How to obtain good results in tough licensure cases: Four examples

Posted on September 9, 2015 by - Licensure

When facing a Board investigation, it is common among practitioners to fear the loss of their license, or the imposition of substantial restrictions upon their practice. Today I will discuss four such cases, involving two physicians, a pharmacist, and a nurse. In one of the cases, the practitioner went so far as to surrender his license, hoping to make it all go away. In all four cases, however, the practitioner prevailed, with the board imposing no discipline whatsoever.

The physician practicing under an evolving standard of care

In the first example, a physician was getting good results for all his patients, and he had no bad outcomes. The standard of care, however, was both disputed and evolving, and the physician had provided his patients with what appeared to be a lot of treatment, and it was the amount of treatment that prompted a complaint to the Medical Board. The case was resolved successfully after the Medical Board came to understand the perspective of several experts, the evolving standard of care, and the above average results that this physician obtained for his patients. In sum, the physician’s knowledge and thoughtful presentation, supported by expert opinion, literature, and good patient outcomes, carried the day. This case was closed without any discipline.

The physician treating chronic pain with narcotics

In the second example, a physician was treating chronic pain with narcotics in a small practice setting. This is a difficult medical practice in the best of settings, given the nature of the patient population, and the scrutiny imposed by state and federal regulators, including the Board of Medicine and the Drug Enforcement Administration (DEA). The physician’s charting was good, however, and, with the assistance of an expert to provide an objective assessment, the physician’s charting was organized into a comprehensive and detailed written report. Small discrepancies were spotted, self-corrected immediately, and disclosed to the Board of Medicine, leaving nothing for the Board to do. The physician’s presentation was persuasive, and the case was closed without any discipline.

The pharmacist-in-charge discovering and reporting a substantial drug loss

In the third example, the pharmacist-in-charge (PIC) discovered a large drug loss in his pharmacy. Security and protocol had been breached. The pharmacist-in-charge was very proactive, however, quick to discover the problem, quick to verify a pattern of theft, and quick to report the drug loss to the Board of Pharmacy and the DEA. The pharmacist-in-charge also confronted the person responsible for the drug theft and further implemented corrective measures. Although the pharmacist-in-charge worked closely with the Board of Pharmacy, it was the pharmacist-in-charge that lead the effort, an effort that was much appreciated by the Board of Pharmacy. And although the drug theft occurred under his watch, the pharmacist-in-charge promptly fulfilled his role in the state and federal regulatory scheme intended to secure the inventory of controlled substances. The case was closed without any discipline.

The nurse alleged to have exceeded his scope of practice

In the final example, a highly skilled nurse was alleged to have exceeded his scope of practice. The nurse’s advanced education and experience carried the day, however. The Board of Nursing concluded that the nurse in fact had the education, training and experience necessary to refute the allegation that the nurse had exceeded his scope of practice. The Board of Nursing reasoned that whatever dispute there was between the hospital and the nurse, it was an employment matter, not a licensure matter. The case was also closed without any discipline.

What you need to know

In difficult cases it is necessary to take the initiative, to perform the research and analysis necessary to take a lead role to get in front of the case, showing your licensing Board what you are doing, and further offering the conclusion the Board should accept without need of discipline. In the four examples offered above, none of the cases proceeded beyond an interview, and in two of the cases, investigators determined that an interview was not warranted. These examples illustrate the value of early action when defending your medical license.

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

Posted on September 4, 2015 by - DEA Prosecutions, Licensure

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.

This is important: Avoid making new license applications while you are under investigation

Posted on August 30, 2015 by - Licensure

If your license to practice medicine, nursing, or pharmacy is under investigation and you know some form of discipline or sanction will soon be imposed, it is only human nature to consider your options. One common mistake, however, is to apply for a new license in a second state before the investigation in the first state closes. The rational may be that you need a fall back position, or that you are tired of the Oregon rain, or that it is time to move back home to be closer to family. These are all explanations I have heard.

What you need to know

What you need to know is that after you are disciplined by one state, that discipline will become public record, and it will become known to any other state in which you are licensed, and – this is important – the other states will open mirror image investigations, and may impose discipline. In effect, an investigation by one state will open an investigation in every other state in which you are licensed. Hopefully, these will be “small fires” to put out, but why risk it unless application for the new license is absolutely necessary.

