CMS Pub. 100-03, ch. 1, § 20.40

A. General

Renal Denervation (RDN) is used in the treatment of uncontrolled hypertension.

B. Coverage Criteria

The Centers for Medicare & Medicaid Services (CMS) covers radiofrequency renal

denervation (rfRDN) and ultrasound renal denervation (uRDN) (collectively RDN) for

uncontrolled hypertension when furnished according to a Food and Drug Administration

(FDA) market-authorized indication and all the following conditions are met:

1. Patient Criteria

The patient meets all the following criteria:

(a) Diagnosis of uncontrolled hypertension (≥ 140 mm Hg systolic blood pressure and >

90 mm Hg diastolic blood pressure) 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 lifestyle modifications and stable doses of maximally tolerated guideline-directed

medical therapy (GDMT), with assessment of adherence to the prescribed regimen, for at

least six weeks before referral for RDN.

(d) As clinically appropriate, secondary hypertension must be evaluated and treated

before determining that blood pressure remains uncontrolled. At a minimum, patients

must be screened for primary aldosteronism, obstructive sleep apnea, and drug or

alcohol induced hypertension before referral to RDN.

(e) The patient has no contraindications to RDN, consistent with the FDA labeling of the

device used.

(f) The primary clinicians must coordinate management of 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 two of the three encounters being virtual.

(g) No prior RDN procedure.

2. Physician Criteria

RDN is furnished by clinicians who meet the following criteria, as applicable:

(a) Clinicians referring Medicare beneficiaries must have longitudinal responsibility for

hypertension management.

(b) 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.

(c) 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. Additionally, they must complete at

least five proctored RDN cases with each approved device used in their practice.

(d) Physicians performing RDN with prior endovascular training and active

endovascular experience must complete at least five proctored RDN cases with each

approved device used in their practice.

3. Facility Criteria

The RDN device and related items and services are furnished at facilities meeting the

following criteria:

(a) Facilities performing RDN must have a hypertension program with contributions

from a hypertension clinician with longitudinal patient management responsibility, a

hypertension navigator, and access to relevant medical specialties (e.g., internal

medicine, endocrinology, sleep medicine, cardiology, and nephrology) as appropriate.

(b) Preprocedural imaging capabilities (e.g., ultrasound, Computed Tomography

Angiography, Magnetic Resonance Angiography).

(c) An appropriate interventional cardiology or radiology suite.

4. CED Study Criteria

The RDN device and related items and services are furnished in the context of a CMS-approved CED study. CMS-approved CED study protocols must: include only those

patients who meet the criteria in section B.1; furnish items and services only through

practitioners who meet the criteria in section B.2; furnish items and services at facilities

meeting the criteria in section B.3; and include all of the following:

(a) One or more primary outcomes of ambulatory systolic blood pressure (ASBP),

ambulatory diastolic blood pressure (ADBP), home systolic blood pressure (HSBP),

home diastolic blood pressure (HDBP), office systolic blood pressure (OSBP), office

diastolic blood pressure (ODBP), worsening renal function, cerebrovascular accident,

acute myocardial infarction, incidence of new-onset heart failure, cardiovascular

mortality, all-cause mortality, or a composite of these, through a minimum of 24

months. Each component of a composite outcome must be individually reported.

(b) An active comparator.

(c) Design sufficient for subgroup analyses by:

• Age (Stratify <65, 65-74, 75+);

• Other clinically important patient demographic factors;

• Chronic kidney disease (Stratify by CKD Stages);

• Progression of CKD;

• Hypertension phenotype (e.g., resistant hypertension vs. uncontrolled for any

reason);

• Medication adherence.

(d) In addition, CMS-approved CED studies must adhere to the scientific standards

(criteria 1-17 below) that have been identified by the Agency for Healthcare Research

and Quality (AHRQ) as set forth in Section VI. of CMS’ Coverage with Evidence

Development Guidance Document, published August 7, 2024 (the “CED Guidance

Document”).

1. Sponsor/Investigator: The study is conducted by sponsors/investigators with the

resources and skills to complete it successfully.

2. Milestones: A written plan is in place that describes a detailed schedule for

completion of key study milestones, including study initiation, enrollment

progress, interim results reporting, and results reporting, to ensure timely

completion of the CED process.

3. Study Protocol: The CED study is registered with ClinicalTrials.gov and a

complete final protocol, including the statistical analysis plan, is delivered to

CMS prior to study initiation. The published protocol includes sufficient detail to

allow a judgment of whether the study is fit-for-purpose and whether reasonable

efforts will be taken to minimize the risk of bias. Any changes to approved study

protocols should be explained and publicly reported.

4. Study Context: The rationale for the study is supported by scientific evidence and

study results are expected to fill the specified CMS-identified evidence deficiency

and provide evidence sufficient to assess health outcomes.

