Description:
Any chemical compound that is used in the prevention, diagnosis, treatment or cure of disease, for the relief of pain or to control or improve any physiological or pathological disorder in humans or animals is considered to be a drug. For the purpose of this guideline, only prescription drugs will be addressed. A prescription drug is one that bears the label stating, "Caution: Law prohibits dispensing without prescription" or "Rx only." Prescription drugs are also known as "legend" drugs. 

Guideline Statement:
Benefits are provided for prescription drugs for which the purpose and dosage of the drug are approved by the Food and Drug Administration (FDA) and ordered by a licensed physician. Any drug being considered experimental/investigational must have prior approval by the medical director(s) to be considered for benefit coverage.

Drugs prescribed for non-covered conditions, such as obesity or infertility, are not a covered benefit unless otherwise specified by the specific contract.

Take-home drugs, dispensed by a physician's office or urgent care, are not a covered benefit, with the EXCEPTION of chemotherapy drugs (see specific provisions used for the determination of chemotherapy drugs in guideline CAM 064 Chemotherapy Drugs and Administration).

Injections:
All injections must be FDA-approved drugs or have prior approval from the medical director(s).

Benefits are provided for drug injections when it is for the treatment of a contractually covered illness. There are no benefits provided for injections given solely for the general well-being of the patient. Typically, the claim filed should reflect only the CPT code for the medication being injected, as the administration of the injection has been included in the reimbursement of the medication. Please see CAM 064 (Chemotherapy Drugs and Administration) for possible exceptions.

Insulin/glugacon injections administered by a physician are considered a covered benefit only when the patient is in a diabetic crisis.

Drug injections given for the treatment of a non-covered medical condition (e.g., obesity, infertility, impotence) are not a covered benefit.

The allowance for injectable drugs is based on Average Wholesale Price (AWP), the Actual Acquisition Cost or the actual charge by the provider, plus an administration allowable. The administration of the drug is not reimbursed as a separate entity.

Vitamin-B12 injections are considered a covered benefit for these conditions only:

• Pernicious anemia, megaloblasitic anemias, macrocyte anemias, fish tapeworm anemia
• Gastrointestinal disorders such as gastrectomy, malabsorption syndromes such as sprue and idiopathic steatorrhea, surgical and mechanical disorders such as resection of the small intestine, strictures, anastomosis and blind loop syndrome
• Neuropathies associated with pernicious anemia or related alcohol abuse

Benefits for Vitamin-B12 injections are limited to one injection weekly for the first month; thereafter, one injection monthly for maintenance. Injections given more frequently should be reviewed and approved by the medical director(s).

Off-Label Drug Use
Off-label or "unlabeled" drug use is the use of an FDA-approved drug for other uses or in treatment regimens or patient populations that are not included in approved labeling. Many off-label uses are effective, well-documented in the literature and widely used.

Off-label drug uses should be viewed as potentially MEDICALLY NECESSARY pending evaluation of the efficacy to determine whether the off-label use improves health outcomes. Questions concerning the off-label use in the treatment regimen of a patient should be referred to the medical director(s) for approval determination.

Dosing and Frequency
Dosing and frequency are based on U.S. Food and Drug Administration (FDA) approved drug dosage and frequency limits, manufacturer, and clinical recommendations.

The drug dosage, frequency and route of administration going above the maximum recommended dosage may be considered on an individual basis for an approved indication when supported by ONE or more of the following:

• Micromedex DRUGDEX^® System or other Drug Information compendia (i.e., Lexicomp^® or Fact and Comparisons^®)
• National Comprehensive Cancer Network^® (NCCN) Drug & Biologics Compendium
• American Hospital Formulary Service Drug Information^® (AHFS) Drug Information^®
• The quantity is supported by clinical research in two articles from major peer reviewed medical journals that present data supporting the proposed dose and frequency as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.

Required Information for Claim Filing:
Name of the patient
The date of the prescription, the drug name and Rx number
A pharmacist's signature or prescription information submitted on the pharmacy letterhead

PLEASE SEE SPECIFIC CONTRACT VERBIAGE FOR EXCLUSIONS, LIMITATIONS AND/OR MAXIMUMS

This medical guideline was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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