NEW YORK – Medicare Administrative Contractor Palmetto GBA released a final local coverage determination offering limited coverage for single-gene and multi-gene pharmacogenomics tests as a medical decision-making tool.
PGx testing is considered reasonable and necessary once a treating physician has narrowed a patient's treatment possibilities to specific medications, or if he or she is already using specified medications that are 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 July 26.
The medications must be chosen through clinical factors or necessity, instead of a PGx test, with PGx testing being used to help the physician's decision-making process for safely administering or dosing the drug. A patient's diagnosis is not enough to deem PGx testing reasonable and necessary, and the physician must have already considered non-genetic factors to make a preliminary drug choice.
The ordering provider of a PGx test must be licensed and qualified to diagnose the condition being treated and to prescribe medications for the condition. However, the policy doesn't restrict PGx testing to provider type, and the actionability of the info gleaned from the PGx test isn't dependent on the provider who submits the order.
If the physician orders a single-gene test or a test for a particular allele but the specific lab tests look for variants in other genes or alleles, the test in that instance is considered a single-gene test for coverage. In this case, providers can bill for the component of the test that was reasonable and necessary.
A multi-gene panel is covered if more than a single gene on the panel is reasonable and necessary for safe use of the medication or if multiple drugs are being considered with different relevant genes. A gene panel must have all the relevant gene/allele content required for the indicated use, which is considered during the test's technical assessment. The multi-gene panel isn't covered if only one gene on the panel is reasonable and necessary.
Combinatorial tests are not covered under the policy because under the evidence submitted, they have not demonstrated independent value. Palmetto noted that there may be multi-gene components of the combinatorial tests that are covered, however.
This decision has coverage implications for Myriad Genetics' GeneSight Psychotropic test for depression medications. Although Myriad's test is combinatorial, it said in a statement that it believes the test is covered as a multi-gene panel, but it is waiting action by CGS Administrators, the MAC covering the GeneSight test. Mark Verratti, president of Myriad Neuroscience and Myriad Autoimmune said in a statement that "multiple clinical studies have demonstrated the clinical value of the GeneSight Psychotropic combinatorial test."
Last year, Palmetto issued a draft LCD for combinatorial PGx tests for patients with psychiatric illness, which Noridian later aligned with.