)

7. Plan for successfully implementing the proposed intervention within the context of laws, regulations, or policies (including policies of individual clinical delivery sites) that relate to substance use during pregnancy or as a parent. The applicant should also explain how it will inform beneficiaries of the implications of these policies and address beneficiary, provider, and other stakeholder concerns related to their enforcement.

8. Description of services that will be available to model enrollees. Each awardee must propose a set of services that address physical and behavioral health care and care-delivery activities including coordination, engagement, and referrals. Physical and behavioral healthcare services must include prenatal, peripartum, and postpartum services and comprehensive treatment for opioid use disorder, including access to MAT. Coordination, engagement, and referral activities must address each the following five components: (1) comprehensive care management, (2) care coordination, (3) health promotion, (4) individual and family support, and (5) linkages to community/support services. (Note that applicants will be required to set out their strategy for coverage and payment of these services in A.4.6.6).

9. Plan for retaining beneficiaries once enrolled in the model. Each applicant should address the role of relapse in treating OUD and define the set of activities that will constitute “substantial outreach” to beneficiaries who are disengaged from care. A beneficiary who is enrolled in the model but has not received a physical or behavioral healthcare service in a given calendar month is considered disengaged from the MOM model in that calendar month. (See A.4.2, Key Terms – Beneficiary Engagement).

10. Explanation for how services identified above, including Medicaid-covered services and model services, will be coordinated in order to deliver care to beneficiaries participating in the model. (Note that applicants will be required to set out their data-sharing strategy in A.4.6.8).

11. The full legal name, all DBAs, address, Tax Identification Number (TIN), and National Provider Identification (NPI) number (if applicable) of each care-delivery partner. For each care-delivery partner, the state must verify its compliance with any applicable Medicaid Program Integrity requirements at 42 C.F.R. Part 455.

12. Description of each care-delivery partner’s capacity to engage clinical delivery sites, including a strategy for engaging these sites and/or an identification of sites that have been engaged at the time of application.

13. Strategy for identifying and recruiting sufficient providers to participate in the model, including physical and behavioral health care providers and care coordinators. This strategy should be aligned with the proposed set of services also required in this section; for example, if a state proposes to make buprenorphine available as one treatment option for all enrollees, it should present evidence that the model will recruit a sufficient number of potential certified prescribers.

14. Description of the nature of the financial relationships (including any downstream relationships) that the applicant foresees pursuing in an effort to achieve the goals of the MOM model. Examples of financial relationships could include, but are not limited to, relationships with care-delivery partners, participating healthcare providers and facilities, community partners, and any other entity with whom the applicant proposes establishing a financial relationship.

15. Plan for selecting and monitoring participating providers to serve beneficiaries enrolled in the model.

This plan must set out the standards that each awardee and its care-delivery partner(s) will use to select and maintain a qualified pool of participating providers. Past or future referrals may not serve as the basis for selecting or retaining participating providers.

16. Plan, including a detailed timeline, for engaging Medicaid Managed Care Programs (MCPs) in the proposed model service area (if applicable). Regardless of the care-delivery partner, awardees will be expected to work with MCPs (as applicable) during the model Pre-Implementation Period to support the implementation of the payment model and ensure that existing MCP care coordination and case management efforts are aligned with the MOM model.

17. Any other information about the proposed implementation design that the applicant believes should be considered.

A.4.6.4 Coverage and Payment Strategy

Each Applicant must detail its proposed Coverage and Payment Strategy for the intervention set out at A.4.6.6. Additionally, the applicant should use this section to present its plan to sustain the intervention implemented through the model in the Medicaid program following the end of the model performance period.

Applicants should describe in detail their strategy for ensuring that model enrollees can access all services identified in the model design and implementation plan above. This strategy should address how the state will determine that prospective model enrollees are eligible for Medicaid; coverage of physical and behavioral healthcare services and care coordination; and funding to support delivery of these services to model enrollees. State-specific factors could influence a state’s strategy, including: existing demonstrations and SPAs; extent of managed-care penetration in the state; broader OUD/SUD efforts; coverage of pregnant women through CHIP; and, the potential for non-model financial incentives provided by the federal government for the uptake of certain flexibilities (e.g., enhanced match for health homes).

Examples of the questions that an applicant should address in its Coverage and Payment strategy include:

• Which Medicaid benefit categories does the state expect to use for submitting a Medicaid State Plan

Amendment (OAGM) or SPAs by the Transition Period (Year 2) to cover any new Medicaid services, if necessary?

• How does the state anticipate meeting federal Medicaid State Plan requirements of statewideness, comparability, and freedom of choice of provider for these services, or requesting authority to waive those requirements? If the model is focused on sub-state regions rather than the entire state, strategies might require an Innovation Center or Medicaid waiver for statewideness prior to receipt of Innovation Center funding in the Transition Period.

• How will the state comply with Early and Periodic Screening, Diagnostic, and Treatment rules that require that all children under 21 (not limited to beneficiaries enrolled in the model) receive medically necessary 1905(a) State Plan services?

• What is the proposed length of time for providing services to postpartum model enrollees? Does the state propose to extend care to the model population beyond the current eligibility period in the state’s existing plan? If so, what is the coverage and payment strategy for supporting this approach?

• Does the applicant propose to include any patient engagement incentives? If so, what incentives are proposed, how would they be funded and monitored by the awardee, and how would beneficiaries qualify for and access incentives?

Coverage Strategy: With respect to coverage, the strategy description must identify any changes to the Medicaid program that the applicant proposes to implement in order to carry out the model; any partners external to the state Medicaid agency who will be involved in executing these changes (including other state agencies); and, a timeline for developing, negotiating, and finalizing these changes. Specifically, the applicant should provide a detailed timeline for developing and implementing any applicable SPAs, waivers and demonstrations, changes to MCP contracts, changes to provider rates, and state regulatory and legislative changes necessary to enable a coverage and/or payment strategy necessary to fulfill the MOM model requirements.

1115A Funding: With respect to Innovation Center funding, the applicant must propose an annual budget that distinguishes between a) Implementation Funding; and b) Transition Funding. If the applicant is requesting Implementation Funding, it must specify, for each of the five years of the model, the level of funding requested and how the funding will support the model intervention set out in A.4.6.4. If the applicant is requesting Transition Funding for the Transition Period of the model, it must specify, for Year 2 only, the level of funding requested and how the funding will support the model implementation plan set out in A.4.6.4. Table A in A.4.3., Model Performance Periods and Associated Funding Structure, includes a non-exhaustive list of examples of potential annual Implementation Funding activities.

Medicaid Funding: The applicant should identify how the state will use Medicaid funding in both a) the Transition Period; and b) the Full Implementation Period.