Summary & Overview
HCPCS C9758: Blinded Interatrial Shunt Implantation for NYHA III/IV Heart Failure
HCPCS Level II code C9758 represents a blinded transcatheter investigational procedure for patients with New York Heart Association (NYHA) class III or IV heart failure, involving implantation of an interatrial shunt or placebo control within an FDA-approved investigational device exemption (IDE) study. The code captures the implant procedure plus procedural diagnostics including right heart catheterization and imaging guidance such as transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
This code matters nationally as interatrial shunt therapies are an emerging interventional approach for advanced heart failure; capturing investigational procedures under a distinct HCPCS Level II code supports clinical trial billing clarity and payer policy development. Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will learn the clinical scope of the code, typical site-of-service and service components, and what to expect when encountering C9758 on a claim. The publication also summarizes benchmarking considerations, common modifiers associated with investigational or complex procedures, and the policy context for reimbursement and coverage of IDE study procedures. Data not available in the input is noted where applicable.
Billing Code Overview
HCPCS Level II code C9758 describes a blinded procedure for NYHA class III/IV heart failure in an approved investigational device exemption (IDE) study. The service encompasses transcatheter implantation of an interatrial shunt or a placebo control, and includes associated procedures performed as part of the study protocol: right heart catheterization, transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE), and all imaging with or without guidance (for example, ultrasound and fluoroscopy).
Service type: Transcatheter investigational interatrial shunt implantation (blinded) with diagnostic and imaging procedures included
Typical site of service: Cardiac catheterization laboratory or hybrid operating room within an investigational/clinical trial setting
Clinical & Coding Specifications
Clinical Context
A 72-year-old patient with chronic symptomatic heart failure, New York Heart Association (NYHA) class III despite guideline-directed medical therapy, is enrolled in an approved investigational device exemption (IDE) randomized, blinded trial evaluating a transcatheter interatrial shunt device versus placebo control. The patient meets inclusion criteria after multidisciplinary review and informed consent. On the day of procedure the workflow includes pre-procedure evaluation and consent confirmation, general anesthesia or monitored anesthesia care, right heart catheterization for hemodynamic assessment, transcatheter transseptal access, and either implantation of the interatrial shunt or a sham (placebo) control according to the randomized blind. Intraprocedural imaging with transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) is used for guidance; fluoroscopy and ultrasound facilitate vascular access, device placement, and confirmation of positioning. Hemodynamics are reassessed after device deployment or sham intervention. Post-procedure recovery includes monitoring for access complications, arrhythmia surveillance, echocardiographic and hemodynamic follow-up, and discharge planning with scheduled IDE follow-up visits and study-specific data collection.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier (standard) | Use when no specific modifier applies; report as the primary service in routine cases. |