Renal Denervation for Uncontrolled Hypertension

Less

As a Physician Assistant working in Cardiology who manages patients with hypertension, I support the decision to provide coverage under a structured evidence framework. However, the current proposal creates barriers that disproportionately impact patients in rural and underserved communities.

Requiring six months of management and three encounters, with only one permitted via telehealth, does not reflect the way care is delivered today. For many patients, virtual visits are essential, not optional. Restricting telehealth access places unnecessary burdens on those who already struggle with transportation or mobility limitations.

I also urge CMS to reconsider the blood pressure threshold. The proposed >140/90 mmHg criterion conflicts with ACC/AHA guidelines and excludes high-risk patients who remain uncontrolled above 130/80 mmHg, according to current definitions.

To achieve equitable access, CMS should align policy with real-world practice and current evidence. Doing so ensures safety without denying care to those most in need.

Less

As a clinical hypertension specialist with nearly three decades of experience and the former Vice President of the American Society of Hypertension (ASH), I strongly support CMS’s proposal to cover renal denervation (RDN) under Coverage with Evidence Development (CED). This policy will expand access to a proven, FDA-approved option for patients with uncontrolled hypertension while ensuring continued collection of high-quality outcomes data. I strongly support the recommendation for multidisciplinary evaluation and longitudinal follow-up to ensure appropriate patient selection, procedural safety, and sustained blood pressure control.

The eligibility criteria are well-targeted overall, but I do have a couple of minor suggested clarifications and revisions to ensure that the highest risk patients are included in the coverage decision and to ensure equal access to potentially underserved populations.

1A. The stated office BP criteria (>140/90 mmHg) is somewhat ambiguous, and I am concerned that it may be interpreted as >140 mmHg systolic AND >90 mmHg diastolic. Older patients on guideline directed medical therapy whose systolic BP remains elevated are at considerable risk of subsequent cardiovascular events regardless of achieved diastolic BP. Both systolic BP and widened pulse pressure are clear risk factors for increased cardiovascular events in older adults, but the relationship between diastolic BP and risk is more complicated. All things being equal, a patient over the age of 65 years with an achieved BP on medication of 162/62 mmHg is generally at higher risk of hypertension related events than one whose BP is 142/92 mmHg. While it is unfortunate that (despite my consistent recommendation) patients with office diastolic BP <90 mmHg have not been included in US randomized clinical trials of RDN to date, to exclude these high-risk patients from CMS coverage would expose them to unnecessary risk. In my practice, I have many high-risk patients with systolic BP considerably >140 mmHg but diastolic BP <90 mmHg who have run out of options for pharmacological and lifestyle modification and are eagerly awaiting the opportunity to explore the potential benefits of RDN. Of note, this is a patient population (systolic >140 mmHg but diastolic <90 mmHg) that should be specifically studied as a subgroup of interest in the CED. As a compromise condition of coverage, the committee could consider revising these criteria to office >140 mmHg systolic AND >90 mmHg diastolic or >150 mmHg systolic if diastolic <90 mmHg to ensure inclusion of the highest risk patients. This coverage framework mirrors that of antihypertensive medications, which were first studied in younger patients with high diastolic BP but are now broadly used for older patients with elevated systolic BP.

Of note, I do not support extending this NCD to patients with achieved BPs consistent with stage 1 systolic BP (130-139 mmHg). This patient population is generally at lower absolute risk than those with higher BP, and the magnitude of BP lowering demonstrated with RDN has consistently correlated with higher baseline BP. Further determination of risk-benefit ratio and cost-effectiveness should be performed before the NCD is extended to this population

1B. I agree that patient eligibility should include out-of-office BP monitoring, such as home or 24-hour ambulatory BP monitoring. However, the NCD needs to clarify that office and out-of-office BP values differ. According to the 2017 ACC/AHA guidelines, systolic office BP >140 mmHg equals daytime ambulatory or mean home BP >135 mmHg, and diastolic office BP >90 mmHg matches daytime ambulatory or home BP >85 mmHg.

1F. As a provider working in an underserved area with a wide rural catchment, I am concerned that the requirement for multiple face-face visits needlessly creates barriers (and increased costs) for underserved populations. In my practice, there is minimal distinction between virtual and in-person visits, and both are covered similarly by CMS. Additionally, this criterion overlooks asynchronous remote patient monitoring, which is also a CMS-covered benefit and has demonstrated effectiveness comparable to, or exceeding, that of conventional care.

I believe that prompt finalization of this NCD will address a major unmet need and improve cardiovascular outcomes for Medicare beneficiaries.

I have served as an investigator in RDN clinical trials and as a paid consultant for both companies with approved devices in the U.S. These recommendations are provided independently of those affiliations. Also, these comments reflect my own views and do not represent those of any affiliated organizations.

Less

Uncontrolled blood pressure remains an important public health problem. In the United States, according to the Centers for Disease Control in 2024, https://www.cdc.gov/high-blood-pressure/data-research/facts-stats/index.html) and other sources, hypertension is present in nearly half of all US adults, and prevalence increases with age. Moreover, nearly two-thirds of all patients over the age of 60 years, with hypertension have uncontrolled blood pressure, i.e. above (BP > 130/80 mmHg) national guidelines (AHA / ACC 2017 Clinical Practice Guidelines for Management of Hypertension (https://www.ahajournals.org/doi/10.1161/hyp.0000000000000065). Hypertension remains the most, important modifiable risk factor for prevention of cardiovascular disease, and yet, despite numerous classes of antihypertensive medications, uncontrolled hypertension persists. Certainly a portion of the lack of control of blood pressure is due to poor accessibility to conventional therapies and therapeutic inertia. However, the sheer number of patients with hypertension and difficulties with adherence to conventional treatment, motivate the need for novel therapies. One such therapy is renal denervation, whether by ultrasound or radiofrequency ablation. In November 2023, the Food and Drug Administration approved both methodologies based on phase 3, randomized, double-blinded, sham-controlled, clinical trials. While the absolute value of blood pressure reduction was modest in these studies, these data are noteworthy for at least two reasons: (1) even a modest reduction in blood pressure, has a substantial effect on lowering of cardiovascular risk, and (2) observational data since the conclusion of such trials have shown a lasting and more substantial drop in blood pressure over time. These data on the effectiveness of renal denervation have been limited to clinical trials and have not yet reached the public in real-world settings. Thus, the importance of reimbursement for these procedures is a necessary step to translate these research studies to the broader public to improve the woefully poor rates of blood pressure control in the United States. This is but one front in the war against non-communicable diseases along with education, improvements in access to care, and food insecurity, and other novel treatments of hypertension. As a director for an American Heart Association-certified Comprehensive Hypertension Center, I support the proposed coverage of these procedures for clinical use in real-world settings.

Vivek Bhalla, MD, FASN, FAHA
Director, Stanford Hypertension Center, AHA-Certified Comprehensive Hypertension Center
Associate Professor of Medicine / Nephrology
Stanford University School of Medicine

Less

Less

Mehmet Oz, MD
Administrator, Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re: NCD for Renal Denervation for Uncontrolled Hypertension (CAG-00470N)

Dear Administrator Oz:

I am a practicing physician trained in interventional cardiology and Professor of Medicine at Emory University School of Medicine. I have spent over twenty years caring for patients with uncontrolled hypertension, as well as those whose lives have been irreversibly altered from the silent ravages of years of excessively high blood pressure. I am an operator skilled in renal denervation (RDN) for the treatment of hypertension, and have served as an investigator in numerous clinical trials that have demonstrated the efficacy and safety of this technology.

I have reviewed the proposed National Coverage Determination (NCD) and commend the Centers for Medicare and Medicaid Services (CMS) in their initiative to create a pathway for patients suffering from hypertension to gain access to an additional option in the armamentarium of available hypertension treatments. Too often, uncontrolled hypertension is tolerated by patients and providers alike from a lack of additional effective pharmaceutical options, intolerance to available medications, and social determinants of health that make adherence to established medical therapy challenging. As a result, we continue to battle the downstream societal costs of uncontrolled hypertension manifested by long-term cardiovascular morbidity and mortality. The proposed NCD is comprehensive and generally well written and grounded in the science of RDN as a treatment for hypertension and the clinical care of these patients, many of which have been espoused by medical guidelines and societal statements. I do have a few comments from my review of the proposed policy:

1) Patient criteria:
a. The cutoff for what is defined as uncontrolled hypertension of >140/90 attempts to align with the guideline definition of treating patients suffering from stage 2 hypertension and with the body of evidence demonstrating the efficacy of renal denervation in these patients. It may be clearer, however, for patients and providers alike to align exactly with current medical guidelines to establish cutoffs of (greater than or equal to) 140mmHg systolic OR (greater than or equal to) 90mmHg diastolic as the definition of stage 2 hypertension (1).
b. I do have concerns that the timeline restrictions mandating that patients have at least three formal visits within six months and no more than one of these be virtual may create disparities in care for those patients who have barriers to accessing this level of healthcare. The definition of uncontrolled hypertension may be achievable with the same number of visits over a longer period of time and the use of virtual telehealth services has broadened the access of care to those individuals that have physical or financial limitations in getting to the doctor’s office. Many of these patients also have been suffering from uncontrolled hypertension for years prior to their referral, but may not meet the specific six month criteria outlined in the proposed NCD. This may create additional barriers to care when they have already have been dealing with their morbid illness for a longer period of time. The six month timeline may make more sense if specified for those patients who have not already undergone longitudinal care and evaluation prior to their referral.
c. I do want to commend CMS for not mandating a minimum number of medications to be taken prior to consideration of RDN. Patients are very diverse in their ability to tolerate anti-hypertensive medications and the proposed NCD takes this into account through the language of “maximally tolerated guideline-directed medical therapy”. Mandating three or more medications creates an undue burden on patients when medical literature has demonstrated that this threshold is commonly unachievable for multiple reasons in the everyday complex lives of our patients (2).
2) Physician criteria:
a. The description and criteria of physicians certified to perform RDN is sound and aligns with those of medical societal statements.
3) Facility criteria:
a. It is imperative that a team-based approach is utilized in the care of hypertensive patients. I do, however, have concerns in the language provided in the proposed NCD regarding a “hypertension clinician” and a “hypertension navigator”. It is unclear what these roles are in the language provided, and whether medical centers could create undue barriers to care by mandating that patients may only be referred if managed by certain providers with niche or detailed titles and/or certifications that may be unachievable for most patient-facing medical centers.
In conclusion, the proposed NCD is a well articulated and thoughtful policy to allow appropriately chosen patients suffering from uncontrolled hypertension access to a therapy that will serve as an adjunct treatment in the goal of lowering blood pressure. In doing so, medical providers that manage hypertensive patients can attempt to reduce the nationwide epidemic of cardiovascular disease that is, in part, driven by uncontrolled hypertension and, as a result, lower the societal costs of advanced end-stage cardiovascular care. Thank you for your consideration and feel free to contact me for any further clarification.

Sincerely,

Chandan Devireddy, MD MBA

References: 1. Whelton, Paul K., Robert M. Carey, Wilbert S. Aronow, Donald E. Casey, Karen J. Collins, Cheryl Dennison Himmelfarb, Sondra M. DePalma et al. "2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines." Journal of the American College of Cardiology 71, no. 19 (2018): e127-e248.
2. Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7. PMID: 34615363; PMCID: PMC11485247.

Less

Despite the well-established efficacy of multiple antihypertensive medication classes and the existence of effective lifestyle interventions, roughly half of US adults have hypertension (HTN), and nearly 80% have blood pressures that are uncontrolled (Jaeger BC, et al. Hypertension 2023;80:1311–1320). Elevated blood pressure poses a significant burden on society through the death and disability that result from heart failure, myocardial infarction, stroke, renal failure other adverse outcomes. Meta-analyses of large population studies (Lewington S, et al. Lancet 2002; 360: 1903–13) and randomized trials (Bundy JD, et al. JAMA Cardiol 2017;2:775-781) have demonstrated that blood pressure reductions of even a few mm Hg, to a floor of 115/75 mm Hg, are associated with reduced risk of atherothrombotic and other events, and prospective randomized trial data have established this relationship (SPRINT Research Group. N Engl J Med N Engl J Med 2021;384:1921-30). Multiple randomized trials have demonstrated that renal denervation (RDN) effectively and safely reduces ambulatory, office and home blood pressures in patients with uncontrolled HTN who are off or on blood pressure-lowering medications (Mufarrih, Aronow HD, et al. J Am Heart Assoc. 2024;13:e034910) and RDN appears cost-effective (Kandzari DE, et al. JSCAI 2024:102234). I appreciate that CMS recognizes the robust evidence base supporting the safety and efficacy of RDN as an adjunct to lifestyle and pharmacologic therapy for patients with uncontrolled hypertension.

I would offer the following specific comments regarding the proposed decision memo:

Patient Criteria
I believe that uncontrolled HTN should be defined at a lower threshold than 140 mm Hg to remain in line with available evidence. Treating HTN to systolic blood pressure of 130 vs. 140 mm Hg could potentially result in 340,000 fewer cardiovascular events and 156,000 fewer deaths each year in the US alone (Bundy JD, et al. JAMA Cardiol 2018 doi:10.1001/jamacardio.2018.1240). Further, the SPRINT randomized trial established that lowering of systolic blood pressure to 120 vs. 140 mm Hg results in a 25% reduction in the hazard for cardiovascular events (composite cardiovascular death, myocardial infarction, other acute coronary syndromes, stroke, or heart failure) and a 27% reduction in the hazard for all-cause mortality.

I agree that most patients should be on stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for a reasonable time (e.g., 3 months) before referral for RDN, but believe CMS should recognize that more urgent triage may be necessary in those patients experiencing hypertensive crises when already on maximally tolerated medical therapy.

I agree that patients should be managed for an appropriate time prior to referral for RDN. However, the requirement that the primary clinicians must manage the patient for a minimum of six months before referral for RDN seems arbitrary and was not required in clinical trials demonstrating the safety and efficacy of this therapy; shorter durations (e.g., 3 months) would seem appropriate. I also agree that multiple encounters are typically needed to adequately manage patients with uncontrolled HTN. However, in an era of expanding virtual care and increasingly available remote patient monitoring, I feel that the requirement for in-person visits should be liberalized.

Physician Criteria
I agree with the requirement that physicians performing RDN without prior endovascular training or renovascular expertise must complete at least ten supervised cases of diagnostic/therapeutic renovascular procedures, half as primary operator, and that they must complete at least five proctored RDN cases with each approved device. This is consistent with what our writing group advocated in the SCAI Position Statement on Renal Denervation for Hypertension: Patient Selection, Operator Competence, Training and Techniques, and Organizational Recommendations (Swaminathan RV, Aronow HD, et al. J Soc Cardiovasc Angiogr Interv. 2023 Aug 21;2(6Part A):101121).

Facility Criteria
I agree that facilities performing RDN must have a hypertension program. However, while this may involve multiple specialties (e.g., internal medicine, endocrinology, cardiology, and nephrology), multispecialty involvement should not be required. Instead, hypertension programs should include a physician with training and expertise in hypertension evaluation and longitudinal management who may or may not be from a different specialty as the RDN operator, as well as an independent RDN operator; together, these individuals should reach a consensus about whether to offer RDN to a given patient through a shared decision-making process. Further, while a hypertension navigator may streamline care for this patient population, such programmatic assets are not available for many patient populations, nor in many facilities, and their absence should not serve as a barrier to care.

While these procedures can be performed in interventional cardiology or radiology suites, the allowable locations should not be restricted to these specialty-specific areas. It remains possible that other endovascular specialties (e.g., vascular surgery) may perform RDN and that this might occur appropriately and safely in hybrid operating rooms or ambulatory surgery centers.

I fully support CMS coverage of RDN and appreciate the opportunity to provide feedback.

Herbert Aronow, MD, MPH, MSCAI, MSVM, FACC
Immediate Past President, Society for Vascular Medicine
Professor, Michigan State University College of Human Medicine
Medical Director, Heart & Vascular Services
Benson Ford Chair in Heart and Vascular
Henry Ford Health
Clara Ford Pavilion, Room 435
7300 Byron Street
Detroit, MI 48202

Less

As a nephrologist with over 45 years of practice treating patients with hypertension, chronic kidney disease and cardiovascular disease, I appreciate the opportunity to comment on the proposed National Coverage Determination for renal denervation (RDN). I commend CMS for their quick process and am pleased to see a proposed decision that will make RDN accessible to a large patient population.

Throughout my time working in hypertension and more recently in renal denervation research, I have witnessed the challenges of hypertension care today, particularly with adherence, and recognize the potential impact RDN could have on outcomes. I served as vice-chair for the AHA Science Statement on Renal Denervation and on the US’s and Canada’s Adult Hypertension guideline committee (Full reference: Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Jennifer L. Cluett, MD, FAHA, Chair, Olivia Blazek, MD, Angela L. Brown, MD, Cara East, MD, Keith C. Ferdinand, MD, FAHA, Naomi D.L. Fisher, MD, Cassandra D. Ford, PhD, FAHA, Karen A. Griffin, MD, FAHA, Carlos I. Mena-Hurtado, MD, FAHA, Harini Sarathy, MD, MHS, Wanpen Vongpatanasin, MD, FAHA, and Raymond R. Townsend, MD, FAHA, Vice Chair on behalf of the American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on the Kidney in Cardiovascular Disease; and Council on Peripheral Vascular Disease. Hypertension 2024;81:e135-e148). Both experiences inform my confidence in RDN and the scientific data that support its use.
I would like CMS to ensure that the final NCD defines uncontrolled hypertension as =140 mmHg systolic or =90 mmHg diastolic, which is concordant with the widely accepted American Heart Association Stage II hypertension guidelines (Full Reference: 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Paul K. Whelton, MB, MD, MSc, FAHA, Robert M. Carey, MD, FAHA, Wilbert S. Aronow, MD, FACC, FAHA, Donald E. Casey, Jr, MD, MPH, MBA, FAHA, Karen J. Collins, MBA, Cheryl Dennison Himmelfarb, RN, ANP, PhD, FAHA, Sondra M. DePalma, MHS, PA-C, CLS, AACC, Samuel Gidding, MD, FAHA, Kenneth A. Jamerson, MD, Daniel W. Jones, MD, FAHA, Eric J. MacLaughlin, PharmD, Paul Muntner, PhD, FAHA, Bruce Ovbiagele, MD, MSc, MAS, MBA, FAHA, Sidney C. Smith, Jr, MD, MACC, FAHA, Crystal C. Spencer, JD, Randall S. Stafford, MD, PhD, Sandra J. Taler, MD, FAHA, Randal J. Thomas, MD, MS, FACC, FAHA, Kim A. Williams, Sr, MD, MACC, FAHA, Jeff D. Williamson, MD, MHS, and Jackson T. Wright, Jr, MD, PhD, FAHA. Hypertension 2018;71:e13-e115).

As patients age, there is a relentless progression to higher systolic blood pressure readings that meet the hypertensive threshold coupled with lower diastolic readings (after age 50 years) that are not considered hypertensive (cited in the reference above). Therefore, to ensure this proposed coverage applies to Medicare beneficiaries in need of treatment, CMS should clarify that the blood pressure requirement can be met by either the systolic or the diastolic blood pressure readings.

Secondly, I support Patient Criteria 1f, requiring physicians to manage a patient for at least six months and have at least three visits. However, the requirement of only one visit being virtual is too restrictive and burdensome based on my experience, given disparities in patients’ access to care. I would request that CMS account for these disparities by either allowing for three virtual visits or extending the six-month period.

Given that RDN is currently only covered on a case-by-case basis, finalizing this proposed NCD is essential to expanding access. Data consistently show the efficacy of RDN in patients with uncontrolled hypertension and those unable to consistently use first-line antihypertensive medications. Coverage by Medicare, however, is key so that these patient populations can access this therapy.

I applaud CMS’ proposal, and I urge CMS to finalize the National Coverage Determination in a timely manner. With access to innovations such as renal denervation, I strongly believe that we will see positive outcomes in patients with uncontrolled hypertension.

Sincerely,
Raymond R. Townsend MD, FAHA

Less

Dear CMS,

With regard to the proposed National Coverage Determination (NCD) for renal denervation (RDN), I would like to express my strong and enthusiastic support for this technology and praise CMS for the recognition of the critical necessity for this evidence-based adjunct to the hypertension treatment armamentarium.

By trade, I am a trained hypertension specialist with over 30 years of experience treating patients with refractory and difficult-to-manage hypertension. Based on my ~12 year experience with patients enrolled in multiple RDN trials, I have witnessed the benefit of this technology to positively impact blood pressure (BP) in a large majority of patients, especially in those with refractory hypertension and those who were unable to tolerate antihypertensive medications in rational combinations and dosing.

I follow a significant number of patients longitudinally who continually express gratitude for the opportunity to have had RDN. Although much attention has been given to initial responder status, an increasing number of studies collectively support a clinically meaningful, durable BP reduction in response to RDN (Hypertension. 2024;81:e63-e70) – I suspect that this may be what underlies the patients’ satisfaction.

Additionally, I would urge CMS to consider the following specific changes:

With respect to PATIENT CRITERIA:
1.) There remains a need for an ‘entry’ point for patients with medication intolerances or those unable to tolerate higher doses of antihypertensive medications (and who have adopted lifestyle modifications). Several trials have clearly shown efficacy of RDN in those off BP medications (Lancet. 2020;395:1444–1451).
2.) I agree with establishing a minimum time-period by which a patient’s BP should be managed prior to the RDN procedure (e.g. six months). I would favor focusing more on an appropriate characterization of the evaluation and refractoriness of BP over that time-period rather than a specified number of visits per se thereby acknowledging that several valid modalities exist to report and track BP (e.g. remote BP monitoring programs).

With respect to FACILITY CRITERIA:
1.) From an evaluation standpoint, I agree wholeheartedly that it is necessary for patients to be assessed by a clinician trained and experienced in the management of hypertension who has “longitudinal patient management responsibility”. Also, as stated, “Institutions should have resources and elements … for screening, testing, and treating hypertension”. Adherence to these requirements should also be sufficient which would then obviate the need to mandate the potentially burdensome creation and maintenance of a formalized multidisciplinary hypertension program.

Thus, the current statement should read, “Facilities performing RDN must have a hypertension clinician with longitudinal patient management responsibility with the capability of contributions from relevant medical specialties (e.g., internal medicine, endocrinology, cardiology, and nephrology) as appropriate.”

Thank you for the opportunity to comment on this very important matter!

Sincerely,

James V. Gainer, MD, FACC
Hypertension Specialist
Vanderbilt University Medical Center

Less

I’ve watched uncontrolled hypertension take a heavy toll on my patients leading to the well established comorbidities that can result from hypertension induced atherosclerotic disease. RDN offers real hope for progress in hypertensive care, but parts of the proposed NCD could be optimized. The 3 points I feel need modification are as follows:

1. Requiring one primary clinician to manage a patient for six months with three visits—only one virtual—doesn’t reflect how care actually works. These patients are managed by a team. Forcing one doctor to check every box just adds delay. Overly prescriptive regulation on physician patient interaction removes both parties autonomy and creates un-necessary barriers to care delivery. I would recommend replacing the 3 visit rule with a requirement for documentation of shared decision making similar to has been suggested in the carotid field.

2. The eGFR <40 cutoff is also too restrictive. Many patients with resistant hypertension have CKD, and studies already include those with eGFR =30. We shouldn’t block patients who are otherwise good candidates.

3. Defining uncontrolled hypertension as >140/90 sets the bar too high. Patients with readings in the 130/80 range while on 3 or more medications, especially with other risk factors, are still in danger. Waiting for them to worsen before acting means missed chances to prevent harm. This also ignores the severe side effects some patients feel related to polypharmacy.

We need an NCD that matches real-world care, uses evidence-based thresholds, allows earlier intervention, and promotes shared decision making for the patients who need it most.

Less

Less

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)

Dear Ms. Syrek Jensen,

Recor Medical is a global medical device company deeply committed to addressing uncontrolled hypertension, a significant public health burden. The FDA's Premarket Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System in November 2023, following extensive clinical evidence (1)(2)(3), underscores the urgent need for this innovative therapy.

We firmly believe this NCD provides a critical opportunity to expand access and offer a safe and effective treatment for Medicare beneficiaries. We commend CMS for initiating the National Coverage Determination (NCD) process for Renal Denervation (RDN). We recognize that several criteria within the proposed NCD are well-considered and will undoubtedly have a positive impact, significantly enhancing patient access to this important, life-changing therapy. We particularly appreciate CMS’s commitment to recognizing the value of RDN as an adjunctive treatment for uncontrolled hypertension, a critical step that will benefit countless Medicare beneficiaries. Furthermore, we appreciate CMS's decision to implement Coverage with Evidence Development (CED) for renal denervation, allowing further study of diverse patient subgroups, while also ensuring that only technologies supported by a CMS-approved study are utilized.

In a spirit of collaborative partnership, we wish to provide specific feedback on certain proposed criteria that, if left unrevised, could inadvertently create significant barriers to patient access and hinder the efficient integration of RDN into real-world clinical practice. We urge CMS to consider the following points:

1. Patient Criteria (f): Primary Clinician Management and Visit Requirements
The proposed requirement that "the primary clinician must manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters, with no more than one of the three encounters being virtual," introduces substantial operational and logistical challenges. While we concur that patients should undergo appropriate medical management, this prescriptive framework is misaligned with both real-world clinical workflows and practice patterns.

From a workflow and scheduling standpoint, mandating a new, fixed six-month observation period with specific in-person visit counts creates unnecessary administrative burden for provider practices already managing high patient volumes. This rigidity fails to acknowledge the increasing adoption of telehealth in real-world practice, which is a vital tool for patient convenience and continuity of care, particularly for beneficiaries in rural or underserved areas. Furthermore, complex hypertension care is inherently multidisciplinary, often involving primary care physicians, cardiologists, and nephrologists. Attributing a strict visit count to a single "primary clinician" disregards this collaborative reality and can create bottlenecks in referral pathways. Even in clinical trials, while follow-up schedules are defined, pre-referral management is typically assessed based on documented history rather than a rigid six-month window. This criterion would unnecessarily delay access for patients who are already well-characterized and clinically ready for RDN.

2. Facility Criteria (a): Multidisciplinary Hypertension Program
CMS's rationale for requiring a multidisciplinary hypertension program is understood to ensure comprehensive patient management. However, the current language, stating "Facilities performing RDN must have a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties," introduces ambiguity and risks creating unintended access barriers.

The lack of precise definition for what constitutes a "program" and how its existence and components should be confirmed (e.g., specific certifications, formal structures, or personnel titles) creates uncertainty for facilities seeking to offer RDN. Given the limited number of formally certified hypertension specialists and designated "hypertension navigator" roles nationwide, this highly specific criterion could disproportionately exclude a significant number of otherwise highly capable cardiovascular programs and facilities. To ensure clarity and avoid unnecessary access barriers, we urge CMS to adopt a broader, more flexible language that emphasizes the presence of a competent, multidisciplinary care team experienced in hypertension management, without dictating rigid organizational structures or specific, scarce personnel certifications.

3. Patient Criteria (e): Estimated Glomerular Filtration Rate (eGFR) Levels
The proposed exclusion of patients with an eGFR < 40 mL/min/1.73m² as a contraindication warrants revision to align with evolving clinical understanding and device labeling.

The Global Paradise System (GPS) US Post Approval Study (NCT06297291)(4), which is designed to collect real-world evidence for the Paradise System, includes patients with an eGFR of = 30 mL/min/m². Aligning the NCD's eGFR criterion with this device-specific inclusion criterion would ensure consistency with FDA-approved labeling and "future-proof" the NCD against potential device-specific changes in indications. Furthermore, the NCD's own Coverage with Evidence Development (CED) requirement and the planned sub-analyses (e.g., various stages of kidney disease) are precisely designed to gather additional evidence on patient populations where data may be less robust. Maintaining a strict eGFR < 40 mL/min/1.73m² limitation would inhibit the ability to study patients with different levels of chronic kidney disease within the NCD's own framework, thereby hindering the very evidence generation CMS seeks. This limitation would unnecessarily restrict access for patients who could potentially benefit from RDN, including those with lower eGFR values who are often more challenging to manage pharmacologically.

In conclusion, Recor Medical fully supports CMS's initiative to establish national coverage for RDN. We believe that by carefully considering and revising these specific patient management, facility, and eGFR criteria, CMS can finalize an NCD that is pragmatic, minimizes delays, and effectively maximizes patient access to the Paradise uRDN System and future innovative RDN technologies. We appreciate the collaborative partnership with CMS and look forward to continuing to work with the agency to ensure the most efficient and effective path to national coverage for Medicare beneficiaries.

Sincerely,
Shon Chakrabarti, MD MPH
Chief Medical Officer
Recor Medical Inc.

