CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Buprenorphine for Treatment of Opioid Dependence

Defines medical necessity criteria, coverage stance, coding and billing guidance for buprenorphine subdermal implants (Probuphine) for Medicare Advantage and commercial products; includes intent, regulatory status, and supporting codes. Prior authorization is not required per policy.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Buprenorphine for Treatment of Opioid Dependence

Policy CodePolicy N/A

Change TypeClarified (evidence update; no clinical policy changes)

Effective DateJan 1, 2017

Next Review Date

Key ActionDocument diagnosis of opioid dependence, current maintenance dose (<=8 mg/day or equivalent), and at least 3 months of stable transmucosal buprenorphine treatment without supplemental dosing or adjustments, and include the patient in a comprehensive treatment program with counseling and psychosocial support.

SourceLink

POLICY UPDATE CHANGES

Policy last updated 10/04/2023 with literature search through May 16, 2022; no clinical policy statement changes indicated in the document.

1Drug product covered (Probuphine / buprenorphine implant)

4Service codes for implant insertion/removal (G0516-8, J0570)

2Maximum lifetime implant courses allowed

Required months of stability on transmucosal buprenorphine

Coverage Summary

This policy covers with criteria the buprenorphine subdermal implant (Probuphine) as a maintenance treatment for opioid dependence when specified medical necessity criteria are met. Probuphine is FDA-approved as a maintenance treatment for patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of transmucosal buprenorphine (targeted for patients on 8 mg/day or less). The policy effective date is 2017-01-01 and the policy was last reviewed on 2023-10-04.

Key Thresholds for Buprenorphine Subdermal Implant Coverage

Maintenance dose threshold<= 8 mg/day (sublingual Subutex or Suboxone or equivalent)

Stability duration required>= 3 months without supplemental dosing or adjustments

Lifetime implant usage limit<= 2 times per lifetime (two 6-month doses)

Maximum lifetime implant courses allowed2

Required months of stability3

Medically Necessary Criteria

Medically Necessary Criteria for Buprenorphine Subdermal Implants (Medicare Advantage & Commercial)

Covered when ALL of the following are met:

ALL of the following

Diagnosed with opioid dependence
Currently on a maintenance dose of 8 mg per day or less of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent<= 8 mg/day (sublingual Subutex or Suboxone or equivalent)
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>= 3 months without supplemental dosing or adjustments

Coding

Covered HCPCS/G-codes for implant services and drugmixedCovered

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

Actions for Providers

Documentation Required

Document sustained clinical stability

Document sustained clinical stability prior to implant placement. Required documentation should demonstrate the patient meets the covered criteria for buprenorphine subdermal implants.

Diagnosis of opioid dependence
Current maintenance dose ≤ 8 mg/day (sublingual Subutex or Suboxone tablet or transmucosal buprenorphine product equivalent)
At least 3 months of stable transmucosal buprenorphine treatment without supplemental dosing or adjustments
Inclusion in a comprehensive substance use disorder treatment program that includes counseling and psychosocial support

Billing Rule

Report implant and associated services with specified codes

Report implant insertion, removal, and removal with reinsertion using the specified G-codes and bill the buprenorphine implant drug with J0570.

Background & Evidence

Probuphine is a subdermal buprenorphine implant delivered via four subdermal rods designed to provide sustained buprenorphine delivery for up to 6 months. It is targeted for patients who are clinically stable on a low-dose transmucosal buprenorphine regimen (8 mg/day or less). The implant was developed to reduce diversion and misuse and to improve adherence. FDA approval is for maintenance treatment in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of transmucosal buprenorphine.

Evidence and Key Trials

Literature search last updatedMay 16, 2022

Key randomized trials referencedRosenthal et al. JAMA 2016; Ling et al. JAMA 2010

Other evidence notesEvidence review created Oct 2016 and updated regularly (PubMed searches)

Clinically stable: Sustained and prolonged clinical stability on transmucosal buprenorphine at <=8 mg/day with no need for supplemental dosing or adjustments for >=3 months.

DATA 2000: Addiction Treatment Act requirements (21 U.S.C. 823(g)) for physicians prescribing buprenorphine for opioid dependence, including notification to HHS and assignment of an identification number that must be included on every prescription.

Revision History

2017-01-01policy_effective

Policy effective date established for coverage criteria of buprenorphine subdermal implants (Probuphine).

2017-10-2016evidence_review_started

Initial evidence review created in October 2016 with ongoing updates of PubMed searches to evaluate clinical evidence for Probuphine.

2020-10-19manufacturer_update

Titan Pharmaceuticals announced plans to discontinue sales of the buprenorphine implant for financial reasons.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Buprenorphine for Treatment of Opioid Dependence

Policy CodePolicy N/A

Change TypeClarified (evidence update; no clinical policy changes)

Effective DateJan 1, 2017

Next Review Date

SourceLink

On This Page

Buprenorphine implants are used as part of a comprehensive substance use disorder treatment program that includes counseling and psychosocial support

Use limited to physicians who meet DATA 2000 qualifying requirements and have notified HHS and been assigned an identification number that must be included on every prescription

DATA 2000 (21 U.S.C. 823(g)) requirement

Not intended for new treatment recipients or those who have not achieved sustained and prolonged clinical stability on equivalent transmucosal buprenorphineClinically stable: sustained stability on transmucosal buprenorphine at <=8 mg/day with no need for supplemental dosing or adjustments for >=3 months

Lifetime use limitation: Use of buprenorphine implants greater than 2 times per lifetime is not medically necessary (FDA labeling prohibits use after two 6-month doses)<= 2 times per lifetime (two 6-month doses)

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

Documentation Required

Provider DATA 2000 compliance and prescription identification

Prescribing physicians must comply with DATA 2000 qualifying requirements for treatment of opioid dependence and must include their assigned HHS identification number on every prescription for this product.

Provider-impact note: the policy states that prior authorization is not required for buprenorphine subdermal implants.

2022-05-16literature_search

Literature search for the evidence review updated through May 16, 2022.

2023-10-04policy_last_updatedLatest

Policy last updated on 10/04/2023; document notes updated evidence review and states no clinical policy statement changes.