CMS Seeks Comments on Proposed Decision Memo for RDN to Treat Hypertension

July 10, 2025—The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo for its National Coverage Analysis (NCA) of renal denervation (RDN)—including radiofrequency (rfRDN) and ultrasound (uRDN) treatments—for uncontrolled hypertension under Coverage with Evidence Development (CED).

CMS stated it is seeking comments on the proposed decision with a comment period from July 10 to August 9, 2025.

The proposed decision memo is posted on the CMS website here. The NCA tracking sheet is available on the CMS website here. The review was initiated in January 2025. The expected NCA completion date is October 8, 2025.

CMS proposes that RDN will be covered for uncontrolled hypertension when furnished according to an FDA market-authorized indication and when meeting the conditions outlined in the proposed decision memorandum. The conditions include patient, physician, facility, and CED study criteria.

As noted in the document, the CED study criteria include that the RDN device and related items and services are furnished in the context of a CMS-approved CED study; RDN is not covered for patients outside of a CMS-approved study.

In the proposed decision memo, CMS advised it is particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of RDN. It also seeks comments on health disparities and equity aspects that should be considered in the review.

The NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from RDN and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies.

Outcomes of interest may include office blood pressure, ambulatory blood pressure, nephroprotection, stroke, heart failure, decreased mortality, decreased emergency room or hospital admissions, and quality of life, stated the CMS proposed decision memo.

In November 2023, Medtronic announced FDA approval and the commercial launch of its Symplicity Spyral rfRDN system for the treatment of hypertension.

Also in November 2023, Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., announced FDA approval and the commercial launch of the Paradise uRDN system.

In its press release on July 10, 2025, Medtronic stated that until a final NCD is announced, coverage for the Symplicity Spyral rfRDN system for Medicare patients remains on a case-by-case basis. The Symplicity Spyral device has been evaluated in the SPYRAL-HTN clinical program, which includes a large real-world registry.

Jason Weidman, Senior Vice President and President of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic, commented in the press release, “We are pleased to see CMS’ proposed National Coverage Determination for the Symplicity Spyral RDN system. This milestone is an important step towards expanding patient access to this innovative treatment for hypertension, a public health crisis in the United States.”

Weidman continued, “The proposed NCD from CMS—as it stands today—will provide many United States Medicare patients in need with access to RDN. We recognize and thank CMS for their ongoing efforts in creating new pathways to expedite access to breakthrough technologies.”

Additionally, Recor and Otsuka announced their support for the NCD in a July 10 press release. Recor’s United States Global Paradise System postapproval study intends to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension.

Recor Medical’s CEO, Lara Barghout, commented in the press release, “We are encouraged by CMS’s proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need. This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.”