Author: Eli Stutsman

One way to avoid mandatory exclusion by the Office of the Inspector General (OIG)

42 U.S.C. 1320a-7: The OIG and “mandatory” vs. “permissive” exclusion

In a prior post, I discussed the difference between “mandatory” and “permissive” exclusion under 42 U.S.C. 1320a-7, which allows, and sometimes requires, the Office of the Inspector General (OIG) to exclude physicians, pharmacists and nurses from employments that receive federal funding which is, unfortunately, most healthcare employments. I also suggested that one strategy to avoid mandatory exclusion is for you and your lawyer to carefully consider plea and sentencing options, to avoid the type of conviction that will trigger mandatory exclusion in the first place, a point I will emphasize here.

Never forget that mandatory exclusion applies whenever there has been any one of the following: (1) a conviction of a program-related crime; (2) a conviction relating to patient abuse; (3) a felony conviction relating to health care fraud; or a (4) felony conviction relating to a controlled substance. See 42 U.S.C. 1320a-7(a) (1)-(4). If any one of these convictions is present, and absent a few truly extraordinary circumstances, exclusion is mandatory for the proscribed period of time, often five years, but in some cases ten years, or permanently. Consequently, if you are facing the risk of exclusion, permissive exclusion is preferable over mandatory exclusion because, with permissive exclusion, the periods of exclusion are shorter, and the OIG has discretion over whether, and how long, to exclude you. Indeed, in one recent case involving an Oregon pharmacist, I persuaded the OIG to forego permissive exclusion altogether.

Carefully consider your plea options to avoid mandatory exclusion by the OIG under 42 U.S.C. 1320a-7

If your case lends itself to plea negotiations, in order to avoid mandatory exclusion, you and your lawyer will want to avoid agreements to plead to (1) program-related crimes or (2) patient abuse, and, if you agree to plead guilty to (3) health care fraud or (4) a crime relating to a controlled substance, you will want the plea agreement to include an understanding that the conviction should be a misdemeanor conviction, not a felony conviction. These plea agreements can become tricky in a hurry because your lawyer will need to persuade both the prosecutor and the court to accept misdemeanor convictions. Each case is different, presenting unique mitigating factors to present the court in favor of misdemeanor convictions (versus felony convictions), but perhaps one point worth stressing is that a mandatory, five-year period of exclusion, is likely a career-ending event which, in some cases, will be more punishment than the sentencing court intends.

Are you risking mandatory or permissive “exclusion” by the Office of the Inspector General (OIG)?

If you are a physician, pharmacist, or nurse facing significant legal of disciplinary action, both you and your lawyer need to be aware of 42 U.S.C. 1320a-7, which allows, and sometimes requires, that the Office of the Inspector General (OIG) exclude certain individuals and entities from participation in Medicare and State health care programs. For most physicians, pharmacists and nurses, the practical effect of being “excluded” from any employment receiving federal funding is that you are rendered unemployable during the period of exclusion.

Permissive vs. mandatory exclusion by the OIG

Generally speaking, there are two types of exclusion, “permissive exclusion” and “mandatory exclusion.” See 42 U.S.C. 1320a-7(a) & (b). With permissive exclusion, the OIG has discretion whether to exclude the practitioner. The OIG will exercise its discretion based upon the consideration of multiple factors, which means that your lawyer will have an opportunity to plead your case, by presenting mitigating factors to the OIG against being excluded. With mandatory exclusion, however, mitigating factors will not help you. With mandatory exclusion, if any one of the triggering events is present, and absent a few truly extraordinary circumstances, the exclusion is mandatory for the proscribed period of time, often five years, but in some cases ten years, or permanently. Consequently, the first thing your lawyer should do is to determine the type of exclusion you risk – mandatory or permissive.

Factors that trigger mandatory exclusion by the OIG

Mandatory exclusion applies, for example, when any one of the following events occur: (1) a conviction of a program-related crime; (2) a conviction relating to patient abuse; (3) a felony conviction relating to health care fraud; or a (4) felony conviction relating to a controlled substance. See 42 U.S.C. 1320a-7(a) (1)-(4).

