CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Non-contact low-frequency ultrasound for wound treatment

Defines coverage stance for non-contact low-frequency ultrasound (NLFU) devices for wound treatment for Medicare Advantage and commercial products, including coding and benefit guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNon-contact low-frequency ultrasound for wound treatment

Policy CodePolicy N/A

Change TypeClarified; no material clinical changes

Effective DateSep 1, 2019

Next Review DateN/A

Key ActionVerify benefits and eligibility against the member's subscriber agreement or group contract because benefits may vary and the Benefit Booklet/Evidence of Coverage supersedes this policy.

POLICY UPDATE CHANGES

Policy states non-contact ultrasound for wounds is not covered for Medicare Advantage and not medically necessary for commercial products due to insufficient evidence.

1CPT codes listed as not covered/not medically necessary

2Payer categories with negative coverage stance (Medicare Advantage, Commercial)

2019-09-01Policy effective date

2026-03-04Last review date

Coverage Summary

Defines coverage stance for non-contact low-frequency ultrasound (NLFU) devices for wound treatment for Medicare Advantage and commercial products, including coding and benefit guidance. Effective date: 09/01/2019. Last review: 03/04/2026.

Medicare Advantage plans: Not covered (evidence insufficient to demonstrate improved net health outcome). Commercial products: Not medically necessary (evidence insufficient to demonstrate improved net health outcome).

Key policy dates and quick facts

Policy effective date2019-09-01

Last review date2026-03-04

CPT codes listed as not covered/not medically necessary97610

Payer categories with negative coverage stanceMedicare Advantage; Commercial

Recent provider updatesProvider Update, May 2026 (also updates in 2025, 2024, 2023, 2022)

Medical-Necessity / Coverage Determinations

Medicare Advantage Coverage Determination

Non-contact ultrasound treatment for wounds is considered not covered when evidence is insufficient to show net health benefit.

ALL of the following

Treatment is non-contact ultrasound (NLFU) for wounds
Evidence is insufficient to determine that the technology results in an improvement in the net health outcome

Treatment is non-contact ultrasound (NLFU) for wounds

Evidence is insufficient to determine that the technology results in an improvement in the net health outcome

Commercial Products Coverage Determination

Non-contact ultrasound treatment for wounds is considered not medically necessary when evidence is insufficient to show net health benefit.

ALL of the following

Treatment is non-contact ultrasound (NLFU) for wounds
Evidence is insufficient to determine that the technology results in an improvement in the net health outcome

Treatment is non-contact ultrasound (NLFU) for wounds

Evidence is insufficient to determine that the technology results in an improvement in the net health outcome

Not Covered / Not Medically Necessary

Non-contact low-frequency ultrasound (NLFU) for wound treatment is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because the evidence is insufficient to determine that the technology improves net health outcomes.

The rationale cites insufficient and methodologically limited evidence from randomized controlled trials and systematic reviews (for example, trials with high dropout rates, baseline imbalances, lack of blinded outcome assessment, and inconsistent use of clinically relevant outcomes such as complete healing).

Provider Actions

Documentation Required

Benefit verification and member-specific limitations

Verify benefits and eligibility against the member's subscriber agreement or group contract because benefits may vary and the Benefit Booklet/Evidence of Coverage supersedes this policy.

Check the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for coverage limitations.
Confirm whether prior authorization or explicit contractual allowance exists before providing non-contact ultrasound services.
If services are noncovered and the member agrees in writing, document the member-paid arrangement per participation agreement requirements.

Denial Risk

Service likely denied or not payable

Claims for non-contact low-frequency ultrasound (CPT 97610) are not covered for Medicare Advantage members and are considered not medically necessary for commercial members; expect denial if billed without explicit contractual allowance or member-paid agreement.

Affected code: 97610

Billing Rule

Code-specific description

If billed, CPT 97610 denotes 'per day' reporting for the non-contact low-frequency ultrasound service; however the policy declares this code not covered/not medically necessary.

CPT 97610 is reported per day and is listed as not covered / not medically necessary in this policy.

Background, Evidence, and Definitions

Several NLFU devices (eg, MIST Therapy System, Qoustic/AR1000) have FDA 510(k) clearance for wound purposes; MIST was cleared in 2005 and AR1000 (Qoustic) was cleared in 2007.

The published evidence includes randomized controlled trials and systematic reviews/meta-analyses. However, the trials and reviews have methodological limitations (eg, few trials used complete healing as the primary outcome, lack of blinded outcome assessment, high dropout rates, and possible imbalance in intensity of face-to-face care between groups).

Overall conclusion: available evidence is insufficient to determine that NLFU results in improved net health outcomes, and therefore the treatment is not covered/not medically necessary per policy.

Evidence Type	Summary
RCTs with results	Some RCTs reported statistically significant primary outcomes favoring NLFU but had methodological limitations (eg, high dropout rates, baseline differences, lack of blinded outcome assessment); few RCTs used complete healing as the primary outcome, limiting clinical relevance.
Systematic reviews	Systematic reviews and meta-analyses exist (including analyses of multiple RCTs of low-frequency ultrasound 20-40 kHz), but overall evidence is considered insufficient to demonstrate improved net health outcomes for coverage.
Regulatory clearance / device background	Several NLFU devices (eg, MIST at 40 kHz, Qoustic/AR1000 at 35 kHz) have FDA 510(k) clearance for wound purposes; devices intended as adjuncts to standard wound care.
Coding / coverage determination	CPT code 97610 (low frequency, non-contact, non-thermal ultrasound) is listed as not covered for Medicare Advantage and not medically necessary for Commercial Products.

Non-contact low-frequency ultrasound (NLFU): Ultrasound in the kilohertz range delivered without direct contact or coupling gel (eg, MIST Therapy System at 40 KHz, Qoustic at 35 KHz) intended as an adjunct to standard wound care.

Revision History

May 2026provider_updateLatest

Provider Update published May 2026; policy header clarifies no material clinical policy statement changes and reiterates that non-contact low-frequency ultrasound for wounds is not covered for Medicare Advantage and is not medically necessary for Commercial products due to insufficient evidence.

May 2025provider_update

Provider Update published May 2025; policy continues to state non-contact ultrasound for wounds is not covered for Medicare Advantage and not medically necessary for Commercial Products.

April 2024provider_update

Provider Update published April 2024; policy affirms coverage stance and coding guidance that CPT 97610 is not covered/not medically necessary.

April 2023provider_update

Provider Update published April 2023; policy continued to list non-contact low-frequency ultrasound as not covered/not medically necessary.

June 2022provider_update

Provider Update published June 2022; prior provider update history recorded with no material clinical policy statement changes indicated.

2019-09-01policy_effective

Policy effective date established as September 1, 2019; documents coverage stance that evidence is insufficient to demonstrate improvement in net health outcome for NLFU.