CMS Opens Coverage Analysis for Renal Denervation

On Monday, the Centers for Medicare & Medicaid Services (CMS) initiated a national coverage analysis of renal denervation for the treatment of uncontrolled hypertension.

Medtronic, which sparked the review by requesting a national coverage determination, noted in a press release that the move comes after the company worked with the agency on a pilot of the Transitional Coverage for Emerging Technologies (TCET) pathway for its radiofrequency-based Symplicity Spyral denervation system.

According to the CMS tracking sheet, a public comment period will run through February 12, with a proposed decision memo date of July 13. The agency expects to complete its analysis by October 11.

“Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients,” Medtronic said.

As previously reported by TCTMD, reimbursement issues in the United States have been slowing uptake of the two US Food and Drug Administration-approved renal denervation technologies, which were both cleared in November 2023—the ultrasound-based Paradise system (Recor Medical) and the Symplicity Spyral system—and a national coverage determination from CMS would help ease that situation.

Also responding to the news, Recor Medical, along with its parent company Otsuka Medical Devices, said in a press release that it “appreciates CMS’ consideration of potential national coverage of renal denervation as a hypertension treatment option for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process.”