CMS Chemotherapy Drugs and their Adjuncts Form

Summary Of Evidence

A compendium is a listing of U.S. Food and Drug Administration (FDA) approved drugs and biologics. In some cases, compendia specialize in a particular subset of drugs, such as those used for anti-cancer treatment. Compendia include a summary of how each drug works in the body, as well as information for health care practitioners about proper dosing and whether the drug is recommended or endorsed for use in treating a specific disease. The compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium.   

As a practical matter, WPS GHA is aware of the broad availability and use of the NCCN guidelines and compendia in oncology clinical practice. While the CMS Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50, Drugs and Biologicals instructions regarding compendia do not give exclusive status to any one of the named compendia, WPS GHA finds that NCCN is more commonly cited by oncology practitioners and providers who seek coverage for chemotherapy. With that in mind, unlabeled uses of chemotherapy are covered, as noted above in Coverage Guidance. This is to assist the provider in real-time coverage that is in accordance with a compendium.  

The contractor may also consider individual cases with provided published peer reviewed literature if the claim denies and the provider feels the treatment is medically necessary. 

The development and coverage guidelines in this policy were based on a review of pertinent medical literature, Medicare regulations, policies from other Medicare contractors, the Medicare approved compendias, and discussions with appropriate specialists. 

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is a fundamental activity of the National Comprehensive Cancer Network. The NCCN Guidelines are updated in an evidence-based process integrated with the expert judgment of multidisciplinary panels of expert physicians from NCCN Member Institutions.

Analysis of Evidence

Level of evidence
Quality-Strong
Strength-Strong
Weight-Strong

Chemotherapy is an ever-expanding area. New agents are frequently receiving FDA approval for cancer treatment, and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is a guiding source for appropriate off-label uses of these chemotherapy agents.

This LCD addresses the coverage for chemotherapy agents based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition, medical necessity and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

1. Per this LCD, chemotherapy agents may be covered if reasonable and medical necessity is met

   AND

   • the drug is FDA approved

   AND

   • listed in the NCCN Clinical Practice Guidelines in Oncology (NCCN) with the specific ICD-10 diagnosis (that is being treated) for the drug/agent.
   • the chemotherapy agent must be listed Category 1 or 2A in NCCN,
   • the chemotherapy agent must be utilized per the NCCN Recommended Use (order or combination).
2. If the medically accepted indications are listed in one of the other Medicare approved compendia (Micromedex DrugDex as Class I, Class IIa, or Class IIb; American Hospital Formulary Service -Drug Information (AHFS) narrative text is “supportive”; Clinical Pharmacology narrative text is “supportive”; or Lexi-Drugs is listed as “Use Off-Label” and rated as “evidence level A”). A use is not medically accepted if the indication appears in the Medicare approved compendia as: NCCN as Category 3; Micromedex DrugDex as Class III; AHFS narrative text is “not supportive”; Clinical Pharmacology narrative text “not supportive”; or Lexi-Drugs is listed as “use: Unsupported”.