Prior Approval

Not applicable.

Device, procedure, and selection documentation

Radiofrequency and ultrasound renal denervation procedures must be documented in the prior authorization and medical record with device and procedure details, including: device platform and model (eg, Symplicity Spyral, Paradise ReCor), catheter type (RFA multielectrode spiral vs ultrasound balloon), laterality (unilateral vs bilateral), arterial access site and approach, intraprocedural imaging/fluoroscopy, number and location of energy applications (main artery and branch treatments when performed), and any adjunctive angiography or pressure measurements.

• Specify device manufacturer and model
• Document catheter type and single-use component HCPCS (eg, C1735, C1736) when available
• Record number/location of ablations and whether accessory renal arteries were treated

Prior authorization: baseline BP and treatment history

Prior authorization requests must include baseline blood pressure measurements and a detailed history of antihypertensive treatment attempts. Provide office BP readings (with dates), daytime ambulatory or 24-hour ambulatory BP values, and documentation of medication regimens, doses, duration, and any intolerance or contraindications.

• List current and prior antihypertensive medications with dose and duration
• Provide dates and results of out-of-office BP testing (daytime ambulatory, 24‑hour ambulatory, or home BP)
• If medication washout was used in trial-like evaluation, document timing relative to ambulatory monitoring

Evidence-based eligibility documentation

Eligibility documentation should mirror the populations and entry criteria used in sham‑controlled trials: daytime ambulatory SBP thresholds, office SBP/DBP ranges, renal function limits, and anatomic suitability. Include explicit exclusions (eg, renal artery stenosis, fibromuscular dysplasia, eGFR <40 mL/min/1.73 m2) and evidence that white‑coat and secondary hypertension were assessed and excluded where appropriate.

• Document daytime ambulatory SBP and/or 24‑hour SBP consistent with trial thresholds (eg, daytime ambulatory SBP ≥135 mmHg or 24‑h SBP ≥140 mmHg where applicable)
• Office SBP/DBP ranges used in trials (eg, office SBP ≥140–180 mmHg; DBP ≥90 mmHg as specified)
• eGFR value to confirm ≥40 mL/min/1.73 m2 when required by device/trial criteria
• Anatomic assessment (renal artery imaging) documenting absence of significant stenosis, aneurysm, or FMD

Selection and multidisciplinary assessment recommended

A multidisciplinary evaluation and shared decision-making process is recommended prior to RDN. Prior authorization should include documentation of specialty input (hypertension specialist, interventional cardiologist/radiologist), risk–benefit discussion, and patient preference when medication intolerance or refusal is a factor.

• Record names/specialties of clinicians involved in the evaluation
• Document that benefits, risks, and alternatives (continued medical therapy) were discussed with the patient
• Include note on patient preference, intolerance to medications, or inability to adhere to pharmacotherapy

Prior authorization for listed procedure/device codes

Prior authorization and claims should reference the appropriate procedure and device codes. Use Category III CPT codes when available for transcatheter RDN (0338T unilateral, 0339T bilateral) or other applicable codes; list HCPCS supply codes for single‑use catheters. Misuse of codes may lead to denial or investigational status determinations.

• Report CPT codes 0338T (unilateral) or 0339T (bilateral) when applicable and note Category III status
• Include HCPCS C1735 for RFA renal denervation catheter and C1736 for ultrasound renal denervation catheter when billing device components
• Attach operative note and device model to claims

Investigational treatment denial risk

Radiofrequency and ultrasound renal denervation are considered investigational per policy because current evidence is insufficient to determine net health benefit. Requests for RDN may be denied when patient selection, documentation, or coding do not align with policy or trial‑based eligibility.

• All Category III codes are considered investigational unless explicitly covered by policy
• Procedures not meeting documented eligibility or lacking required prior authorization information risk denial

Claims may be questioned if patient sele

Claims may be questioned or denied if patient selection does not align with populations studied in trials or if documentation does not verify trial‑consistent evaluation. Common issues include lack of out‑of‑office BP confirmation, incomplete medication history, absent multidisciplinary evaluation, or anatomical contraindications.

• Absence of daytime ambulatory or 24‑hour BP confirmation
• Incomplete antihypertensive medication history or lack of documented attempts at optimization
• Missing renal artery imaging or eGFR documentation

medication stability/adherence documentation

Demonstrate medication stability and adherence when applicable. Trials either required medication washout (OFF‑MED studies) or stable medication regimens for a defined period (ON‑MED studies). For ON‑MED evaluations, document stable doses for at least the trial-specified duration (eg, ≥6 weeks) and adherence assessments where performed.

