Medical Policy:
Opioid Dependence Therapy
Effective Date:
January 1, 2018
Issued Date:
October 8, 2018
Last Revision Date:
October 2018
Annual Review:
October 2017

Opioid dependence therapy is a combination of pharmacological agents and psychosocial therapy. Psychosocial therapy consist of four phases; assessment and treatment planning, induction, stabilization, and maintenance. Physicians should be aware of and adhere to currently accepted guidelines and recommendations for treating opioid dependent patients, including integrating psychosocial treatments and behavior modification strategies for optimal results. Clinicians must be educated on the new treatment modalities and regulations surrounding the use of these therapies.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

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, large insured group health plans (over 50 employees) must also comply with MHPAEA and any subsequent changes to the law. The law 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.


Opioid dependence therapy may be considered medically necessary for the following treatment stages in this order:

  • Assessment and Treatment Planning (i.e., counseling, social support program, treatment goals, etc.)
    • One (1)-two (2) office visits weekly for the four (4)-weeks of initiation of therapy
  • Induction - The medication is administered when an individual with an opioid dependency has abstained from using opioids for 12 to 24 hours and is in the early stages of opioid withdrawal.
    • Three (3) office visits per week for two (2)-weeks
  • Stabilization - Begins after an individual has discontinued or greatly reduced their misuse of the problem drug, no longer has cravings, and experiences few, if any, side effects.
    • One (1)-two (2) office visits per week for eight (8)-weeks
  • Maintenance - Occurs when a patient is doing well on a steady dose of medication.
    • One (1) office visit per month

Psychosocial treatment (i.e., cognitive behavioral, contingency management, coping skills training, etc.) may be considered medically necessary with buprenorphine drug treatment.

An individual must be evaluated by a licensed Drug and Alcohol therapist at least monthly while on maintenance medication.

Opioid dependence therapy is considered not medically necessary for all other indications.






















Related Policies

Refer to medical policy L-102 Drug Testing in Pain Management and Substance Abuse Treatment for additional information.

Refer to medical policy I-92 Naltrexone for Treatment of Alcohol and Opioid Dependence for additional information.

Refer to medical policy I-160 Buprenorphine Implant for Treatment of Opioid Dependence for additional information.

Refer to pharmacy policy J-331 Opioid Dependence Therapy for additional information.

Professional Statements and Societal Positions Guidelines

Substance Abuse and Mental Health Service Administration (SAMHSA)

Federal legislation, regulations, and guidelines govern MAT for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), oversees accreditation standards and certification processes for OTPs. DPT also works with the DEA and the states to regulate certain medications used in MAT. Additionally, DPT works directly with MAT professionals to improve treatment outcomes and to meet regulatory criteria.

Centers for Disease Control and Prevention (CDC) 2016 guideline for prescribing opioids for chronic pain

When prescribing opioids for chronic pain, clinicians should use drug testing before starting opioid therapy and consider drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

42 CFR 8.12 - Federal opioid treatment standards

A OTPs organizational structure and facilities shall be adequate to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part and any regulations regarding the use of opioid agonist treatment medications in the treatment of opioid use disorder which may be promulgated in the future. The medical director shall assume responsibility for administering all medical services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.















Place of Service: Outpatient

Treatment for opioid dependence therapy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business

Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.


This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

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    U.S. Department of Health and Human Services
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    Room 509F, HHH Building
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