(1) Azizi M, Schmieder R, Mahfoud F, Weber MA, Davies J et al.. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018; 391: 2335-2345 (2) Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T et al.. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet.2021; 397: 2476-2486 (3) Azizi M, Saxena M, Wang Y et al.. Endovascular Ultrasound Renal Denervation to Treat HypertensionThe RADIANCE II Randomized Clinical Trial. JAMA. 2023:329(8):651-661 (4) https://clinicaltrials.gov/study/NCT06297291#study-overview

Less

Our institution has been actively performing renal denervation (RDN) since FDA approval through a multidisciplinary hypertension program. Overall, we have had very good success using RDN: to help achieve blood pressure control for our patients who remain uncontrolled despite a high burden of medications; to reduce medication burden in those who struggle with complex medical regimens; and to treat patients who have tried and failed to tolerate medical therapy and lifestyle interventions. In more than 30 patients now treated, we have performed all procedures as same-day discharges without procedural complications, have experienced good clinical outcomes with longitudinal blood pressure improvement, and have received incredibly positive feedback from our treated patients. As such, we are most grateful to see this NCD progress, as our only significant barrier to date has been the lack of reimbursement.

Our program feels that the proposed NCD criteria are appropriate and not overly burdensome to providers. The proposed NCD accounts for the full body of evidence on RDN, encompassing >6 sham-controlled randomized trials. The position also incorporates published publications by SCAI, AHA, and NKF, and we appreciate that the NCD incorporates individual patient care needs, practical issues with creating treatment pathways for RDN in diverse healthcare systems, and the challenges patients and clinicians have in co-managing hypertension.

We would like to highlight a few items that we feel are of importance as the NCD is finalized:

• We feel that CMS’ proposed approach to medical therapy prior to RDN is patient-centric. Some patients cannot tolerate even the smallest dose of certain classes of hypertensive agents, and others have medical comorbidities that preclude use of certain agents. By prioritizing the goal of ensuring a committed attempt that medical therapy is prioritized and exhausted prior to consideration of RDN is consistent with our clinical practice. As approached in the NCD, this also ensures access to patients who may benefit from RDN and is rooted in the data available for RDN, yet doesn’t create barriers such as required use of certain agents when this may not be clinically achievable.
• We feel that using office blood pressure to diagnosis uncontrolled hypertension at the thresholds of >140 systolic or >90 diastolic is based on current guidelines, reflects real-world practice, and reduces any unnecessary barriers to technology not available at all institutions across the United States.
• We agree that the proposed approach to addressing secondary causes of hypertension is appropriate and is based in current standards of care.

In total, we are thrilled to see this current NCD proposal and are supportive of the criteria outlined. We have reviewed most of the current comments, which are overwhelmingly supportive, and we hope that any final feedback incorporated into the NCD prioritizes the clinical community, who see and treat hypertension every day and truly understands the challenges of caring for these patients and the realities of clinical care.

Eric Secemsky, MD
Anna Krawisz, MD

Less

RE: CAG-00470N Renal Denervation for Uncontrolled Hypertension

Dear Ms. Syrek Jensen:

Medtronic is the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the development of high-quality products and innovative therapies that improve health outcomes for all patients, including Medicare beneficiaries.

We appreciate the opportunity to provide public comment on CAG-00470N, the proposed National Coverage Determination (NCD) for renal denervation (RDN) for uncontrolled hypertension. Medtronic strongly supports the proposed NCD, and we believe establishing national coverage for RDN represents a significant step forward in expanding access to innovative chronic disease care for Medicare beneficiaries struggling with hypertension.

We are grateful for the opportunity to collaborate with CMS on RDN as a pilot under the Transitional Coverage for Emerging Technologies (TCET) pathway. In our initial comments, we demonstrated the burden of uncontrolled hypertension, highlighted the need for non-pharmaceutical treatment options, and provided clinical evidence supporting RDN and the Symplicity Spyral™ RDN system. We also proposed coverage criteria aligned with consensus statements and product labeling. We were encouraged by the broad support expressed in public comments and commend CMS for incorporating this feedback into the proposed NCD.

We thank CMS for the timely release of the proposed decision memo and the consequent update to the estimated completion date of this NCA to October 8, 2025, and we look forward to the publication of the final NCD by that date.

In support of this proposed NCD, we have comments on a select set of areas which may benefit from further clarification or refinement in the final NCD:

• The proposed coverage criteria for patients, physicians, and facilities;
• Discussion and support of the proposed CED study criteria; and
• Suggested corrections and clarifications to the Evidence Review.

Proposed Coverage Criteria

Medtronic agrees with the proposed decision and coverage criteria for RDN, which are well-aligned with consensus statements from major medical societies, and we broadly support CMS’ adoption as proposed. We suggest clarifications for the following patient, physician, and facility criteria, either in the language of the individual criterion or in the discussion of the rationale (Section IV.B.5).

Patient Criteria (B.1)

1. The first patient criterion (B.1.a) states: “Diagnosis of uncontrolled hypertension (> 140/90 mmHg) despite active management by a clinician with primary responsibility for blood pressure management.”

   The American Heart Association defines uncontrolled hypertension as systolic BP ≥ 140mmHg or diastolic BP ≥ 90mmHg.[1] Table 1 of Section II(A) in the proposed decision memo reflects this definition of Stage 2 hypertension.

   Consistent with the AHA definition, we suggest revising this patient criterion to “Diagnosis of uncontrolled hypertension (office blood pressure of either ≥140 mmHg systolic BP or ≥90 mmHg diastolic BP) despite active management by a clinician with primary responsibility for blood pressure management” to specify office BP measurement and for alignment with the AHA definition of Stage 2 hypertension.

2. Criterion (B.1.c) states that patients must be “On stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for at least 3 months before referral for RDN.” The term “maximally tolerated” could be interpreted by some to mean patients must reach upper-dose limits available for their medication, regardless of symptoms, prior to being referred for RDN. In contrast, the term “optimally tolerated” may better reflect real-world practice and common understanding, whereby physicians balance efficacy, safety, and patient-specific tolerance to manage medical therapy, which we believe is more aligned with CMS’ intent.

   In criterion (B.1.c), we suggest replacing “maximally tolerated” with “optimally tolerated” guideline-directed medical therapy.

Criterion (B.1.e) lists Estimated Glomerular Filtration Rate (eGFR) <40 mL/min/1.73m² as a contraindication to RDN. While the other populations noted in this criterion are contraindications, per the FDA-approved labeling for both RDN devices with market authorization, the eGFR threshold is not. Rather, it is addressed in the section “Use in Special Populations.” [2,3] Medtronic recognizes and agrees with the intent of this criterion for RDN procedures not to be performed in patients who are contraindicated. However, we note that the labeling for these devices is likely to change over time as additional data becomes available. A durable approach to prevent contraindicated use would be to broadly reference the current FDA labeling of approved devices.

To ensure contraindicated patients are excluded from coverage without specifying conditions in consideration of future changes to approved labeling – and to correct the reference to eGFR – we suggest clarifying criterion (B.1.e) to read as follows: “Patient has no contraindication to RDN, consistent with the FDA labeling of authorized devices.”

3. Criterion (B.1.f) states: “The primary clinicians must manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters, with no more than one of the three encounters being virtual.” Medtronic agrees that hypertension patients should be managed for at least six months. We agree that patients should have at least three encounters during the entire duration of their hypertensive care, which should be at least six months in length.

   Medtronic requests that CMS consider allowing at least two of the three patient encounters to be virtual. We agree with CMS’ rationale stated in Section IV.B.5, that face-to-face encounters are essential; however, we also note the challenges of frequent face-to-face encounters in many regions across the U.S. The U.S. Centers for Disease Control and Prevention (CDC) note the greater risk and higher rates of high blood pressure and heart disease for rural residents [4] and note that telehealth can be an effective approach for communication and counseling for rural communities.[5] Recent analyses show that adoption of telehealth in rural communities has modestly risen compared to before the COVID-19 pandemic, with one study finding that rural telehealth use was not associated with worsened hypertension control. [6,7]

   We suggest criterion (B.1.f) be revised to allow two of the three patient encounters to be virtual visits.

Physician Criteria (B.2)

Medtronic supports the proposed physician criteria, and we are encouraged to see they align with consensus statements from major medical societies.

5. Criteria (B.2.c) and (B.2.d) require physicians to complete “at least five proctored cases with each approved device.” The current wording may cause confusion as to whether CMS intends for physicians performing RDN to conduct five proctored cases on all approved RDN devices available on the market, regardless of which device they may intend to use in their clinical practice.

   We suggest that criteria (B.2.c) and (B.2.d) be clarified to ensure physicians are appropriately trained with five proctored RDN cases with the approved RDN devices they will be using in clinical practice – for example, by changing “with each approved device” to “with the approved device(s) they intend to use.”

Facility Criteria (B.3)

We appreciate CMS’ thoughtful consideration of how to ensure facilities are adequately prepared to provide the RDN procedure safely. We support the proposed criteria, and note the following with respect to the proposed facility criteria:

6. Criterion (B.3.a) states “(a) Facilities performing RDN must have a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties (e.g., internal medicine, endocrinology, cardiology, and nephrology).” Medtronic supports and commends CMS in establishing facility criteria that aim to ensure appropriate longitudinal hypertension care while recognizing that care models and programs take many different, legitimate forms across the U.S. We also appreciate that, in the rationale stated in Section IV.B.5, CMS recognizes that a HTN navigator may be a physician, advanced practice provider, or registered nurse trained in program management.

   Medtronic encourages CMS to consider input from the clinical community on this criterion regarding the importance of flexibility and any need for clarity. We suggest CMS consider noting that facilities may have either a “multidisciplinary hypertension program or renal denervation program” to meet this criterion.

   Proposed CED Study Criteria
   We support the proposed CED study criteria (B.4). Medtronic broadly agrees that the proposed CED study parameters are well-aligned with CMS’ evidence questions and facilitate robust evidence generation using fit-for-purpose real-world studies. Medtronic looks forward to submitting a CED study protocol to CMS.

   Suggested Clarifications to the Evidence Review
   We appreciate the comprehensive review of RDN evidence within this proposed decision memo. We provide an addendum in this comment offering suggested clarifications of the evidence findings for CMS’ consideration.

   Timing and Path to Coverage
   We again thank CMS for initiating the NCA and for the thoughtful development of the proposed NCD. We appreciate CMS’ continued efforts to complete the RDN coverage process, including finalization of the NCD, timely review and approval of the Medtronic CED study protocol, and expeditious transmittal of implementation instructions to the MACs for this NCD upon finalization.

   Thank you again for your consideration.

   Sincerely,

   Carrie Bullock
   Vice President, Health Policy, Reimbursement & CMS Strategy
   Medtronic

   ADDENDUM: Suggested Clarifications to the Evidence Review

   1. In Section II.A., the Clinical Review states “… that at least partial anatomical and functional reinnervation is likely to occur after RDN, but the exact timeframe and relevance to sustained BP control are unclear.”

      We recommend noting that the most recent long-term data for radiofrequency RDN (rfRDN) show durable BP reductions over time, suggesting that functional reinnervation may not be occurring after RDN.

      Recently, a mixed model analysis of >4,000 patients treated with rfRDN from randomized trials and registries also showed sustained BP reductions through 3 years that increased over time.[8] Likewise, two separate recent meta-analyses focusing on studies with a duration of up to 10 years also demonstrated significant and clinically meaningful reductions in office and 24-h systolic BP without adverse effects on renal function.[9,10] A meta-analysis published in July 2025 assessed 18 total trials of rfRDN with a mean follow-up of 4.4 years, ranging 3 to 9.6 years, and reported an office SBP reduction of -23.0 mmHg (95% confidence interval: -26.8 to -19.1, P < 0.05; n=2040 patients) concomitant with a significant reduction in prescribed antihypertensive medication.[11] Taken together, these pre-clinical and clinical results strongly indicate long-term durability of rfRDN to impart sustained lowering of both office and 24-h SBP without increasing the number of prescribed anti-hypertensive drugs.

   2. In Section III.E. (Assessment of Evidence), in the summary of the SPYRAL HTN studies, the proposed decision memo notes the following: “The [HTN-ON MED] authors suggest that, at 12 months, patients in the sham condition were showing decreases in SBP measures with a higher medication burden than those in the rfRDN group.”

      We suggest editing this sentence to note that the higher medication burden in the sham condition was statistically significant. (i.e., “…with a significantly higher medication burden than those in the rfRDN group.”) In the recently published safety and efficacy follow-up data for SPYRAL HTN-ON MED at 12 and 24 months, the sham control group took significantly more medications at 12 months (2.2±0.9 versus 2.5±1.1; P=0.0039).[12]

   3. In Section III.E. (Assessment of Evidence), in the summary of the SPYRAL HTN studies, the proposed decision memo notes the following: “At 24 months, the medication burden was similar between the two groups, but BP increased within the sham group and continued to decrease in the rfRDN group.”

      We suggest editing this sentence to note that these data at 24 months resulted in a statistically significant between-group difference. At 24 months, the ambulatory systolic BP change was significantly greater in RDN patients compared with sham control patients (-12.1±15.3 mmHg versus -7.0±13.1 mmHg; treatment difference: -5.7 mmHg; P=0.039).[13]

   4. In Section III.E. (Assessment of Evidence), in the summary of the SPYRAL HTN studies, the proposed decision memo notes the following: “While the SPYRAL HTN-OFF MED Pivotal trial demonstrated clinically meaningful reductions in both OSBP and 24-hour ASBP at three months, the SPYRAL HTN-ON MED Expansion trial did not achieve similar results at 6 or 12 months, although a significant between-group difference was seen at 24 months (Kandzari et al., 2025).”

      We suggest editing this section to note that, though the ON MED Expansion trial did not achieve similar BP reductions at 6 or 12 months, importantly, the patients in the sham control group had statistically higher antihypertensive medications at 6 and 12 months as compared to the RDN group. In the HTN-ON MED Expansion trial at 6 months, reductions in of?ce systolic BP favored the RDN group compared with sham, with a -9.9±13.9 mmHg change in patients who underwent RDN (n=199) and a -5.1±13.2 mmHg change in sham control patients (n=126; adjusted treatment difference: -4.9 mmHg, 95% CI: -7.9 to -1.9 mmHg, P=0.0015); there were statistically more medications in the control group as compared to the RDN group (1.9 vs 2.1; P=0.0085).[14]

   5. In Section III.F. (Limitations of Evidence), Table 3 provides a comparison of the antihypertensive effects of AHMs and RDN. This table, sourced from Messerli et al (2022), describes having only “months” of data for BP decrease and sustainability. However, evidence of BP reduction to at least three years is published. The recently published 24-month data for SPYRAL HTN-ON MED showed a durable and significant reduction in OSBP and ASBP with RDN vs. sham through two years.[15] Additionally, a meta-analysis of published studies of RDN including long-term data from the GSR DEFINE registry also found a durable and substantial BP reduction following RDN beyond 3 years.[16]

      We also note that Table 3 describes RDN as a “yes” for “BP decrease age dependent.” To date, no publications have shown the magnitude or impact of RDN to be age dependent. On the contrary, an analysis of patients from the Global SYMPLICITY registry found similar reductions in blood pressure in patients < 65 years old compared with patients >65.[17] A smaller study has been completed in patients >75 years old, finding similar blood pressure reductions to younger patients.[18]

      We suggest revising or removing Table 3 to address these corrections (“years” vs. “months” of data for RDN on the first row, and “no” for RDN on the fourth row).

   6. In Section III.F. (Limitations of Evidence), it states the following: “For example, the modest reduction (approximately analogous to adding 1 new AHT) is unlikely to benefit patients with severe, resistant HTN with SBP > 180 despite multiple AHT agents, but this is not confirmed. For context, adding one AHT can similarly achieve 4 to 6 mmHg in ambulatory SBP (equivalent to 7-10 mmHg reduction in OSBP) with RDN. In particular, spironolactone reduced 12-week averaged home SBP by 8.7 mmHg compared with placebo among patients with treatment-resistant HTN (Williams et al., 2015).”

      We note recently presented data at conference podium (recently accepted in Eurointervention with publication forthcoming), which showed the anticipated BP reduction can be dependent on baseline BP. In this analysis, baseline SBP correlation with SBP change after 6 months was statistically significant; based on linear regression, a baseline office SBP of 160mmHg, 170mmHg and 180mmHg were associated with 6-months office SBP reduction by -9.2mmHg, -15.1mmHg and -21.0mmHg, respectively.[19]

      We suggest revising this statement in recognition of data that shows that reductions in BP after RDN may be dependent on baseline BP, with larger reductions anticipated for higher baseline BPs that may be clinically meaningful to patients.

   7. Appendix C, Table C2 notes several datapoints as Not Reported “NR” for antihypertensive drug classes in the SPYRAL HTN-ON MED study.

      We suggest revising Table C2 to include these datapoints, which are reported in Supplemental Table 11 of the study publication.[20]

   REFERENCES
   1. American Heart Association. What is High Blood Pressure? 2024. https://www.heart.org/en/health-topics/high-blood-pressure/the-facts-about-high-blood-pressure
   2. Medtronic Symplicity Spyral™ Instructions for Use. https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220026D.pdf
   3. ReCor Medical Paradise™ Instructions for Use. https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220023C.pdf
   4. U.S. Centers for Disease Control and Prevention. About Rural Health. May 16, 2024. https://www.cdc.gov/rural-health/php/about/index.html
   5. U.S. Centers for Disease Control and Prevention. Preventing Chronic Diseases and Promoting Health in Rural Communities. December 19, 2024. https://www.cdc.gov/health-equity-chronic-disease/health-equity-rural-communities/index.html
   6. Lee JS, et al. Rural and Urban Differences in Hypertension Management Through Telehealth Before and During the COVID-19 Pandemic Among Commercially Insured Patients. Am J Hypertens. 2024 Jan 16;37(2):107-111. doi: 10.1093/ajh/hpad093.
   7. Mackwood M, et al. Telehealth Trends and Hypertension Management Among Rural and Medicaid Patients After COVID-19. Telemed J E Health. 2024 Jun;30(6):e1677-e1688. doi: 10.1089/tmj.2023.0628. Epub 2024 Mar 8.
   8. Mahfoud F, et al. Long-Term, Patient-Level Analysis of Radiofrequency Renal Denervation in the SYMPLICITY Clinical Trial Program. JACC Adv. 2025 Mar;4(3):101606. doi: 10.1016/j.jacadv.2025.101606. Epub 2025 Feb 21.
   9. Sesa-Ashton G, et al. Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis. Hypertension. 2024 Jun;81(6):e63-e70. doi: 10.1161/HYPERTENSIONAHA.123.22314. Epub 2024 Mar 20.
   10. Mahfoud F, et al. JACC Adv. 2025.
   11. Mahfoud F, et al. Long-term outcomes following radiofrequency renal denervation: meta-analysis of 18 reports. Eur J Prev Cardiol. 2025 Jul 15:zwaf368. doi: 10.1093/eurjpc/zwaf368. Epub ahead of print.
   12. Kandzari DE, et al. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.
   13. ibid.
   14. Kandzari DE, et al; SPYRAL HTN-ON MED Investigators. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.
   15. Kandzari DE, et al. Circ Cardiovasc Interv. 2025.
   16. Mahfoud F, et al. Eur J Prev Cardiol. 2025.
   17. Mahfoud F, et al. Renal Denervation in High-Risk Patients With Hypertension. J Am Coll Cardiol. 2020 Jun 16;75(23):2879-2888. doi: 10.1016/j.jacc.2020.04.036.
   18. Ziegler A.K., Bertog S., Kaltenbach B., et al. Efficacy and safety of renal denervation in elderly patients with resistant hypertension. Catheter Cardiovasc Interv 2015;86:299-303
   19. Schmieder R, et al. Higher Baseline Systolic Blood Pressure is associated with greater Blood Pressure reductions following radiofrequency in a pooled cohort in over 3.000 patients from the Symplicity clinical program. Poster Session: “Evolving strategies for renal interventions.” EuroPCR 2024. 2024 May 16.
   20. Kandzari DE, et al. JACC. 2023. Supplement, accessible at https://www.jacc.org/doi/suppl/10.1016/j.jacc.2023.08.045/suppl_file/mmc1.docx .

   Less

I am writing to share a strategic viewpoint, integrating both clinical and operational considerations, on the proposed National Coverage Determination (NCD) for renal denervation (RDN). We are committed to delivering high-quality, accessible cardiovascular care. This is something our team has recognized as a long-standing need, and we view RDN as a promising advancement for our patients with uncontrolled hypertension. However, parts of the proposed NCD’s operational and structural requirements may create barriers to efficient rollout and to reaching all patients who could benefit.

My primary concern revolves around Patient Criteria (f): the stipulation that a primary clinician must manage the patient for a minimum of six months, with at least three encounters, and no more than one being virtual, before RDN referral. Most patients are referred to us as a specialty after several years of management by their primary provider, with a well-established diagnosis. At that point, we have a thorough treatment history to review, and further therapy is often the next step. In our region, restricting appointment types to in-person further limits access for patients, particularly for centers like ours that receive referrals from surrounding rural areas. Hypertension management often relies on medication titration and maintaining detailed blood pressure logs over time. In many cases, requiring a face-to-face visit can be an inefficient use of both provider and patient time and resources. This prescriptive approach would not only place additional strain on our scheduling and resources, but more importantly, it could create unnecessary delays in accessing RDN for patients who are clinically ready for the therapy, potentially extending their exposure to elevated cardiovascular risk.

I would also like to address Facility Criteria (a): the requirement for a multidisciplinary hypertension program with specified contributions from a hypertension clinician, a hypertension navigator, and various medical specialties. While having service line champions can be a valuable resource, it is not essential, and it may limit the widespread adoption of therapy. There is a limited pool of formally certified hypertension specialists and navigators. Many cardiovascular programs with well-established service lines already have the stakeholders, knowledge, and resources needed to manage hypertension programs effectively. This has a direct impact on how readily RDN can be offered across different healthcare settings and risks creating geographic gaps in access to this innovative treatment. Our focus should be on ensuring care teams are skilled and well-integrated, rather than mandating a rigid organizational structure that may not be practical for all high-quality programs.

In conclusion, while we support the intent of the NCD, I urge CMS to revise these two criteria. Adopting more flexible, outcomes-focused language for patient management and facility structure will allow cardiovascular programs across the country to integrate RDN into care pathways more efficiently. This flexibility is essential to removing unnecessary barriers, ensuring that all eligible patients, regardless of location, have timely access to this important new therapy.

Less

Dear Ms. Ashby and Dr. Farmer,

The Society of Interventional Radiology (SIR) is a professional medical association representing over 8,000 members, including U.S. physicians practicing in the specialty of vascular and interventional radiology. The Society is dedicated to improving public health through pioneering advances in minimally invasive, image-guided therapies. SIR supports the proposed National Coverage Determination (NCD) and appreciates the thoughtful approach taken in the decision memo. We value the recognition of the clinical complexity and variability within the Medicare population with uncontrolled hypertension, as well as the emphasis on ensuring patients have received appropriate, guideline-directed care before consideration for renal denervation (RDN). Outlined below, we seek to provide clarity and strengthen the proposed NCD.

Patient Criteria

The current coverage criteria in the decision memo state that patients must have “(a) Diagnosis of uncontrolled hypertension (>140/90 mm Hg) despite active management by a clinician with primary responsibility for blood pressure management.” As written, this may be interpreted to mean that patients must exceed both the systolic and diastolic thresholds. To align with the American Heart Association’s 2024 definition of Stage 2 hypertension, as referenced by CMS on page 10 of the draft NCD (Table 1: Categories of BP in Adults), we recommend revising the language to:

“(a) Diagnosis of uncontrolled hypertension (defined as a systolic blood pressure >140 mm Hg or a diastolic blood pressure >90 mm Hg) despite active management by a clinician with primary responsibility for blood pressure management.”

This clarification would ensure consistency with established clinical guidelines and prevent unnecessary exclusions from coverage.

According to the current coverage criteria, as stated above, the patient must have uncontrolled hypertension (> 140/90 mm Hg). This procedure should not be restricted to stage 2 hypertension; we recommend that CMS extend therapy to stage 1 hypertension, with a target blood pressure of 130/80 mmHg, for patients with persistent blood pressure above this level, particularly those at increased cardiovascular risk.

A substantial number of patients continue to have blood pressure readings above 130/80 mmHg despite receiving optimal medical therapy. Evidence demonstrates that even modest reductions in systolic blood pressure lead to meaningful decreases in cardiovascular events.

The decision memo currently includes the following coverage criterion: “(e) Patient has no contraindication to RDN, including estimated Glomerular Filtration Rate (eGFR) < 40, pregnancy, fibromuscular dysplasia, stented renal artery (< 3 months before RDN), renal artery aneurysm, significant renal artery stenosis (> 50%), or known kidney or secreting adrenal tumors.”

SIR recommends that CMS simplify the eGFR threshold to better align with current FDA-approved device labeling and allow for future updates as evidence evolves. Notably, an eGFR < 40 is not listed as a contraindication in the labeling for the Paradise or Spyral device; rather, it reflects an unstudied population. Adjusting this language would maintain patient safety while supporting broader clinical applicability as more data become available.

The current coverage criteria outlined in Decision Memo (f) — which require that primary clinicians manage the patient for a minimum of six months before referral for RDN, including at least three encounters with no more than one being virtual — place an unrealistic burden on both patients and providers. In the context of nationwide physician shortages and prolonged wait times to see hypertension specialists, such requirements may delay necessary treatment and exacerbate disparities in care.

We strongly recommend modifying the criteria to require a minimum of 90 days of management, with at least two encounters, no more than one of which is virtual, prior to referral for RDN. This adjustment maintains appropriate safeguards while facilitating more timely access to care. Restricting access to care, particularly for Medicare beneficiaries, undermines efforts to improve population health outcomes. Broadening access to renal denervation (RDN) is critical to addressing persistent gaps in hypertension control.

The current CED study criteria state that patients must be “(c) On stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for at least 3 months before referral for RDN.” SIR recommends that CMS clarify whether the term “maximally tolerated” is intended to mean “optimally tolerated.”

In clinical practice, “optimally tolerated” is often viewed as a more patient-centered standard, recognizing individual variability in response, side effects, and comorbid conditions. Reframing this language to “optimally tolerated” would more accurately reflect real-world treatment decisions and promote appropriate, individualized care before considering renal denervation.

Physician Criteria

Under the proposed Physician criteria, physicians without prior endovascular training or renovascular expertise must complete at least ten supervised diagnostic/therapeutic renovascular procedures—half as primary operator—and a minimum of five proctored RDN cases with each approved device (c). Physicians with prior endovascular training and active experience must complete at least five proctored RDN cases with each approved device (d).

SIR recommends that CMS clarify whether these training and proctoring requirements apply to all approved RDN devices on the market or only to the specific device(s) a physician intends to use in clinical practice. Given the procedural and technical differences across RDN systems, we believe it is most appropriate—and practical—for physicians to be trained and proctored only on the device(s) they will use. This approach maintains high standards of procedural competency while avoiding unnecessary redundancy and administrative burden.

Facility Criteria

3. Facility Criteria (a): The current requirement that facilities performing RDN maintain a multidisciplinary hypertension program—including a hypertension clinician with longitudinal management responsibility, a hypertension navigator, and input from various medical specialties (e.g., internal medicine, endocrinology, cardiology, nephrology)—is well-intentioned but may be impractical in many settings.

While we support the inclusion of dedicated blood pressure management as a key component of care, mandating a hypertension navigator is an unrealistic expectation for most facilities, particularly given workforce constraints. We recommend that the criteria allow for flexibility in how comprehensive hypertension management is achieved, without requiring specific roles that may not be feasible to implement universally.

SIR appreciates the opportunity to provide meaningful feedback on the CMS proposed decision memo for renal denervation in the treatment of uncontrolled hypertension.

Sincerely,

Robert A. Lookstein, MD, FSIR
President, Society of Interventional Radiology

Eve Lee, MBA, CAE
Chief Executive Officer, Society of Interventional Radiology

Less

August 8, 2025

The Honorable Dr. Mehmet Oz, M.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Via electronic submission at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?ncaid=318&proposed=Y

Re: Proposed Decision Memo CAG-00470N: Renal Denervation for Uncontrolled Hypertension (Propose NCD title change: Renal Denervation for Uncontrolled or Resistant Hypertension)

Dear Dr. Oz:

We appreciate the opportunity to provide comments to the Centers for Medicare and Medicaid Services (“CMS”) in response to the Proposed National Coverage Decision to cover renal denervation for uncontrolled or resistant hypertension. The FAH is the national representative of nearly 1,000 leading tax-paying hospitals and health systems throughout the United States. FAH members provide patients and communities with access to high quality, affordable care in both urban and rural areas across 46 states, plus Washington, DC, and Puerto Rico. Our members include teaching, acute, inpatient rehabilitation, behavioral health, and long-term care hospitals and provide a wide range of inpatient, ambulatory, post-acute, emergency, children’s, and cancer services.