There can be harsh consequences for making this mistake

As I write this post, I can think of two physicians who obtained new medical licenses in second states unaware of that the new state medical boards will open they own investigations. Yes, the problem can be managed, but it is painful to note that in each case, neither physician ever practiced or even applied for a position in the second state. It was simply a backup plan that was not given much thought, and was never implemented, but it cost the physician a second investigation.

My typical advice

In most cases, my typical advice is to not to apply for a new license in a second state unless and until the investigation in the first state is closed, or well under control, or the outcome is known, and the consequences of the second state’s investigation are understood. If there are extenuating circumstances, be sure to make your decision knowing all the possible legal consequences, and do not make this decision without first seeking competent legal advice.

Can my licensing Board really do that?

Posted on August 20, 2015 by - Licensure

Licensing boards are administrative agencies acting pursuant to administrative law

In the past several years I have been approached by three physicians wanting to sue the Oregon Medical Board in a “real court,” usually meaning a state trial court. All three physicians were angry or frustrated, and all three were dismissive of the Oregon Medical Board’s authority and power. Earlier this year a pharmacist asked me if the Oregon Board of Pharmacy “can really do that?” The pharmacist seemed doubtful that the Board of Pharmacy had that kind of power over his license. All four licensees were frustrated by the strict sanctions threatened by their State licensing Boards.

The range of sanctions

In three of the four cases, the licensing Board was threatening substantial probation and/or revocation, which is at the “heavy end” on the sanction continuum. Sanctions include, for example, being reprimanded; being temporarily suspended, indefinitely suspended, or permanently suspended; or having your license revoked. Sanctions further include fines, continuing education, recurrent training, the imposition of a mentor and/or a monitor, and periods of probation (three to five years is not uncommon). One or more sanctions may be imposed in combination, as each individual case warrants, or the licensing Board sees fit.

The answer is “yes, for the most part, the Board really can do that”

The answer is “yes,” state licensing boards, whether it be the Oregon State Board of Nursing, Oregon Board of Pharmacy, or Oregon Medical Board, are all acting pursuant to State law and, when they are acting within the scope of their enabling legislation (legal authority), they really can do that. The scope of each Board’s legal authority is established by the Legislative Assembly in Salem, which passes statutes to create and empower each of the State licensing Boards. State law also includes the Oregon Administrative Rules (OARs) promulgated by each of the licensing Boards in the furtherance of their mission.

Exceptions

There are some exceptions. For example, if a State licensing Board is acting outside of its scope of its power (the agency’s enabling legislation), then the Board’s action may be challenged on that ground. Similarly, if you contest your case all the way to hearing and lose, you may appeal, seeking judicial review by the Oregon Court of Appeals, but you will not prevail unless you establish that your Board committed legal error, or took action that is not supported by “substantial evidence.” Neither type of challenge is a good bet, and it is not the place to start in any event.

Be smart – do not delay taking action

If you are prudent, you will not stake your case on state court legal challenges and appeals. Your first, best, and least expensive opportunity is to work directly with your State licensing Board. Get involved from the start. Unfortunately, too many licensees wait too long to obtain legal advice – until shortly before or after being interviewed by field investigators or licensing boards, or worse, after receiving written findings and proposed sanctions, i.e., a notice of proposed disciplinary action. At this point, your licensing Board has reached conclusions about your practice and your opportunity to participate and influence proposed findings and sanctions has been greatly lost. But even at this late date, there is still important work to do. For example, the next step may be to negotiate a settlement, or to proceed to an administrative hearing. No matter what you do, however, you will need legal counsel.

Most physicians, many pharmacists, and some nurses have insurance that will cover fees incurred while defending board complaints

Posted on July 12, 2015 by - Licensure

In my experience, most physicians, many pharmacists, and some nurses have insurance that will cover legal expenses incurred while defending a complaint to a professional licensing Board. Perhaps other licensed professional do too. Check your policy, and remember, time may be short to “tender” (file) a claim. Your insurance policy may contain a requirement that you notify the insurance carrier within so many days of the claim, often a short period of time. Although I have successfully tendered one claim many months late, by persuading the insurance carrier to provide a legal defense, late acceptance of an insurance claim should be considered the exception, not the rule, so do not count on it. Seek legal counsel and act swiftly to preserve your contractual rights to insurance coverage.

