[BostonCard]

https://www.sfgate.com/news/editorspicks...042042.php

Stop if you've heard this one before.  uBiome was a high-flying up-and-coming business determined to disrupt the medical testing industry, in this case by claiming that measuring individuals microbiome could predict disease.  Now they have been indicted on multiple federal charges, including conspiracy to commit securities fraud, conspiracy to commit health care fraud and money laundering.

While they are most closely associated with another institution I've trained in (UCSF), one of the founders, Richman is an alum.

http://www.femalefounderstories.com/jess...chman.html

This quote is a bit ominous:

Q: What do you wish someone had told you when you were 15?
It gets better.

Narrator: nope, it gets worse for you

BC

[BostonCard]

https://www.sfgate.com/news/editorspicks...042042.php

Stop if you've heard this one before.  uBiome was a high-flying up-and-coming business determined to disrupt the medical testing industry, in this case by claiming that measuring individuals microbiome could predict disease.  Now they have been indicted on multiple federal charges, including conspiracy to commit securities fraud, conspiracy to commit health care fraud and money laundering.

While they are most closely associated with another institution I've trained in (UCSF), one of the founders, Richman is an alum.

http://www.femalefounderstories.com/jess...chman.html

This quote is a bit ominous:

Q: What do you wish someone had told you when you were 15?
It gets better.

Narrator: nope, it gets worse for you

BC

[martyup]

Interesting to me because a friend gave me the gift of a $125 test kit from Viome, another micro-biome testing company.  Viome tests your poop and gives you a report showing the foods you should eat and foods you should avoid.  The science language in their promotional materials was fairly vague.  I found my results to be pretty consistent with my preferred diet, with just a few exceptions.  They have a mobile app that you can check at the grocery store before buying certain foods. Now I wonder if Viome is also a scam and the advice worthless.

[martyup]

Interesting to me because a friend gave me the gift of a $125 test kit from Viome, another micro-biome testing company.  Viome tests your poop and gives you a report showing the foods you should eat and foods you should avoid.  The science language in their promotional materials was fairly vague.  I found my results to be pretty consistent with my preferred diet, with just a few exceptions.  They have a mobile app that you can check at the grocery store before buying certain foods. Now I wonder if Viome is also a scam and the advice worthless.

[BostonCard]

The promotional material is vague company has to be careful not to make specific health claims lest it run afoul of the FDA.  Thus, they say things like "Enhance energy production for your cells", which is meaningless.

BC

[BostonCard]

The promotional material is vague company has to be careful not to make specific health claims lest it run afoul of the FDA.  Thus, they say things like "Enhance energy production for your cells", which is meaningless.

BC

[Phogge]

Interesting to me because a friend gave me the gift of a $125 test kit from Viome, another micro-biome testing company.  Viome tests your poop and gives you a report showing the foods you should eat and foods you should avoid.  The science language in their promotional materials was fairly vague.  I found my results to be pretty consistent with my preferred diet, with just a few exceptions.  They have a mobile app that you can check at the grocery store before buying certain foods. Now I wonder if Viome is also a scam and the advice worthless.

Wow. Simple for me. If it tastes good then scarf.

[Phogge]

Interesting to me because a friend gave me the gift of a $125 test kit from Viome, another micro-biome testing company.  Viome tests your poop and gives you a report showing the foods you should eat and foods you should avoid.  The science language in their promotional materials was fairly vague.  I found my results to be pretty consistent with my preferred diet, with just a few exceptions.  They have a mobile app that you can check at the grocery store before buying certain foods. Now I wonder if Viome is also a scam and the advice worthless.

Wow. Simple for me. If it tastes good then scarf.

[Softball Fan]

I've read a lot about Theranos.  I felt Elizabeth Holmes started out with honest intentions to make the world a better place.  When she didn't get the hoped-for results she started fudging data; then got drawn deeper and deeper into a dark web. 

