Lower Extremity Peripheral Artery Disease

On July 22, 2015, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will examine 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). For purposes of this MEDCAC, we will focus on three categories along the disease progression continuum (asymptomatic, intermittent claudication, and critical limb ischemia).

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 harms from the interventions. By voting on specific questions, and by their discussions, MEDCAC panel members will 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 peripheral artery disease. MEDCAC panels do not make coverage determinations, but CMS often benefits from their advice.

April 27, 2015

May 4, 2015

July 15, 2015

July 17, 2015

July 24, 2015

September 4, 2015

Peter Bach, MD, Vice Chair
Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 - 8:00 AM

8:00 - 8:10 AM

8:10 - 8:20 AM

8:20 - 9:20 AM

9:20 - 9:40 AM

9:40 - 10:00 AM

10:00 - 10:10 AM

10:10 - 11:45 AM

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Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

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11:45 - 11:50 AM

Public Attendees who wish to address the panel will be given that opportunity

11:50 - 12:35 PM

12:35 - 1:35 PM

1:35 - 2:35 PM

2:35 - 3:35 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:35 - 4:25 PM

4:25 - 4:30 PM

Download meeting minutes.

This MEDCAC meeting will examine 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). Lower extremity PAD is vessel narrowing that occurs over time due to atherosclerosis of the lower extremities. Vessel narrowing can reduce blood flow, which can cause pain when the need for blood flow in the lower extremities increases (e.g., walking, climbing stairs, or exercising) and, in worse circumstances, pain at rest. Accurate ascertainment of symptoms is important as the burden of disease by anatomic imaging may correlate poorly with function.

Symptoms of PAD exist on a continuum from no symptoms to disabling symptoms. Individuals can have narrowing of the arteries and be asymptomatic. As atherosclerosis in the lower extremities progresses, symptoms can present as exertional lower extremity pain, also referred to as intermittent claudication (IC). If narrowing progresses to a critical diameter, it can cause significant disability even at rest, sometimes leading to limb amputation; this stage of the disease is referred to as critical limb ischemia (CLI). For purposes of this MEDCAC we will focus on these three categories along the disease progression continuum (asymptomatic, IC, and CLI).

Existing interventions for lower extremity PAD are grouped into three main categories: medical therapy, exercise training, and revascularization (surgery and endovascular techniques 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 harms from the interventions.

For each voting question, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence and 5 representing high confidence.

1. For adults with asymptomatic lower extremity PAD, how confident are you that there is sufficient evidence for an intervention that improves:
   1. Immediate/near-term health outcomes?
   2. Long-term health outcomes?

   Discussion:

   • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
   • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.
2. For adults with lower extremity intermittent claudication (IC), how confident are you that there is sufficient evidence for an intervention that improves:
   1. Immediate/near-term health outcomes?
   2. Long-term health outcomes?

   Discussion:

   • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
   • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.
3. For adults with lower extremity critical limb ischemia (CLI), how confident are you that there is sufficient evidence for an intervention that improves:
   1. Immediate/near-term health outcomes?
   2. Long-term health outcomes?

   Discussion:

   • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
   • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.

4. Discuss the important evidence gaps that have not been previously or sufficiently addressed.


5. Discuss any apparent lower extremity PAD treatment disparities and how they may affect the health outcomes of Medicare beneficiaries.

Download scoresheet [28KB, PDF].