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".

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 compendia, 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.

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.