Pleural Dynamics announced today that it received a new CMS code for its ACES (automatic continuous effusion shunt) device.
CMS issued a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (NTAPC) assignment for ACES, a device designed to treat chronic pleural effusions.
The new code, C8006, covers the insertion of a pleural-peritoneal hunt with an intercostal pump chamber. It includes imaging, injection(s) of contrast with radiological supervision and interpretation. The device now has a commensurate reimbursement level to support usage of the device.
Minneapolis-based Pleural Dynamics designed the ACES (automatic continuous effusion shunt) system as the first and only fully implantable automatic effusion shunt that uses the motion of normal breathing to remove fluid from the chest. It offers continuous symptom relief without requiring an extended hospital stay, a catheter external to the chest or expensive drainage canisters.
The device addresses the shortcomings of the current standards for care in treating pleural effusion, the company says. Its one-piece, fully implanted system offers a minimally invasive option for a short hospital stay.
ACES received FDA 510(k) clearance in August 2023. The company currently has the device in its early market release phase in the U.S. Earlier this year, the company completed enrollment in a post-market clinical study for the device as well.
“We commend CMS for creating an HCPCS code and granting a New Technology APC assignment for the ACES implant, an important step that validates both the clinical and resource needs associated with this novel procedure,” said Dr. Martin Mayse, CEO and co-founder of Pleural Dynamics. “With this reimbursement pathway, hospitals will now be better positioned to offer ACES, ensuring that more patients have access to a technology designed to improve outcomes, reduce repeat interventions, and enhance quality of life.”
