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July 15, 2022
This article originally appeared in G2 Intelligence, National Lab Reporter, July 2022, published on the G2 website on June 8, 2022.
Last month, the Centers for Medicare & Medicaid Services (CMS) announced quarterly changes affecting lab test reporting and billing under the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). The changes take effect on July 1, 2022. Here are the two key CLFS changes your billing staff needs to know about.
1. Delay in PAMA Reporting
After two years of delay, the 2022 CLFS was supposed to include a Protecting Access to Medicare Act of 2014 (PAMA)-required 15 percent phase-in reduction in Part B reimbursements for Clinical Diagnostic Laboratory Tests (CDLTs). But on December 10, 2021, Congress passed legislation (the Protecting Medicare and American Farmers from Sequester Cuts Act) delaying application of the 15 percent cut for at least another year.
Under the CLFS final rule, labs and other reporting entities must give CMS certain private payor rate information for their component applicable laboratories. The data collection period was for claims for which final payment was received from January 1, 2019, to June 30, 2019. But CMS has reshuffled the reporting timetables in accordance with the delays in phasing in the 15 percent cuts. Specifically, it has based the next data reporting period of January 1, 2023, to March 31, 2023, on the original data collection period of January 1, 2019, to June 30, 2019. After the next data reporting period, there will be a three-year data reporting cycle for CDLTs that aren’t Advanced Diagnostic Laboratory Tests (ADLTs) (2026, 2029, etc.).
CMS has 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 won’t reduce payment by more than 15 percent for CYs 2023-2025.
2. The New PLA Codes
In addition to the PAMA changes, CMS added nine new Proprietary Laboratory Analysis (PLA) CPT codes to the national Healthcare Common Procedure Coding System (HCPCS) file that will be recognized starting July 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 July 1, 2022
|
Laboratory |
CPT Code |
Long Descriptor |
Short Descriptor |
|
Johns HopkinsMetagenomicNext-Generation Sequencing Assay for Infectious Disease Diagnostics, Johns Hopkins Medical Microbiology Laboratory |
0323U
|
Infectious agent detection by nucleic acid (DNA and RNA), central nervous system pathogen,metagenomicnext generation sequencing, cerebrospinal fluid (CSF), identification of pathogenic bacteria, viruses, parasites, or fungi
|
IADNA CNS PTHGN NEXT GEN SEQ |
|
3D Predict Ovarian Doublet Panel, KIYATECInc |
0324U |
Oncology (ovarian), spheroid cell culture, 4-drug panel (carboplatin, doxorubicin, gemcitabine, paclitaxel), tumor chemotherapy response prediction for each drug |
ONC OVAR SPHRD CELL 4 RX PNL |
|
3D Predict Ovarian PARP Panel, KIYATECInc
|
0325U |
Oncology (ovarian), spheroid cell culture, poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib,olaparib,rucaparib,velparib), tumor response prediction for each drug |
ONC OVAR SPHRD CELL PARP |
|
Guardant360, Guardant Health,Inc |
0326U |
Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 83 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden |
TRGT GEN SEQ ALYS PNL 83+ |
|
Vasistera, Natera,Inc |
0327U |
Fetal aneuploidy (trisomy 13, 18, and 21), DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy, includes sex reporting, if performed |
FTL ANEUPLOIDY TRSMY DNA SEQ |
|
CareView360, NewstarMedical Laboratories, LLC
|
0328U
|
Drug assay, definitive, 120 or more drugs and metabolites, urine, quantitative liquid chromatography with tandem mass spectrometry (LC-MS/MS), includes specimen validity and algorithmic analysis describing drug or metabolite and presence or absence of risks for a significant patient-adverse event, per date of service |
DRUG ASSAY 120+ RX & METABLT |
|
OncomapExTra, Exact Sciences,Inc, Genomic HealthInc |
0329U |
Oncology (neoplasia), exome and transcriptome sequence analysis for sequence variants, gene copy number amplifications and deletions, gene rearrangements, microsatellite instability and tumor mutational burden utilizing DNA and RNA from tumor with DNA from normal blood or saliva for subtraction, report of clinically significant mutation(s) with therapy associations |
ONC NEO XOME&TRNS SEQ ALYS |
|
Bridge Women’s Health Infectious Disease Detection Test, Bridge Diagnostics, ThermoFisherandHologicTest Kit on Panther Instrument |
0330U
|
Infectious agent detection by nucleic acid (DNA or RNA), vaginal pathogen panel, identification of 27 organisms, amplified probe technique, vaginal swab
|
IADNA VAG PTHGN PANEL 27 ORG |
|
Augusta Hematology Optical Genome Mapping, Georgia Esoteric and Molecular Labs, Augusta University,Bionano |
0331U |
Oncology (hematolymphoidneoplasia), optical genome mapping for copy number alterations and gene rearrangements utilizing DNA from blood or bone marrow, report of clinically significant alternations |
ONC HL NEO OPT GEN MAPPING |
Source: CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11398
Note: All codes are listed as TOS 5
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This article originally appeared in G2 Intelligence, National Lab Reporter, July 2022, published on the G2 website on June 8, 2022.
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