False Claims, Off-Label Prescribing & Doctors
22 CommentsBy Ed Silverman // December 21st, 2011 // 11:33 am
Over the past fiscal year, the US Justice Department recovered nearly $2.2 billion under the False Claims Act against the pharmaceutical industry for fraud against federal healthcare programs, notably Medicaid and Medicare. In doing so, the feds say drugmakers relied on various forms of illegal promotion or pricing to bolster prescriptions and profits (back story).
To establish marketing fraud, the feds typically examine a sequence of events that involves a drugmaker inducing a doctor to prescribe a drug on an off-label basis. Doctors are free to do so, of course, but drugmakers are not supposed to promote their meds for used not approved by the FDA. Meanwhile, a prescription will later get filled by a pharmacy, ultimately, resulting in a false claim.
Rarely, though, do the feds ever consider pursuing a False Claims Act against physicians. The line of reasoning is simply that individual doctors - or pharmacists, for that matter - are generally not worth the effort in terms of needed resources and potential returns. But one attorney has been waging a court battle in hopes of reducing off-label prescriptions of antipsychotics to children who are on Medicaid.
The issue has been contentious for several years, especially before several drugmakers won FDA approval to market their antipsychotics to increasingly younger children. There is still controversy. A recent US Government Accountability Office report found that foster children - including some as young as one year old - are inappropriately prescribed psychotropics (see here).
And so Jim Gottstein, an attorney who heads an organization called PsychRights, the Law Project of Psychiatric Rights, is pressing a whistleblower lawsuit filed against numerous physicians, clinics and pharmacies that are accused of perpetrating false claims against government healthcare programs (here is the lawsuit). So far, though, he has had little luck; the case was recently dismissed and he is seeking a rehearing (see here).
In his view, the feds should be enforcing Medicaid coverage restrictions of outpatient drugs to those that are for a medically accepted indication, which he believes would greatly reduce off-label prescribing. A medically accepted indication refers to either a drug approved by the FDA or listed in one of three recognized compendia.
However, Gottstein claims the US Center for Medicare & Medicaid Services is not interpreting this in a way that would prevent state programs from reimbursing for off-label prescribing. He cites an exchange of letters four years ago between an assistant attorney general in Utah and CMS officials discussing clarification of covered outpatient drugs and medically accepted indications. The Utah officials maintained covered outpatient drugs do not include those without medically accepted indications. Utah had begun filing lawsuits against drugmakers over false claims at the time (look here).
The CMS officials wrote back that the Social Security Act “does not provide definitive policy on the coverage of Medicaid drugs for the uses you describe in your letter, nor have we addressed this issue in implementing Federal regulations.” We asked CMS if Medicaid coverage of outpatient drugs are prohibited for any use that is not a medically accepted indication, but never received a reply.
In pressing his case, Gottstein believes the feds should be using the law in a way that would make it possible to crack down on inappropriate prescribing by doctors, which he believes would make it harder still for drugmakers to successfully induce physicians to write off-label prescriptions.
“The most straightforward approach to solving the problem of the inappropriate off-label administration of psychotropic drugs to children and youth in foster care is to enforce Medicaid’s outpatient drug restriction to medically accepted indications,” says Gottstein who, by the way, was one of three people named as conspirators in the infamous Zyprexa document scandal four years ago (see this).
Of course, taking this approach would require the feds to commit resources that may not yield significant returns; consider the possible settlements compared with those paid by drugmakers. And while a message may be convincingly sent to the medical community, pursuing individual physicians would raise a host of thorny legal arguments, because doctors do have the write to prescribe off-label. But what do you think? Is this a line of pursuit worth considering?
Should the Feds Pursue Individual Docs and Pharmacies for False Claims?
- Yes (69%, 115 Votes)
- No (32%, 53 Votes)
Total Voters: 167
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Betsy
This is a very complicated situation, considering the fact that Medicaid is involved.
Surely pharmas can’t sell their wares to doctors for off label reasons in general, but there are actually doctors out there who have misunderstood this and refuse to prescribe an off label med at all. I had that problem with a jack ass in my area (a PCP) who refused to prescribe a neurological med (I have a neurological condition) because she said only neurologists could prescribe it. SO WHAT ON EARTH CAN SHE PRESCRIBE AS A PCP?
Help!
Ann
Good for Jim Gottstein, who did the right thing and got the Zyprexa Papers into the hands of Alex Berenson and the front pages of the New York Times…then, of course, had to deal with incredible harrassment from Eli Lilly for his pains.
If this line of reasoning gains traction, surely this will cut down on the very thing revealed in the aforesaid papers - pharmas like Lilly “making up” fake mental health diagnoses in order to push the sales of its lethal drug onto people with no diagnosis at all.
