|MP 2.01.41||Noncontact Radiant Heat Bandage for the Treatment of Wounds|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/7:2008
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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.
The use of a noncontact radiant heat bandage is considered investigational as a treatment of wounds.
No applicable information
BlueCard/National Account Issues
Use of noncontact radiant heat bandages may be initiated in the inpatient or nursing home setting, with requests to continue the therapy on an outpatient basis.
State or federal mandates (e.g., the FEP) may dictate that all devices approved for marketing by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.
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 to isolate the contribution of the intervention compared to underlying wound management. A literature review identified 1 small, randomized crossover trial of Warm-Up Active Wound Therapy involving 13 patients who were followed up for 2 weeks. (1) 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 2-week trial of Warm-Up Active Wound Therapy in which 17 patients with 31 wounds served as their own control. (2) 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 5 patients who received a 2-week trial of Warm-Up Active Wound Therapy. (3) Although 4 of the 5 patients reported complete healing at 6 to 14 weeks after treatment, again 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 (2), it should be noted that wound healing occurred several weeks after discontinuation of the Warm-Up Therapy, further confounding any evaluation of the therapy.
A review of the literature since the original publication of this policy through December 2005 did not identify any studies that would address the limitations noted above. In January 2002, the Centers for Medicare and Medicaid Service (CMS) published a review of the available literature of noncontact, normothermic wound therapy, specifically literature focusing on the Warm-Up Active Wound Therapy device. (4) CMS identified 8 articles that met their selection criteria, including 5 randomized studies (2 of which were not yet published) and 3 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 of 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 Medicare decision, results from 4 small studies (ranging in size from 16–36 patients) were published that found increased wound healing time with use of noncontact normothermic wound therapy. (5-8) However, none of these studies were controlled randomized, 3-arm trials to isolate the effect of the intervention and address the trial design issues noted. (5, 7, 8) In addition, stratification of wound size, duration, and location are also necessary in trial design.
A search of the MEDLINE database for the period of January 2006 through May 2007 identified 1 small (49 patients) open-label randomized trial with standard therapy controls. (9) 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 3 hours per day of off-loading (application for 1 hour 3 times per day), may have improved patient compliance to off-loading instructions. Study in a larger patient population with the appropriate control groups, as described above, is needed.
A search of the MEDLINE database for the period of June 2007 through June 2008 did not identify any recent studies. Improved health outcomes have not been demonstrated with use of a noncontact radiant heat bandage. Therefore, the policy statement is unchanged.
- 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.
- 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.
- Cherry GW, Wilson J. The treatment of ambulatory venous ulcer patients with warming therapy. Ostomy Wound Manage 1999; 45(9):65-70.
- 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.
- 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.
- 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 Surg 2003; 42(1):30-5.
- Karr JC. External thermoregulation of wounds associated with lower-extremity osteomyelitis. A pilot study. J Am Podiatr Med Assoc 2003; 93(1):18-22.
- 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.
|CPT||No specific CPT code|
|ICD-9 Diagnosis||Investigational for all diagnoses|
|HCPCS||E0231||Non-contact wound warming device (temperature control unit, AC adapter and power cord) for use with warming card and wound cover|
|E0232||Warming card for use with the non-contact wound warming device and wound cover|
|A6000||Non-contact wound warming wound cover|
|Type of Service||Durable Medical Equipment|
|Place of Service||
Skilled nursing facility
Noncontact Radiant Heat Bandage, Treatment of Wounds
Warm-up Active Wound Therapy
Wound Therapy, Warm-up Active Wound Therapy
|05/31/01||Add to Medicine section||New policy|
|05/15/02||Replace policy||Policy reviewed; policy statement unchanged; additional information regarding Medicare policy added|
|10/9/03||Replace policy||Literature review update; policy statement unchanged|
|04/1/05||Replace policy||Policy updated with literature review; no change in policy statement|
|3/7/06||Replace policy||Policy updated with literature review; no change in policy statement|
|06/14/07||Replace policy||Policy updated with literature review; no change in policy statement; reference number 9 added.|
|07/10/08||Replace policy||Policy updated with literature review; no change in policy statement|