r:k - West Virginia Department of Health and Human Resources

r:k DËPARTMENT OI.¡ HEALTI.I & HUMAN SERVICES Centers lor Medlcaro & Modicaid Servicos

ücT -6 1017

AdmínistratorWashlngton, DC 20201

Cynthia BeaneCommissionerBureau for Medical ServicesWest Virginia Departrnent of Health and Human Resources

350 Capitol St., Room 251

Charleston, WV 25301

Dear Ms. Beane:

We a¡e pleased to inform you that the Centers for Medicare & Medicaid Services (CMS) has

approved West Virginia's new five-year section I I l5 demonstration, entitled "Creating a

Continuum of Care for Medicaid Enrollees with Substance Use Disorders" (Project Number: I l-W-00307/3). This approval is effective January 1, 2018, through December 31,2022. This approvalauthorizes $/est Virginia to strengthen its substance use disorder (SUD) delivery system toimprove the care and health outcomes for West Virginia Medicaid beneficiaries with SUDthrough expanded SUD service coverage and the introduction of new programs to improve thequality of care.

This demonstration also authorizes West Virginia to implement a new SUD benefit and introduce

SUD delivery system reforms. The West Virginia SUD demonstration, which contributes to acomprehensive statewide strategy to combat prescription drug misuse and opioid use disorders,expands the SUD benefits package to cover the full continuum of SUD treatment, includingmethadone treatment services, peer recovery support servicesn withdrawal management servicesand short-term residential services to all Medicaid enrollees. The demonstration advances thepurposes of the Medicaid program by expanding the SUD benefits package, which is expected toimprove health outcomes for Medicaid beneficiaries. In addition, the demonstration advanses

the purposes of the Medicaid progrâm by inueasing ascess to high quality SUD care and

expanding the SUD provider networks available to serve Medicaid populations.

In implementing the SUD demonstration, West Virginia is delivering SUD services throughcomprehensive managed care plans for managed care enrollees and introducing new policy,provider and managed care requirements to improve quality of the care delivered to WestVirginia Medicaid beneficiaries and to ensure that SUD treatment services are deliveredconsistent with national treatment guidelines established in the American Society of AddictionMedicine (ASAM) Criteria. Importantly, the state will assess short-term residential treatmentproviders as delivedng care consistent with the ASAII4 Criteria prior to their participating in theprogram. In addition, West Virginia is taking steps to improve the quality and access to care forWest Virginia Medicaid beneficiaries with SUD, such as introducing new care coordinationfeatures and collecting and reporting quality and performance measures.

-Ms. Cynthia Beane

Notably, V/estVirginiawill implement increased responsibilities to monitor, report on, andevaluate the impact of this demonstration. We support West Virginia's efforts to improve the careand outcomes for individuals with SUD.

The demonstration is approved in accordance with section I I ls(a) of the Social Securíty Act.CMS approval of this section 1115 demonsüation is subject to the limitations specified in theapproved waiver authorities and compliance with ttre enclosed special terms and conditions (STCs)defining the nature, character, and extent of federal involvement in this project. The state may deviatefrom the Medicaid state plan requirernents only to the extent those requirements have been waived orspecifically listed as not applicable to the expenditure authority. The approval is subject to CMSreceiving your written acknowledgment of the award and acceptance of these STCs within 30 days ofthe date of this letter. A copy ofthe STCs and expenditure authorities are enclosed.

Pleæe send your written acceptance and any communications or official conespondence concerningthe demonsüation to your project officer, Mr. Felix Milbum. He is available to answer anyquestions concerning your section 1l 15 demonstration. Mr. Milburn's contact information is as

follows:Centers for Medicare & Medicaid ServicesCenter for Medicaid and CHIP ServicesMail Stop: 5241-167500 Security BoulevardBaltimore, MD 21244- I 850Telephone: (410) 786-13 1 5

E-mail : [email protected]

Offrcial communications regarding progr¿rm matters should be sent simultaneously toMr. Milburn and to Mr. Francis McCullough, Associate Regional Administrator in ourPhiladelphia Regional Office. Mr. McCullough's contact information is as follows:

The Public Ledger Building150 South Independence Mall West, Suite226Philadelphia, PA 19106Email : Francis. Mccullough@c$s.lrhs. gov

If you have questions regarding this approval, please contact Ms. Judith Cash, Acting Director,State Demonstrations Group, Center for Medicaid & CHIP Services, at (410) 786-9686. Thankyou for all your work wíth us on this new demonstration'

Sincerely,

Seema Venna

Enclosu¡es

CENTERS FOR MEDICARE & MEDICAID SERVICESEXPENDITURE AUTHORITY

NUMBER:

TITLE:

11-W-00307/3

West Virginia Continuum of Care for Medicaid Enrollees withSubstance Use Disorders

AWARDEE: West Virginia Depârtment of Health and Hurnan Services

Under the authority ofsection 1115(a)(2) ofthe Social Security Act (the Act), expenditures madeby West Virginia for the items identified below, which are not otherwise included as

expenclitures rmcler section 1903 ofthe Act shall, for the period of this demonstration, beregarded as expenditures under the state's title XIX plan.

The following expenditure authorities may only be implemented consistent with the approvedSpecial Terms and Conditions (STCs) and shall enable West Virginia to operate its section I I 15

demonstration.

The expenditure authorities listed below promote the objectives of title XIX in the followingways:

o Improves health outcomes for Medicaid and other low-income populations in the state bycovering treatment not otherwise covered by the state plan, and by making coveredtreatments available to previously excluded patients in institutions of mental disease(IMDs).

1. Residential Treatment for Individuals with Substance Use Disorder (SUD).Expenditures for otherwise covered services furnished to otherwise eligible individuals whoare primarily receiving treatment and withdrawal management seruices for SUD who are

sho¡t-term residents in facilities that meet the definition ofan institution for mental disease(IMD).

2. Methadone Treatment. Expenditures for services that could be covered under theMedicaid state plan; however, the state has elected to cover the services through expenditureauthority instead.

3. Peer Recovery Support Services. Expenditures for services that could be covered under theMedicaid state plan; however, the state has elected to cover the services through expenditureauthority instead.

West Virginia Continuum of Care for Medicaid Enrollees with SUDDemonshation Approval Period: January 1,2018 through Decembet 3I,2022

Page 1 of 1

NUMBER:

TITLE:

AWARDEE:

CENTERS F'OR MEDICARE & MEDICAID SERVICESSPECIAL TERMS AND CONDITIONS

11-W-00307/3

West Virginia Continuum of Care for Medicaid Enrollees withSubstance Use Disorders

West Virginia Department of Health and Human Services

I. PREF'ACE

The following are the amended Special Terms and Conditions (STCs) for West Virginia'sSubstance Use Disorders (SUD) section 1 I 15(a) Medicaid demonstration (hereinafter referred toas "demonstration"). The parties to this agreement are the west virginia Department of Healthand Human Services ("state") and the Centers for Medicare & Medicaid Services (CMS). TheSTCs set forth in deiail the nature, character, and extent of federal involvement in thedemonstration and the state's obligations to CMS during the life of the demonstration. The STCswere approved on October 6,2017, for the period of January 1, 2018 through December 31,2022.

The STCs have been arranged into the following subject areas:I. PrefaceII. Program Description and ObjectivesIII. General Program RequirementsIV. Substance Use Disorder DemonstrationV. General Reporting RequirementsVI. Evaluation of the DemonstrationVII. GeneralFinancialRequirementsVm. Monitoring Budget Neutrality for the DemonstrationIX. Schedule of the State Deliverables during the Demonstration

Additional attachments have been included to provide supplementary information and guidancefor specific STCs.

Attachment A: Developing the Evaluation DesignAttachment B: Preparing the Interim and Summative Evaluation ReportsAttachment C: SUD Monitoring Plan Protocol [RESERVED]

II. PROGRAM DESCRIPTION AND OBJECTIVES

The Substance Use Disorder (SUD) demonstration is a demonstration program to test a newparadigm for the delivery of SUD services for all Medicaid enrollees. The SUD programdemonstrates how comprehensive and high quality substance use disorder care can improve thehealth of Medicaid recipients while decreasing other health care system (such as emergency

!ùy'est Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1, 2018 through December 3 l, 2022

Page I of 37

department and inpatient hospital) costs. Critical elements ofthe SUD demonstration includeproviding a continuum of care modeled after the American Society of Addiction MedicineCriteria (ASAM Criteria) for SUD heatment services, inhoducing policy and program guida¡ceto ensure providers meet the ASAM Criteria standards ofcare, integrating SUD treatmentservices into a comprehensive managed care delivery system for those recipients receivingmanaged care under 1915(b) waiver authority; implementing utilization controls to improve careand ensure effrcient use ofresources; and implementing strategies to improve the quality ofcarethrough evidence-based best practices. This approach is expected to provide West VirginiaMedicaid recipients with access to the care needed to achieve sustainable recovery.

Under this demonstration West Virginia expects to achieve the following to promote theobjectives of title XIX:

Improve quality of care and population health outcomes for Medicaid enrollees withSUD;Increase enrollee access to and utilization of appropriate SUD treatment services basedon the ASAM Criteria;Decrease medically inappropriate a¡d avoidable utilization of high-cost emergencydepartment and hospital services by enrollees with SUD; and

Improve care coordination and care hansitions for Medicaid enrollees with SUD.

III. GENERAL PROGRAM REQUIREMENTS

Compliance with F ederal Non-Discrimination Statutes. The state must comply withall applicable federal statutes relating to non-discrimination. These include, but are notlimited to, the Americans with Disabilities Act of 1990, title VI of the Civil Rights Act of1964, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act oft975.

2. Compliance with Medicaid Law, Regulation, and Policy. All requirements of theMedicaid program expressed in law, regulation, and policy statement, not expresslyidentified as not applicable in the expenditure authority documents (of which these termsand conditions are part), must apply to the demonstration.

3. Changes in Medicaid Law, Regulation, and Policy. The state must, within the timeframes specihed in law, regulation, or policy statement, come into compliance with anychanges in federal law, regulation, or policy statement, affecting the Medicaid programthat occur during this demonstration approval period, unless the provision being changedis expressly identified as not applicable.

