Chemotherapy is the use of certain drugs to treat disease, most commonly cancer, as distinct from other forms of treatment, such as surgery. It is used to destroy or inhibit the growth and division of malignant cells. Chemotherapy may be used alone as a primary treatment or may be used before, after, or in conjunction with surgery and/or radiation. A cancer treatment regimen includes drugs used to treat toxicities or side effects of the cancer treatment regimen when the drug is administered incident to a chemotherapy treatment.

Antineoplastic agent or drug is a drug that inhibits or prevents the growth and spread of tumors, neoplasms or malignant cells.

Anti-cancer agent is a drug used against or tending to arrest or prevent cancer.

Immunotherapy is a biological cancer treatment that helps the immune system fight cancer.

Oncologic medications encompass any drug that is being used to treat a cancer diagnosis.

Hydration therapy is when fluids are administered by intravenous infusion directly into the bloodstream when an individual is dehydrated.

An off-labeled use of a drug is a use that is not included as an indication on the drug's label as approved by the Food and Drug Administration (FDA).

Off-Labeled Use for Oncologic Medications

• FDA approved drugs used for indications other than what is indicated on the official label (off-label use) may be considered medically necessary if the use is determined to be medically acceptable when ALL of the following criteria are met:
  • Individual must have failed all approved first line therapies, or their condition precludes their use, and there are no other therapeutic options available; and
  • The off label usage must be found in at least ONE of the drug compendia listed below:
    • American Hospital Formulary Service-Drug Information (AHFS-DI); or
    • Elsevier Clinical Pharmacology Compendium; or
    • National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™; or
    • Micromedex Drug Dex®; and
      • Its usage for the indication has a category 2b or higher grade recommendation; or
      • Usage is not listed as not recommended; or
    • An off-labeled use is supported by the results of the published clinical research that appears in peer-reviewed medical literature. [Peer-reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts) *see table attachment]

The following medications, procedures or services may be considered medically necessary when the appropriate criteria are met:

Oncologic Medications

• Oncologic medications which have FDA approval or being used for an off-label indication meeting the criteria above when supplied by a healthcare provider, given by an eligible method of administration, in an eligible place of service, for an appropriate indication, at appropriate intervals and dosages; or

Other Medications in the Chemotherapy Regimen

• Medications administered as part of a rescue from, or antidote for, severe toxic reactions to the oncologic agent, e.g., leucovorin given as an antidote following  high-dose methotrexate therapy; diuretics with cisplatin; or antiemetics; or
• Oral antiemetic drugs when used as full replacement for intravenous antiemetic drugs as part of a cancer chemotherapeutic regimen; or
• Hydration therapy when uses as a rescue agent in conjunction with chemotherapy; or

Administration

• Only ONE administration, when multiple drugs are administered concurrently by the same route of administration; or
• Separate service code for each administration, when multiple drugs are given sequentially or by different routes of administration. This includes rescue agents, etc. However, only ONE initial service code (unless protocol requires two (2) separate infusion sites must be used) may be considered medically necessary; or
• Instillation of an anti-carcinogenic agent into the bladder; or
• Instillation(s) of therapeutic agent(s) into renal pelvis and/or ureter through established nephrostomy, pyelostomy, or ureterostomy tube (e.g., anti-carcinogenic or antifungal agent); or
• Chemo surgical destruction of a malignant lesion when the antineoplastic drug must be applied by the healthcare provider; or
• If the drug is reported on the same day as the topical administration of chemotherapy, and the charges are itemized, the charges will be combined into the topical administration of chemotherapy; or
• Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day; or

Medical care including observation and examination

• Medical care in conjunction with or as follow-up to chemotherapy provided on an outpatient basis. If a significant, separately identifiable office or other outpatient evaluation and management service is performed, the appropriate E/M service should be reported using modifier 25; and

Surgery

• When drugs are administered into a cavity, e.g., lumbar puncture, peritoneocentesis or thoracentesis the medication is considered medically necessary; and
• The surgical procedure is considered a route of administration. Modifier 59 may be reported with a non-E/M service, to identify it as distinct or independent from other non-E/M services performed on the same day; or

Other types of service such as: pathology, radiology, surgical procedures, etc.

• Pathology, radiology, surgical procedures etc. may be considered medically necessary for the appropriate treatment of the individual based upon the disease and/or diagnosis; and

Supply charges (e.g., needles, swabs, bandages, tubing) but not limited to those listed

• Supplies used in the administration of chemotherapy are considered part of a provider's overhead expense. 

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.