A tool that was meant to help naive medical professionals identify aberrant behaviors is now being unjustly weaponized for criminal intent!

In the ongoing national conversation around opioid abuse and the role of healthcare providers, one of the most misunderstood concepts in the prosecution of prescribers is the use of “red flags” as evidence of criminal intent. These so-called red flags—indicators that might suggest inappropriate prescribing practices—were originally developed as regulatory tools, not legal standards or evidence.

Their application in criminal trials against physicians, pharmacists, and other prescribers represents a significant departure from their intended use, with potentially dangerous consequences for both healthcare and justice.

Origins and Purpose of Red Flags

The term “red flags” emerged from the regulatory efforts of the Drug Enforcement Administration (DEA) and state medical boards to monitor and guide responsible prescribing behavior. These indicators include things like prescribing high doses of opioids, treating out-of-state patients, accepting cash-pay patients, or seeing a high volume of patients with similar complaints. The goal was to identify patterns that could warrant closer scrutiny or intervention—not to define guilt or intent.

Regulatory agencies and professional boards have long used these indicators as part of administrative oversight to ensure practitioners are complying with professional standards. In that context, a red flag is not proof of wrongdoing but a prompt for further investigation or review. Importantly, these flags are not grounded in statutory law, nor are they derived from criminal legal standards. They were meant to be tools of prevention, not prosecution.

The Shift Toward Criminalization

Over the last decade, as the opioid crisis escalated and public outcry grew louder, law enforcement agencies began to adopt red flags as evidentiary tools in criminal cases. Prosecutors began to argue that the presence of these flags demonstrated a prescriber’s knowledge of wrongdoing or willful blindness. Courts, in turn, increasingly accepted these indicators as circumstantial evidence of criminal intent.

However, this shift raises serious constitutional and legal concerns. Criminal trials are supposed to be governed by clear statutory elements, including proof of intent beyond a reasonable doubt. Substituting regulatory guidelines for statutory definitions blurs the lines between negligence, malpractice, and criminal conduct.

A red flag may indicate poor judgment or a need for further review, but it does not equate to intent to commit a crime—especially when the healthcare professional has no prior criminal history and is only receiving standard reimbursement for professional services.

The Supreme Court's Warning

In its 2022 decision in Ruan v. United States, the U.S. Supreme Court directly addressed the role of intent in controlled substance prosecutions. The Court ruled that the government must prove a prescriber knowingly or intentionally acted outside the bounds of professional practice—not merely that red flags existed. In doing so, the Court emphasized the importance of separating regulatory concerns from criminal liability.

The Ruan decision underscores that a prescriber’s guilt cannot be inferred simply from the presence of red flags or deviations from best practices. It reaffirmed that criminal prosecutions require proof of a guilty mind (mens rea), not just evidence of regulatory violations or unusual prescribing patterns.

The Dangers of Misapplication

Using red flags as criminal evidence threatens the integrity of medical judgment and undermines patient care. Faced with the risk of prosecution, some prescribers have become reluctant to treat patients with complex pain or addiction needs, contributing to undertreatment, abandonment, and even suicide—according to a recent article by the FDA. The chilling effect on medical professionals undermines the very goal of responsible prescribing.

Moreover, when red flags become the standard for criminal liability, they create a vague and shifting legal landscape. What counts as a red flag today may be seen as routine care tomorrow, especially as medical standards evolve. This legal uncertainty violates due process and exposes healthcare providers to arbitrary enforcement.

Conclusion

Red flags in controlled substance prescribing were never meant to be a basis for criminal conviction. They were designed as regulatory tools to prompt oversight and ensure safe, ethical medical practices. The misuse of these indicators in criminal trials distorts their original purpose and jeopardizes both justice and public health.

Courts and prosecutors must heed the Supreme Court’s guidance and ensure that criminal liability is grounded in proof of intent—not regulatory inference.

If you are a healthcare professional or an attorney of a healthcare professional faced with unjust “Red Flag” prosecution, contact me today for assistance in disproving these myths with evidence and expert testimony.

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About Michael Staples:
Michael Staples is a former Police Detective and State Medical Board Investigator, a seasoned CME presenter, and a nationally recognized Healthcare Compliance expert. He currently serves as Director of Compliance for medical practices and healthcare businesses and has successfully supported the defense of numerous providers in both state and federal court.

Michael brings a rare combination of law enforcement insight and healthcare expertise—and he’s passionate about helping professionals like you protect what you've worked so hard to build.