4. Impact on Demonstrâtion of Changes in Federal Law, Regulation, and PolicyStâtements.

A. To the extent that a change in federal law, regulation, or policy requires either areduction or an increase in federal financial participation (FFP) for expenditures madeunder this demonstration, the state must adopt, subject to CMS approval, a modified

rùr'est Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1,2018 through December 31, 2022

a

o

a

Page 2 of 37

budget neutrality agreement for the demonstration, as necessary, to comply with suchchange. The modified budget neutrality agreement will be effective upon theimplementation of the change.

B. If mandated changes in the federal law require state legislation, the changes must takeeffect on the day such state legislation becomes effective, or on the day suchlegislation was required.to be in effect under the federal law.

State Plan Amendments. The state shall not be required to suhmit title XIX state planamendments for changes affecting any populations made eligible solely through thedemonstration. If a population eligible through the Medicaid state plan is affected by achange to the demonstration, a conforming amendment to the state plan will be required,except as otherwise noted in these STCs.

6. Changes Subject to the Amendment Process. Changes related to eligibility,enrollment, benefits, enrollee rights, delivery systems, cost sharing, evaluation design,sources of non-federal share of funding and budget neutrality must be submitted to CMSas amendments to the demonstration. All amendment requests are subject to approval atthe discretion ofthe Secretary in accordance with section 1115 ofthe Social Security Act(the Act). The state must not implement changes to these elements without priorapproval by CMS. Amendments to the demonstration are not retroactive and FFP willnot be available for changes to the demonstration that have not been approved throughthe amendment process set forth in STC 7 below.

7. Amendment Process. Requests to amend the demonstration must be submitted to CMSfor approval no later than one hundred twenty (120) days prior to the planned date ofimplementation of the change and may not be implemented until approved. CMSreserves the right to deny or delay approval ofa demonstration amendment based on non-compliance with these STCs, including but not limited to failure by the state to submitrequired reports and othü deliverables in a timely fashion according to the deadlinesspecified herein. Amendment requests must include, but are not limited to, the following:

A. An explanation of the public process used by the state, consistent with therequirements of STC 14, to reach a decision regarding the requested amendment;

B. A data analysis which identifies the specific "with waiver" impact of the proposedamendment on the cunent budget neutrality agreement. Such analysis shall includetotal computable "with waiver" and "without waiver" expenditure estimates as wellas the current federal sha¡e of the "with waiver" and "without waiver" estimates. Thedata analysis shall contain both summriry and detailed level expenditure data throughthe current approval period using the most recent actual expenditures that illustratesthe change in the "with waiver" expenditure total as a result of the proposedamendment, which isolates (by Eligibility Group) the impact of the amendment;

C. A detailed description of the amendment, including impact on beneficiaries, withsufficient supporting documentation; and

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1,2018 through December 31,2022

Page 3 of 37

D. If applicable, a description of how the evaluation design will be modified toincorporate the amendment provisions.

8. Extension of the Demonstration. No later than twelve (12) months prior to theexpiration date ofthe demonstration, the governor or chief executive offrcer of the statemust submit to CMS notification that it expects to cover individuals under the Medicaidstate plan or through some other type of coverage, a demonstration extension request, or aphase-out plan consistent with the requirements of STC 9.

As part ofthe demonstration extension request, the state must provide documentation ofcompliance with the transparency requirements at 42 CFP* 431.412(c) and the publicnotice and tlibal consultation requirernents outlined in STC 14.

9. Demonstration Phase-Out. The state may only suspend or terminate this demonstrationin whole, or in parl, consistent with the following requirements.

A. Notification of Suspension or Termination: The state must promptly notifr CMS inwriting of the reason(s) for the suspension or termination, together with the effectivedate and a transition and phase-out plan. The state must submit its notification letterand a draft phase-out plan to CMS no less than five (5) months before the effectivedate of the demonstration's suspension or termination. Prior to submitting the draftplan to CMS, the state must publish on its website the draÍt plan for a thirty (30) daypublic comment period. In addition, if applicable, the state must conduct tribalconsultation in accordance with its approved tribal consultation state planamendment. Once the thirty (30) day public comment period has ended, the state

must provide a summary ofeach public comment received, the state's response to thecomment and ho\ry the state incorporated the received comment into a revised phase-

out plan.

B. The state must obtain CMS approval of the phase-out plan prior to theimplementation of the phase-out activities. Implementation of transition and phase-

out activities must be no sooner than fourteen (14) days after CMS approval of theplan.

C. Phase-out Plan Requitements: The state must include, at a minimum, in its plan theprocess by which it will notify affected beneficiaries, the content ofsaid notices(including information on the beneficiary's appeal rights), the process by which thestate will conduct administrative reviews of Medicaid eligibility for the affectedbeneficiaries, and ensure ongoing coverage for eligible individuals, as well as any

community outreach activities.

D. Phase-out Procedures: The state must comply with all notice requirements found in42 CFR 431.206, 431 .210 and 437 .213. In addition, the state must assure all appeal

and hearing rights afforded to demonstration participants as outlined in 42 CFR431.220 and 431.221. If a demonstration participant requests a hearing before the

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1,2018 through December 31, 2022

Page 4 of 37

date of action, the state must maintain benefits as required in 42 CFR 43 1.230. Inaddition, the state must conduct administrative renewals for all affected beneficiariesin order to determine if they qualify for Medicaid eligibility under a differenteligibility category as discussed in October 1, 201 0, state Health Official Letter #10-008.

E. Federal Financial Participation (FFP): If the project is terminated or any relevantwaivers suspended by the state, FFP shall be limited to normal closeout costsassociated with terminating the demonstration including services and administ¡ativecosts of disenrolling participants.

10. CMS Right to Terminate or Suspend. CMS may suspend or terminate, subject toadequate public notice, the dernonsttation in wholc or in part at any time before the dateof expiration, whenever it determines, following a hearing, that the state has materiallyfailed to comply with the terms of the project. CMS will promptly notifu the state inwriting of the determination and the reasons for the suspension or te¡mination, togetherwith the effective date.

11. Finding of Non-Compliance. The state does not relinquish its rights to challenge theCMS finding that the state materially failed to comply.

12. Withdrawal of Waiver Authority. CMS reserves the right to withdraw waivers orexpenditure authorities at any time it determines that continuing the waivers orexpenditure authorities would no longer be in the public interest or promote theobjectives of title XIX. CMS will promptly notiS the state in writing of thedetermination and the reasons for the withdrawal, together with the effective date, andafford the state an opportunity to request a hearing to challenge CMS' determinationprior to the effective date. If a waiver or expenditure authority is withdrawn, FFP islimited to normal closeout costs associated with terminating the waiver or expenditureauthority, including services and administrative costs of disenrolling participants.

l3. Adequacy of Infrastructure. The state must ensure the availability of adequateresources for implementation and monitoring ofthe demonstration, including education,outreach, and enrollment; maintaining eligibility systems; compliance with cost sharingrequirements; and reporting on financial and other demonstration components.

14. Public Notice, Tribal Consultation, and Consultation with Interested Parties. Thestate must comply with the state notice proceduros as required in 42 CFR 431.408 prior tosubmitting an application to extend the demonstration. For applications to amend thedemonstration, the state must comply with the state notice procedures set forth in 59 Fed.Reg.49249 (September 27, 1994) prior to submitting such request. The state must alsocomply with the public notice procedures set forth in 42 CFP.447.205 for changes instatewide methods and standards for setting payment rates.

If applicable, the state must also comply with the hibal consultation requirements as setforth in section 1902(a)(73) ofthe Act and implemented in regulation at 42 CFR


Page 5 of 37

431.408(b), and the tribal consultation requirements contained in the state's approvedMedicaid State Plan, when any program changes to the demonstration, either throughamendment or extension, are proposed by the state.

15. Federal Financial Participation (FFP). No federal matching for expenditures for thisdemonstration will take effect until the effective date identified in the demonstrationapproval letter or as expressly stated within these STCs.

IV. SUBSTANCE USE DISORDER (SUD) DEMONSTRATION

16. Program Description and Objectives. The SUD demonstration is a demonstrationprogram to test a new paradigm for the delivery of SUD services for all Medicaidenrollees, both those served via the managed care and fee-for-service delivery systems.No Medicaid state plan beneficiaries are excluded from the SUD demonshation. Thereare two (2) implementation dates of the SUD demonstration- January 1, 2018 for initialimplementation, including coverage for methadone treatment services; and July 1, 2018for full implementation, including residential treatment services, peer recovery supportservices, and withdrawal management services. Note: room and board costs are notconsidered allowable costs for residential treatment service providers unless they qualifyas inpatient facilities under section 1905(a) ofthe Act.

17. SUD Demonstration Benefits. The comprehensive SUD demonstration benefit packageprovides access to a full continuum of care for SUD treatment. Standard SUD servicesapproved through the state plan benefit as well as SUD services approved through thisdemonstration will be available to all West Virginia Medicaid recipients who meetmedical necessity criteria for services. The following service categories outlined in TableOne (1) are included in the SUD demonshation benefit package for West VirginiaMedicaid enrollees with the appropriate Medicaid authority designated:

Table One: SUD Demonstration Bênefits (with Expenditure Authority)


ASAMLevel ofCare

SUD Demonstration Benefit Medicaid Authority Costs Not OtherwiseMatchable

N/A Targeted Case Management State plan Services provided toshort-term residents

N/A Naloxone AdministrationServices

State plan Services provided toshort-term residents

0.5 Screening, Brief Intervention andReferral to Treatment

State plan

I Peer Recovery Support Services Section 1 1 15

demonstrationServices provided toshort-term residents

1 Outpatient Services State olan2.1 Intensive Outpatient Services State Dlan

2.5 Partial Hospitalization Services State plan

Page 6 of 37

3.1 Clinically Managed LowIntensity Residential Services

Section 1 1 l5demonstration

Services provided toshorl-term residents

J.J Clinically Managed Population-Specific High IntensityResidential Serwices

Section I I 15


3.5 Clinically Managed HighIntensity Residential Services

Section 1 I 15


J-t Medically Monitoled IntensiveInpatient Services


4 Medically Managed IntensiveInpatient Services

State plan

l-wM Ambulatory WithdrawalManagement Services

State plan

2-WM Ambulatory WithtlrawalManagement Services

State plan

3.2-WM Clinically Managed ResidentialWithdrawal ManagementServices

Section I I l5demonstration

Services provided toshort-term residents

3.7-WM Medically Monitored InpatientWithdrawal ManagementServices


OTP Opioid Treatment ProgramServices

Section I 1 15


OBOT Office Based Opioid Treatment State plan Services provided toshort-term residents

The state attests that the services indicated in Table One (l), above, as being covered underMedicaid state plan authority are currently covered in the West Virginia Medicaid state plan.The following service definitions and provider qualifications are described for those SUDdemonstration services, which are covered under this section 1115 demonstration.

