It was supposed to occur at the canceled 2020 Vascular Annual Meeting (VAM), but finally given his time at the podium, 2019–2020 Society for Vascular Surgery (SVS) President Kim Hodgson, MD, wasted little time in conveying the message he has long sought to convey to SVS members: that the threat posed to vascular surgery by “bad actors” carrying out inappropriate procedures is real—and that it is long past time to address the issue.
Hodgson was speaking during the 2021 iteration of VAM on Thursday morning (Aug. 19), delivering his Presidential Address a little over 12 months after he was scheduled to do so. The theme was appropriateness in care, a topic he kicked off during the E. Stanley Crawford Critical Issues Forum in 2019 as he began his presidential year. During the address, he referenced the story of a cardiologist and cardiac surgeon whose rate of cardiac procedures and surgeries was 4-5 times the expected rate for the hospital and the population they served. The next day, data were presented by Caitlin W. Hicks, MD, assistant professor of surgery at John Hopkins Medicine in Baltimore, and colleagues at VAM on the overuse of early peripheral vascular interventions for claudication. Since then, further research has built upon the charge that outliers are performing inordinate levels of certain procedures, including atherectomy carried out in the office-based lab (OBL) setting.
“As I lay out my case for changes here today, you might find yourself wondering, why should the SVS lead this charge?” Hodgson told VAM attendees. “To me the answer is simple—because somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. And because no organization is better positioned to lead the way than your SVS, by virtue of the portfolio of quality programs we have developed and the integrity of our members. That last point is critical—the integrity of SVS members—because doing our part to fix this problem is going to require each and every one of us to put our integrity on display by being transparent about who we are and what we do.”
The impact of the explosive growth of atherectomy on patients and healthcare finances is problematic and growing exponentially, Hodgson lamented. He turned to further findings from Hicks showing that of the roughly $267 million reimbursed by Medicare for first-time femoropopliteal peripheral vascular interventions in 2019, 90% was for atherectomy, “leaving only $26 million to pay for all of the other therapies that actually have evidence showing that they work.”
But Hodgson said his message should not be construed as an attack on OBLs writ large. “The SVS recognizes the importance and value of the OBL to our members and their patients, which is precisely why we recently transitioned the OBL Committee into an OBL Section and selected exemplary community practice leaders, Drs. Robert Molnar and Cliff Sales, to lead it,” he continued. “It is also why we created a Community Practice Section, also led by exemplary community practitioners, Drs. Dan McDevitt and James Cravens. Not only do many of its members serve in other SVS leadership positions, including on the Executive Board, but just two months ago we held an election where one of the candidates for vice-president was a community practitioner.”
The SVS recognizes that the overwhelming majority of community practitioners suffer because of those who are practice appropriately, Hodgson said. The SVS is about quality and appropriateness, “and is not anti-OBL, but rather anti-OBL abuse,” he added.
Hodgson called out what he called “the enablers” of this type of practice—”people or constructs that encourage or enable negative behavior in another.” The Centers for Medicare & Medicaid Services (CMS) was one, with “distorted reimbursement incentives” contributing to the problem, he argued. “The OBL, if properly incentivized, would be a very positive development for patients and physicians, but CMS policies have instead incentivized inappropriate behavior.”
The situation is already being addressed, Hodgson went on: With the growth in atherectomy bringing peripheral vascular interventions under increased scrutiny, reimbursement for atherectomy is going to plummet, Hodgson said. This will come on top of the Medicare fee schedule cuts recently announced that appear to specifically target vascular surgery and interventions, he explained. “You think maybe CMS is sending the message that if we don’t do something to curb runaway utilization then they will?” Hodgson posited. “And as always, it is going to be the responsible physicians practicing appropriately who are going to be hurt the most, because they won’t respond by just doing more unnecessary procedures to make up the difference as the less scrupulous—those who have created this situation—are likely to do.”
