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Medical Device Misuse vs. Off-Label Practice

by Jennifer Fink • October 20, 2023

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Within those bounds, physicians have a lot of flexibility to use the tools of medicine to assess and treat patients. Technological advances frequently outpace efforts to establish comprehensive clinical practice guidelines, so physicians must decide how to responsibly use available tools and technology. Often, there’s disagreement.

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Explore This Issue
October 2023

Consider thyroid ultrasonography. Use of ultrasonography as a point-of-care tool has increased in recent years, and so have concerns about inappropriate use. As noted in a 2020 JAMA Surgery research letter, “Physician-Reported Misuse of Thyroid Ultrasonography,” a “substantial number” of surveyed physicians (a mix of primary care doctors, endocrinologists, otolaryngologists, and general surgeons) support the use of ultrasounds for “clinically unsupported reasons,” including patient request, abnormal thyroid function tests, positive thyroid antibody test results, and fatigue (JAMA Surgery. 2020;155:984).

There aren’t yet universal standards for ultrasound credentialing, and there is variability regarding appropriate documentation and image capture for billing in ultrasound procedures of the head and neck outside of thyroid imaging. “The ultrasound represents an overall safe and very accessible tool for providers to implement easily in the office,” said Leila J. Mady, MD, PhD, MPH, an assistant professor of otolaryngology–head and neck surgery at Johns Hopkins Medicine. “But point-of-care sonographers can have widely varied experience and training levels that can impact the interpretation of ultrasound images and, ultimately, patient care.”

Robotic surgery is another area that is quickly evolving, adding urgency to discussions of appropriate versus inappropriate use of this technology. Use of transoral robotic surgery (TORS) has expanded since 2009, when the FDA approved it to treat T1-T2 malignancies of the oral cavity, oropharynx, and larynx (J Clin Med. 2023;12:2303); today, some physicians are performing pediatric TORS to treat residual sleep apnea post tonsillectomy and lingual thyroglossal duct cysts.

Even as researchers continue to study and evaluate new uses of robotic surgery, others are anticipating questions about appropriate use. “I think there will certainly be a question of, do you really need to use a robot?” Dr. Rowan said. It will be important, he said, to delineate when not to use technology that increases cost with limited clinical advantage.

Dramatic stories of medical device misuse tend to inspire reactionary legislation and regulation. They also “increase mistrust of healthcare providers” and fuel skepticism of providers’ intent, Dr. Mady said.

Such skepticism may seem appropriate considering headlines outlining serious misconduct. “When at the doctor, people should receive services that appropriately address their healthcare needs,” said an Office of the Inspector General (OIG) specialist who worked on the Jackson case and asked not to be identified. “Unfortunately, some medical practitioners act insidiously and take advantage of their patients to amass personal profit.”

Unfortunately, efforts to protect patients may inadvertently make it more difficult for patients to access necessary treatment. Despite heinous misuse in some hands, balloon sinuplasty, for instance, remains a valuable tool. “There is absolutely a need for balloon sinuplasty in our space,” Dr. Rowan said. “It’s a shame that it may become more challenging because of a few bad actors.”

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Filed Under: Features, Home Slider Tagged With: Billing standards, medical devices, off-label useIssue: October 2023

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