CMS Grants TPT Payment for Medtronic’s Symplicity Spyral RDN and Recor’s Paradise uRDN Systems

November 1, 2024—Medtronic and Recor Medical, Inc. (and its parent company, Otsuka Medical Devices Co., Ltd.) separately and independently announced that the United States Centers for Medicare & Medicaid Services (CMS) granted transitional pass-through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System for the companies’ respective, recently approved renal denervation (RDN) devices to lower blood pressure in patients with treatment-resistant hypertension.

The devices are Medtronic’s Symplicity Spyral RDN system and Recor’s Paradise ultrasound RDN (uRDN) system.

Both Medtronic and Recor stated that the TPT payment will be effective for up to 3 years beginning January 1, 2025.

The Final Rule is available for public inspection online here and will be published by the United States Department of Health & Human Services in the Federal Register on November 27, 2024.

In Medtronic’s press release, the company noted that that the purpose of the TPT program is to support access to newly approved innovative technologies where the costs to adopt them may otherwise inhibit patient access.

The TPT program reduces barriers for Medicare beneficiaries to access critical health care innovations shortly after products receive FDA approval by providing hospitals with additional payments to cover their costs, while allowing CMS to collect necessary cost data to determine future outpatient payments, stated Medtronic.

Recor advised in its press release that in approving the TPT, CMS created a distinct device category and code—“C1736: Catheter Renal Denervation, Ultrasound”—that recognizes the differentiated ultrasound technology and procedure with the Paradise uRDN system.

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with uRDN for Medicare fee-for-service beneficiaries, noted Recor.

On November 17, 2023, Medtronic announced FDA approval of the Symplicity Spyral RDN system.

Recor announced FDA approval of the Paradise uRDN system on November 7, 2023.