Clinical decision support tools in EHRs are prone to abuse could lead to criminal prosecution, warn top officials in an HHS Inspector General’s office in an opinion piece published today in JAMA Internal Medicine.
The direct access to physicians and the assumption that the tools are unbiased make them a potentially powerful marketing device, note the authors, Julie Taitsman, M.D., J.D.. Andrew VanLandingham, J.D., and Christi Grimm, M.P.A.
“How can a physician at the point of care differentiate between a clinical decision support tell that is objective and evidence based or one that is biased by industry,” they write. “A tool that is commercially biased is analogous to a physician consulting a trusted colleague but unknowingly talking to a sales representative whose goal is to promote a particular drug.”
Taitsman and her co-authors say that federal oversight of clinical decision support tools is evolving but note that vendor incorporate without tools without preapproval or “routine retrospective” from any oversight authority. They say that although purchasers may not set up to inspect system code, they should require vendors to attest that commercial interests have not biased support tools and that the tools are based on unbiased and clinically appropriate standards.
They referenced the federal Anti-Kickback Statute, which makes it a crime to knowingly offer, pay, solicit, or receive remuneration in return for arranging or recommending a good or item reimbursable by a federal health program. Prohibited kickbacks can be subtle and would include paying an EHR vendor to alter an algorithm.
They also note the $145 million payment by Practice Fusion to settle criminal and civil allegations. According to Taitsman, VanLandingham and Grimm, this was the first criminal action against an EHR vendor in the U.S. The company admitted, they say, to conspiring with an opioid manufacturer to create a pain alert tool that encouraged physicians to prescribe more extended release opioids. The manufacturers’s marketing staff helped design the alert, including the clinical criteria that trigger the alert. They note that the conduct occurred before AllScripts purchased Practice Fusion in 2018.