Opportunities to avoid mandatory exclusion by the OIG

If you are facing mandatory exclusion, it is important that your lawyer first verify that you belong in a category that triggers mandatory exclusion. Once you verify that you are properly subject to mandatory exclusion, the opportunities to avoid exclusion are few, but they do exist (e.g., vacation of judgment, or reversal of judgment on appeal, or obtaining a sole community provider waiver). If you cannot avoid permanent exclusion, your lawyer’s next task to hold the period of exclusion to its minimum. Remember, the five and ten-year periods of exclusion are the minimum periods of exclusion – the OIG can extend these minimum periods if aggravating factors warrant. Perhaps the best strategy to avoid a mandatory exclusion is to carefully consider your plea and sentencing options and strategies, to avoid the type of conviction that will trigger mandatory exclusion in the first place.

Factors that trigger permissive exclusion by the OIG

Permissive exclusion may be ordered by the OIG when, for example, there is: (1) a conviction relating to fraud; (2) a conviction relating to obstruction of an investigation or audit; (3) a misdemeanor conviction relating to a controlled substance; (4) a license revocation or suspension; (5) exclusion or suspension by another Federal or State health care program; (6) a claim of excessive charges or unnecessary services or failure of certain organizations to furnish medically necessary services; (7) fraud, kickbacks, and other prohibited activities; (8) an entity controlled by a sanctioned or excluded individual; (9) the failure to disclose required information; (10) failure to supply requested information on subcontractors and suppliers; (11) failure to supply payment information; (12) failure to grant immediate access to premises or records; (13) failure to take corrective action; (14) the default on a health education loan or a scholarship obligation; (15) to individuals controlling a sanctioned entity; or (16) making a false statement or misrepresentation of material fact. See 42 U.S.C. 1320a-7(b) (1)-(16).

Opportunities to avoid permissive exclusion by the OIG

With permissive exclusion, the OIG has discretion whether to exclude the physician, pharmacist, or nurse. The OIG will exercise its discretion based upon the consideration of multiple factors, factors that essentially allow the practitioner to plead his or her case against exclusion. Because each case is unique, the factors that are identified and argued on your behalf will depend upon the skill and experience of your lawyer. For example, I represent physicians, pharmacists, and nurses before the OIG, and I recently helped an Oregon pharmacist avoid permissive exclusion by arguing four mitigating themes, that included: (1) the pharmacist’s unusual circumstances; (2) the pharmacist’s inadequate prior legal representation; (3) the pharmacist’s lack of prior legal or disciplinary history; and (4) the appropriateness in this case of Federal deference to State licensing Boards – i.e., the Oregon Board of Pharmacy and the Washington Board of Pharmacy – as sufficient regulators. It was with a sense of relief that we recently received the OIG’s letter explaining that, based upon our explanation of the underlying circumstances, that the OIG was taking no further action, and instead closing its file.

The Oregon pharmacist’s role in preventing prescription drug diversion

The “corresponding responsibility” imposed on Oregon pharmacists

It is a crime is to “knowingly or intentionally” distribute or dispense a controlled substance unless “authorized” by the Controlled Substances Act (CSA). See, 21 U.S.C. § 841(a). Authorization is obtained by “registering” with the Attorney General. See, 21 U.S.C. § 822(a)(2). Persons registered with the Attorney General are authorized to possess, manufacture, distribute, or dispense controlled substances to the extent authorized by their registration. See, 21 U.S.C. § 822 (b). Physicians licensed by a state and registered with the Attorney General are “practitioners” and, as such, they are authorized to prescribe and dispense controlled substances (see, 21 U.S.C. § 829(a)&(b)) in “the course of [their] professional practice.” See, 21 U.S.C. § 802(21); see also, United States v. Moore, 423 U.S. 122, 140 (1975). Similarly, pharmacists licensed by a state and practicing in a pharmacy registered with the Attorney General, are authorized to dispense controlled substances. Giving effect to this federal statutory scheme, the Drug Enforcement Administration (DEA) promulgated a regulation that broadly requires all prescriptions to be issued for a “legitimate medical purpose” and imposes “a corresponding responsibility [on] the pharmacist who fills the prescription.” See 21 CFR § 1306.04(a). A pharmacist’s failure to observe whether a prescription is issued for a legitimate medical purpose can lead to administrative and criminal sanctions.

The difficult task faced by Oregon pharmacists

Compared to the prescribing physician or nurse, a pharmacist’s exposure to a patient is but a brief encounter. For most patients, a visit to a pharmacy is more akin to a sales transaction that a health care event and, should something seem amiss to the dispensing pharmacist, neither the patient nor the patient’s prescribing physician will have much tolerance for questions. Nonetheless, it is in this environment that the Oregon pharmacist is expected to ensure that all prescriptions are issued for a legitimate medical purpose.

