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MINNEAPOLIS - The Centers for Medicare and Medicaid Services (CMS) has proposed to keep CVRx’s Barostim implant procedure in the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000 for outpatient procedures, according to a press release issued by the company. According to InvestingPro data, CVRx maintains a strong balance sheet with more cash than debt, though the company is currently burning through cash reserves.
The proposal, which would take effect January 1, 2026, follows two other recent reimbursement developments for the heart failure device. As of October 1, 2024, Barostim was assigned to a higher-paying MS-DRG for inpatient procedures, and the device will transition from Category III to Category I CPT codes for physician payments starting January 1, 2026.
CMS is also soliciting comments about the potential need for a Level 6 Neurostimulator APC. The final 2026 Medicare Hospital Outpatient Prospective Payment System rule is expected to be published in November.
"We appreciate CMS’ proposal to keep Barostim in APC 1580, ensuring appropriate payment for the Barostim implant procedure," said Kevin Hykes, President and CEO of CVRx (NASDAQ:CVRX).
Barostim is an implantable neuromodulation device that delivers electrical pulses to baroreceptors in the carotid artery wall. The therapy aims to restore autonomic nervous system balance and reduce heart failure symptoms.
The device received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S. It also holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area.
In other recent news, CVRx Inc. reported its financial results for the first quarter of 2025, showing an earnings per share (EPS) of -$0.53, which was slightly better than the forecasted -$0.54. However, the company’s revenue fell short of expectations, coming in at $12.3 million compared to the anticipated $14.68 million. This revenue miss was partly attributed to a salesforce reorganization that led to higher than expected staff turnover and disruptions in account management. Consequently, CVRx revised its full-year revenue guidance downward from a previous range of $63-65 million to a new range of $55-58 million, although it maintained its gross margin target at 83-84%. In response to these developments, JPMorgan analysts downgraded CVRx’s stock rating from Neutral to Underweight and reduced the price target from $15.00 to $7.00. The downgrade was influenced by the ongoing uncertainty surrounding potential rate changes in the proposed Outpatient Prospective Payment System (OPPS) and inconsistent sales growth trends. Despite these challenges, CVRx continues to focus on expanding its sales territories and is considering a large-scale clinical trial to further support its Barostim therapy.
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