Reimbursement issues raise concerns about future of peripheral interventions

SAN DIEGO — Despite the evidence for the safety, efficacy and cost-effectiveness of drug-coated balloons for peripheral interventions, their use in clinical practice has become overshadowed by fiscal concerns, according to a presentation at TCT 2018.
Physicians often focus on individualized care and value-based care, especially in today’s environment, George L. Adams, MD, associate clinical professor of medicine at the University of North Carolina at Chapel Hill and director of cardiovascular and peripheral vascular research at Rex Hospital, said during his session.
But all of this, according to Adams, eventually boils down to physician behavior, which is affected by a multitude of factors, including the abundance or lack of data in certain areas, as well as fiscal concerns. Therefore, it is important to evaluate whether reimbursement influences behavior in clinical practice, particularly as it pertains to peripheral vascular interventions in light of the loss of the CMS pass-through code for DCBs, he said.
Recent data suggest that an increase in outpatient procedures for peripheral artery disease and a simultaneous decrease in inpatient procedures were associated with a change in Medicare reimbursement, Adams said. These changes can be traced back to several important time points in PAD care. In October 2014, DCBs hit the U.S. market, and the following year, they earned CMS pass-through status. However, the pass-through payment expired in January 2018, leaving clinicians uncertain about the way forward.
“If you have a treatment modality that has evidence showing its benefit, is it really effective in terms of the way we think or how we practice? This includes administrators, physicians and industry. That’s an important question,” Adams said.
A s hift in c are
Currently, the data clearly show that DCBs are effective, according to Adams, who cited the Society for Cardiovascular Angiography and Interventions consensus guidelines for device selection in femoral-popliteal interventions indicating that treatment with DCBs is backed by significant scientific evidence.
The argument can also be made, Adams said, that DCBs are cost-effective, with one study showing that DCB, which was the dominant treatment strategy in the study, had the highest patency and lowest cost when compared with other interventions.
Because previous findings demonstrated that some treatments have fallen out of favor due to a lack of reimbursement, Adams and colleagues sought to determine whether the cost change in January 2018 for DCBs would disincentivize physicians to use the DCBs, thereby leading to altered treatment for PAD. This includes a shift toward increased atherectomy usage, increased stent usage and a movement toward balloon angioplasty. This change, he said, could ultimately limit patient access to quality care, such as DCBs.
The retrospective study looked at treatment of superficial femoral artery and popliteal disease 6 months before and 6 months after the expiration of the CMS pass-through code. Despite similar patient characteristics in both groups, DCB usage was approximately 15% higher from July to December 2017, as compared with January to June 2018, according to Adams. Meanwhile, there was a nonsignificant change in use of drug-eluting stents and bare-metal stents and an approximately 25% reduction in atherectomy usage.
Nevertheless, the study only captures 6 months of data and a deeper dive into the results is necessary, Adams said.
Looking a head
Although the study performed by Adams and colleagues provide compelling data, he noted that they plan to explore whether this shift in treatment is due to other factors, such as lesion characteristics, and they are aiming to determine procedure costs and compare readmission rates between treatment strategies.
“In a world increasingly focused on the value of care, this study provides preliminary insights on the impact of DCB reimbursement changes and their utilization in PAD,” he said. “There is evidence for DCBs to treat femoral-popliteal disease and there is an argument for cost-effectiveness, but the question is how is this going to impact practice with the loss of the pass-through code?”
Without a solution, many stakeholders have come together in hopes of addressing this problem, Adams said.
“What’s interesting is that this has spurred the advent of industry and administrators coming together to collaborate ... in terms of trying to figure out solutions to behavior changes that are more or less caused by the political realm surrounding reimbursement,” he said. – by Melissa Foster
Reference:
Adams GL. Reconciling clinical needs and fiscal responsibility in peripheral vascular interventions. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Disclosure: Adams reports no relevant financial disclosures.