Dosing Discrimination: Regulating PDMP Risk Scores

Abstract

Imagine the following scenario. You are a thirty-year-old Army veteran. While in the service, you were the victim of a horrific sexual assault and diagnosed with post-traumatic stress disorder (PTSD). Your military health care provider (HCP) prescribes a low dose sedative “PRN” (take as needed) to mitigate your PTSD symptoms. Several years later, you are diagnosed with a painful and debilitating inflammatory bowel disorder (IBD), which significantly diminishes your daily functioning without treatment. Your military HCP prescribes you hydrocodone, which allows you to manage your IBD symptoms. As your condition deteriorates, you decide to retire from the military and seek treatment at a civilian clinic. At first, your new HCP continues your prescription drug treatment regimen. A few months later, however, that HCP informs you that (1) she is under U.S. Drug Enforcement Administration (DEA) investigation due to her state prescription drug monitoring program (PDMP) data, (2) you have been flagged by the PDMP as at risk for opioid misuse, and (3) she has no choice but to discontinue your medication. You try to no avail to find another HCP before you lapse into opioid withdrawal and are riddled with severe IBD symptoms. Within a week of your medication discontinuation, you are bedridden, unable to work or take care of your family, severely depressed, and experiencing suicidal ideation. This article exposes and critiques the laws and policies that collude to coerce this scenario and identifies and examines a regulatory oversight framework that can mitigate such needless pain and suffering. The American drug overdose crisis and generous funding by U.S. law enforcement agencies have provoked forty-nine states to implement PDMP surveillance programs. PDMP platforms rely on proprietary, predictive algorithmic tools designed and manufactured by a private company to determine a patient’s risk for drug misuse. Law enforcement conducts dragnet sweeps of PDMP data to target providers that the platform characterizes as “overprescribers” and patients that it deems as high risk of drug diversion, misuse, and overdose. Research demonstrates that PDMP risk scoring coerces clinicians to force taper, discontinue, and even abandon vulnerable patients without regard for the catastrophic collateral consequences that attend to those treatment decisions. The proxies that PDMPs utilize to generate patient risk scores are likely to produce artificially inflated risk scores for vulnerable patients. PDMPs, therefore, have the potential to exacerbate discrimination against vulnerable patients with stigmatized medical conditions by generating flawed, short-cut assessment tools that incentivize providers to deny these individuals indicated treatment. The Federal Food and Drug Administration (FDA) is authorized to regulate PDMP software platforms as medical devices and the agency has recently issued guidance that provides a robust framework for such oversight. This Article contends that FDA is obligated to exercise its regulatory authority over PDMP risk scoring software to ensure that such predictive diagnostic tools are safe and effective for patients.