Paying it Forward

One of the most significant topics of discussion at the inaugural Bioelectronic Medicine Forum earlier this month was the subject of new economic models for neuromodulation therapies [see conference report, p7]. As it turns out, this could prove to be the key factor that defines the bioelectronic medicine industry more so than targets, indications, and technologies.

During a closing session devoted to regulatory and reimbursement issues, NBR senior contributing editor Jeremy Koff related SetPoint Medical’s effort to become the first neuromodulation firm to adopt a pay-per-dose revenue model, as opposed to paying for the device itself. This approach presents some intriguing opportunities but some significant reimbursement challenges. “The big challenge here is trying to determine what data is needed to show that the device is working,” Koff said. It could take three to five years to obtain new reimbursement codes.

Peter Staats, CMO of electroCore Medical, related his firm’s efforts to establish a new reimbursement model for vagus nerve stimulation, including an RFID system that tracks doses delivered by the company’s gammaCore device. electroCore acquired a unique code that allows claims for its therapy to be processed through the pharmacy pathway. This pathway promises faster access to patients and a smoother process for both providers and payers, he said.

Perhaps the biggest benefit to the bioelectronic medicine industry of a pay-per-dose model is that it helps level the playing field for neuromodulation therapies compared to pharmaceutical interventions. All too often, neuromodulation device therapies—particularly implanted devices—have encountered significant hurdles in obtaining reimbursement because the up-front cost of the device and the implantation procedure makes neuromodulation therapies appear to be less cost-effective than drug therapies.

During the meeting, Kris Famm of Galvani Bioelectronics raised one issue that device vendors pursuing this strategy will have to confront: the ethics of denying therapy to patients who have an implanted device but are unable or unwilling to pay the per-dose fee. Still, this challenge can be met, we believe, by enlisting the partnership of medical insurers, who could help underwrite both the cost of the system and risk of “shrinkage” that providers face on a daily basis with conventional medicine.

Indeed we continue to believe that the health insurance industry can play a more proactive role in funding new technologies like bioelectronic medicine and in lowering costs for patients and taxpayers. In return for incurring financial risk by being first to cover a promising new therapy that CMS later determines to be more cost effective, the insurer should be able to share in the cost savings that the government realizes.

James Cavuoto
Editor and Publisher

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