|MP 2.01.79||Non-Contact Ultrasound Treatment for Wounds|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/11:2014
|Return to Medical Policy Index|
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Ultrasound (US) is defined as a mechanical vibration above the upper threshold of human hearing (greater than 20 kHz). US in the megahertz (MHz) range (1–3 MHz) have been used for the treatment of musculoskeletal disorders, primarily by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor and collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the KHz range have also been examined. Low-frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.
The mechanical energy from US is typically transmitted to tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound debridement. Recently, low-intensity US devices have been developed that do not require use of a coupling gel or other direct contact. The MIST Therapy™ System (Celleration, Eden Prairie, MN) delivers a saline mist to the wound with low-frequency US (40 KHz). A second device, the Qoustic Wound Therapy System™ (Arobella Medical, Minnetonka, MN), also uses sterile saline to deliver ultrasound energy (35 KHz) for wound debridement and irrigation.
In 2005, the Celleration MIST Therapy devicereceived marketing clearance through theU.S. Food and Drug Administration’s (FDA) 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” Several wound drainage and wound vacuum systems were listed as predicate devices. In 2004, the FDA had reclassified these devices from class III to class II at the request of Celleration.
In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical) received marketing clearance, listing the Celleration MIST system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system uses a combination of irrigation and US with a contact probe to debride and cleanse wounds. The indications are similar to that of the MIST system, listed as: “selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.” This device is now known as the Qoustic Wound Therapy System™. Several other devices have been approved as being substantially equivalent to the earlier devices.
FDA product code: NRB
Non-contact ultrasound treatment for wounds is considered investigational.
Effective in 2014, there is a category I CPT code specific to this treatment:
97610: Low frequency, non-contact, nonthermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day.
Prior to 2014, there was a category III CPT code:
0183T: Low frequency, non-contact, nonthermal ultrasound, including topical application(s) when performed, wound assessment, and instruction(s) for ongoing care, per day.
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
This policy was originally created in 2007 and was updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through October 3, 2014. Following is a summary of the key literature to date.
The literature review focused on studies, preferably randomized, evaluating whether the addition of noncontact ultrasound (US) improves wound healing in comparison with standard treatment alone.
Two systematic reviews were published in 2011. An industry-sponsored review by Driver et al. considered both controlled and uncontrolled studies on non-contact low-frequency US therapy for treating chronic wounds. (1) To be eligible for inclusion, studies had to have at least 4 weeks of follow-up. Ten studies were initially identified and 2 were excluded, 1 because data were not in a form suitable for pooling and the other because follow-up time was too short. Of the remaining 8 studies, 1 was an RCT, and the remainder were observational studies (5 retrospective analyses and 2 prospective studies). A pooled analysis of findings from 7 studies (total n=429) found that a mean of 32.7% (95% confidence interval [CI], 23.3% to 42.1%) of patients had healed wounds by a mean of 6 weeks. A pooled analysis of 4 studies (total n=188) found a mean of 85.2% (95% CI, 64.7% to 97.6%) reduction in wound area by final follow-up. The major limitation of this meta-analysis was that there were no pooled comparisons of non-contact US therapy to optimal wound care alone, or to an alternative intervention. Thus conclusions cannot be drawn about the incremental benefit of non-contact ultrasound treatment over optimal wound care alone.
The second systematic review only included randomized controlled trials (RCTs); studies could non-contact or contact ultrasound (US) for treating chronic wounds.(2) Five RCTs were identified on non-contact ultrasound, 1 of which was unpublished. The authors conducted 1 pooled analysis of study findings. This meta-analysis of 2 RCTs found a significantly smaller proportion of nonhealed wounds at 3 months in the non-contact US group compared to the control group (risk ratio, 0.74; 95% CI, 0.58 to 0.95). The ability to draw conclusions from this meta-analysis is limited because only 2 RCTs were included and 1 of these used non-contact US delivered during foot bathing (ie, it did not use a modern device). The other RCT, by Ennis et al. had potential methodologic limitations (see next).
Details of the 2 industry-sponsored RCTs that have assessed the incremental benefit of MIST therapy on wound healing are as follows.
