Wound care is a business operating with specific rules and guidelines. The very root of proving you are working within stated clinical, financial, and operational guidelines is the data you'll capture using your specialty electronic medical record (EMR). From the time a patient is called to schedule a service, the documentation process begins and medical necessity and coverage are confirmed and entered into the documentation system. Medical necessity guidelines can be payer specific, but most often payers follow the guidelines published by the Centers for Medicare & Medicaid Services-National Coverage Decisions or Local Coverage Decisions (LCDs). The application of cellular and tissue-based products (CTPs) should be dictated by the clinical presentation of the patient as imparted by your LCD.

Let's review a portion of the CTPs in a current LCD (Wisconsin Physician Services) titled "Application of Bioengineered Skin Substitutes (L30135)"1 to further highlight the importance of understanding regulations and clinical decision making for proper payment:

"Coverage Indications, Limitations, and/or Medical Necessity"

This LCD covers the use of skin substitutes and related products in the treatment of lower-extremity ulcer disease. The LCD does not pertain or otherwise apply to the use of any skin substitutes or related products in the treatment of burns or skin cancer or for true reconstructive surgery.

Indications

Application of bioengineered skin substitutes will be covered when the following conditions are met and documented as appropriate for the individual patient:

1. presence of neuropathic diabetic foot ulcers for greater than 4-week duration

2. presence of venous stasis ulcers of greater than 1-month duration that have failed to respond to documented conservative measures for greater than 1-month duration

3. presence of neuropathic diabetic foot ulcers that have failed to respond to documented conservative measures for greater than 1-month duration; these measures must include appropriate steps to off-load pressure during treatment

4. presence of partial- or full-thickness ulcers

5. measurements of the initial ulcer size, the size following cessation of any conservative management, and the size at the beginning of skin substitute treatment

In all cases, the ulcer must be free of infection and underlying osteomyelitis. Documentation must be provided that these conditions have been successfully treated and resolved, prior to instituting skin substitute treatment.

Surgical Preparation of Wound Prior to Application of Skin Substitute

Repair of donor site requiring skin graft or local flaps is reported separately. Removal of current graft and/or simple cleansing of the wound are included, when performed.

Do not report CPT code 97602. Debridement is considered a separate procedure only when gross contamination requires prolonged cleansing, when appreciable amounts of devitalized or contaminated tissue are removed, or when debridement is carried out separately without immediate primary closure. Select the appropriate code from CPT codes 15271-15278 based on location and size of the defect. For multiple wounds, sum the surface area of all wounds from all anatomic sites that are grouped together into the same code descriptor. For example, sum the surface area of all wounds on the trunk and arms. Do not sum wounds from different groupings of anatomic sites (eg, face and arms).

Medicare accepts the Food and Drug Administration's classification and description of any bioengineered skin substitute. Application of a bioengineered skin substitute is covered when the following conditions are met and documented as appropriate for the individual patient:

1. beneficiaries with diabetes under current medical management and controlled with stable HgbA1c level

2. venous stasis ulcers that have failed to heal, using conservative measures

3. neuropathic diabetic foot ulcers that have failed to heal, using conservative measures

4. ulcers that do not involve tendon, muscle, or joint capsule or have bone exposure that extends through the dermis unless specifically indicated within the Food and Drug Administration-approved package insert

5. beneficiaries with adequate arterial blood supply to the foot evidenced by a palpable pulse on the foot (either dorsalis pedis or posterior tibial artery) or an ankle brachial index of 0.65 or greater

6. neuropathic diabetic foot ulcers that have been treated with appropriate steps to off-load pressure

7. the ulcer must be free of infection and underlying osteomyelitis"

Recognize your responsibility for the oversight and detail of procedures performed are critical:

* Know your payer regulations and review the policies often for updates.

* Understand the payer's coverage indications, limitations, and/or medical necessity.

* Understand the indications for application of the CTP.

* Define the documentation necessary and map your workflows accordingly.

* Develop an audit checklist to validate the documentation supports the regulation's requirements.

Reference