Connecticut Law Tribune
October 23, 2015

This article previously appeared in the October 2015 issue of the Connecticut Law Tribune. Reprinted with permission from CLT. ©2015

Recent changes to our health care system have been at the forefront of the American news cycle for several years.  But certain aspects have not received adequate attention.  One example is the scrutiny federal and state authorities place on medical practitioners who over-prescribe pain medication controlled substances.  As part of its efforts to combat the over prescription (diversion) of pain medication, the Department of Justice organized “Operation Footprint,” a nationwide law enforcement initiative led by the U.S. Attorney’s Offices, the IRS-Criminal Investigation, the DEA, and the U.S. Postal Inspection Service.  In a recent press release following one of the largest medical fraud sweeps in history, the Special Agent in Charge of the U.S. Department of Health and Human Services stated that “Physicians who overprescribe narcotics not only waste valuable taxpayer dollars and defraud Medicare and Medicaid, they also threaten the health and safety of their patients.”  And in 2014, while serving as the U.S. Attorney for the Eastern District of New York, Attorney General Loretta Lynch highlighted the Department of Justice’s focus on these cases: “We are committed to vigorous prosecution of doctors who abdicate their Hippocratic Oath, participate in the illegal distribution of prescription drugs and contribute to the rise of drug abuse and addiction in our communities.” 

Despite these pronouncements, some health care practitioners, especially those who do not regularly practice pain management, are likely unaware of the criminal liability that can stem from the prescriptions they issue. Ignorance of the law, however, is not a defense.  Thus, it is crucial for attorneys who represent health care professionals to ensure that their clients properly understand their responsibilities with respect to prescribing pain killing controlled substances.

The Controlled Substances Act (CSA) governs the administration of such prescription medication.  Under the CSA, it is a felony to prescribe controlled substances, such as the commonly prescribed opioids Oxycodone, Vicodin and Percocet, for reasons other than a legitimate medical purpose and in the usual course of professional practice. 21 CFR 1306.04, a somewhat obscure Federal Regulation  which sets forth the rules governing these prescription drugs, provides that “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner” and “[a]n order purporting to be a prescription issued not in the usual course of professional treatment. . . is not a prescription within the meaning and intent of [the CSA]” and “the person issuing it shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”

The penalties for violating these laws are harsh. A first offense under the CSA can carry a
20-year prison sentence; if the offense results in serious bodily injury or death it can carry a penalty of 20 years to life.  The U.S. Sentencing Guidelines, which serve as the starting point for all federal sentences convert the  quantity of controlled substances to its equivalent quantity of marijuana.  To put this into perspective, a first time offending doctor over-prescribing just 12 grams of Oxymorphone would face a sentencing range of 27-33 months.   Practitioners who violate the CSA may also face prosecution for health care fraud under federal and state programs such as Medicare, Medicaid and SAGA.  Moreover, the potential consequences go beyond fines and prison sentences; the DEA and Drug Control regularly revoke the registrations required to distribute controlled substances and practitioners generally lose their state licenses to practice medicine.  Under Connecticut General Statutes § 20-45, the Connecticut Medical Examining Board may revoke a physician’s, RN’s or APRN’s license for “illegal conduct in the practice of medicine” and for prescribing “controlled substances except for medically proper purposes.”  While it is sometimes possible to have these licenses reinstated, the process can take years.  And insurance carriers routinely drop these practitioners from their provider networks anyway.

The U.S. Attorney’s Office for the District of Connecticut recently brought a case that highlights its commitment to prosecuting those who issue illegal prescriptions.  After a 14-month FBI investigation, the US Attorney’s Office charged three health care practitioners and one personal injury attorney with participation in a long-running insurance fraud scheme involving the over-prescription of pain medication.  Under the scheme, the personal injury attorney and a chiropractor sent clients to a physician who previously lost his license to practice medicine to receive unnecessary prescriptions (the unlicensed physician worked with a licensed physician who wrote the illegal scripts).  The prescribing physicians provided kick-backs to the referring attorney and chiropractor.  All four individuals involved in the scheme received criminal convictions; the unlicensed physician received a sentence that included 24 months in prison and a $434,529 restitution order.

It is important to note that while the CFR places responsibility for prescribing controlled substances on the practitioner, a corresponding responsibility rests with the pharmacists who fill the prescriptions.  In one recent federal case here in Connecticut, both the prescribing physician and the dispensing pharmacists were prosecuted.

State prosecutors have also brought similar cases in Connecticut.  A West Hartford physician was recently convicted of illegally selling controlled substances after two patients died of apparent overdoses, even when one apparently wrote a suicide note (the physician was originally charged with manslaughter.)

Unfortunately, there are no specific guidelines that distinguish between legitimate prescriptions and those subject to prosecution. Indeed, courts have recognized that it is impossible to expand on the phrase “legitimate medical purpose in the usual course of professional practice” in a way that can provide definitive guidelines to address the varied situations practitioners encounter. Without clear guidance from the courts, practitioners who are faced with unique medical scenarios every day (and attorneys advising them) may find the CSA’s definition of over-prescription and the CFR’s regulations to be vague and not easily applied.  Moreover, the DEA’s practitioner’s and pharmacist’s manuals, which are designed to highlight the “red flags” or “indicia” of illegal prescriptions, lack the specificity and context needed to provide sufficient guidance.  The manuals list the following as some of the possible indications that a prescription was not issued for a legitimate medical purpose:

• Prescriber provides scripts for similar quantities and dosages for all patients.
• Prescriber writes significantly more prescriptions (or in larger quantities) than other practitioners in the area.
• The patient appears to return too frequently.
• Prescriptions are refilled too frequently.
• Prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time (drug abusers often request prescriptions for “uppers and downers” at the same time).
• A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.

However, terms like “too frequently,” “significantly more,” and “short time” are inherently subjective. To eliminate the potential for criminal investigation or prosecution, health care professionals should interpret the regulations broadly and exercise caution in cases of pain management and consider taking the following preventative measures: 

• Follow the appropriate pain management guidelines, such as those available from the Agency for Healthcare Research and Quality National Guideline Clearing House.
• Follow the guidance contained in “Model Guidelines for the Use of Controlled Substances for the Treatment of Pain” endorsed by the Federation of State Medical Boards of the United States, Inc.
• Keep detailed records and ensure that all documentation meets the requirements of state and federal regulations. 
• Have the patient chart include the physician’s thought process for prescribing.
• Write actual amounts, not just numbers, on prescriptions.
• Consider referring patients with chronic pain to pain management specialists.
• If prescribing pain medication for more than a short time-period, require a pain management contract with the patient. 
• If a patient demonstrates drug seeking behavior, history of abuse of alcohol, prescription medication or street drugs, terminate the patient immediately.
• Do not prescribe pain medications for those who have no signs or symptoms of pain.
• Only rely on up-to-date medical tests when prescribing pain medication.

The above examples should serve as a warning that prosecutors take these cases seriously. Lawyers advising their health care clients who prescribe pain management opioid controlled substances should make them aware of the “red flags” of diversion.  Providing these practitioners with a similar list of suggested practices will help ensure that they are adequately informed and avoid becoming the next practitioner in a prosecutor’s crosshairs.

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