Peer Recovery Support ServicesPeer recovery support services are designed and delivered by individuals in recovery fromsubstance use disorder (peer recovery coach) to provide counseling support to help preventrelapse and promote recovely. Services can be provided by appropriately trained staff whenworking under the supervision ofa competent behavioral health professional (as defined bythe State). A peer recovery coach must be certified through a West Virginia Department ofHealth and Human Resources-approved training program that provides peer supportproviders with a basic set of competencies necessary to perform the peer suppoft function.The peer must demonstrate the ability to support the recovery of others from substance usedisorders. Similar to other provider types, ongoing continuing educational requirements forpeef support providers must be in place.

Residential Treatment ServicesTreatment services delivered to residents ofan institutional care setting, including facilitiesthat meet the definition of an institution for mental diseases (IMD), are provided to West


Page 7 of 37

Virginia Medicaid recipients with an SUD diagnosis when determined to be medicallynecessary by the MCO utilization staff and in accordance with an individualized service plan.MCO utilization staff, physicians or medical directors will perform independent assessmentsto determine level ofca¡e and length of stay recommendations based upon the ASAMCriteria multidimensional assessment criteria.

a. Residential treatment services are provided in a West Virginia Bureau of MedicalServices (BMS)-certified facility that has been enrolled as a Medicaid provider andassessed by BMS as delivering care consistent with ASAM Levels 3.1. 3.3, 3.5,andlor 3.7, and, for participation in the managed care delivery system, has beencredentialed and enrolled by an MCO as a network provider. Each residentialtreatment provider will be certified as meeting the provider and service specificationsdescribed in the BMS policy manual consistent with the ASAM Criteria for therequisite level or sublevel of care prior to participating in the West Virginia Medicaidprogram under this section 1115 demonstration. The MCOs will provide credentialingfor ASAM Levels 3.1, 3.3, 3.5 a¡d/or 3.7 contingent on the providers receivingcertification from the state.

b. Residential treatment services can be provided in settings of any size.

c. The state's average length of stay for individuals admitted into all BMS-certifiedASAM Level 3.1, 3.3 3.5 and 3.7 facilities is thirty (30) days.

d. The implementation date for residential treatment services is July 1,2018.

e. Room and board costs are not considered allowable costs for residential treaÍnentservice providers unless they qualify as inpatient facilities under section 1905(a) ofthe Act.

Covered services include:

a. Clinically-directed therapeutic treatment to faciliøte recovery skills, relapseprevention, and emotional coping strategies.

b. Addiction pharmacotherapy and drug screening;

c. Motivational enhancement and engagement strategies;

d. Counseling and clinical monitoring;

e. Withdrawal management and related treatment designed to alleviate acute emotional,behavioral, cognitive, or biomedical distress resulting from, or occuring with, anindividual's use ofalcohol and other drugs;

f. Regular monitoring of the individual's medication adherence;


Page 8 of 37

g. Recovery support services;

h. Counseling services involving the beneficiary's family and significant others toadvance the beneficiary's treatment goals, when (l ) the counseling with the familymember and significant others is for the direct benefit of the benefrciary, (2) thecounseling is not aimed at addressing treatment needs ofthe beneficiary's family orsignificant others, and 3) the beneficiary is present except when it is clinicallyappropriate for the beneficiary to be absent in order to advance the bcncficiary'streatment goals; and.

i. Education on benefits of medication assisted treatment and refenal to treatment asnecess¿ìfy.

Opioid Treatment Program Services (methadone treatment services)Physician-supervised daily or several times weekly opioid agonist medication and counselingservices provided to maintain multidimensional stability for those with severe opioid usedisorder in BMS-licensed methadone clinics in accordance with an individualized serviceplan determined by a licensed physician or licensed prescriber and approved and autho¡izedaccording to state requirements.

Covered services include:

a. Linkage to psychological, medical, and psychiatric consultation.

b. Access to emergency medical and psychiatric care through connections with moreintensive levels of care.

c. Access to evaluation and ongoing primary care.

d. Ability to conduct or arrange for appropriate laboratory and toxicology tests includingurine drug screenings.

e . Availability of licensed physicians to evaluate and monitor use of methadone,buprenorphine products or naltrexone products and of pharmacists and nurses todispense and administer these medications.

f. Individualized,person-centered assessmentandtreatment.

g. Assessing, ordering, administering, reassessing, and regulating medication and doselevels appropriate to the individual; supervising withdrawal management from opioidanalgesics, including methadone, buprenorphine products or naltrexone products;overseeing and facilitating access to appropriate treatment for opioid use disorder.

h. Medication for other physical and mental health illness is provided, as needed, eitheron-site or tlrough collaboration with other providers.

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January l, 2018 through December 31,2022

Page 9 of 37

i. Cognitive, behavioral, and other substance use disorder-focused therapies, reflecting a

variety of treatment approaches, provided to the individual on an individual, group,and/ or family basis.

Optional substance use care coordination provided, including integrating behavioralhealth into primary care and specialty medical settings through interdisciplinary careplanning and monitoring individual progress and tracking individual outcomes;supporting conversations between buprenorphine-waivered practitioners andbehavioral health professionals to develop and monitor individualized service plans;linking individuals with community resources to facilitate referrals and respond tosocial service needs; tracking and supporting individuals when they obtain medical,behavioral health, or social services outside the practice.

k. Referral for screening for infectior¡s disea"ses such a.s HTV, hepatitis B and C, an<l

tuberculosis at treatment initiation and then at least annually or more often based onrisk factors.

I 8. Incorporation of Industry Standards of Care. Through revisions of its policy manualand contract requirements for managed care organizations (MCOs), BMS will establishstandards ofca¡e for SUD demonstration services that incorporate industry standard

benchmarks from the ASAM Criteria for patient assessment and placement, service and

staff,rng specifi cations.

a. Residential treatment services are provided in a BMS-certified facility that has been

enrolled as a Medicaid provider and assessed by BMS as delivering care consistentwith ASAM Levels 3. 1 , 3 .3, 3 .5, and/or t.7 , and, for participation in the managed

care delivery system, has been credentialed and enrolled by an MCO as a networkprovider. Each residential treatment provider will be certified as meeting the providerand service specifications described in the BMS policy manual consistent with theASAM Criteria for the requisite level or sublevel ofcare prior to participating in theVy'est Virginia Medicaid program under this section 1115 demonstration.

b. The MCOs will be responsible for credentialing all SUD demonstration serviceproviders consistent with the key benchmarks from ASAM Criteria as set forth in the

BMS policy manual and revised MCO contracts.

c. All MCOs and SUD providers parlicipating under this demonstration will incorporate

the national patient assessment and placement guidelines as established in the ASAMCriteria, into cunent assessment and level of care determination processes. The

multidimensional assessment framework will be implemented as a standard

component of the bio-psychosocial assessment and level ofcare determinationprocess by January 1,2018.

d. Between January 1,2018 and December 1,2018, providers will receive training and

education on the ASAM level ofcare criteria and the application of the ASAMCriteria in the assessment process. MCOs will be required to provide evidence of

West Virginia Continuum of Ca¡e for Medicaid Enrollees with SUDApproval Period: January l, 2018 through December 31, 2022

Page l0 of37

initial and ongoing training ofproviders during site reviews conducted by the state.The state will review a sample of the provider network to corroborate the findingsregarding haining provided by the MCOs. If discrepancies are found, the state willreview additional providers to ensure compliance and issue conective action againstthe MCO. As part of a quality monitoring strategy, the state will review persomel andclinical records of a sample ofthe provider network to determine appropriateapplication and fidelity to the established assessment process.

19. SUD Monitoring Plan Protocol. The state must submit an SUD Monitoring PlanProtocol within 150 calendar days after approval of this demonstration. The SUDMonitoring Plan protocol must be developed in cooperation with CMS and is subject toCMS approval. The approved SUD Monitoring Plan Protocol will be incorporated here asAttaclunent H. At a urinimurr , the SUD Monitoring Plan Protocol will describe the datacollection, reporting and analytic methodologies for performance measures and datapoints identified by the state and CMS for inclusion. The SUD Monitoring Plan Protocolwill specifr the methods of data collection and timeframes for reporting on the state'sprogress on required measures as part of the general reporting requirements described inSubject Area V ofthe demonstration. In addition, for each performance measure, theSUD Monitoring Plan Protocol will identifr a baseline, a target to be achieved by the endofthe demonstration and an annual goal for closing the gap between baseline and targetexpressed as percentage points. Where possible, baselines will be informed by state data,and targets will be benchmarked against performance in best practice settings.

V. GENERAL RX,PORTING REQUIREMENTS

20. Deferral for Failure to Subrnit Timely Demonstration Deliverables. CMS will issuedeferrals in the amount of$5,000,000 (federal share) per deliverable when items fequiredby these STCs (e.g., required data elements, analyses, reports, design documents,presentations, and other items specified in these STCs (hereafter singly or collectivelyreferred to as "deliverable(s)") are not submitted timely to CMS or found to not beconsistent with the requirements approved by CMS. Specifically:

A. Thirty (30) days after the deliverable was due, CMS will issue a written notificationto the state providing advance notifrcation of a pending deferral for late or non-compliant submission of required deliverables.

B. For each deliverable, the state may submit a written request for an extension tosubmit the required deliverable. Extension requests that extend beyond the currentcalendar quarter must include a Corrective Action Plan (CAP).

i. CMS may decline the extension request;

1t. Should CMS agree in writing to the state's request, a conesponding extension ofthe defenal process described below can be provided; and

iii. If the state's request for an extension includes a CAP, CMS may agree to or


Page I I of 37

further negotiate the CAP as an interim step before applying the defenal.