When in doubt, tender the claim

I am not a “coverage attorney,” but I can review your policy with you, tender claims for you, and refer you to a coverage attorney, when and if that becomes necessary. The important thing to do, however, is to determine what insurance policy may cover your claim, and to then tender your claim to the insurance carrier(s) right away. When in doubt, tender the claim, and let the carrier explain why you do not have coverage for a particular claim. If there is a disagreement with your insurance carrier, I can refer you to a coverage attorney.

Common mistakes licensees make when communicating with their licensing Boards – Part II

Posted on June 29, 2015 by - Licensure

Last week, I explained that if you are under investigation, the record you are creating is a public record, and it will serve as the record should your case proceed to a contested case hearing. This is why the communications you receive from your investigator are formal, cogent, and professional. Similarly, your lawyer’s communications, sent on your behalf, should be coordinated, thoughtful, and legally strategic. In the most difficult of cases, this approach is absolutely necessary to succeed, and in the easiest cases, this approach is still necessary to prevent mistakes. Here are a few examples of real mistakes made by licensees when unrepresented by legal counsel.

Example #1 – Gloria

“Gloria,” a physician, was practicing under a restricted license, and she sought to have many of her restrictions lifted or modified. She sent frequent one or two sentence emails to her investigator, asking questions, often using her smart phone, which added the line, “sent from my smart phone.” Gloria would often send follow up emails without allowing the investigator adequate time to answer her first email. Other times, Gloria would fax material to the Board’s investigator, using only a facsimile cover page and the investigator’s name, without any explanation. All of Gloria’s communications would eventually make it into her file, but those communication were too frequent, too casual, and unprofessional. Gloria also appeared to have a “tin ear” for the investigators requests and concerns. She wanted relief from the Board, but she was not providing what the Board wanted from her. Not surprisingly, both Gloria and her investigator were frustrated, neither one able to understand the priorities of the other, bringing forward progress to a standstill.

Example #2 – Sam

“Sam,” a physician, did his own research, and would occasionally find literature helpful to his case. Sam would attach such articles to an email and send it off to the Board’s investigator, without much explanation, but intending to prove that he was meeting the applicable standard of care. In one unfortunate case, Sam found an article with a seemingly helpful introductory summary, and he sent it to the Board. A thorough reading of the article, however, suggested that Sam’s practice protocols did not meet the exacting standards required by the authors of the article, something Sam did not learn until he was harshly examined during his interview. Despite the time Sam put into his preparations, he never generated, much less provided, a single, cohesive, persuasive explanation of his standard of care.

Lessons to be learned

Perhaps half of Gloria’s communications were unnecessary, if not irritating, to the investigator, and the other half should have been consolidated into a few thoughtful, timely, and responsive communications, that would have placed Gloria in a professional light. More importantly, before Gloria could be in a good position to request relief from the Board, she needed to understand and comply with the Board’s requests. Once these mistakes were corrected, forward progress was immediate, and Gloria got the relief she sought.

Sam had the right idea, because he needed to establish that he was meeting the applicable standard of care. Sam’s approach, however, set Sam up for a big loss. Sam acted hastily. Sam’s defense was not persuasive, and, at times, harmful to him. Sam’s various communications should have been consolidated into one or two timely communications, complete with thoughtful analysis, including end notes, a bibliography, and enclosures of the most helpful articles. Inconsistent authority should have been distinguished. Using this approach, Sam’s mistakes would have been avoided, and the art of persuasion honored. Needless to say, the type of mistakes Sam made are not easy to correct.

Mistakes are often easier to prevent that to correct

Overall, Gloria and Sam both communicated too freely, too casually, and too often with their licensing Boards. Gloria and Sam’s mistakes would have been prevented by experienced legal counsel. Experienced legal counsel will communicate less often, but more thoroughly and persuasively on your behalf.

Common mistakes licensees make when communicating with their licensing Boards – Part I

Posted on June 22, 2015 by - Licensure

Knowing that you are under investigation by your licensing Board will, in the best of cases, create a sense of unease, and, in the worst of cases, create a sense of panic. How you respond when you are under investigation is crucial. If you are represented by experienced licensure counsel, your lawyer will take control of the communications and the deadlines. In doing so, your licensure lawyer will create a “comfort zone,” sparing you much grief and anxiety, while serving the greater purpose of providing you with legal representation.

What you need to know

If you are under investigation, the record you are creating is a public record, and it will be the record that is litigated should your case proceed to hearing. This is why the communications you receive from your investigator are formal, cogent, and professional – your investigator knows what he or she is doing. Similarly, your licensure lawyer’s communications, sent on your behalf, will be coordinated, thoughtful, and legally strategic. In the most difficult of cases, this is absolutely necessary to succeed, and in the easiest cases, this is still necessary to help you prevent mistakes.

