Appeal type: Medical necessity
Decision: Overturned

Diagnosis: diabetic wound/ulcer of the lower extremity

Treatment: bioengineered tissue products (artificial alternatives to live skin grafts for wound care and tissue reconstruction, Q4186)

The insurer denied coverage for bioengineered tissue products (artificial alternatives to live skin grafts for wound care and tissue reconstruction, Q4186)

The denial is overturned

According to the documentation submitted this is the case of an adult with a history of morbid obesity, diabetes, chronic ulcers, and fracture of the right leg, cataracts, sleep apnea, hypertension, and congenital malformation of the kidney. The patient was followed in the wound clinic and had ankle brachial index (ABI) noting left ABI was 1.12 and the right ABI was 1.14. In addition, it was noted that dorsalis pedis pulse was palpable bilaterally.

Wound assessment noted that the patient had on the right medial ankle a diabetic wound/ulcer of the lower extremity presumably from trauma. In addition, the History & Physical noted that the patient has a 3rd right toe amputation due to neuropathy. On the recent visit the patient now returned with a new wound on the right medial ankle as he suffered a fall in the shower and broke his right ankle. He had an eschar after the soft cast from rubbing in a particular area. He was treated with Adaptec and Silvercel. The wound was noted to be 1.5 x 2 x 0.1 (centimeters) cm. The fat layer was exposed. There was no tunneling, or undermining noted. There was a medium amount of drainage noted. The wound margin was intact and flat. There was medium red, pink granulation tissue within the bed. There was a small amount of necrotic tissue within the wound bed including adherent slough. Tissue debridement was done. The plan was zinc oxide.
The patient returned for follow up, it was noted the wound was smaller and the plan was to continue with current dressing and return in 1 week.

Last progress notes indicated the wound was epithelialized and healed. However now there was a new wound on his heel after using his shoes and walking a short distance. The plan was Aquacel and zinc oxide.

Labs were included indicating a Glycated hemoglobin (HbA1c) of 7.2.
Based upon the records, the bioengineered tissue products were medically necessary. In addition, the patient did meet the criteria of the insurer for this product as the patient did have ABI's which were normal and continued to have palpable pedal pulses.  Furthermore, the patient did have a HbA1c of 7.2 which was less than the 12% the insurer noted in the policy. Therefore, even by the insurer policy the criteria were met as these were the reasons why the insurer denied the bioengineered tissue products for this patient. 
	
A systematic review and meta-analysis evaluating biologic skin substitutes for healing of diabetic foot ulcers included 5 studies of Apligraf and 7 studies of Dermagraft and found that both agents were associated with improved healing at 12 weeks compared with standard of care alone. However, the authors noted that the analysis was limited by the number of different skin substitutes and protocols included the number of unblinded trials, and the lack of information on adverse events; they stated that more prospective comparative trials are needed to generate evidence-based decisions on which substitute and corresponding application protocol to use. A randomized controlled trial of patients with diabetic foot ulcers found that the 35 patients who received standard wound care healed in a mean time of 57.4 days, while the 33 patients who received Apligraf healed in a mean time of 47.9 days.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for bioengineered tissue products (artificial alternatives to live skin grafts for wound care and tissue reconstruction, Q4186) is substantiated.