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DOJ’s New Increased Focus on Medical Devices: Blame Game

DOJ’s New Increased Focus on Medical Devices: Blame Game

February 18, 2015

Injured patients, consumers, employees and taxpayers alike has the DOJ finally heard the cries?  Will the DOJ now hold another meeting to finally recall mesh and other polypropylene products? Oh don’t get too excited…

When in Doubt Blame Others

Taken directly for Policy and Medicine

Last week’s CBI Medical Device and Diagnostic Compliance Congress* featured an “enforcement panel” that discussed recent trends in healthcare fraud enforcement. Three U.S. Attorneys from the Department of Justice—Benjamin Wagner of the Eastern District of California, Jacob Elberg of New Jersey, and Elizabeth Tonkin of the Eastern District of Tennessee—offered insight into their enforcement process and emerging areas of focus.

*Apparently one has to pay to know what actually went on at CBI Medical Device and Diagnostic Compliance Congress-that’s inconsistent and contradictory language to action for a program that’s discussing compliance as it relates to devices put into our bodies.

Increased Focus on Med Device

Perhaps intending to scare the medical device compliance audience (though echoing a fairly established trend), the U.S. Attorney panel stated that they are placing an increased emphasis on medical device manufacturer misconduct.

Better late than never but 70,000 women in federal court for mesh implants across seven different makers sure wish the DOJ would have paid attention a little sooner.

Red Mesh Ribbon

The panel mentioned a few reasons for the uptick.

According to Benjamin Wagner, there are a number of areas in the country where healthcare fraud has not been a priority until now. His department in Sacramento, for instance, is just getting through its slew of mortgage fraud cases from several years ago. As these cases are trailing off, Wagner notes, a lot of white collar prosecutors are looking for new targets.  Furthermore, better coordination between the FBI, HHS, and other agencies have allowed for more streamlined enforcement. As an example, Wagner noted that the FBI has been looking into more sophisticated crime networks involving durable medical equipment false billing cases. (Just look here, here, and here for recent evidence of DOJ activity in the durable medical equipment space).

Attorney Generals only take cases they think they can win and sadly not all attorney generals understand healthcare fraud.

SUBURBAN-TERRORIST

The panel agreed that prosecution of small to medium sized companies is due not only to increased resources going towards healthcare fraud, but also to how efficiently U.S. attorneys can use these resources. Prosecutors may just be more experienced now than in years past. Furthermore, Elizabeth Tonkin noted that as qui tam cases have been successfully settled, often for a lot of money, this has served to attract more whistleblower complaints to her office. Prosecutors then have an obligation to investigate every qui tam that comes through the door. Tonkin stated that while many of these allegations are very poor, others have well-documented accusations suggesting that many qui tam relators have “done their homework.”

Whistleblower breakdown

#HeyMrDOJ is that taking credit for others work? The DOJ still doesn’t know the difference between pharma and med device as it relates to whistleblowers and until they do that new pipeline of information from small (startups) to medium sized companies will dry up.

Jacob Elberg stated that based on the cases his office and other prosecutors have seen, they “continue to have the feeling that there is more misconduct that isn’t being addressed.” The medical device industry breeds a “whole range of misconduct,” he noted, including improper payments, kickbacks, and off-label activity. Elberg believes that prosecuting such behavior is important for the companies that are doing the right thing. “It’s only fair” to look at smaller companies who may be profiting by skirting some compliance rules that bigger companies have been bound to for quite some time, he notes. Sales reps, for example, shouldn’t have to lose out on business to other reps who rely on kickbacks to sell their devices. He wants companies that follow the rules to know that DOJ is always interested in tips about such misconduct.

Slide9

AG Jacob Elberg forgot a few in the medical device industry breeds a “whole range of misconduct,” like willfully setting out to defraud the U.S. Government via 510 (k) or companies encouraging, replicating and rewarding unethical and or illegal behavior as highlighted in The Sociopathic Business Model™.  Not until the DOJ is willing to put med device executives and further still VC’s in jail will there be positive change in the industry.

An audience member asked why the Department of Justice only seems to go after companies with deep pockets, rather than the physicians who participate in, and may potentially instigate a kickback relationship. Elberg took issue with that. He stated that his office has convicted more than 60 doctors over the last few years, many related to kickbacks in the laboratory referral setting. In fact, Elberg turned the tables a bit on companies, noting that if a doctor is refusing to do business without a kickback payment side deal, companies should proactively bring it to the attention of the DOJ.

That’s double-edged-just as employees are lied to in many cases so are physicians.  Where the DOJ needs to focus is on people like Johnson & Johnson’s paid consultant Dr. Andrew Brill who also sat on the FDA panel.

Some physicians may be particularly insistent on bribes, noted audience members. The U.S. attorneys agreed that such physicians, as well as those that reprocess single use-devices without following FDA protocol, or that import cheaper, non-FDA approved devices, are hurting med device companies. DOJ would love that information too, the panel stated.

