XWRAP® Product & Treatment Advantages (Clinical)

  1. Amniotic Membrane Wrap – Allograft: Sourced from donor tissue and manufactured entirely in the USA, XWRAP’s unique manufacturing process results in a stronger, more elastic, and flexible product with intact collagen and growth factors, offering superior longevity and performance.
  2. Target Patients: Ideal for those suffering from non-healing ulcers or wounds, including diabetic foot ulcers, venous leg ulcers, and severe wounds, particularly in patients aged 65 and over including Veterans.
  3. Promotes Healing: XWRAP® provides a natural wound barrier protection, supporting the body’s healing process and promoting native tissue regeneration, especially in difficult-to-treat wounds.
  4. Versatile Skin Substitute: XWRAP® is a single-layer allograft with strong tensile strength. It can be shaped, sutured, or stapled according to the physician’s preference, offering flexibility in treatment.
  5. Durable and Long-Lasting: Unlike many products that dissolve within days, XWRAP® remains effective longer, often lasting beyond 7 days. This reduces the need for frequent reapplications and aids the healing process.
  6. Immune Privilege: XWRAP® is immune privileged, making it suitable for use in immunocompromised patients.
  7. Infection Management: In many cases, XWRAP® can help manage or reduce the severity of infections in chronic wounds, leading to improved overall healing outcomes.
  8. Scar Reduction: By providing a matrix for tissue growth, XWRAP® helps minimize scarring, enhancing both cosmetic and functional outcomes.
  9. Convenient Storage: XWRAP® has a 5-year shelf life and can be stored at room temperature, requiring no special storage conditions.
  10. Commitment to Your Success: Applied Biologics has invested tens of millions of dollars to ensure that XWRAP® is a superior amniotic membrane allograft product.

 

XWRAP® Process & Q4204 CMS/National ASP (Process/Reimbursement)

  1. Conservative Care Protocol: Begin with 4 weeks of conservative care, maintaining template notes throughout.
  2. Streamlined Ordering Process: Providers submit the attached IVR form, with a 24-hour turnaround for approval. Once approved, submit the purchase order, receive the product, and begin treatment. Next-day delivery is available nationwide, allowing for a quick treatment process.
  3. Clinical Trials and ASP Listing: XWRAP® is currently involved in trials with over 500 patients and will be listed on the National ASP on October 1, 2024.
  4. Unmatched Customer Care: Our commitment to customer care is unparalleled. Any clinical or billing inquiries are promptly addressed internally with additional billing and reimbursement support available through RMBB HEALTH.
  5. Preapproval IVR: Easily setup a username and password for IVR submissions.
  6. Reimbursement: Medicare Part B and Veteran Patients. Veteran Patients are reimbursed at 100%.
  7. HCPCS Code Q4204: XWRAP® is reimbursable after October 1, 2024, at $2,989.20 per sq. cm.
  8. National ASP Pricing: Invoicing is provided at $1,750 per sq. cm under OIG Safe Harbor. Please see the attached PO for pricing and sizes available to the provider.

 

Specific Questions Asked During Meeting:

  1. How do we differentiate ourselves from the competition?  All allografts go through a standard industry process (infectious disease testing, UV, gamma, vancomycin bath, freeze drying, etc.).  The difference with XWRAP is that XWRAP is processed and decellularized without freeze drying the human donor tissue.  When companies freeze dry the product (which is 95% of allografts) it destroys collagen and the tensile strength of the product.  This results in a shorter lifespan of protection a few days if they are lucky) and requires patients to be treated more often with an inferior product running the further risk of exposure, infection, and the slowing of the healing of the wound.  Applied Bio dehumidifies and dehydrates the donor tissue in Scottsdale, AZ where they take advantage of natural low humidity. They have built their processing of the XWRAP around a special dehydration process that allows the strong, tensile strength of the basement membrane to stay intact resulting in a superior, longer lasting wound covering and protective barriers.  Additionally, because we do not freeze dry the product during processing, a significant percentage of growth factors remain in intact helping the body’s healing process accelerate the healing of the wound.  Comparing XWRAP to the competition (hydrated or dehydrated allografts), XWRAP will outlast and outperform protecting the wound and proving the patients a better chance of healing the wound.
  2. If the wound is over 32 sq cm, what does XWRAP’s LCD say about treating wounds above 32 sq. cm greater than a 4×8? Dr. should treat the wound based on medical necessity and not what the MUE or LCD states. 
  3. If they need to use two 32’s for a 64 sq cm., what is the total MUE (is it still 10 applications)? 10 applications over 10 weeks. MUEs have no impact.
  4. How is that billed if LCD is up to 32 sq cm and we need multiple applications? Billed as normal. Need chart notes etc. as will be denied the first time over 32 but then will be approved upon second submission.
  5. Since XWRAP lasts longer than the competition, do all of our XWRAPS absorb into the skin/body or is it still intact some between dressing changes?  (Does it 100% absorb into the body usually)? Each case is different depending on the wound environment (wounds are more acidic after open exposure) and depending on the size of the wound the absorption is different per application as time goes on.  We can effectively state that XWRAP lasts longer than the competition because of the way it is processed and manufactured, allowing fewer dressing changes, and not absorbing into the wound completely unlike the competition.  This is proven within the Provider’s clinical environment and will be experienced in most cases.
  6. Since we are Medicare Part B, how do Medicare A Plans affect the 20% Copay/Co-insurance reimbursement? Using Blue Cross/Blue Shield and Atena as an example, depending on which State and which plan they are on, the 20% may or not be covered. The IVR (Insurance Verification Request Form) when submitted through the RMBB Health portal will come back with coverages. If Provider uses RMBB Health or their Allograft billing, they are experts on onboarding, providing templates, and handle the billing process from start to finish.  It is highly recommended that Providers who use allografts engage with RMBB Health for they are billing experts and can even help with any potential past mistakes or audits.
  7. What about current studies? Level 1 studies will be out in Q4 2024 or Q1 of 2025.  500+ patients are in studies now being treated for various types of wounds and conditions.
  8. What about Reimbursement?  See above.  XWRAP is in CMS after October 1, 2024, at $2,989.20 per Sq. Cm. Provider receives a rate under OIG Safe Harbor at $1,750 per Sq. Cm. Attached PO reflects the pricing per size

X-WRAP Brochure page 1