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 Molecular Diagnostic Services (MolDX): Pharmacogenomics Testing for the following contractors:
- L38394: CGS Administrators, LLC
- L38337: Noridian Healthcare Solutions, LLC
- L38294: Palmetto GBA
- L38435: Wisconsin Physicians Service Insurance Corporation
- L39063: Novitas Solutions, Inc.
- L39073: First Coast Service Options, Inc
Each LCD explains the coverage indications, limitations, and/or medical necessities that are only applicable to that MAC’s jurisdiction.
CPIC support for L38294
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 provided presentations to Palmetto as well as instrumental feedback during the development of L38294. CPIC guidelines are cited throughout the LCD. For example, it states: “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 patient’s 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 following quote also comes directly from Palmetto GBA L38294:“With improvements in genetic technologies and the recognition that inter-individual genetic differences may affect how patients metabolize or physiologically respond to pharmacologically active substances, PGx testing has been proposed as a way to personalize medication selection or dose based on a patient’s individual genes.”
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?
The final LCD determination was issued on PGx testing for Medicare beneficiaries in 2020 broadening coverage and access to millions. As of 1/19/2021, Genomind’s Pharmacogenetic Test is covered and reimbursed by Medicare when the coverage criteria are met.
Register with Genomind to use our precision tools and services and help your patients get better.
References
Note (title image). Huddart, Rachel. “Geographical Impact of the New LCDs.” The PharmGKB Blog, PharmGKB, 3 Mar. 2021, pharmgkb.blogspot.com/2021/03/milestones-in-payer-coverage-set-to.html.
