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| Medical Policy: | I-160-005 |
| Topic: | Buprenorphine (Probuphine®) Implant for Treatment of Opioid Dependence |
| Section: | Injections |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | March 2017 |
Buprenorphine is a partial μ-opioid agonist used with or without naloxone, an opioid antagonist, via transmucosal delivery to treat patients with opioid dependence (or a moderate-to-severe opioid use disorder). Buprenorphine (Probuphine) is an implant to provide sustained delivery of buprenorphine for up to six (6) months when four (4) rods are inserted subdermally. It is intended as a maintenance treatment for a selected subgroup of opioid-dependent patients who are clinically stable on a low dose of transmucosal buprenorphine (less than or equal to 8 mg/d). |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Buprenorphine implants may be considered medically necessary for the treatment of opioid dependence when an individual is greater than or equal to 16 years of age and has met ALL of the following criteria:
- Diagnosed with opioid dependence; and
- Treated with a stable transmucosal buprenorphine dose (less than or equal to 8 mg/d of a sublingual Subutex or Suboxone tablet or its transmucosal buprenorphine product equivalent) for three (3) months or more without any need for supplemental dosing or adjustments; and
- 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 to achieve sustained prolonged clinical stability on transmucosal buprenorphine; and
- Buprenorphine implants are used as part of a comprehensive substance use disorder treatment program that includes
- Counseling; and
- Psychosocial support; and
- The treating physician must hold ALL the following:
- Completed and certified in Probuphine Risk Evaluation and Mitigation Strategy (REMS) program to insert and remove the buprenorphine implants; and
- Certification criteria in Drug Addiction Treatment Act (DATA) of 2000; and
- Issued a Drug Enforcement Administration (DEA) Registration Number, indicating the provider is qualified under the DATA to prescribe buprenorphine implant.
* Food and Drug Administration indications specify that maintenance doses should not be tapered to a lower dose for the sole purpose of transitioning to buprenorphine implants.
Initial treatment consist of inserting up to four (4) buprenorphine implants may be considered medically necessary for six (6) months. Implants must be removed at the end of the six (6) months following insertion.
If indicated, a second set of buprenorphine implants may be considered medically necessary and placed in the contralateral arm when the criteria above are met. The second set of implants must be removed at the end of the second six (6) month treatment period.
Retreatment with buprenorphine implant after a prior 12-month treatment period is considered experimental/investigational and therefore, non-covered. Scientific evidence does not support the use of buprenorphine implant after a 12-month treatment period.
Individuals can be transitioned back to transmucosal buprenorphine-containing medications for continued treatment after 12 months as needed.
Buprenorphine implants are considered experimental/investigational and ,therefore, non-covered for all other indications. Scientific evidence does not support the use of buprenorphine implant for any other indication.
NOTE: Dosage recommendations per the FDA label. Refer to medical policy I-92 Naltrexone for Treatment of Alcohol and Opioid Dependence for further information. Refer to medical policy L-102 Drug Testing in Pain Management and Substance Abuse Treatment for further information. Refer to medical policy Y-22 Opioid dependence Therapy for further information. Refer to pharmacy policy J-331 Opioid Dependence Therapy for further information. |
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Buprenorphine (Probuphine) implant for treatment of opioid dependence is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
04/2017, New Coverage Position for Buprenorphine Implant for Treatment of Opioid Dependence
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
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Room 509F, HHH Building
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1-800-368-1019, 800-537-7697 (TDD)
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