Noridian Aligns With Palmetto on Single-Gene, Multi-Gene PGx Test Coverage

NEW YORK – Medicare Administrative Contractor Noridian Healthcare Solutions aligned its coverage decision with Palmetto GBA's recently announced limited coverage determination for single-gene and multi-gene pharmacogenomics tests. 

Under Noridian's final local coverage determination, the tests are considered reasonable and necessary after a treating physician has narrowed a patient's treatment options to specific medications, or if the patient is already using specified medications known to have clinically actionable gene-drug interactions as defined by the US Food and Drug Administration or the Clinical Pharmacogenetic Implementation Consortium. The LCD applies to services performed on or after Aug. 17. 

Medications must be chosen through clinical factors or necessity, instead of a PGx test, with testing being used to help the clinician's decision-making process for safely administering or dosing the drug. The patient's diagnosis isn't enough for PGx testing to be reasonable and necessary, and the clinician must have already considered non-genetic factors to make a preliminary drug choice, Noridian said.

If a clinician orders a single-gene test or a test for a specific allele but the lab tests look for variants in other genes or alleles, the test is considered a single-gene test in that instance. Providers should bill for the component of the test that was reasonable and necessary. 

Multi-gene panels are covered if more than one gene on the panel is reasonable and necessary for safe use of the medication or if multiple drugs with different relevant genes are being considered. Multi-gene panels aren't covered if only one gene on the panel is reasonable and necessary.

Under the policy, combinatorial tests are not covered because they did not demonstrate independent value under the evidence submitted. However, multi-gene components of the combinatorial tests may be covered.