Friday, 11 August 2017 10:12

ASM Weighs In on Clinical Laboratory Test Prices

Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, Maryland 21244–1850

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS) as outlined in the June 16 Federal Register [CMS–1668–N]. The ASM is the largest single life science association, with over 52,000 members worldwide. Its members work in environmental, educational, research, industrial, and government settings on issues such as the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbial sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

Many ASM members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives developing laboratory products for use, and researchers involved in development and evaluation of new technologies. Therefore, the ASM has significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries.

Attached are the ASM’s recommendations for payment determinations for new Current Procedural Terminology (CPT) codes to be included in the 2018 Medicare CLFS. We have limited our comments to those tests that affect our constituency, and our recommendations are based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs, which reviewed the codes to be addressed and provided input. Our comments include the following information:

  • New test code(s) and descriptor
  • Test purpose and method
  • Recommendation (cross-walking or gap-fill) and data on which recommendation is based

We greatly appreciate the opportunity to comment.  If additional supporting materials are required, we will provide them on request.


Robert Jerris, PhD, D(ABMM)
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board



New Code Name New Code Descriptor Test Purpose and Method ASM Recommendation
876XX Infectious agent   detection by nucleic acid (DNA or RNA); respiratory syncytial virus amplified probe technique Crosswalk to 87498 (Infectious agent detection by nucleic acid (DNA or RNA); enterovirus, amplified probe technique, includes reverse transcription when performed)
87X6X Infectious agent detection by nucleic acid (DNA or RNA); Zika virus amplified probe technique Crosswalk to 87501 (Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, includes reverse transcription, when performed, and amplified probe technique, each type or subtype)
8600X Allergen specific IgE; quantitative or semi-quantitative, recombinant or purified component, each   Crosswalk to CPT Code 86003 (Allergen specific IgE, quantitative or semi-quantitative, each allergen)
86X7X Zika virus, IgM   Crosswalk to CPT Code 86788 (Antibody; West Nile virus, IgM)
0004U Infectious disease (bacterial), DNA, 27 resistance genes, PCR amplification and probe hybridization in microarray format (molecular detection and identification of AmpC, carbapenemase and ESBL coding genes), bacterial culture colonies, report of genes detected or not detected, per isolate PCR amplification and probe hybridization in microarray format Gapfill or crosswalk to a multiplex assay for economies of scale-87633 (multiplex resp.virus-12-25 targets)
0008U Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rRNA, gyrA, pbp1, rdxA and rpoB, formalin-fixed paraffin embedded or fresh tissue, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin next generation sequencing Gapfill
0010U Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate WGS, phylogenetic analysis Gapfill
02X1T Infectious agent detection by nucleic acid (DNA or RNA), Human Papillomavirus (HPV) for five or more separately reported high-risk HPV types (eg, 16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) (ie, genotyping) NAAT CODE WITHDRAWN BY CMS
G0499 Hepatitis B screening in non-pregnant, high risk individual HBsAg, neutralizing confirmatory test and antibodies to (anti-HBs) and (anti-HBc)

Reflex test set, Crosswalk to:

87340: HBsAg, with positive reflex to:

87341: neutralizing confirmatory test for initially reactive

86706: anti-HBs

86704: anti-HBc