CMS establishes $314.54 reimbursement rate for CPT code 97610 for 2027, an approximately 21% reduction vs 2026 rate of $397.81
2027 Hospital outpatient rate for 97610 code set at $235.04, an approximately 15% increase vs 2026 rate of $204.98
Company evaluating options for continued response
EDEN PRAIRIE, Minn., Nov. 05, 2026 (GLOBE NEWSWIRE) — Sanuwave Health, Inc. (the “Company” or “Sanuwave”) (NASDAQ: SNWV), a leading provider of FDA-cleared directed energy systems used in advanced wound care, today commented on the Centers for Medicare & Medicaid Services (“CMS”) Calendar Year 2027 Physician Fee Schedule (“PFS”) final rule, released after close of market November 4, 2026.
Under the rule, the national Medicare payment for CPT code 97610, the code under which Ultramist ultrasound therapy is billed, will be $314.54 per treatment in the physician office and mobile clinic setting for 2027 as compared with $397.81 in 2026.
The 2027 reduction was limited by Section 1848(c)(7) of the Social Security Act, which caps the first-year reduction in a code’s total RVUs at 19% and phases in the remainder the following year. CMS’s final rule files show the non-facility practice expense RVU for 97610 declining to 5.71 at full phase-in in 2028. Absent further rulemaking, the Company expects a significant further reduction in the 2028 rate; the 2028 conversion factor has not been established. (For clarity, the 21% reduction in the 2027 payment rate reflects the 19% reduction in total RVUs combined with a 2.3% reduction in the PFS conversion factor which applies to all services paid under the Physician Fee Schedule.)
Separately, under the CY 2027 Hospital Outpatient Prospective Payment System rule released November 4, 2026, the national unadjusted payment rate for 97610 in the hospital outpatient setting will increase 15% to $235.04, up from $204.98 in 2026.
In addition, the 97610 code was moved from Q1 to T in the HOPD setting which will prevent it from being conditionally packaged when appearing on the same claim with S, T, or V codes and therefore allow hospitals to receive (subject to OPPS multiple-procedure payment rules) separate payment for it when billed with other codes.
These figures are derived from CMS-published RVUs, payment rates, and conversion factors and may be subject to correction or revision by CMS. They should not be relied upon as definitive for making business or investment decisions.
The office-setting reimbursement reduction results from revised practice expense inputs adopted by CMS in response to an interested party’s nomination of CPT 97610 as a potentially misvalued code. The Company believes the assumed inputs rest on an incomplete reading of publicly available information and do not reflect the actual costs incurred or time spent by wound care providers.
“We wholeheartedly support CMS’s goal of accurate, data driven payment,” said CEO Morgan Frank. “But we believe this rule to be in error. It was based neither upon invoices nor practitioner surveys and we believe it severely undervalues Ultramist treatment and underestimates the costs of providing it. We plan to continue to engage with CMS on this issue and others around the restructuring of the 97610 code which is unusual among wound codes in that it contains no scaling mechanisms for treating multiple wounds in one visit, large wounds, or difficult wounds. It pays only $12.73 for physician time which is not in keeping with practice costs. Ultramist is the treatment that many patients rely on when standard of care has failed. We will work to ensure that patient access to the procedure continues and that those in need of care can get it.
Our thanks to all of our partners and users who have engaged with and stood by us here. Your help and support have been overwhelming and we appreciate you. While this final rule is somewhat more positive for our code than the original proposal and we are grateful to CMS for working with us on this matter, we are choosing to view this as the beginning of the discussion rather than the end. We will continue to engage with CMS and other stakeholders and we are evaluating all options to respond to move the ball forward.”
About Sanuwave
Sanuwave Health is focused on the research, development, and commercialization of its patented, non-invasive directed energy systems used in the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.
Sanuwave’s end-to-end wound care portfolio of regenerative medicine products and product candidates help restore the body’s normal healing processes. Sanuwave applies and researches its patented and FDA approved/cleared energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.
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 Medicare payment rates, the Company’s intent to engage with CMS, the potential content and effect of any rulemaking, and the anticipated impact of reimbursement changes on the Company’s business and financial results. Forward-looking statements include all statements that are not statements of historical fact regarding the 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. Rules are subject to change, and there can be no assurance regarding future Medicare payment rates or that the Company’s comments or action will result in any modification or future rulemaking. 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: changes in Medicare or other third-party reimbursement for services performed using the Company’s products, reductions, clawbacks, or recoupments of CMS reimbursement for skin substitutes, allografts, or other advanced wound care products, and their effect on customer behavior and capital budgets; the financial distress, closure, or liquidation of wound care practices and the resulting impact on demand for the Company’s systems; the Company’s ability to sustain applicator and consumable volumes and convert system placements into recurring consumable revenue; 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.
Contact: investors@sanuwave.com