Where the trouble starts

All too often, however, licensees defend their cases on their own, usually until one or more common mistakes become apparent, compelling the licensee to retain licensure counsel. Such mistakes often fall into two broad categories. Licensees in the first category, not sure what to do, but feeling the need to do something, communicate too freely, too casually, and too often, with their licensing Boards. Conversely, licensees in the second category, feeling overwhelmed, if not threatened, are slow to respond, or fail to respond at all. Next week I will share a few examples of common mistakes.

For pharmacists: What you need to know about reporting a drug loss or theft

Posted on June 15, 2015 by - Licensure

Once you discover a drug loss or theft, time is short. The applicable Oregon Administrative Rule (OAR) requires that you report a “significant” drug loss or violation related to theft to the Board of Pharmacy within “one business day.” OAR 855-041-1030(2) & (3) (Reporting Drug Loss) provides as follows:

(2) The outlet shall notify the Board in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board.

To notify the Drug Enforcement Administration (DEA), go online and complete and submit a DEA Form 106. Print a copy and send it to the Oregon Board of Pharmacy, as required by OAR 855-041-1030(3), quoted immediately above. Never forget, however, that you are creating a public record. You are also reporting to the DEA and your licensing Board, both of which have significant enforcement powers. Consequently, you will be well served to have a competent attorney advise you throughout the reporting process. It is my preference to review, if not prepare, both reports.

A significant drug loss or theft will prompt an investigation by the Oregon Board of Pharmacy, and perhaps the DEA as well, depending upon the circumstances. The pharmacist(s), and especially the pharmacist in charge responsible for the pharmacy’s annual audits, perpetual inventories, and security of the pharmacy, will be exposed to additional scrutiny by the Oregon Board of Pharmacy and by the DEA. You will want competent legal counsel from the onset. If you proceed without competent legal counsel, you do so at your own peril.

What you should expect

If the cause of the drug loss or drug theft is not clear from the beginning, an investigation will certainly follow, and that investigation will continue until the cause of the drug loss or drug theft is fully known and understood by the Oregon Board of Pharmacy and, perhaps, the DEA as well. You will be interviewed. You should expect that one, or more, Board of Pharmacy inspectors will be involved until the case is resolved.

You should further expect that your pharmacy’s relevant annual audits and perpetual inventories will be requested and reviewed by pharmacy inspectors. Any shortcomings in your pharmacy’s inventory systems will prompt further review by the pharmacy inspectors. More will be required of the pharmacist in charge, as compared to a staff pharmacist, but all will need to be proactive in the investigation and resolution of any perceived lapse in pharmacy security. If the pharmacy’s inventory systems and procedures are legally inadequate, the responsible pharmacist(s), and especially the pharmacist in charge, will face additional scrutiny, and may face disciplinary proceedings.

If you are reporting a drug theft, and the theft was accomplished due to a security lapse, the Board of Pharmacy will pursue the security lapse until the cause of the security lapse is known. If the drug theft was accomplished after hours by someone other than a pharmacist, the pharmacy inspectors and the Board of Pharmacy will further want to know how, or why, a non-pharmacist had access to pharmacy keys and/or pass codes. OAR 855-041-1020 (Security of Prescription Area) requires the following:

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041-2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

(5) Any security system deviating from the requirements of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such security system, as approved by the Board, shall be maintained in the pharmacy.

Finally, you should expect that the Board of Pharmacy investigation will continue until all discrepancies in inventory and systems have been understood and corrected. To the extent you are pro-active and take charge (if you don’t lead the investigation, a pharmacy inspector will), you will improve your chances of a positive and quick resolution. I would be remiss not to add that you will need legal counsel to guide you through the process.

Medical board complaints

Posted on June 8, 2015 by - Licensure

The medical board investigates complaints asserting violations of state law. Most often, complaints assert one or more violations of the standard of care, inappropriate prescribing, inappropriate relationships with patients, physician impairment, and/or criminal activity.

How will I learn that a complaint has been filed against me?

If you are fortunate, you will have learned about the complaint on your own, usually from a colleague, the patient, or a family member of the patient making the complaint. Other times, you will first learn about a complaint when you receive a letter from the medical board, asking you to provide a written explanation. When you learn about the complaint either way, it may be a blessing in disguise, because you have a small amount of time to collect your thoughts, consult a lawyer, and generally prepare yourself to participate in the board’s investigation, which is something you will want and need to do.

