Regulation Leads to Transparency in Pricing for PNS Devices

by Victor Pikov, contributing editor

October 2024 issue, BioElectRx Business Report

Last year, we reported on the recent CMS Hospital price transparency regulation, which enabled significant advances in pricing transparency for peripheral nerve stimulation therapies by disclosing and annually updating all charges on websites of U.S.-based hospitals and ambulatory surgical centers. Earlier this year, CMS introduced pricing file templates, posted on GitHub. With these pricing file templates, hospitals can now share pricing data more efficiently, which has also facilitated automated data collection, with the data accessible on the web like the Colorado’s statewide search site.

An evaluation of pricing files from top hospitals, including Mayo Clinic, NYU Langone, and Memorial Hermann (Houston), reveals reimbursement trends for CPT and HCPCS codes related to PNS therapies. For the sake of simplicity, we evaluated only HMO pricing for UnitedHealth, Aetna, and Cigna, as these plans are near the middle of a pricing spectrum, with Medicare and Medicaid plans providing lower reimbursement and PPO plans providing higher reimbursement.

Reimbursements for transcutaneous or percutaneous posterior tibial nerve stimulation are low, at $310 per therapy session, while PNS therapies requiring an implantation surgery are reimbursed at a much higher level. Among the implantation procedures, percutaneous (CPT 64561) and open surgical implantation of sacral nerve stimulation leads (CPT 64581) have mid-range reimbursements, between $6,700 and $7,400. Open surgical implantation of cuffs for vagus nerve stimulation (CPT 64568) and hypoglossal nerve stimulation (CPT 64582) has the highest reimbursement, around $34,000.

Implantation of any PNS IPG (CPT 64590) is reimbursed at $610, covering only IPGs that are separable from the leads (such as the Medtronic and Axonics IPGs for SNS) and not for the IPGs integrated with the lead (such as those from Nalu, Neuspera, Curonix, and BlueWind Medical).

Pricing for IPGs for PNS therapies is grouped under a single HCPCS code (C1767), but reimbursement varies by application type. For instance, Enterra’s gastric electrical stimulation IPG is reimbursed at $24,000, while SNS IPGs for overactive bladder from Medtronic and Axonics are reimbursed around $30,000. Mainstay’s ReActiv8 IPG for low back pain is reimbursed at $38,000, while LivaNova’s VNS IPGs have even higher reimbursements, ranging from to $50,000 to $60,000, depending on the model.

Lead pricing for PNS therapies under a single HCPCS code (C1778) also varies, with reimbursement for Mainstay’s ReActiv8 PNS lead at $4,500, Enterra GES lead at $6,000, regular SNS leads from Medtronic and Axonics at $9,000, Medtronic’s MRI-compatible SNS lead at $12,000, and LivaNova’s VNS helical cuffs at $21,000.

A notable trend in PNS therapy is a growing use of closed-loop systems, exemplified by the Inspire therapy for obstructive sleep apnea, which uses two leads—one for hypoglossal nerve stimulation at $5,000 and another for respiratory pressure monitoring at $8,000. As more bioelectronic therapies adopt closed-loop control, overall reimbursement levels may increase, particularly with the use of multiple leads. This pricing transparency may help guide both providers and manufacturers, encouraging more standardized pricing data across states and supporting the expansion of innovative PNS applications in bioelectronic medicine.