• Document medication adherence assessment methods and results
• If ON‑MED pathway: show stable antihypertensive doses and durations (eg, ≥6 weeks at ≥50% of max dose where trial-specified)
• If OFF‑MED pathway: document timing of medication washout relative to ambulatory monitoring

Unclear patient selection and verification of effect

There is currently no validated periprocedural clinical indicator to confirm successful renal nerve destruction, creating uncertainty about which patients will benefit. Prior authorization should therefore emphasize appropriate patient selection, multidisciplinary evaluation, and adherence to trial‑based anatomic and clinical criteria to mitigate uncertain efficacy.

• Acknowledge lack of intra‑procedural biomarker of nerve ablation success in documentation
• Ensure selection criteria and anatomy are consistent with research protocols

Trial-based workup expectations

Expectations for pre-procedure workup should follow trial protocols: rule out secondary hypertension, perform out‑of‑office BP testing (daytime ambulatory or 24‑hour ambulatory), optimize medical therapy or document intolerance, assess renal function and renal artery anatomy, and obtain multidisciplinary review. Failure to perform a trial‑based workup may increase the risk of denial.

• Secondary causes workup (labs, imaging) documented and treated if present
• Out‑of‑office BP testing results included (ambulatory/home)
• Renal imaging and eGFR documented, and multidisciplinary team consultation noted

Coding and documentation

Coding and documentation must use Category III CPT codes when applicable and include device identifiers and operative details. Incorrect coding (eg, use of unlisted CPT instead of 0338T/0339T when Category III code exists) or omission of device HCPCS supply codes may lead to claim denials and classification as investigational.

• Use CPT 0338T/0339T when appropriate
• Include HCPCS C1735/C1736 for single‑use catheters in claim attachments
• Attach operative report with device model and serial numbers when available

Relevant trial eligibility elements incl

Relevant trial eligibility elements should be provided in authorization requests: patient age range, baseline office SBP/DBP, daytime ambulatory or 24‑hour SBP thresholds, eGFR limits, and prior medication regimen (number of agents and stability). These align with the populations evaluated in RADIANCE, SPYRAL, and related trials.

• Age criteria as studied (eg, adult participants typically 18–80 years depending on trial)
• Office SBP/DBP thresholds and ambulatory SBP thresholds used in trials (examples: office SBP ≥140–180 mmHg; daytime ambulatory SBP ≥135 mmHg; 24‑h SBP ≥140 mmHg)
• eGFR ≥40 mL/min/1.73 m2 when required by device/trial

Required clinical documentation elements

Required clinical documentation elements for prior authorization include a complete antihypertensive medication list (agents, doses, start dates), adherence assessment, out‑of‑office BP results with dates, renal function (eGFR), renal artery imaging, and notes from multidisciplinary evaluation including rationale for proceeding to RDN.

• Complete medication list with documentation of intolerance or nonadherence if applicable
• Medication timing relative to ambulatory monitoring (if washout performed)
• Out‑of‑office BP reports (ambulatory/home) with dates and values
• eGFR and relevant labs
• Renal artery imaging (CTA, MRA, or angiography) and operative planning notes
• Multidisciplinary consultation notes and shared‑decision documentation

Required baseline measurements

Required baseline measurements include daytime ambulatory SBP (preferred), 24‑hour average SBP, office SBP/DBP, and eGFR. Ambulatory measurements should be used to exclude white‑coat hypertension and to match trial endpoints.

• Daytime ambulatory SBP with date (eg, ≥135 mmHg threshold used in several trials)
• 24‑hour average SBP when available (eg, ≥140 mmHg in some trials)
• Office SBP/DBP readings with dates
• Serum creatinine and eGFR with date

Multidisciplinary evaluation and shared decision-making

Multidisciplinary evaluation and shared decision‑making should be documented, including inputs from hypertension specialists and proceduralists, discussion of alternative treatments (continued medical therapy vs RDN), and a record of patient consent after counseling on risks, benefits, and uncertainties.

• Document specialist consults (names and specialties)
• Shared decision‑making discussion and informed consent note
• Rationale for choosing RDN over further medical optimization when applicable

Clinical justification and specialty input

Clinical justification should specify why RDN is being pursued (resistant hypertension despite maximally tolerated regimens, intolerance to medications, documented nonadherence, or patient preference after counseling). Specialty input (eg, hypertension expert, interventionalist) should endorse the plan.

