Tag: DEA Registration

Narcotics: too many, too much, too long

Posted on July 9, 2017 by - DEA Prosecutions, Licensure

Oregon Medical Board investigations and narcotic prescribing

It is my recent experience that during medical board investigations, no matter what the nature of the initial complaint, a physician’s prescribing practices will be reviewed if there is any opportunity to do so. And why not? From the Oregon Medical Board’s perspective, there is a national opioid problem, and part of that problem resides in Oregon.  As recently as July 6, 2017, this was the “good news” in Oregon:

“Anne Schuchat, the CDC’s acting director, expressed tempered optimism about the first national decline in opioid prescriptions that the CDC has reported since the crisis began in the late 1990s.

“She said the prescription rate is still triple the level it was in 1999 and four times as much as it is in some European countries.  Even at the reduced prescribing rate, she said, enough opioids were ordered in 2015 to keep every American medicated round-the-clock for three weeks.

“‘It looks a little bit better, but you really have to put that in context,’ Schuchat told the Washington Post. ‘We’re still seeing too many people get too much for too long.'”

Study: Opioid prescriptions largely drop in Oregon counties, July 6, 2017.

The problem is worse in Oregon’s rural counties:

“In Oregon, Curry County prescribers gave out the most opioids per person in 2015, followed by Baker and Malheur counties.  At the bottom of the list — Grant County.”

Study: Opioid prescriptions largely drop in Oregon counties, July 6, 2017.

It is also my experience that rural practitioners will defend their prescribing practices by expressing sympathy for their patients, and explaining that a large percentage are uninsured and there isn’t a pain specialist for miles around. Unfortunately, it is my further experience that these explanations will not get you very far with the Oregon Medical Board.  From the Oregon Medical Board’s perspective, there may be a problem, but narcotics are not the long-term solution in most cases.  If you possess a state medical license and a federal DEA Registration, the Oregon Medical Board expects you to know this, and to do your part to correct the situation.

Sympathy, combined with skepticism and alternatives

The Oregon Medical Board makes its prescribing guidelines – Oregon Opioid Prescribing Guidelines: Recommendations for the Safe Use of Opioid Medications – available on the rotating banner of its website home page, or click here.

Using sarcasm to make a final point, if you truly want to invite trouble from the Drug Enforcement Administration (DEA) or the Oregon Medical Board, treat chronic pain with narcotics in excess of 90 days and 120 MED (morphine equivalent dose), with too much sympathy by the practitioner, in an under-served rural area, with a large percentage of uninsured patients and no pain specialist within miles, which is a recipe for trouble and an invitation for a DEA or Oregon Medical Board inquiry.

A perfect storm is brewing for physicians prescribing narcotics

Posted on May 18, 2017 by - DEA Prosecutions, Licensure

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.

Pharmacist sentenced to 24 years in prison; convicted on “red flag” evidence

Posted on July 1, 2016 by - DEA Prosecutions

Pharmacist dispensed without a “legitimate medical purpose”

A Florida pharmacist was sentenced last week to 24 years in prison on multiple charges that include dispensing oxycodone without a “legitimate medical purpose.”  The evidence against the pharmacist was summarized as follows:  The pharmacist (1) accepted fake prescriptions from (2) customers who came in groups (3) from far distances to get (4) oxycodone.  The prescriptions were written by (5) known suspect prescribers and (6) the patients paid a premium, in cash, for the oxycodone.  In other words, the pharmacist failed to screen for the “red flags” of drug diversion.  Here is a link to the story: http://www.pharmacytimes.com/news/pharmacist-to-serve-24-years-in-prison-for-illegal-oxycodone-dispensing.

The Oregon Board of Pharmacy expects pharmacists to screen for “red flags”

I can assure you from my work as a healthcare defense attorney defending physicians, pharmacists, and prescribing nurses against prescription drug charges by the Drug Enforcement Administration (DEA) that screening for red flags is expected of all prescribing and dispensing practitioners.  Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be considered by the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is suspected drug diversion.  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.  If you are an Oregon pharmacist, I encourage you to view this video.

More on how to “pass” (or fail) your licensing Board interview

Posted on May 30, 2016 by - Licensure

Whether you are being investigated by the Oregon State Board of Nursing (OSBN), the Oregon Medical Board (OMB), or the Drug Enforcement Administration (DEA), your success during your interview is key to the successful resolution of the investigation.  Today I will share with you the experience of three clients – a nurse, a physician, and a dentist – all of whom went to interview within a 14-day span this month.  Two “passed.”  One “failed.”  Let my tell you why.

The nurse and the Oregon State Board of Nursing (OSBN)

Earlier this year I undertook the representation of a well-qualified and experienced nurse under investigation by the Oregon State Board of Nursing (OSBN).  She went to interview this month.  At one hour and 45 minutes, her interview was long, and seemed even longer with four of us in a room that was too small and too hot.  The interview was led by the OSBN nurse investigator and assisted by an OSBN advanced practice nurse, with my client the focus of attention.

The first hour of the interview was necessary to get at the core issues in this unusually complex case.  The OSBN’s investigator and advanced practice nurse were well prepared (aren’t they always?).  My client was also well prepared, however.

