Why ASAM’s Policy on Physician Prosecutions Matters to Providers and Patients
I’ve spent years watching well-intentioned physicians find themselves in the crosshairs of the Department of Justice (DOJ) for doing what every patient hopes they’ll do: act in their best medical judgment. You’d think prescribing controlled substances to treat pain or manage opioid use disorder (OUD) would be considered just that—good faith medicine. But the Controlled Substances Act’s ambiguous language about “legitimate medical purpose” has turned everyday clinical decisions into potential criminal charges. And in the aftermath, patients suffer, too, often left without care when doctors decide it’s safer to stop prescribing altogether.
“LEGITIMATE MEDICAL PURPOSE”
Let’s start with the main culprit: the vague requirement under the Controlled Substances Act that prescriptions be issued “for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” If that sounds straightforward, trust me—it isn’t.
In 2022, the Supreme Court tried to set things straight in Ruan v. United States, telling prosecutors: you can’t convict a doctor for prescribing errors or mere disagreements in treatment unless you prove they knowingly or intentionally acted without a legitimate medical purpose. Seems like a big win, right? Maybe on paper. Because in the trenches, agencies have pretty much carried on with their business as usual—prosecuting doctors for “deviations from standard care,” even if they were trying to do the right thing.
I attempted to put it succinctly in an interview with OR Management News: the Ruan decision was a badly needed “correction” to prosecutorial overreach. But the final word hasn’t landed where it needs to. Doctors are still tiptoeing around the government’s rubber yardstick, not knowing how much will be “too much” or “too unconventional” in the eyes of a DEA agent who’s never met their patients—or felt their pain.
CIRCUITS DESTROYED RUAN
So, the Supreme Court made it crystal clear: to convict a doc, you have to prove they knew what they were doing was unlawful. End of story, right? Not so fast. The lower courts have been busily carving out loopholes and reading the CSA in ways that practically ignore the heart of Ruan.
The epicenter of confusion? Whether the standard for prescribing “in the usual course of professional practice” and for a “legitimate medical purpose” is conjunctive or disjunctive:
- Conjunctive Standard: Prosecutors must prove both a lack of legitimate purpose and a deviation from professional norms.
- Disjunctive Standard: It’s enough to show either a lack of legitimate purpose or a deviation from professional norms.
That might sound like legal minutiae, but believe me, it’s huge. Under the disjunctive view, you can be hauled into court just because your prescribing style doesn’t fit some “usual practice” that likely doesn’t even exist in real life. Meanwhile, none of your good faith or patient-focused intention matters.
Case in point: Dr. Ronald Lubetsky’s petition for certiorari. The Eleventh Circuit pinned him to the wall on a disjunctive reading of the CSA. Did they bother to examine whether he actually had a legitimate reason for what he prescribed? Not so much. They just pointed to how his methods supposedly broke from the “usual course of professional practice.” Wham, criminal liability.
CONJUNCTIVE VS. DISJUNCTIVE:
The conjunctive standard is obviously closer to Congress’s original target—drug traffickers, not doctors. After all, if you genuinely aim to help a patient’s health-related issue, you shouldn’t go to prison for deviating from the next doc’s approach.
But more and more courts are leaning disjunctive. That’s a terrifying prospect if you’re a physician treating, say, a patient addicted to fentanyl who might need higher-than-typical doses of buprenorphine. Or a patient with a unique mental health history who needs off-label stimulants. Either scenario could be flagged as “outside the usual course of practice,” leaving you wide open to prosecution.
The result? Doctors become gun-shy about prescribing anything that might raise an eyebrow. Patients who desperately need meds—particularly those with OUD—end up stuck in limbo, or worse, forced onto the streets for illicit drugs.
