Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Negative pressure wound treatment (woundvac, SNaP System) requires pre-authorization.

2)    Negative pressure wound treatment is used to aid in the closure of chronic poorly healing wounds.

Negative Pressure Wound Therapy (NPWT) Systems will be considered medically

    necessary as part of a comprehensive wound care program that includes treating co- 

    morbidities such as diabetes, nutrition, relief of pressure, etc., in the following

    indications:

A.     Chronic Stage III or IV Pressure Ulcers that have failed to heal despite optimal wound care of greater than 30 days and when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, or

1. Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure AND there is exposed bone, cartilage, tendon, fascia or foreign material within the wound AND no contraindications to use are present, or
2. Wounds in patients with underlying clinical conditions which are known to negatively impact wound healing which are non-healing (at least 14 days) despite optimal wound care. Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity.
3. Initial authorization will be provided for a 30 day trial.

 2) Continuation of NPWT:

A. Continuation of the NPWT system, as part of a comprehensive wound care

     program, may be considered medically necessary following an initial 30

     day therapeutic trial or a subsequent treatment period if the treatment has   

     resulted in documented objective improvements in the wound. Objective

     improvements in the wound should include the development and presence

     of healthy granulation tissue, progressive wound contracture and

     decreasing depth, and/or the commencement of epithelial spread from the

     wound margins. This needs to be documented by providing clinical notes.

B. Continuation of the NPWT system will not be considered medically

     necessary when any of the following occur:

                                                    i.     The therapeutic trail or subsequent treatment period has not resulted in documented objective improvement in the wound, OR

                                                   ii.     The wound has developed evidence of wound complications contraindicating continued NPWT, OR

                                                 iii.     The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.

                                                 iv.      Continuation of healing during use of the NPWT system should be monitored on a frequency not less than every 30 days.

3) Powered NPWT system supplies are typically changed three times a week. SnaP

    system supplies are typically changed twice a week. Payment for these supplies is

    limited to these quantities, unless information is provided about special

    circumstances.

Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.

Codes Used In This BI:

97605           Neg press wound tx < 50 cm
97606           Neg press wound tx > 50 cm
A6550           Neg pres wound ther drsg set
A9272           Disposable mech wound suct
E2402           Neg press wound tx, electrical pump, stationary or portable

1.     Negative pressure wound therapy (NPWT) systems for the treatment of other acute or chronic wounds are considered experimental/investigative.

2.      Contraindications to the use of NPWT systems include the following conditions:

a.     necrotic tissue with eschar,

b.     untreated osteomyelitis,

c.     non-enteric and unexplored fistulas,

d.     malignancy in the wound,

e.     exposed nerve, anastomotic site, or organ

The Vacuum Assisted Closure system consists of a medical-grade, open-cell polyurethane ether foam dressing that has been approved by the FDA for contact with open wounds.  The pore size ranges from 400 to 600 µm to maximize tissue growth.  An evacuation tube with side ports that communicate with the reticulated foam is embedded in the foam.  The open-cell nature of the foam ensures equal distribution of the applied sub atmospheric pressure to all spaces within the system and to all surfaces in contact with the foam.  The foam dressing is cut to the specific wound geometry and placed into the wound defect with the evacuation tube exiting parallel to the skin.

The Vacuum Assisted Closure applies universal force to draw the edges of the wound to the center, thus assisting wound closure.  The negative pressure on the wound created by the Vacuum Assisted Closure also helps reduce edema, increase blood supply and decrease bacterial colonization.

NPWT is the controlled application of sub atmospheric pressure to a wound using an electrical pump or other device to intermittently or continuously convey sub atmospheric pressure through connecting tubing to a specialized wound dressing which includes a resilient, open-cell foam surface dressing, sealed with an occlusive dressing that is meant to contain the sub atmospheric pressure at the wound site and thereby promote wound healing.  Drainage from the wound is collected in a canister.

NPWT has been used to promote healing of chronic wounds and pressure ulcers (decubitus ulcers) by creating controlled negative pressure over the wound that is thought to increase local vascularity and oxygenation of the wound bed, reduce edema by evacuating wound fluid, and remove exudate and bacteria.

More than a dozen systematic evidence reviews produced by independent organizations have questioned the quality of the evidence supporting the use of NPWT, including systematic evidence reviews published by the Cochrane Collaboration (Evans & Land, 2001; Wasiak & Cleland, 2007; Ubbink, et al., 2008), Washington State Department of Labor and Industries (2003), Canadian Coordinating Office for Health Technology Assessment (Fisher & Brady, 2003), Australian Safety and Efficacy Register of New Interventional Procedures -- Surgical (Pham, et al., 2003), NHS Quality Improvement Scotland (NHS QIS, 2003), Centre for Clinical Effectiveness (Higgins, 2003), Agency for Healthcare Research and Quality (Samson, et al., 2004), Technology Assessment Unit of McGill University Health Centre (Costa, et al., 2005), Institute for Quality and Efficiency in Health Care (IQWiG, 2006), Ontario Ministry of Health and Long-Term Care (MAS, 2004; MAS, 2006), Galician Agency for Health Technology Assessment (AVALIA-T, 2005), and BMJ Clinical Evidence (Nelson & Jones, 2006; Nelson & Penthrick, 2007).

