Tuesday, May 7, 2019

Brief Blog: UBIOME - What Did They Actually Do?

With the flurry of press this month about FBI and legal actions against UBIOME, I recalled I got a UBIOME test out of curiousity last November

I hadn't looked closely at the email chains and paperwork until now.

This blog discusses (1) Email chains and (2) Lab methods report.  Link to Zip file at bottom.

(1) Email Chains

I opened a "uBiome Account" on October 15, 2018, and they confirmed to my email that I had.  Also on October 15, I completed a uBiome Request online (it includes questions like your history of milk intolerance, gas, diarrhea, cramps, etc).   uBiome then sent me a collection kit by mail.  (Hint: You tap their swab to your TP.)

I hadn't noticed before, on October 15 they emailed that "your SmartGut Test has been prescribed."   Apparently this is a teledoc or doc-by-wire situation; I didn't even recall knowing that it happened.  The ordering doc, it turns out, was a [name], National City, CA, NPI 1750358768.  National City is on the south side of San Diego.  This provider billed Medicare for a handful of anesthesia sessions and short office visits in CY2016.
Note that this type of order disqualifies for Medicare, since Medicare requires a payable test to be ordered by the patient's treating physician (42 CFR 410.32).  
At least as of CY2016 public CMS data, uBiome (which has an NPI) had no payments from Medicare.  If the ordering physician had been valid, my case and probably a lot of others wouldn't have met Medicare's public rules for medical necessity; in a cloud zip file here.
My uBiome kit was "on its way" to my house on October 16.  It was received back by uBiome on November 5 (hey, I travel alot for work.)  uBiome refers to the collection date as October 27.  This includes a link (I don't recall ever opening this email) to their Billing FAQ for billing insurers.  The 2019 version of that webpage is here (see also Zip at bottom).  An email says:

On November 8, I got an email asking for my feedback:

  • Do you think uBiome is a TRUSTWORTHY company?   
  •    (A) Not really, (B) kind of, or (C) Yes.

I don't recall a paper explanation of benefits from my insurer, but if they had paid $1000 or $2000 to uBiome and I found out about it I would have complained loudly (or blogged or tweeted.)

In fact, by checking online, there were some denied claims from uBiome to my insurer, Blue Shield CA.  It doesn't provide CPT codes but does say that "information was requested from the provider" which apparently never appeared.   BS-CA also classes some of the claims as "duplicates" (a common term in insurance for same provider, same date of service.)  Sterilized (redacted) cloud EOB here.  There are various bills for $135, $1080, $1755, $2835, $2970.  Score: BCBS 1, Lab 0.

My uBiome lab report is dated November 20, which is after the insurance billing events memorialized by BCBS.  They appeared to use my collection date or postmark date of October 27 as the "date of service" although it didn't reach the lab til November 5 nor be signed out til November 20, and in between, November 12 is memorialized by BCBS as the claims submission date for services in October.


The report is in a cloud copy in the zip file at the bottom of this blog.  In addition, I've been told a sample John Doe report is online at uBiome.

Methods and Limitations are on Page 15-16.

In the SmartGut test, microbial DNA is extracted and marker genes are amplified by polymerase chain reaction (PCR) and then sequenced using the Illumina® NextSeq 500 sequencer. The sequence data is processed using a proprietary phylogenetic analysis algorithm. On average, the sensitivity, specificity, precision, and negative predictive value for the microorganisms on our target list are 97.7%, 99.9%, 98.0%, 100.0% for the species, and 97.2%, 99.9%, 99.1%, 99.9% for the genera,  respectively.
This test detects the presence of the following microorganisms: Alistipes, Alloprevotella, Bacteroides, Barnesiella, Bifidobacterium,
Blautia, Butyricimonas, Campylobacter, Catenibacterium, Clostridium, Collinsella, Coprococcus, Dialister, Escherichia/Shigella,
Faecalibacterium, Flavonifractor, Fusobacterium, Gelria, Holdemania, Lactobacillus, Odoribacter, Oscillibacter, Oscillospira,
Parabacteroides, Paraprevotella, Phascolarctobacterium, Prevotella, Roseburia, Ruminococcus, Streptococcus, Tyzzerella, Veillonella,
Akkermansia muciniphila, Anaerotruncus colihominis, Bacillus coagulans, Bacteroides fragilis, Bifidobacterium animalis,
Bifidobacterium bifidum, Butyrivibrio crossotus, Clostridium butyricum, Clostridium difficile, Collinsella aerofaciens, Desulfovibrio
piger, Dialister invisus, Enterococcus italicus, Lactobacillus brevis, Lactobacillus coryniformis, Lactobacillus delbrueckii, Lactobacillus
fermentum, Lactobacillus helveticus, Lactobacillus kefiranofaciens, Lactobacillus kunkeei, Lactobacillus rhamnosus, Lactobacillus
salivarius, Lactococcus lactis, Leuconostoc kimchii, Methanobrevibacter smithii, Oxalobacter formigenes, Pediococcus pentosaceus,
Propionibacterium freudenreichii, Ruminococcus albus, Ruminococcus flavefaciens, Salmonella enterica, Vibrio cholerae, and Weissella
Some of these microorganisms may not be considered pathogenic but are included as they reflect the state of the patient's microbiome. The microbiome and its clinical relevance is an area of active investigation. This sample has passed all laboratory and sample quality metrics.
For more information about the methods underlying uBiome's SmartGut test, please see Almonacid et al., 2017 (http://ubiome.com/gutpaper).  [also in zip file below]

Detection of a microorganism by this test does not imply a diagnosis. Similarly, a lack of detection does not exclude the presence of a disease-causing microorganism or a diagnosis of disease. Please consult your healthcare provider to interpret the results provided in this report. 
The SmartGut test was developed, and its performance characteristics were determined, by uBiome, Inc. For more information about the methods underlying uBiome's SmartGut test, please see Almonacid et al., 2017 (http://ubiome.com/gutpaper).
This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
This test may be used for clinical purposes and should not be regarded as investigational or for research only. uBiome's clinical reference laboratory is accredited by the internationally recognized College of American Pathologists (CAP) and is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
This test is a next-generation sequencing-based assay that can identify 33 species and 32 genera of gastrointestinal microbiomerelated microorganisms from a stool swab sample, including 5 pathogenic organisms. The detection (or lack thereof) of
microorganisms is reported to the medical professional in this report. The report should be considered in context with other clinical criteria (e.g. patient history, physical exam), as well as other studies (such as laboratory, pathology, and imaging) by a qualified
medical professional prior to initiating or changing a patient diagnostic work-up or treatment plan.
Patient management decisions must be based on the independent medical judgment of the treating medical professional. The test and accompanying report are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
The report may include information on the relevance of reported microorganisms. This information is derived from peer-reviewed studies and other publicly available databases and may include associations between the microorganism and a health condition.
Careful consideration must be made by the medical professional when using this information, as it may or may not be relevant to this patient. Organisms not included in this test may also have an effect on the mentioned health conditions. The organisms on this test may affect additional health conditions not mentioned on this report.
SmartGut is a clinical test, successfully validated using samples collected from individuals of mainly adult age, with a subset of minors. When ordered for minors, the results may still provide valuable information about the minor's health; however, the
accuracy of the results will differ from what was validated for the adult age range.
The reference range for each organism was established using 865 samples from self-reported healthy individuals.


Zip file of cited materials here.