CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Non‑contact low‑frequency ultrasound (NLFU) for wound treatment — Coverage Criteria

This policy governs coverage determinations for non‑contact low‑frequency ultrasound (NLFU) devices used to treat wounds for BlueCHiP for Medicare and Commercial products of Blue Cross Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNon‑contact low‑frequency ultrasound (NLFU) for wound treatment — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not pursue prior authorization; verify member benefits and eligibility per the subscriber agreement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

Insufficient evidenceReason

97610Procedure code

MIST, QousticDevice examples

Coverage Determination

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Primary coverage statement: Non-contact ultrasound treatment for wounds is considered not covered for BlueCHiP for Medicare and considered not medically necessary for Commercial products because the evidence is insufficient to determine the effects of the technology on health outcomes.

Includes any wound type (acute or nonhealing).

Relevant Procedure and Billing Codes

Not covered / Not medically necessary CPT codeCPTNot Covered

97610

Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed; wound assessment; and instruction(s) for Ongoing care, per day

Not covered / Not medically necessary CPT codeCPTNot Covered

97610

Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment; and instruction(s) for Ongoing care, per day

Provider Actions & Administrative Notes

Prior Authorization

Prior authorization — Not applicable

Prior authorization does not apply for non‑contact low‑frequency ultrasound treatment for wounds under BlueCHiP for Medicare or Commercial products.

Note

Benefits vary by contract — verify subscriber agreement

Benefits and coverage limitations may vary by contract; verify the member's subscriber agreement or employer agreement for applicable restrictions or exclusions.

Check the subscriber agreement or member certificate for contract‑specific limitations.

Documentation Required

Benefit verification — confirm member eligibility and coverage

Verify member benefits and eligibility prior to providing services; member‑specific benefits determine coverage and supersede this medical policy.

Contact the provider call center or review the member's subscriber agreement for benefit details.
Do not bill the member for services deemed not medically necessary or non‑covered unless the member has agreed in writing.

Denial Risk

Coverage denial risk for NLFU — not covered / not medically necessary

Non‑contact low‑frequency ultrasound for wounds is not covered for BlueCHiP for Medicare and is considered not medically necessary for Commercial products; CPT code 97610 is listed as not covered/not medically necessary.

Do not expect coverage for CPT 97610 for treatment of wounds using low‑frequency non‑contact ultrasound.
Submitting claims for this service risks denial as not covered or not medically necessary.

Background and Evidence Summary

Ultrasound (US) transmits mechanical vibration above human hearing (>20 KHz). Therapeutic US in the megahertz (MHz) range (1–3 MHz) has cellular effects such as angiogenesis, leukocyte adhesion, growth factor production, and modulation of macrophage activity. Low‑frequency US in the kilohertz range has been developed specifically for wound care and may act through mechanical effects in the coupling medium and tissue (for example, by producing and vibrating micron‑sized bubbles). Some NLFU devices deliver saline mist or sterile saline coupling without direct probe contact (examples: the MIST Therapy System at ~40 KHz and the Qoustic system at ~35–40 KHz).

Definitions

Non‑contact low‑frequency ultrasound (NLFU) — definition and delivery method

DefinitionUltrasound in the kilohertz range delivered without direct contact to the wound surface (non‑contact), commonly using a saline mist or sterile saline coupling to transmit energy.

Typical frequenciesApproximately 35–40 KHz (examples: MIST Therapy ~40 KHz; Qoustic ~35–40 KHz).

Delivery methodsDelivered non‑contact via saline mist (e.g., MIST Therapy System) or saline‑coupled aerosol/stream (e.g., Qoustic Wound Therapy System) rather than direct probe contact or coupling gel.

Clinical intentDeveloped for wound care applications including debridement, irrigation, and to promote wound healing through mechanical effects in the coupling medium and tissue.

Mechanism notesLow‑frequency mechanical energy may act via micron‑sized bubble production, vibration, and movement in the coupling medium and tissue to affect collagen and healing processes.