SAN DIEGO—The latest data continue to show an upward trend for the number of balloon dilations performed in the U.S., continuing an explosion of use that’s been seen for the past decade or so. In 2017, 43,936 of the procedures were performed under Medicare Part B, a 4.7% increase from the year before (JAMA Otolaryngol Head Neck Surg [published online ahead of print January 23, 2020] doi: 10.1001/jamaoto.2019.4357).
The level of growth is not as sharp as the eye-popping increases seen in the early part of the last decade, when balloon dilations jumped 75% from one year to the next (JAMA Otolaryngol Head Neck Surg [published online ahead of print January 23, 2020] doi: 10.1001/jamaoto.2019.4357). But the cost of the device is still included every time a balloon code is used, generating huge profits, and the procedures are still being performed at extremely high numbers, panelists said in a discussion here in January at the Triological Society Combined Sections Meeting.
And the procedure still faces the scrutiny of some otolaryngologists who are worried it’s being used without regard to best care. Today, in a roomful of otolaryngologists, the mere mention of the words “balloon sinuplasty” can conjure thoughts of misplaced priorities in medicine.
Otolaryngologists on the panel, moderated by Jastin Antisdel, MD, chair of otolaryngology at Saint Louis University in St. Louis, Mo., talked about how the field ended up doing so many balloon dilations—and where it can go from here.
Beginnings of Criticism
Balloons, which were adapted from cardiac catheters as a way to dilate the sinuses, drew concern as early as 2006 after media reports noted the lack of data showing the procedure’s effectiveness (Abelson, Reed. Too Soon to Breathe Easy? The New York Times, 2016). That same year, a journal commentary piece lamented that “this technology did not go through the proper vetting process in the medical literature before being released in the public media, thereby creating patient expectations that will likely not be realized and potentially damaging the credibility of our specialty in the eyes of the public” (Ann Otol Rhinol Laryngol. 2006;115:789-790).
“This is really the first time, at least in my 18 years in otolaryngology, where we really see this concept of direct-to-consumer marketing, where the physician is bypassed and now we have patients calling our office” about a product, said meeting panelist Pete Batra, MD, chair and professor of otorhinolaryngology at Rush Medical College in Chicago.
The main study that set the framework for discussions about balloon sinuplasty was CLEAR, in which the balloon sinuplasty-only group did generate a statistically significant improvement in SNOT-20 scores (Otolaryngol Head Neck Surg. 2007;137:10-20; Otolaryngol Head Neck Surg. 2009;141:551-554). But physicians questioned the findings because the improvements plateaued after a year, and the comparison group, a “hybrid” of balloon plus ethmoidectomy, started out with higher scores, but still ended up with lower scores than the balloon-only group after two years.
“This is really an uncontrolled, observational study,” Dr. Batra said.
Steven Pletcher, MD, noted that many studies that suggest a benefit for balloon sinuplasty were funded by device companies, and that researchers have received consulting fees over the years that have ranged from $10,000 to $80,000.
One Acclarent-funded study, for instance, showed more improvement in chronic sinusitis scores (CSS) for patients with recurrent acute sinusitis treated with balloon sinuplasty as compared with those receiving medical management, but those in the intervention group had worse disease at baseline, leaving more opportunity for improvement, Dr. Pletcher noted. (Int Forum Allergy Rhinol. 2019;9:140-148).
I do think this is an opportunity for our field to have a discussion about how we make sure that we do the right thing for our patients. —Stacey Tutt Gray, MD
One rare study that was not industry funded, he said, showed significant improvement in both the balloon ostia dilation group and a sham procedure, in a smaller group, for patients with pressure headache and no findings of sinusitis on CT imaging (Otolaryngol Head Neck Surg. 2018;159:178-184).
The overall healthcare expenses of balloon sinus procedures are increasing dramatically, Dr. Pletcher said, with national Medicare payment data demonstrating that physician payments for balloon sinus dilation are now almost 10 times the physician payments for traditional endoscopic sinus surgery (Laryngoscope. 2019;129:2224–2229).
“I think it does raise the question: What is the overall value of sinus dilation?” he said.
Stacey Tutt Gray, MD, associate professor of otolaryngology-head and neck surgery at the Massachusetts Eye and Ear Infirmary in Boston, said there remains a difference of opinion on the merits of the procedure within the otolaryngology community.
She pointed to a comment in an online otolaryngology forum: “This procedure is being done for the wrong indications and this is a real threat to our good name as a specialty.” But in another remark, someone wrote: “The primary reason I offer this procedure to my patients is that it is so obvious to me that it is beneficial. It’s nice to see those checks come in, but not as nice as seeing a thrilled patient at their six-week post-op.”
Still, the financial relationships associated with the use of this procedure are documented in the literature, Dr. Gray said. A 2017 study, for example, found an association with industry payment for those surgeons who performed more than 11 balloon dilations in a year (Int Forum Allergy Rhinol. 2017;7:878-883).
Another study found that, in 2016, high-volume users, defined as more than 10 balloon dilations a year, account for less than 5% of all surgeons, but the number of high-volume users was almost three times the 2012 total of high-volume users (JAMA Otolaryngol Head Neck Surg [published online January 23, 2020] doi: 10.1001/jamaoto.2019.4357).
Dr. Batra said that changes to the coding would help fix what he sees as overuse.
“Typically, most people use one kit, but every sinus that’s dilated has a kit assigned to the practice-expense RVU (relative value unit) calculation, and that’s really what creates this potential for revenue generation,” he said. “If you’re only using one kit, you’re getting paid for multiple kits.”
Dr. Gray said that balloon sinuplasty is just one part—albeit a prominent part—of a “bigger conversation” about treatment performed more in pursuit of profit than in pursuit of patient outcomes.
“I don’t think our patients are worse-off related to the balloon,” she said. “I think it has just uncovered some issues that are maybe more clear because of the fact that this is a separate code that can be identified and trends a little bit more easily. But I do think this is an opportunity for our field to have a discussion about how we make sure that we do the right thing for our patients.”
Thomas R. Collins is a freelance medical writer based in Florida.