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

Rhea-AI Summary

Sanuwave Health (NASDAQ: SNWV) announced that CMS published the final 2026 Physician Fee Schedule for CPT code 97610 (UltraMIST) on Oct 31, 2025, and final rates are materially unchanged from 2025.

Reimbursement for physician office, home visits, long-term care, and hospital settings will remain within $2–$4 of 2025 rates, with overall change for 2026 expected to be less than 1%. The company said this aligns with its Oct 6 preliminary revenue expectations and will discuss further on its Q3 earnings call.

Positive

• Final 2026 reimbursement within $2–$4 of 2025 rates
• Expected 2026 change less than 1% for CPT 97610
• Final rule aligns with company Oct 6 preliminary expectations

Negative

• Minimal reimbursement change implies limited near-term revenue upside

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 6^th.

“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.

Contact: investors@sanuwave.com

FAQ

What did CMS finalize for CPT 97610 UltraMIST reimbursement in 2026 for SNWV?

CMS finalized 2026 rates for CPT 97610 with payments in clinical settings remaining within $2–$4 of 2025 levels.

How large is the expected 2026 reimbursement change for UltraMIST (SNWV)?

The company expects overall 2026 changes for CPT 97610 to be less than 1%.

Will the 2026 CMS rule affect UltraMIST reimbursements in hospitals and home visits for SNWV?

Yes; payments for physician office, home visits, long-term care, and hospitals remain materially unchanged and within $2–$4 of 2025 rates.

Does the final 2026 rate for 97610 match Sanuwave's prior guidance (SNWV)?

Yes; Sanuwave said the final 2026 rates are in line with the proposed rule and with its prior expectations announced on Oct 6, 2025.

What should investors expect on SNWV's upcoming Q3 earnings call about UltraMIST reimbursement?

The company indicated it will discuss the finalized 97610 rates and the reimbursement outlook on its third quarter earnings call.