The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment status to Medtronic and Recor Medical for their renal denervation devices, which are used to treat high blood pressure. This decision is designed to encourage the use of these new, FDA-approved therapies while CMS gathers cost data to determine future reimbursement rates under the Medicare outpatient prospective payment system. Both companies announced the coverage decisions on Friday.
Jason Weidman, president of Medtronic’s coronary and renal denervation business, hailed the payment approval for the Symplicity Spyral catheter as an "important milestone," noting it would reduce cost barriers for healthcare systems. Medtronic has identified the renal denervation market as a potential $1 billion-plus opportunity.
Device Details and Approvals
Both Medtronic and Recor received FDA approval in November 2023 for their renal denervation devices, intended as adjunctive treatments for lowering blood pressure in patients unresponsive to medication and lifestyle changes. Recor, a subsidiary of Otsuka Medical Devices, utilizes ultrasound energy in its Paradise system to ablate nerves around the renal arteries, while Medtronic’s Symplicity Spyral system employs radiofrequency energy.
Past Scrutiny and Future Challenges
During FDA advisory panel reviews last year, questions were raised regarding the effectiveness of renal denervation and the specific patient populations that would benefit most. While panels voted in favor of Recor’s device, they voted against Medtronic’s, citing concerns that the safety risks of Medtronic’s procedure outweighed its benefits. This led to concerns about potential insurer coverage.
Citi Research analyst Joanne Wuensch noted that the CMS decision for Medtronic reflects progress after clinical trial challenges, referencing the Symplicity Spyral's failure to meet its primary efficacy endpoint in its pivotal trial. Wuensch added, "With reimbursement in place in the intermediate-term, management’s next challenge is patient and physician education, changing the treatment paradigm from medication to intervention for drug-resistant hypertension."
Implementation and Technology
The TPT payment for both Medtronic and Recor will be effective for up to three years, starting January 1, 2025. CMS has also established a distinct device category and code for ultrasound renal denervation, recognizing Recor’s unique technology. Recor’s Paradise system delivers two to three doses of ultrasound energy to the surrounding nerves, using sterile water circulated through a balloon catheter to protect the renal artery wall during the procedure.
Recor CEO Lara Barghout stated, "This is a major step forward in the reimbursement available for the Paradise uRDN system, creating additional financial support for hospitals and physicians to provide this novel and effective therapy to their uncontrolled hypertension patients."