The current practice standard: screening for “red flags”

I can assure you from my work defending physicians and pharmacists that screening for red flags is expected of all practitioners. For the pharmacist, however, screening for red flags may be one of the better tools available to detect prescription drug diversion, to ensure that all prescriptions are issued for a legitimate medical purpose. Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be a consideration for the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is a suspicion of drug diversion and one or more red flags were present. The Oregon Board of Pharmacy addresses screening for red flags on its website at: http://www.oregon.gov/Pharmacy/pages/index.aspx), and further links to an YouTube educational video: https://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be:

While screening for red flags to prevent drug diversion has its limits (and its critics, which include patients, prescribing and dispensing practitioners, and pain control advocates who may feel pitted against one another), it is nonetheless the current practice standard against which a pharmacist’s conduct will be measured, and it is therefore important to incorporate this type of scrutiny into the Oregon pharmacist’s day-to-day practice.

 

Criminalizing medicine

Conflating the civil and criminal standards

The civil standard of care and the criminal conviction standard are two distinct legal standards, yet these two legal standards are often substituted, confused, and/or conflated. When this happens, the practice of medicine is “criminalized.” One way this occurs is by the misapplication of the DEA’s rule against prescribing without a legitimate medical purpose, which I discuss on the criminal violations page of this website. It was with this understanding of the law that I shaped the legal theory that won Drs. David and Randall Chube’s release from federal prison in US v. Chube II, 538 F3d 693 (7th Cir. 2008). The Chube case is also discussed on the appeals page of this website.

Criminalizing medical error

What I have learned defending or advising physicians, pharmacists, and prescribing nurses in cases arising out of the Third, Fourth, Seventh, and Ninth Circuits and 13 states, including Indiana, South Carolina, Arizona, Oregon, Virginia, Georgia, Pennsylvania, Florida, Hawaii, Texas, Connecticut, California and Michigan, is that the DEA relies heavily, and sometimes too heavily, on chart-reviewing standard of care experts. These chart-reviewing standard of care experts will first determine that the civil standard of care was not met based upon a chart review, and will then leap to a conclusion that the physician was engaged in criminal activity.

This appears to have occurred in Dr. Larry Eckstein’s case, where a chart-reviewing standard of care expert opined that several aspects of Dr. Eckstein’s treatment of an undercover 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.

I earlier discussed Dr. Eckstein’s case in more detail. As I said then, I have no personal knowledge Dr. Eckstein, or his case, having only read about the doctor in the media. If the allegations and expert opinion against Dr. Eckstein are true, Dr. Eckstein may have fallen short of the standard of care, but this is a properly addressed by restricting, suspending, or revoking Dr. Eckstein’s DEA Registration, or his state medical license, or both, in administrative proceedings. It appears, however, that the opinion of a chart-reviewing standard of care expert was instead used to “criminalize” Dr. Eckstein’s practice of medicine, leading to his indictment and arrest.

Malpractice is not a crime

A violation of the civil standard of care (which may amount to professional negligence, or medical malpractice, same thing) is not, without more, a drug crime. Indeed, a physician may commit malpractice when prescribing controlled substances, but that does not mean the physician committed the crime of drug diversion. Drug diversion requires more. Drug diversion requires the knowing or intentional distribution of a controlled substance outside the course of professional practice, i.e., intentional drug dealing. Beware: Whenever the DEA uses a civil standard of care expert, applying the malpractice standard to reach a conclusion about criminality, the DEA is criminalizing medical error. While medical errors do occur in the practice of medicine, adequate remedies are already in place. Criminalization occurs when there is an unchecked expansion of the law by over-aggressive law enforcement. This is what happened in Drs. David and Randall Chube’s case (discussed above), and it appears to have happened in Dr. Eckstein’s case too. Defense attorneys and courts everywhere must guard against this insidious perversion of the law.

DEA investigations: How much is too much?

Why such lengthy criminal investigations?

In an earlier post I asked whether the number of deaths attributed to Dr. Sylvia Hofstetter’s clinic by the Drug Enforcement Administration (DEA) could have been reduced had the undercover investigation been terminated sooner, after two years instead of four. In other words, what did two more years of undercover work by the DEA add to Dr. Hofstetter’s case?

