On July 26, 2024, Novitas MAC announced it was delaying the finalization of a new LCD for oncology biomarkers:
https://www.discoveriesinhealthpolicy.com/2024/07/novitas-oncology-lcd-carnival-continues.html
On August 16, 2024, Novitas announced a number of pathology/laboratory codes that would require documentation for payment. Find the announcement here:
https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00294519
The text announcement is brief but it links to an Excel file of specific codes (click on the headline, "Pathology and laboratory codes" on the web page.
Apparently Novitas intends this page to be "evergreen" as it states the associated clickable link for documentation codes "may be updated quarterly."
###
New process for pathology and laboratory codes
Important billing information
Effective September 19th, when medical records are not submitted to support the code billed (for the laboratory and pathology codes linked below), the service will reject. The claim must then be resubmitted with the appropriate documentation.
Documentation submitted from the medical record to support the initial claim submission for the pathology and lab codes linked below may include one or more of the following:
- Orders and test results for the test performed
- History and physical examination
- Progress or office notes for the test performed
- Any additional documentation in the medical record that supports the need for the service
Pathology and laboratory codes [see hot link on original Novitas web page]
Avoid negative impacts to your claims by providing medical records with your initial claim submission for the pathology and lab codes linked above. Please consult this list frequently as it may be updated quarterly.
##
Here, I've cut-pasted from the Excel as accessed on 9/08. It looks like many are PLA codes since 1/1/2024 (e.g. not in the 2024 annual book). But some codes in the range over 419U appear omitted, too.
|
Procedure
code |
Description |
|
0020M |
Oncology
(central nervous system), analysis of 30000 DNA methylation loci by
methylation array, utilizing DNA extracted from tumor tissue, diagnostic
algorithm reported as probability of matching a reference tumor subclass |
|
0421U |
Oncology
(colorectal) screening, quantitative real-time target and signal
amplification of 8 RNA markers (GAPDH, SMAD4, ACY1, ARe.g., CDH1, KRAS,
TNFRSF10B, EGLN2) and fecal hemoglobin, algorithm reported as a positive or
negative for colorectal cancer risk (BQ Colosense) |
|
0422U |
Oncology
(pan-solid tumor), analysis of DNA biomarker |
|
0425U |
Genome
(e.g., unexplained constitutional or heritable disorder or syndrome), rapid
sequence analysis, each comparator genome (e.g., parents, siblings) |
|
0426U |
Genome
(e.g., unexplained constitutional or heritable disorder or syndrome),
ultra-rapid sequence analysis |
|
0428U |
Oncology
(breast), targeted hybrid-capture genomic sequence analysis panel,
circulating tumor DNA (ctDNA) analysis of 56 or more genes, interrogation for
sequence variants, gene copy number amplifications, gene rearrangements,
microsatellite instability, and tumor mutation burden |
|
0429U |
Human
papillomavirus (HPV), oropharyngeal swab, 14 high-risk types (i.e., 16, 18,
31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) |
|
0434U |
Drug
metabolism (adverse drug reactions and drug response), genomic analysis
panel, variant analysis of 25 genes with reported phenotypes |
|
0435U |
Oncology,
chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), from
cultured CSCs and primary tumor cells, categorical drug response reported
based on cytotoxicity percentage observed, minimum of 14 drugs or drug
combinations |
|
0436U |
Oncology
(lung), plasma analysis of 388 proteins, using aptamer-based proteomics
technology,predictive algorithm reported as clinical benefit from immune
