Month: January 2016

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

Posted on January 28, 2016 by - Licensure

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

Posted on January 16, 2016 by - Licensure

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

Posted on January 10, 2016 by - DEA Prosecutions

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?

Posted on January 9, 2016 by - DEA Prosecutions

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.