C. The defenal would be issued against the next quarterly expenditure report followingthe wdtten deferral notification.

D. When the state submits the overdue deliverables(s) that are accepted by CMS, thedefenal(s) will be released.

E. As the puqpose ofa section 1115 demonstration is to test new methods of operation orservices, and timely and complete submission ofrequired deliverables is necessaryfor effective testing, a state's failure to submit all required deliverables may precludea state from renewing a demonstration or obtaining a new demonstration.

F. CMS will consicler with the state an alt€rnative set of operational steps forimplementing the intended defenal to align the process with the state's existingdeferral process, for example, which quarter the deferral applies to and how thedeferral is released.

21. Submission of Post-Approval Deliverables. The state must submit all deliverablesusing the process stipulated by CMS and within the timeframes outlined within theseSTCs.

22. Compliance with Federal Systems Innovation. As federal systems continue to evolvearid incorporate additional 1115 waiver reporting and analytics functions, the state willwork with CMS to:

A. Revise the reporting templates and submission processes to accommodate timelycompliance with the requirements of the new systems;

B. Ensure all 1115, Transformed Medicaid Statistical Information System (T-MSIS),a¡d other data elements that have been agreed to are provided; and

C. Submit deliverables through the appropriate system as directed by CMS

23. Cooperation with Federal Evaluators. As required undet 42 CFP. 431.420(f), the state

shall cooperate fully and timely with CMS and its contractors in any federal evaluation ofthe demonstration ot any component ofthe demonstration.

This includes, but is not limited to, commenting on design and other federal evaluationdocuments and providing data and analytic files to CMS, including entering into a data

use agreement that explains how the data and data files will be exchanged, and providinga technical point of contact to support specification of the data and files to be disclosed,as well as relevant data dictiona¡ies and record layouts. The state shall include in itscontracts with entities that collect, produce or maintain data and files for thedemonstration, that they shall make such data available for the federal evaluation as isrequired by the state under 42 CFR 431 .420(Ð to support federal evaluation. The state


Page 12 of 37

may claim administrative match for these activities. Failure to comply with this STC mayresult in a deferral being issued as outlined in STC 20.

24. Cooperation with Federal Learning Collaboration Efforts. The state will cooperatewith improvement and leaming collaboration efforts by CMS.

25. Quarterly and Annual Operational Reports, The state must submit tbree (3) QuarterlyReports and one (1) compiled Annual Report each demonstration year (DY). Theinformation for the fourth quarterly report should be reported as distinct informationwithin the Annual Report. The Quarterly Reports are due no later than sixty (60 days)following the end of each demonstration quarter. The compiled Annual Report is due nolater than ninety (90) days following the end of the DY.

A. The Qtrarterly ancl Anntral Reports will include all tequired elements an<l shoukl notdirect readers to links outside the report. (Additional links not referenced in thedocument may be listed in a Reference/Bibliography section).

B. The Quarlerly and Arurual Reports must follow the framework provided by CMS,which is subject to change as monitoring systems are developed/evolve, and beprovided in a structured ma¡ner that supports federal tracking and analysis.

1. Operational Updates - The reports shall provide sufficient information todocument key operational and other challenges, underlying causes ofchallenges, how challenges are being addressed, as well as key achievementsand to what conditions and efforts successes can be attributed. The discussionshould also include any lawsuits or legal actions; unusual or unanticipatedtrends; legislative updates; and descriptions of any public forums held.

2. Performance Metrics - Any required monitoring and pedormance metricsmust be included in writing in the Quarterly and Annual Reports.

Information in the reports will follow the framework provided by CMS and be

provided in a structured manner that suppofts federal tracking and analysis.

3. Budget Neutralitv and Financial Reportins Requirements - The state mustprovide an updated budget neutrality workbook that includes established

baseline and member months data with every Quarterly and Annual Repoftthat meets all the reporting requitements for monitoring budget neutrality set

forth in section VIL General Financial Requirements of these STCs,

including the submission of corrected budget neutrality data upon request. Inaddition, the state must roport quarterly expenditures associated with thepopulations affected by this demonstration on the Fotm CMS-64.

4. Evaluation Activities and Interim Findines. The state shall include a summary

of the progress of evaluation activities, including key milestones

accomplished, as well as challenges encountered and how they were

addressed. The state shall specify, for CMS approval, a set of performance

and outcome metrics, including their specifications, reporting cycles, level ofreporting (e.g., the state, health plan and provider level, and segmentation by


Page 13 of37

population) to support rapid cycles assessment in trends for monitoring andevaluation of the demonstration.

26. Additional Demonstration Annual Operational Report Requirements. The AnnualReport shall meet the requirements in 42 C.F.R. 431 .428, which address both the contentof the report and the publication of the draft and final reports on the State's publicwebsite. In addition to the fourth quarter information and the aggregated components ofthe Quarterly Reports, the Annual Report must, at a minimum, include the requirementsoutlined below:

A. Items included in the Quarterly Reports must be summa¡ized to reflect theoperation /activities throughout the DY;

B. Total annual expenclitures for the demonstration popr ation for each DY, withadminishative costs reported separately;

C. Total contributions, withdrawals, balances, and credits; and

D. Yearly enrollment reports for demonshation enrollees for each DY (enrollees includeall individuals enrolled in the demonshation) that include the member months, as

required to evaluate compliance with the budget neutrality agreement.

27. Close out Operational Report. Within one hundred twenty (120) days prior to theexpiration of the demonstration, the state must submit a dra.ft Close Out Report to CMSfor comments.

A. The draft Close Out Repoft must comply with the most cunent Guidance from CMS.

B. The state will present to and participate in a discussion with CMS on the Close-OutReport.

C. The state must take into consideration CMS' comments for incorporation into thefinal Close-Out Report.

D. The Final Close-Out Report is due to CMS no later than thirty (30) days after receiptof CMS' comments.

E. A delay in submitting the draft or final version ofthe Close-Out Report may subjectthe state to penalties described in STC 20.

28. State Data Collection. The state must collect data and infotmation necessary to overseeservice utilization and rate setting by providerþlan, comply with the Core Set ofChildren's Health Care Quality Measures for Medicaid and CHIP (Child Core Set) andthe Core Set of Adult Health Care Quality Measures for Medicaid (Adult Core Set),

collectively referred to as the CMS Child and Adult Core Measu¡e Sets for Medicaid and

CHIP, and comply with other existing federal measure sets.


Page 14 of 37

A. The state will use this information in ongoing monitoring of individual well-being,providerþlan performance, and continuous quality improvement efforts, in additionto complying with CMS reporting requirements.

B . The state must maintain data dictionary and file layouts of the data collected

C. The raw and edited data will be mado available to CMS within thirty (30) days of awritten request.

29. Monitoring Calls. CMS will convene periodic conference calls with the state.

A. The purpose of these calls is to discuss any significant actual or antioipatetldevelopments affecting the demonstration.

B. CMS will provide updates on any amendments or concept papers under review, as

well as federal policies and issues that may affect any aspect of the demonstration.

C. The state and CMS will jointly develop the agenda for the calls.

D. Areas to be addressed during the monitoring call include, but are not limited to:

1 . Transition and implementation activities;2. Stakeholder concems;3. Operations and performance;4. Enrollment;5. Cost sharing;6. Quality of care;7. Beneficiary access;

8. Benefit package and wrap around benefrts;9. Audits;10. Lawsuits;1 1. Financial reporting and budget neutrality issues;

12. Progress on evaluation activities and contracts;13. Related legislative developments in the state; and14. Any demonstration changes or amendments the state is considering.

30. Post Award Forum, Pursuant to 42 CFR 431.420(c), within six (6) months of the

demonstration's implementation, and arurually thereafter, the state shall afford the publicwith an opportunity to provide meaningful cornment on the progress of thedemonstration. At least thirty (30) days prior to the date of the planned public forum, thestate must publish the date, time and location of the forum in a prominent location on itswebsite. The state must also post the most recent armual leport on its website with thepublic forum announcement. Pursuant to 42 CFP. 431 .420(c),the state must include a

summary of the comments in the Quarlerly Report associated with the quarter in whichthe forum was held, as well as in its compiled Annual Report.


Page l5 of 37

VI. EVALUATION OX' THE DEMONSTRATION

3 1 . Independent Evaluator. At the beginning of the demonstration period, the state mustarrange with an independent party to conduct an evaluation ofthe demonstration toensure that the necessary data is collected at the level of detail needed to research theapproved hypotheses. The independent party must sign an agreement to conduct thedemonstration evaluation in accord with the CMS-approved, Draft Evaluation Design,which will meet the requirements described in 42 C.F.R. 431 .424 and the guidanceprovided in Attachment B: "Developing the Evaluation Design." For scientific integrity,every effort should be made to follow the approved methodology. State evaluation mustfollow the approved methodology; however, the state may request, and CMS may agree

to, changes in the methodology in appropriate circumstances.

32. Draft Evaluation Design, The draft Evaluation Design must be clevelopecl inaccordance with Attachment A of these STCs. The state must submit, for CMS commentand approval, a Draft Evaluation Design with implementation timeline, for thedemonstration to CMS no later tlan one hundred eighty (180) days after the effectivedate of these STCs. Any modifications to an existing approved Evaluation Design willnot affect previously established requirements and timelines for report submission for thedemonstration, if applicable. The state may choose to use the expertise ofthe independentparty in the development ofthe Draft Evaluation Design.

33. Evaluation Design Approval and Updates. The state must submit a revised DraftEvaluation Design within sixty (60) days after receipt of CMS' comments. Upon CMSapproval of the Draft Evaluation Design, the document will be included as an attachmentto these STCs. Per 42 CFR 431 .424(c), the state will publish the approved EvaluationDesign within thirty (30) days of CMS approval. The state must implement theevaluation design and submit a description of its evaluation implementation progress ineach of the Quarterly Reports and Annual Reports.

34. Evaluation Questions and Hypotheses. Consistent with attachments A and B oftheseSTCs the evaluation documents must include a discussion of the evaluation questions and

hypotheses that the state intends to test. Each demonstration component should have at

least one evaluation question and hypothesis. The hypothesis testing should include,where possible, assessment of both process and outcome measures. CMS recommendshypotheses include an assessment of the objectives of SUD section 1 1 1 5 demonstrations,to include (but is not limited to): initiation and compliance with treatrnent, appropriateutilization of health services (emergency departrnent and inpatient hospital settings), and

a reduction in key outcomes such as deaths due to overdose.