Another enabler is the Food and Drug Administration (FDA), Hodgson said, calling for target lesion revascularization (TLR) to be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in FDA approval trials.” Hodgson also fingered vascular surgery’s industry partners. He said they should be “the canary in the coal mine for inappropriateness. You are uniquely positioned to spot abuse early—before patients are harmed. You know every one of the outliers in vascular care.”
Lastly, he turned to the OBL itself as the ultimate enabler. The OBL is an inanimate structure, he said, so “it’s not guilty of anything. Nor are the overwhelming number of vascular surgeons, in both clinical and academic practice, providing great care in OBLs by prioritizing ethical clinical values over business values in their clinical decisions.” Yet, their lack of meaningful oversight enables the unscrupulous to misbehave, Hodgson said.
Hodgson referenced the 2015 SVS Presidential Address delivered by Peter Lawrence, MD, which was also devoted to appropriateness. The talk contained a list of proposed measures aimed at addressing the problem of overtreatment of vascular disease. “First on his list was the need to accredit OBLs,” recalled Hodgson. Lawrence had noted that “there needs to be an accreditation system that establishes standards for quality in the office, as occurs in the hospital,” Hodgson said.
To Lawrence’s point, continued Hodgson, this raises a new SVS initiative—the prospect of the Vascular Center Verification and Quality Improvement Program (VCV&QIP), which the SVS has developed in partnership with the American College of Surgeons (ACS), helping to clean up vascular care. “Modeled after other successful ACS Quality Improvement programs, the vascular program verifies a facility’s compliance with evidence-based care guidelines, peer review, and continuous quality improvement,” Hodgson explained, as he unveiled the program for the first time.
Hodgson also touched on another feature of his presidential year—the development of an SVS Supervised Exercise Therapy (SET) app. A simple, inexpensive means of treatment contrasted against expensive interventions, it lingers large over discussion of inappropriate care and overutilization of certain procedures.
“That Supervised Exercise Therapy, or SET, works is perhaps the most solidly supported therapy in vascular care,” he said. “A 2017 Cochrane Review determined that ‘High-quality evidence shows that exercise programs provide important benefit compared with placebo or usual care in improving both pain-free and maximum walking distance in people with leg pain from intermittent claudication.’ SET has also been shown to have considerable potential for savings in healthcare spending.”
Why, asked Hodgson—with mounting evidence of its effectiveness—isn’t SET used more often? “I think we all know that lack of reimbursement is just a minor part of the answer. Traditional SET requires patients to schedule an appointment, get at least a little bit cleaned up, travel to a facility, find a parking spot, and, because it’s done in a gym setting, can be boring.”
These types of drawbacks to traditional SET prompted the SVS leadership to establish a Health Information Task Force, now a standing Committee, and ultimately the SVS SET app, Hodgson said.
“We are currently enrolling in a randomized controlled trial to demonstrate the efficacy of the app in reducing or delaying the need for revascularization, and an NIH grant application has been submitted by committee chair, Dr. Judith Lin, to further study the role of the SVS SET app as the initial treatment for claudication,” he added.
Ultimately, though, Hodgson said it is up vascular surgeons themselves to use the tools the SVS has developed in order for appropriateness in care to be addressed.
“We can play whack a mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources,” he told VAM attendees. “So how do we distinguish the good operators from the opportunists in our space? How do we prevent vascular practices from becoming profit centers because of profiteering? As I see it, our only pathway to success is to spotlight those practicing appropriately; you don’t think the news media are going to write exposés on physicians practicing appropriately, do you?
“Your SVS leaders, past, present, and future have spent countless volunteer hours developing a portfolio of tools to help you distinguish yourself through quality practice. Some of them, like Clinical Practice Guidelines and Appropriate Use Criteria, are pretty basic in that they require little from you other than reading them and practicing accordingly; that’s your job. A future SVS Improving Wisely program will give you a snapshot of where you fall on the spectrum of a given practice characteristic. Hopefully you will review it and, if you are an outlier in either direction you will reflect on that.”