CMS proposes to cover both radiofrequency (rfRDN) and ultrasound (uRDN) renal denervation procedures for Medicare beneficiaries with uncontrolled hypertension. However, CMS is proposing to limit this coverage under a Coverage with Evidence Development (CED) framework, meaning that RDN procedures must be delivered within CMS-approved clinical studies designed to generate further evidence on safety and effectiveness.

The proposal represents a significant policy change by introducing Medicare coverage for RDN, but only in the context of research. It outlines stringent requirements for patients, physicians, and facilities and mandates that all procedures be conducted as part of rigorous clinical trials. These trials must include long-term follow-up, active comparators, and detailed data collection to assess outcomes and treatment effects across various patient subgroups.

Patients eligible for RDN under this policy must have uncontrolled hypertension, defined as a blood pressure above 140/90 mm Hg, despite receiving guideline-directed medical therapy and lifestyle interventions for at least three months. They must have been under the care of a hypertension clinician for six months with at least three documented encounters, and secondary causes of hypertension must have been appropriately ruled out or treated. Individuals with prior RDN or specific contraindications, such as low kidney function, pregnancy, or renal artery abnormalities, are excluded.

CMS requires that RDN be performed only within approved CED studies that adhere to strict criteria. These studies must track outcomes for at least 24 months and evaluate key clinical endpoints such as blood pressure, kidney function, cardiovascular events, and mortality. They must also include an active comparator group and be designed to support subgroup analyses based on age, chronic kidney disease stage, hypertension phenotype, and medication adherence.

The FAH appreciates the opportunity to offer our comments on the patient and facility criteria outlined in section B, which we generally believe are too restrictive and will prevent appropriate patients from receiving needed care.

Section B: Patient Criteria
B.1.a. Diagnosis of uncontrolled hypertension (> 140/90 mm Hg) despite active management by a clinician with primary responsibility for blood pressure management.

Clinical Review – Section A – Background
Hypertension Definition and Classification: Uncontrolled hypertension (HTN) is defined as persistently elevated BP above 140/90 mm Hg (Yaxley and Thambar, 2015; Mancia etal., 2023). Resistant hypertension is defined as persistently elevated BP above 140/90 mm Hg despite management with three antihypertensive therapies of different classes, of which one is a diuretic, used concurrently for at least six months, or controlled BP requiring four or more medications (Carey et al., 2018).

The FAH is concerned that the proposed patient criteria of “uncontrolled hypertension (>140/90 mm Hg)…” is overly restrictive and will be a barrier to care. It is not in line with the current patient selection criteria included in the SCAI Position Statement on Renal Denervation for Hypertension. In the current Position Statement, SCAI indicates that “Patients with resistant hypertension, defined by blood pressure >130/80 mm Hg…” are in the selection criteria appropriate for renal denervation.

In addition, it is important to point out that the pivotal ultrasound and RF RDN trials were formulated prior to the 2017 ACC/AHA guidelines that reduced the definition of hypertension to a value of >130/80. It is also noted that the current ESC guidelines and previous ACC/AHA guidelines have different definitions of hypertension and that future changes to these definitions are possible. For this reason, it may be prudent to use the term “stage 1 hypertension or greater” rather than assigning a numerical criterion as a guideline for treatment. This would have the advantage of being flexible for future changes to the guideline definition of hypertension whether it is adjusted upward or downward.

In addition, the proposed criteria limit the potential for therapy as it requires both systolic and diastolic pressure to meet criteria. This is not consistent with current guidelines that define hypertension by either one exceeding the threshold. Both the ACC/AHA guidelines from 2017 and the more recent ESC guidelines specify the criteria for diagnosis is a systolic blood pressure value OR a diastolic blood pressure value that exceeds their specified criteria for hypertension (Illustrated below). It is important to note that it is OR not AND.

The FAH recommends that CMS revise the coverage criteria to include patients with a diagnosis of uncontrolled or resistant hypertension; defined as either: (1) stage 1 hypertension or greater OR (2) based on systolic or diastolic blood pressure of stage 1 hypertension or greater.

References:

Less

We are writing to express our support of the national coverage determination criteria outlined by the Centers for Medicare and Medicaid Services for renal denervation therapy. As organizations committed to supporting health care providers and their patients, one of our foundational goals is to prioritize cardiometabolic disease prevention.

Hypertension remains the most modifiable risk factor for cardiovascular disease, and the vast majority of individuals diagnosed with hypertension do not have it managed, despite lifestyle and pharmacological interventions. There is much progress to be made for this disease state. The criteria as proposed by CMS, we believe, takes this reality into account, and provides reasonable coverage for individuals who cannot get their blood pressure to goal. Providing an appropriate pathway for a non-pharmacological treatment option gives the healthcare system a new tool to combat the leading risk factor that contributes to America’s number one killer. The timing is prescient, as the death rate due to cardiovascular disease has increased since 2011. New tools and approaches are needed to reverse this trend.

Even small reductions such as 5-mmHG in systolic blood pressure can significantly reduce the risk for major cardiovascular events. (1) Renal denervation has demonstrated its ability to achieve even greater reductions in blood pressure, leading major medical societies in the United States, including the American Heart Association, the National Kidney Foundation and the Society for Cardiovascular Angiography & Intervention, to publish statements outlining RDN’s appropriateness in the care pathway. (2) (3) (4)

Finally, we note for CMS that utilization management in cardiovascular care – in particular prior authorization and step therapy – has been a particular challenge in recent years. In fact, the change in utilization management for cardiovascular therapy has outpaced all other disease states in some studies (5). Cardiovascular clinicians and their patients shoulder the consequences of these policies as patients have increasing difficulty obtaining the interventions they need. We ask that CMS bear this in mind as the NCD is finalized and implemented.

Thank you for the opportunity to comment.

Partnership to Advance Cardiovascular Health
American Society of Nephrology
National Kidney Foundation

Less

As a physician, I'm encouraged to see CMS moving forward with a National Coverage Determination for renal denervation (RDN). My practice serves a large population of patients with uncontrolled hypertension, and RDN represents a much-needed addition to our toolkit. However, I must highlight several operational and patient care criteria that, if finalized as proposed, will create significant challenges.
First, the requirement for a primary clinician to manage the patient for at least six months with three encounters is simply not a practical way to select patients for RDN. Many of my patients have long-standing hypertension that has been managed over years by a multi-disciplinary team. To demand a new, rigid six-month period of monitoring from a single clinician is an unnecessary administrative hoop that serves no purpose and only delays a patient's access to care. It puts my patients at continued risk of a cardiovascular event while they wait for an arbitrary timeline to be met.
Second, the proposed eGFR threshold of <40 mL/min/1.73m² is an overly restrictive patient selection limitation. In my experience, a large number of patients with resistant hypertension also have chronic kidney disease. This strict cutoff doesn't align with all current device labeling and could prevent me from treating patients who I believe are clinically appropriate and who desperately need new options. It also goes against the spirit of a Coverage with Evidence Development (CED), which is meant to generate data on these very populations.
Finally, the demand that patients be on stable GDMT for three months before referral is excessive. Most antihypertensive medications achieve their maximal effect within 4-6 weeks. Forcing patients to endure an additional two months on a regimen that is either not working or causing intolerable side effects is both clinically illogical and a detriment to patient well-being. It is a delay that serves no clinical purpose.
I am writing to advocate for a more pragmatic and patient-centered NCD that reflects the reality of clinical practice.

Kind regards,
Jason B. Lindsey, MD

Less

Less

Less

August 8, 2025

Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

RE: Coverage of Renal Denervation for Uncontrolled Hypertension (CAG-00470N)

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and 35 million volunteers and supporters, we appreciate the opportunity to comment on the proposed national coverage determination (NCD) for radiofrequency renal denervation (rfRDN) and ultrasound renal denervation (uRDN) (collectively, RDN) for uncontrolled hypertension under Coverage with Evidence Development (CED) in the Medicare population.

In 2023, the Food and Drug Administration (FDA) approved renal denervation, a catheter-based procedure that ablates the renal sympathetic nerves, as an adjunctive treatment for patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

The Centers for Medicare & Medicaid Services (CMS) proposes to cover RDN for uncontrolled hypertension when furnished according to an FDA market-authorized indication and specific Patient, Physician, and Facility criteria, in addition to CED study criteria that will help address current gaps in the evidence base.

The American Heart Association supports coverage of RDN for uncontrolled hypertension, and offers the following comments as CMS drafts its final Decision Memorandum.

Patient Criteria
CMS proposes that for RDN coverage the patient meets all the following criteria:
a) Diagnosis of uncontrolled hypertension (> 140/90 mm Hg) despite active management by a clinician with primary responsibility for blood pressure management. b) Uncontrolled hypertension diagnosed using either ambulatory blood pressure monitoring or serial home blood pressure readings. c) On stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for at least 3 months before referral for RDN. d) As clinically appropriate, secondary hypertension must be evaluated and treated before determining that blood pressure remains uncontrolled. e) Patient has no contraindication to RDN, including estimated Glomerular Filtration Rate (eGFR) < 40, pregnancy, fibromuscular dysplasia, stented renal artery (< 3 months before RDN), renal artery aneurysm, significant renal artery stenosis (> 50%), or known kidney or secreting adrenal tumors. f) The primary clinicians must manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters, with no more than one of the three encounters being virtual. g) No prior RDN procedure.

Not all patients with hypertension are candidates for RDN. We support CMS’ patient criteria for coverage of RDN and provide the following recommendations to clarify and strengthen those criteria.

Patient Criteria (b): Require Ambulatory Blood Pressure Monitoring or Validated Serial Home Blood Pressure Readings

For patient criteria (b)—Uncontrolled hypertension diagnosed using either ambulatory blood pressure monitoring or serial home blood pressure readings—we support CMS requiring ambulatory blood pressure monitoring or serial home blood pressure readings be used. Further, ambulatory BP monitoring or appropriate home BP measurements should be used to eliminate the diagnosis of white-coat hypertension, which is central to ensuring appropriate referrals for RDN.(1)

For patients using serial home blood pressure readings, the criteria should make clear that the readings must be done using a device that is validated, that the patient is using appropriate technique, and that a standardized BP measurement and monitoring protocol is followed. A common recommendation is that self-measured BP monitoring be based on 2 measurements taken at least 1 minute apart in the morning and evening (i.e., 4 readings per day) optimally for 7 days (i.e., 28 readings total) with a minimum of 3 days (i.e., 12 readings total).

The rationale for patient criteria around home blood pressure readings is evidence-based and recognizes that clinicians and patients should make a good faith effort to achieve blood pressure control using maximally tolerated guideline-directed medical therapy as well as rely on multiple blood pressure readings outside of the clinical setting to confirm a diagnosis of uncontrolled hypertension. CMS specifically highlights the use of ambulatory blood pressure monitoring or serial home blood pressure (BP) readings (also referred to as self-measured blood pressure—SMBP). However, currently, CMS only covers home blood pressure devices for patients with end stage renal disease (ESRD). CMS should cover home blood pressure monitors for all beneficiaries—not just those with ESRD—because SMBP is an important component in identifying patients eligible for RDN. This change will enhance clinical outcomes and align policy with practice.

Patient Criteria (c): Blood Pressure Guideline-Directed Medical Therapy, 6 Months
For patient criteria (c)—"On stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for at least 3 months before referral for RDN”—we recommend that CMS clarify that the GDMT is for blood pressure medications. We also urge CMS to replace “at least 3 months” with “at least 6 months managed by their primary clinician” to align criteria (c) and (f).

Patient Criteria (d): Definitively Rule Out Secondary Hypertension
For patient criteria (d)—“As clinically appropriate, secondary hypertension must be evaluated and treated before determining that blood pressure remains uncontrolled”—we encourage CMS to strengthen this criteria by requiring that all patients have secondary etiologies of hypertension ruled out, as outlined in the American Heart Association’s Renal Denervation for the Treatment of Hypertension: Scientific Statement(2) , and in the upcoming 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Patients with certain treatable secondary causes of hypertension, most commonly primary aldosteronism, which is prevalent and often undiagnosed, should not be directed to RDN. Screening should be performed in all eligible patients because targeted, effective treatment is available.(3)

Patient Criteria (f): Remove Minimum Encounters Requirement
CMS proposes, under criteria (f), to require patients be managed by their primary clinician for at least six months before referral for RDN, during which they have at least three encounters, with no more than one of the three encounters being virtual.

Requiring a minimum number of encounters (i.e., three encounters in six months) might prove to be prohibitive due to access or scheduling issues. For example, a clinician might see the patient four times in the last year but still fails to meet the minimum criteria of having three of the encounters in six months. We recommend revising criteria (f) to remove the minimum encounter requirement to avoid any unintended consequences.

Facility Criteria: Need for a Multidisciplinary Team
CMS proposes that coverage of RDN is conditioned on several facility-level criteria, including “(a) Facilities performing RDN must have a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties (e.g., internal medicine, endocrinology, cardiology, and nephrology).”

The American Heart Association appreciates and supports CMS including a coverage requirement that a facility has a multidisciplinary hypertension program with contributions from relevant medical specialties. However, we are unclear as to what is meant by a “hypertension navigator” and if it is a necessary requirement as part of a facility’s multidisciplinary hypertension program. We recommend CMS clarify the hypertension navigator role and allow for flexibility in meeting this requirement, as the absence of this specific title and role at a facility should not preclude coverage and access to RDN.

Additionally, we urge CMS to require that a multidisciplinary team evaluate the appropriateness of RDN for each patient at each institution before patients are referred to RDN. The multidisciplinary team should conduct plasma renin and aldosterone testing, as noted above, and include interpretation by a physician with expertise in evaluation of primary aldosteronism (PA) in all patients prior to RDN.

CED Study Criteria:
We agree with CMS that coverage for RDN for uncontrolled hypertension should be provided under CED. Specifically, we would highlight the need for a new randomized control trial to compare safety and efficacy of RDN and mineralocorticoid receptor antagonists (MRA) in resistant hypertension. Previous trials, with small sample sizes, showed inferiority of RDN when compared with MRA, in lowering blood pressure, but the device used in those studies was limited to an older generation.(4,5) More data is needed in this area, and with the inclusion of updated device technology.

Conclusion
In summary, we support coverage of RDN for uncontrolled hypertension under CED to identify those who may benefit most from the procedure. We support the patient criteria listed and urge CMS to include language that a validated device be used for SMBP and guideline-based protocols be followed. We believe a multidisciplinary team should evaluate the appropriateness of RDN for each patient, including ruling out white-coat and secondary hypertension in all patients before referral for RDN. We also request that CMS define what is meant by “a hypertension navigator” and further clarify the need for this role as a required part of the multidisciplinary hypertension program.

Thank you for the opportunity to submit comments on this NCD. If you have any questions or require any additional information, please contact Maryellen Guinan at (202) 785-7948 or Maryellen.Guinan@heart.org.

Sincerely,
Stacey Rosen, MD
President, American Heart Association

References:
1. Cluett JL, Blazek O, Brown AL et al. Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. August 2024.
2. Ibid.
3. Ibid.
4. Oliveras A, Armario P, Clara A, Sans-Atxer L, Vazquez S, Pascual J, De la Sierra A. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study: a randomized controlled trial. J Hypertens. 2016;34:1863–1871.
5. Rosa J, Widimsky P, Tousek P, Petrak O, Curila K, Waldauf P, Bednar F, Zelinka T, Holaj R, Strauch B, et al. Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension. 2015;65:407–413.

Less

As a physician practicing in Mississippi, one of the country’s worst states for heart health outcomes, I want to express my support for coverage under Medicare for renal denervation (RDN) therapy. I am pleased to see the Centers for Medicare and Medicaid Services pursue this national coverage determination as I have treated thousands of patients with hypertension over my 21 years as a practicing cardiologist. Hypertension in this country – and in my state – is a major challenge, and innovative treatment options are needed, in my opinion, to see progress for patients who are having difficulty managing this highly modifiable risk factor.

I serve as the governor-elect of the Mississippi Chapter of the American College of Cardiology, the director of the Stern Cardiovascular Lipid Clinic and Director of Cardiac Rehabilitation at Baptist Desoto Hospital in Mississippi, and I have had the opportunity to treat patients who have had the RDN procedure. Overall, I am pleased with the proposed coverage criteria outlined by the national coverage determination, because I believe it will support access for a broad range of patients, which is important, because the hypertensive patient population is so clinically, demographically and socioeconomically diverse. One clarification I believe CMS should address is ensuring that the definition of uncontrolled hypertension aligns with American Heart Association guidelines, which defines stage II hypertension as >140 mmHG systolic OR >90 mmHG diastolic.

The clinical trials for this therapy class show meaningful promise, but I am unfortunately aware from personal experience that if patients cannot access new technologies like RDN, they cannot benefit from them, and we will continue to see poor public health outcomes for hypertension control. This situation has sadly transpired in my state of Mississippi with the advent of so many new interventions. This frustrating lack of access has become especially acute in the last decade. Unrealistic and burdensome prior authorization and step therapy policies, in particular, have made patient treatment far more difficult than it has ever been in my career; I know my sentiment is shared by my clinician colleagues. Making access a priority is imperative: with over three-quarters of patients with diagnosed hypertension uncontrolled – and these staggering rates are despite the current understanding of lifestyle change and current suite of pharmaceutical agents – we will fail patients and their well-meaning clinicians if access to this therapy is burdened by cumbersome utilization management policies.

Thank you for the opportunity to comment.

Less

Dear Administrator Oz:

The Association of Black Cardiologists (ABC) writes to express our strong support for the Centers for Medicare & Medicaid Services’ (CMS) proposal to cover radiofrequency and ultrasound-based renal denervation (RDN) under Coverage with Evidence Development (CED).

About ABC

Since our founding 50 years ago, the Association of Black Cardiologists strives to promote the prevention and treatment of cardiovascular disease in Black and other communities experiencing barriers to optimal health by eliminating gaps in our healthcare ecosystem. We close these gaps through advocacy aimed at consistent guideline-based, culturally-focused medical care , representation in clinical trials, insuring patient access and adherence to therapy, and by tackling barriers to patient access to current state-of-the-art technologies.

Background

High blood pressure contributes greatly to the excess cardiovascular morbidity and mortality experienced by the African American community. As clinicians concerned and responsible for the care of minoritized communities, we believe the addition of renal denervation to the therapeutic armamentarium to treat severe, resistant hypertension will improve care for our patients. Older Black adults are disproportionately more likely to have treatment-resistant hypertension, experience poorer blood pressure control, and suffer more from heart failure and stroke.

Hypertension among Black patients is a public health crisis. Hypertension affects approximately 57% of Black Americans, the highest rate of any racial or ethnic group in the United States and approximately 30% higher than whites, this contributes to the contributes to the disproportionate rates of hypertensive consequences: stroke, heart failure, and chronic kidney disease.

As an interventional cardiologist, I have served as a lead clinician-investigator in numerous renal denervation (RDN) clinical trials for more than a decade and have cared for patients with uncontrolled hypertension for more than 25 years. To address the world’s leading modifiable cause of death and disability, RDN has demonstrated clinically meaningful reductions in both office and ambulatory blood pressure with an exemplary procedural and long-term safety record.

I support the CMS proposal for RDN and the opportunity to address uncontrolled hypertension when traditional therapies have been ineffective. The proposal is founded on evidence and is patient-oriented. Importantly, however, the coverage decision should not impose requirements for patient selection that are impractical or inconsistent with routine clinical care (eg, adherence monitoring). Requirements that are unfamiliar or conflict with existing standards of care may present a formidable burden for both providers and patients, and such mandates are without precedent. To this end, establishing specific criteria by CMS will therefore serve as a reference for both institutions and payors.

The CMS proposal for coverage is a welcomed step toward offering the possibility of RDN to the diverse populations with uncontrolled hypertension in our communities.

Less

WomenHeart: The National Coalition for Women with Heart Disease is the nation’s first and largest organization solely dedicated to women living with or at risk of heart disease. As a leading voice for millions of women, WomenHeart provides peer support, education, and advocacy to ensure better outcomes. The organization champions equitable access to innovative therapies and treatments that improve women’s lives. Thus, WomenHeart strongly supports the finalization of the National Coverage Determination (NCD) issued on July 10, 2025, which would expand Medicare coverage and improve access to therapies that reduce risk for patients with uncontrolled hypertension.

Nearly half (48.1%) of adults in the U.S. have high blood pressure, including more than 2 in 5 women. Among adults over age 60, that number jumps to 71.6%. Heart disease is the leading cause of death for women, and hypertension is responsible for 1 in every 5 female deaths. It is the most significant modifiable risk factor for heart disease in the U.S., contributing to the highest percentage of events related to coronary artery disease, heart failure, and stroke. As noted in an article on guideline-driven hypertension management in the American Heart Association’s Circulation Research, the authors state, “Thus, hypertension is one of the most consequential and remediable threats to the health of individuals and society.”

Hypertension impacts women at all stages of life from teenage years, through family planning and pregnancy, and during menopause and beyond. Hypertension also has a disparate impact as African American women have a 60% greater likelihood of having high blood pressure than white women and have the highest rates of uncontrolled hypertension and the highest mortality rates than any other group.

Despite the high prevalence of high blood pressure, only one in four people have it under control. Uncontrolled high blood pressure can lead to heart disease and stroke, but it also can increase risk of death from other conditions including from COVID-19. Hypertension disorders are also the leading cause of pregnancy-related deaths.

While many patients are able to manage high blood pressure through lifestyle changes and medication, approximately 10% struggle to achieve control despite these efforts. Individuals with hypertension that is resistant or inadequately responsive to treatment face significantly higher risks of “target organ damage, adverse clinical events, and all-cause mortality.” Thus, therapies like renal denervation (RDN) can prove essential in preventing adverse events in these patients and even death.

The SPYRAL HTN program, the largest renal denervation (RDN) clinical study to date, has enrolled more than 4,000 patients globally and demonstrated sustained blood pressure reductions over three years in more than 1,300 patients, without an increase in medication. The National Coverage Determination (NCD) would ensure appropriate access to and Medicare coverage for RDN for patients with uncontrolled hypertension, in alignment with leading clinical society consensus statements. Given the urgent need to control hypertension and reduce adverse outcomes, WomenHeart strongly urges the finalization of this NCD to expand access to this potentially life-saving therapy.

Less

I appreciate the opportunity to comment on the proposed coverage decision for renal denervation (RDN). While the intent to maintain high standards of care is commendable, several requirements—particularly those related to facility qualifications and patient eligibility—could unintentionally restrict access for patients who need this therapy most.

The requirement for a formal “multidisciplinary hypertension program” that includes a certified hypertension clinician and navigator creates a structural barrier for most hospitals. Currently, there are only about 1,500 certified hypertension specialists in the U.S. and 34 certified hypertension centers nationwide. These resources are concentrated in large academic systems, meaning smaller community hospitals—which serve a significant Medicare population—would be excluded despite having experienced teams capable of safely performing RDN. CMS should allow broader definitions of collaborative care teams, including cardiologists, nephrologists, advanced practice providers, and nursing staff who already manage complex hypertension.

Additionally, the proposed rule that a primary clinician manage the patient for six months with three encounters—only one of which may be virtual—does not reflect real-world care patterns. Many patients have years of treatment history and multiple encounters across different clinicians. For rural or mobility-limited patients, telehealth has become essential, and limiting its use risks delaying access for those most vulnerable.

The criteria requiring three months on stable doses of maximally tolerated guideline-directed medical therapy (GDMT) further compounds these delays. Most medications reach maximal effect within four to six weeks, and holding patients for an additional two months exposes them to unnecessary cardiovascular risk.

Finally, the exclusion based on an eGFR threshold of <40 mL/min/1.73m² is overly rigid. Current FDA post-approval study protocols already include patients with lower renal function, and these thresholds will evolve as more evidence emerges. Linking coverage criteria to device-specific Instructions for Use (IFU) is a more future-proof approach than hard-coding a static cutoff.

I urge CMS to revise these criteria to reflect evidence-based guidelines and real-world practice patterns. A more flexible, inclusive approach will ensure timely and equitable access for patients who have exhausted all other options.

Less

The National Forum for Heart Disease & Stroke Prevention commends the Centers for Medicare and Medicaid Services (CMS) for initiating the national coverage process to support Medicare beneficiary access to renal denervation (RDN) for treating uncontrolled hypertension.

The National Forum is a nonpartisan, nonprofit organization whose members represent patients, clinicians, public health leaders, healthcare payers, employers, and scientists, collaborating to prevent cardiovascular disease and stroke.

Uncontrolled hypertension is the leading modifiable cause of death and disability in the United States. Nearly half of U.S. adults have high blood pressure, yet fewer than one in four have it under control. Control rates have stagnated just above 50% among Medicare beneficiaries, with recent declines threatening progress.¹ The persistent burden of hypertension, despite widespread availability of medications, emphasizes the urgent need for new, evidence-based tools.

Renal denervation offers a promising and minimally invasive adjunct treatment. Multiple sham-controlled trials, including RADIANCE-II, have demonstrated RDN’s significant and sustained blood pressure–lowering effects. In RADIANCE-II, patients receiving ultrasound-based RDN saw a 6.3 mm Hg greater reduction in daytime ambulatory systolic BP at two months compared to sham procedures². The Global SYMPLICITY Registry and other long-term studies confirm RDN’s durability, with average office systolic BP reductions of 16.7 mm Hg at 36 months and no adverse effects on renal function³?⁵.

RDN has also proven safe and effective in older populations, including patients 75 years and older, for whom polypharmacy and poor adherence often undermine success⁴. Cost-effectiveness analyses suggest an incremental cost per quality-adjusted life year of approximately $32,700, well below the conservative threshold of $50,000/QALY for high-value interventions⁶.

Hypertension adversely affects all populations, some more than others. Cardiovascular mortality due to hypertension is nearly five times higher among Black individuals than white individuals⁷. Geographic, racial, and ethnic disparities in blood pressure control remain persistent, with rural Medicare beneficiaries facing a higher burden due to specialist shortages and fewer treatment options⁷?⁸. RDN represents an opportunity to reduce these gaps with a safe, scalable, and cost-effective solution.

This innovation fills a critical gap in hypertension management, complementing existing treatments without replacing them.

We urge CMS to finalize the National Coverage Determination quickly and without undue administrative barriers. Renal denervation is a well-studied, low-risk, typically one-time procedure that offers clinically meaningful and sustained reductions in blood pressure, especially for patients not achieving control through current therapies. Delaying access to RDN would prolong avoidable suffering, particularly for patients facing adherence challenges, medication intolerance, or limited specialist care.

We encourage CMS to send a clear signal to other payers, public and private alike, to follow its lead and make RDN broadly accessible. Fair access to this life-saving intervention will help America close persistent gaps in hypertension control and reduce the disproportionate burden of cardiovascular disease in underserved communities.

Respectfully,

John M. Clymer Executive Director National Forum for Heart Disease & Stroke Prevention

________________________________________

References

1. Muntner P, Hardy ST, et al. Trends in Blood Pressure Control Among U.S. Adults With Hypertension, 1999–2018. JAMA. 2020;324(12):1190–1200. https://doi.org/10.1001/jama.2020.14545

2. Azizi M, Schmieder RE, Mahfoud F, et al. Ultrasound Renal Denervation for Hypertension Resistant to a Triple Medication Pill (RADIANCE-HTN TRIO). JAMA. 2023;329(8):651–661. https://doi.org/10.1001/jama.2023.0713

3. Mahfoud?F, et?al. Outcomes Following Radiofrequency Renal Denervation :https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21283

4. Mahfoud F, Algharably EAE, Schmiedel M, et al. Safety and efficacy of RDN in elderly patients with resistant hypertension. Clinical Research in Cardiology. 2024. Https://doi.org/10.1007/s00392-024-02417-2

5. Wang TD, et al. Long-term (10-year) follow-up of renal denervation in patients with resistant hypertension. PMC. 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11654841/

6. Lauder L, Burkard T, Mahfoud F. Balancing Affordability and Need: Should We Use Renal Denervation in Hypertension Management? J Soc Cardiovasc Angiogr Interv. 2024;3(10). doi:10.1016/j.jscai.2023.100832

7. Abrahamowicz, A.A., Ebinger, J., Whelton, S.P. et al. Racial and Ethnic Disparities in Hypertension: Barriers and Opportunities to Improve Blood Pressure Control. Curr Cardiol Rep 25, 17–27 (2023).https://pmc.ncbi.nlm.nih.gov/articles/PMC9838393

8. Association of American Medical Colleges. (2023). Rethinking rural health: A data-driven approach to improving access, equity, and outcomes. Retrieved from https://www.aamc.org/advocacy-policy/rethinking-rural-health

Less

As a hypertension trained physician who has been involved with renal denervation since the early days of supporting randomized clinical trials, I believe that renal denervation should be a treatment option for patients. I am happy to see that CMS is moving forward with the NCD in renal denervation for uncontrolled hypertension; however, I am concerned that the requirements of the NCD are not in line with current guidelines for hypertension or the changing face of healthcare and blood pressure management in the US.

