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A.7.01.174
An ultrasonic diathermy device applies ultrasonic energy to specific body parts at a frequency higher than 20 kilohertz in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. Newer portable stationary devices can be self-applied and used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound. Electrodes attached to adhesive bandages are applied to the skin over the desired treatment area. The continuous low-intensity ultrasound unit can provide treatment for several hours.
Therapeutic Ultrasound
Therapeutic ultrasound is a noninvasive method used to treat a variety of musculoskeletal conditions. Therapeutic ultrasound produces acoustic vibrations of high frequency (≥20 kilohertz) that are outside the range of human hearing. The vibrations generated during therapeutic ultrasound allow the body to generate heat in targeted tissues that are high in collagen (muscles, tendons, ligaments, etc); this is referred to as ultrasound/ultrasonic diathermy. The increased vibrations and heat to the affected areas simulate soft tissue injury repair and pain relief.
Conventionally, high-frequency/high-intensity therapeutic ultrasound is provided in a clinic setting with an average length of treatment ranging from 5 to 10 minutes per session. In this setting, the ultrasound is transmitted through a wand that is applied to the skin with gentle, circular movements. A hypo-allergenic gel aids in the transmission of ultrasonic energy and prevents overheating at the surface of the applicator.
It is important to note that individuals with implanted metal devices, including pacemakers, prostheses, and intrauterine devices, are at risk of serious injury if they undergo diathermy. Furthermore, patients with certain medical conditions, including cancer and others, may not be appropriate candidates for diathermy.
Ultrasonic Diathermy Devices
Newer portable/wearable, stationary devices can be used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound. Electrodes attached to adhesive bandages are self-applied to the skin over the desired treatment area. This type of treatment may also be referred to as sustained acoustic medicine. Similar to conventional high-frequency/high-intensity therapeutic ultrasound, a high-frequency/low-intensity ultrasonic diathermy device applies ultrasonic energy to specific body parts in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. The continuous low-intensity ultrasound device provides treatment for several hours.
Several stationary ultrasonic diathermy devices have been granted 510(k) clearance by the United States Food and Drug Administration (FDA) including Manasport™ (ManaMed, Inc., Las Vegas, NV), Sustained Acoustic Medicine (sam®) (ZetrOZ™, Inc., Trumbull, CT), and PainShield™ MD (NanoVibronix Inc., Elmsford, NY). The intended use of these devices is to supply ultrasound “to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, muscle spasms, joint contractures, and increase local circulation.”
FDA product code: PFW
Ultrasonic diathermy devices for the treatment of musculoskeletal pain are considered investigational.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Individuals with certain medical conditions may not be appropriate candidates for diathermy, including but not limited to those:
with an implanted medical device (pacemaker, deep brain stimulation device, etc)
with a healing fracture in the area to be treated
with a malignancy in the area to be treated
who are pregnant.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
07/01/2023: New policy Added. Approved by the Medical Policy Advisory Committee.
09/26/2023: Code Reference section updated to revise the code description for HCPCS code K1004 and add new HCPCS code K1036, effective 10/01/2023.
02/22/2024: Policy reviewed; no changes.
03/19/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 7.01.174
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
K1004 | Low frequency ultrasonic diathermy treatment device for home use |
K1036 | Supplies and accessories (e.g., transducer) for low frequency ultrasonic diathermy treatment device, per month |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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