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Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
  
   
The rules state that this LCD addresses the coverage for chemotherapy agents based on the patients 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 
o the drug is FDA approved 
AND 
o 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. 
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 (Rationale for Determination) 
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. 
You can find this rule at the Medicare Local Coverage Determination (LCD) L37205: Chemotherapy 
Drugs and their Adjuncts. 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.