What is the MolDX Program?
MolDX® Program (Administered by Palmetto GBA) The MolDX Program was developed in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. MolDX success hinges on three components: test registration and ID assignment, application review, and coverage determination and reimbursement.
Which MACs participate in MolDX?
Participating MACs These include Noridian JE and JF, CGS J15, and WPS J5 and J8. Each of these MACs have coverage policies and websites dedicated to the MolDX program.
What is a PLA code?
What is a PLA code? PLA codes are alpha-numeric CPT® codes with a corresponding descriptor, for labs or manufacturers to more specifically identify their test. Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or manufacturer that offers the test.
What are molecular diagnostic techniques?
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. They overlap with clinical chemistry (medical tests on bodily fluids).
Does Medicare pay for PLA codes?
While Medicare may reimburse for these tests, some commercial payers and state Medicaid programs are not paying for new proprietary laboratory analyses (PLA) codes and multianalyte assays with algorithmic analyses (MAAA) codes. For labs running these tests, experts say the codes themselves bias payers against payment.
Who can report PLA codes?
clinical laboratory
Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or manufacturer that offers the test.
What are the different types of molecular testing?
What are the different types of genetic tests?
- Targeted single variant: Single variant tests look for a specific variant in one gene.
- Single gene: Single gene tests look for any genetic changes in one gene.
- Gene panel: Panel tests look for variants in more than one gene.
What are molecular diagnostic tools?
The major technologies used in gene-related molecular diagnosis are the direct detection of nucleic acids such as fluorescence in situ hybridization (FISH), nucleic acid amplification such as polymerase chain reaction (PCR), microarray-based assays, matrixassisted laser desorption/ionization-time of flight (MALDI-TOF) …