At some point she fully turned over to the dark side and became a criminal with no regard for her product's impact on human lives.  A Stanford kid with fantastic potential who took the wrong turn in life.

[Softball Fan]

I've read a lot about Theranos.  I felt Elizabeth Holmes started out with honest intentions to make the world a better place.  When she didn't get the hoped-for results she started fudging data; then got drawn deeper and deeper into a dark web. 

At some point she fully turned over to the dark side and became a criminal with no regard for her product's impact on human lives.  A Stanford kid with fantastic potential who took the wrong turn in life.

[BostonCard]

I've read a lot about Theranos.  I felt Elizabeth Holmes started out with honest intentions to make the world a better place.  When she didn't get the hoped-for results she started fudging data; then got drawn deeper and deeper into a dark web. 

At some point she fully turned over to the dark side and became a criminal with no regard for her product's impact on human lives.  A Stanford kid with fantastic potential who took the wrong turn in life.

Sounds a lot like what happened in uBiome.  I remember these guys because I was at UCSF when the company was getting off the ground, and I don't think they set out to defraud anyone.  It was a legit kickstarter citizen-science program whose goal was really to try to learn about the microbiome.

But I think there is a relentless pressure in the Valley to monetize and scale, but not all ideas need to lead to unicorns with billion-dollar valuations, and these guys failed to recognize it.

Also, the fear of failure runs strong.

None of this justifies fraud.

BC

[BostonCard]

I've read a lot about Theranos.  I felt Elizabeth Holmes started out with honest intentions to make the world a better place.  When she didn't get the hoped-for results she started fudging data; then got drawn deeper and deeper into a dark web. 

At some point she fully turned over to the dark side and became a criminal with no regard for her product's impact on human lives.  A Stanford kid with fantastic potential who took the wrong turn in life.

Sounds a lot like what happened in uBiome.  I remember these guys because I was at UCSF when the company was getting off the ground, and I don't think they set out to defraud anyone.  It was a legit kickstarter citizen-science program whose goal was really to try to learn about the microbiome.

But I think there is a relentless pressure in the Valley to monetize and scale, but not all ideas need to lead to unicorns with billion-dollar valuations, and these guys failed to recognize it.

Also, the fear of failure runs strong.

None of this justifies fraud.

BC

[jonnyss]

agreed, plus i don't get the sense that UBiome did as much wrong (if anything) as theranos. the feds are throwing dozens of small charges against UBiome rather than 1 big one.  the theranos technology didn't work, whereas it seems UBiome has/had a bunch of viable patents. u can indeed sequence dna in poop. u can indeed correlate it to illness. results were consistent and useful. lots of companies are doing these things now. i wonder if UBiome was maybe too early to the space.

perhaps UBiome overstated company growth predictions, but don't hundreds of start-ups do that every year?  they go out of business and are sometimes sued by investors, but it's not usually a crime. federal charges include some pretty subtle issues like waiving patient copays, issuing vouchers to spur patient interest, double billing.

for example, feds state the company charged insurance companies for tests that “were not validated and not medically necessary." to me that's a very strange criminal accusation. it's not usually a crime to ask the insurance company to pay for a novel or elective test (or procedure or medication). in my experience, insurance companies don't automatically pay for innovative tests. some they pay for, some they don't. they perform due diligence and routinely deny payment for tests that they decide are either experimental or not sufficiently validated, or not medically necessary. one prominent example is 23andme. they were told to stop providing medical diagnoses with their tests, so they switched to genealogical results. but the founders weren't arrested for having providing medical diagnoses. and if you now send the bill for your 23andme test to your insurance company, they simply deny it. the feds don't arrest the 23andme founders. another example: if you ask your insurance company to pay for viagra, they may decline to pay as "not medically necessary"; but, again, they don't arrest the executives of the manufacturer.

