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Nyxoah Gains Favorable CMS Reimbursement Ruling for Genio System

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Key Takeaways

  • NYXH gained a finalized CMS rule assigning CPT 64568 to New Technology APC 1580 for Genio implants.
  • The change boosts NYXH's 2026 reimbursement to about $45,000 in outpatient and $42,373 in ASC settings.
  • Higher rates enhance adoption prospects as NYXH Genio's single-incision procedure suits ASC.

Nyxoah (NYXH - Free Report) recently announced that the CY2026 Hospital Outpatient Prospective Payment System (“HOPPS”) and Ambulatory Surgery Center (“ASC”) Rule has been finalized by the U.S. Centers for Medicare & Medicaid Services (“CMS”). As per the final rule, the code used for all Genio hypoglossal nerve stimulation (HGNS) implants — CPT Code 64568 — has been assigned to New Technology Ambulatory Payment Classification (“APC”) 1580 by the CMS. The newly assigned code significantly increases the reimbursement rates for procedures done using Genio implants.

The Genio implant is approved as a treatment for obstructive sleep apnea (OSA) through neuromodulation. Nyxoah first received the CE mark for the device in 2019 following the successful completion of the BLAST OSA study, gaining commercialization authorization in Europe. This was followed by the expansion of Genio implants’ therapeutic indications to include Complete Concentric Collapse (“CCC”) patients in Europe. The CE mark for CCC patients was granted following the successful completion of the BETTER SLEEP study.

NYXH gained FDA approval for Genio implants in August this year following the successful completion of the DREAM IDE study. However, the FDA approval is for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

Share Price Performance

Nyxoah’s shares have lost 40% so far this year against the industry’s gain of 12.8%. The S&P 500 Index has risen 19% in the same period.

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Although shares of NYXH have lost significantly in 2025, the increase in reimbursement rates for Genio implants in the United States may boost prospects for the company in 2026. A rise in reimbursement rates is likely to drive broader adoption, increased procedural throughput and expansion across Medicare-heavy institutions.

More Details on CMS Rule

The new rule raises reimbursement rates for CPT 64568 by 48% from 2025 levels, bringing the rate to roughly $45,000 for hospital outpatient departments. The new 2026 reimbursement rate for the ASC facility, at $42,373, reflects a 58% increase compared with 2025.

Covering all CPT 64568 procedures, including Genio, these updates improve the economic viability of adopting this therapy in U.S. outpatient and ambulatory settings.

Nyxoah noted that the Genio single-incision procedure is well-suited for the ASC environment, and that the increase in ASC reimbursement rates creates new opportunities for therapy expansion and site-of-service diversification.

The significant hike in rates by the CMS for Genio procedures also reinforces the growing recognition of hypoglossal nerve stimulation as a high-value therapy for OSA.

Nyxoah’s Zacks Rank & Key Picks

Currently, NYXH carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space areBoston Scientific Corporation (BSX - Free Report) , IDEXX Laboratories, Inc. (IDXX - Free Report) and Cardinal Health (CAH - Free Report) .

Boston Scientific, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 16.4%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.36%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Boston Scientific’s shares have gained 13.7% compared with the industry’s 5.8% growth so far this year.

IDEXX, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13%. IDXX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.12%.

IDEXX’s shares have gained 82.1% compared with the industry’s 5.8% gain so far this year.

Cardinal Health, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.9%. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.36%.

Cardinal Health has rallied 79.5% compared with the industry’s 15.6% gain so far this year.

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