News

The undersigned societies acknowledge the release of the Department of Health and Human Services (HHS) Office of Inspector General report OEI-01-24-00250 and resulting media coverage and welcome the opportunity to engage constructively with HHS on its findings. We share OIG's commitment to the appropriate use of Medicare resources and to ensuring that patients with peripheral arterial disease (PAD) receive care that is both medically necessary and consistent with established clinical evidence.

At the same time, we believe several aspects of the report's methodology and clinical framing merit careful consideration. We offer the following observations in a spirit of collaboration and shared interest in getting the science right to improve patient care.

Clinical Characterization of the Evidence. The report characterizes certain procedures — including tibial artery interventions and atherectomy — as broadly concerning across the Medicare PAD population. Current guidelines, including the 2024 ACC/AHA multisociety PAD guideline, draw an important distinction between patients with intermittent claudication and those with chronic limb-threatening ischemia (CLTI). For CLTI — a serious, limb- and life-threatening condition — prompt tibial revascularization is a Class I recommended intervention to prevent amputation and promote wound healing. A claims-based analysis that does not adjust for this distinction may identify specialized limb-salvage practices as outliers even when their care is entirely guideline-concordant. We are concerned that certain characterizations in the report do not fully reflect this distinction and, in some instances, may not accurately represent the sources cited.

Methodological Considerations. The report notes that its claims-based analysis identifies billing that may warrant further review.  However, ICD-10 coding imprecision in PAD is well-documented, and patients with CLTI whose relevant diagnoses appear on inpatient or wound-care claims outside the analyzed universe could be misclassified as having earlier-stage disease. Similarly, any observation that physician reimbursement is higher in office-based labs than in hospital outpatient settings does not account for the substantially higher facility costs to Medicare in the hospital-based setting.  Indeed, a full and accurate site-of-service cost comparison inclusive of much higher facility costs in a hospital would present a very different picture to the one in the report. We believe these methodological considerations are important context for interpreting the report's quantitative findings.

Patient Access. We are attentive to the real-world impact that program integrity activity can have on patient access to care. Physicians who concentrate their practices on CLTI, diabetic foot disease, dialysis-related vascular complications, and multi-level arterial disease — populations that often have limited access to care and face the highest risk of amputation — may appropriately exhibit utilization patterns that differ from general PAD practices. We would encourage any targeted review to incorporate clinical context, including indication-level analysis, before drawing conclusions about individual physicians.

Billing Patterns. We recognize that the report identifies a small number of physicians whose billing patterns differ substantially from their peers, and we agree that such patterns warrant careful review. Where utilization outliers cannot be explained by patient complexity, case mix, or concentration in high-acuity populations such as CLTI or diabetic limb disease, our societies support appropriate scrutiny by CMS and OIG. We would encourage any targeted review to incorporate clinical context before drawing conclusions, but we do not defend billing practices that are inconsistent with guideline-concordant, medically necessary care.

Treatment of Earlier-Stage Disease. The report, and prior analyses, has raised questions about the use of invasive procedures in patients with intermittent claudication or earlier-stage peripheral arterial disease. Current guidelines are clear that for patients with claudication, supervised exercise therapy and medical management are first-line treatments, and that revascularization should generally be reserved for patients who have not responded adequately to those approaches. Our societies have consistently communicated this hierarchy of care to members. At the same time, claims-based analyses face inherent limitations in capturing whether conservative therapies were attempted, contraindicated, or inaccessible to a given patient prior to intervention — context that is essential to a fair assessment of whether any individual case reflects appropriate or inappropriate care.

Our Commitment. Our societies are committed to supporting appropriate, evidence-based use of peripheral vascular procedures, to educating our members on guideline-concordant practice, and to constructive engagement with CMS and OIG on program integrity priorities. We look forward to that dialogue and to working collaboratively toward shared goals that protect both the integrity of the Medicare program and the access of vulnerable patients to necessary care.

Association of Black Cardiologists (ABC)

Society for Cardiovascular Angiography and Interventions (SCAI)

Society of Interventional Radiology (SIR)

Society for Vascular Surgeons (SVS) 

Outpatient Endovascular and Interventional Society (OEIS)