Laboratory Guideline Policy - CAM 235HB

Policy
To be considered for reimbursement, all outpatient laboratory claims should be submitted in accordance with:

  • AMA CPT and HCPCS coding and ICD-10 diagnosis coding guidelines.

  • Other laboratory and pathology coding guidelines.

  • All applicable regulatory guidelines.

This policy outlines additional requirements beyond the guidelines listed above that are required for reimbursement. Note that these guidelines are reviewed and updated periodically. 

Technical, Professional and Global Services (TC, 26 modifiers) 

  • Before using the 26 or TC modifiers, verify that these modifiers are allowable with the procedure code.

  • Do not append these modifiers to the procedure code when performing the global service.

Test Performed by a Reference Laboratory

  • When laboratory procedures are performed by a party other than the treating or reporting physician to other qualified health care professional, the procedure must be identified by adding modifier 90 to the claim line.

  • Only independent clinical laboratories may append modifier 90 to indicate that the service was referred to an outside laboratory.

Repeat Testing

  • While treating a patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. Under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91.

  • Modifier 91 may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable result is all that is required.

  • Modifier 91 may not be used when other code(s) describe a series of test results (e.g., glucose tolerance tests, evocative/suppression testing).

Clinical Laboratory Improvement Amendments (CLIA) Waived Testing

  • Laboratory tests that are CLIA-waived must have the QW modifier appended to the procedure code. 

In accordance with S611b of OBRA of 1989, a referring lab can bill for tests performed by a reference lab only if it meets any one of the following exceptions: 

  • The referring laboratory is in or is part of a rural hospital.

  • The referring lab and the reference lab are "subsidiary related." That is:

    • The referring lab is a wholly owned subsidiary of the reference lab.

    • The referring lab wholly owns the reference lab.

    • Both the referring lab and reference lab are wholly owned subsidiaries of the same entity. 

Some procedure codes will not be reimbursed due to their expiration or replacement with more appropriate codes. 

  • AMA drug assay codes 80320 to 80377 are not accepted and will not be reimbursed. Refer to policy CAM 140 for guidelines for submitting G0480 to G0483.

  • Proprietary Laboratory Analyses (PLA) codes will not be reimbursed unless a laboratory policy specifically covers the PLA code.

  • Unlisted codes (81479, 81599, 84999) will not be accepted if a specific Tier 1, Tier 2, GSP or MAAA code exists. 

Reimbursement for genetic panel testing is as follows: 

  • If a procedure code is available for the multi-gene panel test, then this code is to be utilized (i.e., 81442 Noonan spectrum disorders genomic sequence analysis panel).

  • If there is not a specific next generation sequencing (NGS) procedure code that represents the requested test, the procedure may be represented by a maximum of ONE unit of 81479 [unlisted molecular pathology procedure] (i.e., 81479 X 1 should account for all remaining gene testing) OR All genes tested on the panel must be represented by ALL appropriate Molecular Pathology Tier 1 or 2 procedure codes (with exception of 81479 x 1 only being listed once if it appropriately represents more than one gene in the panel).

  • ALL gene tests in the panel must be listed on the request and the rationale for the clinical utility for the gene test must come from the ordering provider.

  • If ALL codes that represent the testing of the panel are not submitted, the test will be denied as not medically necessary due to incorrect coding process, as neither laboratory nor clinical reviewer should assign meaning to incomplete unspecified panel codes.

Genetic Counseling Reimbursement Guidelines

  • Genetic counseling, when required, is considered MEDICALLY NECESSARY ONLY when performed by a provider who is NOT an employee or contractor of the rendering lab. Genetic counseling should be independent of the laboratory rendering the testing to prevent conflict of interest. Genetic counseling documentation consists of written documentation of the counseling elements provided to the member (may include risks, benefits, care guidance and follow-up plans). Any genetic counseling provided, whether a covered benefit or not, will be considered during review of health plan laboratory policy where counseling is a required component.

