Summary: The Centers for Medicare & Medicaid Services modified NCD 382 to establish formal Medicare coverage for renal denervation (RDN) for uncontrolled hypertension, effective March 25, 2026. Here's what billing teams need to do.
CMS renal denervation coverage policy under NCD 382 Medicare is new territory. Before this modification, RDN had no established national coverage path under Medicare. Now it does — but the criteria are dense, the facility and physician requirements are layered, and coverage is tied to a Coverage with Evidence Development (CED) study requirement. This post breaks down every condition your team needs to document before a claim touches a payer's desk.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Renal Denervation (RDN) for Uncontrolled Hypertension |
| Policy Code | NCD 382 |
| Change Type | Modified |
| Effective Date | March 25, 2026 |
| Impact Level | High |
| Specialties Affected | Interventional Cardiology, Interventional Radiology, Nephrology, Internal Medicine, Hypertension Programs |
| Key Action | Confirm your facility meets the hypertension program and CED enrollment requirements before billing any RDN claim after March 25, 2026 |
CMS Renal Denervation Coverage Criteria and Medical Necessity Requirements 2026
CMS covers two types of RDN under NCD 382: radiofrequency renal denervation (rfRDN) and ultrasound renal denervation (uRDN). Both are covered — but only when furnished under an FDA market-authorized indication and only when every condition in the policy is met. That's not a soft standard. This policy reads like a checklist, and your documentation needs to match it item by item.
The medical necessity bar here is high by design. CMS is covering a procedure with a limited long-term evidence base, so it's wrapping coverage in requirements meant to generate more data. That's the CED model — Coverage with Evidence Development — and it means reimbursement is tied to study participation, not just clinical appropriateness.
Patient Criteria
Before a physician can refer a patient for RDN, six patient-level criteria must all be met:
The patient must have a diagnosis of uncontrolled hypertension — specifically, systolic blood pressure at or above 140 mm Hg and diastolic blood pressure above 90 mm Hg — despite active management by a clinician with primary responsibility for blood pressure control. Measurement must come from ambulatory blood pressure monitoring or serial home blood pressure readings, not a single office reading.
The patient must be on lifestyle modifications and stable doses of maximally tolerated guideline-directed medical therapy (GDMT) for at least six weeks before referral. Adherence must be assessed and documented. This isn't a vague requirement — if your chart notes don't show an explicit adherence assessment, the claim is exposed.
Secondary hypertension must be evaluated and treated before RDN referral. At minimum, that means screening for primary aldosteronism, obstructive sleep apnea, and drug- or alcohol-induced hypertension. Missing any of these screens is a medical necessity documentation gap.
The referring clinician must have coordinated management for at least six months before referral. During that time, the patient must have had at least three encounters — and no more than two of those three can be virtual. That in-person visit requirement will catch practices off guard if they've been running mostly telehealth-based hypertension management.
Finally, the patient must have no contraindications to RDN per the FDA labeling of the specific device used, and must have no prior RDN procedure.
Physician Criteria
The performing physician requirements under this coverage policy are some of the most specific CMS has put into an NCD in years.
Physicians without prior endovascular training must complete at least 10 supervised cases of diagnostic or therapeutic renovascular procedures — half as primary operator — plus at least five proctored RDN cases with each approved device they use. Physicians who already have endovascular training and active experience still need to complete five proctored RDN cases per device. The credentialing documentation for your performing physicians needs to exist before you bill. Get it in the file now, not after the first denial.
Facility Criteria
Your facility must have a formal hypertension program. That program needs a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and access to specialties including internal medicine, endocrinology, sleep medicine, cardiology, and nephrology.
The facility must also have preprocedural imaging capabilities — ultrasound, CT angiography, or MR angiography — and an appropriate interventional cardiology or radiology suite. If your facility can't document all of this, you don't meet the coverage criteria. Period.
CMS Renal Denervation Exclusions and Non-Covered Indications
CMS does not cover RDN outside of FDA-authorized indications. Any use of rfRDN or uRDN for an indication not explicitly authorized by the FDA under the device's market authorization falls outside this coverage policy.
Patients who have had a prior RDN procedure are excluded. There's no coverage for repeat procedures. This is a lifetime restriction, not a time-limited one.
Patients who don't meet the six-month, three-encounter coordination requirement before referral are not eligible — even if they clinically qualify in every other way. That documentation failure alone will generate a claim denial. The same applies if a facility lacks the required hypertension program infrastructure.
