AetnaCommercial Clinical Policy

Injectable Medications Form

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Notes: Some state-to-state and plan type variations exist; please check benefit plan descriptions for details.

Indications

(36258) Does the patient meet the diagnostic criteria for needle phobia according to DSM 5 with documented attempts at management and psychological counseling? 
(36259) Is there no appropriate oral alternative drug available for the patient's condition? 
(36260) Is the injectable medication medically necessary and appropriate to the patient's needs or condition? 
(36261) Is the injectable medication used for an established ‘off label’ use of an FDA-approved prescribed medication? 

Contraindications

(36262) Is the injectable medication experimental, investigational, or not proven safe and effective for the specific disease by FDA or NIH? 
YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

10/06/1995

Last Reviewed

03/06/2023

Original Document

  Reference



Background for this Policy

Appendix

Specific Phobia: DSM 5 Diagnostic Criteria

  • A marked fear or anxiety about a specific object or situation (e.g., flying, heights, animals, receiving an injection, seeing blood). Note: In children, the fear or anxiety may be expressed by crying, tantrums, freezing, or clinging.
  • The phobic object or situation almost always provokes immediate fear or anxiety.
  • The phobic object or situation is actively avoided or endured with intense fear or anxiety.
  • The fear or anxiety is out of proportion to the actual danger posed by the specific object or situation and to the sociocultural context.
  • The fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more.
  • The fear, anxiety, or avoidance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
  • The disturbance is not better explained by the symptoms of another mental disorder, including fear, anxiety, and avoidance of situations associated with panic-like symptoms or other incapacitating symptoms (as in agoraphobia); objects or situations related to obsessions (as in obsessive-compulsive disorder); reminders of traumatic events (as in posttraumatic stress disorder); separation from home or attachment figures (as in separation anxiety disorder); or social situations (as in social anxiety disorder).

    • Source: APA, 2013.

    Scope of Policy

    This Clinical Policy Bulletin addresses injectable medications.

    Medical Necessity

  • Policy requirements for a trial of an injectable drug therapy may be waived for persons who meet diagnostic criteria for needle phobia (see appendix for DSM 5 criteria), if there is documentation of preexisting excessive fear (outside of the particular request being considered) of injections and blood draws with documented attempts at management and psychological counseling, especially if there are associated symptoms (vasovagal syncope, panic attack).
  • Aetna covers injectable medications when an appropriate oral alternative drug does not exist. This coverage includes those medications intended to be self-administered. The medication must be medically necessary and appropriate to the member's needs or condition.

    • Experimental and Investigational

    Experimental or investigational drugs or drugs that have not been proven safe and effective for a specific disease or approved for a mode of treatment by the U.S. Food and Drug Administration (FDA) and/or the National Institutes of Health are not covered. This provision does not exclude coverage of established “off label” uses of otherwise FDA-approved prescribed medications.

    Policy Limitations and Exclusions

  • Drugs related to the treatment of non-covered services are not covered. Infertility injectable medications are covered only when required by regulation or covered by a specific benefit design. Steroids are not covered for the enhancement of performance, as this is not considered treatment of disease.
    • Note

    : Some state-to-state and plan type variations exist.

  • Certain classes of injectable medications are excluded from coverage under some benefit plans. Please check benefit plan descriptions for details:
    • Anabolic steroids when used for performance enhancement
    Contraceptive injectable medications.
    Footnotes **
    Immunizations for travel
  • Infertility injectable medications
    • Footnotes * Footnotes * Exception

    : Infertility injectable medications;are covered only when required by regulation or covered by a specific benefit design.

    Footnotes **

    Contraceptive injectable medications are covered under plans with the contraceptives rider or under plans with a contraceptives benefit, as well as under non-grandfathered plans that are currently subject to DHHS requirements for coverage of preventive services.

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