There are currently no unique ICD-10-PCS codes to describe the noninvasive measurement of flow through a cerebrospinal fluid (CSF) shunt.
Hydrocephalus is a debilitating neurological disorder that results from the overproduction and/or impaired reabsorption of cerebrospinal fluid (CSF) in the ventricles of the brain. Hydrocephalus affects over 1 million people in the United States alone. In nearly all cases, the treatment involves surgical implantation of a pressure-regulated silicone tube assembly, known as a ‘shunt’. Ventricular shunt assemblies typically involve two silicone catheters, connected upstream and downstream of a regulating valve, to drain excess fluid away from the cerebral ventricles to a distal absorptive site, such as the peritoneum, pleural cavity, or right atrium. Unfortunately, shunts suffer from high failure rates, which results in an impaired quality of life for both patients and their caregivers due to the uncertainty associated with the potential for shunt failure.
FlowSense is a wireless, noninvasive thermal flow sensor that can be mounted on a patient’s neck overlying the shunt to detect the presence and magnitude of CSF. FlowSense enables monitoring of CSF flow, which can potentially eliminate delays with diagnostic testing and expedite appropriate triage and treatment for patients. FlowSense uses measurements of temperature and heat transfer to non-invasively tell if and how much fluid is flowing through a shunt in a hydrocephalus patient. Similar in size to a bandage, it is composed of soft silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app.
The procedure typically takes about 20 minutes and provides important spot check information on the presence of flow in the CSF shunt to a physician in order to assist in the determination of shunt function or malfunction. The procedure can be performed in the emergency department for patients showing symptoms of shunt malfunction, in a pre-operative setting for patients undergoing a CSF shunt revision surgery (to validate shunt malfunction), and in a post-operative setting after shunt placement surgery (to confirm functionality of a newly-implanted shunt). According to the requestor, the only known complication associated with this procedure is the potential for skin irritation due to the device adhesive. The FlowSense Noninvasive Thermal Sensor received Breakthrough Device Designation from the FDA in June 2020. The requestor intends to submit a New Technology Add-on Payment (NTAP) application in October 2021 for FY 2023 consideration. Effective 10/1/21 there will be a new code in section 4 table 4B0 Measurement of Physiological Devices, to identify the non-invasive assessment of the flow of cerebrospinal fluid (CSF) through an existing implanted CSF shunt.
Section 4 Measurement and Monitoring
Body System B Physiological Devices
Operation 0 Measurement: Determining the level of a physiological or physical function at a point in time
| Body System | Approach | Function/Device | Qualifier |
| 0 Central Nervous | X External | W Cerebrospinal Fluid Shunt | 0 Wireless Sensor |