Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-92-016
Topic: Naltrexone for Treatment of Alcohol and Opioid Dependence
Section: Injections
Effective Date: June 26, 2017
Issue Date: June 26, 2017
Last Reviewed: February 2017

Naltrexone extended release injection (Vivitrol) is an opioid antagonist that binds to opioid receptors, blocking the euphoric effects of exogenous opioids in those who are opioid or alcohol dependent.

Extended-release naltrexone implants block the effects of opiate drugs by binding to opiate receptors in the body which prevents opiate drugs like heroin or oxycodone from causing a person to experience the usual high. In blocking the effectiveness of the drug, naltrexone helps to break the cycle of drug use.

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.

Alcohol Dependence (Alcohol Use Disorder)

Injectable naltrexone may be considered medically necessary for the treatment (a period of six (6) months) of alcohol dependence (alcohol use disorder) when the individual:

Injectable naltrexone is considered not medically necessary when the individual:

Injectable naltrexone (Vivitrol) is considered not medically necessary for the treatment of alcohol dependence when the criteria above are not met and for all other indications.

Coverage subject to review every six (6) months

Procedure Codes
J2315


Opioid Dependence (Opioid Use Disorder)

Injectable naltrexone may be considered medically necessary for the initial treatment (a period of 6 months) of opioid dependence when ALL of the following criteria are met:

Injectable naltrexone is considered not medically necessary when the individual:

Injectable naltrexone is considered not medically necessary for the treatment of opioid dependence when the criteria above are not met and for all other indications.

Coverage subject to review every six (6) months.

Procedure Codes
J2315


Extended-release naltrexone implants (or pellets) are considered experimental/investigational and, therefore, non-covered for the treatment of alcohol and opioid use disorders (alcohol and opioid dependence) and all other indications.  Scientific evidence does not support the use naltrexone implants (or pellets) for any indication.

Procedure Codes
11981, 11982, 11983, J3490


NOTE: Dosage recommendations per the FDA label. 

Refer to medical policy L-102 Drug Testing in Pain Management and Substance Abuse Treatment for additional information.

Refer to medical policy I-160 Buprenorphine Implant for Treatment of Opioid Dependence for additional information.

Refer to medical policy Y-22 Opioid dependence Therapy for additional information.

Refer to pharmacy policy J-323 Extended Release Opioid Management for additional information.


FEP Guidelines

 

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of naltrexone (Vivitrol) extended release injection 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 not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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.

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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.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.