Three Key Changes Your Lab Staff Need to Know About

CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized starting April 1. Make sure your lab billing staff is aware of the three key changes.

1. The Revised PAMA Reporting Timetable

On December 10, 2021, Congress once more delayed the 15 percent PAMA cut in Part B reimbursements for Clinical Diagnostic Laboratory Tests (CDLTs) that were scheduled to take effect with the 2022 Clinical Laboratory Fee Schedule (CLFS). The legislation also delayed PAMA reporting. As a result, CMS has revised the reporting period to account for the delay. CMS will base the next reporting period of January 1, 2023 through March 31, 2023 on the original data collection period of January 1, 2019 through June 30, 2019. After the next data reporting period, there’s a three-year data reporting cycle for CDLTs that aren’t Advanced Diagnostic Laboratory Tests (ADLTs).

2. The Extension of Phased-In PAMA Cuts

CMS also extended the statutory phase-in of payment reductions resulting from private payor rate implementation through Calendar Year (CY) 2025. There’s a 0.0 percent reduction for CY 2021 and CY 2022, and the agency says it won’t reduce payment by more than 15 percent for CYs 2023-2025.

3. The New PLA Codes

In addition to the PAMA changes, CMS added 17 new Proprietary Laboratory Analysis (PLA) CPT codes to the national HCPCS file that will be recognized starting April 1, 2022. Medicare administrative contractors will decide how much labs in their jurisdiction will be reimbursed for the new PLA codes until a national price is set via the CLFS annual payment determination process.

Newly Listed PLA Codes, Effective April 1, 2022

Laboratory	CPT Code	Long Descriptor	Short Descriptor
Invitae PCM Tissue Profiling and MRD Baseline Assay, Invitae Corp.	0306U	Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis, cell-free DNA, initial (baseline) assessment to determine a patient-specific panel for future comparisons to evaluate for MRD (Don’t report 0306U in conjunction with 0307U)	ONC MRD NXT-GNRJ ALYS 1ST
Invitae PCM MRD Monitoring, Invitae Corp.	0307U	Oncology (minimal residual disease [MRD]), next-generation targeted sequencing analysis of a patient-specific panel, cell-free DNA, subsequent assessment with comparison to previously analyzed patient specimens to evaluate for MRD (Don’t report 0307U in conjunction with 0306U)	ONC MRD NXT-GNRJ ALYS SBSQ
HART CADhs, Prevencio, Inc	0308U	Cardiology (coronary artery disease [CAD]), analysis of 3 proteins (high sensitivity [hs] troponin, adiponectin, and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as risk score for obstructive CAD	CRD CAD ALYS 3 PRTN PLSM ALG
HART CVE, Prevencio, Inc	0309U	Cardiology (cardiovascular disease), analysis of 4 proteins (NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 [TIMP-1], and kidney injury molecule-1 [KIM-1]), plasma, algorithm reported as risk score for major adverse cardiac event	CRD CV DS ALY 4 PRTN PLM ALG
HART KD, Prevencio, Inc	0310U	Pediatrics (vasculitis, Kawasaki disease [KD]), analysis of 3 biomarkers (NTproBNP, C-reactive protein, and T-uptake), plasma, algorithm reported as a risk score for KD	PED VSCLTS KD ALYS 3 BMRKS
Accelerate PhenoTest BC kit, AST configuration, Accelerate Diagnostics, Inc	0311U	Infectious disease (bacterial), quantitative antimicrobial susceptibility reported as phenotypic minimum inhibitory concentration (MIC)–based antimicrobial susceptibility for each organism identified (Don’t report 0311U in conjunction with 87076, 87077, 0086U)	NFCT DS BCT QUAN ANTMCRB SC
Advise Lupus, Exagen Inc	0312U	Autoimmune diseases (eg, systemic lupus erythematosus [SLE]), analysis of 8 IgG autoantibodies and 2 cellbound complement activation products using enzyme-linked immunosorbent immunoassay (ELISA), flow cytometry and indirect immunofluorescence, serum, or plasma and whole blood, individual components reported along with an algorithmic SLE-likelihood assessment	AI DS SLE ALYS 8 IGG AUTOANT
PancreaSeq Genomic Classifier, Molecular and Genomic Pathology Laboratory, University of Pittsburgh Medical Center	0313U	Oncology (pancreas), DNA and mRNA next-generation sequencing analysis of 74 genes and analysis of CEA (CEACAM5) gene expression, pancreatic cyst fluid, algorithm reported as a categorical result (i.e., negative, low probability of neoplasia or positive, high probability of neoplasia)	ONC PNCRS DNA&MRNA SEQ 74
DecisionDx DiffDxMelanoma, Castle Biosciences, Inc.	0314U	Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 35 genes (32 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical result (i.e., benign, intermediate, malignant)	ONC CUTAN MLNMA MRNA 35 GENE
DecisionDx-SCC, Castle Biosciences, Inc	0315U	Oncology (cutaneous squamous cell carcinoma), mRNA gene expression profiling by RT-PCR of 40 genes (34 content and 6 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a categorical risk result (i.e., Class 1, Class 2A, Class 2B)	ONC CUTAN SQ CLL CA MRNA 40
Lyme Borrelia Nanotrap Urine Antigen Test, Galaxy Diagnostics Inc	0316U	Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine	B BRGDRFERI LYME DS OSPA EVL
LungLB, LungLife AI	0317U	Oncology (lung cancer), four-probe FISH (3q29, 3p22.1, 10q22.3, 10cen) assay, whole blood, predictive algorithm-generated evaluation reported as decreased or increased risk for lung cancer	ONC LUNG CA 4-PRB FISH ASSAY
EpiSign Complete, Greenwood Genetic Center	0318U	Pediatrics (congenital epigenetic disorders), whole genome methylation analysis by microarray for 50 or more genes, blood	PED WHL GEN MTHYLTN ALYS 50+
Clarava, Verici Dx, Verici Dx, Inc	0319U	Nephrology (renal transplant), RNA expression by select transcriptome sequencing, using pretransplant peripheral blood, algorithm reported as risk score for early acute rejection	NEPH RNA PRETRNSPL PERPH BLD
Tuteva, Verici Dx, Verici Dx, Inc	0320U	Nephrology (renal transplant), RNA expression by select transcriptome sequencing, using posttransplant peripheral blood, algorithm reported as risk score for acute cellular rejection	NEPH RNA PSTTRNSPL PERPH BLD
Bridge Urinary Tract Infection Detection and Resistance Test, Bridge Diagnostics	0321U	Infectious agent detection by nucleic acid (DNA or RNA), genitourinary pathogens, identification of 20 bacterial and fungal organisms and identification of 16 associated antibiotic-resistance genes, multiplex amplified probe technique	IADNA GU PTHGN 20BCT&FNG ORG
NPDX ASD Test Panel III, Stemina Biomarker Discovery d/b/a NeuroPointDX, Stemina Biomarker Discovery d/b/a NeuroPointDX	0322U	Neurology (autism spectrum disorder [ASD]), quantitative measurements of 14 acyl carnitines and microbiome-derived metabolites, liquid chromatography with tandem mass spectrometry (LC-MS/MS), plasma, results reported as negative or positive for risk of metabolic subtypes associated with ASD	NEURO ASD MEAS 14 ACYL CARN

Source: CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11221

Note: All codes are listed as TOS 5