by Matt Batcheldor
A recent study found that higher reimbursement from the Centers for Medicare & Medicaid Services (CMS) was not associated with wider use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) procedures.
Rather, greater use of the EPD device was associated with centers that had higher volumes of TAVR procedures, according to the paper recently published in JAMA Cardiology, “Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes with Embolic Protection Device Use.”
The finding was surprising to lead author Angela Lowenstern, MD, assistant professor of Medicine in the Division of Cardiovascular Medicine. Prior to the study, she hypothesized that the CMS program New Technology Add-On Payment (NTAP), which provides for reimbursement to encourage new medical technologies, would be associated with increased use of embolic protection devices.
“I think it raises questions about the CMS payment model and the NTAP, with the additional payments for investigational devices, and how it’s truly impacting care,” she said. “And is there a better way to do it?”
The embolic protection device, known as Sentinel, was approved by the FDA in 2017. The device, which consists of a basket in the right innominate artery and another in the left carotid artery, is designed to catch embolic debris from going to the head and causing a stroke. It is deployed during the TAVR procedure, which replaces an improperly working aortic valve with a new valve made of animal tissue, treating aortic stenosis.
The study that led to approval of the Sentinel demonstrated the device’s safety but not its efficacy, Lowenstern said. Additional observational studies after FDA approval have shown a clinical benefit. In 2018, CMS approved a $1,400 add-on payment for use of the device during TAVR procedures.
Lownestern and fellow authors studied 84,353 TAVR patients from 551 sites sourced from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry between Jan. 1, 2018, and Sept. 30, 2019.
The study found that only about 7% of TAVR procedures were completed with an EPD, even though CMS is the primary payer for about 90% of TAVR hospitalizations for patients that would qualify for reimbursement of the EPD.
Lowenstern noted that slow uptake of the device could have been influenced by lack of efficacy data during the study period and by the fact the device is still relatively new. It may be more commonly used in centers with high volume that perform more complex procedures and tend to be the first to adopt new devices.
“The decision to use an EPD during a TAVR procedure likely depends on a combination of factors including perceived device efficacy and safety, patient considerations, proceduralist experience, site teaching institution status and cost considerations,” the paper states.
The study concludes that further study is required to better understand the economic drivers of procedural volume and EPD use.
Other Vanderbilt authors of the paper were Brian Lindman, MD, associate professor of Medicine, Kashish Goel, MD, assistant professor of Medicine, and Colin Barker, MD, associate professor of Medicine.