Here’s hoping for success in this quarter.
company insider
I thought physicians were suppose to have support to use a drug off-label. ANd that it was not really legal to use a drug off-label for any indication they want if they have no support. Does anyone know if this is true or not? I ceertainly do not see state boards using this to stop physicians from prescribing anything to anyone they please.
Jim Gottstein
Thanks Ann.
To Company Insider,
The problem physicians are prescribing drugs off-label based on drug company blandishments, rather than on whether there is scientific support for the off-label prescription.
The legal analysis is that while a doctor is allowed to prescribe off-label for anything, if the prescription is to a Medicaid recipient and is not for a “medically accepted indication,” it is Medicaid Fraud. The government, however, is not enforcing the rule even though it has gotten Billions of dollars from the drug companies for inducing the doctors to make such prescriptions.
This doesn’t work because the doctors keep on prescribing, and the drug companies not only continue to reap in big profits, but they also cap their liability for causing the fraud.
You might want to look at PsychRights’ Briefing Paper on this at http://psychrights.org/Kids/111212BriefingPaperWithoutAttachments.pdf
James
This article (target: pharma companies) represents a sample of the off label prescribing, but what about in areas, like Oncology, for example where the off lable uses account for as much as 60% of drug uses (many generic and no $$ ties)….and are saving lives and improving the Quality of Life (also think pain meds), yet are rarely promoted by the pharma companies - usually it’s from journal published research or abstracts from scientific sessions…in other words, many Medicaid patients would suffer, die prematurely or both in your world. This seems to be more of a “class warfare” hit piece against pharma.
Justice in MI
I am also a supporter of Jim G. However, I do not understand this sentence:
“The legal analysis is that while a doctor is allowed to prescribe off-label for anything, if the prescription is to a Medicaid recipient and is not for a “medically accepted indication,” it is Medicaid Fraud.”
Doesn’t the second part contradict the first? Is it intended to be an exception to the first?
On the face of it, the fact that the pt. is a Medicaid recipient seems to me to be a thin reed upon which to base litigation and certainly policy.
I believe we either have to think through off-label prescribing in a complex way, or not do so.. This is not endorsing a ban on off-label prescribing, which I would oppose. It’s rather a question of whether a policy can be generated about it which is not, essentially, arbitrary.
Jim Gottstein
Dear Justice in MI,
The difference is in what a doctor may legally prescribe, and what is covered (payable) under Medicaid.
In the Medicaid statute, Congress limited coverage for off-label prescriptions to indications that have “support” in one of the compendia. This makes total sense. As the Department of Justice said in a recent court brief, “It . . . would undermine the gatekeeping role of the federal government in protecting public health as well as the public fisc in ensuring that, based on the information available at the time, only indications that have been FDA-approved or are sufficiently supported by scientific literature as safe and effective are reimbursed.” Page 8 of http://psychrights.org/States/Alaska/Matsutani/9thCir10-35887/37-2-110305USPolanskyStatementOfInterest.pdf
When a doctor prescribes a drug that is not for a medically accepted indication, (s)he “causes” a false claim to be made to the government and is subject to liability for that under the False Claims Act.
PsychRights has a web page that walks through the analysis at http://psychrights.org/Education/ModelQuiTam/ModelQuiTam.htm
JG Pharm.D.
The issue of fraud is due to who is paying for the Rx and Medicaid regulations.
Prescribers may prescribe for off label uses but risk malpractice if there is not adequate/reasonable basis for prescribing off label and there is a negative outcome.
Sue Hanson
The worst part of this is the targeting of children with these completely unnecessary and ineffective drugs. I’d like to see the same action taken for all cases where children have been prescribed psychiatric drugs for any “reason”. Now I see that Walmart is dishing them out to kids like candy from their new in-store psyche clinics! This is just pure evil and will result in more suicides and violence in children ref: Drugs For Tots
http://www.psychiatric-times.com
Smarter Than You Think
While we’re on the issue of Medicaid fraud, the government enforcement agencies might want to take a closer look at the recipients of Medicaid who manage to drive up to the drs. offices in shiny new BMWs, Benzs, Range Rovers. Absolutely a farce in the neck of the woods I work in.
harpy
really, smarter than you think? and you’re reporting these frauds, yes?
Emma Goldman
Re: Smarter Than You Think - please, I seriously doubt there are people on mediciad driving luxury cars. I know plenty of poor people on disability whose meager disability checks put them over the income limit for medicaid. I used to work for the state monitoring medicaid fraud, and 99.9% of it is committed by providers, not recipients.
Judge
EMMA,
I know of a few that bilk the system for many things…one “family” I know the parents aren’t married and drive a BMW and a Navigator plus live in a 3500 sq foot home that was built less than 5 years ago in a very nice neighborhood. The kids (a product of an unmarried couple) get free lunches and welfare for the “single” mom, plus gov’t is paying for their Medical, drugs and her college - free ride. Dad has a well paying job and could easily pay for these items, but hey, that’s they way to play the system today. The add’l support of the gov’t makes for a wealthy lifestyle. They have a merry Christmas…
Justice in MI
If anyone can find a system (or industry or institution anywhere) that doesn’t include some corruption, they are living on a different planet than I am.