As we passed through the first hour of the interview, I was impressed by the depth of the discussion and by my client’s answers.  I privately marveled at how few members of the public will ever appreciate how carefully the practice of nursing is regulated in Oregon.  My client was subjected to questions for an hour and 45 minutes, by two investigators, and her interview had the tone of a thoughtful discussion.  She passed the test.  The case isn’t over, but my client did a stellar job, and representing her that day was professionally rewarding.

The dentist and the Drug Enforcement Administration (DEA)

I also prepared a dentist for an interview this month before the Drug Enforcement Administration (DEA). In this case, the dentist sought reinstatement of his DEA Registration, earlier surrendered.

In a December 7, 2015 post, I explained that in the right circumstances, reinstatement of a surrendered or revoked DEA Registration is possible.  These can be tough interviews, however, because in cases where a DEA Registration has been surrendered or revoked, there are usually a few “sensitive” issues.  Also, the interviews are conducted by DEA Drug Diversion Agents and, in my experience, there are always two of them.

This interview was nonetheless a success.  By the end of the interview, my client was advised he would have his DEA Registration back in four to six weeks, with a few temporary, common sense restrictions, but nothing that will interfere with his practice.  It doesn’t get much better than that!

The physician and the Oregon Medical Board (OMB)

In the same 14-day span this month, I was hired by a physician but, unfortunately, her interview occurred the week before I was hired, and she went alone, unprepared, and unrepresented.  She “failed.”  Let’s consider what my client was up against.  By the time of her interview at the Oregon Medical Board, the Board’s investigator, the Board’s Investigative Committee’s (IC), and the Board’s expert, had all finished their work.  Counting the Board’s investigator, the Board’s expert, and the four members of the Investigative Committee, six people were prepared to interview my client that day.  If you find yourself facing a Board interview, ask yourself the following questions:

  • What have you done to prepare?
  • Who has given you legal advice?
  • Who has prepared you?

If you cannot answer these simple questions in a reassuring manner (without rationalizations or excuses), you are not ready for your interview.  As I have said many times before, an interview with your licensing Board is no place to show up and see what happens.

The moral of the story

In this case, there is little doubt in my mind that this physician should have passed her interview, had she been ready.  But she wasn’t ready.  Don’t let this happen to you.  An experienced healthcare defense attorney will help you prepare for your interview.

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.

 

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.

Reinstatement after surrender or revocation of your DEA Registration

Posted on December 7, 2015 by - Licensure

In a prior post (November 26, 2015) I wrote about reinstatement of medical licenses for physicians, pharmacists, and nurses after revocation by (or surrender to) the Oregon State Board of Nursing, the Oregon Board of Pharmacy, or the Oregon Medical Board. Today I want to add that in the right circumstances, reinstatement of your DEA Registration by the Drug Enforcement Administration (DEA), is also possible.

Key considerations that a DEA Registration lawyer can help you with

I have guided one physician through reinstatement of her DEA Registration after it was revoked and that experience was like most other reinstatement applications. There are numerous issues to consider before reapplying and a licensure lawyer with DEA Registration experience can guide you through the analysis. For example, reinstatement of a DEA Registration is more likely if the DEA Registration was surrendered or revoked through an administrative proceeding (which is a civil proceeding), as opposed to a criminal proceeding. This should come as no surprise.

Also, if your DEA Registration was revoked, it will be necessary to wait-out the proscribed period of time before reapplying, and if your DEA Registration was surrendered, it will be necessary to wait-out the agreed upon period of time (if such an agreement was reached) before applying for reinstatement, and whatever the circumstances that led to the surrender or revocation of your DEA Registration should be addressed too. If you are smart and plan ahead, the wait period can be used to address or correct whatever it was that led to the surrender or revocation of your DEA Registration in the first place.

Be aware that the online application to reinstate your DEA Registration is designed to solicit full disclosure, and you will be required to disclose the history that led to the surrender or revocation of your DEA registration. Explanations will be required too. Explanations should be carefully constructed, well in advance; the moment of your online application is no time for experimenting with answers, phrasings, etc.

Know that because you will have answered “yes” to the disclosure questions, a larger review will be triggered. Your answers and explanations will need to be complete and accurate (but without saying more) to withstand the heightened level of scrutiny that will be imposed. Finally, you should expect to be interviewed by drug diversion agents before your application to reinstate your DEA Registration will be granted or denied. Such interviews are in-person and recorded. These interviews require thoughtful and detailed preparations; this is not a time to casually “show up and see what the questions are.” An experienced DEA attorney will know what concerns the DEA and can help you anticipate the questions and provide complete, accurate, and helpful answers.

A second chance for a DEA Registration is rare – don’t waste it

A second chance to possess a DEA Registration is rare and the process is complex. You will be dealing with administrative law, DEA lawyers, and drug diversion investigators. Do not waste your opportunity for reinstatement. Plan ahead, obtain competent legal advice, and do not delay seeking competent legal advice until you know things are going badly. By then, the common mistakes will have been made and you will have lessened your odds of success.