The questions for the meeting were posted by CMS on May 4, and the technology assessment is likely the same as one published by the AHRQ in 2013.
Medicare MEDCACs always begin with a 30 to 45 minute technology assessment presentation. These are done in the name of AHRQ but conducted by one of its institutional "evidence based practice centers" such as Duke, BCBS TEC, ECRI, or others.
The AHRQ published a 2013 technology assessment which is very similar to the CMS webpage for this MEDCAC. The AHRQ assessment protocol was proposed in January 2012 (here and here). The final work product appeared in May 2013 (web page here, summary here (40 pp), full report here (360 pp). See also a "disposition of comments" document, here.)
Some industry watchers wondered if this was related to proposed pay cuts for physician-office based vascular procedures in summer 2013 CMS Part B rulemaking. I don't think so. That rulemaking identified procedures by a blind screen, if they had significantly higher payments in the physician office than in the hospital outpatient setting. This picked up services randomly, as diverse as vascular surgery and pathology immunohistochemistry. Stakeholders were highly dissatisfied with CMS's proposal to cap physician office prices at hospital outpatient prices (see here and here.) CMS did not finalized the proposal. However, as I have described elsewhere, only months later, Congress gave CMS much wider latitude than ever before to set RVUs as it sees fit (here).
Is it unusual to base (as I predict) a MEDCAC in 2015 on data collected and reviewed in 2012? Not entirely. When CMS runs a MEDCAC in the middle of an active coverage decision, the technology assessment often appears online only a couple days before the event. But when there is no active coverage decision, AHRQ reports now appear longer in advance, and include their own interim public comment period before they are finalized. For a March 2015 MedCAC, the pertinent MedCAC was written and published for public review by December 2013 and finalized in summer 2014. (The final version was nearly the same as the December 2013 version). For the July 2015 MEDCAC, the technology assessment will lack any information on some newer clinical topics, like the benefits of drug-coated peripheral stents.
I have done a raw cut and paste of the CMS MEDCAC website below.
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
CMS announces MEDCAC meeting. Posts FR Notice and registration link.
May 4, 2015
Posted questions to panel
Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)
Lower Extremity Peripheral Artery Disease
July 22, 2015
Lower Extremity Peripheral Artery Disease
July 22, 2015
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.
Voting Questions
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 — 2 — 3 — 4 — 5
Low Intermediate High
Confidence Confidence
Low Intermediate High
Confidence Confidence
- For adults with asymptomatic lower extremity PAD, how confident are you that there is sufficient evidence for an intervention that improves:
- Immediate/near-term health outcomes?
- 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.
- For adults with lower extremity intermittent claudication (IC), how confident are you that there is sufficient evidence for an intervention that improves:
- Immediate/near-term health outcomes?
- 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.
- For adults with lower extremity critical limb ischemia (CLI), how confident are you that there is sufficient evidence for an intervention that improves:
- Immediate/near-term health outcomes?
- 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.
Additional Discussion Topics
- Discuss the important evidence gaps that have not been previously or sufficiently addressed.
- Discuss any apparent lower extremity PAD treatment disparities and how they may affect the health outcomes of Medicare beneficiaries.
