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    v1.0.28
    OpenPayerPolicy UpdatesPsychiatry/Behavioral HealthOptum Opioid Treatment Programs Coverage | OpenPay…
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    CurrentOptumPolicy BH803OTPMCS092025

    Opioid Treatment Programs

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    Defines medical necessity, coverage indications, assessment, testing, providers, and documentation expectations for outpatient opioid treatment programs for Medicare beneficiaries managed by Optum.

    Policy Summary
    PayerOptum
    PolicyOpioid Treatment Programs
    Policy CodePolicy BH803OTPMCS092025
    Change TypeAnnual reviewadministrative/template updates
    Effective Date
    Last ReviewSep 16, 2025
    Next Review Date
    Key ActionVerify member eligibility and document required initial assessment elements before initiating pharmacotherapy.
    SourceLink
    POLICY UPDATE CHANGES

    09/16/2025 Annual Review: No content changes, updated template.

    07/22/2025 administrative/formatting update to Introduction & Instructions for Use section.

    No duration limitDuration of treatment

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    Initial assessment required
    Admission documentation
    Drug testing requiredToxicology monitoring
    L39849 referencedPrimary CMS source

    Coverage Criteria for Opioid Treatment Programs (OTPs)

    inv-01: Coverage Indications

    Covered when ALL of the following are met

    OTP Indications (CMS L39849): 1) Diagnosis of opioid use disorder (OUD) using DSM; 2) Voluntary choice of maintenance treatment; 3) Currently addicted to an opioid drug.

    Source: CMS L39849 (2024).

    inv-02: Initial Assessment Criteria

    Required admission documentation prior to initiating pharmacotherapy

    Initial assessment elements: Confirmation of the OUD diagnosis; complete medical history inclusive of concomitant medical conditions, psychiatric disorders, trauma, infectious disease, and pregnancy status; physical exam (unless assessment performed via telehealth); mental health screening for psychiatric disorders; laboratory testing including complete blood count, liver enzyme testing, tuberculosis screening, hepatitis B and C, and HIV or documentation of recent testing/rationale if not performed; authenticated informed consent discussing treatment options, risks/benefits, and patient preferences; formation of an individualized treatment plan including psychosocial services and patient preference for these services; assessment of withdrawal potential with associated plan; assessment of safety including overdose risk, prevention education, and offer of take-home naloxone.

    These elements must be addressed and included in documentation before initiating pharmacotherapy.

    inv-03: Periodic Assessment and Drug Testing

    Ongoing care and monitoring requirements

    Monitoring and periodic assessment: Provide drug testing for substances of abuse; periodic assessments must document evaluation of treatment progress and any appropriate adjustments, review of drug testing and assessment of compliance, review of psychosocial needs with a plan to address unmet needs, and documentation substantiating the necessity for periodic visits. Continued use of other addictive drugs should not alone be a reason to withhold or suspend OUD treatment but may prompt intensified care.

    Drug testing and documented periodic assessments are required components of OTP services.

    inv-04: Covered Providers

    Provider and program requirements

    Qualified providers within certified OTP: Care must be provided by one or a combination of the following as part of a certified opioid treatment program: physicians (MD/DO); clinical psychologists; licensed clinical social workers; nurse practitioners; clinical nurse specialists; physician assistants; and other state-authorized mental health/addiction providers (e.g., licensed professional counselors, licensed clinical alcohol and drug counselors, licensed marriage and family therapists, certified peer specialists).

    Providers must be licensed or otherwise authorized by state law.

    No specific exclusions are enumerated in this guideline. Prior to rendering coverage determinations, reviewers must verify member eligibility and the member-specific benefit plan, since a member's specific benefits or any applicable federal or state regulatory requirements supersede this guideline when conflicts exist. If a requested service is limited, excluded, defined differently, or otherwise in conflict with the member's benefit, the member's benefit governs. Reviewers should also be aware that Optum may adopt or modify external clinical criteria as required by contract or regulation.

    This document does not list any conditions explicitly labeled as not medically necessary. The policy history notes administrative and template updates only and indicates no substantive coverage removals. Reviewers should still follow the Instructions for Use to confirm member benefits and applicable statutes or NCD/LCD guidance before concluding medical necessity.

    Coding and Related Information

    Referenced CMS LCD/LCA Codesmixed
    L39849Local Coverage Determination: Opioid Treatment Programs (Palmetto GBA)
    A59718Local Coverage Article, Billing and Coding: Opioid Treatment Programs
    inv-08: Duration of Treatment 6 No limitation
    Duration limitThere is no limitation to the duration of treatment.
    Documentation requirementAll coverage criteria must be clearly documented in the patient’s medical record and made available to the A/B MAC upon request.
    ApplicabilityApplies to outpatient opioid treatment program services per CMS guidance referenced in this policy.

    Provider Actions, Documentation, and Billing Guidance

    Prior Authorization

    Verify eligibility and benefits

    Confirm member eligibility and review the member-specific benefit plan and any federal or state regulatory requirements that supersede the benefit prior to applying this guideline; when there is a conflict between this guideline and the member's benefit, the member's benefit supersedes the guideline.

