Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Medicare Part B coverage includes oral anti-cancer drugs. For an oral anti-cancer drug to be covered, all ofthe following criteria (1-4) must be met (Medicare Claims Processing Manual, Chapter 17, Section 80.1):1. It is a drug or biological that has been approved by the Food and Drug Administration (FDA), and2. It has the same active ingredients as a non-self-administrable anti-cancer chemotherapeutic drug orbiological that is covered when furnished incident to a practitioner's service. The oral anti-cancer drug andthe non-self-administrable drug must have the same chemical/generic name as indicated by the FDA'sApproved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drugcompendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient whichis found in the non-self-administrable form of the drug, and3. It is used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-labeluses, as the non-self-administrable form of the drug, and4. It is prescribed by a practitioner licensed under state law to prescribe such drugs as anti -cancerchemotherapeutic agents.If criteria 1-4 are not met, the drug will be denied as non-covered. A claim denied for the reason that thediagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD -10 Codes, willreceive a statutory denial as non-covered, but may be covered at appeal if and only if it can be shown to beallowed under Medicare Benefit Policy Manual, Chapter 15, Section 50 and under the Social Security Act,Section 1861(s)(Q). Medicare Benefit Policy Manual, Chapter 15, Section 50.5.3; CGS Administrators,LLC, Local Coverage Article for Oral Anticancer Drugs (A52479) or Noridian Healthcare Solutions, LLC,Local Coverage Article for Oral Anticancer Drugs (A52479).Medicare law defines a covered prescription drug as a drug available only by prescription, approved by theFDA, used and sold in the United States, and used for a medically accepted indication. In general, for PartD drugs used in an anticancer chemotherapeutic regimen, a 'medically accepted indication' means a usethat is:-Approved by the FDA, or-Supported by citation in one of several specified drug compendia, including the American HospitalFormulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN)Drugs and Biologics Compendium, Thomson Micromedex DrugDex, and Clinical Pharmacology; or-Supported by clinical research that appears in the peer reviewed medical literature, specifically in journalsor publications as specified by the Centers for Medicare and Medicaid Services (CMS).Social Security Act, Sections 1860D-2(e)(1) and 1861(t)(2)(B); and Medicare Benefit Policy Manual,Chapter 15, Section 50.4.5.The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare PartA or Part B. The Part D Plan can only cover drugs prescribed for a medically accepted indication. Pleaserefer to the Plan's Evidence of Coverage.