Control of intra-abdominal fluid secretion, facilitation of abdominal exploration, and preservation of the fascia for abdominal wall closure is a major challenge in the management of patients with an open abdomen.  Vacuum-assisted therapy has been reported to help meet the challenges of managing the open abdomen and may be useful in patients with abdominal compartment syndromes, traumatic injuries, and severe intra-abdominal sepsis.  In a review on the management of patients with open abdomen, Kaplan (2004) concluded that controlled clinical studies are needed to establish the safety and effectiveness of this treatment approach and to facilitate the development of treatment guidelines to help manage an increasingly common group of patients who might benefit from this treatment approach. A systematic evidence review by the National Institute for Health and Clinical Excellence (NICE, 2009) found inadequate evidence for the use of NPWT in open abdominal wounds.  The NICE assessment concluded that "[c]urrent evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is inadequate in quality and quantity. There has been concern about the occurrence of intestinal fistulae associated with this procedure but there is currently no evidence about whether NPWT is the cause."

Anecdotal and limited clinical trials demonstrate that there is a subset of problematic wounds where the use of negative pressure wound therapy (NPWT) may provide a significant clinical benefit. However, due to clinical variability and the limited data, it is not possible to determine prospectively which wounds are most likely to respond favorably to NPWT. Therefore, the policy statement indicates that a therapeutic trial of NPWT of not less than 14 days may be considered for acute and chronic wounds with either demonstrated failure to heal despite intense conventional wound therapy for 90 days or more, or for those wounds that have a high probability of failure to heal due to compounding factors involving the wound and the patient. Continued use of NPWT requires objective evidence of wound healing such as the development of healthy granulation tissue and progressive wound contracture.

A number of reports of NPWT in the management of sternotomy wounds, most small case series from outside the US and some that included little data with respect to clinical outcomes including time to healing, have been identified.  Tocco and colleagues (2009) report on 21 patients with mediastinitis after sternotomy all of whom were treated with NPWT for an average of 26 days (range, 14-37). Once wound tissue appeared viable and cultures were negative, the chest was closed; in 9 cases using pectoralis flaps, in 9 using Nitinol clips, in one with a combination of muscle flap and Nitinol clips, and in one with sternal wires. Canadian researchers studied predictors of failure of NPWT closure of sternotomy wounds (Gdalevitch, 2010).  Twelve risk factors for impaired wound healing were identified before data collection to retrospectively evaluate predictors of NPWT failure. Of 37 patients treated with NPWT between January 1997 and July 2003, 8 patients failed NPWT. Of the 12 risk factors, 3 were found to be predictive of poor outcome: bacteremia, wound depth of 4 or more cm, and high degree of bony exposure and sternal instability. The authors advise that prospective randomized studies are needed to validate these hypotheses.

1.     Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Vacuum assisted closure therapy for wound care. Health Technology Literature Review. Toronto, ON: MAS; 2004.

2.     Letter from Cynthia Hake, Director, Centers for Medicare and Medicaid Services HCPCS Workgroup, Baltimore, MD, to Richard Weston, BlueSky Medical Group, Inc., Vista, CA, regarding request to establish a code for portable powered suction pump, trade name: Versitile Wound Vacuum System, October 27, 2005.

3.     Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: A multicenter randomized controlled trial. Lancet. 2005; 366(9498):1704-1710.

4.     Costa V, Brophy J, McGregor M. Vacuum-assisted wound closure therapy (VAC). Report No.19. Montreal, QC: Technology Assessment Unit of the McGill University Health Centre (MUHC); 2005.

5.     Caniano DA, Ruth B, Teich S. Wound management with vacuum-assisted closure: Experience in 51 pediatric patients. J Pediatr Surg. 2005; 40(1):128-132.

6.     Gastelu-Iturri Bilbao J, Atienza Merino G. Vacuum-assisted closure effectiveness for chronic wounds therapy. Technical Report [summary]. CT2005/01. Santiago de Compostela, Spain: Galician Agency for Health Technology Assessment (AVALIA-T); 2005.

7.     Wasiak J, Cleland H. Topical negative pressure for partial thickness burns. Cochrane Database Syst Rev. 2007 ;( 3):CD006215.

8.     Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma. 2006; 60(6):1301-1306.

