Hearing Us Out
by James Cavuoto, editor
The 23rd annual Neurotech Leaders Forum, which took place in San Francisco earlier this month [see conference report p15], offered an excellent opportunity for neurotech professionals to sound off—and to listen in—on pressing issues confronting the industry.
One of the most productive sessions, we think, was devoted to responding to negative publications and negative decisions impacting neuromodulation firms. Attendees benefited greatly from the opportunity to hear from one of the authors of a highly critical paper about SCS published in JAMA Neurology last year [NBR Dec22p1]. Sanket Dhruva, an assistant professor of cardiology at UC San Francisco, showed great grace and humility in attending an event filled with neuromodulation industry professionals. While not everyone in attendance agreed with the conclusions in the paper, Dhruva took the time to explain the authors’ methodology and he acknowledged some of the shortcomings in the study. Among these were the lack of pain and quality of life measures, the reliance on a time horizon shorter than the 2.5 year breakeven-point for SCS, the lack of data from patients not using opioids, and the unavailability of newer-generation SCS therapies—most of their data was obtained from circa-2018 devices or earlier.
An interesting revelation that came out during this session was Dhruva’s observation that no one from the neuromodulation industry had contacted him subsequent to the article’s publication—despite the fact that he was listed as corresponding author. While there are some in our industry who believe it is best to leave critics alone, there are clearly advantages to be gained by engaging in polite, if frank, dialog with those on the opposite side of an issue. And as several conference participants noted, it is healthy for the neuromodulation industry to understand how some investigators, regulators, or payers could come to the conclusion that SCS is not cost effective.
To their credit, several professional societies, notably the North American Neuromodulation Society, the International Neuromodulation Society, and the American Society for Pain and Neuroscience, have undertaken efforts to counteract some of the negative publications and to undo unfavorable coverage and regulatory decisions.
Some of this work has begun to pay off, we believe; there are signs that the state of Washington may reverse its years-long blockade of SCS for its residents. And recently, a key House subcommittee advanced legislation that would revive the coverage provisions from the now-scuttled MCIT program. Whether or not HR 1691 becomes law, it is bound to exert some pressure on CMS to liberalize the proposed TCET alternative it has offered up. And it reinforces the importance of banding together and putting forward well reasoned arguments in the face of opposition.
While the neurotechnology industry currently enjoys broad support from the media, patient advocacy groups, and government institutions, we should not assume that everything will always go our way. But when things go wrong, we should be prepared to look into the matter with an open mind and express our collective point of view in an effective and persuasive manner.