(Story updated Tuesday, July 28.)
The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) expressed moderate confidence Wednesday in treatments of peripheral artery disease. The lukewarm vote means it's unlikely Medicare will pay for tests to diagnose or treat this disease most commonly found in seniors.
Peripheral artery disease causes narrowing of the arteries, mostly in the legs, according to the American Heart Association. PAD patients have a much higher risk of heart attack or stroke. If left untreated, the disease can lead to gangrene and amputation.
For years, clinicians have been pushing Medicare to reimburse a number of PAD-related procedures. The agency now reimburses only for stenting procedures and revascularization surgeries.
To better diagnose PAD, providers want reimbursement for the ankle-brachial index (ABI) test. That compares blood pressure in the feet to that in the arms. The goal is to determine how well the blood is flowing. The test costs $100 a pop, said Dr. Josh Beckman, chair of the Council on Peripheral Vascular Disease at the American Heart Association.
Of the 8.5 million people estimated to have PAD, as many as 5 million may be undiagnosed.
“We're missing millions of patients,” Beckman said. “There is a diagnostic test that's inexpensive and should be covered.”
While the panel was not explicitly asked Wednesday, members said they were against any form of universal PAD diagnostic testing of asymptomatic Medicare beneficiaries and didn't express strong support for testing those who were feeling symptoms.
The 10-member panel acknowledged some research that showed evidence of success with some interventions, but the group questioned the level of their success. Many of the studies had few participants and detailed mostly short-term results.
The panel Wednesday voted on a scale of 1 to 5 how confident they were of interventions and treatments of PAD-associated symptoms like muscle pain.
Physicians want Medicare to pay for supervised therapeutic exercise for PAD patients. Activities like walking have been shown to alleviate symptoms and such treatment is now reimbursed for beneficiaries with other artery ailments, said Dr. Anne Roberts, chief of vascular and interventional radiology at the University of California San Diego Medical Center.
“If you have something like a heart attack, supervised exercise is paid for,” Roberts said.
Dr. Julie Ann Swain, a panel member and director of clinical research at the Department of Cardiothoracic Surgery at the Icahn School of Medicine at Mount Sinai in New York, supported the idea of reimbursing supervised exercise.
Fellow panel member Diana Zuckerman, president of the National Center for Health Research, a think-tank, agreed with Dr. Swain but expressed disappointment in the quality of research regarding the benefits of different types of interventions for most patients.
Other physicians at the MEDCAC meeting also expressed support for the reimbursement of arterial pumps, which stimulate circulation in the calf muscle. The pumps have shown to reduce pain and heal wounds that form on the legs and feet of those who have PAD, said Dr. Daphne Denham, who has a medical practice in Illinois that's dedicated to wound care.
Several panel members noted there is a lack of evidence that these devices are actually helpful.
“We didn't really hear about (the pumps) today, we just saw some dramatic pictures,” said Dr. Peter Bach, vice-chair of MedCac and director of Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center in New York. He was referencing Denham's presentation which showed several graphic images of leg and feet wounds on PAD patients she was treating.
The votes showed little confidence on the amount of evidence regarding interventions that improve health outcomes for asymptomatic PAD patients. Panel votes averaged 1.4 on the likelihood that treatments would improve the near-term health of these patients and 2.8 in the long term.
For PAD patients dealing with leg pain, the panel expressed a little more confidence. Panel votes averaged 3.2 on the likelihood that interventions would help in the short term, and 3.3 in the long term.
For those with restricted blood flow, panel votes averaged 3.6 on the likelihood that intervention could help in the short term, and 3 in the long term.
It's unclear whether the CMS will follow the panel's advice. MEDCAC is generally considered influential, but the CMS recently rejected a panel vote to not recommend Medicare coverage of annual CT scans to detect lung cancer in heavy smokers.
The CMS is not currently considering any national coverage decisions related to PAD. If it does, the agency's intentions will be announced in the next six to eight months, said Tamara Syrek Jensen, director of the coverage and analysis group at CMS.