Sunday, September 8, 2024

Novitas: No LCD, But Burdensom Documents Required for Genomic Codes

 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."

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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.

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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
response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including specific alterations, if appropriate

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