Methadone prescribing and dispensing must be administered through an Opioid Treatment Program (OTP) approved by Substance Abuse and Mental Health Services Administration (SAMHSA), Drug Enforcement Administration's (DEA), state and local agencies accredited by The Joint Commission (TJC), Commission on Accreditation of Rehabilitation Facilities (CARF) and/or The Council on Accreditation (COA). 

Opioid use disorder is a substance use disorder characterized by a problematic pattern of opioid use that causes clinically significant impairment or distress.

Methadone hydrochloride is a synthetic narcotic analgesic with multiple actions quantitatively similar to those of morphine. Its principal use is detoxification or maintenance in opiate addiction (heroin or other morphine-like drugs).

The Delaware Mental Health Parity mandate (18 Del. C. Sections 3343, 3576 and 3578) is applicable to direct pay (individual market) policies and insured small group   plans who use in-network providers. Federal Mental Health Parity laws do not apply to individual and small group.

This Delaware mandate requires that health plans delivered or issued for delivery in Delaware must provide coverage for the diagnosis and treatment of serious mental illness and drug or alcohol dependency*. Serious mental illness is defined by the mandate to include:

• Schizophrenia
• Bipolar disorder
• Obsessive-compulsive disorder
• Major depressive disorder
• Panic disorder
• Anorexia nervosa
• Bulimia nervosa
• Schizo affective disorder 
• Delusional disorder

  *Substance abuse disorder or the chronic, habitual, regular, or recurrent use of alcohol, inhalants, or controlled substances

The Delaware mandate provides, in part, for inpatient coverage for the diagnosis and treatment of drug and alcohol dependencies, including medically necessary inpatient withdrawal management and treatment provided in residential settings.

The most recent Diagnostic and Statistical Manual of Mental Disorders (DSM) shall be used to determine whether a member meets diagnostic criteria.

Mental Health Parity requires that coverage may not contain terms and conditions that place a greater financial burden on an insured than terms applicable to the diagnosis and treatment of any other illness or disease covered by the health benefit plan. Examples of terms and conditions mentioned in the law include: deductibles, co-pays, dollar maximums, co-insurance limits, number of visits, limits on number and duration of in-patient stays, or limits on prescription medicines.

Eligibility for coverage:

• Appropriate professional provider licensure by Delaware Board of Licensing
• Medical necessity of service 
• Additional conditions of coverage may apply if applicable to the same extent as coverage for all other illnesses and diseases.
• Benefit management need not be identical to methods used for the management of benefits for other medical conditions.

Network Services
This mandate is not applicable to out of network services if a Plan has a network of providers to treat mental illnesses and drug and alcohol dependencies. 
 
Coverage for groups with 51 or more employees

The 2008 Federal Mental Health Parity and Addiction Equity Act (MHPAEA) which updated the 1996 Mental Health Parity Act is applicable to all self-insured group health plans with greater than 50 employees.

In addition, there is Delaware law (18 Del. C. Section 3576), that also applies the MHPAEA to large insured group health plans (over 50 employees).

The MHPAEA includes an exception process to the MHPAEA requirements for those group health plans that can prove a significant increase in cost to provide coverage (2% in the first year and 1% in following years).

MHPAEA does not apply to:

• Medicaid managed care plans
• Medicare Advantage plans (unless sponsored by Employer)
• Federal Employee Plan (FEP)
• Non-federal governmental plans with less than 100 employees

The MHPAEA requires that a carrier or group health plan that provides coverage for mental health disorders or substance use disorders cannot impose financial requirements and treatment limitations that are more restrictive/less favorable than those applied to medical benefits. Generally, parity requirements include:

• Lifetime or annual limits on mental health or substance use disorder benefits
• Financial requirements (e.g., co-pays, co-insurance, deductibles)
• Out of Network coverage - if plan includes coverage for out of network medical/surgical benefits, the plan must also include coverage for out of network mental health and substance use disorders
• Quantitative treatment limitations (e.g., day limits, visit limits)
• Non-quantitative treatment limitations (e.g., medical management standards/policies), except to the extent that recognized clinically appropriate standards of care may permit a difference

In addition, Plans and group health plans must provide the internal policies, standards or criteria for medical necessity determinations to a current or potential member or contracting provider. Parity requirements are further and more specifically defined by regulation.

NOTE: MHPAEA does not mandate that a Plan or group health plan provide coverage for mental health or for any specific mental illnesses or conditions; however, where a group health plan or Plan elects to cover a mental health and substance abuse disorder, the law requires parity or general equivalence.

MAT for opioid use disorder (opioid dependence) may be considered medically necessary for adults when ALL of the following indications are met:

• Current diagnosis of opioid use disorder, duration greater than one (1) year; and
• Individual is greater than or equal to 18 years of age; and
• Presence of moderate (4-5 symptoms) to severe (6 or more symptoms) opioid use disorder (refer to chart); and
• Capable to provide informed consent; and
• If pregnant, the individual must be under the supervision of an Obstetrician.

Note: The program physician may waive the requirement of a one (1) year history of addiction for individuals released from penal institutions (within 6 months after release), for pregnant individuals, and for previously treated individuals (up to 2 years after discharge).

All other indications are considered not medically necessary.

MAT for opioid use disorder may be considered medically necessary for individuals less than 18 years of age when ALL of the following indications are met:

• Current diagnosis of opioid use disorder, duration greater than one (1) year; and
• A completed and signed Food and Drug Administration (FDA) consent for methadone treatment by parent, legal guardian, or responsible adult designated by the relevant State authority; and
• Presence of moderate (4-5 symptoms) to severe (6 or more symptoms) opioid use disorder (refer to chart); and
• History of at least two (2) prior unsuccessful detoxification efforts or drug-free treatment within a 12-month period; and
• If pregnant, the individual must be under the supervision of an Obstetrician.

Note: The program physician may waive the requirement of a one (1) year history of addiction for individuals released from penal institutions (within 6 months after release), for pregnant individuals, and for previously treated individuals (up to 2 years after discharge).

All other indications are considered not medically necessary.

Professional practitioners must acquire and maintain valid certifications and valid DEA registration number to legally dispense and prescribe methadone treatment. 

Opioid Use Disorder Symptoms

Severity of opioid use disorder categories:
Mild:  Presence of 1-2 symptoms
Moderate: Presence of 4-5 symptoms
Severe: Presence of 6 or more symptoms

NOTE:  Dosage recommendations per the FDA label.