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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 say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that PGx testing is considered reasonable and necessary in limited circumstances as described 
below as an adjunctive personalized medical decision-making tool once a treating clinician has narrowed 
treatment possibilities to specific medications under consideration for use, or is already using a specified 
medication, based on other clinical considerations including the patients diagnosis, the patients other medical 
conditions, other medications, professional judgment, clinical science and basic science pertinent to the drug, 
and the patients preferences and values.1 
 
PGx tests must demonstrate analytical validity, clinical validity, and clinical utility to be considered reasonable 
and necessary for coverage. This is demonstrated through a required technical assessment of the test. PGx tests 
are considered germline tests and must adhere to other relevant germline testing policies published by this 
contractor. 
 
It is understood that some panel/combinatorial tests may include content that has demonstrated clinical utility 
and some that has not. In such circumstances, this contractor may provide coverage for the components of tests 
that have demonstrated clinical utility when used in the proper clinical context described below. 
 
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 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 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. 
 
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. You can find these rules in the Local Coverage Determination (LCD) 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.