checkpoint inhibitor therapy |
|
0437U |
Psychiatry
(anxiety disorders), mRNA, gene expression profiling by RNA sequencing of 15
biomarkers, whole blood, algorithm reported as predictive risk score |
|
0438U |
Drug
metabolism (adverse drug reactions and drug response), buccal specimen,
gene-drug interactions, variant analysis of 33 genes, including
deletion/duplication analysis of CYP2D6, including reported phenotypes and
impacted gene-drug interactions |
|
0439U |
Cardiology
(coronary heart disease [CHD]), DNA, analysis of 5 single-nucleotide
polymorphisms (SNPS) (rs11716050 [loc105376934], rs6560711 [wdr37], rs3735222
[scin/loc107986769], rs6820447 [intergenic], and rs9638144 [esyt2]) and 3 DNA
methylation markers (cg00300879 [transcription start site {tss200} of
cnksr1], cg09552548 [intergenic], and cg14789911 [body of spatc1l]), qPCR and
digital PCR, whole blood, algorithm reported as a 4-tiered risk score for a
3-year risk of symptomatic CHD |
|
0441U |
Infectious
disease (bacterial, fungal, or viral infection), semiquantitative
biomechanical assessment (via deformability cytometry), whole blood, with
algorithmic analysis and result reported as an index |
|
0442U |
Infectious
disease (respiratory infection), myxovirus resistance protein a (MXA) and
c-reactive protein (CRP), fingerstick whole blood specimen, each biomarker
reported as present or absent |
|
0443U |
Neurofilament
light chain (NfL), ultra-sensitive immunoassay, serum or cerebrospinal fluid |
|
0445U |
B-amyloid
(abeta42) and phospho tau (181p) (ptau181), electrochemiluminescent
immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or
negative for amyloid pathology |
|
0448U |
Oncology
(lung and colon cancer), DNA, qualitative, next generation sequencing
detection of single-nucleotide variants and deletions in egfr and kras genes,
formalin-fixed paraffin-embedded (FFPE) solid tumor samples, reported as
presence or absence of targeted mutation(s), with recommended therapeutic
options |
|
0449U |
Carrier
screening for severe inherited conditions (e.g., cystic fibrosis, spinal
muscular atrophy, beta hemoglobinopathies [including sickle cell disease],
alpha thalassemia), regardless of race or self-identified ancestry, genomic
sequence analysis panel, must include analysis of 5 genes (cftr, smn1, hbb,
hba1, hba2) |
|
0450U |
Oncology
(multiple myeloma), liquid chromatography with tandem mass spectrometry
(LCMS/MS), monoclonal paraprotein sequencing analysis, serum, results
reported as baseline presence or absence of detectable clonotypic peptides |
|
0451U |
Oncology
(multiple myeloma), LCMS/MS, peptide ion quantification, serum, results
compared with baseline to determine monoclonal paraprotein abundance |
|
0452U |
Oncology
(bladder), methylated PENK DNA detection by linear target
enrichment-quantitative methylation-specific real-time PCR (LTE-qMSP), urine,
reported as likelihood of bladder cancer |
|
0453U |
Oncology
(colorectal cancer), cell-free DNA (cfDNA), methylationbased quantitative PCR
assay (SEPTIN9, IKZF1, BCAT1, Septin9-2, VAV3, BCAN), plasma, reported as
presence or absence of circulating tumor DNA (ctDNA) |
|
0454U |
Rare
diseases (constitutional/heritable disorders), identification of copy number
variations, inversions, insertions, translocations, and other structural
variants by optical genome mapping |
|
0455U |
Infectious
agents (sexually transmitted infection), Chlamydia trachomatis, Neisseria
gonorrhoeae, and Trichomonas vaginalis, multiplex amplified probe technique,
vaginal, endocervical, gynecological specimens, oropharyngeal swabs, rectal
swabs, female or male urine, each pathogen reported as detected or not
detected |
|
0456U |
Autoimmune
(rheumatoid arthritis), next-generation sequencing (NGS), gene expression
testing of 19 genes, whole blood, with analysis of anticyclic citrullinated
