Appeal type: unknown
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 pharmacogenomics (PGx) tests are indicated when medications are being considered for use 
(or already being administered) that are medically necessary, appropriate, and approved for use in the patients 
condition and are known to have a gene(s)-drug interaction that has been demonstrated to be clinically 
actionable as defined by the Food and Drug Administration (FDA) or Clinical Pharmacogenetic 
Implementation Consortium (CPIC) guidelines (category A and B). 
 
The selection of the medications in question must be derived from clinical factors/necessity rather than from a 
PGx test. Once the putative therapeutic agents are selected, and those agents are known to have gene-drug 
interactions as identified above, then a PGx test may be considered reasonable and necessary when the result of 
that test is necessary for the physicians decision-making process regarding safely administering or dosing the 
drug. 
 
PGx testing is not considered reasonable and necessary merely on the basis of a patient having a particular 
diagnosis. Unless the record reflects that the treating clinician has already considered non-genetic factors to 
make a preliminary drug selection, PGx testing is not considered reasonable and necessary. 
 
The clinical record must clearly show the use of or intent to prescribe a drug that has known drug-gene 
interactions that require a PGx test to be ordered to define the safe use of that drug in that patient. 
 
If a treating clinician orders a single gene test or a test for a particular allele(s), but as a matter of operational 
practicality, the laboratory tests that single gene or allele on a platform that looks for variants in other genes / 
alleles as well, that particular test done in that particular instance is considered a single gene / allele test for 
coverage purposes. In this scenario the provider may bill for the component of the test that was reasonable and 
necessary (in this example, the single gene test). 
 A multi-gene panel is considered reasonable and necessary if more than one single gene on that panel would be 
considered reasonable and necessary for safe use of the medication in question or if multiple drugs are being 
considered (each fulfilling the criteria of actionable gene-drug interactions identified above) that have different 
relevant genes. Additionally, a gene panel must contain at a minimum all the necessary relevant gene/allele 
content required for their indicated use to meet clinical utility requirements. Such minimum criteria are 
determined by experts including relevant associations such as the Association for Molecular Pathology and are 
considered during the technical assessment. A multi-gene panel is not considered reasonable and necessary if 
only a single gene on the panel is considered reasonable and necessary. 
 
If two or more single genes are tested, rather than a multi-gene panel, then the record must reflect that a 
clinician individually ordered each gene, and each single gene must individually be reasonable and necessary at 
the time they are ordered. 
 
The ordering provider of a PGx test is restricted to providers who have the licensure, qualifications, and 
necessary experience / training to both diagnose the condition being treated and also to prescribe medications 
(the provider must be able to do both) for the condition either independently or in an arrangement as required 
by all the applicable state laws. 
 
You can find this information in Local Coverage Determination: MolDX: Pharmacogenomics 
Testing (L38394). 
 
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.