Explore This IssueOctober 2023
Between 2012 and 2017, an otolaryngologist in central North Carolina was the nation’s top-paid Medicare provider of balloon sinuplasty. But all was not as it seemed.
Anita Louise Jackson, MD, performed 1,555 balloon sinuplasty surgeries on 919 Medicare beneficiary patients with fewer than 40 balloon dilation devices. According to the U.S. Department of Justice, Dr. Jackson lured patients by marketing “free sinus spas” and induced patients to undergo sinuplasties they may not have needed by intentionally failing to charge co-pays.
In January 2023, Dr. Jackson was convicted on 10 counts of illegally inducing her patients to receive sinuplasty and found guilty on charges of adulterating medical devices for use on patients with intent to defraud and mislead, fabricating medical and healthcare records, paying illegal renumerations, and engaging in mail fraud and conspiracy. She was ordered to forfeit more than $4.7 million dollars and sentenced to 25 years in prison.
The Jackson case is a gross example of medical device misuse. But what about less egregious cases? Is using a microflow spacer to deliver steroids to the sinuses medical device misuse, if the device is only FDA approved to deliver saline? What about performing an in-office thyroid ultrasound on a patient with abnormal thyroid function test results?
The line between appropriate and inappropriate use isn’t always bright and clear cut. Medical practice (and billing) evolves with new technology and research. Busy physicians do their best to keep up with advancing science and certainly don’t have time to personally review all new clinical research and each of their billing statements.
“The vast majority of physicians and otolaryngologists in this country are honest and ethical and want to do the right thing for their patients,” said Rodney Schlosser, MD, professor and director of rhinology at the Medical University of South Carolina in Charleston. Most otolaryngologists use medical devices as outlined in clinical practice guidelines. Some extend the boundaries of medical practice by intentionally (and thoughtfully) using medical devices off label. Some doctors unwittingly charge payors for unapproved uses of devices. And a few engage in clear misconduct.
Dramatic outliers, such as Dr. Jackson, generate headlines and concern. Yet detecting and reining in medical device misuse is a challenge in a society that prizes profit, innovation, autonomy, and productivity.
Profit Motive May Encourage Misuse
Balloon sinuplasty is a potentially lucrative procedure. “It can be potentially very easy to make a profit,” said Nicholas Rowan, MD, associate professor of otolaryngology—head and neck surgery at Johns Hopkins Medicine in Baltimore. As of 2014, reimbursement for balloon sinuplasty surgery was approximately 10 times greater than for functional endoscopic sinus surgery. Additionally, a single-use balloon can be used to open multiple sinuses in a single patient, and Medicare, Medicaid, and most private insurance companies will cover balloon dilation once per sinus per the beneficiary’s lifetime.
“As an example, if you balloon dilate one sinus, you may be able to break even; however, if you find pathology in six different sinuses, you may go from no profit or minimal profit to several-fold times what you would have had,” Dr. Rowan said, while noting that balloon sinuplasty is an extremely useful tool that allows physicians to access and treat pathology that might otherwise require expensive, difficult-to-access subspecialist care.
Because the procedure is profitable, easy to perform, and generally well-tolerated, the number of balloon sinuplasties performed in the United States skyrocketed over the last 15 years or so. The push toward pay-for-performance may also be a factor.
“You have a workforce that’s perhaps being incentivized to be more productive,” Dr. Rowan said. “That’s a challenging predicament for people who are really trying to do the right thing.”
Providers can also be impacted by the need to turn a profit and please investors. That may be what happened when Acclarent allegedly caused healthcare providers to submit false claims to Medicare and other federal healthcare programs by marketing and distributing its Relieva Stratus MicroFlow Spacer for use as a drug delivery device without FDA approval for that use (https://www.justice.gov/usao-ma/pr/medical-device-manufacturer-acclarent-inc-pay-18-million-settle-false-claims-act).
“The goal for a start-up company is to make eight to 10 times the investors’ investment in three to five years,” said Melayna Lokosky, a former Acclarent sales rep turned whistleblower who shared information with the Department of Justice (DOJ) showing that Acclarent actively encouraged its sales reps to promote the Stratus spacer as a steroid-delivery device to be used with Kenalog-40, which is intended for injection into living tissue.
Because it’s common for otolaryngologists and other physicians to use drugs and devices off label—and because steroids are routinely used to decrease inflammation—Acclarent’s marketing of the Stratus spacer didn’t initially attract concern. Sales reps realized, though, that the device, which was approved for use with saline, didn’t work for that purpose.
“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,” Lokosky said. She believes “it was decided and built into the business model from inception: We need doctors to use this off label.” The DOJ investigation, she said, “could not find a single device that was used on label.”
In 2016, Acclarent, a subsidiary of Johnson & Johnson, agreed to pay $18 million to resolve the allegations against the company.
Who Decides Appropriate Use?
Physicians have a legal duty to provide a certain standard of care to their patients (CMAJ. 2010;182:167–170). And according to the American Medical Association Code of Medical Ethics, physicians individually and collectively share the obligation to ensure that the care patients receive is safe, effective, patient centered, timely, efficient, and equitable.
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.
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.”
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.
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.