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Medical Device Misuse vs. Off-Label Practice

by Jennifer Fink • October 20, 2023

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Explore This Issue
October 2023

Scrutinizing Outliers

Most otolaryngologists’ use of medical devices is aligned with best practices, institutional and regulatory rules, and clinical guidelines, when available. The few who misuse devices are frequently out of step with their colleagues.

We all knew that if you put saline in it, it ran out instantly. So, we felt bad selling it on label because we knew it didn’t work on label.— Melayna Lokosky

In 2020, JAMA Otolaryngology–Head and Neck Surgery published a retrospective analysis of Medicare claims data for balloon catheter sinus dilations that reported a 270% increase in the number of otolaryngologists who performed more than 10 such procedures per year between 2012 and 2016. There were only 100 to 400 so-called “high-volume” physicians identified in each of those years, accounting for less than 5% of otolaryngologists, charging Medicare for balloon sinus dilation, yet these high-volume otolaryngologists performed nearly two-thirds of balloon sinuplasty surgeries in 2016 (JAMA Otolaryngol Head Neck Surg. 2020;146:264–269).

Dr. Jackson attracted attention because she was consistently a top biller for balloon sinuplasty, even though two of her three offices were located outside of a major metropolitan area. “She was aberrant both because of the amount she’d been paid and because she was doing a lot of balloon sinuplasty procedures and not of lot of the other types of services that an ear, nose, and throat provider typically provides,” said the OIG specialist. “We’re constantly looking at the claims data to see what makes sense and what might not make sense. There’s a lot of comparison with peers, both geographically and in terms of size of practice and specialty.”

Should the medical community at large play a role in detecting and responding to potentially problematic device use? Perhaps.

“I think those outliers are probably the ones that most need to be looked at with a critical eye to try to determine if they’re using that technology appropriately for their patients,” Dr. Schlosser said.

Of course, determining for whom (or how) to monitor medical device use is tricky. Physicians’ collective desire to preserve their autonomy and protect patients’ access to care makes some doctors hesitant to police the practice of other otolaryngologists. “Healthcare is already a very challenging environment, and I wouldn’t want to make it any more difficult for somebody to get the care that they need,” Dr. Rowan said. “We already have a hard time getting payor approval. Nobody wants to make the approval process more difficult.”

Yet identifying outliers is important, he said, adding, “Who actually does the policing, I think, is what’s really challenging.”

Many specialty societies, including the American Rhinologic Society, are volunteer based. State medical boards investigate complaints; they don’t monitor practice. (There is no record of the North Carolina Medical Board ever investigating or taking administrative or disciplinary action against Dr. Jackson. Her medical license expired on May 11, 2023, and she is currently listed as inactive.) Groups within the American Academy of Otolaryngology–Head and Neck Surgery potentially have a vested interest in assessing data and details associated with CPT codes, Dr. Rowan said, but it’s not at all clear if that’s feasible or advisable.

Self-scrutiny is one way individual physicians can protect themselves from claims of inappropriate device use or billing. “If you’re practicing outside of established guidelines, and outside of the algorithm to a large extent, I think you need to critically examine what you’re doing,” Dr. Schlosser said. Your practice may be perfectly appropriate for your patient population, so it’s important to compare your practice to those of others treating a similar population. You may want to ask a trusted colleague for feedback.

“We all have the potential for biases,” said Dr. Schlosser. “Obviously, in medicine, there’s the potential for financial bias—there are consulting relationships, and, as ENTs, we’re compensated for doing surgeries and procedures. There’s also potential bias in our training—how otorhinolaryngologists go forward treating patients may be different than our nonsurgical colleagues, such as allergy physicians who don’t perform surgery. It’s always good to take an honest look at your practice.” 

Jennifer Fink is a freelance medical writer based in Wisconsin.

Pages: 1 2 3 4 5 | Single Page

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

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