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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 rules state that pharmacogenomic (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 patient's
condition and are known to have a gene(s)-drug interaction that has been demonstrated to be clinically
actionable as defined by the Food & Drug Administration (FDA) (PGx information required for safe drug
administration) 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 genedrug
interactions as identified above, then a PGx test may be considered reasonable and necessary when the
result of that test is necessary for the physician's 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. 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. 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. You
can find these rules in Local Coverage Determination (LCD) MolDX: Pharmacogenomics Testing (L38394).
The rules state that there is a broad consensus in medical literature that MTHFR genotyping has no clinical
utility in any clinical scenario. This testing is considered investigational and is not a Medicare benefit. You can
find this rule in Local Coverage Determination (LCD) MolDX: Genetic Testing for
Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin, MTHFR) (L35984).
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.