I would urge CMS to consider the following:

• The definition of hypertension as 140/90 mmHg is out of date with the current AHA/ACC guidelines. As you even state on your website, stage I hypertension is described as 130-139 mmHg systolic OR 80-89 mmHg diastolic. Stage II hypertension is described as =140 mmHg systolic OR =90 mmHg diastolic. Your criteria for inclusion should align with these guidelines.
• The requirement for the primary clinician to manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters with no more than one of the three encounters being virtual, is not in line with today’s current blood pressure monitoring practices and will be extremely limiting. Patients are rarely able to be seen that frequently in a 6-month period and if they are, it is because of an increase in reliance on telehealth. Patients are often referred to a specialist before the 6-month period if the blood pressure is deemed very difficult to manage. I would urge you to reconsider this requirement and make it more pragmatic.
• Based on my clinical experience, I believe that RDN is beneficial for select Medicare patients. By definition, the majority of these people are older and often have multiple comorbidities requiring multiple medications or polypharmacy. Numerous studies have shown that polypharmacy increases the risk of drug interactions and adverse events in this population. RDN has the potential to not only aid in blood pressure control and decrease CV risk but also address the issue of polypharmacy in this population.

I appreciate your consideration of these recommendations as we move to make renal denervation more accessible for our patients with uncontrolled hypertension.

Less

August 8th, 2025

The Honorable Mehmet Oz, MD
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: NCA for Renal Denervation for Uncontrolled Hypertension (CAG-00470N)

Dear Administrator Oz:

On behalf of the Preventive Cardiovascular Nurses Association (PCNA), thank you for the opportunity to comment on the National Coverage Analysis for Renal Denervation for Uncontrolled Hypertension (CAG-00470N).

The Preventive Cardiovascular Nurses Association (PCNA) was founded in 1992 by a group of nurses working in cardiovascular disease management and has since expanded into 41 chapters across the United States. As PCNA has expanded, we are the leading nursing organization dedicated to preventing and managing cardiovascular disease. Our mission is to support the utilization and dissemination of research and support evidence-based practice in cardiovascular risk reduction and disease management.

We are pleased to see that the proposed National Coverage Determination for Renal Denervation for Uncontrolled Hypertension would provide coverage under Medicare for renal denervation, a U.S. Food and Drug Administration (FDA) approved device manufactured by Medtronic and others to help manage uncontrolled hypertension. (1) As the leading risk factor for cardiovascular disease, hypertension, or high blood pressure, affects nearly 120 million adults in the United States. (2) Moreover, less than a quarter of adults in the United States with hypertension have blood pressure (BP) readings within the recommended target of <130/80 mm Hg. (2)

Hypertension is especially prevalent in minority communities. From 2021 to 2023, rates of hypertension among non-Hispanic Black adults reached 58 percent, exceeding the national average of 44.5 percent of U.S. adults with hypertension. (3) When uncontrolled, hypertension can have detrimental effects on longevity, leading to increased risk of mortality from cardiovascular disease, kidney disease, stroke, and dementia, among other comorbidities. (4) In a 2021 study using data from the National Health and Nutrition Examination Survey (NHANES), non-Hispanic Black and Hispanic participants were found to have a significantly lower prevalence of BP control (39 percent and 40 percent, respectively) when compared to their non-Hispanic White counterparts (49 percent). (5) Disparities in awareness and treatment of hypertension among different racial groups highlight the unmet need for access to new treatment options for uncontrolled hypertension.

Renal denervation (RDN) offers a minimally invasive therapeutic alternative or adjunct to medication to treat uncontrolled hypertension. (6) Recent studies involving the catheter-based technique have shown efficacy in reducing BP in patients with untreated hypertension to a similar degree as seen with 1 antihypertensive drug. (6) Specifically, findings from two clinical trial studies of RDN using the Symplicity Spyral™ system by Medtronic showed a reduction in systolic BP by 4 to 5 mm Hg in a 24-hour period, compared with the control group. (6)

Comparably, multiple rigorous sham-controlled trials such as SPRAL HTN-ON-MED and SYMPLICITY HTN-3 found clinically significant BP reductions in patients both on and off hypertension medication. (7) These reductions were sustained over three years, but a recent meta-analysis showed that reductions span well past three years. (7) While RDN received approval from the FDA in November of 2023, the technology still lacks formal coverage from the Centers for Medicare and Medicaid Services (CMS). As advocates for increased prevention of cardiovascular disease, PCNA sees promise in this treatment option for uncontrolled hypertension.

By providing coverage for renal denervation, CMS will help advance the cardiovascular community in our goal toward improved patient outcomes by promoting better hypertension management, especially among minority communities. PCNA believes the Proposed Decision, as written, makes this novel treatment an option for many different patients, and appropriately recognizes that the hypertensive patient population is quite diverse. PCNA supports CMS’ proposed decision to cover renal denervation technology so that patients have increased options for treating uncontrolled hypertension and can avoid future comorbidities.

Thank you,
Preventive Cardiovascular Nurses Association

References:
1. https://www.fda.gov/medical-devices/recently-approved-devices/paradise-ultrasound-renal-denervation- system-p220023
2. https://www.ahajournals.org/doi/10.1161/HYP.0000000000000240
3. https://www.cdc.gov/mmwr/volumes/73/wr/mm7348a5.htm#:~:text=During%20August%202021%E2%80%93August%202023,among%20both%20men%20and%20women
4. https://www.cdc.gov/pcd/issues/2018/17_0362.htm
5. https://www.cdc.gov/pcd/issues/2023/23_0065.htm
6. https://www.ahajournals.org/doi/10.1161/HYP.0000000000000240
7. https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.22314

Less

To whom it may concern,

As a physician who has worked directly with the Paradise ultrasound renal denervation system and has seen its benefit firsthand in patients with resistant hypertension, I appreciate the opportunity to provide feedback on CMS’s proposed NCD decision memo.

The proposed coverage is a welcome step toward offering and evidence based interventional option for patients with resistant hypertension. However, I have several concerns regarding Patient Criteria a, c, e and f noted in your memo. These criteria, if left unchanged, could unnecessarily limit access to RDN for patients who stand to benefit significantly from the RDN procedure.

The proposed memo defines uncontrolled hypertension as BP>140/90mmHg. I respectfully suggest that CMS consider aligning its definition with current AHA/ACC guidelines, which define stage 1 hypertension as =130/80 mmHg and recommend intensification of therapy for patients with persistent blood pressure above this level, particularly those at increased cardiovascular risk.

Many patients remain above 130/80 mmHg despite maximal medical therapy, and data show that even modest reductions in systolic BP confer significant reductions in cardiovascular events.

While I understand CMS’s intent to ensure that patients have been adequately treated with guideline directed medical therapy before undergoing renal denervation, the requirement for stable does for at least 3 months may inadvertently delay access to beneficial intervention.

In clinical practice, it is not uncommon to recognize much earlier that a patient is not responding adequately to GDMT, especially when multiple agents have already been tried and optimized over time. I recommend that CMS allow for clinical discretion in determining whether a patient has failed tolerated GDMT, without mandating an arbitrary 3-momth stabilization period. That would allow for more timely access to renal denervation in appropriate candidates.

The proposed exclusion of patients with eGFR<40mL/min/1.73m 2 may be overly restrictive. A large proportion of patients with resistant hypertension also have chronic kidney disease (CKD). While these patients were not the majority in pivotal RDN trials, emerging data supports the potential safety and benefit of RDN in this population. I would recommend tying the eGFR criteria to each device’s FDA-approved Instruction for Use (IFU). This would help ensure decisions are grounded in the most current clinical evidence and regulatory guidance, while also making it easier for patients to benefit from the technology.

Similarly to my comment above regarding the 3-month stabilization period, I believe the requirement that the referring clinician must manage the patient for minimum of six months is unnecessarily rigid. This criterion risks delaying access for patients who may already be well characterized and managed within a shorter timeframe, especially in a modern care models that integrate telehealth and multidisciplinary teams. The frequency and mode of encounters should be left to clinical discretion based on patient needs.

In summary, I encourage CMS to adopt a more flexible and clinically aligned framework that reflects current guidelines, real-world practice patterns, and patient needs to allow equitable and timely access to RDN where appropriate.

Thank you for your consideration.

Less

August 8, 2025

Tamara Syrek Jensen, JD Director,
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00470N – Proposed Decision Memo for Renal Denervation for Uncontrolled Hypertension

Dear Ms. Syrek Jensen,

The American College of Cardiology (ACC), the Society of Cardiovascular Angiography & Interventions (SCAI), and the Society for Vascular Medicine (SVM) support a National Coverage Determination (NCD) for renal denervation (RDN). We commend CMS for recognizing the robust body of clinical evidence supporting RDN as a safe and effective adjunct to lifestyle and pharmacologic therapy for patients with uncontrolled hypertension.

Patient Selection for Uncontrolled Hypertension
As noted in the SCAI Position Statement on Renal Denervation for Hypertension (1), patients with resistant hypertension, characterized by blood pressure that still exceeds 130/80 mm Hg despite being on three maximally tolerated medications from classes with proven outcomes (such as mineralocorticoid receptor antagonists, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, calcium channel blockers, thiazide diuretics, and beta blockers), benefit from RDN. Additionally, patients with uncontrolled hypertension who have tried lifestyle modifications and antihypertensive medications but are either intolerant of additional medications or for whom escalation of medications is ineffective, and who are willing to undergo renal denervation after shared decision-making, are also suitable candidates.

While we are generally comfortable with the use of a systolic blood pressure (SBP) threshold of >140 mmHg to define uncontrolled hypertension, we are concerned about the requirement that both systolic and diastolic values must exceed their respective thresholds. This approach could inadvertently exclude patients with isolated systolic hypertension—such as those with readings of160/70 mmHg—which is common among older adults, including many Medicare beneficiaries. To better reflect real-world clinical practice and avoid unnecessary exclusions, we recommend that CMS adopt a definition based solely on SBP >140 mmHg, without a diastolic requirement. While combined systolic and diastolic hypertension was a common enrollment criterion in clinical trials, there is ample evidence supporting the efficacy of RDN in patients with isolated systolic hypertension. Limiting RDN eligibility to only those with combined hypertension would exclude a large population of patients who may benefit from this intervention.

Moreover, we also wish to express concern regarding the criterion that patients must be on stable doses of maximally tolerated guideline-directed medical therapy (GDMT), including lifestyle modifications, for at least 3 months before referral for RDN. We fully support the prioritization of GDMT and agree that patients should be given adequate time to respond to pharmacologic and lifestyle interventions. However, we are concerned that a strict 3- month stability requirement may inadvertently delay intervention for high-risk patients—particularly those experiencing hypertensive crises or require urgent up-titration of an already substantial regimen. To balance the intent of ensuring robust GDMT with the need for timely intervention, we recommend that CMS consider allowing clinical discretion or exceptions to this requirement in urgent or refractory scenarios.

Clarification on Visit Requirements
While we do not find the overall timeline for demonstrating uncontrolled hypertension burdensome, we are concerned that the requirement stating the primary clinician must manage the patient for at least six months, with at least three encounters (no more than one of which may be virtual), could be misinterpreted. As we understand it, this provision is intended to ensure continuity of care and adequate clinical engagement prior to referral for RDN, rather than to impose a rigid prerequisite for coverage. However, in practice, this language could be misunderstood as a strict documentation requirement, potentially leading to access barriers or coverage denials, particularly for patients in rural or underserved areas. We recommend that CMS clarify the intent of this provision to ensure it supports appropriate care without inadvertently limiting access. We also recommend CMS consider allowing greater flexibility in how these visits are conducted, particularly in light of evolving telehealth and remote patient monitoring capabilities. Additionally, we suggest that patients who have been receiving ongoing hypertension management for at least six months—potentially at an outside institution from the one performing the procedure—should be considered to meet this requirement. In many cases, busy interventional practices receive referrals from large private providers who are actively managing the patient’s hypertension but are not involved in the procedure itself. This model of care should be acceptable and clearly supported to avoid unnecessary barriers to access.

Definition of “Multidisciplinary Hypertension Program” and “Hypertension Navigator”
We understand that CMS envisions a multidisciplinary hypertension program to include screening, testing, and treatment of hypertension, and defines a hypertension navigator as a physician, advanced practice provider, or registered nurse trained in program management. While these elements may be appropriate in some settings, we urge CMS to adopt a flexible approach that accommodates referring practitioners who have longstanding relationships with patients and can coordinate care effectively.

In that context, we seek clarification on the term “multidisciplinary hypertension program” as referenced in the proposed decision. While we support the involvement of multidisciplinary expertise, we do not recommend that a formal program be required. Rather, we advised that institutions should have access to the necessary expertise and services to support comprehensive hypertension management—including serial blood pressure monitoring, evaluation for secondary hypertension, renal artery imaging, and post-procedural follow-up. Additionally, we are concerned that the description of care team roles—such as requiring a “hypertension navigator”—may be too rigid. Smaller or rural hospitals may not have such roles formally defined, and ambiguity in terminology could lead to inconsistent implementation or misinterpretation by payers. To avoid confusion and prevent inappropriate coverage denials, we strongly recommend that CMS clearly define these terms and allow flexibility in care team composition while maintaining the intent of multidisciplinary care. Overly prescriptive requirements risk introducing redundancies and creating unnecessary barriers to coverage or facility participation.

Recommendation on Terminology in Clinical Criteria
We recommend revising the language in section (e) of the proposed criteria. The current phrasing—“Patient has no contraindication to RDN…”—may be overly restrictive and could be misinterpreted as an exclusionary list. Instead, we suggest rewording this to:
“Patient is not part of a group with limited clinical data, including those with pregnancy, fibromuscular dysplasia, stented renal artery (< 3 months before RDN), renal artery aneurysm, significant renal artery stenosis (> 50%), or known kidney or secreting adrenal tumors.”
This revision better reflects the evolving evidence base and allows the conduct of clinical trials in these selected populations without the use of the word “contraindication” which could hamper enrollment in trials (e.g. for patients with ESRD, for example). This edit would also align with the broader goal of ensuring access while maintaining safety.

Additionally, we recommend CMS remove the exclusion for patients with estimated Glomerular Filtration Rate (eGFR) < 40 and instead, align the eGFR requirement with the FDA-approved labeling for the device to ensure consistency and avoid unnecessary exclusions. While we understand that CMS’s current language reflects the inclusion criteria used in clinical trials, it’s important to distinguish between formal contraindications and populations that were simply underrepresented in pivotal studies. For example, patients with lower eGFRs have been included in broader, real-world studies and are often treated safely and effectively in clinical practice. Although these patients were not part of the trials supporting regulatory approval, they are not excluded by the device’s FDA labeling, and the SCAI expert position statement (1) does not recommend excluding patients solely on the basis of kidney function. A precedent for this approach exists in other areas of cardiovascular care—for instance, drug-eluting stents are frequently used in populations beyond those studied in trials, with reimbursement supporting such use. Clarifying that the absence of trial data does not equate to a contraindication would help ensure that coverage decisions reflect both regulatory labeling and real-world clinical practice, without introducing unnecessary barriers to care.

Shared Decision Making
We recognize shared decision making as an essential component of RDN therapy. Given the procedural nature of RDN and the variability in individual patient response, it is critical that patients are fully informed about the risks, benefits, and alternatives after which, the patient’s preferences should also be included into the shared decision making process. The ACC has developed a patient-facing infographic and will soon publish a comprehensive decision aid to support clinicians and patients in making informed, values-based decisions about RDN.

CED Requirements
Coverage with Evidence Development (CED) is an extremely powerful mechanism offering significant value to payers, clinicians, and patients. CED has been demonstrated to be a technique that promotes the diffusion of diverse innovative cardiovascular technologies and services into the marketplace while simultaneously promoting timely clinical safety and effectiveness evaluations. The societies support the use of CED to provide Medicare beneficiaries with prompt access to newer technologies and services when early evidence suggests, but does not yet convincingly demonstrate, a net benefit for beneficiaries.

Professional societies have been instrumental in data collection for CED through registries. The National Cardiovascular Data Registry (NCDR) is uniquely positioned to collaborate with stakeholders on RDN real-world data collection, while minimizing the burden on hospitals. Leveraging its extensive experience and resources, the NCDR can streamline the data collection process, providing valuable insights to assess the reasonableness and necessity of treatments for regulatory decision-making.

Finally, CMS’ provision of clarity regarding what specific criteria and evidence are required for authorization is essential. A requirement to provide all clinical and institutional criteria for individual patients introduces a formidable burden that may be without precedent. Moreover, the lack of a clear criteria may enable wide interpretation among varied payers to set different thresholds of approval and wide standards for reimbursement. Establishing criteria by CMS at the forefront will therefore serve as a reference for independent payer organizations.

RDN is a reasonable and effective treatment option for the Medicare population, providing a valuable alternative for managing uncontrolled and resistant hypertension when traditional treatments are insufficient. The societies support Medicare coverage of RDN and appreciate the opportunity to provide feedback on the proposed decision memo. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.

Sincerely,

Christopher M. Kramer, MD, FACC
President, American College of Cardiology

Srihari Naidu, MD, MSCAI
President, Society for Cardiovascular Angiography and Interventions

Elizabeth V. Ratchford, MD, FSVM
President, Society for Vascular Medicine

References
Swaminathan RV, East CA, Feldman DN, Fisher ND, Garasic JM, Giri JS, Kandzari DE, Kirtane AJ, Klein A, Kobayashi T, Koenig G, Li J, Secemsky E, Townsend RR, Aronow HD. SCAI Position Statement on Renal Denervation for Hypertension: Patient Selection, Operator Competence, Training and Techniques, and Organizational Recommendations. J Soc Cardiovasc Angiogr Interv. 2023 Aug 21;2(6Part A):101121.

Less

The proposal to expand coverage for renal denervation is a welcome development for patients and clinicians alike. It recognizes that medication alone does not resolve hypertension for every individual. However, several aspects of the eligibility framework deserve reconsideration to ensure the policy supports timely access without adding barriers unrelated to safety or effectiveness.

The first area is the blood pressure requirement. Defining uncontrolled hypertension as systolic values above 140 and diastolic values above 90 sets a threshold that diverges from the widely accepted ACC/AHA criteria for Stage 2 hypertension, which use “or” rather than “and.” This difference matters. It excludes patients whose clinical risk is significant even when only one parameter exceeds target and removes any pathway for patients in Stage 1 whose blood pressure remains persistently above 130/80 despite maximal therapy. Aligning with established guidelines would allow this policy to mirror the standards clinicians already apply every day.

The second issue relates to the expectation for multiple visits over a six-month period. Verifying longitudinal care is an appropriate safeguard, but in practice, many patients have fragmented documentation across systems or rely on specialist follow-up rather than primary care alone. These patterns are common and do not reflect a lack of oversight; they reflect the complexity of managing chronic disease in modern healthcare. Restricting flexibility—particularly in how visits are counted—risks disqualifying patients based on administrative details rather than clinical readiness. Allowing specialist visits to satisfy this requirement and expanding the role of telehealth would better capture the continuity CMS intends to confirm.

Lastly, the requirement for prolonged stability on guideline-directed therapy should not become a barrier for patients who have clearly exhausted available pharmacologic options. These individuals have often undergone multiple medication adjustments over extended periods. Extending the waiting period after therapy has already failed does not add clinical value; it only delays access to an intervention designed for precisely this scenario. Providing discretion to the treating clinician to determine when therapy has been adequately optimized would strike a balance between rigor and practicality.

Renal denervation represents progress in treating a condition that drives substantial cardiovascular risk. By refining these provisions to reflect real-world care patterns, CMS can make this coverage policy both clinically sound and practically achievable.

Less

Hypertension is the most prevalent modifiable risk factor for cardiovascular disease, affecting almost 50% of the population. Renal artery denervation is an important tool to be offered in conjunction with anti- hypertensive medical therapy in patients with resistant hypertension.

As an interventional cardiologist who has performed this procedure, I have seen the clinical benefits first hand. This is a safe, minimally invasive procedure with excellent data from clinical trials. I strongly urge CMS to move forward with the national coverage decision so we can offer this procedure to all patients who will benefit.

Less

As a physician managing complex hypertension, I offer my insights regarding CMS's proposed NCD for renal denervation (RDN). RDN is a vital therapeutic avenue for patients whose blood pressure remains uncontrolled despite diligent medical management. However, several proposed criteria could impede appropriate patient access.

My foremost concern is the rigid threshold of greater than 140/90 mmHg for uncontrolled hypertension. This criterion stands in stark contrast to prevailing ACC/AHA guidelines, which classify Stage 1 hypertension at a systolic BP of 130-139 mmHg or a diastolic BP of 80-89 mmHg. Robust evidence consistently demonstrates increased cardiovascular risk beginning at these lower levels. Adhering to the 140/90 mmHg cutoff would exclude a substantial segment of Medicare beneficiaries, particularly older adults, who are at elevated risk and would benefit from RDN to reach their blood pressure goals. I advocate for aligning the NCD's definition of uncontrolled hypertension with current ACC/AHA guidelines.

Secondly, the stipulated requirement that a primary clinician manage the patient for a minimum of six months, encompassing at least three encounters with no more than one virtual visit, is highly impractical and outmoded. This prescriptive structure does not reflect contemporary hypertension care, where telehealth plays an increasingly vital role, particularly for patients in rural or underserved areas. Requiring a single "primary clinician" to document this rigid visit structure creates unnecessary complexity and delays. A more flexible standard, accommodating multidisciplinary care and various visit formats, would better serve patients.

Lastly, the mandate that patients be on stable doses of maximally tolerated guideline-directed medical therapy (GDMT) for a minimum of three months before referral is problematic. Most antihypertensive medications achieve their maximal effect within 4 to 6 weeks. Prolonging this period unnecessarily delays access for poorly controlled patients or those with intolerable side effects. I recommend revising this requirement to reflect typical medication response timelines.

In closing, thoughtful adjustments to these patient management and eligibility criteria are essential to truly facilitate access to this life-changing therapy.

Less

To Whom It May Concern:

Thank you for the opportunity to provide commentary on the proposed decision memo, NCA – Renal Denervation for Uncontrolled Hypertension (CAG-00470N), during the public comment period. As a physician I have provided medical care for hypertension patients, both in practice and while conducting clinical research, for many years. I believe that my perspective on this patient population would be beneficial and the following is my feedback on several of the criteria listed in the draft NCA.

Please consider modifying the blood pressure criterion to align with AHA’s guidelines for Hypertension Stage 1 defined as 130-139 mmHg (systolic) and 80-80 mmHg (diastolic). The elevated risk factor for hypertensive individuals for negative cardiovascular disease outcomes (stroke, myocardial infarction, and heart failure) points to the need for prompt and effective treatment. Considering that renal denervation may result in an immediate, persistent, and clinically significant drop in blood pressure, expanding the diagnosis threshold to Stage 1 Hypertension seems warranted.

Please consider removing the specific minimum timing and encounter requirements before recommending a referral for renal denervation. Individual patient care is complex and may look vastly different between individuals. There is no doubt that a patient’s diagnosis of hypertension should be sound and grounded in unmistakable evidence, but that clinical history may be documented in a variety of ways and over variable amounts of time. The responsibility should lie with the clinician to take the totality of information available to make the best recommendation possible of when and what treatment should be considered.

Please consider offering more flexibility for the prerequisite of a hypertension program for facilities performing renal denervation. The specifics of this criterion suggest that only certain institutions may be able to fulfil all elements, potentially excluding facilities that are perfectly able to perform the procedure and serve patients. Indeed, I would point to the American Heart Association website that lists the eligibility requirements for hypertensive center certification. The very first requirement listed is, “Center is located in either academic medical center or large multi-specialty clinics.” My concern is that many perfectly capable locations and teams will be unnecessarily prohibited from performing renal denervation and will prevent patients from accessing this treatment, if warranted.

Thank you for your consideration of this commentary. I look forward to the final outcome of the national coverage determination.

Respectfully,

Less

As a hypertension specialist who has seen firsthand the benefits of renal denervation (RDN) in addition to current medical management, I am pleased CMS is moving forward with an NCD. However, I am concerned that several proposed requirements are not reflecting the every-day realities of patient care.

The requirement that patients be on stable doses of maximally tolerated guideline-directed medical therapy (GDMT) for at least three months is delaying the benefits of this new technology in the group of patients that will benefit most from it. Most antihypertensive medications achieve their maximal effect within one month. Mandating a three-month stable period will unnecessarily delay appropriate care, especially for elderly patients or those already poorly controlled. This can hinder achieving timely blood pressure goals and increase the possibility of target organ damage in these vulnerable patient population. I recommend either removing this duration requirement or decreasing it from 3 month to 4-6 weeks.

Furthermore, the proposed definition of uncontrolled hypertension, specifically the >140/90 mmHg threshold, is controversial. Current ACC/AHA guidelines classify Stage 1 hypertension as 130-139 mmHg systolic or 80-89 mmHg diastolic, and Stage 2 as =140 mmHg systolic or =90 mmHg diastolic. Patients at these levels are at increased cardiovascular risk. Adopting the guideline-consistent definition would ensure RDN is available to a broader, appropriate patient population, including those struggling with multiple medications.

Thank you for considering these recommendations. Adapting the NCD to reflect current guidelines and practical considerations will improve access to this important therapy.

Less

Less

In my years treating patients with uncontrolled hypertension, I have witnessed the devastating consequences this condition brings—heart attacks, strokes, kidney failure, and shortened life expectancy. Renal denervation (RDN) represents a significant breakthrough, providing a novel tool to lower blood pressure and reshape long-term outcomes in ways that once seemed out of reach.

From this clinical vantage point, I urge CMS to revise elements of the proposed National Coverage Determination (NCD) that could inadvertently restrict patient access to this therapy.

Blood Pressure Criteria
The proposed treatment threshold of 140/90 mmHg is unnecessarily high. The ACC/AHA defines Stage 1 hypertension at 130/80 mmHg—levels already linked to elevated cardiovascular risk. Requiring patients to progress to 140/90 mmHg before considering RDN effectively delays intervention until avoidable damage occurs. For individuals whose hypertension does not respond to standard treatment, initiating RDN while still in Stage 1 offers a greater chance to avert irreversible harm.

Definition of “Hypertension Programs”
Limiting eligibility to programs with formal certifications or rigid structures creates access barriers. Successful hypertension care depends on collaborative teams—physicians, advanced practice clinicians, nurses, and pharmacists—working in coordination. Requiring a certified “hypertension specialist” or “navigator” would exclude many high-quality programs, especially in rural or underserved regions, where such certifications are uncommon despite the delivery of excellent care.

I encourage CMS to adopt flexible, patient-focused standards that account for blood pressure thresholds, medication protocols, visit schedules, and program definitions as they exist in real-world practice. Such an approach will allow RDN to reach the patients who need it most, at the right time, maximizing its potential to safeguard health.

Less

As a practicing cardiologist and specialist in the management of hypertension, I am writing to express my strong support for the approval of renal denervation (RDN) as a treatment option for patients with uncontrolled or treatment-resistant hypertension.

Despite advances in pharmacotherapy, a substantial subset of patients continues to struggle with uncontrolled blood pressure, either due to medication intolerance, nonadherence, or true treatment resistance. These individuals are at significantly increased risk for cardiovascular events including stroke, myocardial infarction, heart failure, and chronic kidney disease progression. The burden on both patient quality of life and the healthcare system is considerable.

Multiple well-conducted randomized, sham-controlled trials—including SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, and RADIANCE-HTN—have demonstrated that renal denervation produces statistically and clinically meaningful reductions in systolic blood pressure in a variety of patient populations, including those both on and off antihypertensive medications. These results have been consistent and reproducible, with durable effects extending beyond 6 months and minimal adverse safety signals.

From a procedural standpoint, renal denervation is minimally invasive, safe, and does not require ongoing patient adherence—an important factor in real-world settings where medication compliance is a persistent challenge. In my clinical judgment, it represents a valuable adjunct to medical therapy for selected patients with poorly controlled hypertension who are at high cardiovascular risk.

I respectfully urge the FDA to recognize the compelling body of evidence supporting renal denervation and to approve its use in the appropriate patient population. Doing so would provide physicians with an evidence-based, effective tool to reduce cardiovascular risk and improve long-term outcomes for a group of patients who remain difficult to treat with existing therapies.