5. Study Design: The study design is selected to safely and efficiently generate valid

evidence of health outcomes. The sponsors/investigators minimize the impact of

confounding and biases on inferences through rigorous design and appropriate

statistical techniques. If a contemporaneous comparison group is not included,

this choice should be justified, and the sponsors/investigators discuss in detail

how the design contributes useful information on issues such as durability or

adverse event frequency that are not clearly answered in comparative studies.

6. Study Population: The study population reflects the demographic and clinical

diversity among the Medicare beneficiaries who are the intended population of

the intervention, particularly when there is good clinical or scientific reason to

expect that the results observed in premarket studies might not be observed in

older adults or subpopulations identified by other clinical or demographic

factors.

7. Subgroup Analyses: The study protocol explicitly discusses beneficiary

subpopulations affected by the item or service under investigation, particularly

traditionally underrepresented groups in clinical studies, how the inclusion and

exclusion requirements effect enrollment of these populations, and a plan for the

retention and reporting of said populations in the trial. In the protocol, the

sponsors/investigators describe plans for analyzing demographic subpopulations

as well as clinically-relevant subgroups as identified in existing evidence.

Description of plans for exploratory analyses, as relevant subgroups emerge, are

also included.

8. Care Setting: When feasible and appropriate for answering the CED question,

data for the study should come from beneficiaries in their expected sites of care.

9. Health Outcomes: The primary health outcome(s) for the study are those

important to patients and their caregivers and that are clinically meaningful. A

validated surrogate outcome that reliably predicts these outcomes may be

appropriate for some questions. Generally, when study sponsors propose using

surrogate endpoints to measure outcomes, they should cite validation studies

published in peer-reviewed journals to provide a rationale for assuming these

endpoints predict the health outcomes of interest. The cited validation studies

should be longitudinal and demonstrate a statistical association between the

surrogate endpoint and the health outcomes it is thought to predict.

10. Objective Success Criteria: In consultation with CMS and AHRQ,

sponsors/investigators establish an evidentiary threshold for the primary health

outcome(s) so as to demonstrate clinically meaningful differences with sufficient

precision.

11. Data Quality: The data are generated or selected with attention to provenance,

bias, completeness, accuracy, sufficiency of duration of observation to

demonstrate durability of health outcomes, and sufficiency of sample size as

required by the question.

12. Construct Validity: Sponsors/investigators provide information about the validity

of drawing warranted conclusions about the study population, primary

exposure(s) (intervention, control), health outcome measures, and core covariates

when using either primary data collected for the study about individuals or

proxies of the variables of interest, or existing (secondary) data about individuals

or proxies of the variables of interest.

13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of

results by conducting pre-specified sensitivity testing using alternative variable or

model specifications as appropriate.

14. Reporting: Final results are provided to CMS and submitted for publication or

reported in a publicly accessible manner within 12 months of the study’s primary

completion date. Wherever possible, the study is submitted for peer review with

the goal of publication using a reporting guideline appropriate for the study

design and structured to enable replication. If peer-reviewed publication is not

possible, results may also be published in an online publicly accessible registry

dedicated to the dissemination of clinical trial information such as

ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g.,

for studies with incomplete results).

15. Sharing: The sponsors/investigators commit to making study data publicly

available by sharing data, methods, analytic code, and analytical output with

CMS or with a CMS-approved third party. The study should comply with all

applicable laws regarding subject privacy, including 45 CFR § 164.514 within

the regulations promulgated under the Health Insurance Portability and

Accountability Act of 1996 (HIPAA) and 42 CFR, Part 2: Confidentiality of

Substance Use Disorder Patient Records.

16. Governance: The protocol describes the information governance and data

security provisions that have been established to satisfy Federal security

regulations issued pursuant to HIPAA and codified at 45 CFR Parts 160 and 164

(Subparts A & C), United States Department of Health and Human Services

(HHS) regulations at 42 CFR, Part 2: Confidentiality of Substance Use Disorder

Patient and HHS regulations at 45 CFR Part 46, regarding informed consent for

clinical study involving human subjects. In addition to the requirements under 42

CFR and 45 CFR, studies that are subject to FDA regulation must also comply

with regulations at 21 CFR Parts 50 and 56 regarding the protection of human

subjects and institutional review boards, respectively.

17. Legal: The study is not designed to exclusively test toxicity or disease

pathophysiology in healthy individuals, although it is acceptable for a study to

test a reduction in toxicity of a product relative to standard of care or an

appropriate comparator. For studies that involve researching the safety and

effectiveness of new drugs and biological products aimed at treating life-threatening or severely-debilitating diseases, refer to additional requirements set

forth in 21 CFR § 312.81(a).

Consistent with section 1142 of the Act, AHRQ supports clinical research studies that

CMS determines meet all the criteria and standards identified above.

C. National Non-Covered Indications

RDN is not covered for patients outside of a CMS-approved study.

D. Other

Nothing in this NCD would preclude coverage of RDN through NCD 310.1 (Clinical

Trial Policy) or through the Investigational Device Exemption (IDE) Policy.

(This NCD last reviewed October 28, 2025)