Tag: DEA investigation

A perfect storm is brewing for physicians prescribing narcotics

Defending physicians prescribing narcotics for chronic pain has never been easy and I have long criticized the the Drug enforcement Administration (DEA) for conflating the civil standard of care with the criminal conviction standard, thereby criminalizing the practice of medicine. Sixteen months ago I commented that the DEA unnecessarily extends its investigations to the detriment of physicians and patients (DEA investigations: How much is too much?), and 11 months ago I commented that a new standard of care has emerged for the treatment of chronic pain (The pendulum has swung: Treat chronic pain cautiously). Now Attorney General Jeff Sessions, who heads the DEA, has ordered his federal prosecutors to seek the maximum punishment for federal drug offenses. All tolled, a perfect storm is brewing for physicians prescribing narcotics to treat chronic pain.

Treating chronic pain > 90 days and 120 MED (morphine equivalent dose)

With a few exceptions (e.g., cancer pain or hospice care), if you treat chronic pain with narcotics in excess of 90 days and 120 MED (morphine equivalent dose) and your prescribing practices have not evolved over the past five to seven years consistent with the emerging standard of care, you have likely failed to “keep up” and you may be at risk of regulatory intervention. If you treat chronic pain with narcotics in excess of 90 days and 120 MED, and you are not a pain specialist, or you do not refer your patients to a pain specialist, and your patients are not on taper plans, your medical practice may be a ticking time bomb

Prescribing guidelines: The emerging standard of care

The following practice guidelines, offered by the Oregon Medical Board and Oregon Health & Science University (OHSU), reflect current standard of care expectations when prescribing narcotics to treat chronic pain:

If your practice is not in line with these recent guidelines, you may be risking sanctions by your state medical board or the DEA. If your practice comes to the attention of your state medical board, your medical license may be subject to quick restriction or threatened revocation. Similarly, if your practice comes to the attention of the DEA, your DEA Registration may be subject to restriction or revocation and, in a worst case scenario, you may be subject to a criminal investigation. This already serious problem has been exacerbated by a newly invigorated DEA that has been instructed United States Attorney General Jeff Sessions to pursue the maximum punishment available for federal drug law violations.

Is Dr. Larry Eckstein a criminal?

Doctor Larry Eckstein, of Boulder, Colorado, was indicted this summer by a Boulder County grand jury on one felony count of distribution of a controlled substance. I have no personal knowledge of this case, or of doctor Larry Eckstein, having only read about the doctor in the media. As I understand it from the news reports, however, Dr. Eckstein’s case is a small case, as drug cases go, and the doctor has garnered much community support, evidenced by crowd fundraising, a Facebook page, and public letter writing and comments. Based upon what I read, I further question whether Dr. Eckstein’s case is properly treated as a criminal case.

The allegations against Dr. Eckstein

According to the lead news report, the factual allegations against doctor Larry Eckstein are that:

“an undercover police detective scheduled an appointment for July 22, 2014, at Eckstein’s Boulder office, 2760 29th St. The detective complained of “chronic soreness” and said that a friend’s “Roxies” ‚Äî the street name for the opiate Roxicodone ‚Äî had helped him before.

“Eckstein gave the detective a basic physical examination and then prescribed him hydrocodone, according to the indictment. Eckstein approved two more refills for the hydrocodone and made a second prescription for the drug at a second appointment with the undercover detective in October.

“But on a third appointment Oct. 30, Eckstein prescribed the undercover detective oxycodone, and he did so again at four other appointments between December and February, according to the indictment.

“Between Oct. 30 and Feb. 25, Eckstein dispensed 30 grams of oxycodone to the undercover officer, according to court documents.”

See, Boulder doctor indicted on charge of distributing oxycodone, Boulder News, August 19, 2015.

The government’s expert

According to the same news report, the expert opinion of a chart-reviewing physician offered in support of the indictment, is that several aspects of Dr. Eckstein’s treatment of the detective fell “outside the ordinary course of the professional practice,” because Dr. Eckstein (1) never made a diagnosis, (2) never performed any of the appropriate physical examinations, (3) did not perform a risk assessment on the detective, (4) mixed opioids with other prescription drugs, and (5) increased the amount of drugs in the prescription “massively,” without a diagnosis or treatment plan. See, Boulder doctor indicted on charge of distributing oxycodone, Boulder News, August 19, 2015.

Several observations worth consideration

Overall, it appears that Dr. Eckstein wrote two prescriptions for hydrocodone (allowing two refills) and five prescriptions for oxycodone, on seven different occasions, over the course of eight months, spanning July 2014 through March of 2015, in response to an undercover detective’s complaints of chronic pain.

Is the government’s expert opinion worth that much?

