DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Medicaid and Medical Assistance

PROPOSED

PUBLIC NOTICE

Medication-Assisted Treatment (MAT)

In compliance with the State's Administrative Procedures Act (APA - Title 29, Chapter 101 of the Delaware Code), 42 CFR §447.205, and under the authority of 31 Del. C. § 512, Delaware Health and Social Services (DHSS) / Division of Medicaid and Medical Assistance (DMMA) is proposing to amend Title XIX Medicaid State Plan regarding Medication-Assisted Treatment (MAT) to move coverage of the MAT benefit from the optional services sections of the Medicaid State Plan to the mandatory services section of the Medicaid State Plan for categorically needy populations, per federal requirements.

Any person who wishes to make written suggestions, compilations of data, testimony, briefs, or other written materials concerning the proposed new regulations must submit same to Planning, Policy and Quality Unit, Division of Medicaid and Medical Assistance, 1901 North DuPont Highway, P.O. Box 906, New Castle, Delaware 19720-0906, by email to Nicole.M.Cunningham@delaware.gov, or by fax to 302-255-4413 by 4:30 p.m. on March 31, 2021. Please identify in the subject line: Medication-Assisted Treatment (MAT).

The action concerning the determination of whether to adopt the proposed regulation will be based upon the results of Department and Division staff analysis and the consideration of the comments and written materials filed by other interested persons.

SUMMARY OF PROPOSAL

The purpose of this notice is to advise the public that Delaware Health and Social Services (DHSS)/Division of Medicaid and Medical Assistance (DMMA) is proposing to amend Title XIX Medicaid State Plan regarding Medication-Assisted Treatment (MAT) to move coverage of the MAT benefit from the optional services sections of the Medicaid State Plan to the mandatory services section of the Medicaid State Plan for categorically needy populations, per federal requirements.

Statutory Authority

Background

Section 1006(b) of the SUPPORT Act, signed into law on October 24, 2018, amends section 1902(a)(10)(A) of the Social Security Act (the Act) to require state Medicaid plans to include coverage of MAT for all eligible to enroll in the state plan or waiver of state plan. States are also required to cover counseling services and behavioral therapies associated with provision of the required drug and biological coverage.

States that already use existing Medicaid authorities to cover items and services that will now be covered under the new mandatory MAT benefit, including FDA-approved or licensed drugs and biologicals used for MAT to treat Opioid Use Disorder (OUD), and associated counseling services and behavioral therapies, are expected to submit a State Plan Amendment (SPA) to move their coverage of these items and services to a new page in their Medicaid state plans for the new mandatory benefit at section 1905(a)(29) of the Act. Delaware currently covers MAT as an optional benefit and is publishing this regulation so as to move this coverage from an optional benefit to a mandatory benefit.

Upon receipt of the State Health Official dated December 30, 2020, issuing guidance about the requirements of section 1006(b), Delaware submitted a modification request of SPA submission requirements at 42 C.F.R. 430.20 in order to submit a SPA implementing section 1905(a)(29) of the Act by March 31, 2021 that would take effect on October 1, 2020. Pursuant to section 1135(b) of the Act, Delaware requested modification of the public notice time frames set forth at 42 C.F.R. 447.205 in order to obtain an effective date of October 1, 2020.

Summary of Proposal

Purpose

The purpose of this proposed regulation is to move coverage of MAT benefit from the optional services sections of the Medicaid State Plan to the mandatory services section of the Medicaid State Plan for categorically needy populations, per federal requirements.

Summary of Proposed Changes

Effective for services provided on and after October 1, 2020 DHSS/ DMMA proposes to amend Attachment 3.l-A Page 2A and Attachment 4-19-B Page 18 of Title XIX Medicaid State Plan regarding MAT to move coverage of the MAT benefit from the optional services sections of the Medicaid State Plan to the mandatory services section of the Medicaid State Plan for categorically needy populations, per federal requirements.

Public Notice

In accordance with the federal public notice requirements established at Section 1902(a)(13)(A) of the Social Security Act and 42 CFR 447.205 and the state public notice requirements of Title 29, Chapter 101 of the Delaware Code, DHSS/DMMA gives public notice and provides an open comment period for 30 days to allow all stakeholders an opportunity to provide input on the proposed regulation. Comments must be received by 4:30 p.m. on March 31, 2021.

Centers for Medicare and Medicaid Services Review and Approval

The provisions of this SPA are subject to approval by the Centers for Medicare and Medicaid Services (CMS). The draft SPA page(s) may undergo further revisions before and after submittal to CMS based upon public comment and/or CMS feedback. The final version may be subject to significant change.

