United Healthcare has updated its Skin and Soft Tissue Substitutes policy effective May 1, 2024, which details the coverage and documentation criteria specifically for EpiFix or Grafix® (GrafixPL, GrafixPRIME and GrafixPL PRIME) (Non-Injectable). The policy also includes an extensive list of products that will NOT be covered by United Healthcare.
UnitedHealthcare® Commercial and Individual Exchange Medical Policy
Skin and Soft Tissue Substitutes
Policy Number: 2024T0592W Effective Date: May 1, 2024
Coverage Rationale
EpiFix or Grafix® (GrafixPL, GrafixPRIME and GrafixPL PRIME) (Non-Injectable)
EpiFix or Grafix is proven and medically necessary for treating diabetic foot ulcer when all of the following criteria are met:
- Adequate circulation to the affected extremity as indicated by one or more of the following:
- Pedal pulses palpable
- Ankle-brachial index (ABI) between 0.7 and 1.2
- Dorsum transcutaneous oxygen test (TcPO2) ≥ 30 mm Hg within the last 60 days
- Triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg
- Optimal glucose control glycated hemoglobin test (HgA1c) < 12% (within the last 90 days)
- Individual has a diagnosis of Type 1 or Type 2 diabetes
- Ulcer size ≥ 1 cm2 and < 25 cm2
- Ulcer has failed to demonstrate Measurable Signs of Healing* with at least 4 weeks of standard wound care which includes all of the following:
- Application of dressings to maintain a moist wound environment
- Debridement of necrotic tissue, if present
- Offloading
- Individual does not have active Charcot deformity or major structural abnormalities of the affected foot
- Individual does not have a known or suspected malignancy of the current ulcer being treated
- Standard wound care continues
- Ulcer being treated does not extend to tendon, muscle, capsule, or bone
EpiFix and Grafix Application Limitations
- EpiFix is limited to one application per week for up to 12 weeks
- Grafix is limited to one application per week for up to 12 weeks
Due to insufficient evidence of efficacy, EpiFix and/or Grafix are unproven and not medically necessary for all other indications including but not limited to:
- EpiFix application more frequently than once a week or beyond 12 weeks
- Grafix application more frequently than once a week or beyond 12 weeks
*Measurable Signs of Healing: Wound is diminishing in size (either surface or depth) and there is decreased amount of exudate and necrotic tissue (Gould et al., 2016)
(Read the policy to find the long list of products NOT covered . . .)
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
