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CMS Publishes Final Rule for Calendar Year 2026 Physician Fee Schedule for UltraMIST Procedure (CPT code 97610)

Key Takeaway: Sanuwave Health, Inc. announced that the final rule for the 2026 Physician Fee Schedule by CMS maintains reimbursement rates for the UltraMIST procedure (CPT code 97610) largely unchanged from 2025. The company expects slight increases in reimbursement for many providers, aligning with their prior expectations. CEO Morgan Frank emphasized the stability of these rates amidst changes in other wound care reimbursements.
Price reaction · baseline $28.94 (2025-10-31 close) · hit pre-market · 1 other SNWV headline(s) in the window, move may be shared
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Market Sentiment Analysis

POSITIVE FACTORS

  • Reimbursement rates for UltraMIST remain stable and in line with expectations.
  • Sanuwave anticipates a slight increase in reimbursement for many providers.
  • The final rule aligns with the proposed rule, indicating consistency in policy.

Full Press Release Details

CMS adopts Final Rule for 2026 Physician Fee Schedule in line with proposed rule for CPT code 97610
2026 rates for physician offices, home visits, long-term care, and hospitals are in line with the proposed rule and remain materially unchanged from 2025
EDEN PRAIRIE, Minn., Nov. 03, 2025 (GLOBE NEWSWIRE) --Sanuwave Health, Inc.(the "Company" or "Sanuwave”) (NASDAQ: SNWV), a leading provider of next-generation FDA-approved wound care products, today provided a business update regarding the anticipated impact of the final rule from the Centers for Medicare & Medicaid Services (“CMS”) for the 2026 Physician Fee Schedule, which were published after the close of business on Friday, October 31, 2025. This schedule established reimbursement rates for CPT codes for the coming calendar year.
Reimbursement for the 97610 code for UltraMIST®products remains materially unchanged for 2026 with payment for treatment provided in the physician office, home visit, long-term care, and hospital settings remaining within $2-4 of 2025 rates. This is in line with the expectations the Company expressed in its preliminary revenue results release on October 6th.
“In light of some changes on other wound care reimbursement, and in response to numerous inquiries from investors and providers about UltraMIST®reimbursement rates for 2026, we wanted to provide this informational update,” said Sanuwave CEO Morgan Frank. “Final 2026 rates for 97610 are in line with the proposed rule and with our prior expectations. Changes for 2026 should be less than 1% with many providers seeing a slight increase in reimbursement. We look forward to discussing this further on our third quarter earnings call.”

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to expected reimbursement levels for the UltraMIST procedure, future financial results, production expectations, and plans for future business development activities. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with regulatory oversight, the Company’s ability to manage its capital resources, competition and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement, except as may be required by applicable law.

Frequently Asked Questions

What is the 2026 reimbursement rate for UltraMIST?

The reimbursement rates for UltraMIST remain largely unchanged from 2025, within $2-4.

How does the final rule affect Sanuwave's expectations?

Sanuwave's expectations for reimbursement rates align with the final rule, indicating stability.

What did Sanuwave's CEO say about the 2026 rates?

CEO Morgan Frank noted that many providers may see a slight increase in reimbursement.

When was the final rule for the fee schedule published?

The final rule was published by CMS on October 31, 2025.

Last updated: Nov 3, 2025