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.

Agenda
Medicare Evidence Development & Coverage Advisory Committee
July 22, 2015
7:30 AM – 4:30 PM
CMS Auditorium

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

7:30 – 8:00 AM
Registration

8:00 – 8:10 AM
Opening Remarks— Maria Ellis/Tamara Syrek Jensen, JD/Peter Bach, MD

8:10 – 8:20 AM
CMS Presentation & Voting Questions – Jamie Hermansen

8:20 – 9:20 AM
TA Presentation: Schuyler Jones, MD, Assistant Professor of Medicine, Duke University Medical Center and Manesh Patel, MD, Associate Professor of Medicine, Cardiology, Duke University Medical Center

9:20 – 9:40 AM
Jack L. Cronenwett, MD, Medical Director, Society for Vascular Surgery Patient Safety Organization, Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth-Hitchcock Medical Center

9:40 – 10:00 AM
Matthew T. Menard, MD, Co-Director, Endovascular Surgery, Program Director, Vascular Surgery Fellowship, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital

10:00 – 10:10 AM
BREAK

10:10 – 11:45 AM
Scheduled Public Comments
(Refer to Speaker List)
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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
Open Public Comments
Public Attendees who wish to address the panel will be given that opportunity

11:50 – 12:35 PM
LUNCH

12:35 – 1:35 PM
Questions to Presenters

1:35 – 2:35 PM
Initial Open Panel Discussion: Dr. Bach

2:35 – 3:35 PM
Formal Remarks and Voting Questions
The Chairperson will ask each panel member to state his or her position on the voting questions.

3:35 – 4:25 PM
Final Open Panel Discussion: Dr. Bach

4:25 – 4:30 PM
Closing Remarks/Adjournment: Tamara Syrek Jensen & Dr. Bach

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