Efrem M. Grail

The first six tips and part one of this series is 

Practitioners must take significant precautions to prevent diversion of prescription narcotics and other controlled substances they prescribe and dispense in light of the increased federal law enforcement initiatives. 

In an effort to stem the nationwide opioid abuse epidemic, last summer the Justice Department set up task forces in eleven different geographic regions headed up by specially-funded, full-time Assistant U.S. Attorneys dedicated to “investigating and prosecuting health care fraud related to prescription opioids, including pill mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.” 

These task forces, headquartered in Florida, Michigan, Alabama, Tennessee, Nevada, Kentucky, Maryland, Pennsylvania, Ohio, California, North Carolina, and West Virginia are supported by federal agents from, primarily from the Drug Enforcement Agency (DEA) and the Office of the Inspector General for the Department of Health & Human Services. 

In announcing the new program’s roll-out, Attorney General Jeff Sessions referenced a new “data analytics program” to identify physicians “writing opioid prescriptions at a rate that far exceeds their peers…”  In conjunction with stepped-up requirements for prescribers through next-day narcotic reporting through state-run websites, these federally-funded and supported enforcement task force have already come after physicians and other

DEA registrants who do not adequately prevent diversion of scheduled narcotics through their medical practices.Here are six more tips on how to keep from becoming caught up in the government’s newly-energized enforcement initiative.  They should strike every medical practitioner as self-evident - none of this is rocket science.  But every one of them is based on some enforcement action where a medical professional faced the prospect of state board discipline, loss of DEA registration, or worse.

1. Be aware of “frequent flyer” pharmaceutical consumers, especially those of scheduled substances and narcotics.

If a patient presents with the need for an amount of drugs that, under the circumstances, is “consistent with a readily-diagnosable condition,” consider if she should be referred to a pain management clinic or other specialist.  Otherwise, protect yourself by documenting in the patient’s file why the treatment would be recognized as proper by “a responsible segment of the medical profession,” as regulations most states and the federal government require.

2. When it comes to dangerous drugs, especially narcotics, practice medicine defensively.

While a physician should not automatically distrust a patient, experience teaches that they don’t always tell the truth. Not everyone you see in your medical practice always acts in good faith.  The life you save could be theirs, but the career you save is your own.

3. If a request for narcotics, from anyone - including from another physician - sounds suspect, it probably is.
When you get a request for a narcotics prescription - even if from a trusted colleague, friend, or family member - and it sounds suspicions, it probably is.  Fellow practitioners, medical professionals, and loved ones are not immune from addiction and misuse.  A large minority of enforcement proceedings against practitioners involve diversion to colleagues, friends and family whom the doctors know and trust.

4. Avoid the “Holy Trinity” at all costs.

Everyone has a pet peeve and all diversion enforcement agents share the same one: practitioners who prescribe Oxycodone or Hydrocodone, along with Soma and Xanax (or other drugs from their classes) together.  If you have justifiable medical reasons to prescribe a drug from each of these three categories of controlled substances simultaneously, be certain to document your reasons each and every time you write the prescriptions.  Be certain you have entered the drug orders into the state Prescription Drug Monitoring Program as required.  If scripts aren’t medically necessary, don’t write them, regardless of patient pressure. 

5. Be attuned to “Red Flag” prescribing situations.

There are other “hot buttons” for the prescription police to watch out for: doctors who write scripts for the same or similar opioids in the same quantities for large numbers of patients, often on the same day or in the same week, patients who routinely travel long distances just to see you, especially when other, closer clinics closer to them could be consulted, patients arriving in the waiting room as a group, but who act as if they don’t know each other, and prescriptions written for the same quantities of controlled substances for family members or other patients who all share the same last name(s) on the same day of treatment. 

6.  Addiction Treatment Requires Special Considerations

Even though Buprenorphine may well be at least one of the “wonder drugs” that helps end the opioid crisis, law enforcement is still coming down hard on practitioners who prescribe it in ways that support usage outside of legitimate medical treatment.  If you practice office-based (i.e., non-methadone) addiction therapy, be certain to confirm that a patient seeking Suboxone or Subutex in fact has an addiction, instead of a resale business, and determine if the patient is seeking other necessary treatment (such as therapy) to manage their addiction, before you prescribe. 

, defends medical professionals and health care provider entities in federal and state criminal and administrative enforcement matters in Pittsburgh and the rest of the country. Mr. Grail wishes to thank a compliance attorney, several prosecutors and an enforcement agent who read and critiqued this paper, which contains neither legal nor medical advice.]

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In part two of this series, attorney, Efrem Grail shares six more tips on how to avoid trouble from the law when prescribing opioids.

Stay Out of Opioid-Related Prescription Trouble

Your medical license is likely your most valuable -- and expensive – investment. Don't lose it by taking needless risks or doing something that looks stupid in hindsight, and could result in the diversion of prescription drugs to illegitimate use. Understand the laws designed to prevent diversion, know how the government investigates and prosecutes it, and apply practical steps you can take right now to stay on the right side of the DEA, the U.S. Attorney's Office and the your state's Attorney General's enforcement unit, and the licensing board. Your medical license and prescription privileges depend on it. 