More likely than not, the additional two years added nothing of value. By the DEA’s own account, illicit drug use and deaths continued, unabated by the DEA, while the DEA continued its lengthy investigation, and for what purpose? The additional evidence accumulated against Dr. Hofstetter was of questionable value. If the allegations are true, Dr. Hofstetter’s case would have been overwhelming to defend after the first year. As I write this, I can think of two physicians convicted of only one count of drug diversion that were sentenced to 5 years each, and one physician convicted of only six counts of drug diversion that was sentenced to 15 years. And all it takes is one patient death to impose a mandatory 20-year sentence. So why spend four years investigating Dr. Hofstetter, when one year, or even six months, will suffice?

Some might argue that the DEA is preoccupied with large undercover investigations at the expense of preventing harm to others. Think about it. If there were an active shooter in a shopping mall, police would not secretly stand by, accumulating more evidence, allowing more deaths to occur, before intervening to save lives. If the DEA is right about the harm inflicted by drug diversion, and by Dr. Hofstetter, why then does the DEA stand by and allow the harm to continue? What interests are served?

Why wait for a crime or injury to occur in the first place?

And here’s the larger question – why not shut down questionable prescribing practices early-on, when the suspect prescribing practices are first brought to the DEA’s attention, before anyone is harmed? There is, after all, no need to wait for even one criminal act to occur. Criminality is not necessary before the DEA may take action. The DEA may restrict, suspend, or revoke the prescribing physician’s DEA Registration by exercising the DEA’s administrative powers over DEA Registrants, much like a state licensing Board will pursue a physician, pharmacist, or nurse for practicing below the standard of care under state law.

It doesn’t take much to stop illegal prescribing

As I write this, I can think of a doctor and a nurse that engaged is almost identical misconduct while prescribing controlled drugs. Each wrote prescriptions to another, knowing the other would fill the prescriptions and return the controlled drugs to the doctor or nurse, for the doctor or nurse’s personal use. In each case, the standard of care was violated, and a fraudulent medical record was created, a crime. If insurance paid for the controlled drugs, then insurance fraud occurred too, also a crime.

Both the doctor and the nurse were easily caught, and easily stopped. Both were reported by their co-workers. The doctor was reported to the Oregon Medical Board (OMB). He’s in treatment, on probation, and his license is restricted, but he’s still practicing medicine. The nurse, unfortunately, was reported to the police first, and then to the Oregon State Board of Nursing. She too obtained treatment, but the police report led to a criminal indictment and she eventually entered a plea agreement on two counts. The sentencing court, wishing to send a message, insisted on criminal convictions over misdemeanors. Because the nurse was convicted of two felonies, she surrendered her RN and NP licenses to the Oregon State Board of Nursing. And because the nurse was convicted of two drug felonies, she was further “excluded” by the Office of the Inspector General (OIG) from participation in any and all healthcare programs receiving federal dollars for five years!

As an aside, the doctor and the nurse were involved in similar misconduct, but were treated in a disparate fashion, because law enforcement became involved in the nurse’s case, but not the doctor’s case. The doctor is still practicing, albeit with a restricted license while on probation and receiving treatment. The nurse, however, is not practicing, because she had the misfortune of being reported to the police first, and then the Oregon State Board of Nursing. She lost her licensure and was excluded by the Office of the Inspector General (OIG) from working in any setting that received federal funding, which is most clinical settings. Such disparate treatment is worrisome, but the point I want to make is that in both cases, the prescribing misconduct was stopped early on, before it became a larger societal problem.

Early intervention may be best for all involved

Which brings me back to where I started. Imagine how much pain and suffering, not to mention loss of life, might have been spared had the DEA exercised is administrative powers, and stepped in four years earlier, at the first sign of trouble, to restrict, suspend, or revoke Dr. Sylvia Hofstetter’s DEA Registration, and then perhaps pursue criminal sanctions too.

When to bring in an appeals attorney

A recent win on appeal

I recently won a quick and good result on appeal. This case in particular illustrates the importance of making your record for appeal, a fact appellate lawyers know to their core. This recent victory also illustrates the importance of bringing in an appellate lawyer sooner, rather than later, to prepare for the appeal. An appellate lawyer can ensure that an legal error (or legal issue) is properly preserved for appeal. An appellate lawyer will also be familiar with the various standards of review applicable on appeal.

