Boston Scientific’s coronary DCB gains new Medicare reimbursement
Boston Scientific has received improved Medicare reimbursements for its Agent Drug-Coated Balloon (DCB), a device approved by the U.S. Food and Drug Administration (FDA) for the treatment of coronary in-stent restenosis in patients with coronary artery disease.
The Agent DCB targets scar tissue with a therapeutic dose of paclitaxel to help reduce the risk of in-stent restenosis. The U.S. Centers for Medicare and Medicaid Services (CMS) has now officially approved a new technology add-on payment (NTAP) to be used by care teams when treating patients with an Agent DCB. The NTAP goes into effect on Oct. 1.
CMS uses NTAPs to provide additional payments when newer technologies are associated with significant clinical benefits and costs that could be high enough to limit implementation.
“The CMS determination is a positive development for patients with in-stent restenosis and supports clinical findings that the Agent DCB is statistically superior to conventional balloon angioplasty for treating the condition,” Lance Bates, a senior vice president with Boston Scientific and president of the company’s interventional cardiology therapies division. “We applaud this ruling as it will allow hospitals to receive additional reimbursement when treating patients with the device, supporting access to the Agent DCB for Medicare beneficiaries.”
Device’s FDA approval came after years of waiting
The Agent DCB was available in other parts of the world for years before the FDA announced its approval in 2024. It was the first coronary DCB to gain FDA approval.
The FDA’s decision was based largely on data from the AGENT IDE trial, which compared treatment with the Agent DCB to traditional balloon angioplasty. Robert W. Yeh, MD, MSc, MBA, an interventional cardiologist with Beth Israel Deaconess Medical Center, presented initial findings from AGENT IDE at TCT 2023, highlighting the fact that target lesion failure after one year was seen in 28.7% of balloon angioplasty patients and 17.9% of Agent DCB patients. The Boston Scientific device was also linked to a reduced risk of stent thrombosis, target lesion revascularization and target vessel myocardial infarction.
“For 25 years, we’ve been trying to peel back this restenosis problem,” former American College of Cardiology President B. Hadley Wilson, MD, said when those initial AGENT IDE findings were presented at TCT. “Now we can see light at the end of the tunnel. This is really terrific work.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.