Risk, Reward and Pain: Doctor Lessons from An Opioid Trial

Nope. No opioids here.

Opioid medications continue to be in the news, as demonstrated by the recent nationwide state attorneys-general investigation.  This situation only demands more attention from physicians and other healthcare providers who may face significant criminal sanctions.

Brandon Essig

My law partner Brandon Essig recently wrote in Medical Economics:

Over the past three decades, opioids have become a standard and effective component of pain management for many practitioners. They are effectively and safely prescribed in every conceivable clinical environment—primary care facilities, hospitals, pain management clinics and even dentist offices. They are prescribed to treat chronic and intractable pain, such as advanced stage cancer pain or severe burns, but they are also prescribed to treat soft tissue injuries and even prophylactically for post-operative situations where the practitioner knows that the recovery typically, but not always, involves pain. 

However, the medical community in the United States, and indeed society as a whole, is also now facing the reality that the side effects of opioid medications can be devastating. When misused and abused, opioids can have the same ill effects on society as any other illicit drug—addiction, crime, overdose, massive public health costs and death. In other words, society is now grappling with the dual realities of opioid medication: 1 – its use as an effective pain management tool is proven and here to stay; and 2 – its dangers and risks are also proven and must be contained. 

Medical practitioners who prescribe opioid medications as part of their treatment of patients in pain are caught in the middle of this struggle. Unfortunately for them, one of the primary ways society has chosen to address the dangers and risks of opioids is through legal action—both civil and criminal—against the healthcare practitioners who prescribe them to their patients. Therefore, physicians and other practitioners who prescribe controlled substances are participating in what is perhaps the most high-risk practice of medicine today. 

Read the entire article here.  (The byline also bears my name, but all I did was review the draft with a see-through in hand).

The opioid issue is not going away.  As  Caleb Hawley notes, “we all got problems/we all got pain”:

 

 

 


Stethoscopes, Handcuffs and Pain

The ties that bind.

When does managing pain become a crime?

And, what can a healthcare provider do to stay out of trouble in these days of the “opioid epidemic”new federal legislation and the criminal prosecution of doctors?

I make a few suggestions here in Pain Management News:

That’s the question many physicians, nurse practitioners (NPs), certified registered nurse anesthetists (CRNAs) and physician assistants (PAs) are asking in the wake of a tidal wave of prosecutions related to pain medicine. This has been partly spurred on by the “opioid epidemic.” There has been a sharp spike in convictions—either by guilty plea or by conviction after a trial—of health care professionals involved in pain medicine.

The facts of each case are different, but the gist of each charge is that health care providers are operating a “pill mill,” where prescriptions are being provided “outside the usual course of medical practice” and “not for a legitimate medical purpose.” There also may be a charge that procedures or tests are not “medically necessary.”

Read the full article here, and our previous notes on related topics:

And my mens rea is unknown, too.

Mute Oracle: The Controlled Substances Act and Physicians’ Criminal Conduct

“In Flanders fields . . . .”
(via Zyance)

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Pill Mills, Poppy Flowers, Dead Poets and the Human Resources Department

We’ll be right with you.

Electronic Medical Records and Federal Criminal Prosecution


Mute Oracle: The Controlled Substances Act and Physicians’ Criminal Conduct

 Balance in the law?

Balance in the law?

Criminal laws are supposed to give persons regulated by the law sufficient notice of what conduct, exactly, is prohibited.  Criminal laws, as interpreted by courts, are also supposed to provide clear standards for mens rea (that is, the level of intent the Government must prove at trial).  With regard to physicians and their prescribing practices, the federal Controlled Substances Act does neither.

Or, as my Lightfoot colleagues Brandon Essig, Jeff Doss and I put it in a recent article for Law 360:

With the Eleventh Circuit’s recent decision in United States v. Enmon, physicians continue to face two critical questions in the uncertain case law under the federal Controlled Substances Act. First, what conduct is prohibited? Second, what intent must the physician be shown to possess in order to support a conviction? Given the government’s increasingly aggressive prosecution of physicians with regard to controlled substances, white-collar practitioners who represent a physician or other healthcare professional in a “pill mill” case understand and address these issues in pretrial briefing and in preparing their trial strategy and must do so early.

And my mens rea is unknown, too.

And my mens rea is unknown, too.

Read the entire article: Questioning The Controlled Substances Act After Enmon


Pill Mills, Poppy Flowers, Dead Poets and the Human Resources Department

"In Flanders fields . . . ." (via Zyance)

“In Flanders fields . . . .”
(via Zyance)

Having been through a seven-week federal criminal “pill mill” trial, I think a lot about enforcement of the Controlled Substances Act and its effect on physicians.  Aggressive enforcement effects others in healthcare as well, including management:

“It’s very hard for medical professionals and those in upper management, such as hospital CFOs, CEOs, and CMOs, to see themselves as criminals,” says Jack Sharman, partner at Lightfoot, Franklin, and White, a law firm headquartered in Birmingham, AL.

“This difficulty to perceive what someone else might think merits a criminal investigation impedes judgment and slows internal response.”

While physicians might not see themselves as criminals for managing patients’ pain or making sure they had enough pills to get through a holiday, it’s not hard for others to come to that conclusion, says Sharman.

Health Leaders MediaHere is the full text of my interview with Health Leaders Media:What the Crackdown on Painkiller Prescribing Means for HR

 

John McRae (1872-1918)

John McRae (1872-1918)

If your recall for literature is not what it once was, In Flanders Field is a poem by John McRae, spoken from the point of view of World War I dead:

In Flanders fields the poppies blow
Between the crosses, row on row, 
That mark our place, and in the sky, 
The larks, still bravely singing, fly, 
Scarce heard amid the guns below. 

We are the dead; short days ago
We lived, felt dawn, saw sunset glow, 
Loved and were loved, and now we lie
In Flanders fields. 

Take up our quarrel with the foe! 
To you from failing hands we throw
The torch; be yours to hold it high! 
If ye break faith with us who die
We shall not sleep, though poppies grow
In Flanders fields.