CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Buprenorphine for Treatment of Opioid Dependence (buprenorphine subdermal implants / Probuphine)

Defines medical coverage, clinical criteria, regulatory and billing guidance for buprenorphine subdermal implants used as maintenance treatment for opioid dependence in patients stable on low-dose transmucosal buprenorphine; applies to Medicare Advantage and Commercial products under Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBuprenorphine for Treatment of Opioid Dependence (Probuphine implants)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01|01|2017

Next Review DateN/A

Key ActionEnsure patients are clinically stable on a transmucosal buprenorphine dose equivalent to ≤8 mg/day and document participation in a comprehensive substance use disorder treatment program before using implants.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤8 mg/dmax daily transmucosal equivalent

up to 6 moimplant duration

2max lifetime uses

J0570, G0516-18covered codes

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Medical necessity criteria — Medicare Advantage and Commercial Products

Covered when ALL of the following are met:

Eligibility for buprenorphine implant: Patient has a diagnosis of opioid dependence; has been treated with a stable transmucosal buprenorphine dose without need for supplemental dosing or adjustments; currently maintained on a sublingual Subutex or Suboxone tablet or an equivalent transmucosal buprenorphine product achieving sustained prolonged clinical stability; the transmucosal buprenorphine maintenance dose is equivalent to ≤8 mg/day; implants will be used as part of a comprehensive substance use disorder treatment program that includes counseling and psychosocial support; prescriber meets DATA requirements and is authorized under any applicable Probuphine REMS program for insertion and removal.≤8 mg/day

Use limited to certified prescribers and distribution under Probuphine REMS.

Limits and not medically necessary

Not covered / Not medically necessary when:

Not medically necessary conditions: Use of buprenorphine implants greater than 2 times per lifetime (FDA labeling prohibits use after two 6-month doses); use in new treatment recipients or patients who have not achieved sustained and prolonged clinical stability on transmucosal buprenorphine.>2 lifetime implants

FDA labeling restriction.

Implants are not appropriate for patients who are initiating treatment with buprenorphine or for those who have not demonstrated sustained and prolonged clinical stability on a transmucosal buprenorphine product. The policy limits implant use to individuals who have been treated with a stable transmucosal buprenorphine dose without need for supplemental dosing or adjustments and who are currently maintained on an equivalent dose achieving clinical stability (see eligibility criteria).

Because the implant is intended as a maintenance modality for a selected subgroup of patients, it should only be considered after stability on transmucosal buprenorphine has been established and documented; implantation for new treatment recipients or unstable patients is not consistent with the medical necessity criteria.

Use of buprenorphine implants more than 2 times per lifetime is considered not medically necessary. This restriction aligns with FDA labeling, which prohibits use after two 6‑month doses.

Billing and Codes

Covered HCPCS/G-codes and J-codeHCPCSCovered

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

Covered HCPCS/G-codes and J-code (alternate grouping)mixedCovered

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

Maximum transmucosal buprenorphine equivalent dose for implant eligibility

Maximum transmucosal buprenorphine equivalent dose≤8 mg/day

Implant dose form referencedEquivalent to Subutex or Suboxone sublingual tablet or generic equivalent

Purpose for dose thresholdEligibility requires sustained prolonged clinical stability on low-dose transmucosal buprenorphine

Provider Requirements and Operational Notes

Prior Authorization

Prior authorization review is not required for buprenorphine subdermal implants (Probuphine).

Applicable to Medicare Advantage Plans and Commercial Products

Note

Stability Before Implant

Buprenorphine implants are intended only for patients who have achieved and sustained prolonged clinical stability on a low dose (≤ 8 mg/day) of transmucosal buprenorphine (eg, sublingual Subutex or Suboxone or generic equivalent). Implants are not appropriate for initiating treatment.

Must be maintained on a stable transmucosal buprenorphine dose without need for supplemental dosing or adjustments
Intended for maintenance therapy, not induction/ initiation

Documentation Required

Required Clinical and Regulatory Documentation

Provide clinical and regulatory documentation to support medical necessity and patient eligibility.

