Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Stage IV sacral pressure ulceration. 
Treatment: Grafix prime tissue engineered skin substitute. 

The insurer denied coverage for Grafix prime tissue engineered skin substitute. 

The denial is overturned. 

According to the documentation submitted this is the case of a male with a history of stage IV sacral pressure ulceration, diabetes, paraplegia, immobility, and acute osteomyelitis. The patient had a physician follow up for management of stage IV sacral pressure ulceration and the note stated that the patient should continue management of chronic sacrococcygeal ulceration, and the wound has mild improvement. The progress note details a lengthy history from last year for treatment of stage IV sacrococcygeal pressure injury which included antibiotics, collagen, foam dressing, and dressing changes. As of the note  the dressing displaced off the wound, and the patient was refusing outer supportive drape and secondary foam. 

There is scientific evidence to show that bioengineered skin substitutes lead to improvement in health outcomes with earlier closures of wound and healing. 

Milliman Care Guidelines (MCG) Health Ambulatory Care 27th edition Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer ACG: A-0326 (AC) noted that tissue-engineered skin substitute may be indicated for 1 or more of the following: Diabetic ulcers, and Apligraf or Dermagraft needed, as indicated by ALL of the following: Adequate perfusion of involved limb; Conventional wound care and glycemic management to continue during treatment; Diabetes mellitus (type 1 or type 2);  Full-thickness foot ulcer with location on plantar, medial, or lateral area, and no exposure of tendon, muscle, capsule, or bone; Ulcer history, as indicated by 1 or more of the following: Duration greater than 3 weeks (prior to Apligraf), Duration greater than 6 weeks (prior to Dermagraft), No allergy to bovine products; No response to conventional therapy, including ALL of the following: Dressings to maintain moist environment (e.g., saline-moistened dressings), No weight-bearing, Optimal glycemic management (e.g., glycated hemoglobin (HbA1c) of 7% or less); Sharp debridement; No wound infection. 

Thus the patient met the indications for placement of bioengineered tissue product to cover his wound as bioengineered skin substitute is used for ulcers especially in diabetics. 

Finally, Gibbons reported on "Grafix, a Cryopreserved Placental Membrane, for the Treatment of Chronic/Stalled Wounds" in Adv Wound Care (New Rochelle) 2015 and concluded that "Clinical evidences support the benefits of Grafix for head-to-toe wound treatment." 

Grafix prime tissue engineered skin substitute does have approval of the appropriate regulatory body. 

This patient has been treated for a chronic decubitus ulcer that is slowly healing. The provider feels that at this point in time and because of the patient's needs that Grafix would help to finally lead to a full closure and healing of this chronic wound. 

The Grafix skin substitute is as good as any of the other treatments available for this patient. The literature has shown that this is a viable treatment option. 

The adverse risks are not increased over standard treatment services by using bioengineered skin substitute. 
	
Based upon the records, the bioengineered tissue products can be as beneficial as standard treatments for this patient to aid in the closure of this wound. 

In summary, the denial of Grafix prime tissue engineered skin substitute and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.