[jonnyss]

agreed, plus i don't get the sense that UBiome did as much wrong (if anything) as theranos. the feds are throwing dozens of small charges against UBiome rather than 1 big one.  the theranos technology didn't work, whereas it seems UBiome has/had a bunch of viable patents. u can indeed sequence dna in poop. u can indeed correlate it to illness. results were consistent and useful. lots of companies are doing these things now. i wonder if UBiome was maybe too early to the space.

perhaps UBiome overstated company growth predictions, but don't hundreds of start-ups do that every year?  they go out of business and are sometimes sued by investors, but it's not usually a crime. federal charges include some pretty subtle issues like waiving patient copays, issuing vouchers to spur patient interest, double billing.

for example, feds state the company charged insurance companies for tests that “were not validated and not medically necessary." to me that's a very strange criminal accusation. it's not usually a crime to ask the insurance company to pay for a novel or elective test (or procedure or medication). in my experience, insurance companies don't automatically pay for innovative tests. some they pay for, some they don't. they perform due diligence and routinely deny payment for tests that they decide are either experimental or not sufficiently validated, or not medically necessary. one prominent example is 23andme. they were told to stop providing medical diagnoses with their tests, so they switched to genealogical results. but the founders weren't arrested for having providing medical diagnoses. and if you now send the bill for your 23andme test to your insurance company, they simply deny it. the feds don't arrest the 23andme founders. another example: if you ask your insurance company to pay for viagra, they may decline to pay as "not medically necessary"; but, again, they don't arrest the executives of the manufacturer.

[BostonCard]

I think the biggest allegation is the insurance fraud.

The company grew to include “clinical” tests of gut and vaginal microbiomes, which were aimed to be used by medical providers so uBiome could seek up to $3,000 in reimbursements from health insurance companies. The federal indictment states that uBiome sought upwards of $300 million in reimbursement claims from private and public health insurers between 2015 and 2019. The company was ultimately paid more than $35 million for tests that “were not validated and not medically necessary."

It's one thing if people like Marty's friend buy a kit for kicks and giggles and are careful to say that it is not meant to diagnose or treat disease, but once you get doctors to use it and bill insurance companies for it, you better make sure it is well-validated and clinically needed.

BC

[BostonCard]

I think the biggest allegation is the insurance fraud.

The company grew to include “clinical” tests of gut and vaginal microbiomes, which were aimed to be used by medical providers so uBiome could seek up to $3,000 in reimbursements from health insurance companies. The federal indictment states that uBiome sought upwards of $300 million in reimbursement claims from private and public health insurers between 2015 and 2019. The company was ultimately paid more than $35 million for tests that “were not validated and not medically necessary."

It's one thing if people like Marty's friend buy a kit for kicks and giggles and are careful to say that it is not meant to diagnose or treat disease, but once you get doctors to use it and bill insurance companies for it, you better make sure it is well-validated and clinically needed.

BC

[jonnyss]

I think the biggest allegation is the insurance fraud.

The company grew to include “clinical” tests of gut and vaginal microbiomes, which were aimed to be used by medical providers so uBiome could seek up to $3,000 in reimbursements from health insurance companies. The federal indictment states that uBiome sought upwards of $300 million in reimbursement claims from private and public health insurers between 2015 and 2019. The company was ultimately paid more than $35 million for tests that “were not validated and not medically necessary."

It's one thing if people like Marty's friend buy a kit for kicks and giggles and are careful to say that it is not meant to diagnose or treat disease, but once you get doctors to use it and bill insurance companies for it, you better make sure it is well-validated and clinically needed.

BC

not that simple.  they apparently obtained fda approval - a multi-stage process requiring lots of evidence. they are being charged with billing insurance companies 9 times without the patient's consent. so these patients gave their insurance company name and insurance id but didn't sign the line that said please bill my insurance company? pretty ticky tacky.

and they are being charged with urging doctors to order the tests. that's criminal?

in the background is that this is a crowd-funded venture intended (like 23andme) to give patients options to choose tests without depending on doctors. this is politically controversial, but imo certainly not evil.

[jonnyss]

I think the biggest allegation is the insurance fraud.

