Laminate’s VasQ Extravascular Support Device Granted TPT Payment by CMS

September 10, 2024—Laminate Medical Technologies announced that the United States Centers for Medicare & Medicaid Services (CMS) granted the company’s VasQ extravascular support device a Transitional Pass-Through (TPT) Payment under billing code C8000 (support device, extravascular, for arteriovenous fistula [implantable]).

Effective starting October 1, 2024, the code 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.

According to the company, VasQ, which is Laminate’s flagship product, is an external support device granted de novo status by the FDA in September 2023 to improve surgical fistula outcomes by providing permanent reinforcement to the artery-vein connection, promoting stability against wall tension, and decreasing turbulent flow. The new Medicare billing code will allow health care facilities to more easily integrate VasQ into their existing vascular access procedures, stated the company.

The company noted that CMS developed the TPT program to facilitate more immediate access for patients to new, innovative devices, like devices that have received in the FDA Breakthrough Devices designation, which VasQ received in June 2020. The TPT program allows for adequate payment to providers while the necessary cost data is collected to incorporate them into the procedure Ambulatory Payment Category rate.

Laminate stated that the TPT Payment was granted by CMS, in part, because of grassroots national support from dialysis patients, caregivers, and advocates organized by the American Association of Kidney Patients (AAKP).

According to the company, AAKP has worked with Laminate Medical since 2021 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 2023 with support from AAKP.

“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,” commented Edward Hickey, III, President of AAKP and Chair of the Veterans Health Initiative, in the Laminate press release. “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.”