New CMS Rules Will Impact Bioelectronic Medicine Vendors

by Victor Pikov, contributing editor

October 2023 issue, BioElectRx Business Report

The U.S. Centers for Medicare & Medicaid Services recently issued draft rules for hospital price transparency, which stand to exert a profound effect on manufacturers of implanted bioelectronic medicine systems. The new rules state that beginning January 1, 2024, CMS will start enforcing the requirement that all U.S.-based hospitals and ambulatory surgical centers publicly list their standard patient charges in a machine-readable file.

In anticipation of that deadline, some hospitals already listed their pricing information, including both implantable pulse generators and implanted leads for peripheral nerve stimulation applications. While pricing for the deep brain stimulation and spinal cord stimulation is based on the CPT codes inclusive of the device (IPG and leads) and the implantation surgery, pricing for PNS applications is based on individual CPT codes and varies significantly among the PNS applications. In addition, hospital-negotiated pricing for CMS and various private payers varies significantly as well, so for the sake of simplicity, we will consider only an averaged pricing for Aetna and Kaiser, as these payers are near the middle of a pricing spectrum.

Regarding the implantation surgery, there are currently separate CPT codes for open surgical implantation of the hypoglossal nerve (which is singled out from other cranial nerves), open surgical implantation of other cranial nerves (including the vagus), percutaneous surgical implantation of the sacral nerve, and percutaneous surgical implantation of other nerves. Prices for implanting these leads vary from $1400 to $5000, and there is an additional price of about $600 for implanting the IPG.

The IPG prices vary based on the PNS application and the IPG features, with the cheapest one being the SNS IPG at around $10K, while a VNS IPG with a primary battery is priced at around $20K, and a VNS IPG with a rechargeable battery and MRI compatibility has the price of nearly $30K.

Pricing for implanted leads exhibits a much greater variability than for the IPGs. Percutaneous leads for posterior tibial nerve stimulation are the cheapest at just $300, while other percutaneous leads (such as those used for treating pain in the shoulder, knee, or low back) are priced at about $700. Pricing for SNS leads depend on the use of two CPTs, 64581 and C1778, with the first code priced at around $1500 and the second at around $3400. The most expensive are cuff electrodes for cranial nerves, with a VNS helical cuff priced at around $5000, despite using the same CPT code as the SNS (C1778). Remarkably, the pricing of PTNS and VNS leads shows a nearly 20-fold difference.

With a forthcoming expansion of PNS applications into bioelectronic medicine, it would be important for CMS and private payers to establish proper pricing for complex implanted cuffs, such as those developed by SetPoint Medical and Galvani Bioelectronics.