"Florida Cancer Specialists" Admits to Antitrust Crime and Agrees to Pay $100 Million Criminal Penalty

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SneakyBooger

SneakyBooger

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News from sunny South Florida:

“The FBI has no tolerance for medical providers who stand to profit by criminally exploiting cancer patients”

www.justice.gov

Leading Cancer Treatment Center Admits to Antitrust Crime and Agrees to Pay $100 Million Criminal Penalty

Florida Cancer Specialists & Research Institute LLC (FCS), an oncology group headquartered in Fort Myers, Florida, was charged with conspiring to allocate medical and radiation oncology treatments for cancer patients in Southwest Florida, the Department of Justice announced. This charge is the...
www.justice.gov www.justice.gov
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SneakyBooger said:
News from sunny South Florida:

“The FBI has no tolerance for medical providers who stand to profit by criminally exploiting cancer patients”

www.justice.gov

Leading Cancer Treatment Center Admits to Antitrust Crime and Agrees to Pay $100 Million Criminal Penalty

Florida Cancer Specialists & Research Institute LLC (FCS), an oncology group headquartered in Fort Myers, Florida, was charged with conspiring to allocate medical and radiation oncology treatments for cancer patients in Southwest Florida, the Department of Justice announced. This charge is the...
www.justice.gov www.justice.gov
Click to expand...
Discussed in the 21C thread, they were the co-conspirator

forums.studentdoctor.net

21 century corruption

21 century at it again- wall street journal article - please post it. Wall Street Journal (subscription)-Sep 26, 2017 ... through a sweetheart deal with one of the largest public health-care systems in the U.S., North Broward Hospital District, or Broward Health. Anyway here are the salient...
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PhotonBomb said:
They should probably fine all Florida practitioners just to be sure. horrid state, medically speaking.
Click to expand...
Yeah, definitely the only place this stuff happens. Nailed it as usual, PB


forums.studentdoctor.net

CCS Oncology - Imminent closure, bankruptcy, FBI investigation

Cancer Treatment in Buffalo & Western New York | CCS Oncology This is a large multi-specialty, multi-site Oncology group located in the metro Buffalo NY area. This story is blowing up in Buffalo and nationally in Oncology circles. (CCS Oncology - Bing News) Initially they declared Chapter 11...
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www.justice.gov

Baylor University Medical Center to Pay More Than $900,000 for False Medicare Claims for Radiation Oncology Services

Baylor University Medical Center, Baylor Health Care System and HealthTexas Provider Network have agreed to pay the United States $907,355 to settle allegations that Baylor submitted false claims to Medicare, the Civilian Health and Medical Program of the Uniformed Services and the Federal...
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www.justice.gov

Two California Urologists Agree to Pay More than $1 Million to Settle False Claims Act Allegations Related to Radiation Therapy Referrals

Drs. Aytac Apaydin and Stephen Worsham, urologists based in Northern California, will pay $1.085 million to resolve allegations that they submitted and caused the submission of false claims to Medicare for image guided radiation therapy (IGRT) that was referred and billed in violation of the...
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topclassactions.com

Radiation Center Pays $3M in Medicare Billing Fraud Settlement

In a new Medicare billing fraud settlement, a radiation center has agreed to pay $3 million to settle claims that it submitted false claims to Medicare.
topclassactions.com topclassactions.com
 
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PhotonBomb said:
They should probably fine all Florida practitioners just to be sure. horrid state, medically speaking.
Click to expand...

“There are things that have to be done and you do them and you never talk about them. You don't try to justify them. They can't be justified. You just do them. Then you forget it.” Mario Puzo
 
medgator said:
Discussed in the 21C thread, they were the co-conspirator

forums.studentdoctor.net

21 century corruption

21 century at it again- wall street journal article - please post it. Wall Street Journal (subscription)-Sep 26, 2017 ... through a sweetheart deal with one of the largest public health-care systems in the U.S., North Broward Hospital District, or Broward Health. Anyway here are the salient...
forums.studentdoctor.net forums.studentdoctor.net
Click to expand...
I will be interested who co conspirator Company D is, a “large hospital system.”