9.     Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Negative pressure wound therapy. Health Technology Literature Review. Toronto, ON: MAS; 2006.

10. Institute for Quality and Efficiency in Health Care (IQWiG). Scientific evaluation of the current status of medical knowledge on vacuum assisted closure (VAC) therapy of wounds [summary]. Technology Assessment. Cologne, Germany: IQWiG; 2006.

11. TriCenturion LLC. Negative pressure wound therapy (NPWT) widespread probe results. Jurisdiction A – Final Report. Jurisdiction A/B DME PSC. LPET20070219-E2402. Columbia, SC: Tricenturion; February 2007. Available at: http://www.tricenturion.com/content/pcalpet.cfm. Accessed April 13, 2007.

12. Vlayen J, Camberlin C, Ramaekers D. Negative pressure wound therapy: A rapid assessment. KCE Reports 61. Brussels, Belgium: Belgian Health Care Knowledge Centre (KCE); 2007.

13. Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: What is the role of wound chronicity? Int Wound J. 2007; 4(1):79-86.

14. Schimmer C, Sommer SP, Bensch M, Leyh R. Primary treatment of deep sternal wound infection after cardiac surgery: A survey of German heart surgery centers. Interact Cardiovascular Thorax Surg. 2007; 6(6):708-711.

15. Morris GS, Brueilly KE, Hanzelka H. Negative pressure wound therapy achieved by vacuum-assisted closure: Evaluating the assumptions. Ostomy Wound Manage. 2007; 53(1):52-57.

16. Gregor S, Maegele M, Sauerland S, et al. Negative pressure wound therapy: A vacuum of evidence? Arch Surg. 2008; 143(2):189-196.

17. Blume PA, Walters J, Payne W, et al. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: A multicenter randomized controlled trial. Diabetes Care. 2008; 31(4):631-636.

18. Ubbink DT, Westerbos SJ, Evans D, et al. Topical negative pressure for treating chronic wounds. Cochrane Database Syst Rev. 2008 ;( 3):CD001898.

19. Vikatmaa P, Juutilainen V, Kuukasjärvi P, et al. Negative pressure wound therapy: A systematic review on effectiveness and safety. Eur J Vasc Endovasc Surg. 2008; 36(4):438-448.

20. Bee TK, Croce MA, Magnotti LJ, et al. Temporary abdominal closure techniques: A prospective randomized trial comparing polyglactin 910 mesh and vacuum-assisted closure. J Trauma. 2008; 65(2):337-342.

21. Expert Working Group. Vacuum assisted closure: Recommendations for use. A consensus document. Int Wound J. 2008; 5 Suppl 4: iii-19.

22. Bovill E, Banwell PE, Teot L, et al; International Advisory Panel on Topical Negative Pressure. Topical negative pressure wound therapy: A review of its role and guidelines for its use in the management of acute wounds. Int Wound J. 2008; 5(4):511-529.

23. Sumpio BE, Allie DE, Horvath KA, et al. Role of negative pressure wound therapy in treating peripheral vascular graft infections. Vascular. 2008; 16(4):194-200.

24. Baharestani MM, Houliston-Otto DB, Barnes S. Early versus late initiation of negative pressure wound therapy: Examining the impact on home care length of stay. Ostomy Wound Manage. 2008; 54(11):48-53.

25. Baharestani MM, Driver VR, de Leon JM, et al. Optimizing clinical and cost effectiveness with early intervention of v.a.c.(R) therapy. Ostomy Wound Manage. 2008; 54(11):1-15.

26. Sadat U, Chang G, Noorani A, et al. Efficacy of TNP on lower limb wounds: A meta-analysis. J Wound Care. 2008; 17(1): 45-48.

27. Sullivan N, Snyder DL, Tipton K, et al. Negative pressure wound therapy devices. Technology Assessment Report. Prepared by the ECRI Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ), Contract No. 290-2007-10063. Project ID: WNDT1108. Rockville, MD: AHRQ; March 30, 2009.

28. Gregor S, Maegele M, Sauerland S, et al. Negative pressure wound therapy: A vacuum of evidence? Arch Surg. 2008; 143(2):189-196.

29. Ubbink DT, Vermeulen H, Segers P, Goslings JC. Negative pressure therapy for surgical wounds. Ned Tijdschr Geneeskd. 2009; 153:A365.

30. Open Abdomen Advisory Panel, Campbell A, Chang M, Fabian T, et al. Management of the open abdomen: From initial operation to definitive closure. Am Surg. 2009; 75(11 Suppl):S1-S22.

31. National Institute for Health and Clinical Excellence (NICE). Negative pressure wound therapy for the open abdomen. Interventional Procedure Guidance 322. London, UK: NICE; December 2009.

Addendum:

Effective 08/01/2017: Clarification of documentation requirements for continuation.