peptides (CCP) levels, combined with sex, patient global assessment, and body
mass index (BMI), algorithm reported as a score that predicts nonresponse to
tumor necrosis factor inhibitor (TNFi) therapy |
|
0459U |
β-amyloid
(Abeta42) and total tau (tTau), electrochemiluminescent immunoassay (ECLIA),
cerebral spinal fluid, ratio reported as positive or negative for amyloid
pathology |
|
0460U |
Oncology,
whole blood or buccal, DNA single-nucleotide polymorphism (SNP) genotyping by
real-time PCR of 24 genes, with variant analysis and reported phenotypes |
|
0461U |
Oncology,
pharmacogenomic analysis of single-nucleotide polymorphism (SNP) genotyping
by real-time PCR of 24 genes, whole blood or buccal swab, with variant
analysis, including impacted gene-drug interactions and reported phenotypes |
|
0464U |
Oncology
(colorectal) screening, quantitative real-time target and signal
amplification, methylated DNA markers, including LASS4, LRRC4 and PPP2R5C, a
reference marker ZDHHC1, and a protein marker (fecal hemoglobin), utilizing
stool, algorithm reported as a positive or negative result [BQ Cologuard Plus] |
|
0465U |
Oncology
(urothelial carcinoma), DNA, quantitative methylationspecific PCR of 2 genes
(ONECUT2, VIM), algorithmic analysis reported as positive or negative |
|
0466U |
Cardiology
(coronary artery disease [CAD]), DNA, genomewide association studies (564856
single-nucleotide polymorphisms [SNPs], targeted variant genotyping), patient
lifestyle and clinical data, buccal swab, algorithm reported as polygenic
risk to acquired heart disease |
|
0467U |
Oncology
(bladder), DNA, nextgeneration sequencing (NGS) of 60 genes and whole genome
aneuploidy, urine, algorithms reported as minimal residual disease (MRD)
status positive or negative and quantitative disease burden |
|
0468U |
Hepatology
(nonalcoholic steatohepatitis [NASH]), miR-34a5p, alpha 2-macroglobulin,
YKL40, HbA1c, serum and whole blood, algorithm reported as a single score for
NASH activity and fibrosis |
|
0469U |
Rare
diseases (constitutional/heritable disorders), whole genome sequence analysis
for chromosomal abnormalities, copy number variants, duplications/deletions, inversions,
unbalanced translocations, regions of homozygosity (ROH), inheritance pattern
that indicate uniparental disomy (UPD), and aneuploidy, fetal sample
(amniotic fluid, chorionic villus sample, or products of conception),
identification and categorization of genetic variants, diagnostic report of
fetal results based on phenotype with maternal sample and paternal sample, if
performed, as comparators and/or maternal cell contamination |
|
0471U |
Oncology
(colorectal cancer), qualitative real-time PCR of 35 variants of KRAS and
NRAS genes (exons 2, 3, 4), formalin-fixed paraffin-embedded (FFPE),
predictive, identification of detected mutations |
|
0472U |
Carbonic
anhydrase VI (CA VI), parotid specific/secretory protein (PSP) and salivary
protein (SP1) IgG, IgM, and IgA antibodies, enzyme-linked immunosorbent assay
(ELISA), semiqualitative, blood, reported as predictive evidence of early
Sjögren syndrome |
|
0474U |
Hereditary
pan-cancer (e.g., hereditary sarcomas, hereditary endocrine tumors,
hereditary neuroendocrine tumors, hereditary cutaneous melanoma), genomic
sequence analysis panel of 88 genes with 20 duplications/deletions using
nextgeneration sequencing (NGS), Sanger sequencing, blood or saliva, reported
as positive or negative for germline variants, each gene |
|
0475U |
Hereditary
prostate cancerrelated disorders, genomic sequence analysis panel using
next-generation sequencing (NGS), Sanger sequencing, multiplex
ligation-dependent probe amplification (MLPA), and array comparative genomic
hybridization (CGH), evaluation of 23 genes and duplications/deletions when
indicated, pathologic mutations reported with a genetic risk score for
prostate cancer |
