The rapid growth of office-based laboratories (OBLs) created to treat peripheral artery disease (PAD) during the past decade has triggered increasing scrutiny focusing attention on limited outcome data and unnecessary repeat revascularizations.
A New York Times article published in July highlighted health risks associated with OBLs, including a spike in use of atherectomy devices, repeat procedures, and unnecessary amputations in some cases. The Times article reported that more than 80,000 atherectomies were billed to Medicare in 2021 for OBL procedures—an increase of 60,000 since 2011, when regulations first allowed outpatient atherectomies.
In June, ProPublica, a nonprofit newsroom, published an article highlighting concerns about unnecessary PAD treatments, many of which introduced new risks to patients. Duke interventional cardiologist and PAD specialist William Schuyler Jones, MD, contributed to the ProPublica research.
Concerns about OBL outcomes and oversight for PAD procedures are familiar topics to Schuyler and many Duke cardiologists. A group of Duke Health cardiologists were among the first clinicians from a major medical center to voice warnings about potential risks associated with the accelerated expansion of OBLs in a 2015 study published by the Journal of the American College of Cardiology.
The Duke Heart team highlighted significant variations in the performance of peripheral vascular interventions (PVI) to treat PAD in outpatient and office-based clinics, notably the higher risk of repeat revascularizations. Jones, the lead author, says the study’s key conclusions – the need for better oversight and additional outcome studies—are continuing sources of concern.
“There have obviously been several signals about some of the practices, including concerns about volume and quality,” Jones says. “In vascular care, repeat procedures usually means there is a problem. This is especially true if the patient does not experience improvement of symptoms. We should not be performing routine procedures over and over again, as this introduces unnecessary risk for our patients.”
The increase in the use of atherectomy devices in OBLs is another concern, Jones adds, noting that outcomes as a result of routine use of these devices has not been well studied. They may introduce higher risk to patients, Jones says, compared to other routine options such as balloon angioplasty and/or stenting procedures. “When needed to treat a specific anatomic issue like severe calcification, it’s a safe option. But the reasons for its use must be examined and understood,” he says.
Both media articles cited the significant changes in PAD treatments following a 2008 policy change from the Centers for Medicare and Medicaid Services (CMS) that contributed to the creation of large numbers of OBLs. The objective of the federal change, Jones says, was to lower costs by offering out-of-hospital clinical options. But new reimbursement model resulted in a rush by PAD specialists and device companies to create more labs in offices with less clinical oversight.
“It may have proved less costly for CMS,” Jones says. “But the problem is when you start reimbursing for this sort of clinical service based only on cost, it will become ubiquitous. Unfortunately, no one’s looking, no one’s monitoring, and overuse is inevitable. You have an unintended consequence for trying to do something that makes sense.”
Although Jones emphasizes that many OBLs meet an important need and maintain clinically sound operations, some physicians in office settings perform more procedures more often, including revascularizations. He encouraged referring cardiologists to educate patients about the risks of multiple procedures for PAD and to consider hospital-based treatments when convenient for patients.