Thank you for your continued commitment to improving cardiovascular health and for considering this important therapeutic advance.

Less

Thank you for the opportunity to provide comments on the proposed decision memo regarding Medicare coverage for Renal Denervation in the management of hypertension.

The proposal to cover renal denervation is a significant step forward for patients with hypertension that has resisted standard therapy. This is a great advancement in acknowledgment that we need more tools for patients who simply don’t respond to medication. However, some of the outlined requirements may unintentionally limit access in ways that do not improve safety or quality.

The proposed decision would benefit from a more clear definition of "resistant hypertension" and "uncontrolled hypertension." I recommend this aligns with the American Heart Association definition and has flexibility for patients with medication intolerance or significant side effects that preclude standard multi-drug regimens, especially in older adults or those with comorbidities.

Requiring a formal multidisciplinary hypertension program, complete with a navigator and potentially a certified hypertension specialist, sets a standard that many capable hospitals cannot meet. While I do feel like coordination of care is very important for this therapy, many hospitals manage complex hypertension through well-coordinated teams of cardiologists, nephrologists, APPs, and pharmacists—models that work effectively without being labeled as a formal program. These are high-functioning, collaborative teams. If CMS keeps this definition narrow, participation will concentrate in limited areas, restricting patients to few or no options. The language around a “hypertension-trained clinician” introduces additional uncertainty. If this is interpreted as requiring formal certification, most hospitals will be unable to comply. Certified specialists are scarce, and their distribution is uneven across the country. If the intent is to include cardiologists and nephrologists—physicians who routinely handle advanced hypertension—that should be stated clearly. CMS has the chance to make this practical without sacrificing quality by focusing on what truly matters: having qualified clinicians, proven protocols, and proper follow-up, regardless of how the team is labeled.

Renal denervation offers an important option for patients who have exhausted conventional approaches. The success of this coverage policy will depend on balancing rigor with practicality. By refining the facility requirements to reflect how care is delivered across diverse settings, CMS can ensure this therapy reaches the patients it is designed to help.

Thank you for considering these comments in your final decision.

Sincerely,
Katie Kerlin, APRN
Renal Denervation Coordinator

Less

As a physician actively involved with renal denervation (RDN) from its early randomized clinical trials, I am encouraged by CMS’s proposed NCD. RDN offers a much-needed additional option for patients facing the challenges of uncontrolled hypertension. However, I must underscore several critical areas where the proposed policy risks creating undue constraints.

My first primary contention is with fixed GFR criteria as many trials are still undergoing for GFR 30, like GPS study it will be hard to enroll patients if certain cutoff of GFR 40 is mentioned.
My second significant concern pertains to the patient management requirements, specifically the six-month duration and the restrictive visit formats (three encounters, no more than one virtual). While appropriate medical management pre-RDN is paramount, this fixed structure is fundamentally impractical. Patients are often followed for hypertension over many years, with well-documented blood pressure histories. In the current healthcare climate, remote patient monitoring and telehealth visits are indispensable for consistent follow-up, especially for patients who face geographical or logistical barriers to frequent in-person appointments. This criterion would inadvertently penalize effective, flexible care models and create unnecessary delays in accessing RDN. I urge CMS to adopt more adaptable language, focusing on confirming uncontrolled hypertension through multiple encounters over time, without rigid stipulations on duration or visit modality.
Finally, the proposed criterion that patients must be on stable doses of maximally tolerated GDMT for at least three months before referral is ill-suited to clinical realities. Some patients are constantly in the hospital for hypertensive emergency and urgency and high risk for stroke or are post stroke and cannot wait 3 months then it should be available as an option for such rare patients I believe these strategic adjustments are critical to ensuring the NCD for RDN is both clinically appropriate and practically implementable.

Less

On behalf of the Medical Device Manufacturers of America (MDMA), I am pleased to submit the following comments on the proposed National Coverage Determination (NCD) for renal denervation (RDN) for uncontrolled hypertension (CAG-00470N). MDMA supports national Medicare coverage of RDN under an NCD that includes Coverage with Evidence Development (CED).

MDMA is a national trade association that provides educational and advocacy assistance to hundreds of innovative companies in the field of medical technology. Our members, the majority of which are small to mid-sized medical device companies, have a strong record of delivering breakthrough therapies to treat chronic diseases and life-threatening conditions while lowering the cost of care. MDMA’s mission is to ensure that patients have timely access to the latest advancements of safe and e?ective medical technologies that improve health outcomes.

We commend CMS for taking this crucial step toward a national coverage policy for RDN, which will provide an important new option for physicians and Medicare beneficiaries struggling with uncontrolled hypertension. We appreciate that CMS has developed this proposed NCD with consideration of the strong body of evidence on RDN and to ensure appropriate access for patients.

MDMA believes that the majority of the proposed coverage criteria are balanced and consistent with recent clinical consensus statements on RDN; however, we wish to call CMS’ attention to four of the proposed coverage criteria – Patient Criterion (f), Physician Criteria (c)-(d) and Facility Criterion (a) – that may generate confusion among both RDN proceduralists and referring physicians with primary care responsibilities for hypertension patients, and that could be overly restrictive in their current form. We encourage CMS to review these criteria to ensure appropriate access without undue burden or barriers for Medicare beneficiaries who could benefit from RDN.

1. Patient Criterion (f): Six-Month Management and Visit Requirements

This requirement proposes that a primary clinician “must manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters, with no more than one of the three encounters being virtual.” Our members note that many patients have been under treatment for hypertension for longer than six months, with some patients under a physician’s continuous care for hypertension for years. CMS should clarify that for patients under the care of a primary clinician for more than six months, the patient must have had a minimum of three encounters during the course of that care, but those encounters need not have all been within the preceding six months. This would align with the rationale stated by CMS in the proposed decision memo for this criterion, allowing adequate time with multiple clinical encounters to ensure antihypertensive medications can achieve their maximal effect with evaluation of a patient’s blood pressure response, potential side effects and laboratory test results.

Limiting this criterion to only be met in the six-month period directly preceding referral to RDN would be overly rigid and would risk delaying access for patients who may be struggling with uncontrolled hypertension despite a history of continuous care with their primary clinician(s). In particular:

• Such a rigid interpretation would not reflect the real-world variability in how patients engage with care teams.
• Many patients, especially those in rural or underserved areas, rely on telehealth for consistent follow-up. Limiting virtual visits to just one encounter may disincentivize flexible, patient-centered care models.
• A strict requirement of the three visits limited to a six-month timeline may be unnecessary, excessive, and redundant care for patients who have been under long-term care with their care team for medication optimization and monitoring.

We believe CMS intends for this criterion to ensure alignment to guideline-based medical therapy prior to referral to RDN without overly restricting patient access or burdening providers with extraneous visits. We recommend that CMS fully allow telehealth visits to meet this requirement and to clarify this requirement to not limit encounters to only a six-month period if the patient has been under a longer duration of care.

2. Physician Criteria (c)-(d): Proctored Cases

MDMA recommends CMS modify the proposed requirement in paragraph (c) that physicians “complete at least five proctored RDN cases with each approved device” and instead require physicians to complete device-specific training required by the manufacturer. Modifying criterion (c) would obviate the need for criterion (d) or, in the alternative, CMS could modify (d) to also focus on completion of device-specific training required by the manufacturer.

3. Facility Criterion (a): Multidisciplinary Hypertension Program

The proposed criterion states that facilities performing RDN must have a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties. We support the goal of ensuring high-quality care and note that hypertension and RDN programs take multiple forms across the United States to deliver guideline-based care to Medicare beneficiaries. We encourage CMS to ensure that this criterion can be understood to be flexible in recognition of the range of programmatic approaches to hypertension care and not inadvertently exclude facilities with valid hypertension care pathways and staff.

For example, we note that there are about 1,500 Certified Hypertension Specialists or Clinicians across the U.S., Canada, and internationally, and the American Heart Association lists 34 Certified Hypertension Centers nationwide. Despite these numbers, hypertension care is effectively delivered nationally outside of these formal certification mechanisms. This may especially be the case in rural or underserved communities with deep experience in treating hypertension but without the access or resources to formal certification programs.

MDMA recommends that CMS consider broadening its definition of a multidisciplinary hypertension program to reflect the real-world capabilities of diverse care settings. We recommend removing or clarifying specific requirements and personnel involved in the "hypertension program" to reflect a real-world multi-disciplinary practice.

In conclusion, MDMA supports CMS's goal of establishing national Medicare coverage for RDN and thanks CMS for the progress so far. We recommend that CMS consider clarifying the criteria described above to ensure the policy is pragmatic and reflective of how quality hypertension care is delivered for Medicare beneficiaries nationally, to enable patient access to this important new medical technology.

Sincerely,

Daniel Waldmann
EVP, Health Policy & Reimbursement
Medical Device Manufacturers Association

Less

To Whom it may concern,
I am reaching out with some thoughts regarding the recent NCD decision memo issued by CMS for renal denervation. I have several years of direct experience with renal denervation through managing many patients with hypertension and involved in evolution of this therapy for patients. Overall, I believe the coverage criteria is consistent with my experience and meets the needs of the patients; however, there are a few areas that will likely hinder the ability to treat patients who would benefit from this therapy.
First, the diagnosis of uncontrolled hypertension should be adjusted from the specific number of >140/90mm Hg to stage 1 and stage 2 hypertension because >140/90mm Hg is inconsistent with the ACC/AHA hypertension guidelines of >130/90mm Hg. Changing to stage 1 and stage 2 hypertension keeps the patient criteria consistent with the guidelines even if the guidelines change over time.
Second, the criteria for a primary clinician to manage the patient for a minimum of six months with at least three encounters before referral for RDN seems unnecessarily prescriptive. I agree patients should be under the care of a physician and have tried multiple treatment strategies before referring for renal denervation but requiring three encounters, only one of which can be telehealth is not feasible for many patients. I suggest less specific language such as “multiple encounters” to allows for more real-world situations and not delay treatment for patients who would likely benefit from this therapy.
My last comment is specific to the requirement for a facility performing RDN to have a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties. This again is too prescriptive and does not allow for many real-world scenarios especially at the beginning stages of this therapy. I agree there should be a multidisciplinary care team, but I caution dictating specific functions, especially a certified hypertension clinician and navigator. This specificity may prohibit centers that could build a robust, effective program RDN program from participating.
I appreciate your consideration of my points to revise these very specific requirements to not hinder the ability of patients struggling with hypertension to receive renal denervation.

Less

August 7, 2025

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Renal Denervation (RDN) for Uncontrolled Hypertension (CAG-00470N)

Dear Ms. Syrek Jensen,

On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the Proposed Decision Memo for Renal Denervation (RDN) for Uncontrolled Hypertension (CAG-00470N). AdvaMed and CMS share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients, including equitable access for the 55 percent of Medicare-eligible patients enrolled in Medicare Advantage organizations in 2025 (1).

AdvaMed member companies develop and produce the medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. We are committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

AdvaMed applauds CMS’ work to support Medicare beneficiary access to RDN for the treatment of uncontrolled hypertension, which is widespread with significant disease burden and unmet need. While pharmacological medications and lifestyle modifications are well-established as first-line treatment options, hypertension control rates remain low and have been worsening over the last decade, with hospitalizations for acute hypertension more than doubling between 2009 and 2019 among the Medicare population (2). This is particularly troubling because hypertension is the leading modifiable risk factor associated with death (3), and uncontrolled hypertension is associated with higher risk of cardiovascular events, including heart attack, stroke, heart failure, and kidney failure (4,5). National coverage of RDN as an adjunct to medications to help improve blood pressure management and chronic disease care among Medicare beneficiaries is therefore critically important.

We applaud the agency for drafting a proposed decision memo that fundamentally reflects the significant evidence base presented by both PMA-approved RDN modalities and leverages the work that has already been done through the TCET pilot and formal national coverages processes. CMS has the opportunity with RDN to demonstrate the value of the TCET framework in delivering transparent, predictable, and expedited national coverage for innovative technologies.

AdvaMed is supportive of this proposed decision memo and pleased to see the patient criteria appropriately set the stage for understanding the treatment's effectiveness across a heterogeneous population. Before finalization, we ask CMS to carefully consider feedback from the stakeholder community to ensure that the patient, physician, and facility requirements support a high standard of care but are not overly prescriptive relative to clinical practice standards that are commonly in place today.

AdvaMed also seeks clarification on two areas of this proposal. First, with regards to coverage criterion 1(a), “Diagnosis of uncontrolled hypertension (> 140/90 mm Hg) despite active management by a clinician with primary responsibility for blood pressure management,” we ask CMS to confirm that this criterion would mean that a patient would need to have an office systolic pressure of at least 140 mm Hg OR an office diastolic blood pressure level of at least 90 mm Hg. Secondly, with regards to coverage criterion 1(e), estimated Glomerular Filtration Rate (eGFR) < 40 is not a contraindication in either of the approved RDA modalities. This criterion would benefit from more flexible language that aligns contraindications with FDA labeling, such as: “Contraindications per the FDA-approved labeling apply”. This approach would accommodate device variations and future FDA label updates as additional modalities receive approval.

AdvaMed encourages CMS to work quickly to complete the NCD process and all actions necessary to ensure prompt Medicare beneficiary access to RDN. In particular, as the formal request for coverage for RDN was considered as a pilot to test the processes and concepts of TCET, AdvaMed urges CMS to expedite the steps involved in completing the NCD process and enabling patient access immediately upon finalization – including the approval of CED studies (where necessary) – concurrent with the issuance of the final decision memo so that the policy can be effectuated without delay. AdvaMed was very pleased to see CMS’ rapid approval of the CED study for the recently finalized TCET pilot for Transcatheter Tricuspid Valve Replacement (TTVR) and encourage this practice continue for the rest of the TCET pilot studies.

We look forward to continuing our work with the Agency. If you have questions regarding these comments or if you require additional information, please contact me at tburke@advamed.org.

Sincerely,

Tara Burke, PhD
VP, Payment & Healthcare Delivery Policy
AdvaMed

References

(1) “July 2025: A Data Book: Healthcare Spending and the Medicare Program.” Medicare Payment Advisory Committee (MedPAC), Chapter 9, 17 July 2025, www.medpac.gov/document-type/data-book/. Accessed 28 July 2025.
(2) Lu Y, Wang Y, Spatz ES, et al. National Trends and Disparities in Hospitalization for Acute Hypertension Among Medicare Beneficiaries (1999-2019). Circulation. 2021 Nov 23;144(21):1683-1693. doi: 10.1161/CIRCULATIONAHA.121.057056. Epub 2021 Nov 8. Erratum in: Circulation. 2021 Nov 23;144(21):e333.
(3) Beaney T, Schutte AE, Tomaszewski M, et al. MMM Investigators May Measurement Month 2017: an analysis of blood pressure screening results worldwide. Lancet Glob Health. 2018;6:e736-e743.
(4) Whelton P, Carey R, Aronow W, et. al. 2017 ACC/AHA/AAPA/ABC/ ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Originally published 13 Nov 2017. https://doi.org/10.1161/ HYP.0000000000000065. Hypertension 2018;71:e13–e115.
(5) Mayo Clinic. High blood pressure dangers: Hypertension’s effects on your body. https://www.mayoclinic.org/diseasesconditions/highblood-pressure/in-depth/high-blood-pressure/art-20045868.

Less

Your proposed national coverage determination for renal denervation therapy is an important advancement. However, specific criteria within the proposal could unintentionally limit patient access and clinical practicality.
Firstly, the rigid definition of hypertension requiring blood pressure strictly above 140/90 mmHg unnecessarily restricts access. Current ACC/AHA guidelines define Stage 1 hypertension starting at 130/80 mmHg, recognizing substantial cardiovascular risk at these lower thresholds. Adopting this broader, evidence-based definition ensures patients receive needed intervention at clinically meaningful stages.
Facility requirements add further challenges. Ambiguity in defining a "hypertension-trained clinician" may inadvertently restrict facilities from offering this therapy. CMS must explicitly state that cardiologists and nephrologists inherently qualify without requiring additional hypertension-specific certifications. Due to the scarcity of certified hypertension specialists nationwide, hospitals may otherwise interpret this criterion conservatively, severely limiting implementation.
Furthermore, requiring a formalized multidisciplinary hypertension program within each facility may unnecessarily hinder participation, particularly for smaller hospitals. Allowing flexibility for existing clinical teams—composed of cardiologists, nephrologists, nurses, and advanced practice providers who routinely manage hypertension collaboratively—would significantly enhance implementation without reducing patient safety.
Finally, the proposed six-month management timeline and strict telehealth limitations are impractical. Many referred patients have extensive prior management histories. Rigid time and telehealth restrictions may unnecessarily delay beneficial treatment. Flexibility allowing clinical discretion regarding timelines and telehealth would greatly enhance practicality and timely patient access. These recommendations will substantially improve your policy's practicality, ensuring broader patient access while maintaining rigorous clinical standards.

Less

As Co-Director of the Center for Blood Pressures Disorders at the main campus of the Cleveland Clinic, I appreciate that CMS views RDN as an important advancement in the treatment of hypertension. Below are certain comments regarding CMS's proposed national coverage determination for renal denervation (RDN) that I believe are important.
1) Defining uncontrolled hypertension strictly as blood pressure 140/90 mm Hg or greater is an outdated definition that is not consistent with current American Heart Association or American College of Cardiology guidelines (in which hypertension is defined as >130/80 mm Hg.) We know that cardiovascular risk (and mortality) increases when only targeting < 140 mmHg compared with 120 mmHg, now demonstrated in multiple large RCTs.
2) The term primary clinician is ambiguous and not keeping with contemporary practice wherein patients see there primary care clinicians at best twice per year because of lack of access.
3) The requirements for a minimum # of visits in a six month period, as well as a minimum # of in-person visits introduces unnecessary barriers to access that will undoubtedly lead to a lack of equitable access to this technology. Consider patients in rural settings that may not have access to a Hypertension specialty center close to home.
Telehealth is clearly a part of our medical care landscape and we should take advantage of it.

Less

Less

Blue Cross Blue Shield of Michigan (BCBSM) appreciates the opportunity to provide feedback on the proposal to cover radiofrequency renal denervation (rfRDN) and ultrasound renal denervation (uRDN), comprehensively referred to as RDN, for uncontrolled hypertension.

BCBSM agrees that clinical studies have shown the efficacy and safety of RDN in treating drug-resistant hypertension in carefully selected populations.
Delivery and coverage of this treatment should be provided to patients who have confirmed uncontrolled hypertension based on out-of-office measures. Qualified patients should have a blood pressure reading greater than 140/90 mmHg both in an office setting and in an ambulatory or home setting. Patients who only show elevated blood pressure in office settings should be excluded.

BCBSM’s position is that patients should only receive treatment if they have documented uncontrolled hypertension despite:

• Maximally tolerated doses of three anti-hypertensive medications including a diuretic and
• Demonstrated medication adherence, preferably confirmed via pharmacy refill data or electronic pill monitoring systems.

Additionally, we request the following criteria be considered in coverage decisions:

• Patients should be between 18 and 75 years of age.
• Estimated glomerular filtration rate (eGFR) should be greater than 45 mL/min/1.73 m²
• Patients should not have significant renal artery stenosis.
• Patients should not have secondary hypertension (e.g. primary aldosteronism, pheochromocytoma, etc.).
• Decision-making documentation should be shared appropriately between patient and provider.
• Procedure must be performed by an intervention specialist trained in RDN and
• Centers must have an established hypertension program with out-of-office blood pressure monitoring capabilities.

Thank you for your consideration of our feedback. Please feel free to reach out to me directly with any questions.

Less

To whom it may concern:
I am a practicing physician and work in practice serving a diverse population of patients. The bulk of my practice includes patients with chronic kidney disease and complex hypertension among other chronic disease states including diabetes and cardiovascular disease. Many of these patients are struggling with multiple comorbidities and managing multiple medications with their associated side effects is problematic.
As a physician who directly manages these complex patients, ensuring an opportunity for adjunct therapies as an option is paramount. While I am glad to see CMS’ progress towards this national coverage determination for renal denervation, my concern lies in the specific requirement of a systolic BP of 140mmHg and diastolic BP of 90mmHg. As an example, my patients include those taking multiple medications who remain uncontrolled. The goal to drive their BP below 120/80, as is indicated for a CKD population within the Kidney Disease Outcomes Quality Initiative (KDOQI) guidance is a direct intent to maximize their hypertension therapy and reduce the progression of CKD which is affected by uncontrolled BP. Furthermore, a eGFR requirement of 40ml/min/1.73 m2 seems to contradict a broader threshold of 30ml/min/1.73 m2 which is also currently used in Recor Medical’s US GPS post-market study in real world patients. A third area of concern is for the feasibility to complete 3 encounters for an RDN candidate within 6 months. Most of my patients have longstanding hypertension and are seen within my clinic a couple times per year when further medication adjustments are limited; achieving 3 encounters in 6 months is unrealistic in this circumstance. I suggest that this criteria be changed to indicate patients with a known and documented history of hypertension without specific encounter frequency requirements.
In summary, my recommendations to CMS are to prioritize a hypertension diagnosis instead of solely having systolic and diastolic blood pressure thresholds, adjust the eGFR requirement to 30ml/min, and substitute the need for 3 encounters with the need for documented hypertension by a qualified provider.
I appreciate the opportunity to address CMS and highlight my opinions and feedback with the proposed coverage.

Best
Summer Aldrugh

Less

As a Nurse Practitioner (NP) deeply involved in the longitudinal care of patients with chronic conditions, particularly hypertension, I am writing to provide my perspective on the proposed National Coverage Determination (NCD) for renal denervation (RDN). I commend CMS for recognizing RDN as a valuable therapeutic option, yet I must express significant concerns regarding certain patient selection criteria that, from a frontline clinical standpoint, appear overly restrictive and could inadvertently limit access for many deserving individuals.

My first point of concern is the proposed definition of uncontrolled hypertension, which specifies a blood pressure (BP) greater than 140/90 mmHg. In my daily practice, I manage a diverse patient population, and current ACC/AHA guidelines define Stage 1 hypertension as a systolic BP of 130-139 mmHg or a diastolic BP of 80-89 mmHg. Patients within this lower range are unequivocally at increased cardiovascular risk and are often actively seeking more effective interventions. By setting the eligibility threshold at 140/90 mmHg, the NCD would exclude a substantial number of Medicare beneficiaries who, despite diligent management, remain uncontrolled by contemporary clinical standards. This directly impacts access for patients I routinely care for, who could significantly benefit from RDN to mitigate their health risks.

Secondly, the requirement that patients be on stable doses of maximally tolerated guideline-directed medical therapy (GDMT) for at least three months before RDN referral is, in my experience, an impractical and potentially detrimental delay. As NPs, we are often at the forefront of medication titration and adherence counseling. We observe that most antihypertensive medications achieve their maximal effect within 4 to 6 weeks. Forcing patients to remain on an ineffective or poorly tolerated regimen for a full three months, simply to meet coverage criteria, prolongs their exposure to uncontrolled hypertension and its associated comorbidities. This delays their access to RDN, even when it's clinically evident that oral therapies have been exhausted or are causing unacceptable side effects.

Finally, the proposed exclusion of patients with an estimated Glomerular Filtration Rate (eGFR) < 40 mL/min/1.73m² as a contraindication is overly restrictive. A significant portion of patients with resistant hypertension also present with chronic kidney disease, a comorbidity that NPs frequently manage. This fixed cutoff of 40 mL/min/1.73m² does not align with all current evidence or device labeling, unnecessarily limiting access for a vulnerable subpopulation of patients who could safely and effectively benefit from RDN.

In conclusion, while I strongly support CMS's move to cover RDN, I urge a revision of these patient selection criteria. Adopting more flexible, evidence-based guidelines for blood pressure thresholds, GDMT duration, and eGFR would ensure that this innovative therapy is accessible to all appropriate Medicare beneficiaries, aligning the NCD with real-world clinical practice and ultimately improving patient outcomes.

Less

I am an interventional cardiologist and vascular medicine/endovascular specialist who is actively engaged in clinical practice, teaching and education, and clinical research for more than 27 years. I am currently the Interventional Cardiology program director, Cath Lab director, medical director of cardiovascular services at our institution, over 1000 bad hospital system, I have have had extensive experience by virtue of formal and informal leadership roles in program development and quality assurance, and I am a strong patient advocate.

Hypertension plays a very important role in patient outcome, cardiovascular mortality, stroke risk, Renal failure risk. Etc I feel this therapy (Renal denervation)has added a very important weapon in the arsenals of fighting this pandemic, for those patient with resistant hypertension, those were intolerant specific medication’s or sub optimal responder to those medication’s

Less

Dear Administrator Oz,

I would like to thank CMS for considering coverage for renal denervation (RDN) and for the opportunity to comment on the proposed policy. As it is currently written, I support the proposed coverage criteria.

I have spent more than 10 years as a structural and peripheral cardiologist, and I currently am a co-chair of the Structural Heart Committee for the Association of Black Cardiologists, where I work with a task force of physician-scientists dedicated to addressing disparities in care for minority patients.

Hypertension impacts almost 50% of the U.S. population and is a highly variable condition in terms of treatment efficacy (1). Clinicians often spend many visits exploring several options to find a treatment that works for their patients. Disparities in hypertension care and outcomes are extremely prevalent today. Social determinants of health further exacerbate the difficulty of treating hypertension. Black Americans have a disproportionately higher prevalence and incidence of hypertension (2).

Even when proper treatments are prescribed, around 75% of Americans with hypertension struggle to get their blood pressure under control (1). Vulnerable populations suffer most, with lower medication adherence rates among patients with lower socioeconomic status and minority backgrounds (3). For these reasons specifically, I applaud CMS for releasing draft coverage criteria for RDN that are not overly burdensome for patients or providers.

Renal denervation offers a path forward for patients who cannot lower their blood pressure through lifestyle modifications or medication alone. Physicians need new tools to manage hypertension, and I am confident that CMS’s thoughtful RDN coverage policy can lead to significant improvements for appropriate patients.

Sincerely,

Dr. Aaron Horne, Jr., MD

Less

Thank you for the opportunity to provide comments on the proposed NCD for renal denervation (RDN). I am writing to express my support for the coverage criteria outlined by the Centers for Medicare and Medicaid Services. As a nephrologist and hypertension specialist, I have seen first-hand the complications that arise from uncontrolled hypertension including kidney disease and stroke. Unfortunately, blood pressure control rates in the US are suboptimal and there are opportunities to improve how blood pressure is currently being managed. With this in mind, I am hopeful that innovative treatments for hypertension like RDN will be more available in the future in an effort to improve blood pressure control and avoid hypertension-associated complications. One barrier to BP control is my own practice is suboptimal medication adherence and suboptimal adherence to recommended lifestyle modifications. RDN overcomes these barriers as it doesn’t require an additional medication nor does it involve more lifestyle changes. With RDN, If we can prevent even just one patient from ending up on dialysis and avoid the suffering that occurs when on dialysis, then to me, this would justify RDN as a treatment for uncontrolled hypertension that should be made available.

I reviewed CMS’s proposed policy for RDN coverage. I agree with many of the criteria in the proposed policy and specifically agree with the emphasis on out of office BP monitoring in the patient criteria and the importance of screening for primary aldosteronism in resistant hypertension. However, I do have some suggestions/areas for clarification:

Patient criteria:
1) While I agree that hypertension management requires longitudinal care with multiple visits, the proposed criteria states that there should be three visits with a primary clinician who manages hypertension prior to the procedure. These three visits should be allowed over a period longer than six months if a patient has been treated for hypertension by a referring physician. In my personal experience, it is possible for the recommended workup for patient selection to be done prior to referral to our hypertension clinic. In this case, the decision to pursue RDN may not require several visits with me over 6 months prior to the procedure.
2) Consideration should be given for screening for primary aldosteronism in patients with hypertension that is not resistant (i.e. Stage 1 and Stage 2 Hypertension). The estimated prevalence of primary aldosteronism is about 10% among all hypertensives. Of course, targeted therapy exists to treat hyperaldosteronism. I would suggest explicitly mentioning this in the patient criteria.

