A non-powered negative pressure wound therapy (NPWT) system (e.g., SNaP Wound Care System) and related supplies are covered for the following conditions:

1. The patient has a chronic (i.e., being present for at least 30 days) Stage II or III pressure ulcer, diabetic ulcer of the lower extremity or venous ulcer of the lower extremity.
   
   
2. An ulcer therapy program as described below, as applicable to the type of ulcer, should have been tried or considered and ruled out prior to application of non-powered NPWT.
   1. For all ulcers, the ulcer therapy program must include a minimum of all of the following general measures which should either be addressed, applied, or considered and ruled out prior to application of non-powered NPWT:
      • Documentation in the patient's medical record of evaluation, care and ulcer measurements by a licensed medical professional, and
      • Application of dressings to maintain a moist environment, and
      • Debridement of necrotic tissue if present, and
      • Evaluation of and provision for adequate nutritional status
   2. For Stage II or III pressure ulcers:
      • The patient has been appropriately turned and positioned, and
      • The patient has used an appropriate support surface for pressure ulcers on the posterior trunk or pelvis,
      • The patient's moisture and incontinence have been appropriately managed.
   3. For diabetic ulcers:
      • The patient has been on a comprehensive diabetic management program, and
      • Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
   4. For venous insufficiency ulcers:
      • Compression bandages and/or garments have been consistently applied, and
      • Leg elevation and ambulation have been encouraged.

A non-powered negative pressure wound therapy system will be denied as not medically necessary when submitted for the treatment of surgical (e.g., dehiscence), traumatic, and other types of wounds.

Currently, the available non-powered NPWT dressing is 15x15cm in size. Allowing for the suggested 1cm overlap on each border to create a good seal, 13x13cm is currently the maximum diameter for the ulcer being treated with this system. 

The non-powered negative pressure wound therapy system (e.g., Smart Negative Pressure [SNaP] Wound Care System) is currently indicated for removal of small amounts of exudate.

If the above criteria are not met, the non-powered NPWT system and related supplies will be denied as not medically necessary.

The non-powered NPWT system must be prescribed by a physician who is actively involved in the ulcer care management of the patient.

A licensed health care professional, for the purposes of this policy, may be a physician, physician's assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT). The practitioner should be licensed to assess ulcers and/or administer ulcer care within the state where the member is receiving non-powered NPWT.

Once placed on a non-powered NPWT system and supplies, in order for coverage to continue, a licensed medical professional must, on a regular basis:

1. directly assess the ulcer(s) being treated with the non-powered NPWT system, and
2. at least monthly, document changes in the ulcer's dimensions and characteristics.

The health care professional must also record ulcer measurements consistently and regularly in the patient's records. This documentation is necessary to establish the medical necessity of the device for the individual member and must continue in order for coverage to continue for an eligible non-powered NPWT system.

Staging of Pressure Ulcers
The following description of staging of pressure ulcers should be used when reviewing use of the NPWT device in the treatment of ulcers:

Stage I: Observable pressure related alteration of intact skin whose indicators as compared to the adjacent or opposite area on the body may include changes in one or more of the following: skin temperature (warmth or coolness), tissue consistency (firm or boggy feel), and/or sensation (pain, itching). The ulcer appears as a defined area of persistent redness in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues.

Stage II: Partial thickness skin loss involving epidermis and/or dermis. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater.

Stage III: Full thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue.

Stage IV: Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.

A non-powered NPWT system and supplies will be denied at any time as not medically necessary, if one or more of the following are present:

• Actively infected ulcers
• Inadequately drained ulcers
• Inadequately debrided ulcers
• Exposed blood vessels, anastomotic sites, organs, tendons, or nerves
• Ulcer containing malignancy
• Fistulas
• Untreated osteomyelitis within the vicinity of the ulcer
• Actively bleeding ulcers

Supplies
Supplies for non-powered NPWT are limited to the following. Requests for amounts greater than the stated limits will be denied as not medically necessary.

• Cartridge (E1399) - 10 cartridges per ulcer per month - Additional cartridges per month must be supported by documentation evidencing the volume of drainage of exudates.
• Dressings (A4649) – 10 dressings per ulcer per month - Additional dressings per month must be supported by documentation in the patient’s medical record, and must be available upon request. 

Currently, the available non-powered NPWT dressing is 15x15cm in size. Allowing for the suggested 1cm overlap on each border to create a good seal, 13x13cm is currently the maximum diameter for the ulcer being treated with this system.

Only 1 strap (E1399) per episode of treatment is considered medically necessary.

Also, the non-powered NPWT system and supplies will be denied as not medically necessary with any of the following, whichever occurs first:

1. Adequate ulcer healing has occurred to the degree that non-powered NPWT may be discontinued, in the judgment of the treating physician, or
2. Any measurable degree of ulcer healing has failed to occur over the prior month as documented in the patient’s records, or
3. Four months (including the time non-powered NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using a non-powered NPWT device in the treatment of any ulcer.