    • Identify member eligibility and benefit-specific coverage before making coverage determinations.
    • Confirm any superseding federal or state regulatory requirements.
    Step Therapy

    Use ASAM Criteria to supplement Medicare guidance

    ASAM Criteria may be consulted to supplement Medicare NCDs/LCDs when those determinations do not fully address the appropriate treatment type or setting; this document does not specify any step therapy rules.

    • Use The ASAM Criteria for comprehensive six-dimension analysis when NCDs/LCDs are insufficient to determine appropriate level of care.

    Background

    Opioid Treatment Programs (OTPs) deliver ambulatory care for beneficiaries with opioid use disorder (OUD), combining medication-assisted treatment with psychosocial supports and ongoing monitoring to reduce overdose risk and support recovery. OTPs must operate in compliance with federal regulations governing medications for OUD and be provided within certified programs by appropriately licensed or authorized clinicians. When Medicare guidance is incomplete, the ASAM Criteria may be used to supplement NCDs/LCDs to determine appropriate level and intensity of care.

    Definitions

    inv-14: Opioid Use Disorder (OUD) 6 Definition per DSM and related beneficiary considerations
    Formal diagnostic criteriaDiagnosis of Opioid Use Disorder (OUD) using the Diagnostic and Statistical Manual for Mental Disorders (DSM).
    Voluntary treatmentBeneficiary must voluntarily choose maintenance treatment.
    Current addictionBeneficiary must be currently addicted to an opioid drug.
    Context of useThese indications are drawn from CMS Local Coverage Determination L39849 and form the coverage basis for OTP services.
    inv-15: Initial assessment 6 Definition and components of the intake/assessment
    Required elements (must be documented before pharmacotherapy)Confirmation of OUD diagnosis; complete medical history (including concomitant conditions, psychiatric disorders, trauma, infectious disease, and pregnancy); physical exam (unless performed via telehealth); mental health screening; required laboratory testing (CBC, liver enzymes, tuberculosis screening, hepatitis B and C, HIV) or documentation of recent testing/rationale; authenticated informed consent (options, risks/benefits, patient preferences); individualized treatment plan including psychosocial services; assessment of withdrawal potential and plan; safety and overdose risk assessment with offer of take-home naloxone.

    Level of Care — Outpatient / Ambulatory OTP

    Treatment Modalities

    inv-17: Medication-assisted treatment (MAT)

    Medication treatment criteria and related notes

    Pharmacotherapy initiation: Pharmacotherapy may be initiated after completion of the required initial assessment; monitoring during treatment includes drug testing and periodic reassessment as described in periodic assessment requirements.

    ASAM Criteria may be consulted to determine appropriate intensity/setting when NCD/LCD do not fully address treatment setting.

    Policy Summary
    PayerOptum
    PolicyOpioid Treatment Programs
    Policy CodePolicy BH803OTPMCS092025
    Change TypeAnnual reviewadministrative/template updates
    Effective Date
    Last ReviewSep 16, 2025
    Next Review Date
    Key ActionVerify member eligibility and document required initial assessment elements before initiating pharmacotherapy.
    SourceLink
    On This Page
    Coverage Criteria for Opioid Treatment Programs (OTPs)Coding and Related InformationProvider Actions, Documentation, and Billing GuidanceBackgroundDefinitionsLevel of Care — Outpatient / Ambulatory OTPTreatment Modalities
  1. No step therapy requirements are specified in this guideline.
    2. Documentation Required

    Required documentation elements for admission and ongoing care

    Document the required initial assessment elements and ongoing care components in the medical record prior to initiating pharmacotherapy and throughout treatment.

    • Confirmation of OUD diagnosis.
    • Complete medical history including comorbidities and pregnancy status.
    • Physical exam (unless performed via telehealth).
    • Mental health screening for psychiatric disorders.
    • Laboratory testing (CBC, liver enzymes, TB screening, hepatitis B & C, HIV) or documentation of recent testing/rationale.
    • Authenticated informed consent covering treatment options, risks/benefits, and patient preferences.
    • Individualized treatment plan including psychosocial services and withdrawal/safety assessments; offer of take-home naloxone.
    • Periodic assessments documenting treatment progress, drug testing review, compliance, and psychosocial needs.
    • Ensure all coverage criteria are available to the A/B MAC upon request.
    Denial Risk

    Denial risk for insufficient documentation

    Failure to document the required initial assessment elements, periodic assessments, drug testing, or other coverage criteria in the medical record (which must be made available to the A/B MAC on request) may lead to coverage denial or inability to substantiate medical necessity.

    • Retain and present documentation of initial assessment and periodic reassessments when requested by the A/B MAC.
    • Ongoing drug testing and documentation of results and treatment adjustments are required to support continued coverage.
    Medical history scopeInclude concomitant medical conditions, psychiatric disorders, trauma, infectious disease, and pregnancy status.
    Laboratory testing specificsCBC, liver enzyme testing, tuberculosis screening, hepatitis B and C, and HIV; if not performed, include recent testing documentation or rationale for omission.
    Informed consent contentAuthenticated informed consent must document treatment options discussed, risk/benefit consideration of pharmacotherapy, and the patient’s treatment preferences.