Coverage Indications at a Glance
| Indication | Status | Notes |
|---|---|---|
| Radiofrequency RDN (rfRDN) for uncontrolled hypertension per FDA authorization | Covered | All seven patient, physician, and facility criteria must be met; CED study enrollment required |
| Ultrasound RDN (uRDN) for uncontrolled hypertension per FDA authorization | Covered | Same criteria apply as rfRDN |
| RDN for secondary hypertension (not yet evaluated or treated) | Not Covered | Secondary causes must be screened and treated first |
| Repeat RDN (prior procedure history) | Not Covered | Lifetime one-procedure limit |
| RDN outside FDA market-authorized indication | Not Covered | No coverage for off-label device use |
| RDN at facility without required hypertension program | Not Covered | Facility must meet all structural criteria |
| RDN by physician without required training or proctored cases | Not Covered | Credentialing requirements are mandatory, not optional |
| RDN without CED study enrollment | Not Covered | Coverage is contingent on CMS-approved study participation |
CMS Renal Denervation Billing Guidelines and Action Items 2026
The effective date of March 25, 2026 is close. Here's what your team needs to do before then.
| # | Action Item |
|---|---|
| 1 | Confirm CED study enrollment now. Coverage under NCD 382 requires that RDN be furnished in the context of a CMS-approved Coverage with Evidence Development study. If your facility is not enrolled in an approved registry or trial, renal denervation billing will result in denial regardless of clinical compliance. Contact your facility's research or compliance team immediately to identify the approved study and confirm enrollment status. |
| 2 | Build a pre-referral documentation checklist. Every referral for RDN must be backed by documentation showing: ambulatory or home BP monitoring results confirming uncontrolled hypertension (≥140/90), six weeks of stable GDMT with adherence assessment, completed secondary hypertension screening (primary aldosteronism, OSA, drug/alcohol-induced hypertension), and six months of coordinated care with at least three encounters — including at least one in-person visit. If your referral workflow doesn't generate all of this automatically, fix it before March 25, 2026. |
| 3 | Verify physician credentialing files before the first case. Pull the training and proctoring records for every physician who will perform RDN at your facility. Confirm they meet the training thresholds: five proctored cases per device for endovascularly trained physicians, 10 supervised renovascular cases plus five proctored RDN cases per device for those without that background. These records need to be in the physician file, not in someone's memory. |
| 4 | Audit your facility's hypertension program structure. CMS requires a named hypertension clinician with longitudinal responsibility, a hypertension navigator, and access to the relevant specialty network. If your program doesn't have a documented navigator role or lacks reliable access to sleep medicine or endocrinology, that's a coverage gap. Document the program structure in writing before you bill. |
| 5 | Confirm FDA device authorization for each device used. Coverage is tied to FDA market-authorized indications for each device. If your facility is using more than one RDN device, confirm that each one has current FDA authorization for the indication being treated. Don't assume — get the authorization documentation on file. |
| 6 | Set up a claim denial tracking flag for RDN. Because this is a new coverage pathway with heavy documentation requirements, early claim denial rates will be informative. Flag all RDN claims starting March 25, 2026 and monitor denial patterns at 30, 60, and 90 days. Early denials will tell you where your documentation process is breaking down. |
| 7 | Talk to your compliance officer before your first case. The CED requirement, the physician credentialing standards, and the facility program requirements all interact in ways that are easy to misread. If you're uncertain how the CED enrollment obligation applies to your specific facility or practice arrangement, loop in your compliance officer before March 25, 2026 — not after your first denial. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Renal Denervation Under NCD 382
The Centers for Medicare & Medicaid Services did not publish specific CPT or HCPCS codes in the NCD 382 policy document at the time of this modification. This is not unusual for a newly established coverage pathway — codes are often established or crosswalked through separate transmittals or Medicare Administrative Contractor guidance after an NCD is finalized.
What This Means for Your Billing Team
Do not assume existing catheter-based procedure codes map cleanly to rfRDN or uRDN. Billing renal denervation under a general interventional code without confirmed payer guidance increases your exposure to claim denial and potential overpayment recovery.
Watch for updates from your Medicare Administrative Contractor. The MAC serving your region will issue guidance on billing codes for RDN under NCD 382. Sign up for MAC transmittals if you haven't already. When code guidance is published, update your charge capture immediately — don't wait for the first claim to come back wrong.
Check the CMS transmittal system and the approved CED study protocols. CED studies often include billing guidance specific to the registry, and the study protocol may specify codes required for data capture. Your billing team and your research team need to be talking to each other before the first case goes to the OR.
PayerPolicy will update this post when CMS or the applicable MACs publish billing code guidance for NCD 382.
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.