Facility criteria:
1) The proposed criteria recommends that there should be a multidisciplinary hypertension program and that the hypertension should have a clinician trained in hypertension. To reduce the variability in hypertension programs, it should be clarified what is meant by “multidisciplinary” and what is meant by “trained in hypertension.” I would suggest that there should be a list of minimal requirements for a hypertension program to better clarify what is meant by these terms. Requirements could include the following: 1) having a home blood pressure monitoring program or access to 24-hr ambulatory blood pressure monitoring 2) having a systematic approach to monitor and address medication non-adherence 3) emphasis on patient education and engagement for lifestyle modifications 4) use of evidence based medications 5) access to tests needed to evaluate for secondary causes of hypertension 6) attention to accurate blood pressure measurement both in and out of the office and 6) has an ability to collect data, participate in registries and follow outcomes from RDN. At the helm of the program there should be a clinician with specialty interest and expertise in hypertension. This person should ideally be an AHA certified hypertension specialist but this should not be a requirement in my opinion so that more practices can engage in RDN. In addition, the hypertension program should ideally be an AHA certified hypertension program but again, is not a requirement in my opinion so that more practices can engage in RDN.

Lastly, a team based care approach can help to accomplish all of the above criteria and is a suggested route for delivering a comprehensive hypertension program. However, not all clinics will be able to offer a team based approach. At a bare minimum, the program should have a clinician with experience and expertise in hypertension. This clinician should have access to people and providers in multiple disciplines who can help in hypertension management. In addition, this hypertension clinician should have a trained support clinical staff. The key point is that a clinician, other than the interventional cardiologist who is performing RDN, is selecting patients prior to RDN based on an independent evaluation. Multiple studies have demonstrated that a collaborative approach to diagnosis, treatment and follow-up is effective in hypertension management.

As a clinician actively managing patients with both routine and complex hypertension, I am hopeful and looking forward to offering RDN for patients who are unable to control their blood pressure with lifestyle modifications and medications only. I am appreciative of this opportunity to review and comment on the proposed criteria from CMS and glad that CMS is thoughtfully considering coverage criteria so that access to RDN is provided for patients with uncontrolled hypertension.

References:

Abdalla et al. Implementation Strategies to Improve Blood Pressure Control in the United States: A Scientific Statement from the American Heart Association and the American Medical Association. Hypertension 2023 80(10) e143-e157

Brown et al. The Unrecognized Prevalence of Primary Aldosteronism. Annals of Internal Medicine. 2020 173(1)

AHA Certified Hypertension Centers. www.heart.org. Last accessed August 6, 2025

Less

I write to offer a hypertension specialist's feedback regarding the proposed National Coverage Determination (NCD) for Renal Denervation (RDN) therapy. While CMS’s proactive stance to make innovative therapies accessible under the Coverage with Evidence Development (CED) framework is commendable, several of the proposed criteria will present significant implementation challenges. I recommend the NCD align with contemporary clinical guidelines, to ensure both the effectiveness and equitable availability of this therapeutic intervention.

Blood Pressure Threshold Criteria

One of the primary issues with the proposed NCD is the blood pressure (BP) threshold for defining uncontrolled hypertension, currently set at BP> 140/90 mmHg. Current national guidelines issued by the American College of Cardiology and the American Heart Association clearly define hypertension by SBP>130 or DBP >80 mm Hg. Hypertensive systolic or diastolic blood pressure requires clinical intervention. By requiring a higher threshold of 140/90 mm Hg, which represents Stage 2 hypertension, CMS would exclude a substantial portion of patients whose hypertension is uncontrolled despite optimal medical management and who demonstrably carry significant cardiovascular risk. It is well-established that even Stage 1 hypertension significantly increases cardiovascular risk. Many patients with this diagnosis are Medicare beneficiaries who have already exhausted multiple therapeutic strategies and are already taking maximally tolerated antihypertensive medications. Restricting access based on an overly stringent criterion does not align with clinical realities. I strongly recommend CMS adopt the widely accepted and guideline-directed hypertension threshold of 130/80 mm Hg.

Management Timeline and Visit Requirements

Requiring primary care providers to manage the patient for a minimum of six months with at least three encounters, and at least two of these conducted virtually, is overly restrictive. Yes, it is essential to confirm persistent uncontrolled hypertension, but the parameters in CMS’s proposal introduce are inappropriately rigid. Many patients suitable for RDN have extensive histories of hypertension management spanning years. Imposing an arbitrary six-month management period by the referring doctor resets the timeline unnecessarily, prolonging exposure to poorly controlled blood pressure. Delays in treatment increase risk for stroke, myocardial infarction, and renal dysfunction.

Moreover, telehealth is now a fundamental component of chronic care management, greatly enhancing access and continuity, especially for Medicare beneficiaries in rural, underserved, or mobility-limited contexts. CMS’s limitation to one virtual encounter is particularly restrictive, undermining the significant progress made toward health equity and access during recent years. A more pragmatic approach would involve requiring multiple clinician encounters—either virtual or face-to-face—to confirm medication optimization and persistent uncontrolled hypertension, without prescribing fixed durations or visit formats. This would balance rigorous clinical oversight with the practical realities of patient management today.

Facility Criteria and Ambiguity of Definitions

The proposed facility criterion introduces an additional complication by specifying that centers offering RDN must include a "hypertension-trained clinician," without clearly defining this term. Clarity is required. Physicians who commonly manage hypertension—including cardiologists, nephrologists, internists, or advanced practice providers with substantial hypertension experience—should qualify.

Without explicit clarification, hospitals, particularly smaller community-based facilities, may adopt conservative interpretations to avoid non-compliance risks, inadvertently restricting access to centers that could otherwise safely and effectively administer RDN therapy. Clearer guidance from CMS, either specifying acceptable credentials or providing explicit examples of acceptable clinician backgrounds, would dramatically reduce interpretative uncertainties and facilitate broader, yet still clinically appropriate, implementation.

Renal Function (eGFR) Criteria

Finally, the eGFR exclusion criterion of patients with estimated glomerular filtration rates (eGFR) < 40 mL/min/1.73m² does not reflect the evolving evidence base surrounding RDN. Current FDA-approved post-approval studies for renal denervation devices permit enrollment of patients with eGFR levels as low as 30, reflecting growing scientific understanding and confidence in procedural safety in these populations. Adopting a criterion of eGFR =40 risks prematurely excluding patients who stand to benefit significantly from this therapy.

Rather than static numerical thresholds, linking CMS eligibility criteria directly to the FDA-approved Instructions for Use (IFU) of each RDN device ensures the flexibility to adapt to emerging evidence rapidly and consistently. This approach prevents frequent administrative updates and maintains alignment with evolving safety and efficacy standards.

Conclusion and Recommendations

In summary, to fully realize the potential benefits of renal denervation therapy under the proposed NCD, CMS should consider these targeted adjustments:

• Broaden BP criteria to include patients with uncontrolled hypertension, aligning precisely with ACC/AHA guidelines and clinical reality.
• Relax visit restrictions and timelines, focusing on verification of persistent uncontrolled hypertension rather than prescriptive timelines and formats of visits.
• Clarify facility criteria, removing ambiguity around definitions of qualified clinicians to avoid overly restrictive interpretations.
• Tie renal function criteria explicitly to evolving FDA-approved IFUs, ensuring future-proof flexibility that aligns coverage decisions with the best available evidence.

Implementing these recommendations will ensure the coverage framework balances clinical rigor with practicality, expanding patient access without compromising safety or quality.

Thank you for considering these critical refinements. By making these adjustments, CMS will more effectively foster equitable, evidence-based care that significantly advances cardiovascular health outcomes for Medicare beneficiaries.

Less

Background: I am an experienced interventional cardiologist and vascular medicine/endovascular specialist who is actively engaged in clinical practice, teaching and education, and clinical research for more than 40 years. I have had extensive experience by virtue of formal and informal leadership roles in program development and quality assurance, and I am a strong patient advocate.

Summary of Proposed NCD for RDN: I appreciate that CMS has created the opportunity for public comment on the proposed NCD. In my opinion, policies that enhance patient access and safety; ensure high physician/institutional quality and performance; and promote lifelong education and training should be strongly endorsed, and those policies that are overly-restrictive for reasons other than safety and quality should be re-evaluated and revised. With these considerations in mind, I would like to offer the following comments for your consideration:

A. Patient criteria:

B. Physician criteria:

C. Facility criteria:

Respectfully submitted,

Robert D. Safian MD FACC MSCAI
Professor of Medicine
Oakland University William Beaumont School of Medicine
The Lucia Zurkowski Endowed Chair, Center for Innovation & Research in Cardiovascular Diseases, William Beaumont University Hospital
Royal Oak, MI

Less

Less

The Mended Heart, Inc (MHI) is pleased to express support for the proposed coverage criteria under Medicare for renal denervation therapy (RDN).

MHI advocates for improving quality of life for heart patients and their families through peer-to-peer support, education and advocacy. We represent the largest patient peer support network in the world with over 100,000 members in over 74 countries. Our mission is to give patients who are recovering from a cardiovascular event or navigating cardiovascular disease and other related conditions the support they need.

As the largest cardiovascular peer-to-peer support network in the world our membership reflects the many faces of hypertension. Hypertension management can vary widely and be difficult to sustain over extended periods of time. In fact, fewer than one-fourth of patients with hypertension reach their treatment goals (1). Access to new treatments is needed in order to improve America’s hypertension management.

For many patients, lifestyle changes and medication management are often not enough, making an option like RDN extremely valuable because of its “always-on” effect. We agree that RDN should not be a first-line treatment; however, for appropriate patients, we believe access to this therapy should be available without unnecessary burden. As written, We believe that the coverage criteria will give a broad range of patients the opportunity to take advantage of this technology, and this approach appropriately addresses the diverse hypertensive patient population we see in America today.

While The Mended Hearts, Inc. continues to champion awareness and education, we know that knowledge alone isn't always enough. Coverage for renal denervation would represent a meaningful step forward for those who need more options.

We applaud CMS’ proposed coverage criteria, which will give our members a new, non-pharmacological treatment option for their patients.

Sincerely,
Mandy Sandkuhler
Director, Partnerships and Communications
The Mended Hearts, Inc.

(1) Cluett, Jennifer L., et al. (2024). Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Hypertension, 81(10), 135-148. https://doi.org/10.1161/HYP.0000000000000240.

Less

Thank you for the opportunity to provide comments on the proposed NCD for renal denervation (RDN). I am writing to express my support for the coverage criteria outlined by the Centers for Medicare and Medicaid Services. The trials for this technology have shown promise, and I am hopeful that technological advances like RDN, with supportive coverage policy, can help us in the management of hypertension which is a big driver of cardiovascular mortality and morbidity.

My specialty is in general, preventive and women’s cardiology, where I have witnessed many patients struggle with hypertension management. The unmet need in hypertension is significant: fewer than one-fourth of individuals diagnosed with hypertension currently have the disease managed.
This is principally why I support CMS’s proposed policy for RDN coverage, which I believe reflects the complexity of the condition and its heterogenous patient population. Narrow patient criteria would have been overly proscriptive and would have restricted access for patients who could significantly benefit from this intervention. To that end, I do have a few suggestions for modification to the proposed criteria:
1) Stage II hypertension is defined as > 140 mm HG systolic or >90 diastolic, which is specified in the Clinical Review section. To avoid confusion and not have Medicare beneficiaries excluded from RDN, I suggest ensuring that section 1a matches this description.
2) While I am aligned with patients having three visits with a clinician who manages hypertension prior to the procedure, I suggest latitude to allow these visits to take place virtually, given point of access differences across the US, or for the three visits to take place over a period longer than six months if a patient has been treated for hypertension by a referring physician.

We know that even modest reductions in hypertension can improve rates of cardiovascular mortality, and the clinical evidence for this procedure have shown clinically significant and safe blood pressure reductions sustained through three years in patients both on and off medications (1).

Based upon my years of experience researching how behavioral, technological and pharmacological interventions impact cardiometabolic disease and as a clinician actively managing patients, I am optimistic that safe and effective interventions like RDN can be an impactful tool for appropriate patients. I am grateful that CMS recognizes that fact.

Sincerely,
Pam R. Taub, MD, FACC, FASPC

References:
1. Sesa-Ashton G, Nolde JM, Muente I, Carnagarin R, Macefield VG, Dawood T, Lambert EA, Lambert GW, Walton A, Esler MD, Schlaich MP. Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis. Hypertension. 2024 Jun;81(6):e63-e70. doi: 10.1161/HYPERTENSIONAHA.123.22314. Epub 2024 Mar 20. PMID: 38506059.

Less

I strongly support the proposed National Coverage Determination (NCD) for renal denervation (RDN), but several criteria require critical refinements to achieve optimal outcomes. Below, I've outlined key areas needing clarification and adjustment:

• Ambiguity in Facility Criteria:
  o CMS requires facilities to include a “hypertension-trained clinician,” yet offers no definition or guidance on acceptable qualifications.
  o It remains unclear whether clinicians routinely managing hypertension—such as cardiologists, nephrologists, or internists without formal hypertension certification—would satisfy this requirement.
  o Without clarity, hospitals may adopt unnecessarily strict interpretations, significantly restricting eligible facilities and patient access.

• Restrictions on Telehealth and Visit Requirements:
  o The current proposal mandates a minimum six-month primary clinician management period with exactly three encounters, only one of which can be virtual.
  o Many patients considered for RDN have extensive medication histories, often spanning years of clinical management. Requiring a new six-month “reset” is impractical and clinically redundant.
  o Limiting telehealth use contradicts contemporary care models. Telemedicine has proven essential for equitable chronic disease management, particularly benefiting rural and underserved populations.

• Blood Pressure Eligibility Criteria:
  o CMS proposes defining uncontrolled hypertension strictly at >140/90 mmHg.
  o Current ACC/AHA guidelines classify:
  ? Stage 1 hypertension: Systolic 130–139 mmHg or Diastolic 80–89 mmHg
  ? Stage 2 hypertension: Systolic =140 mmHg or Diastolic =90 mmHg
  o The current CMS threshold exclusively aligns with Stage 2 hypertension, inadvertently excluding Stage 1 patients who remain uncontrolled despite rigorous medication optimization. Aligning CMS criteria with Stage 1 hypertension or greater would be more inclusive and clinically accurate, ensuring patients at genuine cardiovascular risk receive timely treatment.

• Medication Stability Period:
  o Requiring patients to maintain stable guideline-directed medical therapy (GDMT) for three months extends risk exposure unnecessarily.
  o Pharmacologically, antihypertensive therapies typically achieve full therapeutic efficacy within 4–6 weeks, making the proposed three-month period unnecessarily prolonged.

Addressing these specific points will help CMS ensure its NCD achieves the intended objectives—delivering equitable, evidence-based, and clinically effective care to patients who urgently need it.
Thank you for your consideration.

Less

August 5, 2025

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

Submitted electronically through the Public Comment Portal found at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=318

RE: National Coverage Analysis (NCA) Proposed Decision Memo - Renal Denervation for Uncontrolled Hypertension [CAG-00470N]

Dear Ms. Syrek Jensen,

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients worldwide. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries. We appreciate the opportunity to provide comments regarding the Centers for Medicare & Medicaid Services’ (CMS) National Coverage Analysis (NCA) Proposed Decision Memorandum for Renal Denervation for Uncontrolled Hypertension (CAG-00470N).

Boston Scientific Corporation (BSC) commends and supports CMS in proposing a coverage pathway for Renal Denervation (RDN) for Uncontrolled Hypertension. However, our review of the Proposed Decision Memo finds some proposed criteria to be overly prescriptive, with the potential to unintentionally limit Medicare beneficiary access to RDN.

CMS Proposed Patient Criteria

BSC supports the CMS patient criteria as proposed, with recommendations for two important modifications to patient criterion (f) requiring two of the three required patient encounters to be in-person visits, and (g) disallowing patients access to RDN treatment, if the patient had a prior RDN procedure.

BSC proposes a revision to criterion (f), removing the limit on virtual visits, as follows:

People living in rural areas are at significantly higher risk of developing high blood pressure (hypertension) compared to those in urban areas, with studies showing a higher prevalence of hypertension diagnoses in rural populations due to factors like limited access to healthcare and healthy dietary options, and lower levels of physical activity.ⁱ Telehealth can connect individuals with healthcare providers regardless of location, which is particularly beneficial for those in rural or remote areas. Additionally, a subset analysis of the ALLHAT RCT of over 33,000 patients enrolled in a clinical trial that provided free medication reported the degree to which blood pressure was lowered was less in those receiving care in the lowest income sites in the United States compared to those receiving care in the highest income sites. Both visit and medication adherence were lower in the lowest income sites. Other studies report access to transportation, social support, and health behaviors may indirectly and directly impact outcomes.ⁱⁱ Telehealth eliminates the need for travel, saving money on transportation expenses, which can be a significant burden for low-income individuals. The availability of, and access to renal denervation through in person or virtual care has the potential to address these disparities by providing patients with an effective and durable treatment option.

BSC recommends CMS take a less prescriptive approach and remove the requirement limiting the number of virtual encounters. Telehealth is an accepted model of health care service delivery. Specifically, it provides opportunities to expand treatment access and reduce barriers to care in underserved and rural areas.ⁱⁱⁱ Telehealth models have been associated with positive outcomes for patients and health care professionals, suggesting these models are feasible and can be effective ⁱⁱ. “The pandemic showed removing restrictions [to telehealth visits] is an essential tool to providing care, especially in rural areas where transportation can be challenging.”^iv “Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension.^v The use of automated home blood pressure recordings with cloud-based transmission of data provided to investigators/physicians who may be engaged through telehealth visits, is being routinely used by providers in the care and treatment of hypertensive patients.^vi

BSC proposes a revision to criterion (g), allowing for RDN retreatment to be studied by limiting the moratorium on retreatment to two years until more definitive data is available, as follows:

There is limited but promising data showing RDN may be durable for 10 years. ^{vii, viii, ix, x} While there is high potential for long-term durability of effect, based on the limited availability of data and ongoing technological improvements likely to improve efficacy, BSC suggests limiting patient access to RDN retreatment at this time to be premature. BSC proposes gathering more information on the potential need and role of RDN retreatment through the Coverage with Evidence Development (CED) period.^{xi, xii, xiii, xiv}

CMS Proposed Physician Criteria

BSC supports the CMS physician criteria as proposed, with two important modifications. BCS recommends CMS vacate the proposed proctoring requirement and instead rely on existing facility physician privileging processes to identify physicians with the skill set necessary to perform RDN, and use device-specific training required by the manufacturer. BSC’s recommended revisions to criterion (c), which would negate the need for criterion (d), are as follows:

The proposed revision to criterion (c) relies on existing facility physician privileging processes to identify physicians with the skill set necessary to perform RDN procedures and would align CMS’s directive regarding device training for RDN with other CMS NCD/NCAs device training requirements.

We appreciate many organizations use “proctoring” as a tool to confirm competence when learning new skills, which may be performed concurrently (through precept/watching a provider perform a procedure, for example) or retrospectively (an evaluation typically carried out by review of the patient record).^xv However, as proctoring is commonly conducted through precept for medical training, BSC has concern about potential misinterpretation of this proposed criterion by third parties.

Additionally, CMS has not been as prescriptive regarding clinician device training in other CED NCDs that address significantly more complicated medical devices and procedures. For example, in the Transcatheter Aortic Valve Replacement (TAVR) [20.32] NCD, CMS requires “Device-specific training as required by the manufacturer.” In the Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation [20.33 NCD], CMS specifies, “All physicians who participate in the procedure must have device-specific training as required by the manufacturer.” In the recent TCET NCAs for Transcatheter Tricuspid Valve Replacement (TTVR) [CAG-00467N] and Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) [CAG-00468N], there is no requirement for proctored training.

CMS Proposed Facility Criteria

BSC recommends a minor revision to facility criterion (a), as follows:

There is a severe shortage of specialists in the rural areas of the United States. According to the Association of American Medical Colleges, “there were nearly 7 times as many active cardiologists and anesthesiologists … in urban areas than in rural areas in 2022.” xvi While BSC fully supports facilities performing RDN should have their own, or partner with, a hypertension program, BSC requests CMS not require those programs to be facility-based and specifically multi-specialty. In some rural areas, hypertension programs are successfully conducted by independent single-specialty practices who engage with other specialties for additional patient evaluation and treatment, as appropriate. These programs may be fully independent and not directly run by the facility but rather run by a provider in the community who is fully committed to caring for and has the necessary expertise to treat hypertensive patients. Small suburban or rural hospitals may also be part of a larger health system with access to the larger health system hypertensive team, provided virtually, certainly those types of partnerships should be recognized under this NCA, helping to ensure uncontrolled hypertensive patients have access to RDN.

Predictable and Timely CMS Review/Approval Process for CED Studies Needed

Finally, CMS has proposed coverage for the RDN device, with related items and services is dependent on the procedure being furnished within the context of a CMS-approved CED study. However, CMS has not provided any details or expectations regarding the CMS approval process for these trials. We request CMS commit to timely review and subsequent approval, as appropriate, of RDN CED studies submitted for approval within 30 days.

Conclusion
BSC supports CMS’s Proposed Decision Memorandum for Renal Denervation for Uncontrolled Hypertension, recommending minor revisions to the Proposed Memorandum to mitigate any unintended barriers to patient access to RDN, a potentially life-saving technology.

Thank you for considering our comments. We look forward to working with CMS to expand access to safe and innovative renal denervation therapies for Medicare beneficiaries. Please contact me at liesl.hargens@bsci.com if I can be of any further assistance or if you would like me to connect you with our in-house clinical experts.

Sincerely,

Liesl Hargens
Vice President, Global Lead Health Economics and Market Access
Boston Scientific Corporation

cc: Lori Ashby, CMS, Lead Analyst, Lori.Ashby@cms.hhs.gov
Karen Nordahl, BSC
Michael Jaff, D.O., BSC
Alex Weir, BSC
Dawn Gray, BSC

Less

Dear CMS,

I am writing to express my thoughts on the recently proposed NCD for renal denervation. I am an interventional cardiologist treating hypertensive patients daily.

As a dedicated physician, I am compelled to address critical flaws in the draft National Coverage Determination (NCD) for renal denervation (RDN). While RDN offers substantial benefits for patients with uncontrolled hypertension, the proposed criteria create significant barriers to access and fail to reflect modern clinical standards.

The NCD’s requirement of a blood pressure above 140/90 mmHg to qualify as uncontrolled hypertension is inconsistent with the 2017 ACC/AHA guidelines, which set Stage 1 hypertension at 130/80 mmHg. This outdated threshold excludes many Medicare patients who face serious cardiovascular risks—for instance, those with sustained readings of 135/85 mmHg— denying them access to a potentially life-changing treatment. Adopting the current guideline threshold would better align eligibility with clinical realities.

The mandate for a primary clinician to oversee a patient for six months with three visits, only one of which can be virtual, is impractical and restrictive. Contemporary hypertension management often relies on telehealth and involves multiple providers over time. This inflexible rule unfairly burdens patients in remote areas or with mobility challenges, forcing unnecessary delays or travel. A more adaptable approach to care delivery would enhance patient access without compromising quality.

Requiring a “multidisciplinary hypertension program” with designated roles, such as a “hypertension navigator,” is excessively rigid. Many qualified medical centers, particularly in underserved regions, cannot meet this narrow standard due to limited resources. This criterion risks barring numerous facilities from providing RDN, reducing its availability across diverse communities. A more inclusive definition of program capabilities would broaden access while maintaining high standards.

The proposed eGFR cutoff of <40 mL/min/1.73m² is overly stringent, as some RDN device guidelines allow treatment for patients with eGFR 30 mL/min/1.73m². This restrictive limit unnecessarily excludes patients who could safely benefit from the procedure. Adjusting this threshold to align with device safety profiles would expand access appropriately.

To ensure fair and effective access to RDN, I strongly recommend that CMS revise the NCD to reflect ACC/AHA guidelines, support diverse care delivery models, relax overly specific program requirements, and adjust the eGFR cutoff to align with device indications. These changes would enable clinicians to prioritize patient needs and fully realize RDN’s potential for Medicare beneficiaries. With further clinical trials, I suspect the eGFR minimum will broaden the new labelling of the devices.

Please take my clinical expertise and comments into consideration on your final RDN NCD decision.

Sincerely,
George Sipa Yankey, MD, FACC.
yankey@musc.edu

Less

To Whom It May Concern,

I am an interventional cardiologist with 40 years' experience in managing hypertensive patients. I am writing to urge critical revisions to the proposed National Coverage. Determination (NCD) for renal denervation (RDN). While RDN holds significant promise for managing uncontrolled hypertension, the current draft criteria impose restrictive barriers that undermine equitable patient access and diverge from contemporary medical standards.

The NCD’s requirement of a blood pressure threshold exceeding 140/90 mmHg for uncont hypertension is outdated and misaligned with the 2017 ACC/AHA guidelines, which define Stage 1 hypertension at 130/80 mmHg. This discrepancy excludes Medicare beneficiaries with clinically significant hypertension—such as those with persistent readings of 135/85 mmHg—who face elevated cardiovascular risks but would be denied access to RDN. Aligning the NCD with current guidelines would ensure eligibility reflects actual clinical need.

The stipulation that a primary clinician manage a patient for six months with three encounters, only one of which may be virtual, is impractical. Modern hypertension care often involves telehealth and multiple specialists, particularly for complex cases. This rigid criterion disproportionately burdens patients in rural or underserved areas who rely on virtual care, imposing unnecessary delays or travel hardships. A more flexible framework that accommodates diverse care models would better serve patients.

Mandating a “multidisciplinary hypertension program” with specific roles, such as a “hypertension navigator,” is overly prescriptive. Many capable healthcare facilities, especially in underserved regions, lack the resources to meet this narrow definition. This requirement risks excluding numerous hospitals and clinics from offering RDN, limiting its geographic availability. A broader, more inclusive definition of program capabilities would enhance access without compromising care quality.

The proposed eGFR <40 mL/min/1.73m² contraindication is unduly restrictive. Some RDN device instructions for use permit treatment for patients with eGFR ff30 mL/min/1.73m², indicating that safer, broader eligibility is feasible. This exclusion unnecessarily limits access for patients who could safely benefit from RDN.

To ensure equitable access to RDN, I urge CMS to revise the NCD to align with current ACC/AHA guidelines, accommodate flexible care delivery models, broaden program eligibility criteria, and adjust the eGFR threshold to reflect device safety profiles. These changes would empower clinicians to deliver patient-centered care and maximize the therapeutic potential of RDN for Medicare beneficiaries.

Thank you for your attention to my concerns.

Sincerely,
Michael Foster, MD, FACC, FSCAI
Medical Director, Cardiovascular Services, MUSC Columbia
Medical Director, Claude W. Smith School of Cardiovascular Technology
fostermi@musc.edu

Less

I am submitting this comment in support of renal artery denervation as a treatment option for hypertension. Like many others who have commented, I care for patients who suffer the consequences of poorly controlled blood pressure. I strongly believe—and the data supports—that this procedure, when used in the appropriate patient population, can prevent undue suffering from the cardiovascular complications of hypertension.
While medical therapy and lifestyle modification remain the cornerstone of hypertension management, they are often insufficient for many patients. This may be due to truly resistant hypertension, medication intolerances, or socioeconomic factors that limit access to care. For patients with signs of end-organ damage related to hypertension—such as coronary artery disease, peripheral vascular disease, stroke, or chronic kidney disease—renal denervation offers a promising therapeutic option.
Importantly, renal denervation is not only beneficial for those who have already developed end-organ damage, but also for patients who are at high risk of developing these complications. Early intervention in such individuals can significantly reduce long-term cardiovascular risk, slow disease progression, and improve overall outcomes. Moreover, by preventing costly complications and hospitalizations, early use of renal denervation may lead to substantial long-term cost savings for our overstretched healthcare system. I currently practice at an institution that affords my patients access to a multidisciplinary hypertension program, and I have seen firsthand the value this team brings to the management of complex hypertensive patients. Their expertise enhances care and outcomes, especially for those with resistant or secondary hypertension.
As we enter a new era in the management of hypertension, I understand the desire to involve hypertension specialists in the care of these patients. However, I am concerned that this could inadvertently restrict access to care, limiting treatment to only those with the means to seek out specialized services. It is essential that we balance innovation with equitable access to ensure that all patients who could benefit from this therapy are able to receive it.

Less

CMS proposes to cover renal denervation for uncontrolled hypertension when furnished according to a Food and Drug Administration (FDA) market-authorized indication under certain conditions. Those conditions include being furnished in the context of a CMS-approved study that meets the Coverage with Evidence Development (CED) criteria, measures one or more specified outcomes, and involves at least 24 months of follow-up. The proposed NCD is not specific to a particular modality, such as radiofrequency and/or ultrasound.

Ablative Solutions strongly supports the broad scope of the NCD because new approaches to renal denervation are under development, including transcatheter alcohol-mediated renal denervation. Any technology, regardless of modality, that has a FDA market-authorization for renal denervation for uncontrolled hypertension should be covered under the NCD. Inclusion of all modalities under the same NCD will allow CMS to gather consistent evidence to consider in developing future NCDs. We also note that this approach aligns with the recommendations of multiple commenters who suggested that CMS not limit coverage to currently available technologies. In contrast, establishing a modality-specific NCD would inappropriately restrict beneficiary access to innovative technology and improperly advantage devices that are first to market.

