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CMS Panel: Some PAD Treatments Warrant National Coverage
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The Medicare Evidence Development and Coverage Advisory Committee of the CMS voted that it has moderate confidence that there is sufficient evidence for at least one intervention that improves most forms of lower-extremity peripheral artery disease.
The panel’s vote could serve as a basis for a National Coverage Decision from the CMS. There is currently no CMS national coverage pertaining to therapies for lower-extremity PAD, though some are covered on a state-by-state basis, Tamara Syrek Jensen, JD, director of CMS’ coverage and analysis group, said at the meeting.
Moderate confidence
After a review of the existing evidence, the panel voted that it has low confidence that there is sufficient evidence for at least one intervention that improves asymptomatic PAD in the short term; moderate confidence that there is sufficient evidence for at least one intervention that improves asymptomatic PAD in the long term, intermittent claudication in the short and long term and critical limb ischemia (CLI) in the long term; and moderate-to-high confidence that there is sufficient evidence for at least one intervention that improves CLI in the short term.
“We have a conflict between what we know logically should work [and] data that … just aren’t very good,” panel member Diana Zuckerman, PhD, president of the National Center for Health Research Cancer Prevention and Treatment Fund, said. She was one of several panelists who emphasized the need for more long-term data.
J. Jeffrey Carr
Panelist J. Jeffrey Carr, MD, professor of radiology, bioinformatics and cardiovascular medicine at Vanderbilt University, said that CMS should incentivize providers to do a better job of diagnosing PAD at an earlier stage.
“There is a huge proportion of PAD in the community that is underdiagnosed,” he said. “I urge CMS to develop strategies to detect PAD when its clinical features are not manifest.”
The panel also identified a number of research gaps, including optimal treatments by race and sex and longer-term results for almost every available therapy.
Technology assessment
In a presentation to the panel, authors of the technology assessment report written for the CMS by the Duke Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality outlined their findings on the evidence for treatment strategies for patients with asymptomatic PAD, intermittent claudication and CLI.
For patients with asymptomatic PAD, the evidence suggests that aspirin has no benefit over placebo, W. Schuyler Jones, MD, assistant professor of medicine at Duke University Medical Center, told the panel.
He added that for patients with intermittent claudication, clopidogrel is associated with better outcomes than aspirin, but for patients with claudication or CLI, dual antiplatelet therapy is not superior at reducing CV events compared with aspirin alone.
For patients with claudication, exercise therapy, cilostazol and endovascular intervention all were associated with improvement of functional status and quality of life, but improvement in CV outcomes and mortality is unclear, and no therapy proved superior when compared to another, Jones said.
For patients with CLI, comparisons of endovascular intervention vs. surgical intervention have mostly come from observational studies, and heterogeneity among these studies makes drawing conclusions difficult, he said. The ongoing BEST-CLI randomized controlled trial may provide a more definitive answer to this question, Matthew T. Menard, MD, co-director of endovascular surgery and program director of the vascular surgery fellowship in the vascular and endovascular surgery division at Brigham & Women’s Hospital, told the panel.
During the public portion of the meeting, many of the speakers emphasized that treatment of PAD requires collaboration by physicians from multiple disciplines, and that the reimbursement structure needs to reflect that.
“PAD is a team sport,” James B. Froehlich, MD, MPH, president of the Society for Vascular Medicine, told the panel. “We need to incentivize multidisciplinary care.”
The CMS will consider the MEDCAC panel’s recommendations over the next 6 to 8 months as it decides whether to open the National Coverage Decision process for therapies for lower-extremity PAD and whether other courses of action should be taken, Syrek Jensen said. – by Erik Swain
Disclosure: The standing members of the MEDCAC panel report no relevant financial disclosures beyond possibly holding equity in health care companies in 401(k) accounts; guest panel member Alan T. Hirsch, MD, reports receiving research grants via his institution from Aastrom Biosciences, Abbott Vascular, AstraZeneca, Bayer, Merck and Viromed. Jones reports receiving research grants via his institution from AstraZeneca, Boston Scientific and Bristol-Myers Squibb. Menard reports consulting for Merck and Proteon. Froehlich reports consulting for Boehringer Ingelheim, Janssen Pharmaceuticals, Johnson & Johnson, Merck and Sanofi Aventis and receiving research funding from Blue Cross/Blue Shield of Michigan and Sanofi Aventis.