CMS MEDCAC Panel Considers Evidence for Lower Extremity PAD Interventions

July 22, 2015—The Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel examined the scientific evidence of existing interventions that aim to improve health outcomes in the Medicare population and address areas where evidence gaps exist related to lower extremity peripheral artery disease (PAD). The MEDCAC panel focused on three categories along the disease progression continuum (asymptomatic, intermittent claudication, and critical limb ischemia). Overall, the panel found that there was an intermediate level of confidence that there is sufficient evidence for interventions that improve outcomes in these patients.

MEDCAC panel members voted on specific questions and led discussions to advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about Medicare coverage for interventions related to lower extremity PAD. MEDCAC panels do not make coverage determinations, but CMS often relies on their recommendations.

In this discussion, existing interventions for lower extremity PAD were grouped into three main categories: medical therapy, exercise training, and revascularization (surgery and endovascular therapies—including angioplasty, stenting, and atherectomy). Clinical outcomes of interest to the Medicare program include reduction in pain; avoidance of amputation; improvement in quality of life and/or functional capacity, including walking distance; wound healing; avoidance of cardiovascular events, including myocardial infarction, stroke, cardiovascular death, and all-cause mortality; and avoidance of harm from the interventions.

After hearing presentations by practitioners, clinical investigators, and medical society representatives, the MEDCAC panelists voted using a scale of 1 (low or no confidence) to 5 (high confidence) on six questions regarding the evidence for treatment of the three disease levels, considering the near-term and long-term health outcomes. If the average of the 13 panelists’ votes on each question was greater than 2.5, there was further discussion to expand on their viewpoints. 

For adults with asymptomatic lower extremity PAD, the average of panelists’ votes was 1.4, or low confidence (on the 1–5 scale), that there is sufficient evidence for an intervention that improves immediate or near-term health outcomes for these patients. However, the panelists had more confidence (2.7 average, intermediate) that there was sufficient evidence that intervention improves long-term health outcomes in patients with asymptomatic lower extremity PAD.

For adults with lower extremity intermittent claudication, the panel voted with intermediate confidence (average, 3.4) that there is sufficient evidence for an intervention that improves immediate or near-term health outcomes and intermediate confidence (average, 3.5) for long-term health outcomes.

For adults with lower extremity critical limb ischemia, the average vote of 3.7 indicated an intermediate level of confidence that there is sufficient evidence for an intervention that improves immediate or near-term health outcomes. The panel was somewhat less confident (average, 3) regarding evidence for improvement in long-term health outcomes.

The Society for Cardiovascular Angiography and Interventions (SCAI) issued a statement noting that the MEDCAC panel votes reflect the value of PAD interventions on patient outcomes, even though long-term data are not yet available in this relatively young field of health care. The society also agreed with the consensus of the discussion that there is a critical need for more long-term data and looks forward to working with PAD coalition partners in setting the research agenda and filling current evidence gaps.

SCAI joined with other leading nonprofit professional associations, representing the majority of PAD specialists in the United States, to present before MEDCAC and advocate for continued access to PAD treatments.

SCAI President-Elect Kenneth Rosenfield, MD, attended the MEDCAC panel meeting. In SCAI’s press release, Dr. Rosenfield commented, “The data are clear: lower extremity revascularization saves limbs and changes lives dramatically. The issue is which revascularization procedures are optimal across a range of conditions. Until the research is more definitive, it’s essential we preserve the physician’s freedom to recommend the best treatment for his or her patients.”

He continued, “There was agreement on the panel that even as we await critically needed data on PAD treatments, it would be unconscionable to not treat these patients, especially when limbs are at stake.” Dr. Rosenfield is Section Head for the Vascular Medicine and Interventional Division of Cardiology at Massachusetts General Hospital in Boston Massachusetts.