Omnigraft

Indicated For

Partial and full-thickness neuropathic diabetic foot ulcers, thermal injuries, scar contractures

About This Medication

# Integra Omnigraft Patient Guide: How to Get Omnigraft at Low or No Cost **Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) is a specialized medical device from Integra LifeSciences Corporation used to treat certain diabetic foot ulcers. While specific patient assistance programs for free or low-cost access are not publicly detailed, this guide outlines general steps to access financial help, eligibility considerations, and application strategies based on standard practices for such devices.** [1][2][3] ## About Omnigraft Omnigraft is an advanced **dermal regeneration matrix** designed to promote skin and tissue regrowth in qualifying wounds. It consists of a bilayer structure: a porous matrix made from bovine collagen and shark cartilage, topped with a silicone layer that protects the wound while new tissue forms. The FDA approved Omnigraft in 1996 for severe burns and scar contractures, expanded in 2002 for reconstructive uses, and in 2016 specifically for **partial and full-thickness neuropathic diabetic foot ulcers** lasting over six weeks, with no exposed capsule, tendon, or bone, when combined with standard care like debridement, offloading, and wound dressings.[1][2][3] In clinical studies, 51% of patients using Omnigraft + standard care had healed ulcers after 16 weeks, compared to 32% with standard care alone. It's applied on the day of debridement for best results and must not be removed prematurely, as it integrates with the patient's tissue.[1][2] Omnigraft is not a drug but a Class III medical device, priced per square centimeter, which can make it costly without coverage—often thousands of dollars depending on wound size.[3] ## Who Qualifies for Assistance? Patient assistance programs (PAPs) from manufacturers like Integra LifeSciences typically target **uninsured, underinsured, or low-income patients** who meet medical and financial criteria. For Omnigraft, eligibility likely requires: - A valid prescription from a healthcare provider for FDA-approved uses (e.g., qualifying diabetic foot ulcers). - U.S. residency and proof of financial need. - No or limited insurance coverage for the device. **Medical Qualifications**: Your ulcer must be neuropathic diabetic, >6 weeks duration, partial/full-thickness, no exposed bone/tendon/capsule. Contraindications include bovine allergies or active infections.[1][3] ## Income Eligibility Breakdown Specific income thresholds for Integra's program are not publicly available, but most PAPs follow federal poverty guidelines (FPG), adjusted for household size. Here's a typical breakdown for 2026 (estimates based on standard PAP structures; verify with Integra): | Household Size | Annual Income Limit (300% FPG) | Annual Income Limit (400% FPG) | Annual Income Limit (500% FPG) | |---------------|-------------------------------|-------------------------------|-------------------------------| | 1 | $45,180 | $60,240 | $75,300 | | 2 | $61,320 | $81,760 | $102,200 | | 3 | $77,460 | $103,280 | $129,100 | | 4 | $93,600 | $124,800 | $156,000 | | +1 per person | +$16,140 | +$21,520 | +$26,900 | Programs may cover 100% for <400% FPG or copay assistance up to 500% FPG. Assets like savings are sometimes reviewed.[3] ## Insurance Requirements Most PAPs require that **insurance denies coverage** or that you have high copays/out-of-pocket costs. Medicare Part B often covers wound care devices like Omnigraft if medically necessary, but prior authorization is common. Private insurance varies—submit claims first. Provide denial letters or Explanation of Benefits (EOB). Uninsured patients qualify more easily. Medicare patients may use Extra Help or state programs alongside PAPs.[3] ## Step-by-Step Application Process 1. **Consult Your Doctor**: Get a prescription specifying Omnigraft for your condition. Discuss if it's the best option. 2. **Check Insurance**: File a claim; obtain denial/EOB if applicable. 3. **Contact Integra**: Call Integra LifeSciences at 1-800-654-2873 (general contact) or visit their website to inquire about PAPs. Ask for the Omnigraft access program.[2] 4. **Gather Documents**: Proof of income (tax returns, pay stubs), ID, prescription, insurance denial, doctor's note. 5. **Apply**: Download forms online or request by phone/mail. Submit via upload, mail, or fax. 6. **Follow Up**: Track status weekly. ## Timeline and Delivery Processing typically takes 2-4 weeks after complete submission. Approval grants 1-12 months supply, shipped to your doctor or home. Refills require reapplication. Delays occur with incomplete docs.[3] ## Alternatives if Denied - **Manufacturer Appeal**: Provide more docs or doctor letter. - **Other PAPs**: NeedyMeds.org, RxAssist.org, or PAN Foundation. - **State Programs**: Medicaid, pharmaceutical aid foundations. - **Hospital Charity Care**: Many facilities cover wound devices. - **Clinical Trials**: Search ClinicalTrials.gov for Omnigraft studies. - **Biosimilars/Alternatives**: No direct biosimilars; consider other matrices like Apligraf or EpiFix if eligible.[3] ## Disclaimer This guide is for informational purposes only and not medical/financial advice. Program details change; contact Integra directly for current info. Consult healthcare professionals for treatment decisions. Eligibility not guaranteed. Word count: 950.

Program information last verified: March 30, 2026