• State whether patient meets resistant hypertension definition or other justification (intolerance, nonadherence)
• Include specialist sign‑offs or recommendations supporting RDN

Required clinical evaluation documentation

Required clinical evaluation documentation must confirm exclusion of white‑coat and secondary hypertension, document renal artery anatomy suitable for the procedure, and list contraindications considered (eg, renal artery stenosis, aneurysm, FMD, eGFR <40). Treatable secondary causes should be addressed prior to referral.

• Evidence excluding white‑coat hypertension (ambulatory/home BP)
• Workup results for secondary causes (if suspected) and management plan
• Renal artery imaging confirming suitable anatomy and absence of exclusions

Therapy positioning

Therapy positioning: RDN is positioned as an adjunctive, nonpharmacologic option after optimization of medical therapy and lifestyle measures, or for patients intolerant of additional pharmacotherapy or unwilling/unable to adhere to medications. It is not a first‑line substitute for guideline‑recommended medical therapy.

• RDN considered adjunctive to BP medications and lifestyle interventions
• Preferential consideration for those with resistant hypertension, medication intolerance, or documented nonadherence

Patients in trials continued or were com

In many trials, patients randomized to RDN continued background antihypertensive therapy (ON‑MED trials) or were studied after supervised medication washout (OFF‑MED trials). Prior authorization should clarify whether the evaluation pathway followed an ON‑MED or OFF‑MED approach and include supporting documentation.

• State whether patient evaluation followed ON‑MED (stable meds) or OFF‑MED (washout) trial paradigms
• Attach documentation of medication stability or washout timing

conservative therapy attempted

Conservative therapy should be attempted and documented prior to RDN referral. Document lifestyle interventions (diet, exercise, sodium reduction, weight loss) and attempts at medication optimization, including use of guideline‑recommended medication classes and diuretics where indicated.

• Record lifestyle modification counseling and follow‑up
• Document trials of guideline‑based medication regimens and any barriers encountered (intolerance, nonadherence)

Step therapy vs continued medical treatment

Step therapy versus continued medical treatment: RDN is typically considered after attempts at medical escalation per guidelines. However, formal payer step‑therapy protocols are not specified; instead, documentation must show prior appropriate medical therapy or justified intolerance/refusal.

• No payer‑specified step therapy is mandated; include clinical rationale if step escalation was not completed
• Document medication classes tried and reasons for not escalating therapy when applicable

Optimization of medical therapy prior to procedure

Optimization of medical therapy prior to procedure is expected. Trials and society guidance emphasize maximally tolerated doses of guideline‑directed agents (including thiazide diuretics) and assessment for adherence before considering RDN.

• Document attempts to optimize antihypertensive regimen and doses
• Include rationale when additional agents were not added (intolerance, patient preference)

Medication optimization recommended prior to RDN

Medication optimization is recommended prior to RDN per society guidance. Ensure use of agents with outcome data (ACE inhibitors/ARBs, calcium channel blockers, thiazide diuretics, beta‑blockers when indicated) at maximally tolerated doses unless contraindicated.

• Detail classes and doses tried and outcomes
• Note contraindications or adverse effects that preclude further optimization

No step therapy specified

No specific payer step therapy sequence is specified in this policy. Clinical documentation should therefore focus on demonstrating appropriate attempts at guideline‑based therapy, intolerance, or documented nonadherence to justify proceeding to RDN evaluation.

• Clarify that absence of a formal step therapy requirement does not obviate need for documentation of medical therapy attempts

Therapy optimization before RDN

Therapy optimization before RDN should mirror trial protocols when possible: confirm out‑of‑office BP, optimize or document intolerance to medications, and ensure renal function and anatomy are suitable. Patient preference and shared decision‑making may justify proceeding when optimization is limited by intolerance or nonadherence.

• Follow trial‑aligned workflows for medication stability/washout and ambulatory BP testing
• Document shared decision outcomes when medical optimization is incomplete due to validated reasons

Medication trial and patient preference

When a medication trial cannot be tolerated or the patient prefers an interventional approach, document the trial of therapy, reasons for intolerance or refusal, and that the decision for RDN was reached after multidisciplinary discussion and informed consent.

• Document adverse effects or contraindications leading to medication discontinuation
• Capture patient's informed preference and consent after counseling on alternatives