Barry Straus, MD, JD
This is the first in a series on the legal aspects of prescribing controlled substances. The series will cover federal and state issues regarding prescribing controlled substances.
Controlled substance prescribing is regulated by both federal and state laws. The Controlled Substances Act, codified at 21 U. S. C. §841, makes it a federal crime, “[e]xcept as authorized [,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance,” such as opioids. 84 Stat. 1260, 21 U. S. C. §841(a) (emphasis added). Registered doctors may prescribe these substances to their patients. But, as provided by regulation, a prescription is only authorized when a doctor issues it “for a legitimate medical purpose . . . acting in the usual course of his professional practice.” 21 CFR §1306.04(a) (2021). Essentially, all drugs listed as controlled substances are illegal under federal law unless prescribed by a registered doctor. Ruan V US states that to be CRIMINALLY liable one must “knowingly or intentionally” violate the law. Criminal, as opposed to civil, law seeks to punish the “ ‘vicious will.’ ” Morissette v. United States, 342 U. S. 246, 251 (1952). With few exceptions, “ ‘wrongdoing must be conscious to be criminal.’ ” Elonis v. United States, 575 U. S. 723, 734 (2015). The government must prove beyond a reasonable doubt that the prescription was not “for a legitimate medical purpose…acting in the usual course of his medical practice”. The Court specifically stated that circumstantial evidence may be used to show this. Good faith alone is a portion of the defense, either as an affirmative defense or as a reputable proposition. Just claiming good faith is not enough however. The question is what evidence may be used for and against you in a prosecution.
We are presumed to know ALL applicable laws and regulations related to our activities. “Ignorance of the law is not a defense”. This would include not only the federal CSA and regulations but all your state laws and regulations. Every state has regulations regarding narcotic prescribing. A simple example is most states have ruled that a controlled substance prescription written for a family member or for someone you are having sex with is per se not a legitimate prescription. This would then expose you to federal criminal liability. PDMP flags/warnings, insurer notifications regarding controlled substance dosage and combinations, exceeding the recent CDC guidelines, violating the DEA practitioner manual, ignoring warning signs of abuse or diversion, violating your own controlled substance policy/contract can all be used as evidence of knowingly writing for a non-legitimate purpose. These should be addressed in the record with some medical reasoning provided. Addressing these facts in the medical record will help prevent criminal prosecution and bolster a defense in the worst case. Having a controlled substance agreement will help one’s defense. Violating your own agreement without addressing that in the chart will harm the defense. Writing controlled substances without a charge suggests being written for an illegitimate purpose. Paying for strippers/prostitutes by writing controlled substances for them is not a good idea. It has been tried multiple times and multiple physicians have been convicted because of it. They will use you as a “get out of jail” card.
The DEA and other law enforcement agencies can and will get access to your banking records and social media. Texts, phone records, social media posts, e mails, electronic records, access logs, and internet searches can all be subpoenaed and used as evidence. Information from these could be used as evidence of knowingly violating the CSA. Your malpractice carrier would be happy to advise you on a social media policy. The DEA has found that many practitioners who fall afoul of the CSA often have money or sex issues. Recent expensive divorce, single or multiple, and/or mistresses/boyfriends/girlfriends/sugar babies often can cause one to be vulnerable to “get rich quick” schemes. The DEA will look for this, as will your significant other. The more your lifestyle looks like “Miami Vice” or “Scarface” the easier to prove intent.
Defense from criminal prosecution may have been made easier by the recent CMS LCD on Urine Drug Testing. This LCD has adopted the Purdue position that C2 medications are not highly abused and have minimal risk of abuse. They claim that one can predict abuse by the response to SOAPP or ORT. The assumption is that substance abusers will always tell you the truth about their abuse. CMS has included that statement in the education to prescribers that they have promulgated. Following that LCD could be used as evidence that you were not knowingly violating the CSA.
TL/DL- document why you are writing the drugs you prescribe. Do not look like a drug dealer.