Calendar Year (CY) 2019 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

New Codes Effective January 1, 2019

Proprietary Laboratory Analysis (PLAs)

The following new codes have been included in the national HCPCS file correction with an effective date of January 1, 2019 and may need to be manually added to the HCPCS file by the MACs. These new codes are also contractor-priced until they are addressed at the annual Clinical Laboratory Public Meeting, which will take place in June or July 2019 as they were received after the 2018 public meeting. MACs shall only price PLA codes for laboratories within their jurisdiction.

New Codes

1. CPT Code: 0080U o Short Descriptor: ONC LNG 5 CLIN RSK FACTR ALG

• Long Descriptor: Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma, algorithm reported as a categorical probability of malignancy
• Laboratory: BDX-XL2, Biodesix®, Inc

2. CPT Code: 0081U o Short Descriptor: ONC UVEAL MLNMA MRNA 15 GENE

• Long Descriptor: Oncology (uveal melanoma), mRNA, gene-expression profiling by real-time RT-PCR of 15 genes (12 content and 3 housekeeping genes), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis
• Laboratory:DecisionDx®-UM, Castle Biosciences, Inc

3. CPT Code: 0082U o Short Descriptor: RX TEST DEF 90+ RX/SBSTS UR

• Long Descriptor: Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service
• Laboratory:NextGen Precision™ Testing, Precision Diagnostics LBN Precision Toxicology, LLC

4. CPT Code: 0083U o Short Descriptor: ONC RSPSE CHEMO CNTRST TOMOG

• Long Descriptor: Oncology, response to chemotherapy drugs using motility contrast tomography, fresh or frozen tissue, reported as likelihood of sensitivity or resistance to drugs or drug combinations
• Laboratory: Onco4D™, Animated Dynamics, Inc

CR Transmittal Number: R4208CP

Source: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11076.pdf