As mentioned in that other thread you mentioned, the FCS “scheme” of referral coordination is also known as “Tuesday” in large medical (academic and non academic) systems. There they can shellac a veneer of properness on the process because it’s all “internal.” Try to do this external and you’re on the hook for a hundred rocks, as Tony Soprano might say.
 
SneakyBooger said:
$1B made, $100M fine = 10% "tax"
Click to expand...
FCS ain't worried 'bout a thang.
Look how much fun they're having!
They just opened a big new treatment and drug development center in Lake Mary; 30+ treatment chairs and good trial money flowing in. Med oncs can make a lot of money doing "trials" these days. I did a H&N study with a med onc last year and got $1500 for doing an IMRT plan... my only experience with industry-sponsored trials thus far but I would love to do more heh.
I am sure the $100 million was financeable (ie they took a note to pay the penalty) over 10+ years at a very low interest rate too.
 
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scarbrtj said:
FCS ain't worried 'bout a thang.
Look how much fun they're having!
They just opened a big new treatment and drug development center in Lake Mary; 30+ treatment chairs and good trial money flowing in. Med oncs can make a lot of money doing "trials" these days. I did a H&N study with a med onc last year and got $1500 for doing an IMRT plan... my only experience with industry-sponsored trials thus far but I would love to do more heh.
I am sure the $100 million was financeable (ie they took a note to pay the penalty) over 10+ years at a very low interest rate too.
Click to expand...
Per my reading, it is the largest settlement ever, and it was done as a criminal, rather than civil, case. Sounds like they would have sent some of these folks to the slammer for what they did if they hadn't entered a deferred prosecution agreement with them which they sought with them to avoid affecting patient care.

DOJ/oig was pissed, and i can kinda see where they were coming from.... essentially it would be like a city with two large hospital systems agreeing to split up who provides services

www.jdsupra.com

DOJ’s First Antitrust Criminal Prosecution of a Health Care Provider in 25 Years May Signal a New Era for Health Care Antitrust | JD Supra

Antitrust enforcement against physicians and hospitals is common, but criminal antitrust prosecutions of health care providers are very rare. There...
www.jdsupra.com www.jdsupra.com

www.jdsupra.com

Florida Cancer Center Admits to Violating U.S. Antitrust Laws, Agrees to Pay More Than $120 Million in Penalties | JD Supra

In the first case of its kind, the Antitrust Division of the U.S. Department of Justice (“DOJ”) announced that it had entered into a deferred...
www.jdsupra.com www.jdsupra.com
 
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scarbrtj said:
I did a H&N study with a med onc last year and got $1500 for doing an IMRT plan... my only experience with industry-sponsored trial but I would love to do more heh.
Click to expand...

Some of these things, oh my. Our H&N person was getting $20K per patient for a H&N trial (Phase 3). I just opened a phase 1 trial for a GI site and will get $13K per patient to cover nursing costs, DSM, data management, etc. all in with correlatives it’s right at $20 K per patient plus drug. The university will get its 26% F&A on top of that. The funny thing is, this is the reduced rate that I had to fight for. They gave me all the reasons the “real” costs would be more (Narrator voice: they aren’t) and I had to push to bring it down to a number the company could agree to. There is so much money in these. And so much potential for fraud (intentional or not) when people end up trying to bill for extra assessments etc that are not SOC. it’s kind of scary because someone in admin could do something shady and at the end of the day it will be me they come after. Scary, but a first world problem to be sure.
 
ramsesthenice said:
Some of these things, oh my. Our H&N person was getting $20K per patient for a H&N trial (Phase 3). I just opened a phase 1 trial for a GI site and will get $13K per patient to cover nursing costs, DSM, data management, etc. all in with correlatives it’s right at $20 K per patient plus drug. The university will get its 26% F&A on top of that. The funny thing is, this is the reduced rate that I had to fight for. They gave me all the reasons the “real” costs would be more (Narrator voice: they aren’t) and I had to push to bring it down to a number the company could agree to. There is so much money in these. And so much potential for fraud (intentional or not) when people end up trying to bill for extra assessments etc that are not SOC. it’s kind of scary because someone in admin could do something shady and at the end of the day it will be me they come after. Scary, but a first world problem to be sure.
Click to expand...
FCS said it was on “firm footing financially” to pay the 100 mil; stuff like this is how. And it just opened a new treatment and drug development center.
 
scarbrtj said:
FCS said it was on “firm footing financially” to pay the 100 mil; stuff like this is how. And it just opened a new treatment and drug development center.
Click to expand...

