Stemple Quoted on Navigating Drug Representative Visits in Duke Health Article

Duke Health Clinical Practice Newsletter

Health Care Partner Hillary Stemple was recently quoted on how physicians and other providers can navigate visits from drug and device manufacturer representatives, highlighting the legal and ethical complexities involved.

Hillary said, “Visits from drug reps have always been a high-risk touchpoint,” due to potential violations of the Anti-Kickback Statute and associated False Claims Act, as well as patient privacy implications related to Health Insurance Portability and Accountability Act (HIPAA) compliance. She pointed out the importance of following guidance issued by the US Department of Health and Human Services and professional associations like the American Medical Association and emphasized that meals from manufacturers should be “modest” by local standards and should involve a substantive discussion with the manufacturer representative.

Hillary stressed the importance of protecting patient privacy, noting that reps should never access patient-identifying information. She also warned against providing services or assistance that could be considered “expense relief”, which could also implicate the Anti-Kickback Statute. Expense relief is “something of value to the physician practice that they would otherwise have to pay for,” she said.

Hillary also highlighted the need for physicians to carefully review payments reported in the Open Payments (Sunshine Act) database, as higher-than-average payments may raise questions with enforcement agencies.

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