In 2005, Ennis et al. published findings of a double-blind multicenter RCT that used MIST therapy for recalcitrant diabetic foot ulcers.(3) Most of the 133 patients (85%) were enrolled and treated at 17 different wound clinics/private practice centers. An additional 15% of patients were enrolled at 6 university medical clinics. Patients with recalcitrant foot ulcers were treated with active or sham saline mist therapy 3 times per week, with debridement as needed and a weekly evaluation by an independent investigator. Twenty-four patients were lost to follow-up, and data from 54 patients were excluded from analysis due to protocol violations (5 centers were found to have inverted the treatment distances for the active and sham devices), leaving 55 patients (41%) for the per-protocol analysis. The investigators reported significant improvement in the active treatment group (11 of 27 patients, 41%) compared to the control group (4 of 28 patients, 14%) in the proportion of wounds healed (defined as complete epithelialization without drainage). However, intention-to-treat (ITT) analysis showed no difference in wound healing (26% vs 22%, respectively) between the active (n=70) and control (n= 63) groups. In addition to the 59% loss to follow-up, there was a difference in the ulcer area at baseline (1.7 vs 4.4 cm2, respectively) and chronicity of wounds (35 vs 67 weeks, respectively) that favored MIST therapy in the per-protocol groups. Due to the serious limitations of this study, these results are considered inconclusive.
In 2007, Kavros et al. published an open-label (nonblinded) RCT comparing 12 weeks of MIST therapy plus standard care to standard care alone in 70 patients with nonhealing (2 months) foot, ankle, or leg.(4) To participate, patients need to have documented ischemia (transcutaneous oximetry of 40 mm Hg or less) and to agree to 3 times per week visits for therapy. The study found that a greater proportion of patients in the MIST therapy group (22 of 35, 63%) achieved wound healing (defined as a reduction of wound area > 50%) in comparison with standard of care alone (10 of 35, 29% of patients). The authors did not control for potential nonspecific effects of the additional treatment sessions for patients in the non-contact US group, eg, by including a sham treatment group. In addition, although the study reported on the importance of baseline transcutaneous partial pressure of oxygen (TcPo2) on wound healing, patients with low (1–20 mm Hg) and high (21–40 mm Hg) TcPo 2 levels did not appear to be equally distributed between the groups.
Since publication of the 2011 systematic reviews, 1 additional RCT was published that evaluated the incremental benefit of non-contact US on wound healing. The study, by Olyaie et al., was nonblinded and was conducted in Iran.(5) Sponsorship of the study was not discussed. Ninety patients with venous leg ulcers were randomized to 1 of 3 groups (30 patients per group): standard care only; standard care plus high-frequency US; or non-contact US using MIST therapy. Patients in the 2 US groups received treatments 3 times per week for 3 months or until healing occurred. After 4 months, mean ulcer size was 3.23 cm 2 (standard deviation [SD]=2.39) in the high-frequency US group, 2.72 cm 2 (SD=2.16) in the non-contact US group, and 4.28 cm 2 (SD=2.80) in the standard care group, p<0.04. Patients were followed for a mean of 7.5 months. The mean time to complete healing (in months) was 6.86 (SD=2.04) in the high-frequency US group, 6.65 (SD=1.59) in the non-contact US group, and 8.50 (SD=2.17) in the standard care group. The difference in time to healing among the 3 groups was statistically significant (p<0.001). The authors did not report paired comparisons between the standard care and non-contact US groups. The main limitation of this trial is that it was not blinded—this could have led to differential treatment of patients in the 3 groups as they received standard care, and could have biased outcome assessment. Also, as evidenced by the complete healing of ulcers in all patients in the standard care group, it is unlikely that patients had received optimal wound care prior to enrolling in the study.
Ongoing Clinical Trials
MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers (NCT01671748)(6): This single-blind RCT is comparing MIST ultrasound therapy to standard care in the United Kingdom for treatment of nonhealing venous leg ulcers. The primary outcome is change in wound area. The investigators expect to enroll 40 patients, and the expected date of study completion is November 2013.
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (NCT01549860)(7): This single-blind RCT, underway at multiple sites in the United States, is comparing MIST US therapy plus standard of care with standard of care alone for treatment of nonhealing lower extremity venous ulcers The primary outcome measure is the wound reduction area after 4 weeks. Estimated enrollment is 156 patients and the expected date of study completion is December 2014.