Yes they have plenty of $. The US Government gave them the money to pay the fine. It's all good.

www.tampabay.com

Florida oncology network that bilked cancer patients gets $67 million in COVID-19 aid

Florida Cancer Specialists said that coronavirus relief dollars from taxpayers will not be used to pay back their fines.
www.tampabay.com www.tampabay.com
 
www.justice.gov

Former Cancer Center President Indicted For Participation In Long-Running Antitrust Conspiracy

A federal grand jury returned an indictment against Dr. William Harwin, founder and former President of Florida Cancer Specialists & Research Institute LLC (FCS), for conspiring to allocate medical and radiation oncology treatments for patients in Southwest Florida, the Department of Justice...
www.justice.gov www.justice.gov

www.natlawreview.com

The Other Shoe Drops: Ringleader of Oncology Treatment Market Allocation Scheme Indicted in Florida District Court

Earlier this year, Mintz covered the U.S. Department of Justice’s announcement of a deferred prosecution agreement resolving criminal charges against Florida Cancer Specialists & Research Institute LLC (“FCS”) in a 17-year market allocation scheme. As part of that deferred prosecution agreement...
www.natlawreview.com www.natlawreview.com
 
medgator said:
www.justice.gov

Former Cancer Center President Indicted For Participation In Long-Running Antitrust Conspiracy

A federal grand jury returned an indictment against Dr. William Harwin, founder and former President of Florida Cancer Specialists & Research Institute LLC (FCS), for conspiring to allocate medical and radiation oncology treatments for patients in Southwest Florida, the Department of Justice...
www.justice.gov www.justice.gov

www.natlawreview.com

The Other Shoe Drops: Ringleader of Oncology Treatment Market Allocation Scheme Indicted in Florida District Court

Earlier this year, Mintz covered the U.S. Department of Justice’s announcement of a deferred prosecution agreement resolving criminal charges against Florida Cancer Specialists & Research Institute LLC (“FCS”) in a 17-year market allocation scheme. As part of that deferred prosecution agreement...
www.natlawreview.com www.natlawreview.com
Click to expand...
The indictment alleges that Dr. Harwin had an agreement in place with an unidentified “Individual 1” at “Company A” whereby FCS would agree to not provide radiation oncology treatments to patients in Southwest Florida, and in return, Company A would agree to not provide medical oncology treatments to patients in the same region.

I think we know Individual 1 and Company A don't we?

Mario Puzo would be proud-

  • After learning that Oncology Company A was administering the drug Provenge to cancer patients (a form of medical oncology), Dr. Harwin informed Individual 1, “we expect you will end this”;
  • After Oncology Company A’s acquisition of an oncology group that employed oncologists, Dr. Harwin instructed Individual 1 to “Make then[sic] disappear.”; and
  • Specifically noting in correspondence that “I told [Individual 1] that there is no way I will be ok with [Oncology Company A] hiring med oncs, ours or others. Period.”
 
scarbrtj said:
FCS ain't worried 'bout a thang.
Look how much fun they're having!
They just opened a big new treatment and drug development center in Lake Mary; 30+ treatment chairs and good trial money flowing in. Med oncs can make a lot of money doing "trials" these days. I did a H&N study with a med onc last year and got $1500 for doing an IMRT plan... my only experience with industry-sponsored trials thus far but I would love to do more heh.
I am sure the $100 million was financeable (ie they took a note to pay the penalty) over 10+ years at a very low interest rate too.
Click to expand...

Can you tell us more about how med oncs get paid for running clinical trials? I thought any grant that was written would go to the cost of the trial... not to the pockets of the med onc?
 
sallyhasanidea said:
Can you tell us more about how med oncs get paid for running clinical trials? I thought any grant that was written would go to the cost of the trial... not to the pockets of the med onc?
Click to expand...