Unless you have real data and percentages, it is all so much smoke (and mirrors, as they used to say at AZ).
dzieczko
@Judge - thanks for trotting out the classic schtick - the ONE *family* you know who is gaming the system is why the whole system needs to be killed.
Dan Abshear
First of all, judgements against pharmaceutical companies for violating these offenses does not deter their behavior. Normally, they are given deferred or non prosecution agreements once convicted, with corporate integrity agreements that are rarely enforced. The monetary settlements they pay barely make a dent in their overall financial well being. It’s unlikely that if I’m ever convicted of a crime, that I will get a deferred or non prosecution agreement.
As far as whether or not doctors and pharmacies should be convicted of violating false claims, I think they should. If I am an illegal drug dealer on the streets, and I’m selling these drugs to another, both the buyer and seller get convicted, if they are caught committing such an offense. When I bribed doctors in big pharma, I found many if not most would not take the bribes I offered them. Doctors and pharmacies have a choice when it comes to accepting money from big pharma.
Justice in MI
Dan–I appreciate your views. But it is clearly true that some number of patients benefit from off-label prescribing. (Were it all banned, for example, there would be no steroid depot injections for joint or spine inflammation. I’m not a big fan personally of steroid injections, they obviously seem to work better than placebo for enough pts to justify their continued existence.)
In the end, I think docs can and should be able to defend themselves on the basis of a particular pts’s situation, history, and conventional practice.
The culpability of companies promoting drugs _in general_ for unapprovaed indications–and especially when they are aware of data which demonstrates general lack of efficacy or worse–does not compare, in my view, with a not-corrupted doc (and most aren’t) trying to make the best choices for particular pts.
Dr. Toby Watson
This is not about a cost-benefit ratio with RxP practices (i.e. off-label or not). This is about doctors, pharmacies and hospitals who signed agreements with Medicaid/Medicare stating they would not use certain drugs off label due very min. standard for safety and effectiveness. Since safety and effectiveness has not been established for these drugs, the government has indicated, if you want to be paid by us…use a drug that has been shown to be “safe” and “effective”…by their minimum standard, which by the way is already a sham. Thus, the players know what is expected, but they write Rx for whatever drug they happen to be most conditioned to write. We know that the drug representatives greatly influence these practices, and in turn, the drugs getting prescribed are the newest and most expensive, not the most safe and effective. Thus, these lawsuits are about forcing doctors to practice more ethically…by a min. safety standard and with taking the blinders off on how their RxP practices are based not on research, but on good marketing and perks. As a doc, and with many doc friends, I understand the problem of being so overworked that is almost impossible to keep up on the research. There needs to be a drastic change in our culture and in their medical practice. Unfortunately, it usually is only changed by lawsuit.
Teflon no more
Does anyone have any doubt that bigpharma practices such business approach which includes both legal and illegal activities? This deliberately, with detailed and inventive planning and approval from top top to bottom of their management food chain.
This is the rule judging by so many key cos already caught and fined under FCA and other laws (no jail time yet)but we can admit there might be some exceptions. Who ever knows one let us know. As for the doctors, it has been commented here that they too bare a giant part of the responsibility for bigpharma’s misconduct. Simply put if so many doctors did not support what bigpharma does in terms of unethical, immoral, illegal and criminal behaviour, this corrupt business would not be able to do what they do. It is that simple. Now the question still not answered is wheather all docs who “support” be bigpharma’s game do it deliberately or they just do it without much thinking. They are being told a drug is good for this and that (”that” being off label) and they just use it for both as result of crooked promotion. Or they know what is going on and still support bigpharma’s claims for they too benefit from increase in sales of that drug. Yes the role of physicians in this sorry story has not been discussed anywhere yet. Don’t forget it takes two to tango.
Huey Long
Teflon, as we used to say in N’awlins, “No bout a doubt it”.
in and out
While the plaintiff seems to have a worthy objective (reducing the inappropriate use of psych drugs on a vulnerable population), the methods he’s using will contribute to an even further separation between the two kinds of health care we have today: care for those that have money (who can get off-label prescribing) and care for those who don’t (who depend on Medicaid, and therefore can’t get anything off-label).
Evelyn Pringle
I applaud Jim Gottstein’s efforts to stop the psych drugging of children in this country on the tax payer’s dime. He is an “Unsung Hero.”
I resent that my tax dollars make me a part of the off-label marketing schemes that result in the poisoning of innocent children, as young as 0, who through no fault of their own end up on Medicaid and become profit receptacles for the psychopharmaceutical industry.