Medical Policy: 05.01.115 

Original Effective Date: August 2016 

Reviewed: June 2021 

Revised: December 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Naloxone is indicated for the complete or partial reversal of opioid depression (including respiratory depression) induced by natural and synthetic opioids (eg, propoxyphene, methadone, nalbuphine, butorphanol, pentazocine). Naloxone is also indicated for the diagnosis of suspected or known acute opioid over-dosage. It is available as a nasal spray, injectable convenience kit, vials for intramuscular injection, and prefilled syringes for intranasal use.

 

LifEMS Naloxone is an injectable naloxone convenience kit indicated for the complete or partial reversal of opioid depression (including respiratory depression) induced by natural and synthetic opioids (eg, propoxyphene, methadone, nalbuphine, butorphanol, pentazocine). It is designed to treat a single episode of an opioid overdose and the naloxone provided in the kit must be used on the patient experiencing signs and symptoms of an overdose.

 

Prior Approval:

Not applicable

 

Policy:

LifEMS Naloxone (naloxone convenience kit) is considered not medically necessary for all applications because there are equivalent and less expensive forms of the drug available for nasal or injectable administration.

 

Clinical Rationale

LifEMS Naloxone is supplied as a naloxone convenience kit that contains one naloxone hydrochloride injection (1 mg/mL) 2 mL single dose disposable prefilled syringe in a MINI-I-JET® syringe with a 21 G. X 1-1/2 needle and two alcohol pads for administration. The MINI-I-JET® syringe with needle is a two-part pre-filled syringe that is intended to administer the naloxone via intramuscular or subcutaneous route for a single episode of an opioid overdose. The needle should be discarded in an appropriate sharps container after use. The price of one LifEMS naloxone convenience kit is around $1700.

 

Other lower cost options are available in a different dosage form. Narcan nasal spray is available as a needle-free, ready-to-use nasal spray to deliver a single 4-mg dose of naloxone. One carton contains 2 blister packages, each with a single nasal spray that can’t be reused. It costs around $75 per nasal spray, a fraction of the cost of high cost naloxone injectables.

 

Naloxone can also be supplied in vials for intramuscular injection, or in prefilled syringes for intranasal use. For intramuscular use, it is recommended that naloxone be provided as 0.4 mg/mL in two 2 mL single-dose vials or one 10 mL multi-dose vial. For each injection, a 23 gauge, 3 cc syringe with a 1-inch needle will be needed. For intranasal administration using the injectable solution, two naloxone 2 mg/2 mL luer-lock prefilled syringes are needed along with two mucosal atomization devices that fit into the luer-lock of the syringe.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • J3590 Unclassified biologics
  • J3490 Unclassified drugs
  • C9399 Unclassified drugs or biologicals
  • (LifEMS Naloxone Convenience Kit): NDC 72336-0077-19

 

Selected References:

  • LifEMS Naloxone (Naloxone Convenience Kit) [package insert]. So. El Monte, CA: IMS, Limited.; November 2020.
  • Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
  • Narcan [package insert]. Radnor, PA: Adapt Pharma, Inc.; August 2020.

 

Policy History:

  • June 2021 - Annual Review, Policy Renewed
  • December 2020 - Interim Review, Policy Revised
  • June 2020 - Annual Review, Policy Renewed
  • June 2019 - Annual Review, Policy Revised
  • June 2018 - Annual Review, Policy Renewed
  • June 2017 - Annual Review, Policy Renewed
  • August 2016 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.