CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Buprenorphine (Probuphine) subdermal implant — Coverage Criteria

Coverage policy for buprenorphine subdermal implants (Probuphine) as a maintenance treatment for select patients with opioid dependence who are clinically stable on low-dose transmucosal buprenorphine; applies to Medicare Advantage and commercial products of Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBuprenorphine (Probuphine) subdermal implant — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2017

Next Review DateJan 21, 2026

Key ActionDocument opioid dependence, evidence of ≥3 months stability on ≤8 mg/day transmucosal buprenorphine, current maintenance dose, enrollment in comprehensive SUD treatment, and prescriber's DATA waiver ID.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤8 mg/dmax transmucosal dose eligible

≥3 monthsmin duration stable before implant

up to 6 moimplant duration per set

≤2FDA lifetime uses limit

J0570

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Coverage Criteria

Medically Necessary Criteria (Medicare Advantage and Commercial)

Covered when ALL of the following are met

Eligibility for buprenorphine implant: Member has a diagnosis of opioid dependence; has been treated with a stable transmucosal buprenorphine dose (≤8 mg/day of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent) for 3 months or more without any need for supplemental dosing or adjustments; is currently maintained on a dose of ≤8 mg/day to achieve sustained prolonged clinical stability; and the implant will be used as part of a comprehensive substance use disorder treatment program that includes counseling and psychosocial support.

Prescriber Regulatory Requirements

Regulatory and prescriber requirements: Use in the treatment of opioid dependence is limited to physicians who meet DATA waiver qualifying requirements, have notified HHS of their intent to prescribe or dispense this product for opioid dependence, and have been assigned a unique identification number which must be included on every prescription.

Buprenorphine implants are intended only for patients who have already achieved and sustained clinical stability on transmucosal buprenorphine. They are not appropriate for new treatment recipients or patients who have not achieved prolonged, sustained stability on a transmucosal formulation. Clinical trial data and the FDA review found the implant dose was too low to provide effective treatment for patients new to buprenorphine, and benefit is limited to those stabilized on low-to-moderate transmucosal doses.

Before a transition to an implant, the patient must have been maintained on a stable transmucosal buprenorphine dose (see policy thresholds) without need for supplemental dosing or adjustment; implants are a maintenance strategy to improve adherence and reduce diversion, not an initiation strategy for opioid dependence treatment.

FDA labeling restricts lifetime use of buprenorphine implants. Use of buprenorphine implants greater than 2 times per lifetime is considered not medically necessary because the FDA prohibits use after two 6‑month doses. Requests exceeding this lifetime limit will not meet medical necessity criteria.

Coding

Covered HCPCS/CPT CodesmixedCovered

G0516	Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal rod implant)
G0517	Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)
G0518	Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)
J0570	Buprenorphine implant, 74.2 mg (Code Deleted Effective 12/31/2024; Code Reactivated Effective 10/1/2025)

Covered HCPCS/CPT Codes (alternate grouping)mixed

No codes listed

Transmucosal buprenorphine maintenance dose — ≤8 mg/day

Maximum eligible transmucosal maintenance dose≤8 mg/day of sublingual Subutex or Suboxone (or transmucosal equivalent)

FDA-specified dose contextApproved for patients who achieved sustained prolonged clinical stability on doses of ≤8 mg/day

Documentation requirementCurrent maintenance dose must be ≤8 mg/day to qualify for implant

Minimum duration on stable transmucosal dose — ≥3 months

Minimum duration on stable transmucosal dose≥3 months of stability on a transmucosal buprenorphine dose without supplemental dosing or adjustments

Purpose of duration requirementEnsures sustained prolonged clinical stability prior to implant placement

Provider Actions and Documentation

Billing Rule

Prior authorization and billing codes

Prior authorization: Not applicable. Providers must still meet coverage criteria and document required information at the time of service to support medical necessity.

Covered codes: G0516, G0517, G0518, J0570 (see billing rules for status changes)
Prior authorization: Not required for this product under the payer policy

Documentation Required

Requirement to be stable on transmucosal buprenorphine

Member must be clinically stable on a transmucosal buprenorphine regimen prior to implantation. Stability is defined as treatment with a transmucosal buprenorphine dose ≤8 mg/day (sublingual Subutex, Suboxone, or equivalent) for at least 3 months without need for supplemental dosing or dose adjustment, and currently maintained on a dose of 8 mg/day or less.

Background

Buprenorphine is a partial μ‑opioid receptor agonist used as a core component of medication‑assisted treatment for opioid dependence. Transmucosal formulations (sublingual tablets or films) provide effective outpatient maintenance therapy but carry risks of diversion, misuse, and accidental pediatric ingestion.

To address these risks and to improve adherence, a subdermal buprenorphine implant (Probuphine®) was developed to provide sustained drug delivery via four subdermal rods for up to six months. The implant was FDA‑approved for maintenance treatment only in patients who have achieved and sustained prolonged clinical stability on low‑to‑moderate doses of transmucosal buprenorphine (≤8 mg/day).

Clinical evidence showed the implant dose was not adequate for patients who are new to buprenorphine treatment; however, a subset of patients stabilized on ≤8 mg/day transmucosal buprenorphine may achieve comparable buprenorphine exposure with the implant and therefore benefit from reduced diversion and improved adherence.

Definitions

Clinically stable on transmucosal buprenorphine — definition and thresholds (≤8 mg/day for ≥3 months)

Definition of clinically stable on transmucosal buprenorphineTreatment with a stable transmucosal buprenorphine dose (≤8 mg/day of sublingual Subutex or Suboxone or equivalent) for 3 months or more without need for supplemental dosing or adjustments

Current maintenance dose thresholdMember must be currently maintained on a dose of ≤8 mg/day to achieve sustained prolonged clinical stability

Inappropriate candidatesNot appropriate for new treatment recipients or patients who have not achieved sustained and prolonged clinical stability on transmucosal buprenorphine

FDA approval contextProbuphine approved for maintenance in patients who have achieved and sustained prolonged clinical stability on doses of ≤8 mg/day

Level of Care Criteria

Treatment Modalities

Buprenorphine implant (Probuphine)

Implant modality: Probuphine implant provides sustained buprenorphine delivery via 4 subdermal rods for up to 6 months to improve adherence and reduce diversion compared with transmucosal formulations; appropriate only for patients who are clinically stable on a low-dose transmucosal buprenorphine (≤8 mg/day) and not for new treatment recipients.