Archived Policies - DME


Noncontact Wound Therapy

Number:DME101.044

Effective Date:11-01-2014

End Date:06-30-2015

Coverage:

Ultrasound wound (US) therapy is considered experimental, investigational and/or unproven.

Use of noncontact normothermic wound therapy, either as a primary intervention or as an adjunct to other wound therapies, is considered experimental, investigational and/or unproven.

Description:

Ultrasound (US) Wound Therapy

Low-frequency ultrasound (US) in the kilohertz (kHz) range may improve wound healing. Several non-contact US devices have received regulatory approval for wound treatment.

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 2004, the FDA had reclassified these devices from class III to class II at the request of Celleration. In 2005, the Celleration MIST Therapy device received marketing clearance through the U.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 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™.

Normothermic Wound Therapy

An optimal environment for wound healing is thought to include a moist normothermic environment that functions in part to enhance the subcutaneous oxygen tension and to increase the blood flow to the wound. Warm-up active wound therapy is a device approved for marketing by the U.S. Food and Drug Administration (FDA) that attempts to create this environment. The device includes a noncontact bandage and a warming unit designed to maintain 100% relative humidity and to produce normothermia in the wound and surrounding tissues. The bandage is composed of a sterile foam collar that adheres to the periwound skin and a sterile, transparent film that covers the top of the wound but does not touch it. An infrared warming card is inserted into a pocket in the film covering. Treatments are typically administered 3 times per day in 1-hour sessions.

Rationale:

Ultrasound (US) Wound Therapy

The literature review focused on studies evaluating whether the addition of non-contact 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 randomized controlled trial, 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 RCTs; studies could non-contact or contact 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).

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, non-blinded 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 greater than 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.

There is a ongoing clinical trial comparing MIST ultrasound therapy to the United Kingdom standard of care for the treatment of non-healing venous leg ulcers (NCT01671748) (6). 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. To date, there are no outcomes reported.

Summary

Non-contact low-frequency US in the kilohertz range is proposed to promote wound healing. The available published evidence does not permit conclusions concerning the effect of non-contact US on health outcomes compared to standard wound treatment. One blinded RCT and 2 non- blinded RCTs have evaluated the incremental benefit of commercially available non-contact US devices on wound healing. The blinded RCT had substantial methodologic flaws, e.g., high dropout rate, baseline differences between groups that limit the validity of the findings. Well-designed, 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, non-contact ultrasound treatment for wounds is considered experimental, investigational, and/or unproven.

Practice Guidelines and Position Statements

In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers.(7) 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.(8)

Normothermic Wound Therapy

Standard components of wound care include sharp debridement of devitalized tissue, infection control, non-weight bearing, and treatment of underlying co-morbidities, such as adequate nutrition or glycemic control in diabetics. Therefore, validation of any adjunct to standard wound management requires a randomized controlled trial (RCT) to isolate the contribution of the intervention compared to underlying wound management. A literature review identified one small, randomized crossover trial of warm-up active wound therapy involving 13 patients who were followed up for two weeks.(10) Compared to the control group, more patients in the treatment group improved (62.5% vs. 37.5%). However, the term “improvement” was not fully defined, and no statistical analysis was provided. Santilli and colleagues reported a two-week trial of warm-up active wound therapy in which 17 patients with 31 wounds served as their own control.(11) Almost half of these patients, all refractory to prior therapy, reported complete healing within 12 weeks after treatment. While studies of wound-healing therapies frequently use patients as their own control, this trial design cannot isolate the contribution of the intervention. It is possible that the wound-healing effect may be in part due to increased attentiveness to underlying wound care rather than to the warm-up active wound therapy itself. Finally, Cherry and Wilson reported on a case series of five patients who received a two-week trial of warm-up active wound therapy. (12) Although four of the five patients reported complete healing at 6-14 weeks after treatment, a case series does not permit isolation of the contribution of the warm-up therapy. In addition, both in this trial and in the previous trial reviewed(11), it should be noted that wound healing occurred several weeks after discontinuation of the warm-up therapy, further confounding any evaluation of the therapy.

In January 2002, the Centers for Medicare and Medicaid Services (CMS) published a review of the available literature of noncontact normothermic wound therapy, specifically literature focusing on the warm-up active wound therapy device.(13) CMS identified eight articles that met their selection criteria, including five randomized studies (two of which were not yet published) and three case series. Data were separately analyzed for different types of wounds, i.e., pressure ulcers, venous stasis ulcers, diabetic/neuropathic ulcers, non-healing surgical incisions, and other types of chronic wounds. The CMS review identified methodologic flaws in all the trials in ensuring standard wound care in all patients, reporting outcomes, or reporting statistical or clinical significance of outcomes. The CMS assessment offered the following conclusion: "In summary, the medical literature does not support a finding that noncontact normothermic wound therapy (NNWT) heals any wound type better than conventional treatment. While the submitted studies purport better healing, due to serious methodologic weaknesses, inadequate controls, and a variety of biases, the improved outcomes could also easily disappear in a properly controlled randomized trial. Furthermore, there is no reason why such a trial could not be readily performed. A trial that would best answer our coverage concerns would be one in which there was randomization to three arms: 1) experimental arm which would receive NNWT; 2) experimental arm which would receive NNWT, but with the heating element turned off; and 3) control arm, which would only receive conventional therapy. Conventional therapy should be standardized across all three arms as applicable."

