MINNEAPOLIS - CVRx, Inc. (NASDAQ: CVRX), a commercial-stage medical device company, has received a favorable payment classification from the Centers for Medicare and Medicaid Services (CMS) for its Barostim procedure. The CMS has assigned the Barostim procedure to the New Technology Ambulatory Payment Classification (APC) 1580, with an approximate payment of $45,000, a rate that will be maintained into 2025 according to the 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule.
This development comes on the heels of the American Medical Association CPT Editorial Panel's approval to transition Barostim from Category III to Category I CPT codes, which is anticipated to take effect on January 1, 2026. In addition, CMS has recently reassigned Barostim to a higher paying MS-DRG for inpatient procedures, effective from October 1, 2024. This reassignment increases the payment to $43,000, up from a previous range of $17,000-$23,000.
Kevin Hykes, President and CEO of CVRx, expressed gratitude for the CMS's recognition of the resources required for the Barostim implant procedure in the outpatient setting and for the support from medical societies and the hospital and physician community during the public comment period.
Barostim, developed by CVRx, is the first FDA-approved medical technology that uses neuromodulation to improve heart failure symptoms. The implantable device delivers electrical pulses to baroreceptors in the carotid artery wall, activating the body's baroreflex and triggering an autonomic response to the heart, aimed at restoring balance to the autonomic nervous system and reducing heart failure symptoms.
The recent reimbursement changes are seen as a comprehensive improvement in physician coding and hospital reimbursement for Barostim therapy, which could enhance patient access to this treatment and strengthen CVRx's commercial foundation.
The information in this article is based on a press release statement from CVRx, Inc.
In other recent news, Minneapolis-based medical device company, CVRx, Inc., announced that its Barostim procedure will continue to receive a Medicare payment of approximately $45,000 until 2025. This development is significant for CVRx as the assignment by the Centers for Medicare and Medicaid Services ensures a consistent reimbursement rate for the procedure. In financial updates, CVRx reported a 27% increase in total revenue for Q3 2024, amounting to $13.4 million, largely driven by its US Heart Failure business. Despite the revenue growth, the company experienced a net loss of $13.1 million. Noteworthy, CVRx announced significant reimbursement achievements for its Barostim therapy, which are expected to enhance patient access and streamline payment procedures. The company anticipates total revenue for the full year to be between $50.5 million and $51.5 million. However, it's worth noting that the company's net loss widened from $9 million in Q3 2023 to $13.1 million in Q3 2024. Additionally, selling, general, and administrative expenses increased by 38% due to higher compensation and operational costs. These are the recent developments from CVRx.
InvestingPro Insights
The recent favorable payment classification for CVRx's Barostim procedure aligns with the company's strong revenue growth trajectory. According to InvestingPro data, CVRx has shown impressive revenue growth of 34.38% over the last twelve months as of Q3 2024, with quarterly revenue growth of 27.23% in Q3 2024. This growth trend could be further bolstered by the improved reimbursement rates, potentially driving increased adoption of the Barostim therapy.
Despite the positive news on reimbursement, investors should note that CVRx is not currently profitable, with an adjusted operating income of -$58.88 million over the last twelve months. An InvestingPro Tip highlights that analysts do not anticipate the company will be profitable this year. However, the company's strong gross profit margin of 84.16% suggests that as revenue scales, there's potential for profitability improvement.
Another InvestingPro Tip indicates that CVRx holds more cash than debt on its balance sheet, which could provide financial flexibility as the company seeks to capitalize on the improved reimbursement landscape. This solid financial position is crucial for a growing medical device company investing in market expansion.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for CVRx, providing a deeper understanding of the company's financial health and market position.
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