Understanding Medicare Coverage of Pharmacogenomic Testing

Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) are decisions by Medicare and their administrative contractors that provide coverage information and determine whether certain services offered by participating providers are reasonable and necessary.

What is a National Coverage Determination (NCD)?

The Centers for Medicare and Medicaid Services (CMS) establishes national coverage determination (NCD) policies for items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). An NCD is mandated at the national level and all fiscal intermediaries, carriers, and Medicare Administrative Contractors (MACs) follow those guidelines.

Is there a NCD for pharmacogenomic (PGx) testing?

As of the date of this article, there is only one NCD for PGx testing. The NCD for Pharmacogenomic Testing for Warfarin Response (90.1) became effective on August 3, 2009.

Although the FDA now has more than 270 medications with pharmacogenomic precautions, warnings, or dosing guidance in the label, this is the sole NCD for PGx testing. However, in the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination (LCD).

What is a Local Coverage Determination (LCD)?

LCDs are decisions made by a Medicare Administrative Contractor (MAC) whether to cover a particular item or service in a MAC’s jurisdiction. LCDs are developed when there is no NCD or when there is a need to further define an NCD.

What is a Medicare Administrative Contractor (MAC)?

MACs are Medicare contractors that develop LCDs and process Medicare claims. The MAC’s decision is based on whether the service or item is considered reasonable and necessary. An LCD is mandated at the MAC level and those guidelines are only applicable to that MAC’s jurisdiction.

Does Medicare cover pharmacogenetic testing?

Currently, there are LCDs for Pharmacogenetic Testing for the following contractors:

Each LCD explains the coverage indications, limitations, and/or medical necessities that are only applicable to that MAC’s jurisdiction.

Similarities across PGx LCDs

Although these LCDs pertain to different jurisdictions, they are all remarkably similar. These LCDs address single gene, multi-gene panels, and combinatorial tests aimed at determining an individual’s drug response:

• Single-gene test – a laboratory test to detect relevant genetic variants (alleles) of 1 gene. If two or more different single genes are ordered individually but simultaneously, this is not a panel but rather a couple of or multiple single gene tests.
• Multi-gene panel – a laboratory test to detect genetic variants of at least 2 genes, wherein the clinician does not individually order genes, but orders a panel with a specified list of genes.
• Combinatorial PGx test – a type of multi-gene panel that requires a proprietary algorithm to evaluate pharmacokinetic or pharmacodynamic relationships resulting in drug recommendations or warnings.

Does Medicare cover Genomind testing?

Coverage for pharmacogenetic testing by Medicare depends upon the MAC of the PGx laboratory. Since Genomind’s laboratory is in Pennsylvania, the Novitas MAC LCD applies. This LCD has been in effect since December of 2021 and the full policy and billing guide can be found here: L39063 and here: A5880. The indications for medical necessity include:

1. The provider considering a medication for which a PGx test would impact the use of that drug AND
2. The drug-gene pair is considered actionable by either CPIC or the FDA.

The Clinical Pharmacogenetics Implementation Consortium (CPIC) consists of a group of researchers that specialize in pharmacogenetics from major institutions across the U.S. and several other countries. They have produced more than 25 peer-reviewed guidelines involving numerous drugs in order to facilitate the translation of PGx into actionable prescribing algorithms. CPIC scores drug-gene pairs and the Novitas LCD adopts their definition of actionability by referencing those pairs that fall into category A or B. For example, the antidepressant venlafaxine and drug metabolism gene CYP2D6 would be considered a Category A (actionable) drug gene pair and would likely meet the threshold for coverage. The billing guide includes a comprehensive list of drug-gene pairs and associated CPT codes.

In addition to the criteria above, eligible providers include those that can both diagnose a medical condition AND have the authority to prescribe medications for that condition. It must be the treating provider of the patient who places the order.

So when these criteria are met and the proper documentation is included, the Genomind PGx test is typically covered.

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