Provider Manuals and Communications Update

Also, there may be additional provider manuals that may require updates as a result of these changes. The applicable Delaware Medical Assistance Program (DMAP) Provider Policy Specific Manuals and/or Delaware Medical Assistance Portal will be updated. Manual updates, revised pages or additions to the provider manual are issued, as required, for new policy, policy clarification, and/or revisions to the DMAP program. Provider billing guidelines or instructions to incorporate any new requirement may also be issued. A newsletter system is utilized to distribute new or revised manual material and to provide any other pertinent information regarding DMAP updates. DMAP updates are available on the Delaware Medical Assistance Portal website: https://medicaid.dhss.delaware.gov/provider

Fiscal Impact

There is no anticipated fiscal impact as Delaware currently covers MAT.

Attachment 3.1-A

Page 2A

STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT

STATE/TERRITORY: DELAWARE

AMOUNT, DURATION, AND SCOPE OF MEDICAL

AND REMEDIAL CARE AND SERVICES PROVIDED TO THE CATEGORICALLY NEEDY

1905(a)(29) Medication-Assisted Treatment (MAT)

i. General Assurance

MAT is covered under the Delaware Medicaid state plan for all Medicaid beneficiaries who meet the

medical necessity criteria for receipt of the service for the period beginning October 1, 2020, and ending

September 30, 2025.

ii. Assurances

a. The state assures coverage of Naltrexone, Buprenorphine, and Methadone and all of the forms of

these drugs for MAT that are approved under section 505 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355) and all biological products licensed under section 351 of the

Public Health Service Act (42 U.S.C. 262).

b. The state assures that Methadone for MAT is provided by Opioid Treatment Programs that

meet the requirements in 42 C.F.R. Part 8.

iii. Service Package

The state covers the following counseling services and behavioral health therapies as part of MAT.

Outpatient Addiction Services

MAT may be provided as part of outpatient addiction services which are community-based addiction

services not provided in an outpatient hospital setting and include individual-centered activities

consistent with the beneficiary's assessed treatment needs with a rehabilitation and recovery focus

designed to promote skills for coping with and managing symptoms and behaviors associated with

substance use disorders (SUD). These activities are designed to help beneficiaries achieve and

maintain recovery from SUDs. Outpatient SUD services include medically necessary care according

to assessed needs including the four (4) component activities: (1) Assessment and clinical treatment

plan development - The purpose of the assessment is to provide sufficient information for problem

identification, SUD treatment or referral for the beneficiary to gain access to other needed Medicaid

SUD or mental health services. The treatment plan for Medicaid SUD or mental health services must

be patient centered and developed in collaboration with the patient; (2) Skill development for coping

with and managing symptoms and behaviors associated with substance use disorders (SUD)

such as the participant's perspective and lack of impulse control or signs and symptoms of

withdrawal; (3) Counseling to address a beneficiary's major lifestyle, attitudinal, and behavioral

problems. Counseling includes highly structured psychosocial therapy to address issues that have the

potential to undermine the goals of treatment; (4) Medication Assisted Therapies (MAT), when clinically

appropriate and desired by the patient, including the direct administration of medication.

Attachment 3.1-A

Page 2B

Outpatient activities are delivered on an individual or group basis in a wide variety of settings including

site-based facility, in the community or in the beneficiary's place of residence. These services may be

provided on site or on a mobile basis as defined by Delaware Health and Social Services (DHSS) or its

designee. The setting will be determined by the goal which is identified to be achieved in the beneficiary's

written treatment plan. Outpatient services may be indicated as an initial modality of care for a beneficiary

whose severity of illness warrants this level of treatment, or when a beneficiary's progress warrants a less

intensive modality of service than they are currently receiving. The intensity of the services will be

driven by medical necessity. Medication Assisted Therapies (MAT) should only be utilized when a

beneficiary has an established SUD (e.g., opiate or alcohol dependence condition) that is clinically

appropriate for MAT.

Provider qualifications: Outpatient addiction services are provided by licensed and unlicensed

professional staff, who are at least eighteen (18) years of age with a high school or equivalent diploma,

according to their areas of competence as determined by degree, required levels of experience as

defined by state law and regulations and approved program guidelines and certifications approved by

DHSS or its designee. All outpatient substance use disorder (SUD) programs are licensed or certified

under state law. Licensed practitioners under Delaware state regulation are licensed by Delaware

and include Licensed Clinical Social Workers (LCSWs), Licensed Professional Counselors of

Mental Health (LPCMH), Licensed Marriage and Family Therapists (LMFTs), nurse practitioners (NPs),

advanced practice nurses (APNs), medical doctors (MD and DO), Licensed Chemical Dependency

Professionals (LCDPs), and psychologists.

