The purpose of the non-powered negative pressure wound therapy system (NPWT) is to promote wound healing. The non-powered NPWT system is a portable negative pressure wound therapy device indicated for individuals 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.

A non-powered negative pressure wound therapy system (e.g., Smart Negative Pressure [SNaP] Wound Care System, PICO) and related supplies may be considered medically necessary for the following conditions:

• The individual has a chronic (i.e., being present for at least 30 days) Stage III or IV pressure ulcer, diabetic ulcer of the lower extremity or venous ulcer of the lower extremity.
• 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.
  • 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 individual’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.
  • For Stage III or IV pressure ulcers:
    • The individual has been appropriately turned and positioned; and
    • The individual  has used an appropriate support surface for pressure ulcers on the posterior trunk or pelvis; and
    • The individual’s moisture and incontinence have been appropriately managed.
  • For diabetic ulcers:
    • The individual has been on a comprehensive diabetic management program; and
    • Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
  • For venous insufficiency ulcers:
    • Compression bandages and/or garments have been consistently applied; and
    • Leg elevation and ambulation have been encouraged.  

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

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:

• Directly assess the ulcer(s) being treated with the non-powered NPWT system; and
• 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 individual’s records. This documentation is necessary to establish the medical necessity of the device for the individual and must continue in order for coverage to continue for an eligible non-powered NPWT system.

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.

A non-powered NPWT system used in the treatment of children from birth up to and including 12 years of age is considered experimental/investigational and, therefore, non-covered. According to the U.S. Food and Drug Administration (FDA), the safety and effectiveness of NPWT systems in newborns, infants and children has not been established.

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

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

• Adequate ulcer healing has occurred to the degree that non-powered NPWT may be discontinued, in the judgment of the treating physician; or
• Any measurable degree of ulcer healing has failed to occur over the prior month as documented in the  individual’s records; or
• 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 4 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.

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 - 10 cartridges per ulcer per month - Additional cartridges per month must be supported by documentation evidencing the volume of drainage of exudates.
• Dressings – 10 dressings per ulcer per month - Additional dressings per month must be supported by documentation in the individual’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 per episode of treatment may be considered medically necessary.

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.