What was unusual about this recent case, is that the trial lawyer accurately predicted she could win three important but difficult rulings, and she associated me early on to help her make the best possible record in anticipation of the other side’s threatened appeal. Working together, we ensured that the proper law was applied for each legal issue, and we further furnished the trial court with concise and forceful, legal and factual arguments, on each legal issue, enabling the trial court to rule in our favor on all three difficult issues.

As expected, the other side appealed. Our response on appeal was (a) that the trial court applied the correct law when deciding each of the three legal issues raised on appeal, (b) the trial court record was inadequate to reach the other side’s first two legal issues, and (3) the trial court did not abuse its discretion on the third legal issue. In sum, we successfully defended all three key rulings in our client’s favor because we prepared for the appeal while we were still in the trial court. The appeal was won in great part because of what we did in the trial court. This is but one example of what an appellate lawyer can contribute while a case is still before the trial court.

Another case soon going up on appeal

I was recently retained in another new case, where the other side is attempting to set aside the parties’ judgment. The trial lawyer in this new case recommended to his client that I be added to the legal team, for at least three reasons. First, he wants to win, and he volunteered that appellate lawyers are more familiar with the legal standards applicable to set-aside motions. Second, he wants to make the best record possible, in anticipation of an appeal, because the other side is already threatening to appeal if they lose their motion to set aside the judgment. And third, if there is an appeal, he wants to defend it as the respondent on appeal, not file it as the appellant on appeal. As I write this, I know very little about this new case, but I well know my role as appellate attorney – here we go again – let’s win, and if not, let’s ensure we make the best record possible for appeal.

Associating an appeals attorney before there is an appeal

My point, of course, is that appellate lawyers can do more for you if we are involved sooner than you might think. Here are a few thoughts for your consideration:

Before and during trial

Occasionally, appellate attorneys will be working in the background during trial preparation and trial, as illustrated by the two cases discussed above. Appellate attorneys are also involved in larger cases, those with ample budgets, and the need for several attorneys just to get the case to trial. If there are several attorneys preparing your case for trial, it makes sense that one of them should have appellate experience, to round-out the team.

After trial, but before judgment

More often, appellate lawyers are brought in soon after a loss in the trial court, to help prepare the judgment, in anticipation of an appeal. I often characterize the preparation of the judgment as the interface between the trial and the appeal. By this point, the outcome of the trial is known, and remaining task is to reduce various trial court rulings and findings to a written judgment. There is much work to be done, and many considerations in anticipation of the appeal. The terms of the proposed judgment are extremely important, and any disagreements will be resolved by the trial court, creating one more opportunity to improve the record for appeal. If execution on the judgment (i.e., collection efforts) is a further concern, the timing of the entry of the judgment, and preparation and filing of the bonding to stay (prevent) execution on the judgment, is also important, if not urgent. An award of attorney fees may also be an issue and, if so, this presents another consideration for appeal. After trial, but before judgment, there is plenty to do, and this type of work is often done by, or with the assistance of, appellate lawyers.

After judgment

Most often perhaps, appellate lawyers are brought in after entry of judgment, to prepare the notice of appeal, before time runs out to do so. At this point, an appellate lawyer can handle the bonding necessary to stay execution of the judgment, and also take the case up on appeal, but the opportunity to improve the record and the judgment for appeal, will have passed.

How to evaluate when to involve an appeals attorney

Most cases will not go up on appeal, and experienced trial lawyers will quickly recognize these cases. Other cases, predictable in nature, and handled by experienced trial lawyers, may not justify or require an appellate lawyer. However, in those cases where an appeal is threatened, likely, or certain, the question is not whether to bring in an appellate lawyer, but when. Each case is different. Consult an appellate lawyer whenever an appeal is foreseeable, or likely. Most appellate lawyers will have this initial discussion with you at no cost, so make the call, to determine what will work best in your case.

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?

Could some deaths been prevented in Dr. Sylvia Hofstetter’s case?