References

  1. Centers for Medicare & Medicaid Services, “Medically Unlikely Edits” https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/MUE.html

  2. American Medical Association, Current Procedural Terminology (CPT®), Professional Edition

  3. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

  4. CMS Pub. 100-04, chapter 16, section 40.1.1 external link (PDF, 497 KB

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

Coding Section

Code  Number Description
  0450U  (effective 07/01/2024) Oncology (multiple myeloma), liquid chromatography with tandem mass spectrometry (LC-MS/MS), monoclonal paraprotein sequencing analysis, serum, results reported as baseline presence or absence of detectable clonotypic peptides
  0451U (effective 07/01/2024) Oncology (multiple myeloma), LC-MS/MS, peptide ion quantification, serum, results compared with baseline to determine monoclonal paraprotein abundance
  0457U (effective 07/01/2024) Perfluoroalkyl substances (PFAS) (eg, perfluorooctanoic acid, perfluorooctane sulfonic acid), 9 PFAS compounds by LC-MS/MS, plasma or serum, quantitative
  0458U (effective 07/01/2024) Oncology (breast cancer), S100A8 and S100A9, by enzyme-linked immunosorbent assay (ELISA), tear fluid with age, algorithm reported as a risk score
  0472U (effective 07/01/2024) 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’s syndrome
CPT 0482U (effective 10/01/2024) Obstetrics (preeclampsia), biochemical assay of soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF), serum, ratio reported for sFlt-1/PlGF, with risk of progression for preeclampsia with severe features within 2 weeks
  0483U (effective 10/01/2024) Infectious disease (Neisseria gonorrhoeae), sensitivity, ciprofloxacin resistance (gyrA S91F point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of fluoroquinolone resistance
  0484U (effective 10/01/2024) Infectious disease (Mycoplasma genitalium), macrolide sensitivity (23S rRNA point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of macrolide resistance
  0486U (effective 10/01/2024) Oncology (pan-solid tumor), next-generation sequencing analysis of tumor methylation markers present in cell-free circulating tumor DNA, algorithm reported as quantitative measurement of methylation as a correlate of tumor fraction
  0510U (effective 10/01/2024) Oncology (pancreatic cancer), augmentative algorithmic analysis of 16 genes from previously sequenced RNA wholetranscriptome data, reported as probability of predicted molecular subtype
  0511U (effective 10/01/2024) Oncology (solid tumor), tumor cell culture in 3D microenvironment, 36 or more drug panel, reported as tumor-response prediction for each drug
  0522U (effective 01/01/2025) Carbonic anhydrase VI, parotid specific/secretory protein and salivary protein 1 (SP1), IgG, IgM, and IgA antibodies, chemiluminescence, semiqualitative, blood  (This code will be effective on 01/01/2025).
  0524U (effective 01/01/2025) Obstetrics (preeclampsia), sFlt-1/PlGF ratio, immunoassay, utilizing serum or plasma, reported as a value (This code will be effective on 01/01/2025).
  0526U (effective 01/01/2025) Nephrology (renal transplant), quantification of CXCL10 chemokines, flow cytometry, urine, reported as pg/mL creatinine baseline and monitoring over time (This code will be effective on 01/01/2025).
  0527U (effective 01/01/2025) Herpes simplex virus (HSV) types 1 and 2 and Varicella zoster virus (VZV), amplified probe technique, each pathogen reported as detected or not detected (This code will be effective on 01/01/2025).

History From 2024 Forward     

11/22/2024
Updated CPT coding. Added codes 0522U, 0524U, 0526U, 0527U. These codes will be effective 01/01/2025. No other changes made
08/27/2024 Interim review. Added PLA codes 0078U, 0482U, 0483U, 0484U, 0486U, 0510U and 0511U to coding section. 
05/03/2024 Annual review moved to January 2025. No other changes. 
01/01/2024 New Policy.
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