HeyMrDOJ-Lack of accountability on the part of the government while placing blame.  The FDA could run reports to see if there is one physician or specialty that’s abusing a code.  How don’t they have that technology at this point? Or better someone who knows how to run an internal report?

The panel agreed that often it takes longer to prosecute individual physicians, especially under a criminal statute. Putting someone in jail because of “medically unnecessary” procedures presents tough litigation challenges especially since these cases typically go to trial. However, Tonkin noted that HHS-OIG has the ability to assess penalties directly against physicians who are accused of kickbacks, without the physician being prosecuted separately.

Must Companies Proactively Search Out “Excessive” Use of Devices

One of the more interesting discussions from the panel focused on the Open Payments and Medicare payments release—two yearly data streams that contain vast amounts of information on provider behavior. The U.S. Attorneys believe these new tools are a good way to track outliers in prescribing behavior. Wagner stated that the DOJ’s ability to find a “needle in the haystack” is much better than it used to be. Using the data allows them to track situations where doctors are implanting medical devices of a certain type where the area’s demographics don’t seem to support that level of use.

Alex Gorsky Gary Pruden Bridget Ross JNJ Ethicon Gynecare with JNJ and FDA consultant Dr. Andrew Brill

Really? The DOJ wants unrepentant pathological companies to self-report when it comes to excessive implanting-guess they missed that’s the goal of every device maker.  One step forward one hundred steps back.

One question device manufacturers had is whether the government would trace a doctor’s abnormal device utilization behavior back to, for example, the stent manufacturer. Would DOJ hold the medical device manufacturer liable for having so many more sales to that doctor than to other doctors?

The panel stated that more than likely the government would be going after the doctor in that situation, but only up to a certain point. Prosecutors’ chief concern is unnecessary invasive medical procedures—these both defraud the government, but more importantly put patients at risk. These cases are prosecutors’ “bread and butter,” noted Wagner. “If we find examples where we can show that people are going under the knife for reasons that are not medical justified, we are going to track that back as far as we can.”

Elberg stated that companies should already have processes in place to monitor customers for doctors who purchase and/or utilize a high number of devices—both from a business perspective and a risk-management perspective regarding off-label use. Elberg added that the government expects companies to then ask the question of whether this physician’s behavior is the result of improper sales practices, for example.

For a company to avoid liability, “it’s not going to be sufficient for [them] to say, ‘the doctor was asking for [a lot], and we’re a for profit company,’” Wagner advised.

And the government no longer gets a pass of placing blame without taking accountability when it comes to fraud. Because from where I’m sitting we’ve allowed two known corrupt entities (Med device and the U.S. Government) to negotiate on behalf of the American people behind closed doors for too long.

Checklist-of-Characteristic-of-The-Sociopathic-Business-Model (1)

 

6 Comments
  • Doctors should be forced to write prescriptions for the devices they surgically implant and the prescription they write put into the patients hospital and doctor’s office medical records. Patients do not know what is implanted and, many times, even that a device is implanted.

    I personally did not know for almost 4 years after implantation of a Johnson and Johnson, Ethicon Gynecare TVT Prolene polypropylene bladder sling was inside of me. I never heard of a medical device. There was nothing on the informed consent to alert me to a thermoplastic polymer being placed inside my body.

    Hopefully this might put a layer of protection between patient and device company. Laws do not deter crime. Enforcement does. So physicians might think twice about implanting if they could so easily be found out. That’s my opinion.

    As to the DOJ, the failures of the FDA, device companies and doctors related to synthetic surgical mesh has been presented to the DOJ’s in at least 42 states and at the Federal level in D.C.

    February 18, 2015 at 11:28 am
  • Thank you for providing more education to the community of mesh injured people and families.

    February 18, 2015 at 1:55 pm
  • John
    Reply

    Thank you for the very well written information on the misuse and overuse of medical devices and over use of procedures to implant them.
    The kick back and over use of procedures are astronomical in the Gastroenterology Specialist Departments.The overuse of stenting in the bile duct and pancreas leads to more severe complications and ultimately invasive surgery.I know first hand of the misuse and cover up on these plastic polymer stents.I have been injured by them which ultimately lead to damage to my pancreas and bile ducts.The damage has lead to open surgery to correct the problem.
    After talking to doctors and legal experts, I was told that I never needed the stents to begin with.
    The lies and falsifying of my medical records began shortly after I was notified that a stent was placed.I even have documentation of the FDA animal test trials of the plastic stenting injuring and killing dogs and pigs when the device first became available. The same morbidity and mortality rates still occur in humans (oocclusion ,stone formation, bacteria build up, infection, necrosis…) until this day.
    The DOJ needs to step up to the plate and investigate ALL plastic medical devices,Including mesh bladder support,pancreas stents, biliary stents, heart stents, and,the overuse of unnecessary procedures to implant them at patients risk, just to make a profit for both the doctor and manufacturers.

    February 18, 2015 at 4:22 pm
  • Jan Urban
    Reply

    I was on the Mesh Problem Web site and found your Link. Outstanding, informative and to the point. Thank you

    February 21, 2015 at 4:17 am

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