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Showing posts with label Labs. Show all posts
Showing posts with label Labs. Show all posts

New Lab Codes Effective July 1, 2021

The New HCPCS Lab Codes are released which is Effective from July 1, 2021. These new codes are contractor-priced (where applicable) until they are nationally priced and undergo the CLFS annual payment determination process. 

The MACs will only price PLA codes for laboratories within their jurisdiction. and Type of Service (TOS) for all the codes should be "5".

0248U - Oncology (brain), spheroid cell culture in a 3D microenvironment, 12 drug panel, tumor-response prediction for each drug.

0249U - Oncology (breast), semiquantitative analysis of 32 phosphoproteins and protein analytes, includes laser capture microdissection, with algorithmic analysis and interpretative report.

0250U - Oncology (solid organ neoplasm), targeted genomic sequence DNA analysis of 505 genes, interrogation for somatic alterations (SNVs [single nucleotide variant], small insertions and deletions, one amplification, and four translocations), microsatellite instability and tumor-mutation burden.

0251U - Hepcidin-25, enzyme-linked immunosorbent assay (ELISA), serum or plasma.

0252U - Fetal aneuploidy short tandem–repeat comparative analysis, fetal DNA from products of conception, reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy.

0253U - Reproductive medicine (endometrial receptivity analysis), RNA gene expression profile, 238 genes by nextgeneration sequencing, endometrial tissue, predictive algorithm reported as endometrial window of implantation (eg, pre-receptive, receptive, post-receptive).

0254U - Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using embryonic DNA genomic sequence analysis for aneuploidy, and a mitochondrial DNA score in euploid embryos, results reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy, per embryo tested.

G0327 - Colorectal cancer screening; blood-based biomarker.


New Waived Tests for Labs - Modifier QW Updates

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. 

To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver.

The listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. 

The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. 

However, the below-mentioned tests did not require a QW modifier to be recognized as a waived test.

Example (i.e., CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) 

  • 81002 - Dipstick or tablet reagent urinalysis – non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.
  • 81025 - Urine pregnancy tests by visual color comparison.
  • 82270 & 82272 - Fecal occult blood.
  • 82962 - Blood glucose by glucose monitoring devices cleared by the FDA for home use.
  • 83026 - Hemoglobin by copper sulfate – nonautomated.
  • 84830 - Ovulation tests by visual color comparison for human luteinizing hormone.
  • 85013 - Blood count; spun microhematocrit.
  • 85651 - Erythrocyte sedimentation rate – nonautomated. 

The CPT code 80305 is required modifier QW, effective date, and description for the latest tests approved by the FDA as waived tests under CLIA is the following,

  • August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup;
  • August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip;
  • September 23, 2020, Axium BioResearchInc.DrugExam Multi-Drug Screen Test;
  • October 9, 2020, American Screening LLC Discover Panel Dip Card Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 2000;
  • October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 2000;
  • October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 2000;
  • October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR300
  • October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR2000;
  • October 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR2000;
  • October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR300; and
  • October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR2000.

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