Proposed measures should be selected from nationally-recognized sources and nationalmeasures sets, where possible. Measures sets could include CMS's Core Set of HealthCare Quality Measures for Children in Medicaid and CHIP, Consumer Assessment ofHealth Care Providers and Systems (CAHPS), the Initial Core Set of Health Care QualityMeasures for Medicaid-Eligible Adults and/or measures endorsed by National QualityForum (NQF).

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1, 2018 through December 31,2022

Page 16 of37

35. Evaluation Budget. A budget for the evaluation shall be provided with the DraftEvaluation Design. It will include the total estimated cost, as well as a breakdown ofestimated staff, administrative and other costs for all aspects of the evaluation such as anysurvey and measurement development, quantitative and qualitative data collection andcleaning, analyses and report generation. A justification of the costs may be required byCMS ifthe estimates provided do not appear to sufficiently cover the costs of the design,if CMS finds that the design is not sufficiently developed, or if the estimates appear to beexcessive.

36. Evaluation Requirernents. The demonstration evaluation will meet the prevailingstandards of scientific evaluation and academic rigor, as appropriate and feasible for eachaspect of the evaluation, including standards for the evaluation design, conduct, andinterpretation and reporting of findings. In addition, the evaluation design plan willinclude a description of how the effects ofthe demonstration will be isolated from thoseother changes occurring in the state at the same time through the use of comparison orcontrol groups, regarding significant aspects of the demonstration.

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

B. The state shall arrange with an independent entity to conduct the evaluation. Theevaluation design shall discuss the state's process for amanging with an independententity to conduct the evaluation, including a description ofthe qualifications theentity must possess, how the state will ensure no conflict of interest, and a budget forevaluation activities.

37. State Presentations for CMS. CMS reserves the right to request that the state present

and participate in a discussion with CMS on the final Evaluation Design, the interimevaluation, and/or the summative evaluation.

38. State Must Separately Evaluate Components of the Demonstration. The outcomesfrom each evaluation component must be integrated into one programmatic summary thatdescribes whether the state met the demonstration goal, with recommendations for futureefforts regarding all components.

39. Draft Interim Evaluation Reports. The state must submit an Interim Evaluation Reportfor the completed years ofthe demonstration, and for each subsequent renewal orextension of the demonstration, as outlined in 42 CFR 431.412(c)(2)(vi). Whensubmitting an application for renewal, the Evaluation Report should be posted to thestate's website with the application for public comment. Also refer to Attachment B foradditional information on the Interim Evaluation Report.

A. The interim evaluation report will discuss evaluation progress and presentfindings to date as per the approved evaluation design.

B. For demonstration authority that expires prior to the overall demonstration's

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January l, 2018 through December31,2022

Page 17 of 37

expiration date, the Interim Evaluation Report must include an evaluation of theauthority as approved by CMS.

C. If the state is seeking to renew or extend the demonstration, the draft InterimEvaluation Report is due when the application for renewal is submitted. Ifthestate made changes to the demonstration in its application for renewal, theresearch questions, hypotheses and how the design was adapted should beincluded. If the state is not requesting a renewal for a demonshation, an InterimEvalnation report is due one (1) year prior to the end ofthe demonstration. Fordemonstration phase outs prior to the expiration of the approval period, the draftInterim Evaluation Report is due to CMS on the date that will be specified inthe notice ol termination or suspension.

D. The state must submit the final Interim Evaluation Report sixty (60) days afterreceiving CMS comments on thc draft Intcrim Evaluation Report and post thecf ocument to the state's website .

E. The Interim Evaluation Report must comply with Attachment B of these STCs.

40. Summative Evaluation Report. The state must submit a draft Summative EvaluationReport for the demonstration's current approval period within eighteen (18) months ofthe end ofthis approval period. The dral Summative Evaluation Report must include theinformation in the approved Evaluation Design. Refer to Attachment B for additionalinformation on the evaluation report.

A. Unless otherwise agreed upon in writing by CMS, the state shall submit the hnalSummative Evaluation Report within sixty (60) days of receiving comments fromCMS on the draft.

B. The final Summative Evaluation Report must be posted to the state's Medicaidwebsite within thirty (30) days of approval by CMS.

41. Public Access. The state shall post the final documents (e.g., Quarterly and AnnualReports, Final Operational Report, approved Evaluation Design, Final Interim EvaluationReport(s), Final Summative Evaluation Report(s), and the Final Evaluation Report) onthe state's Medicaid \üebsite \ryithin thirty (30) days of approval by CMS.

42. Additional Publications and Presentations. For a period of twenty-four (24) monthsfollowing CMS approval of the final repofis, CMS will be notified prior to presentationofother reports and related publications (including, for example, journal articles), by thestate, contractor, or any other third party (an entity which is not the state or contractor)over which the state Medicaid agency has control. Prior to release of these reports,articles and other publications, CMS will be provided a copy including any associatedpress materials. CMS will be given thirty (30) days to review and comment onpublications before they are released, CMS may choose to decline to comment or reviewsome or all ofthese notifications and reviews.


Page l8of37

XII. GENERAL FINANCIAL REQUIREMENTS

43. Quarterþ Expenditure Reports. The state must complete quarterly expenditure reportsthrough the Medicaid and Children's Health Insura¡ce Program Budget and ExpenditureSystem (MBES/CBES), following routine CMS-64 reporting instructions outlined insection 2500 ofthe State Medicaid Manual, for services provided through thisdemonstration and that are subject to budget neutrality. CMS shall provide FFP forallowable demonstration expenditures only as long as they do nót exceed the pre-definedlimits on the costs incurred as specified in section VIII (Monitoring Budget Neutrality).

44. Reporting Expenditures Subject to the Title XIX Budget Neutrality ExpenditureLimit. The following describes the reporting of expenditures subject to the budgetneutrality limit:

a. Tracking Expenditures. In order to track expenditures under this demonstration, thestate must repoÉ demonstration expenditures through the Medicaid and Children'sHealth Insurance Program Budget and Expenditure System (MBES/CBES), followingroutine CMS-64 reporting inshuctions outlined in section 2500 of the state MedicaidManual. All demonstration expenditures claimed under the authority of title XIX ofthe Act and subject to the budget neutrality expenditure limit must be reported eachquafier on separate Forms CMS-64.9 Waiver and/or CMS-64.9P Waiver, identifiedby the demonstration project number (11-W-00307/3) assigned by CMS, includingthe project number extension, which indicates the DY in which services wererendered.

b. Cost Settlements. For monitoring purposes, cost settlements attributable to thedemonstration must be recorded on the appropriate prior period adjustment schedules(form CMS-64.9P Waiver) for the summary sheet line 108, in lieu of lines 9 or 10C.

For any cost settlement not attributable to this demonstration, the adjustments shouldbe reported as otherwise instructed in the State Medicaid Manual.

c. Pharmacy Rebates. The state may propose a methodology for assigning a portion ofpharmacy rebates to the demonstration services, in a way that reasonably reflects the

actual rebate-eligible pharmacy utilization ofthose populations, and which reasonably

identifies pharmacy rebate amounts with DYs. Use of the methodology is subject tothe approval in advance by the CMS Regional Office, and changes to the

methodology must be approved in advance by the Regional Office. A portion ofpharmacy rebates assigned to the demonstration using the approved methodology willbe reported on the appropriate Forms CMS-64.9 Waiver for the demonstration and

not on any other CMS-64.9 form to avoid double-counting. Each rebate amount must

be distributed as state and federal revenue consistent with the federal matching rates

under which the claim was paid.

d. Use of Waiver X'orms. For each DY, separate Forms CMS-64.9 Waiver andlorCMS-64.9P Waiver shall be submitted reporting expenditures for individuals enrolledin the demonshation, subject to the budget neutrality limit (Section VIII of these


Page 19 of 37

STCs). The state must complete separate waiver forms for the following eligibilitygroup/waiver names:

i. EG I - "SUD IMD" - This EG corresponds to ExpenditureAuthority#1 (Residential Treatment for Individuals with SUD) whichincludes all medical assistance expenditures including residentialtreatment costs with dates of service in a month when thebeneficiary was a patient in an IMD.

ii. EG 2 - "Methadone and Peer Support'- This EG conesponds toExpenditure Authorities #2 (Methadone Treatment) and #3 (PeerRecovery Support Services) which includes the PMPM cost ofmethadone and peer recovery support services.

45. Title XIX Administrative Costs. Administrative costs \ryill not be inch¡ded in thebudget neutrality agreement, but the state must separately track and report additionaladministrative costs that are directly attributable to the demonstration. All administrativecosts must be identified on Forms CMS-64.10 Waiver and/or CMS-64.10P Waiver.Administrative costs that are directly attributable to the demonstration must be reportedunder waiver name "SUD Admin."

46. Claining Period. All claims for expenditures subject to the budget neutralityexpenditure limit (including any cost settlements) must be made within two (2) years

after the calendar quarter in which the state made the expenditures. All claims forservices during the demonstration period (including any cost settlements) must be madewithin two (2) years a.fter the conclusion or termination of the demonstration. During thelatter t$/o (2) year period, the state must continue to identiff separately net expendituresrelated to dates ofservice during the operation of the section 1115 demonstration on theCMS-64 waiver forms in order to properly account for these expenditures in determiningbudget neutrality.

47. Reporting Member Months. The following describes the reporting of member monthsfor the demonstration:

a, For the purpose of calculating the budget neutrality expenditure limit, the state mustprovide to CMS, as part ofthe quarterly and annual reports as required under STC 25,the actual number of eligible member months for all demonstration expenditures.The state must submit a statement accompanying the quarterly and annual reports,certifying the accuracy of this information.

b. The term "eligible member mont¡s" refers to the number of months in which persons

enrolled in the demonstration are eligible to receive services. For example, for EG 1

"IMD"/ Expenditure Authority #l Residential Treatment for Individuals with SUD,member months are months of Medicaid eligibility during which the individual is an

inpatient in an IMD under the terms of the demonstration for any day during themonth. For EG 2 "Methadone and Peer Support," member months are all Medicaideligible member months for Medicaid populations eligible for the SUD demonstraton

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January l, 2018 through December 31, 2022

Page 20 of 37

that are not EG 1 "IMD" member months.

