The Cost & Reimbursement Disconnect

Integrating new technology into everyday peripheral artery disease (PAD) practice may become a case of following the heart, or at least the coronaries.

The past few years have witnessed a leap in therapies for treating atherosclerosis in the lower limbs, with the introduction of methods to deliver drugs to the arterial walls setting a new mark. The first drug-eluting stent for treating diseased femoropopliteal arteries received FDA approval in 2012, followed by the first approved drug-coated balloon in 2014. 

Winning FDA approval is only half the battle, though. The other half involves getting these sanctioned devices into physicians’ hands. Drug-eluting stents and drug-coated balloons should cost more than bare-metal stents and plain balloons. If reimbursement doesn’t cover the difference, hospitals are reluctant to stock the items, even when physicians ask for them. 

“Many of us practitioners, particularly those who have conducted the research and feel the data are very strong, feel like this is an important technology to have for our patients,” says Sahil Parikh, MD, a clinical researcher and cardiologist who specializes in complex coronary and vascular revascularizations at the University Hospitals Case Medical Center in Cleveland. But he understands hospitals’ quandary, too.

Drug-eluting stents for PAD received a hand when the Centers for Medicare & Medicaid Services (CMS) allowed an add-on payment in 2013 to help close the cost gap. This year CMS also approved add-on reimbursement for drug-coated balloons for PAD for outpatient procedures, too, and inpatient support may follow soon.

The temporary add-ons are designed to take some of the sting out of costs, letting devices get a foothold into practice. Then they may prove their worth by showing (or failing to show) in real-world practice that long-term benefits justify their prices. PAD drug-eluting stents and drug-coated balloons may follow the path of coronary drug-eluting stents, which experienced an initial mismatch between price and reimbursement but now are used commonly—and at a lower cost. 

The clock is ticking, though, for aligning costs and reimbursement, Parikh warns. “My hope is that this window is relatively short so that by the time it is made close to cost-neutral, [physicians] will understand how to use these technologies and select the right patient.”