Laminate Medical Technologies announced last month that the US 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, which came into effect 1 October 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 programme to facilitate more immediate access for patients to new and truly innovative devices, like devices in the US 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.
According to Laminate Medical, the TPT payment was granted by CMS, in part, due to the “overwhelming grassroots national support from dialysis patients, caregivers and advocates”, which was organised by the American Association of Kidney Patients (AAKP), the USAs largest kidney patient organisation. 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 US FDA regulatory process and the CMS payment determination process related to VasQ. The US FDA granted de novo status to VasQ in September of 2023 with strong AAKP support.
The company also stated that 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. Its hope is that VasQ supported fistula patients will be able to remove their central venous catheters (CVC) earlier to avoid the increased risk of hospitalisation and death due to infection, including those caused by catheter related blood stream infections (CRBSIs). Additionally, the low aneurysmal rates reported by the VasQ US pivotal study provides hope that the fewer patients may suffer from the morbidity that can result from upper arm fistulas growing too large.
Edward Hickey, III, president of AAKP and chair of the Veterans Health Initiative stated, “AAKP believes the future of patient-centred kidney medicine, and reductions in patient mortality, is dependent upon more consistent alignments between US FDA regulatory decisions and CMS payment determinations. We thank the US 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, chief executive officer (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 US 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”, according to the press release, 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.
