CAM 20141

Noncontact Radiant Heat Bandage for the Treatment of Wounds

Category:Medicine   Last Reviewed:January 2019
Department(s):Medical Affairs   Next Review:January 2999
Original Date:May 2001    

Description:
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 percent 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 three times per day in one-hour sessions.

Policy:
The use of a noncontact radiant heat bandage is considered INVESTIGATIONAL as a treatment of wounds
.

Benefit Application:
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., 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.

Rationale:
Standard components of wound care include sharp debridement of devitalized tissue, infection control, non-weight bearing and treatment of underlying comorbidities, 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 one small, randomized crossover trial of warm-up active wound therapy involving 13 patients who were followed up for two weeks. (1) Compared to the control group, more patients in the treatment group improved (62.5 percent vs. 37.5 percent). 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. (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 five patients who received a two-week trial of warm-up active wound therapy. (3) Although four of the five patients reported complete healing at six 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.

2002-2006 Update
In January 2002, the Centers for Medicare & 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. (4) CMS identified eight articles that met its 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 that would receive NNWT; 2) experimental arm that 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 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. (5–8) 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. (5, 7, 8) In addition, stratification of wound size, duration and location are also necessary in trial design.

References:

  1. 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.
  2. 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.
  3. Cherry GW, Wilson J. The treatment of ambulatory venous ulcer patients with warming therapy. Ostomy Wound Manage 1999; 45(9):65-70.
  4. 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.
  5. 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.
  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.
  7. Karr JC. External thermoregulation of wounds associated with lower-extremity osteomyelitis. A pilot study. J Am Podiatr Med Assoc 2003; 93(1):18-22.
  8. 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.

Coding Section

Codes Number  Desription 
CPT  No specific CPT code   
ICD-9 Procedure     
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  Home, Inpatient, Skilled nursing facility   

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.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/30/2019 

Annual review, no change to policy intent.

01/29/2018 

Annual review, no change to policy intent. 

01/19/2017 

Annual review, no change to policy intent. 

01/11/2016 

Annual review, no change to policy intent. Deleted index. 

01/20/2015 

Annual review, no change to policy intent. Added coding. 

01/09/2014

Annual Review. No Changes.

 


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