FEAR AND LOATHING IN THE EXAM ROOM:
HOW LEGAL UNCERTAINTY UNDERMINES PUBLIC HEALTH
It’s not just about doctors’ livelihoods; this is about people who need medical help. OUD is rampant. Tens of thousands die yearly from overdoses, a crisis that only grows when legitimate prescribers back away. Even an investigation (no charges, no conviction) can drain a doctor’s finances, ruin their reputation, and leave them skittish to ever prescribe again. So you get a ripple effect: fewer docs willing to write for buprenorphine or other medications, forcing patients to tough it out or turn to illicit drugs.
This is precisely why this author and policy groups such as ASAM keep hammering on the need to implement Ruan as it was intended. If we want to solve the opioid crisis, we can’t be scaring away the very professionals best equipped to handle it.
ALIGNING ENFORCEMENT WITH THE CSA’S ORIGINAL PURPOSE
I’m all for catching the real bad apples. But that was always the CSA’s goal: to curb drug trafficking, not micromanage medical care. If a doctor is merely a “bad doctor,” we have malpractice laws and medical boards for that.
Criminal penalties should be reserved for those knowingly prescribing for non-medical reasons—straight-up drug dealing, pure profit schemes, or fueling diversion. The rest? That’s a matter for civil court or professional discipline, not the feds.
WHAT NEEDS TO CHANGE:
POLICY & PRACTICE RECOMMENDATIONS
- Clarify “Legitimate Medical Purpose”
The DOJ, DEA, and U.S. Attorney General should step up and declare, in plain language, that a legitimate purpose means treating or preventing a real health condition. Period. A little clarity goes a long way in preventing prosecutorial fishing expeditions. - Embrace the Conjunctive Standard Nationwide
Let’s make it uniform: to convict a doctor, you’ve got to prove they both lacked a legitimate purpose and acted outside the usual practice. Good-faith prescribing shouldn’t be a felony, even if it’s unconventional. - Focus on Genuine Drug Trafficking
With limited resources, the DOJ should target the real criminals—pill mills and blatant diversion schemes—rather than second-guess thousands of doctors making honest, complex treatment decisions. - Leverage Civil Remedies Over Criminal Prosecution
When there’s a borderline practice issue, leave it to malpractice suits or professional boards. There’s a big difference between sloppy care and criminal intent.
WHY IT MATTERS NOW MORE THAN EVER
The United States is in the thick of an overdose crisis that’s shown no sign of backing down. The big irony is that, while the government purports to fight opioid abuse, it’s also making it riskier to prescribe the very medications that can help people climb out of addiction. Blocking access to MOUD is like throwing water on a fire while someone else is pouring gasoline on it.
Moreover, it’s not just an “opioid” problem anymore. With fentanyl and polysubstance use creeping in, doctors need the freedom to try novel approaches, higher doses, or off-label options. If they’re too afraid of federal indictments, more patients will be left in the dark.
CONCLUSION: RESTORING COMMON SENSE AND SAVING LIVES
We need a tectonic shift in how the CSA is enforced. Ruan v. United States was a step in the right direction, but without the Supreme Court firmly batting down the disjunctive standard across all circuits, it’s like locking the front door while leaving the back window wide open. A uniform, conjunctive standard—combined with clear definitions of “legitimate medical purpose”—would put doctors’ minds at ease and keep the DEA’s attention where it belongs: on real criminals.
Until then, we risk more stories of decent doctors ensnared by vague guidelines, prosecutorial zeal, and unlicensed government actors who, ironically, get off easier than the folks in their crosshairs. Meanwhile, patients with OUD continue to die from untreated addiction, and our national crisis deepens.
At the end of the day, it’s about returning the CSA to its original intent—stopping actual drug trafficking—and letting honest physicians practice medicine without paranoia. Because when medical decisions become crimes, everyone loses: the doctor, the system, and most of all, the patient.
Safe Harbor Group is a healthcare consulting firm committed to guiding medical providers and health systems through complex regulatory environments. In a time when the CSA’s murkiness can derail a physician’s career, our mission is to help practitioners protect themselves, advocate for policy reform, and—above all—deliver life-saving care to those who need it most