There is a lot of squishiness to these things. When you get money for a trial you agree on trial costs with the sponsor. But it’s based on what is considered fair market value. You could propose that the trial could require a full FTE of research nursing and 15% of your time and request that they cover the cost of both. If they agree to the terms you keep the money regardless of how much time/support the trial actually requires. You are right, no one is supposed to directly profit from these trials but if they are covering your salary and you don’t have to pay yourself that Monopoly money can quickly become cold hard cash.

Academic chairman love industry trials because unlike NIH/NCI/DOD, there is no salary cap. 15% support really is 15% support.
 
sallyhasanidea said:
Can you tell us more about how med oncs get paid for running clinical trials? I thought any grant that was written would go to the cost of the trial... not to the pockets of the med onc?
Click to expand...

This is all second hand so don't hold me to this but have heard the same basic story from several reliable people. Was told it is very difficult and costly to set up clinical trials in the community so very high barrier to entry. But if done right, a med onc can personally net 7 figures a year on trial patients.
 
Reaganite said:
This is all second hand so don't hold me to this but have heard the same basic story from several reliable people. Was told it is very difficult and costly to set up clinical trials in the community so very high barrier to entry. But if done right, a med onc can personally net 7 figures a year on trial patients.
Click to expand...
Have heard the same.... Requires a research nurse/staffing etc, but it's a volume business, and you get paid per enrollee for covering costs. Once that's done, it's gravy (not that different than running a linac).
 
medgator said:
Have heard the same.... Requires a research nurse/staffing etc, but it's a volume business, and you get paid per enrollee for covering costs. Once that's done, it's gravy (not that different than running a linac).
Click to expand...

Bingo. The biggest difference between these and government trials is they done generally do any kind of due diligence. As long as the figure for the specific trial is reasonable that’s all there is to it. if you are running 12 trials you may have a total of 300% salary support and 5 FTEs for nursing (even though you only have 2). Unlike NIH/DOD, they don’t generally ask you to disclose your total support. high enrollers get approvals faster and that’s the bottom line.

@sally: for academics you are not wrong. I don’t get the gravy from my trials. The money is dispersed to my department, not me. It gets me some perks (like money towards lab space/regulatory support I don’t have to spend from my NIH support or new toys for the Brachy program via departmental funding) but they are all indirect and I personally won’t see most of it.
 
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sallyhasanidea said:
Can you tell us more about how med oncs get paid for running clinical trials? I thought any grant that was written would go to the cost of the trial... not to the pockets of the med onc?
Click to expand...
A “grant” to me conjures up some non profit or govt funded thing. What we are talking about is pharma funding studies and for the MDs who enter or treat patients on the studies, the MDs get paid by the third party independent research coordinators (who are funded by pharma to run the studies) for their time and effort and record keeping duties. Maybe bad analogy but just like when MD gets paid to be an expert at trial. These studies can be time consuming and for sure require extra MD (or practice FTEs) work/effort. Rad oncs, by virtue of never really being major potential receivers of such (pharm) industry largesse, will always remain more or less unburdened by such remunerative worries.
 
scarbrtj said:
Rad oncs, by virtue of never really being major potential receivers of such (pharm) industry largesse, will always remain more or less unburdened by such remunerative worries.
Click to expand...

Not the the extent of medical oncologists but never is an overstatement. I have a little over 1M in industry support for a 3 year IST as the PI and another 350 in support for a separate trial as a co-investigator. And I don't have the most in my modest-sized group. I don't want to out people by name (since industry funding can be considered touchy) but there are a few prominent rad oncs that have had near or above R01 equivalent support running pharma trials for extended periods of time. Not going second hand here. I am basing this from CVs reviewed at study sections. There is more than people recognize. The trick is breaking through the glass. It took me almost 2 years to get my first big one through because there are NO rad oncs at any of these companies. It takes time and effort to help them understand what you are trying to do and how it is different from the pure medical oncology trials. But it can be done.
 
scarbrtj said:
A “grant” to me conjures up some non profit or govt funded thing.
Click to expand...