Please know that when a chart-reviewing “expert” physician concludes that another physician’s treatment of a patient falls “outside the ordinary course of the professional practice,” as happened here, the expert is most often rendering a standard of care opinion (i.e., a malpractice opinion), while using words taken from a criminal statute. This type of opinion can be very misleading, because malpractice (professional negligence), without more, is usually not criminal. In other words, the expert might very well render an opinion that the medical standard of care was not met, as appears to be the case here, but where is the rest of the evidence? – the evidence necessary to push Dr. Eckstein’s case into the realm of criminal drug dealing?

A crime, malpractice, or none of the above?

There can be little doubt that the undercover detective intended to do as much as possible to obtain prescriptions for controlled drugs from Dr. Eckstein, without helping the doctor. Under the circumstances, does Dr. Eckstein’s treatment of the detective sound like criminal activity, or malpractice, or none of the above? At least one clinician, having some expertise himself and writing in support of Dr. Eckstein, suggests it was no more than professional negligence. See, Charles Horowitz: Prescribing pain medication often a tough call, Boulder News (Opinion), August 29, 2015.

Why not leave this matter with the Colorado Medical Board?

As a matter of public policy, why isn’t the Colorado Medical Board’s emergency suspension of Dr. Eckstein’s medical license “on suspicion of a ‘deliberate and willful violation of the Medical Practice Act,’ ” an adequate response in this case? See, Colorado suspends license of Bolder doctor indicted on drug charges, Boulder News, September 15, 2015. It is, after all, the role of a State licensing board to regulate the practice of medicine, and here the Colorado Medical Board has stepped in and suspended Dr. Eckstein’s medical license, meaning Dr. Eckstein can no longer practice medicine, much less prescribe controlled drugs. In a case like this, I would expect the Colorado Medical Board to investigate, to determine whether the Medical Practice Act was violated and, if it was, to discipline Dr. Eckstein accordingly, by imposing restrictions on him and his license. Why isn’t that enough in a case like this?

Why not suspend, restrict, or revoke Dr. Eckstein’s DEA Registration?

As a matter of public policy, why did those with decision-making authority prefer to indict Dr. Eckstein when they could have more efficiently and cost effectively suspended, restricted, or revoked his DEA Registration? A DEA Registration is necessary to prescribe controlled drugs, and it was the DEA that issued Dr. Eckstein’s DEA Registration in the first place. The DEA is similarly empowered to suspend, restrict and/or revoke Dr. Eckstein’s Registration for failure to meet the medical standard of care and, without DEA authority obtained via his DEA Registration, Dr. Eckstein can no longer prescribe controlled drugs. Why isn’t that enough in a case like this?

Dr. Lawrence Wean, of Media, Pennsylvania, sentenced to prison

Yesterday it was reported that 61 year-old doctor Lawrence Wean, of Media, Pennsylvania, a suburb of Philadelphia, was sentenced to prison for 10 to 20 years, and that he had earlier rejected a plea agreement that would have required less prison time. Experienced lawyers will know that rejecting a plea agreement and proceeding to trial is something of a gamble, and if you lose that gamble, you can expect to serve more time than what might otherwise been ordered after a plea, so a longer sentence for doctor Lawrence Wean comes as no surprise.

I have no personal knowledge of Dr. Lawrence Wean, or of his case, having only read about Dr. Wean’s case in the media. As I understand it from news reports, Dr. Wean sold prescription drugs to undercover officers, was convicted in October of writing unlawful prescriptions and filing false insurance claims, has been ordered to pay over $40,000 in fines and $62,000 in restitution, and was just sentenced to 10 to 20 years.

Too much exposure for physicians?

One of the things I have learned as an appellate lawyer defending physicians on appeal is that the additional time imposed at sentencing, after losing at trial, is disproportionately more time than anyone expected when measured against earlier plea offers or negotiations. In other words, the gamble for physicians facing drug diversion charges for prescription drug crimes, may be a larger gamble than the typical defendant might face when rejecting a plea agreement. Physicians, family members, and lawyers defending physicians for the first time, are genuinely surprised, something I have witnessed first hand.

Is there a better approach for some physicians?

One of the opportunities I would like to explore when the right case presents itself, is the idea of negotiating a very early and favorable plea agreement, followed by an quick sentencing and an early self-report to serve time, before the typical two-or-more years have passed, and extensive financial resources have been depleted, which is common when taking drug diversion charges to trial. Some might recall that this type of efficient resolution was Martha Stewart’s solution to her legal woes a few years back. She quickly negotiated a plea agreement, was sentenced, surrendered, served her time, and then got on with her life.

