Q4315, Regenelink amniotic membrane allograft, per square centimeter (add-on, list
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
$127.26
Non-Facility
$127.26
Documentation Required
- Documentation of adequate circulation to the affected extremity: either pedal pulses palpable or pulses confirmed with Doppler examination, or an ankle-brachial index (ABI) between 0.7 and 1.2 (as applicable). Recent laboratory evidence of glycemic control: Glycated hemoglobin test (HgA1c) < 12% within the last 90 days. Documentation that the ulcer has failed to demonstrate adequate healing after at least 4 weeks of standard wound care — including records that standard wound care was provided and what it included (application of dressings to maintain a moist wound environment, debridement if necrotic tissue present, and offloading for diabetic foot ulcers). Clinical documentation excluding known contraindications (e.g., no active Charcot deformity or major structural abnormalities of the affected foot; no chronic infection at the ulcer site; no known or suspected malignancy of the current ulcer). Documentation of wound depth/extent showing the ulcer does not extend to tendon, muscle, capsule, or bone for the covered diabetic foot ulcer indication. For TransCyte coverage: documentation that burn wounds were surgically excised and are full-thickness thermal burns or deep partial-thickness thermal burns, and that application is prior to autograft placement (documentation of surgical plan/timing and burn depth required). Any clinical notes, wound measurements and photos, debridement records, offloading/pressure-relief plans, and prior treatment logs to substantiate both the failure of conservative care and the appropriateness of the specific skin substitute per the policy criteria. Many clinical trials of placental/amniotic products required documentation demonstrating adequate limb perfusion: examples include "dorsum transcutaneous oxygen test (TcPO2) >= 30 mm Hg, ankle-brachial index (ABI) between 0.7 and 1.2, or triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg." Diabetic foot ulcer (DFU) trial enrollment criteria commonly documented: "ulcer size >= 1 cm^2 and < 25 cm^2; Type I or II Diabetes; ulcer duration of >= 4 weeks; unresponsive to standard wound care; no clinical signs of infection; serum creatinine < 3.0 mg/dL (within the last 6 months); HbA1c < 12% (within the last 60 days)." Run-in / responsiveness documentation: some RCTs required a run-in period of standard care and documentation of limited healing response prior to randomization (e.g., 14-day run-in with moist wound therapy and off-loading; randomization if <= 30% wound area reduction post-debridement). Venous leg ulcer (VLU) trial documentation: criteria included VLU "extending through the full thickness of the skin but not down to muscle, tendon, or bone", presence for at least 1 month, and prior treatment with compression therapy for at least 14 days. Exclusion/documentation of absence of infection or other contraindications: trials excluded wounds with active infection or clinical signs of infection; documentation of no infection was required in those studies. Some trials excluded wounds probing to bone, cases with Charcot foot, individuals currently receiving radiation or chemotherapy, known or suspected malignancy of current ulcer, autoimmune connective tissue disease, recent use of growth factors, pregnancy or breastfeeding, and those taking immune-system-modulating medications—documentation of these exclusions was required in study records. Documentation of prior standard wound care (debridement, appropriate off-loading, multilayer compression for VLUs) and documentation of adherence/noncompliance issues were part of trial protocols and analyses. For certain products, documentation of wound characteristics (size in cm^2, duration in weeks/months, depth, presence of exposed structures such as tendon or bone) was required in study data. Adjudication/measurement methods used in trials included photographic documentation and standardized measurement systems (e.g., Silhouette camera, laser measuring device) — documentation of wound measurements and photos were part of study protocols. Documentation of standard wound care (SOC) prior to initiation of adjunctive skin/soft tissue substitute therapy (examples of SOC: moist dressings, offloading, appropriate debridement) and timing (many trials used 2- to 4-week SOC screening/run-in periods). Objective wound measurements and progression tracking (wound dimensions/area over time, percent area reduction) to demonstrate failure to improve with SOC (guideline threshold cited: failure to demonstrate >50% wound area reduction after minimum 4 weeks of standard wound therapy). Clinical documentation of wound characteristics: etiology (DFU, VLU, pressure ulcer, burn, surgical wound, trauma), depth/full-thickness status, presence/absence of exposed tendon/capsule/bone, signs of infection, vascular status (e.g., ankle-brachial index, duplex studies), neuropathy assessment where relevant (e.g., Semmes-Weinstein monofilament), and relevant labs (e.g., HbA1c) where applicable. Records of prior and concurrent therapies (offloading devices, debridement dates, topical agents, systemic antibiotics if used), and dates of prior treatments. Photographic documentation of wounds (serial photos) is implied by trial methods and is typically required to substantiate wound status and response. For product-specific use, documentation should reflect adherence to any product labeling/indications (e.g., product intended uses such as protective covering for acute/chronic wounds, application frequency and number of applications used in trials). Re-evaluation documentation (vascular/infection/offloading) prior to initiation of adjunct therapy, per guideline recommendations. No explicit clinical documentation requirements (e.g., specific medical records, test results, or prior-treatment documentation) are specified in the provided excerpt. Administrative/instructional requirements: reference the member specific benefit plan document and any applicable federal or state mandates before applying this policy. UnitedHealthcare may use third-party tools (e.g., InterQual® criteria) to assist in administering benefits; check plan/vendor requirements as applicable.
Key Coverage Criteria
- EpiFix or Grafix (GrafixPL, GrafixPRIME, and GrafixPL PRIME) (Non-Injectable) — Proven and medically necessary for treating a 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 or pulses confirmed with doppler examination; ankle-brachial index (ABI) between 0.7 and 1.2; glycated hemoglobin test (HgA1c) < 12% (within the last 90 days); ulcer has failed to demonstrate ade [...]
- Use of skin substitute grafts for treatment of diabetic foot ulcers.
- Use of skin substitute grafts for treatment of venous leg ulcers.
- Use of skin substitutes for chronic wounds when managed as part of a wound care treatment plan.
- Up to four initial applications of skin and soft tissue substitutes/CTPs are medically necessary for diabetic foot ulcers (DFU) when there is a non-infected wound and required documentation criteria are met.
- Up to four initial applications of skin and soft tissue substitutes/CTPs are medically necessary for venous leg ulcers (VLU) when there is a non-infected wound and required documentation criteria are met.
4 Active Policies
UHC-POL-skin-soft-tissue-substitutes, Skin and Soft Tissue Substitutes
AMBETTER-CP.MP.185, Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers
UMR-POL-UMR-skin-soft-tissue-substitutes, Skin and Soft Tissue Substitutes
SUREST-POL-SUREST-skin-soft-tissue-substitutes, Skin and Soft Tissue Substitutes
Related Codes
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