48. Standard Medicaid Funding Process. The standard Medicaid funding proçess must beused during the demonstration. The state must estimate matchable Medicaidexpenditures on the quarterly Form CMS-37. In addition, the estimate of matchabledemonstration expenditures (total computable and fèderal share) subject to the budgetneutrality expenditure limit and separately report these eipenditures by quarter for eachFFY on the Form C\4S-37 (narrative section) for both the Medical Assistance Payments(MAP) and state and local administration costs (ADM). CMS shall make federal fundsavailable based upon the state's estimate, as approved by CMS. Within thirty (30) daysa{Ìer the end of each quarter, the state must submit the Form CMS-64 quarterly Medicaidexpenditure report, showing Medicaid expenditures made in the quafter just ended. CMSshall reconcile expenditures reported on the Form CMS-64 with federal fundingpreviously made available to the state, and include the reconciling adjustment in thefinalization of the grant award to the state.

49. Extent of Federal X'inancial Participation for the Demonstration. Subject to CMSapproval of the source(s) of the non-federal share of funding, CMS shall provide FFP atthe applicable federal matching rates for the demonstration as a whole as outlined below,subject to the budget neutrality limits described in section VIIL

a. Administrative costs, including those associated with the administration of thedemonstration; and

b. Net expenditures and prior period adjustments, made under approved ExpenditureAuthorities granted through section 1115(a)(2) of the Act, with dates ofserviceduring the operation ofthe demonstration and consistent with the applicable STCrequirements.

50. Sources ofNon-X'ederal Share. The state must certify that matching non-federal share

of funds for the demonstration are state/local monies. The state further assures that such

funds shall not be used as the match for any other federal grant or contract, except as

permitted by law. All sources of non-federal funding must be compliant with section1903(w) of the Act and applicable regulations. In addition, all sources ofthe non-federal

share of funding are subject to CMS approval

a. CMS may review at any time the sources of the non-federal share of funding for thedemonstration. The state agrees that all funding sources deemed unacceptable byCMS shall be addressed within the time frames set by CMS.

b. Any amendments that impact the financial status of the program shall require the state

to provide information to CMS regarding all sources ofthe non-federal share offunding.

5 1 . State Certification of F unding Conditions. The state must certify that the followingconditions for non-federal share of demonstration expenditures are met:


Page 2l o137

a. Units of government, including govemmentally operated health care providers, maycertify that state or local tax dollars have been expended as the non-federal share offunds under the demonstration.

b. 'l'o the extent the state utilizes certified public expenditures (CPEs) as the fundingmechanism for title XIX (or under section 1115 authority) payments, CMS mustapprove a cost reimbursement methodology. This methodology mr¡st inchtde a

detailed explanation of the process by which the state would identi$' those costseligible under title XIX (or under section I 1 15 authority) for purposes of certifyingpublic expenditures.

c. To the extent the state utilizes CPEs as the funding mechanism to claim federal matchfor payments under the demonstration, govemmental entities to which generalrevenue funds are appropriated must certify to the state the amount ofsuch taxrevenue (state or local) used to satisfii demonstration expenditures. The entities thatincurred the cost must also provide cost documentation to support the state's claimfor federal match.

d. The state may use intergovernmental transfers to the extent that such funds are

derived from state or local tax revenues and are transfeffed by units of govemrnentwithin the state. Any transfers from govemmentally operated health care providersmust be made in an amount not to exceed the non-federal share of title XIXpayments. Under all circumstances, health care providers must retain one hundred( 1 00) percent of the claimed expenditure . Moreover, no pre-ananged agreements(contractual or otherwise) exist between health care providers and state and/or localgovernment to retum and/or redirect any portion of the Medicaid payments. Thisconfirmation of Medicaid payment retention is made with the understanding thatpayments that are the normal operating expenses of conducting business, such as

payments related to taxes, (including health care provider-related taxes), fees,

business relationships with govemments that are umelated to Medicaid and in whichthere is no connection to Medicaid payments, are not considered returning and/orredirecting a Medicaid payment.

52. Program Integrity. The state must have processes in place to ensure that there is noduplication of federal funding for any aspect ofthe demonstration.

VIII. MONITORING BUDGET NEUTRALITY X'OR THE DEMONSTRATION

53. Limit on Title XIX Funding. The state must be subject to a limit on the amount offederal title XIX funding that the state may receive on approved demonstration serviceexpenditures incuned during the period of approval of the demonstration. The limit is

detemined by using a per capita cost method, and budget neutrality expenditure caps are

set on a yearly basis with a cumulative budget neutrality expenditure limit for the lengthof the entire demonstration. The data supplied by the state to CMS to set the annual caps

is subject to review and audit, and if found to be inaccurate, will result in a modified


Page 22 of 37

budget neutrality expenditure limit. CMS' assessment of the state's compliance withthese a¡nual limits will be done using the Schedule C report from the CMS-64.

54. Risk. The state must be at risk for the per capita cost (as determined by the methoddescribed below) for demonstration eligibles under this budget neutrality agreement, butnot for the number of demonsnation eligibles. Because CMS provides FFP for alldemonstration eligibles, West Virginia must not be at risk for changing economicconditions that impact enrollment levels. However, by placing West Virginia at risk forthe per capita costs for current eligibles, CMS assures that the federal demonstrationexpenditures do not exceed the level of expenditures had there been no demonstration.

55. Budget Neutrality Expenditure Limit. The budget neutrality test includes an allowancefor hypothetical services. The expcctcd costs of the hypothetical services are reflected inthe "without waiver" budget neutraJity expenditure limit. The stat€ must not accruebudget neutrality o'savings" from the hypothetical services.

Trend DYl DY2 DY3 DY4 DY5SUD IMDPMPM

sA% $2,807.1 I $2,958.69 $3,118.46 $3,286.86 $3,464.35

Methadon€and PeerSupportsPMPMNote: TheDYIPMPMincludes six(6) ratherthan twelve(12 monthsofpeersupports;and, as aresult, thePMPM forthis EG islower in DY1.

5.4o/o $ 1.8s $3.32 $3.s0 $1.69 $3.89

56. Cornposite Federal Share Ratio. The federal share ofthe budget neutrality expenditurelimit is calculated by multiplying the limit times the Composite Federal Share. TheComposite Federal Share is the ratio calculated by dividing the sum total of federalfinancial participation (FFP) received by the state on actual demonstration expendituresduring the approval period, as reported through the Medicaid Budget and ExpenditureSyster/State Children's Health Insurance Program Budget and Expenditure System(MBES/CBES) a¡d summa¡ized on Schedule C with consolidation of additionalallowable demonstration offsets such as, but not limited to, premium collections andpharmacy rebates, by total computable demonstration expenditures for the same period as


Page 23 of 37

reported on the same forms. For the purpose of interim monitoring of budget neutrality, areasonable èstimate of Composite Federal Share may be developed and used though thesame process or through an alternative mutually agreed-upon method.

57. X'uture Adjustments to the Budget Neutrality Expenditure Limit. CMS reserves theright to adjust the budget neutrality expenditure limit to be consistent with enforcementof impermissible provider payments, health care related taxes, new federa.l statutes, orpolicy interpretations implementecl through letters, memorancla, or regnlations withrespect to the provision of services covered under the demonstration.

58. Enforcement of Budget Neutrality. CMS will enforce budget neutrality over the life ofthis demonstration rather t¡an on an annual basis. However, if the state's expendituresexceed the calculatcd cumulativc budgct ncutrality cxpcnditurc cap by thc percentagcidentified below for any of the demonstration years, the state must submit a correctiveaction plan to CMS for approval.

Demo Year Cumulative Târset Delinition PercentaseDYl DY I budget limit amount plus: 1 .0 percent

DY2 DYs 1 through 2 combined budget limit amountþlus:

1.0 percent

DY3 DYs 1 through 3 combined budget limit amountplus:

1.0 percent

DY4 DYs 1 through 4 combined budget limit amountþlus:

0.5 percent

DY5 DYs I through 5 combined budget limit amountplus:

0 percent

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1,2018 through Decembet 31,2022

Page 24 of 37

Date - Specific Deliverable STC Reference150 days afterapprovalMarch 4. 2018

Submit SUD Monitoring Plan Protocol STC 19

180 days afterapprovalApril 3,2018

Submit draft Evaluation Design STC 32

60 days after CMScomments received

Submit revised Evaluation Design STC 33

0910u2022 Submit Draft Close Out Reporl STC27

Ànnual By March 31 - Draft Amual Report STC 25

Annual Within 30 days of receipt of CMS comments -Final Annual Report

sTC25,26

Quarterly Quarterly Progress Reports STC 25

IX. SCHEDULE OF'STATE DELIVERABLES DURING THE DEMONSTRATION

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1, 2018 through December 3I,2022

Page 25 of 37

Attachment A: Developing the Evaluation Design

Introduction

For states that a¡e testing new approaches and flexibilities in their Medicaid programs throughsection 1115 demonstrations, evaluations are crucial to understand and disseminate what is or isnot working and why. The evaluations of new initiatives seek to produce new knowledge anddirection for programs and inform both Congress and CMS about Medicaid policy for the future.While a nanative about what happened during a demonstration provides important information,the principal focus of the evaluation ofa section 1115 demonstration should be obtaining andanalyzing data on the process (e.g., whether the demonstration is being implemented as

intended), outcomes (e.g., whether the demonstration is having the intended effects on the targetpopulation), and impacts ofthe demonstration (e.g., whether the outcomes observed in thetargeted population differ from outcomes in similar populations not affected by thedemonshation). Both state and federal govemments could benefit from improved quantitativeand qualitative evidence to inform policy decisions.

Expectations for Evaluation Designs

All states with Medicaid section 1115 demonstrations are required to conduct an evaluation, andthe Evaluation Design is the roadmap for conducting the evaluation. The roadmap begins withthe stated goals for the demonstration followed by the measurable evaluation questions andquantifiable hypotheses, all to support a determination of the extent to which the demonstrationhas achieved its goals.

The format for the Evaluation Design is as follows:General Background Information;Evaluation Questions and Hypotheses;Methodology;Methodolo gical Limitations;Attachments.