A unique physician will be necessary

This approach will require the right type of individual, and I have no way of knowing whether doctor Lawrence Wean was such an individual. Most physicians, it seems, are willing to postpone the start of trial as often as will be permitted, and they appear further willing to spend all that they have to avoid serving time. These tendencies appear to be true even after conviction, if the case is on appeal (although “bond” is seldom allowed on appeal, I have helped physicians remain free pending appeal). Nonetheless, for the right physician, I find the idea of a quick resolution and sentence intriguing. In the right case, a physician could enter a plea and serve his or her time in three years, at little financial cost, relatively speaking. In sharp contrast, however, at the end of three years, all many physicians will have to show for their efforts is one of more convictions and financial ruin, with a sentencing hearing, a prison term, and an uncertain appeal, on the horizon.

What happened to the doctor “let go” by Dr. Sylvia Hofstetter?

The story of doctor Sylvia Hofstetter, in what has been characterized as “the largest drug network unearthed so far in East Tennessee,” is unfolding publicly this year, although the investigation certainly traces back several years. I have no personal knowledge of this case, or of Dr. Sylvia Hofstetter, having only read about Dr. Hofstsetter’s case in the media. As I understand it from news reports, Dr. Hofstetter was indicted earlier this year and is facing trial next year for prescription drug charges arising out of a large “pill mill operation” in Knowxville and Lenoir City. The facts as alleged certainly look bad for doctor Sylvia Hofstetter and her colleagues, but they always do, even in the cases that turn out better in the end.

At least one doctor was viewed favorably

What caught my eye was the testimony of an FBI Special Agent, who reportedly testified that Dr. Sylvia Hofstetter let one doctor “go” because that doctor spent more time with patients and wouldn’t always write a prescription for a narcotic. One implication from the Special Agent’s testimony is that this doctor was exercising clinical judgment, which suggests he was practicing medicine, and not intentionally dealing (i.e., diverting) drugs. Even if you assume the factual allegations are true with respect to Dr. Hofstetter and the others, this doctor is situated differently, even in the eyes of the FBI Special Agent. The doctor is not identified by name and I wonder what happened to him. Most often, every physician in the clinic is indicted, but was this doctor spared from indictment?

A “legitimate medical purpose,” or intentionally dealing drugs?

If this doctor was indicted, the issue for him will likely be whether he was practicing medicine or intentionally dealing drugs, and it is further likely his case will become entangled in the quarrel between what constitutes “prescribing without a legitimate medical purpose” (in my opinion, this agency rule is often misused by the DEA), and what constitutes the “knowing or intentional distribution of a controlled substance outside the course of professional practice,” which is the statutory crime legislated by Congress in the Controlled Substances Act, a quarrel I have discussed elsewhere on this website, and will not repeat again here today.

 

If a DEA Drug Diversion Agent asks you to sign a waiver or release, just say “no.”

If you possess a DEA Registration to prescribe, possess, or dispense controlled substances, you may one day be approached by a DEA Drug Diversion Investigator requesting an interview and asking you to sign a release or waiver of your right to remain silent. Just say “no.”

As my late friend Glen Crick has written,

“if you are told, ‘You have the right to remain silent,’ then remain silent. This warning is only given to someone who is the subject of a criminal investigation. If an investigator tells you that you have the right to remain silent, there is no guesswork involved. You are the subject of a criminal investigation, and there is nothing to be gained, and much to be lost, by talking to an investigator without legal counsel present.”

Two examples of what can go wrong

In one case, a senior physician was duped into writing prescriptions to young, drug seeking “patients.” His clinical assessments and charting were both good, and the drugs prescribed were appropriate and in therapeutic doses. The trouble arose, however, not from his charting, but from the statements he made during his voluntary interview with the Drug Diversion Investigator – he made the big mistake of signing a written release of his rights, and he then sat for an interview. Unfortunately, the mistakes he made during that interview hurt him, and he later pled to one “small count” (small by drug diversion standards) resulting in a sentence of probation, the surrender of his DEA Registration, and the closure of his practice. It was my opinion, however, that without the statements he made during his voluntary interview, his case was entirely defensible.

In another case, a physician made the same mistake of signing a written release of her rights, and she then sat for an interview with two Drug Diversion Investigators without legal counsel present. Before that interview was over, she was further persuaded to surrender her DEA Registration. This physician never faced allegations of criminal wrong doing, but she incurred much legal expense and trouble in an attempt to restore her Registration and medical practice. Although this case was never fully developed, it was my opinion based upon what was known, and what has been learned since, that this physician would not have lost her DEA Registration and there was no reason to surrender it to the DEA investigators in the first place.

What you need to know

In both the of the examples above, the physicians released their rights and agreed to be interviewed by Drug Diversion Investigators. It was my opinion that both cases were fully defensible. The lesson to be learned is that if a DEA Drug Diversion Investigator wants to interview you and asks you to sign a release or waiver of your right to remain silent, don’t do it. Just say “no.” If you are told, “You have the right to remain silent,” then remain silent. Decline all interviews until you have consulted with a lawyer familiar with prescribing issues under state and federal law. Whatever you do, don’t go it alone.