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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 say that screening tests are excluded from coverage. You can find this rule at 42 CFR Section
411.15(a)(1) and 42 CFR Section 410.64.
The rules say that for coverage of Pharmacogenomics Testing (PGx) 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. The treating clinician receiving the laboratory report must be able
to use the genetic information presented to guide treatment. To accomplish this, the laboratory must clearly
report the clinical significance of the resultant genotype, based on empirical data or validated methodologies, as
an annotation or interpretation. For clarity, the report should document the specific genotype-drug interaction
that led to the resultant interpretation. 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. For any of these testing services to be covered, the
patient's medical record must clearly reflect the following: 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 patient's diagnosis. The clinician has made an initial
personalized decision for the patient based on the patient's diagnosis, the patient's 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 patient's past medical history and when pertinent family
history and the patient's preferences and values. 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 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.