Sanuwave Health Comments on 2027 Medicare Physician Fee Schedule Rate for Ultramist

Hospital outpatient payments will increase, while Sanuwave expects another office-setting reimbursement reduction in 2028 absent further rulemaking.

Rhea-AI Summary

Sanuwave Health (SNWV) said Medicare reimbursement for Ultramist treatments in physician offices and mobile clinics will fall to $314.54 in 2027. The payment for billing code 97610 declines approximately 21% from $397.81 in 2026 under the final Physician Fee Schedule rule released November 4, 2026.

Hospital outpatient reimbursement will rise approximately 15% to $235.04, from $204.98 in 2026. A payment-status change will also allow separate hospital payment alongside other codes, subject to multiple-procedure payment rules.

Full phase-in lowers the code’s non-facility practice expense weighting to 5.71 in 2028. Sanuwave expects a further reimbursement reduction absent additional rulemaking; the 2028 conversion factor is not established. The company plans continued engagement with CMS and is evaluating response options. CMS may correct or revise the published figures.

2 points · 0 major

MixediHow this balance works

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Hospital outpatient reimbursement rises approximately 15% to $235.04 in 2027, from $204.98 in 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Code 97610 moves from Q1 to T, allowing separate hospital payment alongside other codes, subject to multiple-procedure rules.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Office and mobile-clinic reimbursement falls approximately 21% to $314.54 in 2027, from $397.81 in 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Sanuwave expects a further 2028 rate reduction absent further rulemaking; the conversion factor remains unestablished.

Key Figures

2027 physician-office reimbursement: $314.54 per treatment 2027 hospital outpatient rate: $235.04 First-year total RVU reduction cap: 19% +3 more

2027 physician-office reimbursement

$314.54 per treatment

For CPT code 97610; 2026 rate was $397.81

2027 hospital outpatient rate

$235.04

For code 97610; 15% increase from $204.98 in 2026

First-year total RVU reduction cap

19%

Statutory cap under Section 1848(c)(7)

PFS conversion-factor reduction

2.3%

Applies to all services paid under the Physician Fee Schedule

Non-facility practice expense RVU

5.71

CPT code 97610 at full phase-in in 2028

Payment for physician time

$12.73

Amount stated for code 97610

Historical Context

1 past event · Latest: Aug 06

1 event

1. Aug 06

   Q2 results and guidance

   24h Move

   -2.0%

   Withdrew 2026 guidance pending the CMS final rule for code 97610.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cpt code, rvus, hospital outpatient prospective payment system

3 terms

cpt code regulatory

"the code under which Ultramist ultrasound therapy is billed"

A CPT code is a standardized numeric label used by healthcare providers and insurers to identify medical procedures, tests, and services for billing and reimbursement. Think of it as a SKU or price tag for each clinical service: which code is used and how it’s reimbursed directly affects a provider’s revenue and a medical product’s market adoption, so investors watch codes and payment rules to estimate financial impact.

rvus technical

"caps the first-year reduction in a code’s total RVUs"

Relative value units (RVUs) are a standardized points system used in healthcare to measure the resource intensity of medical services—combining clinician time and effort, practice overhead, and liability risk. Investors care because RVUs are a primary driver of reimbursement from government and many private payers, so shifts in RVU valuation or volume directly affect provider revenue and profitability; think of RVUs as the point score that turns clinical activity into a billing amount.

hospital outpatient prospective payment system regulatory

"under the CY 2027 Hospital Outpatient Prospective Payment System rule"

A hospital outpatient prospective payment system (HOPPS) is a government-set pricing rule that pays hospitals a fixed amount for specific outpatient services instead of reimbursing every item separately. Think of it like a pre-priced menu: hospitals receive set payments for defined procedures or visits, which makes revenue more predictable and forces cost control — a key factor investors use to gauge a hospital’s profit stability and how policy changes might affect margins.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Sanuwave Ultramist’s Medicare reimbursement rate for 2027?

Medicare payment for Ultramist under billing code 97610 will be $314.54 per treatment in physician offices and mobile clinics in 2027, compared with $397.81 in 2026. The hospital outpatient rate will be $235.04, compared with $204.98 in 2026.

Why does Ultramist’s 2027 Medicare payment fall approximately 21% if the first-year reduction is capped at 19%?

The cap applies to total relative value units, the weights used in calculating payment, rather than the final reimbursement amount. The 2027 payment reduction reflects a 19% reduction in those units combined with a 2.3% reduction in the Physician Fee Schedule conversion factor, which applies to all services paid under that schedule.

How does the 2027 payment-status change affect hospitals billing for Ultramist?

The change from Q1 to T prevents code 97610 from being conditionally bundled into another payment when it appears on the same claim with S, T, or V codes. Hospitals can therefore receive separate payment when billing it with other codes, subject to outpatient multiple-procedure payment rules.