We urge CMS to finalize this approach as proposed and to explicitly state that the NCD is not limited to radiofrequency and/or ultrasound technology and includes any technology with the required indications and furnished in a CMS-approved CED trial.

Less

As a hypertension specialist, I have previously been limited in what I can offer my medication non-compliant as well as difficult to control patients. We know that lifestyle changes and medication are only as effective as the patient is willing. This can be an insurmountable task, with lasting consequences. The arrival of RDN as an option for patients will allow us as HTN specialists to offer a greater range of options for patients. It will not be a cure-all but will allow us a better chance to achieve BP control and prevent its long-term consequences.

Renal denervation has served several of my patients very well, and I intend to continue to refer patients for the procedure. There are some items in the proposed NCD that may pose a challenge based on my experience.

First, Patient Criteria (f), requires that clinicians should manage each patient for at least 6 months and see them for at least three encounters, two in-person, before they are eligible for RDN. While I agree that repeated encounters with patients are important in hypertension management, I think these guidelines around specific duration and visits are too strict. Instead, I would favor more flexibility to accommodate individual patients’ needs. By the time I am seeing the patient they have had multiple encounters already for poorly controlled HTN. For rural patients, traveling to see a hypertension specialist this is already enough of a burden. To facilitate ongoing care, we do our best to incorporate virtual visits. Patients may also see more than one physician for HTN management, and the current language specifying that specifically the primary clinician must see them at least 3 times could delay their opportunity for RDN.

Second, Patient Criteria (a), diagnosis of uncontrolled HTN (>140/90) despite active management. This I approach with an eye on the ACC/AHA Hypertension guidelines, which define uncontrolled hypertension as >130/80. A patient unhappily on 4/5 meds is far less likely to achieve long term control. I would not wish to limit this group’s access based on the cutoff of 140/90 when studies have consistently shown the cardiovascular benefits of achieving a BP under 130/80. I would prefer to be able to incorporate patient preference and allow patients’ experience with medications and lifestyle to inform decisions on renal denervation. Furthermore, in the trials the patients had to be on at least three meds to qualify, and I fear that the definition of optimal medical care can be abused by third party payers and Medicare Advantage programs who may decide on their own that optimal medical care for HTN may need to be 5 or 6 medications which is unjustified especially knowing that compliance with medications goes down steadily after 3 medications are added to the regimen.

I believe that this treatment option should be made more available and not more restricted especially in cities like mine, Memphis, where HTN and its sequelae are catastrophic.

Thank you for your consideration,

Less

Less

I am an academic nephrologist and a hypertension specialist and have focused my career on treating complex hypertension with a focus on secondary hypertension. I have been involved in renal denervation research from the beginning and am pleased to see a statement by CMS regarding coverage for RDN. I have 2 minor comments on the CMS statement:

1. Patient Criteria: this is confusing - In section 1a of the “Patient Criteria” CMS states coverage for patients with BP 140/90 in the text and then >140 or >90 in the table in the Clinical Review section of the document. I agree with the second statement of SBP >140 or > 90 mm Hg. I agree with the SBP > 140 but strongly feel the DBP limit should be > 80 mm Hg as otherwise coverage will exclude an important group of patients with isolated systolic hypertension.

2. All patients should have Primary aldosteronism excluded and criteria should be followed as per recent endocrine society guidelines to ensure the correct patients are referred for RDN (Adler GK, et al. J Clin Endocrinol Metab. 2025. PMID: 40658480)

Less

To Whom It May Concern,

As an interventional cardiologist practicing in Nashville, Fayetteville, and Gallatin, Tennessee, I provide care for a broad and diverse patient population with complex cardiovascular disease, including many individuals suffering from uncontrolled hypertension despite adherence to multiple medical therapies. These patients frequently present with advanced manifestations of hypertensive heart disease—including stroke, myocardial infarction, and heart failure—and represent a cohort in urgent need of innovative treatment options beyond pharmacologic therapy.

With this in mind, I welcome the proposed National Coverage Determination (NCD) issued by CMS recommending coverage for the Paradise Ultrasound Renal Denervation (RDN) system. RDN has the potential to fill a critical therapeutic gap, particularly for patients who have exhausted traditional medication strategies and remain at high risk for adverse outcomes.

I appreciate the opportunity to offer feedback on key aspects of the proposed patient selection criteria, particularly sections (a), (c), and (f), based on my experience caring for this vulnerable population.

Patient Criteria (a): Hypertension Threshold

I respectfully recommend that CMS reconsider the =140/90 mmHg blood pressure threshold, and instead adopt the American Heart Association (AHA) guidelines, which define Stage 1 hypertension beginning at 130/80 mmHg. In my clinical practice across Middle Tennessee, I routinely care for patients whose systolic blood pressures range from 130–139 mmHg, despite adherence to multiple medications. These patients have nonetheless suffered strokes or myocardial infarctions and have clear evidence of end-organ damage. By limiting access to patients with blood pressures =140 mmHg, CMS risks excluding individuals who are both high-risk and likely to benefit from RDN.

Patient Criteria (c): Duration of Medication Trial

The proposed requirement that patients remain on three medications for a minimum of three months prior to referral for RDN may not align with real-world patient experiences. Many of my patients experience intolerable side effects or demonstrate medication non-adherence within weeks of initiating therapy. Forcing a uniform three-month waiting period in such cases risks delay of more effective interventions and may increase the likelihood of further cardiovascular events. I urge CMS to allow clinicians the flexibility to determine the appropriate length of medication trials based on individual tolerance and clinical stability.

Patient Criteria (f): Visit and Documentation Burden

The stipulation that patients must complete three visits over a six-month period, with at least two in-person, places an undue burden on both patients and providers—particularly in rural communities like Fayetteville and Gallatin. Transportation barriers, economic limitations, and workforce shortages already challenge patient access. Furthermore, we increasingly use remote patient monitoring (RPM) and telehealth platforms to manage hypertension, allowing for more frequent and higher-quality engagement than traditional visits alone. These tools should be recognized as equivalent or superior in monitoring blood pressure trends and adjusting care in a timely manner. CMS should modernize its criteria to reflect current standards of care and digital health capabilities.

Additional Concern: eGFR Cutoff

Lastly, I encourage reconsideration of the exclusion of patients with eGFR <40. Many of my patients with resistant hypertension also suffer from chronic kidney disease (CKD), and renal denervation may offer not only blood pressure control but potentially kidney-sparing benefits. An overly conservative eGFR cutoff risks denying access to a subgroup of patients who are among the most in need.

Thank you for the opportunity to share this feedback. I strongly support the inclusion of renal denervation in the treatment landscape for patients with resistant hypertension. I hope CMS will consider modifications that reflect the realities of contemporary cardiovascular practice and the needs of the patients we serve daily.

Warm regards,
Jimmy L. Kerrigan, MD, FSCAI, FACC
Interventional Cardiologist
Ascension Saint Thomas Heart – Nashville, Fayetteville & Gallatin, TN
Assistant Professor of Medicine, University of Tennessee Health Science Center

Less

Renal denervation offers an opportunity to transform hypertension care for patients who have exhausted every medication option without success. Your willingness to advance coverage is commendable, yet several provisions risk undermining access and slowing innovation.

Defining uncontrolled blood pressure as >140/90 mmHg fails to reflect contemporary science and guidelines. ACC/AHA guidelines define uncontrolled hypertension as =130/80 mmHg, and every major cardiovascular society recognizes the risk associated with sustained pressures above this level. Basing policy on an outdated metric creates an artificial barrier and could necessitate future revisions as evidence evolves.

The requirement for six months of management with strict visit rules is equally problematic. Many patients referred for RDN have years of failed medication adjustments. Requiring them to restart a compliance clock delays intervention for no clinical reason. Moreover, restricting telehealth to a single encounter penalizes patients who rely on virtual care for routine follow-up. Telemedicine has become integral to managing chronic disease—CMS policy should reflect that progress, not reverse it.

Medication stability requirements further extend the timeline without improving outcomes. Most antihypertensive medications reach peak effect within weeks. Holding patients for three additional months contradicts clinical reality and increases their risk of adverse events without associated benefit.

Lastly, the expectation for formal multidisciplinary programs with certified specialists imposes barriers that most community hospitals cannot meet. Excellent care is already provided through collaborative models involving cardiology, nephrology, nursing, and advanced practice providers. Requiring certifications that fewer than 40 U.S. centers currently hold will centralize care and exacerbate disparities.

A more flexible policy—one aligned with current guidelines, reflective of real-world care, and responsive to future data—will ensure that innovation benefits the patients who need it most.

Less

I am the Associate Director of the Cardiology Division of Cardiology at the MedStar Washington Hospital Center in DC; throughout my career, I’ve seen firsthand the impact that high blood pressure has on cardiovascular outcomes and end organ damage. As CMS is aware, high blood pressure is the leading cause of CV disease in the US, with higher rates in the Medicare population and disproportionate impacts on rural communities.

I supported the opening of this coverage assessment by CMS earlier in the year, and I am pleased to see this draft proposal for coverage of renal denervation (RDN). The proposed coverage criteria will enable access for Medicare patients who continue to struggle with controlling their blood pressure, despite guideline-based therapy. Particularly to adequately provide access to the Medicare-aged population, CMS should cover patients with either elevated systolic (greater than 140mmHg) or diastolic blood pressure (greater than 90mmHg). CMS should also recognize that appropriate titration of antihypertensive medications for patients should take into consideration individual patient responses, tolerance, and side effects of medication when seeking to up-titrate to higher available/maximum doses.

Overall, I appreciate the action taken by CMS to develop this coverage decision and make this technology accessible to those in need. With this policy, CMS will help to address one of the most prevalent chronic diseases in the US and significantly improve cardiovascular health outcomes for millions of Americans.

Less

I am an Interventional Cardiologist practicing at the University of North Carolina and have been working in the field of renal denervation for approximately 14 years. I have been part of the clinical trial programs conducted by both Recor Medical and Medtronic. I am writing to provide input on “National Coverage Determination (NCD) for renal denervation (RDN),” published on July 10 and currently open for public comment.

Hypertension is a leading modifiable risk factor for cardiovascular diseases, stroke, chronic kidney disease, and premature mortality. But despite the availability of a large number of pharmacological treatments, data from the National Health and Nutrition Examination Survey (NHANES) showed that only 48% of adult hypertensive patients achieved controlled hypertension between August 2021 and August 2023 (Am J Hypertens. 2025;38:120-128). Thus I strongly support the National Coverage Determination for renal artery denervation as this will provide another treatment option for these patients. Studies have shown that even modest reductions in blood pressure are associated with significant decreases in cardiovascular outcomes in patients with hypertension.

Expert consensus statements from Europe, Asia, and North America are in general agreement in support of RDN as a potential adjunct treatment in patients with uncontrolled hypertension despite maximal efforts at lifestyle modification and medication interventions, offering guidance on patient selection, shared decision-making, procedural training, and post-procedure follow-up. All of these consensus statements support the availability of RDN to provide another therapeutic option in treatment of patients with uncontrolled hypertension.

I agree with the ‘Patient Criteria’ and ‘Facility Criteria’.

I believe, however that the ‘Physician Criteria’ are too lenient and that there should be stricter criteria required of all physicians who perform this procedure. I fully agree with statement ‘b’ under Physician Criteria that ‘Physicians performing RDN must have interventional and endovascular skills to perform effective RDN treatments. Additionally, they must be able to manage potential complications either themselves or with institutional support from colleagues who are immediately available to assist in emergency management.’ This means that physicians performing RDN must be skilled in obtaining arterial access, cannulating the renal artery, performing renal angiography, placing wires in the distal renal artery, delivering equipment safely into the renal artery and dealing with potential complications. I do not believe that completing ‘at least ten supervised cases of diagnostic/therapeutic renovascular procedures, half as primary operator’ will be sufficient.

I would advocate that all physicians performing RDN need advanced training in interventional cardiology, interventional radiology or vascular surgery to acquire the necessary ‘interventional and endovascular skills.’ Physicians meeting this criteria should then be required to complete ‘at least ten supervised cases of diagnostic/therapeutic renovascular procedures, half as primary operator. Additionally, they must complete at least five proctored RDN cases with each approved device.’

I am worried that without stricter criteria, RDN procedures will be done by inexperienced physicians and this will lead to preventable bad outcomes. Doing a minimum number of cases, without advanced training in interventional skills, does not provide sufficient endovascular and renovascular expertise. I do not think any of us would want this procedure performed on us or a loved one by someone who has only done 10 intra-arterial procedures in their career.

To assure high quality procedures, the physician training criteria for RDN should be similar to that required for renal artery stenting. In particular, the 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) A Report of the ACC Competency Management Committee." (JACC: Cardiovascular Interventions 16.10 (2023):1239-1291) requires completion of an interventional cardiology fellowship, ‘extensive knowledge of procedural indications and contraindications, management of complications, and the risks versus benefits of conservative therapy’, and completion of 100 diagnostic and 50 peripheral vascular interventions. The criteria for RDN should be no less strict.

If physicians performing this procedure do not have sufficient endovascular and renovascular expertise, they will expose patients to unnecessary risks. Moreover, any center with ‘a multidisciplinary hypertension program with contributions from a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and contributions from relevant medical specialties (e.g., internal medicine, endocrinology, cardiology, and nephrology)’ will have physicians on staff with the requisite skills. Requiring both a multidisciplinary hypertension clinic and experienced renovascular operators will lead to the best patient outcomes.

Less

Less

The expectation of a formalized hypertension program—including a certified specialist and dedicated navigator—sounds ideal in theory but doesn’t reflect the way care is delivered across much of the country. Many hospitals manage hypertension through team-based approaches that integrate cardiology, nephrology, nursing, and pharmacy.

These models work well, but they don’t always meet the rigid definition outlined in the proposal. If CMS limits participation to facilities with this exact structure, it will exclude capable hospitals and deny patients access based solely on administrative design.

The ambiguity around what qualifies as a “hypertension-trained clinician” compounds the problem. Hospitals are likely to interpret this conservatively, assuming certification is required—a requirement that would eliminate most sites immediately. Clarifying that cardiologists and nephrologists qualify without additional credentials is essential to prevent unnecessary delay in care.

Finally, the restrictions on telehealth in the visit requirement do not reflect current practice. Limiting patients to one virtual visit creates barriers without improving oversight. For patients who rely on virtual care for transportation or mobility reasons, this limitation could be the difference between qualifying or not.

Flexibility in these areas will make the difference between a policy that reflects true patient centered care vs administrative delay.

Thank you for your consideration

Less

Less

To Whom it May Concern,

As a board-certified physician with several years of clinical experience, I appreciate the opportunity to comment on CMS’s proposed National Coverage Determination (NCD) for renal denervation. I have had the privilege of being involved in both clinical practice and investigational studies of renal denervation, and I believe this perspective is valuable in shaping a coverage policy that supports patient access and maintains clinical care.

I have several concerns with the current draft of the NCD, mainly with how it defines eligible patient populations and structures the care pathway.

First, the proposed blood pressure threshold of >140/90 mmHg as an inclusion criterion appears misaligned with the current American Heart Association (AHA) and American College of Cardiology (ACC) definitions of hypertension. SBP 130-139 or DBP 80-89 for Stage 1 hypertension, and SBP =140 or DBP =90 for Stage 2 hypertension. By excluding patients with systolic pressures in the 130–139 mmHg range, the proposal overlooks a large segment of Medicare beneficiaries who could benefit from this adjunctive therapy. Additionally, data from pivotal renal denervation trials include many older patients with systolic blood pressure between 130–140 mmHg, who would be unnecessarily excluded under this criterion. I encourage CMS to revise this language to accommodate real-world patient profiles.

Second, the requirement for six months of management by a primary clinician with a minimum of three documented encounters—two of which must be in-person—is not reflective of how hypertension is often managed today. In many clinical settings, especially post-pandemic, remote monitoring and telehealth visits are not only common but highly effective. Blood pressure control is frequently monitored through home devices, with dose adjustments and follow-up taking place virtually. Many of my patients—especially those in underserved communities, would face delays or barriers to care under this requirement. A more practical approach would be to require evidence of sustained elevated blood pressure over multiple encounters, irrespective of modality.

Lastly, the condition that patients be on stable, maximally tolerated antihypertensive therapy for at least three months before referral is unnecessarily long. Most antihypertensive agents reach peak efficacy within 4–6 weeks, and clinicians typically assess response and adjust therapy accordingly within that window. Extending this period to three months may prolong suboptimal control for patients many of whom have already demonstrated medication resistance or intolerance.

Thank you for considering these comments Renal denervation offers a safe and durable new option for patients struggling to achieve target blood pressure. I hope CMS will consider refining the proposed NCD language to better reflect evidence-based guidelines and the need for innovation in hypertension management.

Sincerely,
Adib Chaus

Less

We appreciate that CMS has released this proposed National Coverage Determination for renal denervation, underlying the importance of treating hypertension properly in the Medicare population, would like to thank CMS for giving us the opportunity to comment on this proposal.
As a clinician and a hypertension specialist practicing at an American Heart Association Designated Comprehensive Hypertension Center, I see patients with difficult-to-treat and resistant hypertension on a daily basis. Renal denervation is a valuable tool in our armamentarium to combat the epidemic of HTN, and should be made available for widespread use as soon as possible.
I would personally recommend revisiting the threshold of a diastolic blood pressure (DBP) of 90 mm Hg as a criterion for approval of the procedure. I do understand where this may be coming from, since secondary analysis of the Symplicity-3 trial showed a lack of benefit with renal denervation in lowering blood pressure in patients with isolated systolic hypertension (ISH). I believe that this data warrants a closer look. A pooled analysis of the Global Symplicity Registry and the SYMPLICITY–3 cohorts showed that renal denervation was more effective in lowering office blood pressure in patients with combined hypertension compared to those with isolated systolic hypertension (18.7 mm Hg drop in office SBP versus a 10.9 mm Hg drop, p<0.001) (2). Nevertheless, when examining the data more closely, pulse pressure in the ISH group was 87.9 mm Hg, compared to 74.5 mm Hg in the combined HTN group. The lack of benefit from renal denervation in the ISH group derived more from the wide pulse pressure, rather than the absolute DBP number. Still, with a pulse pressure of 74.5 mm Hg, — which is abnormal and indeed consistent with the diagnosis of ISH —, renal denervation was still very effective in lowering blood pressure. Another study identified central pulse pressure and systolic blood pressure, but not the DBP, also surrogate markers of vascular stiffness that predict outcomes following RDN (2). Henceforth emphasis should be placed more on widened pulse pressure rather than the absolute DBP number. It would be an error to deprive patients with uncontrolled hypertension and DBP in the 80s range from having renal denervation for blood pressure lowering, when their pulse pressure is within the 70–80 mm Hg range, since we know from available data at hand that they do benefit from the procedure. From a pathophysiological perspective, renal denervation is most effective in lowering blood pressure in patients whose hypertension is sympathetically driven. The number of medications and the degree of control of hypertension by itself are not determinants of who may or who may not benefit from the procedure. So, it is not about being on a maximally-tolerate dose or not, but rather on what is the underlying pathway driving the blood pressure elevation in the individual patient. While adding an antihypertensive medication may intuitively seem to be more cost effective than performing renal denervation, the underlying benefits of the procedure in diverse patient populations, encompassing left ventricular hypertrophy regression and improvement of diastolic function independently of blood pressure reduction, reducing cardiac arrhythmias rates including atrial fibrillation, reducing pill burden and improving overall adherence to antihypertensive therapy, and improving total time in target blood pressure may prove far more cost-effective for CMS on the long term when it comes to healthcare expenditures, hospitalizations and development of end-organ damage from uncontrolled HTN at the population level.

Omar Al Dhaybi, MD, MSc, FASN
Director, AHA Comprehensive Hypertension Center at Mount Sinai Fuster Heart
The Zena & Michael A. Wiener Cardiovascular Institute
1190 5th Avenue, Box 1030
New York, NY 10029

References:

1. Mahfoud F, Bakris G, Bhatt DL, et al. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100.
2. Ott C, Schmid A, Toennes et al. Central pulse pressure predicts BP reduction after renal denervation in patients with treatment-resistant hypertension. EuroIntervention 2015;11:110–116.
3. Böhm M, Linz D, Ukena C, et al. Renal denervation for the treatment of cardiovascular high risk-hypertension or beyond? Circ Res 2014;115:400-409.

Less

I have focused most of my career in medical practice and research on the treatment of hypertension. I am a former president of the American Society of Hypertension and the credentialing committee for hypertension specialists. I have served on the FDA’s Cardiovascular and Renal Drugs Advisory Board and was Chair of the Joint Writing Committee on Hypertension Practice Guidelines of the American and International Societies of Hypertension. Of recent relevance I have been a member of the clinical trial steering committees and advisory boards of both Medtronic and Recor, the two companies with FDA-approved renal denervation devices.
I believe the recent statement by CMS regarding coverage for RDN is a major step forward in making this therapy available to patients with uncontrolled hypertension. I have just 2 minor comments on the CMS statement:

1. Patient Criteria: CMS recommends that eligible patients should have BPs > 140/90 mmHg. I fully agree with the systolic cut point of 140 mmHg, but I believe that the diastolic cut point of 90 mmHg is too high. Most patients with so-called isolated systolic hypertension are at particularly high cardiovascular risk and have been shown to experience major benefits when their systolic values are decreased. For instance, the NIH’s SPRINT trial showed that older patients experienced highly significant benefits — especially CV mortality — when systolic values were reduced even when diastolic values were low. Patients with isolated systolic hypertension represent a very important at-risk group in clinical practice. At the very least I would strongly recommend that the criterion for eligibility for RDN be changed to >140/80 mmHg.
2. Facility Criteria: I support the comments made by others regarding the availability of hypertension expertise at facilities where RDN is performed. Organized groups such as Hypertension Centers exist in only a handful of medical centers across the United States, even though relevant specialists such as nephrologists, endocrinologists and internists are conveniently available at almost all institutions where renal denervation is likely to be offered. So, I would recommend that the CMS wording be slightly modified to require the availability of such expertise without the need for a formal hypertension organization.

Less

To: CMS
RE: Renal Denervation

I am an Interventional Cardiologist and Associate Professor of Medicine at Vanderbilt University Medical Center and have been the site principal investigator for multiple renal denervation trials since 2012. Specifically I have been our site PI for Symplicity III, the Radiance trials and the Spyral affirm trial. I am also a practicing clinician and see thousands of patients with uncontrolled HTN.
The number of patients we see with HTN is not surprising given the global pandemic that affects > 1 billion individuals worldwide (Mills. Nat Rev Nephrol. 2020;16:223-237). We know that lowering SBP by 5-10 points would reduce MI by 20%, stroke by 40% and CHF by 50% (Kannel. JAMA 1996; 275:1571-6). The good news is that we have seen SBP reductions by -6 to - 18 mmHg in multiple randomized renal denervation trials and registries (Böhm et al. Lancet 2020;395:1444-1451; Azizi et al. Lancet 2021; 397:2476-2486; Mahfoud et al. EHJ 2019; 20:3474-3482). We have seen in the Global Symplicity Registry (Mahfoud et al. EHJ 2019; 20:3474-3482) a -16.5 point drop in SBP that was sustained at 3 years. Extrapolating back to our population studies, we can only imagine the decreases in overall MI, CHF, and Stroke. The benefit to lives saved and costs to the health care system should not be underestimated.
As a practicing cardiologist I see many pts with uncontrolled HTN (> 140/90) despite >= 3 anti-htn meds. I also see patients with extremely high BP's > 160 who tolerate no meds due to side effects. They must live with the risks noted above. It is known that > 50% of patients are non-adherent to meds. Imagine the difficulty our > 65 yo population has taking > 3 meds 1-3 times per day. What if we could offer all of these types of individuals a therapy that can be administered once, and that is always "on". This is the promise of renal denervation.
We also see many patients who are socially disadvantaged and have difficulty with medication compliance due to financial and social factors. These patients would greatly benefit from a one time procedure which offers an “always on / always present” therapy.
In summary, coverage for Renal Denervation has the potential to save lives and overall health care costs by decreasing MI, Stroke, and CHF and their associated hospitalizations and other costly procedures (cardiac and neuro cath procedures, bypass surgery, and advanced chf therapies). I believe that as time passes, we will also see improvement in many other disease processes that involve the sympathetic nervous system including atrial fibrillation, another highly prevalent disease in our Medicare population. Thus, coverage of renal denervation should be considered an investment in the health and finances of the Medicare population and system respectively.

Pete Fong, MD, FSCAI, FACC

Less

I am writing to advocate for crucial adjustments to CMS's proposed NCD for renal denervation (RDN). As a physician, I firmly believe RDN is a vital tool for my patients with uncontrolled hypertension, yet current proposed criteria create unnecessary barriers. The proposed blood pressure threshold of >140/90 mmHg for eligibility is out of step with current ACC/AHA guidelines, which recognize Stage 1 hypertension at =130/80 mmHg. Cardiovascular risk begins at these lower levels, and clinical trials have effectively shown RDN's benefits for patients below the proposed cutoff. Limiting access to those with higher readings ignores a significant population in need.
Additionally, the proposed facility requirement for a multidisciplinary hypertension program, including a specific "hypertension clinician with longitudinal patient management responsibility" and a "hypertension navigator," is impractical for many institutions. In rural settings, clinicians often fill multiple roles, and dedicated resources for a hypertension navigator are limited. This does not equate to inferior care. There are only about 1,500 Certified Hypertension Specialists nationwide, making this requirement unrealistic for widespread implementation. Overly rigid facility requirements will delay or deny access in underserved areas. I urge CMS to broaden this definition to reflect the capabilities of diverse care settings and multidisciplinary teams.
Finally, the requirement for a primary clinician to manage the patient for at least six months with three encounters, only one virtual, is unduly restrictive. Our practice, like many, increasingly utilizes telehealth for efficient patient management. Mandating frequent in-person visits overlooks modern care delivery and patient convenience, particularly for those in rural areas. We can confirm uncontrolled hypertension through various means without such rigid constraints.
I urge CMS to revise these patient criteria to align with current clinical guidelines and real-world practice.

Less

Howard S. Bush, MD
Cleveland Clinic Florida
2950 Cleveland Clinic Blvd
Weston, Florida 33331
(954)659-5290
bushh@ccf.org

August 1, 2025

To: CMS

Re: National Coverage Determination for Renal Denervation

As a front-line physician confronting the severe consequences of uncontrolled hypertension, I am writing to underscore the profound need for novel therapies like renal denervation (RDN). The proposed CMS NCD for RDN is a welcome development, yet certain stipulations within it warrant careful reconsideration to prevent unintended barriers to patient access.

My primary concern relates to the facility criterion mandating a highly specific "multidisciplinary hypertension program" with prescribed roles, including a "hypertension navigator," —— this is potentially restrictive. While a team-based approach to hypertension care is valuable , such a rigid structure fails to recognize the diverse realities of clinical settings across the U.S.. With only approximately 1,500 certified hypertension specialists nationally, expecting all facilities to meet this level of formality is not realistic, especially for rural or community-based programs. I would advocate for broader language that emphasizes a "hypertension-trained clinician" and a multidisciplinary approach without dictating specific personnel or titles.

Lastly, the requirement for patients to be on stable doses of maximally tolerated GDMT for at least three months is not consistent with the pharmacokinetics of these medications. Most anti-hypertensive agents achieve their peak effect within several weeks, therefore, to require a three-month waiting period may prolong optimal control for patients. Access RDN should be considered once the medications have been optimally titrated and no further improvement in blood pressure is anticipated..

I urge CMS to consider these important and practical refinements into the final NCD.

Howard Bush MD FACC FSCAI

Less

I appreciate the thoughtful development of the proposed coverage for renal denervation (RDN). I urge CMS to carefully consider the following specific adjustments to optimize this policy.

Blood Pressure Eligibility Threshold Concerns

The current proposal limits eligibility to blood pressure exceeding 140/90 mmHg. The American College of Cardiology (ACC) and American Heart Association (AHA) define hypertension as follows:

• Stage 1: Systolic 130–139 mmHg or Diastolic 80–89 mmHg
• Stage 2: Systolic =140 mmHg or Diastolic =90 mmHg

Excluding Stage 1 patients denies timely intervention to patients still at significant cardiovascular risk despite intensive medical therapy. Moreover, it also limits treatment options for patients who may be near target, but receiving a significant medication burden (i.e., 4+ anti-hypertensive medications). Increasing number of medications results in decreased patient quality of life and compliance to therapy, as well as increased costs to the system (both directly and indirectly from complications of uncontrolled hypertension). Adopting thresholds that full encompass the diagnosis of hypertension would better align CMS policy with contemporary clinical practice and evidence-based guidelines.