Document diagnosis of opioid dependence (opioid use disorder)
Document sustained clinical stability on a transmucosal buprenorphine product equivalent to ≤ 8 mg/day (including duration and lack of dose adjustments)
Include evidence that implants will be used as part of a comprehensive SUD treatment program (counseling and psychosocial support)
If applicable, document prior implant history (number of prior lifetime implant uses)
Prescribers must be certified in the Probuphine REMS Program and include their assigned identifier on prescriptions as required under DATA and REMS

Denial Risk

Lifetime Use and Stability Requirement

Use of buprenorphine implants greater than two times per lifetime is not medically necessary and may be denied; FDA labeling and coverage limit to two 6‑month doses lifetime. Implants are inappropriate for patients who have not first been stabilized on transmucosal buprenorphine.

Maximum of 2 lifetime uses (two 6‑month doses) — exceeding this may result in denial
Not for initiation of therapy; patient must be stabilized on transmucosal buprenorphine prior to implant placement

Definitions and Terms

Probuphine

Product definitionProbuphine (buprenorphine subdermal implant)

Delivery mechanismSubdermal insertion of 4 rods providing sustained buprenorphine delivery

Duration of deliveryUp to 6 months when 4 rods are inserted

Regulatory restrictionAvailable only through the Probuphine REMS program with certified prescribers and restricted distribution

Clinically stable on transmucosal buprenorphine

Definition of sustained prolonged clinical stabilityTreated with a stable transmucosal buprenorphine dose without need for supplemental dosing or adjustments

Maintenance dose requirementCurrently maintained on a transmucosal product (eg, Subutex or Suboxone) at an equivalent dose of ≤8 mg/day

Treatment contextPart of a comprehensive substance use disorder treatment program including counseling and psychosocial support

Most actionable requirementImplants intended only for patients already stabilized on low-dose transmucosal buprenorphine (≤8 mg/day) — not for initiating therapy

Background

Buprenorphine is a partial μ‑opioid agonist used in medication‑assisted treatment for opioid dependence (moderate to severe opioid use disorder). Transmucosal buprenorphine formulations (with or without naloxone) are effective but carry risks of nonadherence, diversion, abuse, and accidental pediatric ingestion.

To address these risks, a subdermal buprenorphine implant (Probuphine) was developed to provide sustained delivery for up to 6 months when four rods are inserted subdermally. The implant is intended as a maintenance treatment for a selected subgroup of patients who are clinically stable on a low-dose transmucosal buprenorphine regimen (≤8 mg/day) and who remain in a comprehensive substance use disorder treatment program with counseling and psychosocial support.

Setting and Level of Care

Outpatient (maintenance implant insertion/removal)

Covered when ALL of the following are met for outpatient maintenance insertion or removal:

Outpatient (maintenance implant insertion/removal): Patient meets the medical necessity criteria for Probuphine (see medical necessity section); patient is clinically stable on a transmucosal buprenorphine maintenance dose equivalent to ≤8 mg/day; insertion or removal is performed in an outpatient setting by a provider certified under the Probuphine REMS program; patient is enrolled in a comprehensive substance use disorder treatment program including counseling and psychosocial support; ongoing monitoring is available for device complications (e.g., migration, protrusion, expulsion, nerve injury) and for need of supplemental transmucosal dosing.≤8 mg/day

Procedure codes G0516, G0517, or G0518 apply for insertion/removal of 4 or more non-biodegradable drug delivery implants; J0570 is the drug code for the buprenorphine implant.

Treatment Modalities

Buprenorphine implant (Probuphine)

Buprenorphine implant (Probuphine): Implant intended as a maintenance treatment modality for selected patients who are clinically stable on a low-dose transmucosal buprenorphine regimen (equivalent to ≤8 mg/day); not intended for initiation of buprenorphine therapy; provides sustained delivery for up to 6 months when 4 rods are inserted subdermally.≤8 mg/day

Available only through a REMS requiring certified prescribers; appropriate only for patients with sustained prolonged clinical stability on transmucosal buprenorphine.