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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 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. 
Test components that are not reasonable and necessary 
Genes not identified as having actionable use are not considered reasonable and necessary. The algorithms 
employed in combinatorial testing are also not currently considered reasonable and necessary components of 
multi-gene testing. Noncovered Indications 
PGx testing is not covered when a treating clinician is not considering treatment with a medication that has an 
actionable drug-gene interaction, or when the use of a medication with a drug-gene interaction is not reasonable 
and necessary. 
Special Documentation Requirements 
In order for any of the above services to be covered, the patients medical record must clearly reflect the 
following: 
1. The patient has a diagnosis for which pharmacologic therapy is reasonable and necessary, and the drug 
or drugs that the clinician is considering using must be reasonable and necessary for the treatment of the 
patients diagnosis. 
2. The clinician has made an initial personalized decision for the patient based on the patients diagnosis, 
the patients other medical conditions, other medications the patient is taking, professional judgement, 
clinical science and basic science pertinent to the drug (e.g. mechanism of action, side effects), the 
patients past medical history and when pertinent family history and the patients preferences and 
values. 
3. The provider performing the service must have a record of what drug(s) is/are being considered and for 
what indication(s) to ensure the test performed is reasonable and necessary. 
You can find this rule in the Centers for Medicare and Medicaid Services, Local Coverage Determination 
(LCD): MolDX: Pharmacogenomics Testing (L38435). 
 
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.