Facility Requirements: Ambiguity on Clinician Qualifications

The proposed language referencing a "hypertension-trained clinician" lacks specificity. While I am a certified hypertension specialist, CMS should explicitly recognize cardiologists and nephrologists as inherently qualified clinicians, without additional certifications. Given the shortage of formally certified hypertension specialists nationwide (fewer than 1,500), failure to clarify this explicitly may severely restrict practice participation without a clinical, evidence-based reason.

Management Timeline and Telehealth Restrictions

Requiring six months of oversight with only one permitted virtual encounter is overly prescriptive. Many patients have extensive histories of medication optimization, often with more than one provider, making this timeline redundant and clinically unnecessary. Allowing clinician discretion and increased telehealth flexibility would reflect current clinical realities more effectively. It would also allow us, as consulting specialists, to be more respectful to our referring physicians. It is easy to understand how an internist would feel slighted if he referred a patient who is on maximal doses of a thiazide, a calcium channel blockers, an angiotensin receptor blocker, and a beta-blocker, but I were to inform him I cannot provide the treatment he referred the patient for because the patient has not seen me three times in half a year.

A far more important consideration is adequate documentation of the clinical need for the procedure. Patients who have been shackled to 3+ medications, who remain uncontrolled despite multiple agents, or who are unable to tolerate appropriate therapies due to side effects should not be restricted from receiving evidence-based care. A reasonable approach is to require two visits separated by at least a month for patients who have been on intensive regimen, or three visits over three months for patients who are only now starting their management journey.

Facility Program Requirements: Rigid and Potentially Restrictive

The mandate requiring hospitals to implement a formalized "multidisciplinary hypertension program" could pose unintended operational challenges, particularly for smaller community and rural hospitals. This would increase already existent healthcare disparities. Allowing greater flexibility, such as permitting collaboration among existing clinical staff (e.g., cardiologists, nephrologists, advanced practice providers), would better accommodate diverse hospital settings without compromising care quality or safety.

Thank you for addressing these vital considerations to refine and optimize this policy.

Less

I thank CMS for the opportunity to participate in public commentary for the proposed National Coverage Determination Statement regarding renal denervation (RDN) as an adjunctive treatment strategy for resistant hypertension (RH).
As a clinical and academic interventional cardiologist practicing in a high volume and enhanced acuity quaternary care health system, I have the privilege of providing care for adult patients across the spectrum of acute and chronic cardiovascular disease. Nearly all of these patients have baseline or newly diagnosed hypertension, a condition with an age-adjusted prevalence rate of nearly 50% among US adults and the leading modifiable risk for heart disease in the United States. Despite patient education and advances in pharmacotherapy, nearly 15% of all patients with treated hypertension are unable to achieve AHA target goal blood pressure <130/80 mm Hg, a condition known as resistant hypertension (RH). This cohort is particularly high risk, as they are nearly 36% more likely to develop heart failure and 26% more likely to have a non-fatal stroke compared to hypertensive patients who are responsive to therapies. It was in this context that I and many clinicians around the United States were pleased when the FDA approved the commercial release of ultrasound- and radiofrequency-guided RDN in November 2023 following clinical trial data demonstrating the safety and efficacy of this treatment strategy.
Over the last 15 months, I have offered select RH patient RDN therapy, and I have been pleased with the clinical results and excellent safety profile of this treatment strategy. With an aging population and associated cardiovascular co-morbidities, RDN presents a unique and novel treatment strategy for select patients in whom lifestyle modification measures and antihypertensive medications are not effective in achieving target blood pressures. The American Heart Association, Society for Cardiovascular Angiography and Interventions and the National Kidney Foundation have offered similar endorsement.
It is with this perspective that I would first like to thank CMS for synthesizing the NCA, as this is a landmark moment in helping to streamline the care of patients with RH. However after having read the document in detail, I would like to offer commentary on a few proposed criteria that may significantly limit coverage for patients who are clinically appropriate and may derive benefit from this therapy.

1. Patient Criteria (a) requires a systolic blood pressure of 140mmHg for this therapy with concomitant diastolic blood pressure of 90mmHg. This is above the current AHA/ACC guideline definition of uncontrolled hypertension, which defines Stage 1 as > 130 systolic OR > 90 diastolic. There is a large body of evidence demonstrating that patients with BP > 130 systolic or >90 diastolic suffer adverse health consequences as they may develop resistance to medications over time. Putting this requirement in place, beyond what is defined in the guidelines, will unfortunately limit patient access and contribute to adverse consequences for patients that might otherwise benefit from uRDN.
2. Patient Criteria (f) stated that a clinician must manage the patient for a minimum of six months before referral for RDN. Clinicians will posit is that this would substantially limit and delay patient access to this therapy. One would suggest removing this specific requirement around duration, number of visits, and the format of visits. In our practice, our multi-specialty hypertension team can determine when and if a patient is on maximally tolerated guideline directed therapy for hypertension at steady state. In many cases this can occur before a six-month timeline. Further, in the post COVID era, it is quite commonplace for me to manage blood pressure using telehealth visits and the requirement for in person visits seems quite obstructive.
3. Lastly, I would like to address Facility Criteria (a). This criteria states that a multidisciplinary hypertension program is required for facilities performing RDN. While this may a pragmatic proposition at academic and quaternary health systems, the specifics are not germane to how hypertension care is administered in community clinics and smaller health systems . As an example, there may be specialties other than the ones listed in these criteria managing complex hypertension patients. An alternative approach would be to omit specific requirements and personnel involved in the hypertension program to reflect a real world multidisciplinary practice.
Thank you again very much for your time and attention and please feel free to reach out to me if you have any questions about my comments on this important NCD.

References:
1. Martin SS et al. 2025 Heart disease and stroke stastistics: A report of US and global data from the American Heart Association. Circulation 2025
2. Carey RM et al. Prevalence of apparent treatment-resistant hypertension. Hypertension 2019
3. Kumbhani DJ et al. Resistant hypertension: a frequent and ominous finding among hypertensive patients with atherothrombosis. European Heart Journal 2012.
4. Kirtane AJ et al. Patient-level pooled analysis of ultrasound renal denervation in sham-controlled RADIANCE II, RADIANCE-HTN-SOLO and RADIANCE-HTN TRIO trials. JAMA Cardiology 2023
5. Mahmoud F et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): A randomized, sham-controlled trial. Lancet 2022.
6. Cluett JL et al. Renal denervation for the treatment of hypertension: A Scientific Statement from the American Heart Association. Hypertension 2024
7. Swaminathan RV et al. SCAI position statement on renal denervation for hypertension: Patient selection, operator competence, training and techniques, and organizational recommendations. JSCAI 2023
8. Blood Pressure Lowering Treatment Trialists’ Collaboration. Pharmacological blood pressure lowering for primary and secondary prevention for cardiovascular disease across different levels of blood pressure: an individual participant-level data meta-analysis. Lancet 2021.

Less

Hello,
I have been closely following your proposed national coverage decision regarding renal denervation (RDN). As a clinician who regularly navigates the complexities of treatment-resistant hypertension, I am encouraged by your recognition of this crucial therapeutic innovation. However, certain aspects of the current proposal raise genuine concerns about how practical and feasible implementation will truly be for my patients.
One major concern lies within the facility criteria, specifically the ambiguity regarding a “hypertension-trained clinician.” As someone who routinely performs specialized procedures, I fear that without clear guidance, hospitals will interpret this narrowly. Cardiologists and nephrologists, who handle advanced hypertension cases daily, might unjustly be excluded. There simply are not enough formally certified hypertension specialists to meet the inevitable demand. I have personally seen patients in smaller, community-based practices struggle to access treatments due to similarly ambiguous definitions in other policies. Clarifying explicitly that cardiologists and nephrologists inherently qualify would reassure hospitals and ultimately safeguard patient access.
The current blood pressure thresholds (above 140/90 mmHg) also merit reconsideration from a practical clinical perspective. Patients often present to my practice with blood pressures consistently in the high-130s systolic, well above the recommended 130/80 mmHg stage 1 threshold outlined by ACC/AHA guidelines. These patients are already facing increased cardiovascular risk and frustration after repeated medication failures. From a clinical standpoint, waiting for them to surpass the arbitrary 140/90 mmHg barrier before intervention seems both counterintuitive and potentially harmful.
In conclusion, the rigidly prescribed timeline—six months of stringent oversight and limited telehealth visits—appears disconnected from the actual clinical workflows I have observed. In reality, patients referred for RDN have typically undergone several years of meticulous blood pressure management, often under the supervision of multiple specialists. Imposing an additional six-month delay could potentially harm the very individuals we are attempting to safeguard.
I appreciate your thoughtful consideration of these practical perspectives. This therapy possesses transformative potential, and nuanced adjustments to your policy could have a profound impact on patients who require it most.

Less

Thank you for the opportunity to respond on this NCD for renal denervation. I have been using renal denervation (RDN) in several clinical trials over the past 3 years, and more recently commercially. I have found this to be a very safe procedure that my hypertensive patients have generally had a favorable response to this therapy with the majority achieving SBP < 140 mm Hg.

As I live in Mississippi, this population of patients has a large burden of uncontrolled hypertension, and likely contributes to our excessive cardiovascular morbidity and mortality. Many of our patients struggle with limited access to care, high medication burden, and medication related side-effects. I welcome this NCD as it will protect our patients access to medical care which based on the science and not denied access due to pure financial profit considerations — and based on my experience, this RDN NCD will offer a pathway to help lower blood pressure responsibly and sustainably, reduce poly HTN medication dependence, and likely reduce the risk of heart attacks, strokes, and kidney disease—especially in our underserved population.

My comments on the NCD specifics:

1) Isolated systolic HTN (SBP > 140 mm Hg) should be included as an inclusion criteria (even if diastolic BP is at goal) based on several trials including SHEP which looked at patients > 60 years.

2) Patients with prior stroke and perhaps history of other CV events, should be considered for RDN with BP >130/85 despite maximally tolerated BP meds, as they are at higher risk of future CV events due to even mild hypertension.

3) Patients with documented intolerance to anti-hypertensive medications should not be excluded. These patients need all the extra help they can get as medications may not be an option. I would support a pre-requisite trial of diuretics and ACE-I/ARB or calcium antagonist.

4) While I support coordinated hypertension care, the requirement for a formal hypertension program with a dedicated navigator is overly prescriptive and may limit access to this therapy, particularly in some rural and community hospital settings. I would, however, support a pre-requisite assessment for evaluation for secondary causes of hypertension.

5) To maintain quality and preserve patient safety, I support the provider and facility requirements in this NCD.

Less

As an interventional cardiologist who has been performing renal denervation procedures commercially for over a year, I write to express my strong support for national CMS coverage of renal denervation for the treatment of resistant hypertension. Hypertension remains the leading modifiable risk factor for cardiovascular disease and death in the United States. Despite decades of pharmacologic innovation, nearly half of all adults with hypertension are not adequately controlled. These patients face significantly higher risks of stroke, heart failure, chronic kidney disease, and premature death. Multiple rigorous, randomized, sham-controlled trials—including SPYRAL HTN-ON MED and SPYRAL HTN-OFF MED have demonstrated that renal denervation significantly reduces both ambulatory and office-based blood pressure beyond what is achievable with lifestyle and medications alone. Moreover, these studies consistently demonstrate that renal denervation is not only effective, but also safe, durable, and free from the adherence challenges and side effects associated with polypharmacy.

It is also critical to highlight that hypertension disproportionately impacts underserved communities, including racial and ethnic minorities, rural populations, and individuals with limited access to healthcare. These groups are more likely to experience uncontrolled hypertension and its downstream complications. The availability of renal denervation as a one-time, procedure-based intervention—particularly when delivered through community-focused programs and mobile health initiatives—offers a promising opportunity to close persistent gaps in hypertension control.

By providing CMS coverage, we can help ensure that this life-saving treatment is not limited to those with commercial insurance or access to large academic centers, but is accessible to the very populations that need it most. Given the strength of the evidence, the magnitude of the public health burden, and the opportunity to improve equity in care, I respectfully urge CMS to approve national coverage for renal denervation.

Thank you for the opportunity to comment.

Less

I am writing to express concern about the proposed requirement that facilities performing RDN must have a formal multidisciplinary hypertension program that includes a dedicated hypertension clinician with longitudinal management responsibility, a hypertension navigator, and contributions from multiple medical specialties. While I strongly support the goal of ensuring high-quality, coordinated hypertension care, I believe this level of programmatic infrastructure is overly prescriptive and may limit access to this therapy, particularly in rural and community hospital settings.

Many capable hospitals do not have the staffing or resources to support a formal hypertension program with a dedicated navigator. This does not reflect a lack of clinical competency, but rather the structural realities of smaller facilities that successfully manage complex conditions through cross-trained teams and shared roles.

Effective hypertension management often occurs through collaborative models involving cardiologists, internists, nephrologists, nurses, and advanced practice providers, even when not organized under a formally designated "program." Requiring a rigid team structure risks excluding centers that are otherwise capable of safely and effectively performing RDN.

Imposing strict structural requirements could delay implementation and reduce access to care for patients who might benefit from RDN, especially as health systems struggle with staffing shortages and resource constraints.

Less

Dear CMS Colleagues,

The following statement expresses support for the proposed NCD outlining Coverage with Evidence Development (CED) for renal denervation (RDN) for the treatment of uncontrolled hypertension.

39 million (60%) Medicare beneficiaries have hypertension. 29 million (75%) of these beneficiaries cannot achieve adequate blood pressure control, often due to medication intolerance, non-adherence, or the complexity of managing multiple drug regimens. These beneficiaries are at drastically increases the risk of serious complications such as stroke, heart attack, heart failure, and kidney disease.

Renal denervation (RDN) offers a promising option for these patients. As a minimally invasive, catheter-based procedure, RDN targets the overactivity of the sympathetic nervous system in the kidneys, which contributes to hypertension. Well-designed, appropriately powered, randomized controlled studies have shown that RDN can effectively lower blood pressure in patients with uncontrolled hypertension, including those resistant to traditional medical treatments.

The proposed NCD, with its CED framework, is a critical step in bringing this therapy to Medicare beneficiaries. The CED requirement ensures that while providing access to a potentially life-changing intervention, the collection of real-world data on its long-term effectiveness and safety within the Medicare population continues. This evidence is crucial for refining treatment algorithms, identifying the patients most likely to benefit, identifying disparities in Medicare beneficiary access and outcomes, and ensuring the responsible and cost effective integration of RDN into clinical practice.

The proposed NCD's emphasis on appropriate training and experience for physicians performing RDN, along with the required facility infrastructure, is appreciated. This focus on quality and patient safety is important for any new procedure and helps build confidence in the safe and cost-effective delivery of care.

By covering renal denervation under a CED framework, CMS is providing a pathway for Medicare beneficiaries to access an important new therapy that has the potential to:

• Significantly improve hypertension control in a population that often has limited alternatives.
• Reduce the long-term incidence of devastating complications such as stroke, myocardial infarction, and kidney failure.
• Potentially reduce medication burden for some patients, addressing issues of adherence and side effects.
• Generate essential real-world evidence to guide future clinical practice and coverage decisions.
• Reduce the overall cost of care by decreasing use of prescription antihypertensives and hypertension-related hospital admissions

I strongly urge CMS to finalize this NCD. This decision will help address a critical unmet need in hypertension management and improve the health and well-being of tens of millions of Medicare beneficiaries.

Sincerely,

Ezana Azene, MD, PhD
Vascular and Interventional Radiologist
Emplify Health
La Crosse, WI

Less

Less

Less

Less

Less

I wanted to thank CMS for recognizing the importance of providing access to RDN for hypertension patients and encourage expeditious review and publication of the final NCD

I am a board-certified interventional cardiologist and a hypertension specialist who works at a dedicated complex hypertension program at a large academic center. I have closely followed the clinical trials data for over a decade and have been performing renal denervation in the right states since it is approval in November 2023.

My own professional experience with this technology in my patients has been gratifying. Patients struggling to control the blood pressure on multiple therapies (some were intolerant to most therapies and thus are not on many medicines) derived significant blood pressure lowering to bring it in the safe zone.

I agree with the CMS proposal that these patients should have documented difficult to control blood pressure on tolerated medicines. I also agree that there should be some consistent follow-up by physicians primarily responsible for management of their blood pressure. I also agree with the need for post procedure follow-up real world setting.

I do have the following suggestions however which differ from the current proposal:

1. In my opinion, the suggested inclusion criteria of greater than 140/90 will exclude patients with isolated systolic hypertension. In my own experience, these patients have also derived significant benefit from this procedure. Many of these patients are at the highest risk of cardiovascular adverse events and since many of them are older are even more intolerant to side effects of medications such as orthostatic hypotension etc. which predisposes them to falls

2. While the procedure is unique, the technical skills are very similar to coronary interventions. Having performed a significant number of procedures myself with the current system of training, I feel confident that doing 5 cases under Proctorship of nonphysician trained industry representatives is adequate especially if they have undergone a robust virtual training session with an experienced physician discussing various cases and challenges.

3. While I agree with the patients having been adequately worked up for secondary causes and managed appropriately with medications prior to being referred, I believe a 6-month recommendation is too strict as most of these patients have struggled for decades and years through different providers. Thus, if a physician who routinely manages hypertension does a careful review of their prior history and medication use and documents inability to control blood pressure then a 6-month requirement should not be mandated. While HTN is a chronic disease, many of these patients have more urgent end organ issues such as worsening heart failure, worsening renal disease etc and have already been tried on most medications by various providers. Thus, when they see a HTN provider, a mere documentation of prior efforts and history should suffice.

4. The requirement for a hypertension navigator in my opinion would be difficult to fulfill due to cost issues for most centers. In my own center where we have a robust program for managing hypertension we worked closely with multiple specialties such as endocrinology and nephrology but even we do not have a dedicated hypertension navigator. I do believe it is important to have an identified team that manages hypertension and will see these patients before and in follow-up at least for a few months prior to sending them back to their referring physicians.

5. In my opinion RDN is an integral part of contemporary Hypertension Management and the physicians performing the procedure should be an integral part of the hypertension management team. Having built and participated in such a team in our center I feel that interventional cardiologists are most invested in hypertension and should be the primary proceduralist for this procedure.

Less

As an interventional cardiologist practicing in East Texas, I see numerous patients with varying degrees of hypertension. Additionally, I treat patients with complications of longstanding, poorly controlled hypertension despite medical management. Using American Heart Association estimates there roughly 100,000 patients in East Texas with hypertension. Of that number approximately 15% or 15,000 demonstrate some degree of resistance medical antihypertensive treatment. This would imply that the current standard of care for hypertension management is insufficient. Roughly 80% of patients with hypertension do not have their blood pressure under adequate control and approximately 50% of hypertension patients become noncompliant within about 1 year. Studies of hypertension management have demonstrated that even small declines in systolic blood pressure in the range of 5-10 mm of Hg have dramatic effects on long-term complications such as congestive heart failure, stroke, myocardial infarction and the development of end-stage renal disease (ESRD). In this region we predominantly see ESRD, because of hypertension, in our African American population. The mortality in this population is significantly greater than in white Americans. Additionally, we have a high proportion of hypertensive Hispanic patients, many of whom not received treatment. A large proportion of those who do are still not controlled.

Renal denervation presents an effective treatment option in these populations to help manage their hypertension. Extensive studies have been performed on the SPYRAL catheter. Clinical trials have demonstrated decreased blood pressure utilizing the SYMPLICITY RDN system without the need to increase medications. Additionally, the safety profile of this device has been excellent in clinical trials as well as in my own experience. I have been fortunate enough to participate in the SPYRAL AFFIRM trial here at UT Health East Texas in Tyler, Texas and this has granted us ample opportunity to utilize this device in a wide range of hypertensive patients in a real-world trial. That experience allows us comment on the efficacy and safety of this device as an adjunct in the management of hypertension.

Despite its effectiveness and safety, I certainly agree that renal denervation with the SPYRAL catheter or any system should not be considered a first-line treatment approach but, ultimately, should not be restricted only to those patients with treatment-resistant hypertension. Patients who may benefit from this procedure also include those patients who are intolerant or nonadherent to the antihypertensive medications or have elevated cardiovascular risk. Clinicians in conjunction with patients through shared decision-making will allow this procedure to be used in the most appropriate fashion. This would always involve an explanation of the denervation procedures risks and benefits and a discussion and incorporation of the patient's personal preferences in choosing a treatment plan.

I appreciate CMS recognizing the importance of treating hypertension through utilization of renal denervation in the Medicare population through opening this NCA. An expeditious review process and a final NCD will help to enhance patient access to what I feel is a crucial adjunct in the management of hypertension in the management of my patients.

References:

1 CMS NCA Tracking Sheet – Renal Denervation for Uncontrolled Hypertension. : https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=318&ncacaldoctype=all&status=all&sortBy=status&bc=17. Accessed 1/13/2025.

2 U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020

3 Centers for Medicaid and Medicare Services Office of Minority Health, Hypertension Disparities in Medicare Fee-For-Service Beneficiaries. [(accessed on 20 January 2023)];2023 Available online: https://www.cms.gov/Files/document/data-snapshot-hypertension-jan-2023.pdf .

4 World Health Organization. Hypertension fact sheet. https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed August 23, 2023.

5 Berra E, Azizi M, Capron A, et al. A. Evaluation of Adherence Should Become an Integral Part of Assessment of Patients With Apparently Treatment-Resistant Hypertension. Hypertension. 2016 Aug;68(2):297-306.

6 Muntner P, et al. Blood Pressure Control Among US Adults, 2009 to 2012 Through 2017 to 2020. Hypertension. 2022;79(9):1971-1980.

7 Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. March 5, 2016;387(10022):957-967.

8 Canoy D, Copland E, Nazarzadeh M, Ramakrishnan R, Pinho-Gomes AC, Salam A, Dwyer JP, Farzadfar F, Sundström J, Woodward M, Davis BR, Rahimi K; Blood Pressure Lowering Treatment Trialists' Collaboration; Blood Pressure Lowering Treatment Trialists Collaboration. Antihypertensive drug effects on long-term blood pressure: an individual-level data meta- analysis of randomized clinical trials. Heart. 2022 Jul 27;108(16):1281-1289.

9 Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association. Circulation. 2022;145(8). doi: https://doi.org/10.1161/cir.0000000000001052.

10 Aggarwal R, Chiu N, Wadhera RK, et al. Racial/Ethnic Disparities in Hypertension Prevalence, Awareness, Treatment, and Control in the United States, 2013 to 2018. Hypertension. 2021;78(6). doi: https://doi.org/10.1161/hypertensionaha.121.17570

11 Medtronic Symplicity Spyral multi-electrode renal denervation catheter Instructions for Use.

12 Mahfoud F, et al. Renal denervation results in substantial nocturnal BP reduction in patients with a reverse dipping pattern: Global SYMPLICITY Registry DEFINE. EuroPCR 2024.

13 Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham controlled trial. Lancet. 2020;395(10234):1444–1451.

14 Kandzari D, Townsend R, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov, 82 (19) 1809–1823.

15 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. April 9,2022;399(10234):1401–1410.

16 Mahfoud et al. Blood pressure and MACE reductions after renal denervation: 3-year GSR results. PCR2022.

17 Mahfoud, F, Mancia, G, Schmieder, R. et al. Renal Denervation in High-Risk Patients With Hypertension. JACC. 2020 Jun, 75 (23) 2879–2888.

18 Cluett JL, Blazek O, Brown AL, East C, et al.; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on the Kidney in Cardiovascular Disease; and Council on Peripheral Vascular Disease. Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Hypertension. 2024 Aug 5. doi: 10.1161/HYP.0000000000000240 Cluett JL, Blazek O, Brown AL, East C, et al.; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on the Kidney in Cardiovascular Disease; and Council on Peripheral Vascular Disease. Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association. Hypertension. 2024 Aug 5. doi: 10.1161/HYP.0000000000000240.

20 Swaminathan RV, East CA, Feldman DN, et al. 2023 SCAI position statement on Renal Denervation for hypertension: Patient selection, operator competence, training and techniques, and organizational recommendations. Journal of the Society for Cardiovascular Angiography & Interventions. 2(6),101121. https://doi.org/10.1016/j.jscai.2023.101121.

21 Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Böhm M. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug;80(8):1759-1770.

22 Kandzari DE, Townsend RR, Bakris G, Basile J, Bloch MJ, Cohen DL, East C, Ferdinand KC, Fisher N, Kirtane A, Lee DP, Puckrein G, Rader F, Vassalotti JA, Weber MA, Willis K, Secemsky E. Renal denervation in hypertension patients: Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF. Catheter Cardiovasc Interv. 2021 Sep;98(3):416-426.

Less

I have been involved with renal denervation in clinical trials and commercial use for many years. This technology is effective and can make difference for patients who often have been dealing with uncontrolled hypertension for years. I welcome the NCD rules but have a few comments:

1) the goal BP among hypertensive patients is <130/80 and therefore, if patients cannot achieve this goal with medications, renal denervation should be available for such patients (who have a BP >130/80).
2) Isolated systolic HTN should be included (even if diastolic BP is at goal).
3)There are some patients who do not tolerate antihypertensive medications, this is a small group of patients, but they absolutely also need to have access to renal denervation as only possible means to lower their hypertension-related risk.

Thank you for your attention!
Dr. Florian Rader, MD, MSc
Cedars-Sinai Hypertension Center of Excellence

Less

(E) known kidney or secreting adrenal tumors.
Needs specified…I assume it is meant that the patient must not have a functional neuro-hormonal tumor. This would include pheochromocytoma, adrenal adenoma, and hypernephroma.

(f) The primary clinicians must manage the patient for a minimum of six months before referral for RDN, during which the patient had at least three encounters, with no more than one of the three encounters being virtual.

How can I be sure my referred patient has this criterion? I don’t ever receive the last 3 notes over the last six months. This requirement is excessive and the spirit of this requirement is fulfilled in the criterion requiring max tolerated doses of GDMT.

The study requirements are vigorous. It would require funding for a local PI in addition to a study coordinator RN. What about IRB approval? This isn’t addressed. You mention it is a registry, so you may not think it is required, but patients should sign a form consenting for a registry. Also, how shall we consent the comparator group? You cannot give PHI to Medicare without consent. The current reimbursement obtained by the hospital barely covers the catheter and supplies. If this registry is needed, reimbursement for the hospital must increase substantially to cover these costs. Also, physician reimbursement should increase due to the time requirements for providing this data to the study coordinator about the active patient and the comparator patient.

Less

Uncontrolled hypertension remains a major contributor to cardiovascular morbidity and mortality in the United States, affecting millions of patients despite adherence to multiple antihypertensive medications. There is an urgent need for additional safe and effective treatment options for patients who are unable to achieve target blood pressure levels through lifestyle modification and pharmacologic therapy alone.

Renal denervation (RDN) is a catheter-based, minimally invasive procedure that reduces sympathetic nervous system activity, resulting in sustained reductions in blood pressure. Several high-quality, sham-controlled randomized clinical trials have demonstrated the efficacy and safety of RDN.

For example, the SPYRAL HTN-OFF MED trial showed that RDN significantly lowered both office and ambulatory blood pressures in patients not taking antihypertensive medications (Böhm et al., Lancet, 2017). Similarly, the RADIANCE-HTN TRIO trial demonstrated that RDN effectively reduced blood pressure in patients with resistant hypertension already on a standardized triple therapy regimen (Azizi et al., Lancet, 2021). Importantly, these benefits were achieved with a favorable safety profile, making RDN a promising adjunctive treatment strategy.

By providing Medicare coverage for RDN, CMS would enable access to this innovative therapy for a vulnerable patient population at high risk for adverse cardiovascular outcomes. Coverage would also encourage further data collection and long-term outcome monitoring, ultimately improving hypertension management and reducing downstream healthcare costs associated with complications such as stroke, heart failure, and chronic kidney disease.

From a population health perspective, we often encounter patients with uncontrolled hypertension who are unable to tolerate, adhere to, or afford multiple antihypertensive medications due to side effects, cost, or other social determinants of health. For these patients, blood pressure remains persistently elevated, putting them at high risk for cardiovascular and renal complications.

Renal denervation offers a unique, one-time procedural option that provides continuous, sustained (partial or optimal) blood pressure reduction — working 24/7 without the variability of medication highs and lows. This durable effect (even partial control) can improve long-term outcomes, reduce the burden of hypertension-related complications, and ultimately enhance quality of life. The benefits of this approach extend beyond individual patients, supporting broader population health goals and reducing healthcare system costs over time.

References:

Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomized, sham-controlled, proof-of-concept trial. Lancet. 2017;390(10108):2160-2170.

Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN TRIO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2021;397(10293):2476-2486.

Less

Less