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