An NPWT pump and supplies are covered for the following conditions:

1. Ulcers and Wounds in the Home Setting
   
   
   1. The patient has chronic Stage III or IV pressure ulcer, neuropathic ulcer, e.g., diabetic, venous or arterial insufficiency ulcer, or a chronic ulcer of mixed etiology, i.e., being present for at least 30 days.
      
      
   2. A wound therapy program as described below, as applicable to the type of wound, should have been tried or considered and ruled out prior to application of NPWT.
      
      
      1. For all ulcers or wounds, the wound 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 NPWT:
         
         1. Documentation in the patient's medical record of evaluation, care and wound measurements by a licensed medical professional, and
         2. Application of dressings to maintain a moist wound environment, and
         3. Debridement of necrotic tissue if present, and
         4. Evaluation of and provision for adequate nutritional status
         
         
      2. For Stage III or IV pressure ulcers:
         
         1. The patient has been appropriately turned and positioned, and
         2. The patient has used a support surface for pressure ulcers if on the trunk or pelvis and
         3. The patient's moisture and incontinence have been appropriately managed.
         
         
      3. For neuropathic, e.g., diabetic, ulcers:
         
         1. The patient has been on a comprehensive diabetic management program, and
         2. Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
         
         
      4. For venous insufficiency ulcers:
         1. Compression bandages and/or garments have been consistently applied, and
         2. Leg elevation and ambulation have been encouraged.
   
   
2. Ulcers and Wounds in an Inpatient Setting, i.e., treatment continuation is ordered beyond discharge to the home setting.

   An ulcer or wound is encountered in the inpatient setting and, after wound treatments have been tried or considered and ruled out, NPWT is initiated because it is considered in the judgment of the treating physician, the best available treatment option.

   The patient has complications of a surgically created wound, e.g., dehiscence, or a traumatic wound, e.g., pre-operative flap or graft, where there is documentation of the medical necessity for accelerated formation of granulation tissue which cannot be achieved by other available topical wound treatments, e.g., other conditions of the patient that will not allow for healing times achievable with other topical wound treatments.

If the above criteria are not met for use of the NPWT device in either setting, the pump and supplies will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

The NPWT pumps must be capable of accommodating more than one wound dressing set for multiple wounds on a patient. Therefore, more than one pump (E2402) billed per patient for the same time period will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

The NPWT device must be prescribed by a physician and a health care professional licensed to assess wounds and/or administer wound care must, on a regular basis:

1. directly assess the wound(s) being treated with the NPWT pump, and
2. supervise or directly perform the NPWT dressing changes, and
3. at least monthly, document changes in the ulcer's dimensions and characteristics.

The health care professional must also record wound 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 NPWT device. The health care professional services can be reported under code 97605 or 97606.

Staging of Pressure Wounds
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:

nonblanchable erythema of intact light toned skin or darker or violet hue in darkly pigmented skin

Stage II:

partial thickness skin loss involving epidermis and/or dermis

Stage III:

full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia

Stage IV:

full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures

An NPWT pump and supplies will be denied at any time as not medically necessary, and nonbillable by a participating, preferred, or network provider if one or more of the following are present:

• the presence in the wound of necrotic tissue with eschar, if debridement is not attempted;
• untreated osteomyelitis within the vicinity of the wound;
• cancer present in the wound;
• the presence of a fistula to an organ or body cavity within the vicinity of the wound.

Supplies
Supplies for NPWT are limited to the following. Requests for amounts greater than the stated limits will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

• A6550 - 15 dressings/month - Additional dressings per month must be supported by documentation that the wound size requires more than one dressing kit for each dressing change.
  
• A6551 - 10 canister sets/month - Additional canister sets per month must be supported by documentation evidencing a large volume of drainage (greater than 90 ml of exudate per day).

Also, the pump and supplies will be denied as not medically necessary with any of the following, whichever occurs first:

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

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

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

Description

Negative pressure wound therapy (NPWT) is the controlled application of subatmospheric pressure to a wound using an electrical pump (E2402). The pump intermittently or continuously conveys subatmospheric pressure through connecting tubing to a specialized wound dressing (A6550). The dressing includes a resilient, open-cell foam surface dressing, sealed with an occlusive dressing that is meant to contain the subatmospheric pressure at the wound site and thereby promote wound healing. Drainage from the wound is collected in a canister (A6551).

The stationary or portable NPWT electrical pump (E2402) provides controlled subatmospheric pressure and is designed for use with NPWT dressings to promote wound healing. Such an NPWT pump is capable of being selectively switched between continuous and intermittent modes of operation and is controllable to adjust the degree of subatmospheric pressure conveyed to the wound in a range from 25 to not greater than but equal to 200 mm Hg subatmospheric pressure. The pump is capable of sounding an audible alarm when desired pressures are not being achieved (that is, where there is a leak in the dressing seal) and when its wound drainage canister (A6551) is full. The pump is designed to fill the canister to full capacity.

The dressing set (A6550) is used in conjunction with a stationary or portable NPWT pump, and contains all necessary components, including but not limited to a resilient, open-cell foam surface dressing, drainage tubing, and an occlusive dressing which creates a seal around the wound site for maintaining subatmospheric pressure at the wound.

The canister set (A6551) is used in conjunction with a stationary or portable NPWT pump, and contains all necessary components, including but not limited to a container, to collect wound exudate. Canisters may be various sizes to accommodate stationary or portable NPWT pumps.

The purpose of the NPWT device is to promote wound healing. 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.

PRN References

02/2001, Guidelines clarified for specific Durable Medical Equipment

Region A DMERC MPB 14.31