If you are unfortunate, however, you will learn about the complaint when you receive a telephone call from the board’s investigator, or worse, an in person surprise visit by the board’s investigator. These surprise calls and visits are most uncomfortable for the physician, they seldom go well, and, in my experience, it means that the medical board believes the complaint is of a more serious type, and that certain desired evidence may best be gained by surprise.

What should I do if I receive a surprise call or visit from a medical board investigator?

I advise my clients to be cooperative, but always decline a surprise interview, and never sign anything without your lawyer’s approval. Instead, request that the interview be scheduled in the next five business days, and offer a time or two. This will usually be adequate for the investigator. If the investigator persists, explain that your calendar cannot accommodate a spontaneous interview and that you are uncomfortable under the circumstances. If the investigator still persists, explain that you want to consult your lawyer and, if necessary, call your lawyer in the investigator’s presence.

Do not be seduced

Friendly questions, or a “few simple questions,” will lead to progressively more difficult questions. Although the investigator is entitled to investigate, and you will want to cooperate with the medical board’s investigation to protect your license and ability to practice, the bottom line is that no physician, and no lawyer, is so skilled and knowledgeable that he/she is prepared for a surprise interview by a skilled investigator. Only the investigator is prepared in that situation, while you are not.

For Pharmacists: Three medication errors could mean probation and loss of PIC

Posted on June 1, 2015 by - Licensure

It is well accepted that dispensing or medication errors occur with some regularity in the practice of pharmacy. While most dispensing errors are never reported to the Board of Pharmacy, once they are, there are consequences for the dispensing pharmacist. For a first and second reported dispensing error, the dispensing pharmacist is at risk of professional discipline by the Board of Pharmacy, most likely a reprimand, and a fine ranging from $1,000 to $5,000.

During one recent case, however, it was revealed to me that the Board of Pharmacy is of the view that for a third reported dispensing error, the presumptive sanction is a fine, plus five-years of probation, and loss of pharmacist-in-charge (PIC) privileges. This is true even when pharmacy workload is a factor, and the prescription involves a look-alike or sound-alike drug.

What you need to know

You need to know that the Board of Pharmacy is imposing discipline upon pharmacists for dispensing errors even though pharmacists know, and the literature establishes, that dispensing errors cannot be fully prevented. For example, according to one study cited by the Institute of Medicine’s 2007 report, 1.7 percent of new and refill prescriptions are dispensed in error:

This more recent, large-scale study of both new prescriptions and prescription refills found an error rate of 1.7 percent (Flynn, et al., 2003). This dispensing error rate translates to approximately 4 errors per 250 prescriptions per pharmacy per day, or an estimated 51.5 million errors during the filling of 3 billion prescriptions each year. One study of medication errors at Medco Health Solutions, Inc., a large mail order pharmacy, carried out by Medco employees, found a dispensing error rate of 0.075 percent—16 dispensing errors among 21,252 prescriptions (Teagarden, et al., 2005).

Preventing Medication Errors: Quality Chasm Series (2007). Retrieved from: http://books.nap.edu/openbook.php?record_id=11623&page=113.

Applying the above error rate of 1.7% to a pharmacy filling 1,500 prescriptions per week indicates that 25 dispensing errors occur each week in that pharmacy. Dispensing errors are not, however, fully preventable, due to what has been described by Stuart R. Levine, et al., as a “latent failure” in the practice of pharmacy:

“Medication errors rarely occur from the failure of a single element or because of mistakes from a single practitioner. Rather medication errors are the result of the combined effects of ‚Äòlatent failures’ in the system and ‚Äòactive failures’ by individuals. Latent failures are weaknesses in the structure of the organization, * * * . By themselves, latent failures are often subtle and may cause no problems. Their consequences are hidden, becoming apparent only when they occur in proper sequence and are combined with active failures of individuals to penetrate or bypass the system’s safety nets. Many of the latent and active failures that were at the root of medication errors are not apparent until a root cause analysis is performed. [Footnote omitted] For this reason, providing an optimal level medication safety requires both recognition and correction of latent failures in the system. * * * . It is unrealistic to expect absolute perfection or error free performance from any person. * * * .”

Stuart R. Levine, et al., Guidelines for Preventing Mediation Errors in Pediatrics, p. 427.