Overview

This document addresses extended-release, implantable naltrexone. Naltrexone is an opioid antagonist that binds to opioid receptors, blocking the euphoric effects of exogenous opioids in those who have an opioid or alcohol use disorder. Currently available formulations of naltrexone implantable pellets are compounded by pharmacies using a bulk powder formulation and are not approved by the United States Food and Drug Administration (FDA).

Naltrexone extended-release formulations have been made available as implantable pellets and are most commonly used for the treatment of alcohol and opioid use disorders. Neither naltrexone implants, nor the bulk powder used to compound them, are approved by the FDA.

This document does not address the extended-release, injectable naltrexone (Vivitrol) or the oral formulation of naltrexone (Revia).

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

• Extended-release naltrexone implants (or pellets) may not be approved for the treatment of alcohol and opioid use disorders (alcohol and opioid dependence) and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

• 11981
• 11983
• 17999
• 22999
• 49999

• J3490
• J7999

Insertion, non-biodegradable drug delivery implant [when specified as insertion of naltrexone pellets]

Removal with reinsertion, non-biodegradable drug delivery implant [when specified as reinsertion of naltrexone pellets]

Unlisted procedure, skin, mucous membrane and subcutaneous tissue [when specified as insertion of biodegradable naltrexone pellets]

Unlisted procedure, abdomen, musculoskeletal system [when specified as insertion of biodegradable naltrexone pellets]

Unlisted procedure, abdomen, peritoneum and omentum

Unclassified drugs [when specified as implantable naltrexone pellets]

Compounded drug, not otherwise classified [when specified as implantable naltrexone pellets]

ICD-10 Diagnosis:

F10.10-F10.99
All diagnoses including, but not limited to, the following:
Alcohol related disorders
F11.10-F11.99
Opioid related disorders

Document History

Reviewed: 08/18/2023