CurrentCentenePolicy CP PMN.82

Buprenorphine Sublingual Tablets

Coverage and medical necessity criteria for buprenorphine sublingual tablets for treatment of opioid dependence across Centene lines of business (Commercial, HIM, Medicaid). Affects prescribers and pharmacy prior authorization reviewers.

Policy Summary

PayerCentene

PolicyBuprenorphine Sublingual Tablets

Policy CodePolicy CP PMN.82

Change TypeNo material changes

Effective Date09.01.17

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results) demonstrating the member meets all approval criteria and dose limits (≤24 mg/day and ≤3 tablets/day).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 mg/daymaximum daily dose

2, 8 mgtablet strengths available

5 daysinduction therapy duration

Commercial, HIM, MedicaidLines of business

Coverage Criteria

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Opioid Dependence (Initial Approval)

Covered when ALL of the following are met

Initial approval criteria: 1) Diagnosis of opioid dependence; 2) Member is pregnant; 3) Member meets one of the following: a) Request is for induction therapy (treatment duration < 5 days); b) Member has experienced clinically significant adverse effects or contraindication(s) to buprenorphine/naloxone; c) (other listed clinical criteria if applicable per chart) ; 4) Requested dose does not exceed both: 24 mg per day AND 3 tablets per day.<= 24 mg/day; <= 3 tablets/day

Induction approval duration: 5 days; as specified in policy chunks 4, 5, and dosing guidance in chunk 13

Opioid Dependence Maintenance Therapy

Covered when ALL of the following are met

Maintenance criteria: 1) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Member has NOT received an opioid analgesic since the last approval OR prescriber documents that any opioid use since last approval was for acute pain; 4) If a dose increase is requested, the new dose does not exceed both: 24 mg per day AND 3 tablets per day.<= 24 mg/day; <= 3 tablets/day

Approval duration: duration of request or 12 months, whichever is less (see chunk 5)

Other diagnoses/indications

Other indications handling: If the requested use is not specifically listed in this policy, follow the applicable formulary/off‑label/non‑formulary policies for the member's line of business (refer to CP.CPA.190, HIM.PA.154, CP.PMN.53, CP.PMN.16 or other referenced policies as appropriate).

See chunks 6 and 9 for policy references and handling depending on formulary status

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid, or unless the member’s evidence of coverage documents explicitly support the use.

Coverage determinations and benefit administration for requests under this policy are governed by the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). These documents, together with applicable state and federal requirements and Health Plan‑level administrative policies and procedures, determine final coverage and payment.

Use of buprenorphine sublingual tablets for pain management is considered not authorized under this policy.

inv-07: Maximum daily dose — 24 mg per day

Maximum daily dose24 mg per day

Dose rationaleDoses higher than 24 mg have not been demonstrated to provide clinical advantage

Typical target doseRecommended target dose is 16 mg per day

Induction Therapy Criteria

Induction Therapy

Induction therapy requirements

Induction therapy: Request must be for induction therapy (treatment duration < 5 days); induction dosing should follow labeled induction regimen and must not exceed 24 mg per day and 3 tablets per day; induction approval duration: 5 days.<= 24 mg/day; <= 3 tablets/day

Re‑authorization for continuation beyond the initial induction period is not permitted (see policy chunk 5)

Maintenance / Continuation Therapy

Maintenance Therapy

Continuation/maintenance rules

Maintenance therapy: Member must be currently receiving medication via the Centene benefit or have previously met initial approval criteria; member must be responding positively to therapy; member must not have received an opioid analgesic since last approval unless prescriber documents that opioid use was for acute pain; dose limits apply (new or current dose must not exceed 24 mg per day and 3 tablets per day).<= 24 mg/day; <= 3 tablets/day

Approval duration: duration of request or 12 months, whichever is less

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization requires documentation of opioid dependence diagnosis and meeting the specific induction or maintenance criteria. Requests for induction therapy are limited to treatment duration of < 5 days; re-authorization for continuation beyond induction is not permitted.

Induction therapy limited to < 5 days
Re-authorization beyond induction not permitted; members must meet initial approval criteria for any continuation
Dose limits: ≤ 24 mg/day and ≤ 3 tablets/day where applicable

Documentation Required

Required Documentation & Provider Responsibilities

Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Providers submitting claims are bound by the terms and conditions of the Health Plan and should follow applicable Health Plan administrative policies and procedures when requesting authorization or submitting claims.