Drug diversion redirects legitimate prescription medication, usually scheduled narcotics, to illegitimate purposes. Federal DEA agents work alongside state Attorney General investigators to "make" criminal and administrative cases based on diversion against providers: MDs, ODs, PAs, NPs, nurses, dentists, pharmacists, and even veterinarians and academic researchers. Prosecutions have far reaching consequences, especially for licensing, insurance and patient eligibility, for years to follow. 

Even those who escape prosecution and retain their licenses may still face the loss of DEA-controlled substance prescribing authorization, resulting in suspension or revocation of hospital privileges, required reporting to the National Practitioner Data Bank, exclusion from participation in Medicare and Medicaid, loss of credentialing by patient insurers, and even possible inability to obtain or retain malpractice coverage. 

Read more: Stay out of opioid-related prescription trouble

Prosecutors and state board enforcement attorneys primarily rely on providers' patient records in carrying out their investigation in the first instance:  Have records documenting diagnosis, treatment and overall care been kept? Does the patient chart demonstrate that the practitioner conducted a verifiable, in-depth (or at least not cursory) patient examination? Does a physician's appointment list reflect that some unreasonably large number of patients were seen in a single day, making it virtually impossible for the practitioner to exam each of them properly?

In tandem with increased governmental enforcement efforts, private medical practices, hospitals, and even provider institutions are establishing prescription monitoring programs designed to collect, analyze and report information on controlled substance prescribing by practitioners to an easily–accessed central data bank. Many states have mandated participation in state-wide Prescription Drug Monitoring Programs, their records can serve as damning evidence.

Be careful. Keep your license. Here are six tips based on actual cases where federal and state criminal and regulatory enforcement agents brought charges against licensed practitioners. All of these cases were avoidable, provided the doctors had used good judgment and applied proactive compliance protocols.

Always write your scripts with the patient in front of you. Do not pre-sign any script in blank, and keep your prescription pads secure and inaccessible to patients. Don't ever sign scripts for your staff to fill in the name of a patient when you aren't present.

2. Avoid manually dispensing controlled substances

Other than where an automated dispensing station (i.e., a "pharmacy robot,") is used, avoid manually dispensing narcotics if at all possible. You can't be arrested for diverting something you don't have. Stores of scheduled narcotics are simply too attractive as targets for patients and staff to take and abuse or resell on the street. If you must dispense, maintain physical security of narcotics, and maintain your medication log. Always record the name of the patient/recipient, the date, the quantity and the dosage of dispensed narcotics, as well as the diagnosis that made the prescription necessary. There have been cases filed involving blank "med" logs, falsified ones, and even logs where the doctor knowingly recorded the truthful, accurate date, amount, strength and name(s) of the person(s) with whom the prescription narcotic was knowingly (and wrongfully) shared, i.e., diverted (e.g., wives, mistresses, etc.)

Read more: How to safely prescribe and manage opioidsâ¨

3. Don't dispense or prescribe controlled substances for friends or family

Other than in a true medical emergency that occurs in an isolated setting where there is no other qualified physician available, practitioners should not prescribe or dispense controlled substances or scheduled narcotics for themselves, their immediate family, their friends, or their neighbors. And if they must, perform a real examination and document it in writing, with a diagnosis requiring prescription medication. Note the amount, strength, frequency and date of the script, and keep the record of the exam and treatment. 

4. Don't prescribe pharmaceuticals outside of an established medical relationship

New state-wide PDMP programs require prescription entry into a database before the end of the next business day – there is no "Friends & Family" exception. 

5. Avoid "courtesy" writing of prescriptions

For the renewal of non-conflicting medication prescriptions written by another treating physician, which the patient requests as a "courtesy," the practitioner should never prescribe without independently assessing the condition or illness for which the drug is being prescribed, or obtaining the medical records from the original prescribing physician documenting the condition. Beware of simply relying on a patients "naked" request, not supported by an examination and a diagnosis.

Read more: 13 red flags your pain patient is a drug seeker

6. Don't write a prescription without examining a new patient first-and be in the same room with them

Medical protocols are changing, and "telemedicine" envisions doctors completing examinations and treatment of new patients even when the physician is halfway across town or halfway across the globe. But we are not there yet. Do not provide scripts for controlled substances for the husband or child of a patient you never met, the mistress of your medical practice partner, or anyone else who could have easily come in person for an office examination but didn't. It may be one thing to "call in" a script to the pharmacy for an existing patient who calls for a refill, or who e-mails about a reaction to a prescribed medication and wants a substitute – but it's entirely another for someone just passing through town and who never "presents" to your practice for a proper examination and diagnosis.

, defends medical professionals and health care provider entities in federal and state criminal and administrative enforcement matters in Pittsburgh and the rest of the country.

How to keep to your license and stay out of prison. Advice from the front lines of the DEA's war on prescribers.