Submission TimelinesThere is a specified timeline for the state's submission of Evaluation Design and Reports. (Thegraphic below depicts an example of this timeline). In addition, the state should be aware thatsection I 1 15 evaluation documents are public records. The state is required to publish the

Evaluation Design to the state's website within thirty (30) days of CMS approval, as per 42 CFR431.424(e). CMS will also publish a copy to the Medicaid.gov website.

tüest Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January l, 2018 through December 31, 2022

Page 26 of 37

C>ÊmoAÞÞroYcd Jän

!.. :¡(}:.7

I ñt€ai ñEvð¡uåtion C>êt,3t, ?Cre(' (cråtâfrom f,lY t-2-5)

Sumñåt¡vÊEvãluätion forJân" 1 2t)l-7 -CtGc. 31,2O21.CluG .l{¡nê .}(),

20¿3

Êvå I ùãtíôñCt€s i Eñ

Ap.¡l 3(}" 2O1?

¡lçñcwrl Jän- !.,2C,72

Required Core Components of All Evaluation DesignsThe Ivaluation Design sets the stage for the Interim and Summative Evaluation Reports. It isimportant that the Evaluation Design explain the goals and objectives of the demonstration, thehypotheses related to the demonstration, and the methodology (and limitations) for theevaluation. A copy of the state's Driver Diagram (described in more detail in paragraph 82below) should be included with an explanation of the depicted information.

A. General Background Information - In this section, the state should include basicinformation about the demonstration, such as:

l) The issue/s that the state is trying to address with its section I I l5 demonstration and/orexpenditure authorities, the potential magnitude of the issue/s, and why the stateselected this course of action to address the issue/s (e.g., a narrative on why the statesubmitted an I115 demonstration proposal).

2) The name of the demonstration, approval date of the demonstration, and period of timecovered by the evaluation;

3) A brief description of the demonstration and history of the implementation, andwhether the draft Evaluation Design applies to an amendment, extension, renewal, orexpansion of, the demonstration;

4) For renewals, amendments, and major operational changes: A description of anychanges to the demonstration during the approval period; the primary reason or reasons

f'or the change; and how the Evaluation Design was altered or augmented to addressthese changes.

5) Describe the population groups impacted by the demonstration

B. Evaluation Questions and Hypotheses - In this section, the state should:

l. Describe how the state's demonstration goals are translated into quantifiable targetsfor improvement, so that the performance of the demonstration in achieving these

targets could be measured.


Page27 of37

2. Include a Driver Diagram to visually aid readers in understanding the rationale behindthe cause and effect of the variants behind the demonsÍation features and intendedoutcomes. A driver diagram is a particularly effective modeling tool when working toimprove health and health care through specifrc interventions. The diagram includesinformation about the goal of the demonstration, and the features of the demonstration.

. A driver diagram depicts the relationship between the aim, the primary drivers thatconhibute directly to achieving the aim, and the secondary drivers that are necessary

to achieve the primary drivers for the demonstration, For an example and moreinformation on driver diagrams:https ://innovation.cms. sov/files/x/hciatwoaimsdrvrs.pdf

3. Identify the state's hypotheses about the outcomes ofthe demonstration:

4. Discuss how the evaluation questions align with the hypotheses ancf the goals of the

demonstration;

5. Address how the research questions / hypotheses of this demonstration promote theobjectives of Titles XIX andlor XXI.

C. Methodotory- In this section, the state is to describe in detail the proposed research

methodology. The focus is on showing that the evaluation meets the prevailing standards

of scientific and academic rigor, and the results are statistically valid and reliable, and

that where appropriate it builds upon other published research (use refetences).

This section provides the evidence that the demonstration evaluation will use the best available

data; repofts on, conhols for, and makes appropriate adjustments for the limitations of the data

and their effects on results; and discusses the generalizability of results. This section shouldprovide enough transparency to explain what will be measured and how. Specifically, thissection establishes:

l) Evaluation Design - Provide information on how the evaluation will be designed. Forexample, will the evaluation utilize a pre/post comparison? A post-only assessment?

Will a comparison group be included?

2) Target and Comparison Populalio¡4s - Describe the characteristics of the target and

comparison populations, to include the inclusion and exclusion criteria. Includeinformation about the level of analysis (beneficiary, provider, or program level), and

if populations will be stratified into subgroups' Additionally discuss the sampling

methodology for the populations, as well as support that a statistically reliable sample

size is available.

3) Evaluatìon Period Describe the time periods for which data will be included.

4) Evaluation Measures - List all measures that will be calculated to evaluate the

demonstration. Include the measure stewards (i.e., the organization(s) responsible forthe evaluation data elements/sets by "owning", defining, validating; securing; and

West Virginia Continuum of Care for Medicaid Enrollees with SUD

Approval Period: January l, 2018 through December 31,2022Page 28 of 37

submitting for endorsement, etc.) Include numerator and denominator information.Additional items to ensure:

a. The measures contain assessments of both process and outcomes to evaluatethe effects of the demonstration during the period of approval.

b. Qualitative analysis methods may be used, and must be described in detail.c. Benchmarking and comparisons to national and state standards, should be

used, where appropriate.d. Proposed health measures could include CMS's Core Set of Health Carc

Quality Measures for Children in Medicaid and CHIp, Consumer Assessmentof Health Care Providers and Systems (CAHPS), the Initial Core Set of HealthCare Quality Measures for Medicaid-Eligible Adults and/or measuresendorsed by National Quality Forum (NQF).

e. Proposed performance metrics can be selected from nationally recognizedmetrics, for example from sets developed by the Center for Medicare andMedicaid Innovation or for meaningful use under Health InformationTechnology (HIT).

f. Among considerations in selecting the menics shall be opportunities identi{iedby the state for improving quality ofcare and health outcomes, and controllingcost of care.

5) Data Sources Explain where the data will be obtained, and efforts to validate andclea¡ the data. Discuss the quality and limitations of the data sources.

If primary data (data collected specifically for the evaluation) - The methods bywhich the data will be collected, the source of the proposed question/responses, thefrequency and timing of data collection, and the metlod of data collection. (Copiesof any proposed surveys must be reviewed with CMS for approval beforeimplementation).

6) Analytic Methods - This section includes the details ofthe selected quantitativeand/or qualitative measures to adequately assess the effectiveness ofthedemonshation. This section should:

a. Identify the specific statistical testing which will be undertaken for eachmeasure (e.9., t-tests, chi-square, odds ratio, ANOVA, regression). Table A isan example of how the state might want to articulate the anal¡ic methods foreach research question and measure.

b. Explain how the state will isolate the effects of the demonstration (from otherinitiatives occurring in the state at the same time) through the use ofcomparison groups.

c. A discussion of how propensity score matching and difference in differencesdesign may be used to adjust for differences in comparison populations over time(if applicable).

d. The application of sensitivity analyses, as appropriate, should be considered.

rùy'est Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1, 2018 through December 31, 2022

Page 29 of 37

7) Orher Addìtions -The state may provide any other information pertinent to theEvaluation Design of the demonstration.

Table A. Example Dosign Table for the Evaluation of the Demonstrat¡on

D, Methodological Limitations - This section provides detailed information on thelimitations of the evaluation. This could include the design, the data sources or collectionprocess, or analytic methods. The state should also identi$ any efforts to minimize thelimitations. Additionally, this section should include any information about features ofthe demonshation that effectively present methodological constraints that the state wouldlike CMS to take into consideration in its review. For example:

1) When the state demonstration is:a. Long-standing, non-complex, unchanged, orb. Has previously been rigorously evaluated and found to be successful, orc. Could now be considered standard Medicaid policy (CMS published

regulations or guidance)

2) When the demonstration is also considered successful without issues or concems thatwould require more regular reporting, such as:

a. Operating smoothly without administrative changes; andb. No or minimal appeals and grievances; andc. No state issues with CMS-64 reporting or budget neuhality; andd. No Corrective Action Plans (CAP) for the demonstration.

E. Attachments

A. Independent Evaluator. The process the state will use for obtaining an independententity to conduct the analysis and write the Evaluation Report, including a descriptionof the qualifications the entity must possess. As soon as known, this section shouldbe updated to include:

a. Information about the organization conducting the evaluation;

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period:January 1,2018 through December 31,2022

ResearchOueslion

Outcome measuregused to address therêsêârch duêstiôn

Sample orsubqrouos to

populal¡onbe compared Data Sources Anâlvt¡c Methôds

Hypothesis IResearchquest¡on 1a

-Measure-Measure-Measure

-Sample e.g. All attr¡butedMed¡ca¡d benefic¡ar¡es-Benef¡c¡aries with diabetesdiaonosis

-Medica¡d fee-for-serv¡ce andencounter claimsrêcôrals

-lnterrupted t¡meser¡es

Researchquestion 1b

-Measure 1

-Measure 2-Measure 3-Measure 4

-sample, e.9., PPS patienlswho meet survey selectionrequirements (usedservices w¡th¡n the last 6months)

-Pat¡ent survey Descript¡vestat¡stics

Researchquest¡on 2a

-Measure 1

-Measure 2-Sample, e.9., PPSadministrators

-Key informants Qual¡tat¡veanalys¡s of¡nfêrv¡êìr, mâlêr¡âl

Page 30 of 37

b. Contact information for the organization, including how to obtain a copy ofthe evaluation;

c . The name and contact information of the Principal Investigator; andd. Cuniculum Vitae ofthe Principal Investigator.

B. No Conllict of Interest. Explain how the state wilt assure that the IndependentEvaluator will conduct a fair and impartial evaluation, prepare an objectiveEvaluation Report, and that there would be no conflict ofinterest. This includes,.NoConflict of Interest" signed conformation statements.

C, Evaluation Budget. A budget for implementing the evaluation shall be providedwith the draft Evaluation Design. It will include the total estimated cost, as well as abreakdown of estimated staff, administrative, and other costs for.all aspects of theevaluation. Examples include, but are not limited to: the development ofall surveyand measurement instruments; quantitative and qualitative data collection; datacleaning and analyses; and reports generation. A justification of the costs may berequired by CMS if the estimates provided do not appear to suffrciently cover thecosts of the draft Evaluation Design or if CMS finds that the draft Evaluation Designis not sufficiently developed.

D. Timeline and Major Milestones. Describe the timeline for conducting the variousevaluation activities, including dates for evaluation-related milestones, includingthose related to procurement of an outside contractor, if applicable, and deliverables.The Final Evaluation Design shall incorporate an Interim and SummativeEvaluation. Pursuant to 42 CFP. 431.424(c)(v), this timeline should also include thedate by which the Final Summative Evaluation report is due.


