Laminate Medical Technologies Thanks Kidney Patients for Advocacy

NEW YORK, Sept. 10, 2024 /PRNewswire/ -- Laminate Medical Technologies today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) granted their VasQ™ extravascular support device a Transitional Pass-Through (TPT) Payment under billing code C8000 (Support device, extravascular, for arteriovenous fistula (implantable). The code, effective starting October 1, 2024, will provide incremental Medicare reimbursement to medical providers for the creation of an extravascular supported fistula with VasQ in addition to the established payment rate for fistula creation. CMS developed the TPT program to facilitate more immediate access for patients to new and truly innovative devices, like devices in the U.S. Food and Drug Administration (FDA) Breakthrough Devices designation, in which VasQ falls, by allowing for adequate payment to providers while the necessary cost data is collected to incorporate them into the procedure Ambulatory Payment Category (APC) rate.

Laminate Medical Technologies is committed to advancing arteriovenous fistula (AVF) function for hemodialysis patients globally. Laminate's flagship product, VasQ™, is an external support device granted FDA De Novo to improve surgical fistula outcomes by providing permanent reinforcement to the artery-vein connection, promoting stability against wall tension, and decreasing turbulent flow.

The TPT Payment was granted by CMS, in part, due to the overwhelming grassroots national support from dialysis patients, caregivers and advocates organized by the American Association of Kidney Patients (AAKP), the nation's largest kidney patient organization. Since 2021, AAKP has worked closely with Laminate Medical to raise the unmet need for greater innovation in dialysis patient access and improved care outcomes by engaging thousands of patients throughout the FDA regulatory process and the CMS payment determination process related to VasQ. FDA granted De Novo status to VasQ in September of 2023 with strong AAKP support.

Patients are excited for the potential of VasQ to increase the success rate of their fistulas without the need for additional surgical procedures, which has been consistently demonstrated over multiple studies.1-8 The hope is that VasQ supported fistula patients will be able to remove their central venous catheters (CVC) earlier to avoid the increased risk of hospitalization and death due to infection, including those caused by catheter related blood stream infections (CRBSIs). Additionally, the low aneurysmal rates reported by the VasQ U.S. Pivotal study provides hope that the fewer patients may suffer from the morbidity that can result from upper arm fistulas growing too large.1

Edward Hickey, III, president of AAKP and Chair of the Veterans Health Initiative stated, "AAKP believes the future of patient-centered kidney medicine, and reductions in patient mortality, is dependent upon more consistent alignments between FDA regulatory decisions and CMS payment determinations. We thank the FDA for carefully listening to dialysis patients and valuing their insights on an innovation that will contribute to safer dialysis access. AAKP is pleased with this CMS decision and remains fully engaged in the policy process to ensure all future regulatory and payment decisions are similarly aligned."

Tammy Gilon, CEO of Laminate Medical Technologies, expressed her enthusiasm for the CMS decision: "The assignment of the Medicare billing code is a critical step forward in our mission and commitment to transcend status quo care for hemodialysis patients through timely innovations. We are deeply appreciative to the patients who raised their voices throughout this process via AAKP and to FDA and CMS for hearing them. With VasQ, we are offering a choice and a solution that has the potential to improve patient outcomes, reduce burdens on healthcare providers and prevent additional kidney care costs to taxpayers."

The new Medicare billing code marks a significant milestone that will empower healthcare facilities to more easily integrate VasQ into their existing vascular access procedures, ensuring that more patients can benefit from this innovative technology. For more information about TPT and how to bring VasQ into your practice, contact info@laminatemedical.com.

About Laminate Medical Technologies
Laminate Medical Technologies is a patient-centered company committed to advancing arteriovenous fistula (AVF) function for hemodialysis patients globally. Laminate's flagship product, VasQ™, is an external support device granted FDA De Novo to improve surgical fistula outcomes by providing permanent reinforcement to the artery-vein connection, promoting stability against wall tension, and decreasing turbulent flow.

To see a demonstration video of VasQ, visit https://www.youtube.com/watch?v=2W3HoTH2x58. Visit Laminate at www.laminatemedical.com.

  1. Dillavou et al. J Vasc Surg, July 30, 2023
  2. Karydis et al. Am J Kidney Dis 2019; 75(1):45-53.
  3. Shahverdyan et al. J Vasc Access 2021; 22(2):166-172.
  4. Benedetto et al. J Vasc Access 2022; 23(4):524-531.
  5. Chemla et al. J Vasc Access 2016; 17(3):243-248.
  6. Shahverdyan et al. J Vasc Surg 2021 ;75(1):248-254.
  7. Leonardi G et al. J Vasc Access. 2021 Jul;22(4):658-665.
  8. Shahverdyan et al. Semin Dial. 2023 Mar;36(2):147-154.

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SOURCE Laminate Medical Technologies

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