Summary of Evidence
The available published evidence does not permit conclusions concerning the effect of noncontact ultrasound (US) on health outcomes compared with standard wound treatment. One blinded randomized controlled trial (RCT) and 2 nonblinded RCTs have evaluated the incremental benefit of commercially available noncontact US devices on wound healing. The blinded RCT had substantial methodologic flaws, eg, high dropout rate, baseline differences between groups that limit the validity of the findings. Welldesigned, blinded studies that have adequate numbers of patients and that include all relevant outcomes are needed to further evaluate the efficacy of this treatment. Therefore, noncontact US treatment for wounds is considered investigational.
Practice Guidelines and Position Statements
In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers.(8) Non-contact ultrasound therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing.
The AAWC guideline on treatment of venous ulcers, updated in 2010, states that low-frequency ultrasound treatment requires additional evidence before it can be considered an appropriate treatment.(9)
US Preventive Services Task Force Recommendations
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
- Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis. Wound Rep Reg 2011; 19(4):475-80.
- Voigt J, Wendelken M, Driver V et al. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds 2011; 10(4):190-9.
- Ennis WJ, Foremann P, Mozen N et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage 2005; 51(8):24-39.
- Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo Clinic experience, 2004-2006. Adv Skin Wound Care 2007; 20(4):221-6.
- Olyaie M, Rad FS, Elahifar MA et al. High-frequency and Noncontact Low-frequency Ultrasound Therapy for Venous Leg Ulcer Treatment: A Randomized, Controlled Study. Ostomy Wound Manage 2013; 59(8):14-20.
- Sponsored by Cardiff and Vale University Health Board in collaboration with Celleration. MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers (NCT01671748. Available online at: www.clinicaltrials.gov. Last accessed September, 2013.
- Sponsored by Celleration Inc. Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (NCT01549860). www.clinicaltrials.gov. Accessed October 6, 2014.
- Association for the Advancement of Wound Care (AAWC). Pressure Ulcer Guideline. www.guideline.gov. Accessed August 20, 2014.
- Association for the Advancement of Wound Care (AAWC). Venous Ulcer Guideline. www.guideline.gov. Accessed August 20, 2014.
|CPT||97610||Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day (new code 1/1/14)|
|ICD-9 Diagnosis||Investigational for all diagnoses|
|ICD-10-CM (effective 10/1/15)||Investigational for all diagnoses|
|E08.621, E08.622, E09.621, E09.622, E10.621, E10.622, E11.621, E11.622, E13.621, E13.622||Various types of diabetes with skin complications (foot ulcer or other skin ulcer) code list|
|I83.001-I83.029; I83.201-I83.229||Varicose veins with ulcer code range|
|L00 – L08.9||Infections of the skin code range (includes cellulitis – L03)|
|L89.00-L89.95||Pressure ulcer code range|
|L97.10-L97.929||Non-pressure chronic ulcer of skin code range|
|L98.41-L98.499||Non-pressure chronic ulcer of skin not otherwise classified code range|
|L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for the initiation or application of this therapy.|
|12/13/07||Add policy to Medicine Section||New policy|
|10/07/08||Replace policy||Policy updated with literature review through August 2008; reference numbers 4 and 5 added; policy statement unchanged|
|10/06/09||Replace policy||Policy updated with literature review through August 2008; references renumbered and references 5 and 6 added; policy statement unchanged|
|10/08/10||Replace policy||Policy updated with literature review through August 2010; rationale re-written; references renumbered and reference number 5 added; policy statement unchanged|
|10/04/11||Replace policy||Policy updated with literature review through August 2011; references 4 and 8 added; other references renumbered or removed; policy statement unchanged|
|10/11/12||Replace policy||Policy updated with literature review through August 2012; references 5, 6 and 8 added; other references renumbered or removed; policy statement unchanged.|
|11/14/13||Replace policy||Policy updated with literature review through September 19, 2013; references 5 and 6 added; other references renumbered or removed; policy statement unchanged.|
|11/13/14||Replace policy||Policy updated with literature review through October 3, 2014. Reference 7 added. Policy statement unchanged.|