The company grew to include “clinical” tests of gut and vaginal microbiomes, which were aimed to be used by medical providers so uBiome could seek up to $3,000 in reimbursements from health insurance companies. The federal indictment states that uBiome sought upwards of $300 million in reimbursement claims from private and public health insurers between 2015 and 2019. The company was ultimately paid more than $35 million for tests that “were not validated and not medically necessary."

It's one thing if people like Marty's friend buy a kit for kicks and giggles and are careful to say that it is not meant to diagnose or treat disease, but once you get doctors to use it and bill insurance companies for it, you better make sure it is well-validated and clinically needed.

BC

not that simple.  they apparently obtained fda approval - a multi-stage process requiring lots of evidence. they are being charged with billing insurance companies 9 times without the patient's consent. so these patients gave their insurance company name and insurance id but didn't sign the line that said please bill my insurance company? pretty ticky tacky.

and they are being charged with urging doctors to order the tests. that's criminal?

in the background is that this is a crowd-funded venture intended (like 23andme) to give patients options to choose tests without depending on doctors. this is politically controversial, but imo certainly not evil.

[BostonCard]

There are more details here:

https://endpts.com/founders-of-poop-test...investors/

The SEC brought those concerns to light in its complaint. Regulators claim that in order to generate revenue, Richman and Apte directed uBiome to fool doctors into ordering unnecessary tests and, despite several warnings from employees and their general counsel, ignored the need for the tests to meet certain health insurance company requirements.

    Defendants ignored these warnings and adopted and approved several improper billing practices that they knew, or were reckless in not knowing, fell below insurer requirements and thus, once discovered, would prompt insurers to reject reimbursement claims for uBiome’s clinical tests. Defendants engaged in deceptive acts to conceal facts pertinent to uBiome’s practices from the company’s general counsel, the uBiome board, prescribing doctors, and insurers.

BC

[BostonCard]

There are more details here:

https://endpts.com/founders-of-poop-test...investors/

The SEC brought those concerns to light in its complaint. Regulators claim that in order to generate revenue, Richman and Apte directed uBiome to fool doctors into ordering unnecessary tests and, despite several warnings from employees and their general counsel, ignored the need for the tests to meet certain health insurance company requirements.

    Defendants ignored these warnings and adopted and approved several improper billing practices that they knew, or were reckless in not knowing, fell below insurer requirements and thus, once discovered, would prompt insurers to reject reimbursement claims for uBiome’s clinical tests. Defendants engaged in deceptive acts to conceal facts pertinent to uBiome’s practices from the company’s general counsel, the uBiome board, prescribing doctors, and insurers.

BC

[M T]

Something doesn't seem right there.  In our society, I thought it was the MDs, along with approval of FDA, that decide on treatment.  Insurance companies may set whatever policies for reimbursement, but "... ignored the need for the tests to meet certain health insurance company requirements" does not seem to be something wrong per se.  

If they misled the doctors or the FDA regarding, for instance, what the tests measure and how well they do that measurement, that's a different thing.

[M T]

Something doesn't seem right there.  In our society, I thought it was the MDs, along with approval of FDA, that decide on treatment.  Insurance companies may set whatever policies for reimbursement, but "... ignored the need for the tests to meet certain health insurance company requirements" does not seem to be something wrong per se.  

If they misled the doctors or the FDA regarding, for instance, what the tests measure and how well they do that measurement, that's a different thing.

[jonnyss]

yes!  

my internist likes to be extra careful and order a blood test called ca 19-9. (fortunately it's normal). my insurer doesn't pay for it, so i have to pay $!67; and i'm fine with that.  this is standard practice, not criminal. i could give dozens of similar examples.

[jonnyss]

yes!  

my internist likes to be extra careful and order a blood test called ca 19-9. (fortunately it's normal). my insurer doesn't pay for it, so i have to pay $!67; and i'm fine with that.  this is standard practice, not criminal. i could give dozens of similar examples.