CMS posted its FY25 Inpatient Prospective Payment System (IPPS) Final Rule, which includes the New Technology Add-on Payment (NTAP) program. NTAP supports access for newly approved, innovative technologies where the cost to adopt may prove a hurdle for patient access.
The program includes devices which have FDA breakthrough device designations, like the Symplicity Spyral from Medtronic and Paradise system from Recor.
Renal denervation treats high blood pressure, or hypertension. Medtronic received a landmark approval for the system in November 2023. Approval made Medtronic the second company with such approval, following Recor Medical’s nod earlier that month.
Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.
After sedation, a doctor inserts a catheter that can treat a range of vessel sizes into the artery leading to the kidney. The doctor then administers energy to calm the excessive activity of the nerves connected to the kidney. Then, the doctor removes the catheter, leaving no implant behind.
In its Final Rule, CMS approved the NTAP for the Symplicity Spyral catheter. It will go into effect on Oct. 1, 2024, and will be in place for three years.
“Medtronic is pleased to see the final rule for the Medtronic Symplicity Spyral application for NTAP,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business in the Medtronic Cardiovascular portfolio. “Although we expect a small number of inpatient renal denervation procedures, this a notable milestone in developing reimbursement for Symplicity Spyral.”
More from Weidman: What Medtronic learned on its long road to RDN approval
Recor Medical also picks up NTAP designation
The NTAP approved for the Recor Medical Paradise uRDN system provides up to an additional $14,950 in reimbursement on top of the regular Medicare Severity Diagnosis Related Group (MS-DRG) payment for an inpatient procedure.
Paradise technology denervates the sympathetic nerves surrounding the renal arteries. This lowers blood pressure by reducing the overactivity that can lead to hypertension.
The system delivers two to three doses of 360-degree ultrasound energy, lasting seven seconds each. The energy travels through each of the main renal arteries to the surrounding nerves. Its catheter features the Recor HydroCooling system that circulates sterile water to protect the renal artery wall during the procedure.
“We greatly appreciate CMS’s support in helping Medicare beneficiaries gain access to innovative therapies like the Paradise uRDN system,” said Lara Barghout, Recor president and CEO. “Uncontrolled hypertension remains a top concern among physicians, with many patients remaining at increased risk of cardiovascular disease and adverse consequences in spite of lifestyle changes and treatment with available medications. The availability of an NTAP for the Paradise uRDN system makes it possible for physicians to provide their patients with an additional therapeutic option that can help reduce their blood pressure.”
Medical Design & Outsourcing: How Recor Medical won the renal denervation race for FDA approval
