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January 9, 2016

MolDX: BioFire Gastrointestinal (GI) Panel Coding and Billing Guidelines (CM00099)

The BioFire FilmArray GI Panel is a 510(k)-cleared in vitro diagnostic (IVD) test capable of simultaneous detection and identification of nucleic acids from multiple bacteria (n=13), viruses (n=5), parasites (n=4), directly from stool samples collected in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal (GI) infection. The FilmArray GI Panel is indicated as an aid in the diagnosis of specific agents of GI illness, and is used in conjunction with other clinical and laboratory data.

The FilmArray reagent pouch stores all the necessary reagents for sample preparation, reverse transcription, PCR and detection for 22 targets in a freeze-dried format. Hydration solution is added and combined with sample buffer in the FilmArray Pouch requiring 2 minutes of hands-on time, and approximately 1 hour for specimen analysis on a desk-top FilmArray instrument.

Laboratory testing for infectious causes of diarrhea are generally not indicated when the diarrhea is community acquired and of less than 7 days duration, and without signs or risk factors for severe disease such as fever, bloody diarrhea, dysentery, dehydration, severe abdominal pain, hospitalization and/or immunocompromised state. Laboratory testing for an infectious etiology of diarrhea may be indicated in community-acquired diarrhea of ≥ 7 days duration or travel-related diarrhea or diarrhea with signs or risk factors for severe disease.1

Although MolDx recently published an article addressing panel testing with a large number of targets as "screening and not a Medicare benefit", the FilmArray GI panel is a closed system that does not allow random access for selection of specific targets that are appropriate for an individual based on signs and symptoms. As such, the BioFire FilmArray GI Panel is a covered Medicare benefit. As with any test, providers must document that utilization is reasonable and medically necessary.

Each laboratory billing Medicare must register the FilmArray GI Panel with the McKesson Diagnostics ExchangeExternal Website to obtain a DEX Z-Code™ identifier. Until February 1, 2017, claims may enter 'BioFire GI' in the claim line comment/narrative field. Effective February 1, 2017 claims submitted without the DEX Z-Code™ identifier will reject.

To bill Part B for the FilmArray GI Panel services, please provide the following claim information:

  • Effective immediately: CPT code 87999 – Unlisted microbiology procedure
  • Enter the assigned DEX Z-Code™ identifier or 'BioFire GI' in the comment/narrative field for the following claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P electronic claim
    • Submit assigned DEX Z-Code™ identifier on an attachment to the claim form for paper claim
  • Select the appropriate ICD-10-CM diagnosis

To bill Part A for the FilmArray GI Panel services, please provide the following claim information:

  • Effective immediately: CPT code 87999 – Unlisted microbiology procedure
  • Enter either the assigned DEX Z-Code™ identifier or enter 'BioFire GI' in the narrative field for the following claim field/types:
    • Block 80 for the UB04 claim form
    • Line SV202-7 for the 837I electronic claim
  • Select the appropriate ICD-10-CM diagnosis

1. Riddle MS, DuPont, HL, Connor BA. ACG Clinical Guideline: Diagnosis, treatment, and Prevention of acute diarrheal infections in adults. Am J Gastroenterol 2016;111:602-22.

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