“We are in active communications” with Smith+Nephew to assess progress on the payment front, he noted. “The emails have been circulating. We really want to be able to offer this to our families who have concerns about anesthesia in the OR.”
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April 2025A current procedural terminology code is likely needed to cover the cost of the device and the 30 to 40 minutes spent in counseling and surgery in these cases, Dr. Waldman noted. He also noted that “without better reimbursement, Tula can’t be used in Medicaid patients, which are a large percentage of our patient base.”
Dr. Waldman said he looks forward to the cost challenge being solved because “overwhelmingly, patients and families love Tula.” In fact, when the Tula trial ended and a few patients who needed the tubes redone due to extrusion called for another procedure, “I had to tell them Tula was no longer available.” Having to switch those patients to the OR, with all its attendant hassles and potential risks, he noted, “was really upsetting to them, after having had such a great experience with the in-office awake option.”
Dr. Waldman noted that not all children are good candidates for the device. He cited, as an example, patients with narrow ear canals and other anatomy that precludes sufficient inspection of the tympanic membrane. “Tula has a fixed diameter; we have to be able to see well enough to use the device in an awake patient,” he explained.
There’s also the issue of the patient’s disposition. Hyperactive children or those having “insufficient behavioral compliance,” as described in the Tula trial, led to those patients being excluded from the study. “We were pretty selective in choosing our patients,” Dr. Waldman said. “Awake procedures are not for every child.”
The disposition of the parents also plays a big role. “Some parents feel that anesthesia is awful, while some feel that any amount of their child’s crying or discomfort is awful.” Both of those divergent dispositions “could tilt the balance for or against an in-office procedure.”
More Hummingbird Experience
Shelagh A. Cofer, MD, a pediatric otolaryngologist and surgeon at the Mayo Clinic Children’s Center in Rochester, Minn., agreed with Dr. Waldman that patient selection should not be taken lightly when choosing the best site of care for children needing tympanostomy tubes. “I always say that it’s got to be the right patient, the right parent, and the right place,” said Dr. Cofer, who has participated in several Hummingbird trials, including the aforementioned study showing a 99.1% success rate.
I always say that it’s got to be the right patient, the right parent, and the right place.” —Shelagh A. Cofer, MD
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