Endovascular Office-Based Labs: Balancing Upsides Against Potential for Abuse

VEITHsymposium speakers stressed the need for internal audits, third-party inventory management, and conscientious care.

Endovascular Office-Based Labs: Balancing Upsides Against Potential for Abuse

NEW YORK, NY—Office-based labs (OBLs) offer many advantages for patients needing endovascular procedures, as well as significant financial advantages for physicians, but the community as a whole needs to be vigilant about their use and potential for abuse, several presenters said here last week at the 46th annual VEITHsymposium.

TCTMD has looked in-depth at the proliferation of OBLs and the potential for abuse; the topic is increasingly cropping up in endovascular meetings programs where experts are debating the pros and cons of starting an OBL. While not new, these types of these facilities have grown in number following reimbursement changes by the US Centers for Medicare & Medicaid Services (CMS) in 2008 intended to encourage peripheral interventions at outpatient hospital settings. The changes theoretically save the healthcare system money by paying a lower total amount for each procedure, but allow for the entire payment to be paid to the OBL or ambulatory surgical centers, rather than shared with a hospital.

Krishna M. Jain, MD (Western Michigan University, Kalamazoo, MI), who has been involved in the growth of office-based endovascular centers for more than a decade, noted that just about every procedure that can be performed in a hospital can be done in an OBL. Benefits to patients include the ability to get procedures scheduled faster than would be possible in a hospital setting, less stress, and documented high degrees of patient satisfaction. For the physician, Jain said, working in an OBL environment compared with a hospital is more convenient because the cases are scheduled and not surprises at 2 AM, for example, allowing for a more controlled work schedule and lifestyle; this in turn increases productivity and prevents burnout.

A study by Jain and colleagues, published online ahead of print recently in the Journal of Vascular Surgery, provides support for the safety of OBL atherectomy procedures. In the study, 282 patients were treated with lower extremity atherectomy at an OBL between 2011 and 2016. At 1 year, primary patency in the treated vessels was 90%, with a similar—minimal—complication rate between those treated with atherectomy in conjunction with angioplasty and/or stenting.

More evidence of safety comes from another recent article in the same journal looking at how transitioning from a primarily hospital-based setting to an OBL impacted physician practice patterns and outcomes for treatment of PAD. So-called “switch physicians” who transitioned to working in the OBL had no significant decreases in 30-day and 1-year patient mortality compared with when they were working in a hospital, although they did see modest decreases in rates of above-ankle amputation at 30 days and 1 year. However, higher reintervention rates after the initial procedure were observed after the switch compared with hospital-based procedures.

Matthew Mell, MD (University of California, Davis, CA), one of the co-authors of that study, noted that patients treated at OBLs tended to be younger and less likely to be in advanced Rutherford stages. Compared with hospital-based physicians, switch physicians performed more procedures per patient within 30 days and 1 year. Switch physicians also had higher total procedure and atherectomy volumes after transitioning to OBLs, lower hospitalization rates, and higher costs to CMS.

“We believe that the financial incentives associated with physician ownership in OBLs led to increases in use of procedures and atherectomies, and that the original plan by CMS to control costs was offset by increased volume and type of procedures,” he said.

Avoiding Temptation and Overuse

In his presentation at the VEITHsymposium, Stephen M. Bauer, MD (The Vascular Experts, Stamford, CT), said OBLs are lucrative and allow physicians to be entrepreneurial, but that they can also lead to the temptation to overtreat and to avoid referring patients for timely surgery. Not only does this hurt patients, “it damages your reputation and your referral base,” and it overcharges insurance companies, he added.

Bauer described some methods the eight OBLs in his practice have used to prevent overtreatment and misuse of OBL procedures.

“The first thing we do is that our OBLs are not high volume and we all share the money equally to try to prevent competition,” he said. They also perform internal peer review of all complications and most encourage staff to report things they see that might result in complications. Bauer said his group also performs internal audits and gives money back to insurance companies if they find errors. To avoid device companies tempting physicians to use specific devices, they also do third-party inventory management, something he said is particularly helpful for young physicians who might be more easily influenced by industry representatives.

“OBLs are not for everyone," said Sam S. Ahn, MD (Methodist Dallas Medical Center, TX), in his presentation. “It’s very important in this space to do it properly, do it well, and do it conscientiously.” On the other end of the spectrum, financial considerations for physicians considering starting an OBL are considerable, making partnering with other physicians and institutions important. Ahn said before taking the leap, physicians should ask themselves if they are risk-tolerant enough to handle it, due to the clinical and financial risk to which they will be exposing themselves.

Clifford M. Sales, MD, MBA (Cardiovascular Care Group, Westfield, NJ), noted in his presentation that physician income can increase by as much as 600% in some situations when they switch to working in an OBL. But Sales said growing concern about overuse of atherectomy, in particular, in the OBL setting is real.

“There are some real bad apples out there and we know that,” he observed.

According to Dipankar Mukherjee, MD  (Inova Vascular, Falls Church, VA), Medicare data suggest that irresponsible use of atherectomy contributes to amputation rates as high as 8% among PAD patients with claudication.

“Atherectomy has been around for three decades and there still is not any level 1 evidence to suggest that it is efficacious,” he said. “I submit to you, atherectomy, the way it is being done is not a responsible use of the taxpayer dollar. I suggest that we all look inward and question this wide use of atherectomy in the OBL.”

  • Jain K. Why outpatient centers and office-based labs (OBLs) are the best place to do which endovascular procedures: best for patients and best for operators: when can atherectomies be performed safely there; when not. Presented at: VEITHsymposium 2019. November 20, 2019. New York, NY.

  • Mukherjee D. Real world results of lower extremity atherectomy (mostly in outpatient centers) from Medicare billing data is much worse than favorable registry data: where lies the truth. Presented at: VEITHsymposium 2019. November 20, 2019. New York, NY.

  • Bauer S. How to avoid unethical practices in an outpatient center or office-based lab (OBL): the temptation and incentives to overtreat is great. Presented at: VEITHsymposium 2019. November 20, 2019. New York, NY.

  • Ahn SS. Characteristics of physicians who are suited to work in an OBL and characteristics of those who are not. Presented at: VEITHsymposium 2019. November 20, 2019. New York, NY.

  • Sales CM. Office-based versus hospital-based vascular care: impact on indications, physician income and overall costs. VEITHsymposium 2019. November 20, 2019. New York, NY.

  • Mell M. Another view of the impact of office-based vascular practice patterns on indications, physician incomes and outcomes. VEITHsymposium 2019. November 20, 2019. New York, NY.

  • All presenters report no relevant conflicts of interest.