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Theraskin (Q4121) Coding Guidelines


TheraSkin® is a biologically active cryopreserved real human skin allograft with both epidermis and dermis layers. TheraSkin provides, upon application, an “at ready” supply of growth factors, cytokines and collagen to jumpstart wound healing in non-progressing chronic wounds.

Theraskin is reported with code Q4121 (TheraSkin®, per square centimeter)

TheraSkin® will be considered reasonable and necessary when the following conditions are satisfied and documented when used with standard therapeutic compression for venous stasis ulcer (VSU):

1. Only for ulcers that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression.

A "failed response" is defined as an ulcer that has increased in size or depth, or for which there has been no change in baseline size or depth and no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress towards closing. Documentation of response or lack thereof, requires measurement of the ulcer at baseline, following cessation of conservative or conventional management. Documentation should also include measurement of the ulcer immediately prior to the placement of TheraSkin®.

2. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g. hypertension, is provided and documented in conjunction with the treatment; and

3. Only for ulcers that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material that could interfere with the adherence of TheraSkin® and wound healing.

When used with standard diabetic foot ulcer care for neuropathic Diabetic Foot Ulcer (DFU)s:

1. Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus;

2. Only if the patient does not have a current HbA1C reading exceeding 12%;

3. Only for full thickness ulcers of greater than three weeks in duration, which extend through the dermis, with or without tendon, muscle, capsule or bone exposure;

4. Only when adequate treatment of the underlying disease process(es) contributing to the ulcer, e.g., diabetes is provided and documented in conjunction with treatment; and

5. Only for ulcers located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material that could interfere with the adherence of TheraSkin®, and the process of wound healing.

For both VSUs and DFUs all of the following must also be satisfied and documented:

1. The patient must have adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb undergoing the procedure;

2. TheraSkin® treatment must be used in conjunction with following standard conservative measures:

a. Use of pressure-reducing footwear;
b. A non-weight bearing regiment;
c. Debridement of necrotic and callused tissue when necessary; and
d. Acceptable methods of wound care, such as saline moistened dressings

The patient must be competent and/or have the support system required to participate in follow-up care associated with treatment of the wound with TheraSkin®.

The use of TheraSkin® on ulcers with any of the following conditions is considered not necessary and reasonable, and will result in denial of a claim:

1. cellulitis;
2. osteomyelitis;
3. necrotic ulcer;
4. draining wound; or
5. clinically significant wound healing impairment due to uncontrolled diabetes.


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