Coverage beyond four months will be given individual consideration based upon additional documentation.

This additional documentation must address the initial condition of the ulcer including measurements, efforts to address all aspects of ulcer care, subsequent monthly ulcer measurements, and what changes in ulcer therapy are being applied to effect ulcer healing. This information must be updated with each subsequent request for additional months of use of non-powered NPWT.

Services that do not meet the medical necessity guidelines on the policy will be considered not medically necessary. A participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records

Documentation Requirements

Documentation of the history, previous treatment regimens (if applicable), and current ulcer management for which a non-powered NPWT system is being billed must be present in the patient's medical record and be available on request. This documentation must include such elements as length of sessions of use, dressing types and frequency of change, and changes in ulcer conditions, including precise measurements, quantity of exudates, presence of granulation and necrotic tissue and concurrent measures being addressed relevant to ulcer therapy (debridement, nutritional concerns, support surfaces in use, positioning, incontinence control, etc.).

Documentation of ulcer evaluation and treatment, recorded in the patient's medical record, must indicate regular evaluation and treatment of the patient's ulcers. Documentation of quantitative measurements of ulcer characteristics including ulcer length and width (surface area), and depth, and amount of ulcer exudate (drainage), indicating progress of healing must be entered at least monthly. This documentation must be available upon request.

See Medical Policy Bulletin E-31 for information on powered Negative Pressure Wound Therapy Pumps/Vacuum Assisted Closure of Chronic Wounds.

Coverage for durable medical equipment is determined according to individual or group customer benefits.

Description

The purpose of the non-powered negative pressure wound therapy system (e.g., Smart Negative Pressure [SNaP] Wound Care System) is to promote wound healing. The non-powered NPWT system is a portable negative pressure wound therapy device indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. It is also indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (e.g., diabetic or pressure), and surgically closed incisions and flaps. According to manufacturer information, it provides the same level of negative pressure therapy as competitive technologies, but requires no electric or battery power, and is a fully disposable off-the-shelf system.

Wound healing is defined as improvement occurring in either surface area or depth of the wound. Lack of improvement of a wound is defined as a lack of progress in quantitative measurements of wound characteristics including wound length and width (surface area), or depth measured serially and documented over a specified time interval.

The SNaP Wound Care System is comprised of 3 main components:

• SNaP Wound Care System Cartridge (E1399);
• SNaP Wound Care System Dressing (A4649); and
• SNaP Wound Care System Strap (E1399).

The SNaP Wound Care System Cartridge acts as the negative pressure source and exudate canister. It weighs less than 3 oz, has a capacity of 60cc for wound exudate, is fully disposable, and operates silently. The SNaP Wound Care System Cartridge is powered by technology that maintains constant negative pressure in the chamber. It is available in three models, each capable of creating a preset negative pressure level (-75, -100, and -125 mmHg) that cannot be changed.

The SNaP Wound Care System Dressing is comprised of a proprietary, thin hydrocolloid that provides a strong seal while protecting the patient’s periwound skin, and includes an integrated check-valve that prevents reflux of exudate to the wound. It is easily connected to the SNaP Wound Care System Cartridge with integrated cut-to-length tubing.

The SNaP Wound Care System Strap attaches the SNaP Wound Care System Cartridge to the leg for maximum patient mobility, and allows for the system to be completely hidden under normal clothing. The SNaP® Wound Care System Strap is available in small, medium, and large sizes.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

DME MAC Jurisdiction A L11500

Fong KD, Hu D, Eichstadt S, Gupta DM, Pinto M, et al. The SNaP System: Biomechanical and Animal Model Testing of a Novel Ultraportable Negative-Pressure Wound Therapy System. Plast Reconstr Surg. 2010 May;125(5):1362-71.

Lerman B, Oldenbrook L, Ryu J, Fong KD, Schubart PJ. The SNaP Wound Care System: A Case Series Using a Novel Ultraportable Negative Pressure Wound Therapy Device for the Treatment of Diabetic Lower Extremity Wounds. J Diabetes Sci Technol. 2010 Jul 1;4(4):825-30.

Landsman A. Analysis of the SNaP Wound Care System, A Negative Pressure Wound Device for Treatment of Diabetic Lower Extremity Wounds. J Diabetes Sci Technol. 2010 Jul 1;4(4):831-2.

Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, et al. Initial Clinical Experience Using a Novel Ultraportable Negative Pressure Wound Therapy Device. Wounds. 01 September 2010, Issue 9:230-236.

Lerman B, Oldenbrook L, Eichstadt SL, Ryu J, Fong KD, Schubart PJ. Evaluation of Chronic Wound Treatment with the SNaP Wound Care System versus Modern Dressing Protocols. Plast Reconstr Surg. 2010 Oct;126(4):1253-61.