Submit office chart notes, labs, and any documentation of opioid dependence diagnosis
Follow Health Plan administrative policies and procedures and coverage document terms, conditions, exclusions, and limitations

Step Therapy

Step / Quantity Restrictions

Step/quantity restrictions — Medical management techniques, including quantity management beyond step therapy, are not allowed for members in Nevada per SB 439. Step-therapy and quantity limits apply as stated in the clinical criteria for induction and maintenance.

Nevada members: no medical management beyond step therapy (SB 439)
Induction: treatment duration < 5 days
Maintenance: approval duration up to duration of request or 12 months, whichever is less

Denial Risk

Exclusions & Coverage Reminder

Exclusion triggers and coverage decision reminder — Non-FDA approved indications are not authorized unless supported by the Health Plan off-label use policies or evidence of coverage; pain management is not covered under this policy. Coverage decisions and the administration of benefits remain subject to all terms, conditions, exclusions, and limitations of the coverage documents.

Non-FDA indications excluded unless supported by CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable
Pain management indication is not covered under this policy
Coverage subject to member's evidence of coverage and Health Plan policies

Note

Prior Authorization Guidance

Prior authorization guidance — This clinical policy is a guide to medical necessity to assist in making coverage decisions and administering benefits. The Health Plan makes no guarantee of payment; providers must adhere to state and federal requirements and Health Plan-level administrative procedures when requesting authorization.

Clinical policy guides medical necessity determinations but is not a guarantee of payment
Providers must comply with state/federal requirements and Health Plan administrative procedures

Coding & Limits

inv-07: Maximum daily dose — 24 mg per day

Maximum daily dose24 mg per day

Documentation notePrior authorization requires dose information not exceeding 24 mg/day

Clinical guidanceAdjust dosage in 2–4 mg increments to suppress withdrawal while not exceeding 24 mg/day

Step Therapy / Quantity Management

Step	Requirement	Approval duration / Notes
1	Induction therapy only: request must be for induction (treatment duration <5 days). Re-authorization for continuation beyond initial induction is not permitted; members must meet initial approval criteria for any subsequent request.	Induction approval duration: not applicable / induction limited; re-authorization for continuation of induction not permitted.
Nevada-specific restriction	For members in Nevada, medical management techniques, including quantity management beyond step therapy, are not allowed (per SB 439).	Applies to Nevada members only; overrides additional quantity-management beyond step therapy.

Quantity Limits

inv-23: buprenorphine sublingual tablets — 3 tablets

Quantity limit (per day)3 tablets per day

Induction durationInduction approval duration: 5 days

Maintenance approvalMaintenance duration: duration of request or 12 months, whichever is less

Site of Care

Note

Infusion center / site-of-care note

No specific site-of-care requirement is stated in this policy; however, for members in Nevada the policy notes that medical management techniques, including quantity management beyond step therapy, are not allowed.

If treating Nevada members, do not apply quantity-management beyond step therapy per SB 439.

Definitions

inv-17: Opioid dependence — A condition treated with buprenorphine sublingual tablets; buprenorphine is indicated for this use and preferred for induction.

DefinitionOpioid dependence is a condition treated with buprenorphine sublingual tablets; buprenorphine is indicated for this use and preferred for induction.

Indication detailSublingual buprenorphine is FDA‑approved for opioid dependence and is the preferred formulation for induction.

Treatment noteMaintenance dosing generally ranges from 4 mg to 24 mg per day with a recommended target of 16 mg per day.

inv-18: Medical necessity (as used in this policy) — Medical necessity guidance: criteria used to assist in coverage decisions and benefit administration; not a contract or payment guarantee.

Purpose of medical necessity guidanceCriteria used to assist in making coverage decisions and administering benefits; not a contract or guarantee of payment.

ScopeCoverage decisions are subject to terms, conditions, exclusions, and limitations of the member's coverage documents and applicable laws.

Provider responsibilityThis clinical policy is not medical advice and providers must exercise professional judgment in patient care.

inv-19: Provider status — Providers referenced are independent contractors and not agents or employees of the Health Plan.

Provider relationship to Health PlanProviders referenced are independent contractors who exercise independent judgment and are not agents or employees of the Health Plan.

Liability and controlThe Health Plan has no control or right of control over providers referenced in this policy.

Contractual bindingProviders, members, and representatives are bound by policy terms through their contracts or by providing services/submitting claims.

Background

Buprenorphine is a partial mu‑opioid receptor agonist and kappa opioid receptor antagonist. The sublingual tablet formulation is FDA‑approved for the treatment of opioid dependence and is the preferred formulation for induction. Typical dosing regimens for opioid dependence include induction schedules and maintenance doses with a maximum daily dose of 24 mg; induction dosing commonly targets 8–16 mg in the first days of therapy and induction duration is limited per policy.