Since the CMS decision, results from four small studies (ranging in size from 16–36 patients) were published that found increased wound healing time with use of noncontact normothermic wound therapy. (14-17) However, none of these studies was a controlled randomized, three-arm trial to isolate the effect of the intervention and address the trial design issues noted. (14, 16, 17) In addition, stratification of wound size, duration, and location are also necessary in trial design.

Alvarez et al. conducted a small (49 patients) open-label randomized trial with standard therapy controls. (18) The study found an improvement in wound healing with NNWT; at 12 weeks, 18% of NNWT wounds had complete healing compared to 9% in the control group. However, as the authors noted, the three hours per day of off-loading (application for one hour three times per day), may have improved patient compliance to off-loading instructions. A study in a larger patient population with the appropriate control groups, as described, is needed.

Summary

In summary, improved health outcomes have not been demonstrated with the use of a noncontact radiant heat bandage. Additional studies are needed to further evaluate the safety and efficacy of this treatment modality.

Practice Guidelines and Position Statements

The 2010 Association for the Advancement of Wound Care (AAWC) guideline on treatment of venous ulcers does not include normothermic wound therapy as a potential treatment modality.(8)

2014 update

A search of peer reviewed literature through July 2014 identified no new clinical publications or any additional information that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

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.

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97610, [Deleted 1/2014:0183T]

HCPCS Codes

E0231, E0232, A6000

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

86.22, 86.27, 86.28.

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

6A750ZZ, 6A751ZZ.


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.

References:

Ultrasound (US) Wound Therapy

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Association for the Advancement of Wound Care (AAWC). Pressure Ulcer Guideline. Available online at: www.guideline.gov. Last accessed August 27, 2014

8. Association for the Advancement of Wound Care (AAWC). Venous Ulcer Guideline. Available online at: www.guideline.gov. Last accessed August 27, 2014.

9. Non-Contact Ultrasound Treatment for Wounds. Chicago, Illinois: Blue Cross Blue Shield Association medical Policy reference Manual (2012 February) Medicine; 2.01.79.

10. Robinson C, Santilli SM. Warm-Up Active Wound Therapy: a novel approach to the management of chronic venous stasis ulcers. J Vasc Nurs 1998; 16(2):38-42.

11. Santilli SM, Valusek PA, Robinson C. Use of a noncontact radiant heat bandage for the treatment of chronic venous stasis ulcers. Adv Wound Care 1999; 12(2):89-93.

12. Cherry GW, Wilson J. The treatment of ambulatory venous ulcer patients with warming therapy. Ostomy Wound Manage 1999; 45(9):65-70.

13. CMS— Decision memo for warm-up therapy® a/k/a noncontact normothermic wound therapy (NNWT). (January 14, 2002) Centers for Medicare and Medicaid Services. Available at <www.cms.gov> Last accessed August 27, 2014.

14. McCulloch J, Knight CA. Noncontact normothermic wound therapy and offloading in the treatment of neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage 2002; 48(3):38-44.

15. Kloth LC, Berman JE, Nett M et al. A randomized controlled clinical trial to evaluate the effects of noncontact normothermic wound therapy on chronic full-thickness pressure ulcers. Adv Skin Wound Care 2002; 15(6):270-6.

16. Alvarez OM, Rogers RS, Booker JG et al. Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: an interim analysis of 20 patients. J Foot Ankle Surgery 2003; 42(1):30-5.

17. Karr JC. External thermoregulation of wounds associated with lower-extremity osteomyelitis. A pilot study. J Am Podiatr Med Assoc 2003; 93(1):18-22.

18. Alvarez O, Patel M, Rogers R et al. Effect of non-contact normothermic wound therapy on the healing of diabetic neuropathic foot ulcers. J Tissue Viability 2006; 16(1):8-11.

19. Noncontact Radiant Heat Bandage for the Treatment of Wounds. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 July—Archived) Medicine: 2.01.41.

Policy History:

Date Reason
11/1/2014 Document updated with literature review. Coverage unchanged.
4/15/2012 Document updated with literature review. Coverage unchanged.
4/1/2010 Document updated with literature review. Coverage unchanged.
1/1/2008 Document updated with literature review. The following change was made: Noncontact, low frequency ultrasound wound therapy is considered experimental, investigational and unproven.
10/1/2006 Document updated with literature review
7/1/2004 New medical document.

Archived Document(s):

Title:Effective Date:End Date:
Ultrasound Wound Therapy07-01-201804-14-2019
Ultrasound Wound Therapy06-15-201706-30-2018
Ultrasound Wound Therapy07-01-201606-14-2017
Noncontact Wound Therapy07-01-201506-30-2016
Noncontact Wound Therapy11-01-201406-30-2015
Noncontact Wound Therapy04-15-201210-31-2014
Noncontact Wound Therapy04-01-201004-14-2012
Noncontact Wound Therapy01-01-200803-31-2010
Noncontact Normothermic Wound Therapy10-01-200612-31-2007
Noncontact Normothermic Wound Therapy07-01-200409-30-2006
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