Officials at the Centers for Medicare and Medicaid Services are planning a deep look into treatments available to improve poor blood flow in the legs, a condition that can lead to gangrene and amputations in severe cases and raises risk for strokes and heart attacks.
The agency may take as long as eight months to consider what steps it may take next regarding the condition, known as peripheral artery disease, said Tamara Syrek Jensen, director of CMS Coverage and Analysis Group, at the conclusion of a Wednesday meeting of an evidence and coverage committee to assess evidence supporting treatments for the disease.
About 8 million to 12 million people in the United States have clogging of the arteries in legs, which can make walking painful. Given the rising incidence of diabetes and the aging of the nation’s population, more Americans likely will suffer ill affects from this clogging of arteries in their legs. Medicare covers many of the services and products used for peripheral artery disease through the most common agency approach, one that rests some flexibility about administering policies with contractors.
CMS could look to establish more of a blanket policy regarding treatments of peripheral artery disease through a national coverage decision, or NCD. CMS uses relatively rarely uses this approach. An agency database shows information about 338 national coverage decisions.
“That’s why were looking at this today, to determine whether we want to open up an NCD,” Jensen said at the meeting.
The agency asked its advisory panel to widely review the data available to support use of treatments such as surgical interventions and drugs. At the end of the meeting, the panel gave mixed reviews to the body of research in a series of six votes. CMS had asked the panelists to use a scale of 1-5, with a 1 indicating little or no confidence that the current body of evidence showed a treatment had near- or long-term benefit for patients.
The panel’s ratings ranged from a low of 1.4 on a question about whether sufficient evidence exists that treatments produce a near-term benefit for people who are not yet suffering any obvious symptoms from peripheral artery disease. The highest score given by the panel, a 3.6, was given for the evidence on near-term benefit for people with more advanced disease.
In preparing for the meeting, CMS and the panel looked to a 2013 report from the Agency for Healthcare Resources and Quality that concluded that advances in care in both medical therapy and invasive therapy have not been rigorously tested.
At the meeting, representatives of makers of medical devices and groups representing doctors who treat peripheral artery disease sought to counter that conclusion. Roughly two dozen speakers gave short presentations, many of which were intended to highlight newer data and studies showing progress in the development of medical devices. Among the speakers was Jeff Carr of the CardioVascular Coalition, which represents about 150 stand-alone medical center focused on cardiac and peripheral artery conditions.
He summed up his arguments after the meeting in an e-mail to CQ HealthBeat. “Research indicates preventing amputations through treatment of clogged leg arteries can reduce health costs, particularly those for Medicare,” he wrote.
“Studies indicate that the rate of lower limb amputations among Medicare patients in the U.S. decreased by 45 percent over nearly 15 years, correlating with a significant increase in access to endovascular interventions,” Carr said. “In addition to reducing healthcare costs, interventions can ultimately result in limb preservation that offer the best possible clinical outcome and improved quality of life for our patients.”
A notable drop in leg and foot amputations was reported in 2012 by the Centers for Disease Control and Prevention. Looking at cases reported for diabetics 40 and older, a group more at risk for losing limbs than the general population, CDC reported a decline of 65 percent in leg and foot amputations between 1996 and 2008.
In calculating these figures, researchers focused on amputations due to disease, and not trauma and injuries such as car accidents. The rate of lower limb amputations linked to poor blood flow was 3.9 amputations per 1,000 people with diagnosed diabetes in 2008 compared to 11.2 per 1,000 people in 1996.
Members of the Medicare advisory panel, though, cautioned against linking the decline directly to the increased use of treatments such as surgery and implanted medical devices for peripheral artery disease. Reductions in smoking and other public health gains likely played a role, they said.
The agency has a difficult task in trying to make decisions now about treatments, given the current gaps in knowledge about the outcomes achieved, said Julie Swain, a member of the panel and a former Food and Drug Administration adviser who is now a researcher at Mount Sinai Heart Institute at New York.
CMS has a problem right now with using evidence-based medicine because there is very little good evidence on the leg-artery treatments, Swain said.