I believe the poster is a resident. In academics these things are treated like grants when it comes to promotion and tenure. But as you and I both alluded to, they are quite different. All of the oversight for these trials comes from the FDA once the trials are registered. There is much less justification for costs and allocation than there is with the government agencies.
 
scarbrtj said:
A “grant” to me conjures up some non profit or govt funded thing. What we are talking about is pharma funding studies and for the MDs who enter or treat patients on the studies, the MDs get paid by the third party independent research coordinators (who are funded by pharma to run the studies) for their time and effort and record keeping duties. Maybe bad analogy but just like when MD gets paid to be an expert at trial. These studies can be time consuming and for sure require extra MD (or practice FTEs) work/effort. Rad oncs, by virtue of never really being major potential receivers of such (pharm) industry largesse, will always remain more or less unburdened by such remunerative worries.
Click to expand...

Our multispecialty practice splits study revenue between all partners in the practice, so we radoncs do see some of it.
 
Reaganite said:
This is all second hand so don't hold me to this but have heard the same basic story from several reliable people. Was told it is very difficult and costly to set up clinical trials in the community so very high barrier to entry. But if done right, a med onc can personally net 7 figures a year on trial patients.
Click to expand...

How can someone get involved in these in the community, what would be something we could do during residency to set ourselves up to be involved as an attending? For both med oncs and rad oncs. Is it CV based, previous involvement in clinical trials? Or is it entirely based on patient volume at your private practice?


ramsesthenice said:
Not the the extent of medical oncologists but never is an overstatement. I have a little over 1M in industry support for a 3 year IST as the PI and another 350 in support for a separate trial as a co-investigator. And I don't have the most in my modest-sized group. I don't want to out people by name (since industry funding can be considered touchy) but there are a few prominent rad oncs that have had near or above R01 equivalent support running pharma trials for extended periods of time. Not going second hand here. I am basing this from CVs reviewed at study sections. There is more than people recognize. The trick is breaking through the glass. It took me almost 2 years to get my first big one through because there are NO rad oncs at any of these companies. It takes time and effort to help them understand what you are trying to do and how it is different from the pure medical oncology trials. But it can be done.
Click to expand...

Any tips on breaking through the glass?
 
sallyhasanidea said:
How can someone get involved in these in the community, what would be something we could do during residency to set ourselves up to be involved as an attending? For both med oncs and rad oncs. Is it CV based, previous involvement in clinical trials? Or is it entirely based on patient volume at your private practice?

Any tips on breaking through the glass?
Click to expand...

Work with people who are already doing the type of work you think you want to do. No reason to think about all the nuances so early on in your career though.
 
sallyhasanidea said:
How can someone get involved in these in the community, what would be something we could do during residency to set ourselves up to be involved as an attending? For both med oncs and rad oncs. Is it CV based, previous involvement in clinical trials? Or is it entirely based on patient volume at your private practice?




Any tips on breaking through the glass?
Click to expand...

By far the most important thing is to know someone who knows someone on the inside. One of the hardest things to do is get through the normal channels to make sure the decision makers actually hear your idea. As a rad onc, you don’t want to rely on a medical science liaison to convey the novelty/relevance of your trial to more non-rad oncs. As a junior faculty member you also really need to align yourself with a senior investigator who has completed comparable trials in the past (ie, if it’s a phase 1 trial, other phase 1 trials).
 
scarbrtj said:
A “grant” to me conjures up some non profit or govt funded thing. What we are talking about is pharma funding studies and for the MDs who enter or treat patients on the studies, the MDs get paid by the third party independent research coordinators (who are funded by pharma to run the studies) for their time and effort and record keeping duties. Maybe bad analogy but just like when MD gets paid to be an expert at trial. These studies can be time consuming and for sure require extra MD (or practice FTEs) work/effort. Rad oncs, by virtue of never really being major potential receivers of such (pharm) industry largesse, will always remain more or less unburdened by such remunerative worries.
Click to expand...

Do you know if collaboration with industry trials is prevalent in other specialties as a revenue stream, or is this unique to oncology due to the high volume of cancer trials?
 
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