WASHINGTON - Today, the Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to review scientific evidence on interventions aimed at improving care for Medicare patients with lower extremity peripheral artery disease (PAD). The panel discussed care for patients with three levels of disease progression: asymptomatic, intermittent claudication, and critical limb ischemia (CLI). It is important to note that MEDCAC panels do not make coverage determinations, but rather serve an advisory role.

Today’s panel vote reflects the value of PAD interventions on patient outcomes, even though long-term data is not yet available in this relatively young field of healthcare. The panel voted with an intermediate level of confidence that there is sufficient evidence interventional therapies in asymptomatic patients result in long-term health outcomes. The panel also voted with an intermediate level of confidence there is sufficient evidence that CLI improves immediate health outcomes, as well as long-term health outcomes.

Among patients with intermittent claudication, a moderate form of PAD, some patients may benefit from interventional treatment, while others may be better suited for ongoing monitoring. The panel voted with an intermediate level of confidence that there is sufficient evidence for immediate and long-term health outcomes.

The Society for Cardiovascular Angiography and Interventions (SCAI) applauds the panel for supporting the physician’s ability to make the best judgment for each individual patient’s condition, and maintaining access to life-enhancing treatments. SCAI is pleased the panel sees the value of PAD interventions on patient outcomes, as evidenced by the panel’s vote of intermediate confidence for nearly all levels of disease discussed today. SCAI also agrees with the discussion today that there is a critical need for more long-term data in this relatively young field and looks forward to working with PAD coalition partners in setting the research agenda and filling current evidence gaps.

SCAI joined together with a coalition of other leading non-profit professional associations and a voluntary health organization with combined membership of more than 100,000 physicians to present before MEDCAC and advocate for continued access to PAD treatments. The organizations represent the majority of PAD specialists in the United States.

The organizations will continue to work together to encourage greater research on PAD interventions and encourage public awareness of this increasingly common, but underdiagnosed and undertreated condition. PAD affects eight to 12 million Americans, including one in 20 adults over age 50. It can often be a sign of more widespread cardiovascular disease, and raises the patient’s risk for heart attack and stroke. Lower extremity revascularization procedures can save limbs and enhance the quality of life for patients with significant PAD. To the extent it prevents amputation and attendant treatment, lower extremity revascularization may also contribute to reduced costs. 

Remarks from SCAI Leadership:

“The data are clear: Lower extremity revascularization saves limbs and changes lives dramatically,” said Dr. Kenneth Rosenfield, MD, MHCDS, MSCAI, section head for the Vascular Medicine and Interventional Division of Cardiology at Massachusetts General Hospital, and president-elect of SCAI. “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.”

“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,” said Dr. Rosenfield.