CMS grants new reimbursement code for Pleural Dynamics’ ACES device

Pleural Dynamics' ACES device: ©Pleural Dynamics

The Centers for Medicare and Medicaid Services has issued a new Healthcare Common Procedure Coding System code and New Technology Ambulatory Payment Classification assignment for the ACES (Automatic Continuous Effusion Shunt) device, developed by Pleural Dynamics, to treat chronic pleural effusions.

The newly designated code, C8006, covers “insertion of pleural-peritoneal shunt with intercostal pump chamber, including imaging, injection(s) of contrast with radiological supervision and interpretation, when performed,” and establishes a reimbursement rate designed to support the clinical use of the ACES device.

“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 Martin Mayse, M.D., 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.”

The ACES Automatic Continuous Effusion Shunt System is the first and only fully implantable automatic effusion shunt that uses the motion of normal breathing to remove fluid from the chest. It is designed for continuous symptom relief without requiring an extended hospital stay, external catheters, or costly drainage canisters. The ACES System received FDA 510(k) clearance in August 2023 and is currently in early market release in the United States.

Existing treatments for recurrent pleural effusion, such as pleurodesis and indwelling pleural catheters, often fall short of providing long-term relief. Pleurodesis can be painful and may require extended hospitalization, while indwelling catheters involve external components and frequent manual drainage. The ACES device, by contrast, is implanted through a minimally invasive procedure and automatically transfers pleural fluid to the abdomen for reabsorption, potentially reducing hospitalizations and improving patient comfort.

Advances in pleural effusion management and minimally invasive thoracic care

The approval of new reimbursement pathways for devices like ACES reflects a broader shift in thoracic medicine toward minimally invasive, patient-centered technologies that reduce procedural burden and improve quality of life. Chronic pleural effusion—often caused by cancer, heart failure, or infection—remains a significant clinical challenge, with an estimated 150,000 new cases each year in the United States.

Recent innovations have focused on making drainage systems less invasive, more automated, and increasingly implantable, helping patients avoid frequent hospital visits and the discomfort of external catheters. These advancements align with a health care-wide trend toward ambulatory and home-based care, supported by better reimbursement models and new device classifications from CMS.

Additionally, the integration of smart sensing and pressure-regulated drainage technologies is improving how physicians monitor and manage pleural fluid accumulation over time. New-generation implants are being designed to respond to patient physiology automatically, minimizing the need for manual intervention.

In tandem, the development of biocompatible materials and low-profile implant designs is helping reduce infection risks and procedural complications, making long-term management safer for patients with recurrent effusions. As regulatory and reimbursement frameworks evolve to accommodate these devices, hospitals and outpatient facilities are better equipped to offer innovative, cost-effective alternatives to traditional procedures—potentially redefining the standard of care for pleural effusion management.