Page 31 of 37

Attachment B: Preparing the Interim and Summative Evaluation Reports

IntroductionFor states that are testing new approaches and flexibilities in their Medicaid programs throughsection 1115 demonstrations, evaluations are crucial to understand and disseminate what is or isnot working and why. The evaluations of new initiatives seek to produce new knowledge anddirection for programs and inform Medicaid policy for the future. While a nanative about whathappened during a demonstration provide important information, the principal focus oftheevaluation ofa section 1115 demonstration should be obtaining and analyzing data on theprocess (e.g., whether the demonstration is being implemented as intended), outcomes (e.g.,whether the demonstration is having the intended effects on the target population), and impactsof the demonstration (e.g., whether the outcomes observed in the targeted population differ fromoutcomes in similar populations not affected by the demonstration). Both state and federalgovernments could benefit from improved quantitative and qualitative evidence to inform policydecisions.

Expectations for Evaluation ReportsMedicaid section I 1 15 demonstrations are required to conduct an evaluation that is valid (theextent to which the evaluation measures what it is intended to measure), and reliable (the extentto which the evaluation could produce the same results when used repeatedly). To this end, thealready approved Evaluation Design is a map that begins with the demonstration goals, thentransitions to the evaluation questions, and to the specific hypotheses, which will be used toinvestigate whethe¡ the demonstration has achieved its goals. States should have a well-structured analysis plan for their evaluation. As these valid analyses multiply (by a single stateor by multiple states with similar demonstrations) and the data sorrrces improve, the reliability ofevaluation findings will be able to shape Medicaid policy in order to improve the health andwelfare of Medicaid beneficiaries for decades to come. When submitting an application forrenewal, the interim evaluation report should be posted on the state's website with theapplication for public comment. Additionally, the interim evaluation report must be included inits entirety with the application submitted to CMS.

Intent of this GuidanceThe Social Security Act (the Act) requires an evaluation of every section I I 15 demonstration. Inorder to fulfill this requirement, the state's submission must provide a comprehensive writtenpresentation ofall key components of the demonstration, and include all required elementsspecified in the approved Evaluation Design. This Guidance is intended to assist states withorganizing the required information in a standardized format and understanding the criteria thatCMS will use in reviewing the submitted Interim and Summative Evaluation Reports.

The. format for the Interim and Summative Evaluation reports is as follows:A. Executive Summary;B. General Background Information;C. Evaluation Questions and Hypotheses;D. Methodology;E. Methodological Limitations;F. Results;

West Virginia Continuum of Care for Medicaid Enrollees with SUDApproval Period: January 1, 2018 through December 31, 2022

Page 32 of 37

G. Conclusions;H. Interpretations, and Policy Implications and Interactions with Other State Initiatives;I. Lessons Learned and Recommendations; andJ. Attachment(s).

Submission TimelinesThere is a specified timeline for the state's submission of Evaluation Designs and EvaluationReports. These dates are specified in the demonstration Special Terms and Conditions (STCs).(The graphic below depicts an example of this timeline). In addition, the state should be awarethat section I I l5 evaluation documents are public records. In order to assure the disseminationof the evaluation findings, lessons learned, and recommendations, the state is required to publishto the state's website the evaluation design within thirty (30) days of CMS approval, and publishrcports within thirty (30) days of submission to CMS , pursuant to 42 CFR 431.424. CMS willalso puhlish a copy to Meclicaid.gov.

O€m(}ÂtrÞrÖvÊd J{tñ

1,2017

t ñter ¡aÏrE9å lt,r¡ti('n O{ic31, ?Õ2(' {dðtôfrom C)Y a-?.51

Súfnñätivågvr lú¿rtiôn fô.,¡rn. 12('t7-t)èc. 31, 2O21t)ur JunG 3O,

2(}23

gvålLråt¡Õrlf}Ês¡8n

Aprit 3O.2Al7

Rènë$/¿rl J¿rñ, 1.2()22

Required Core Components of Interim and Summative Evaluation Reports

The section I I l5 Evaluation Report presents the research about the section I I 15 Demonstration.It is important that the report incotporate a discussion about the structure of the EvaluationDesign to explain the goals and objectives of the demonstration, the hypotheses related to thedemonstration, and the methodology fbr the evaluation. A copy of the state's Driver Diagram(described in the Evaluation Design guidance) must be included with an explanation of thedepicted information. The Evaluation Report should present the relevant data and aninterpretation of the findings; assess the outcomes (what worked and what did not work); explainthe limitations of the design, data, and analyses; offer recommendations regarding what (inhindsight) the state would further advance, or do differently, and why; and discuss theimplications on future Medicaid policy. Therefore, the state's submission must include:

A. Executive Summary - A summary of the demonstration, the principal results,interpretations, and recommendations of the evaluation.

B. General Background Information about the Demonstration - In this section, the stateshould include basic information about the demonstration, such as:


Page 33 of37

1) The issues that the state is trying to address with its section I I 15 demonstration and/orexpenditure authorities, how the state became aware ofthe issue, the potentialmagnitude of the issue, and why the state selected this course ofaction to address theissues.

2) The name of the demonstration, approval date of the demonstration, and period of timecovered by the evaluation;

3) A brief description of the demonstration and history of the implementation, and if theevaluation is for an amendment, extension, renewal, or expansion of, thedemonstration;

4) For renewals, amendments, and major operational changes: A description ofanychanges to the demonstration during the approval period; whether the motivation forchange was due to political, economic, and fiscal factors at the state and/or federallevel; whether the programmatic changes wer.e irnplernented [o improve beneficiaryhealth, provider/health plan performance, or administrative efficiency; and how theEvaluation Design was altered or augmented to address these changes.

5) Describe the population groups impacted by the demonstration.

C. Evaluation Questions and Hypotheses - In this section, the state should:1) Describe how the state's demonstration goals were translated into quantifiable targets

for improvement, so that the performance ofthe demonstration in achieving thesetargets could be measured. The inclusion of a Driver Diagram in the EvaluationReport is highly encouraged, as the visual can aid readers in understanding therationale behind the demonstration features and intended outcomes.

2) Identify the state's hypotheses about the outcomes ofthe demonstration;a. Discuss how the goals ofthe demonstration align with the evaluation questions

and hypotheses;b. Explain how this Evaluation Report builds upon and expands earlier

demonstration evaluation findings (if applicable); andc. Address how the research questions / hypotheses of this demonstration promote

the objectives of Titles XIX and XXI.

D. Methodology - In this section, the state is to provide an overview of the resea¡ch thatwas conducted to evaluate the section 1115 demonstration consistent with the approvedEvaluation Design. The evaluation design should also be included as an attachment to thereport. The focus is on showing that the evaluation builds upon other published research(use references), and meets the prevailing standards ofscientific and academic rigor, andthe results are statistically valid and reliable.

An interim report should provide any available dala Ío date, including both qua¡titative andqualitative assessments. The Evaluation Design should assure there is appropriate datadevelopment and collection in a timely manner to support developing an interim evaluation.

This section provides the evidence that the demonstration evaluation used the best available dataand describes why potential altemative data sources were not used; reported on, controlled for,and made appropriate adjustments for the limitations ofthe data and their effects on results; anddiscusses the generalizability ofresults. This section should provide enough transparency to


Page 34 of 37

explain what was measured and how. specifically, this section establishes that the approvedEvaluation Design was followed by describing:

l. Evaluation Deslgz - will the evaluation be an assessment of: pre/post, post-only, withor without comparison groups, etc.?

2. Target and Comparison Populallons - Describe the target and comparisonpopulations; include inclusion and exclusion criteria.

3. Evaluation Períod - Descibe the time periods for which data will be collected4. Evaluation Meantres - what measures are used to evaluate the demonstration, and

who are the measure stewards?5. Datq Sources - Explain where the data will be obtained, and efforts to validate and

clean the data.6. Analytic methods - Identify specific statistical testing which will be undertaken for

each measure (t-tests, chi-squale, odds ratio, ANOVA, regression, etc.).7. Orher Additi.ons - The state may provide any other information pertinent to the

evaluation of the demonstration.A. Möthodological Limitations

This section provides sufficient information for disceming the strengths and weaknessesof the study design, data sources/collection, and analyses.

B' Results - In this section, the state presents and uses the quantitative and qualitative datato show to whether and to what degree the evaluation questions and hypotheses of thedemonstration were achieved. The findings should visually depict the demonstrationresults (tables, charts, graphs). This section should include information on the statisticaltests conducted.

C' Conclusions In this section, the state will present the conclusions about the evaluationresults.1) In general, did the results show that the demonstration was/was not effective in

achieving the goals and objectives established at the beginning ofthe demonstration?

2) Based on the {indings, discuss the outcomes and impacts of the demonstration andidentifu the opportunities for improvements. Specifically:a. If the state did not fully achieve its intended goals, why not? What could be done

in the future that would better enable such an effort to more fully achieve thosepurposes, aims, objectives, and goals?

D.Inúerpretations, Policy Implications and Interactions with Other State Initiatives -In this section, the state will discuss the section 1115 demonstration within an overallMedicaid context and long range planning. This should include interrelations of thedemonstration with other aspects of the state's Medicaid program, interactions with otherMedicaid demonstrations, and other federal awards affecting service delivery, healthoutcomes and the cost of care under Medicaid. This section provides the state with anoppofunity to provide interpretation of the data using evaluative reasoning to makejudgments about the demonstration. This section should also include a discussion of theimplications ofthe findings at both the state and national levels.


Page 35 of 37

E. Lessons Learned and Recommendations - This section of the EvaluationReport involves the transfer of knowledge. Specifically, the ',opportunities" for futureor revised demonstrations to inform Medicaid policymakers, advocates, andstakeholders isjust as significant as identifying current successful strategies. Rased onthe evaluation results:

1. What lessons were learned as a result of the demonstration?2. What would you recommend to other states which may be interested in

implementing a similar approach?

F. AttachmentEvaluation Design: Provide the CMS-approved Evaluation Design


Page 36 of 37

Attachment C: SUD Monitorine plan protocol

[To be incorporated after CMS approval]


Page 37 of 37

r:k - West Virginia Department of Health and Human Resources

Documents

Transcript of r:k - West Virginia Department of Health and Human Resources