The lengthy DEA investigation of doctor Sylvia Hofstetter

I earlier commented on the case involving doctor Sylvia Hofstetter and, as I explained then, I have no personal knowledge of Dr. Hofstetter or her case, having only read about Dr. Hofstsetter in the media. Nonetheless, any lawyer having any experience defending doctors against drug diversion charges will know that the government’s investigations can be quite thorough, and this is certainly true of the investigation into Dr. Sylvia Hofstetter. By one account, it was described as a “lengthy multi-year investigation” into Dr. Hofstetter’s move from Florida to Knoxville, Tennessee. It was further reported that “there were at least seven overdose deaths” due to controlled drugs prescribed by Dr. Hofstetter’s clinics, and that number does not include “dozens” of other potential deaths, as follows:

“In four years, the FBI said prescriptions for more than 12 million pills were written by Hofstetter’s clinics * * * [and] there were at least seven overdose deaths due entirely to opioid drugs that were prescribed by Hofstetter’s clinics. [The investigator] said seven deaths was a solid estimate because that number does not include dozens of other overdose deaths where other drugs may have been in the victims’ systems.”

See http://www.wbir.com/story/news/crime/2015/03/13/overdose-deaths–organized-crime-linked-to-pill-mill-operation/70285100/

The unasked questions

How many deaths could have been prevented had the government concluded its investigation of doctor Sylvia Hofstetter in two years instead of four? It does not appear that the government’s case against Dr. Hofstetter would have been compromised in any way that would have affected the government’s ability to pursue Dr. Hofstetter on criminal grounds after a two-year investigation. Alternatively, how many deaths would have been prevented had the DEA acted quickly after Dr. Hofstetter’s practice standards became suspect, by administratively suspending and then revoking Dr. Hofstetter’s DEA Registration, which would have ended her ability to prescribe controlled drugs all together?

A matter of public policy

These questions are public policy questions only, exploring the tip of the iceberg of social values, priorities, and the allocation of public resources. These questions are not intended to suggest a legal defense.

Drug diversion? Why “medical necessity” is not the standard

Last month two physicians, doctor John Couch and doctor Xiulu Ruan of Mobile, Alabama, pleaded not guilty to multiple charges of drug diversion. I have no personal knowledge of either Dr. John Couch or Dr. Xiulu Ruan, or of their case, having only read about the doctors in the media. What caught my attention was that the news report included a discussion of “medical necessity,” i.e., whether there was a “medical necessity for dispensing the controlled substance.” Medical necessity is not, however, the legal standard by which the crime is measured. Nor is malpractice. This is an issue I have devoted some time to while defending physicians charged with prescription drug crimes. Rather, “drug diversion” is a specific intent crime. To convict a doctor of drug diversion, the government must prove more than malpractice, and more than the absence of medical necessity.

The elements of the crime of drug diversion

Doctors Couch and Ruan had authority to prescribe controlled drugs by virtue of their DEA Registrations. Under 21 U.S.C. § 841(a)(1), it is generally agreed that the government must prove (1) that both doctors prescribed or dispensed a controlled substance, (2) that they acted knowingly and intentionally, and (3) that they did so other than for a legitimate medical purpose and in the usual course of his or her professional practice. See, e.g., United States v. Norris, 780 F2d 1207, 1209 (5th Cir. 1986); citing, U.S. v. Rosen, 582 F2d 1032, 1033 (5th Cir. 1978).

It is important to know, however, that the Controlled Substances Act (CSA), which is the statutory scheme passed by Congress, includes only the first two elements above. The third element,”legitimate medical purpose,” is rooted in an agency Rule promulgated by the Drug Enforcement Administration (DEA). See 21 C.F.R. 1306.04(a). That Rule provides that a controlled substance can be dispensed by a prescription “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. 1306.04(a); Norris, 780 F2d 1207,1209. Thus, lawyers defending doctors need to be careful that the agency’s Rule does not swallow the federal statute, watering down the criminal conviction standard.

Did the doctors “knowingly and intentionally” divert drugs?

Keeping the federal statute front and center, the question is whether Dr. John Couch or Dr. Xiulu Ruan intended to divert drugs, a specific intent crime. The DEA’s attorneys might very well prove that Dr. John Couch or Dr. Xiulu Ruan prescribed without medical necessity, or that they committed malpractice while prescribing, but more is required to prove the specific intent crime of drug diversion. The DEA’s attorneys must prove that doctors John Couch and Xiulu Ruan “knowingly and intentionally” diverted drugs to an illicit purpose. This is the burden of proof imposed upon the government, by the Congress, pursuant to 21 U.S.C. § 841(a)(1).

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.