Thursday, August 30, 2018

MolDx Retires Special Coding, Pricing for Biofire FilmArray GI Panel

As of August 2018, MolDx was still running a "provider alert" that in March 2018, it was retiring its article on the Biofire FilmArray GI panel.


I'm guessing the article was similar to a MolDx article on Biofire GI coding and billing that was still available in August on the CGS MAC website.  Note the publication date is the beginning of 20016 (January 9, 2006). 

I've clipped a cut/paste of the article below and put a web version of the article in the cloud here.

According to the Biofire website, at least as of 2017 coding, the GI test panel would be coding as 87507 and CMS priced at $571.72.   The PAMA target price for this panel is $300, so it is falling 10% a year toward $300 (2018 price at $463).

Biofire GI Coding for 2017 (released 082016)

It looks to me like Medicare paid $12.7M for 87507 in CY2016, per public CMS data at the lab (or doctor) level, for about 28,000 tests.   Test volume was highly unevenly distributed, with "RK" in Memphis being credited with 5,845 tests and  Diatherix in Alabama with 8,954.  These two providers were near half of total volume (of 109 billing entities.)   See the full 2016 data in the CMS cloud here.

Virtually all providers providers billed CMS greater than the CMS fee schedule of about $567.   However, Diatherix, just mentioned, billed $299.  Puzzlingly, Labcorp billed $781 but was paid $267.   Diagnostic Reference Group and Piedmont Pathology also charged well above Medicare's rate but were paid $230-260 per test.   (These billing records have stumped the expert).  Labcorp and Piedmont are in NC, a MolDx state.    Only these two labs and one other (in GA) were substantially underpaid, both below the fee schedule AND below charge.

It's hard to know what MolDx paid for the Biofire test because it had the test recoded as 87999, as shown below.  HOWEVER, it appears that MolDx was paying for 87507 in some MolDx states (e.g. see for Genesis Molecular in Torrance, CA, 2,347 cases) without voiding 87507 or requiring recoding as 87999.   (Note, though, that the article is specific for Biofire trademark product but the AMA CPT code 87507 is not, and the code service could be replicated with LDT probes without triggering the instructions of the Biofire article). 


Cut Paste of CGS Biofire Article (2016 article, captured 20180830).

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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