CMS Draft Rule Would Impact BioElectRx Vendors

by Victor Pikov, contributing editor

July 2025 issue, BioElectRx Business Report

On July 15, 2025, The Centers for Medicare & Medicaid Services issued a draft rule that aims to create a level playing field for hospitals and ambulatory surgical centers. CMS believes that advancements in medical technology, surgical techniques, and recovery protocols have nearly eliminated the need for recovery times exceeding 24 hours, which defines inpatient care. Consequently, CMS plans to shift all 1,731 inpatient procedures to outpatient settings with recovery times under 24 hours between 2026 and 2028.

The transition will begin in 2026 with 285 inpatient procedures shifting to outpatient settings and 547 procedures being added to the ASC list, including 271 former inpatient procedures. This represents a dramatic increase compared to 2025, when only 21 procedures were added to the ASC list, with 19 being dental procedures.

While surgical procedures involving neuromodulation devices were not affected by the proposed CMS shift to outpatient care, the draft rule does propose updated pricing for neuromodulation devices. In 2026, among the five pricing levels for neuromodulation devices, the two highest levels —Level 4 and Level 5— will have mean prices of $20,440 and $32,246, respectively. CMS also solicited comments on potentially creating a Level 6 pricing category for advanced neuromodulation devices.

In response, the Neuromodulation Payment Policy Coalition increased its lobbying efforts for creating Level 6 pricing. This coalition consists of five bioelectronic medicine companies: CVRx (carotid sinus stimulation for heart failure), ZOLL Respicardia (phrenic nerve stimulation for central sleep apnea), MicroTransponder (VNS for stroke), LivaNova (VNS for epilepsy and depression), and SetPoint Medical (VNS for rheumatoid arthritis). The coalition has proposed a pricing range of $44,000 to $52,000 for Level 6, building on their initial efforts that began in 2022.

Given the accelerated pace of CMS changes this year, including their recent approval of Level 6 pricing ($28,285) for musculoskeletal surgical procedures alongside the existing Level 5 ($18,338), there is reason for optimism that bioelectronic medicine companies can establish autonomic nerve implants as the highest pricing category among existing neuromodulation devices.