Residential Addiction Services

MAT may be provided as part of residential services which include individual-centered residential

services consistent with the beneficiary’s assessed treatment needs, with a rehabilitation and

recovery focus designed to promote skills for coping with and managing substance use disorder

symptoms and behaviors. These services are designed to help beneficiaries achieve changes in their

substance use disorder behaviors. Services should address the beneficiary’s major lifestyle,

attitudinal, and behavioral problems that have the potential to undermine the goals of treatment.

Residential SUD services include medically necessary care according to assessed needs including

the four (4) component activities: (1) Assessment and clinical treatment plan development – The

purpose of the assessment is to provide sufficient information for problem identification, SUD treatment

or referral for the beneficiary to gain access to other needed Medicaid SUD or mental health

services. The treatment plan for Medicaid SUD or mental health services must be patient-centered

and developed in collaboration with the patient; (2) Skill development for coping with and managing

symptoms and behaviors associated with substance use disorders (SUD) such as the participant’s

perspective and lack of impulse control or signs and symptoms of withdrawal; (3) Counseling to

address a beneficiary’s major lifestyle, attitudinal, and behavioral problems. Counseling includes

highly structured psychosocial therapy to address issues that have the potential to undermine

the goals of treatment; (4) Medication Assisted Therapies (MAT) when clinically appropriate and

desired by the patient, including the direct administration of medication. Residential services are

delivered on an individual or group basis in a wide variety of settings including treatment in residential

settings of sixteen (16) beds or less designed to help beneficiaries achieve changes in their

substance use disorder behaviors.

Provider qualifications: Services are provided by licensed and unlicensed professional staff, who

are at least eighteen (18) years of age with a high school or equivalent diploma, according to

their areas of competence as determined by degree, required levels of experience as defined by

state law and regulations and departmentally approved program guidelines and certifications.

All residential programs are licensed or certified under state law per Delaware Administrative Code

Title 16.6001. The licensure applies to all programs providing services to beneficiaries in need of

programs and

Attachment 3.1-A

Page 2C

services for diagnosed substance use and/or mental disorders. The licensure at a minimum requires

documentation of all insurance coverage required in regulation; the maximum client capacity requested;

and a copy of the agency’s Delaware business license and home state license, when applicable. The

licensure or certification also requires a description of the services to be provided by the program,

including a statement of the program philosophy, goals and objectives, and a description of the

methodology for each service element; and organization charts of showing incumbent names, positions,

degrees and credentials (e.g., license, certification); all vacant positions; and illustrating direct and indirect

reporting and supervisory relationships. Licensed practitioners under Delaware State regulation are

licensed by Delaware an include Licensed Clinical Social Workers (LCSWs), Licensed Professional

Counselors of Mental Health (LPCMH), Licensed Marriage and Family Therapists (LMFTs), nurse

practitioners (NPs); advanced practice nurses (APNs), medical doctors (MD and DO), Licensed Chemical

Dependency Professionals (LCDPs), and psychologists. Any staff who is unlicensed and providing addiction

services must be credentialed by DHSS or its designee and/or the credentialing board or, if a Recovery

Coach or Credentialed Behavioral Health Technician, be under the supervision of a qualified health

professional (QHP) or Clinical Supervisor.

Attachment 3.1-A

Page 2D

1905(a)(29) Medication-Assisted Treatment (MAT)

Amount, Duration, and Scope of Medical and Remedial Care Services Provided to the Categorically Needy

(continued)

iv. Utilization Controls

The state has drug utilization controls in place. (Check each of the following that apply)

Generic first policy

X Preferred drug lists

X Clinical criteria

X Quantity limits

The state does not have drug utilization controls in place.

v. Limitations

Describe the state’s limitations on amount, duration, and scope of MAT drugs, biologicals, and counseling

and behavioral therapies related to MAT.

authorization is approved.

Attachment 4.19-B

Page 18

STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT

STATE/TERRITORY: DELAWARE

METHODS AND STANDARDS FOR ESTABLISHING PAYMENT RATES –

OTHER TYPES OF CARE

Payments for Medication Assisted Treatment

Effective October 1, 2020, the Medicaid agency will continue to pay qualified providers for evaluation and management (E/M) or HCPCS Code as applicable when Medication Assisted Treatment (MAT) is part of a visit.

The reimbursement for the MAT drugs that meet the definition of a covered outpatient drug in section 1927(k) of the Social Security Act will continue to follow the same reimbursement provided in the table on page Attachment 4.19-B Page 14a related to generic and brand drugs.