A panel that advises the CMS on Medicare coverage decisions concluded there's too little evidence that current treatments for diseased leg veins improve health outcomes.
The Medicare Evidence Development and Coverage Advisory Committee voted Wednesday against recommending national Medicare coverage for the procedures. If the CMS agrees, the conclusion would leave in place the patchwork of local coverage decisions by Medicare contractors, which has led to inconsistent reimbursement for providers and access for patients.
It is estimated that more than 25 million Americans have varicose veins and up to 6 million people have advanced stages of venous disease.
A CMS spokeswoman said that despite there not being a decision in favor of national coverage, a vast majority of procedures are generally paid for by Medicare.
During the meeting, members of the nine-member MEDCAC panel were asked to vote on a scale of one to five how confident they were that current treatments now in use result in better outcomes in both the long and short-term for people with chronic venous disease in the legs, an ailment that occurs when leg veins do not allow blood to travel back to the heart. Most of the questions yielded median votes of less than three.
“There just isn't a great deal of evidence to support it, even though this is a serious problem,” said Dr. Sandra Lewis, a panel member and cardiologist at the Northwest Cardiovascular Institute in Oregon.
“It's frustrating to me that as a clinician I want to suggest things I know will help my patients, but it seems like the cart got ahead of the horse,” said Dr. Rita Redberg, chair of the Medicare committee and professor of medicine at the UCSF School of Medicine, referring to the fact that many of the treatments out there aren't clinically proven to be effective.
There is adequate data, she said, that diet and exercise will benefit people battling venous disease.
Panel members said additional studies for venous disease treatments should be performed, with key focus on disparities in race, gender and age.
MEDCAC panels do not make coverage determinations, but CMS often listens to its advice.
The most common symptom of venous disease is varicose veins. Individuals with more serious venous disease can develop severe pain, swelling, leg ulcers and blood clots that can travel to the lungs.
Some of the most common treatments for chronic venous disease include:
- Compression stockings, which apply pressure on the legs and help blood flow.
- Sclerotherapy, which involves injecting a chemical into the affected veins so that they can no longer carry blood. This procedure forces blood to reroute through healthier veins.
- Ligation, which involves tying off an affected vein so that blood no longer flows through it, this achieving a similar effect to sclerotherapy.
“The part of the population MEDCAC is most interested in, data are insufficient currently to provide evidence of efficacy,” said Dr. Peter Gloviczki, director emeritus of the Gonda Vascular Center at the Mayo Clinic, who attended the meeting. “The message is not that these techniques don't work.“The message is that in the Medicare population we don't have enough data to support efficacy.”
Others at the meeting expressed confidence that Medicare would ultimately grant coverage in the future given the scope of the problem.
“Coverage for venous disease must still occur as there are millions of patients affected with the problems discussed today,” said Dr. Thomas Wakefield, a professor of vascular surgery at the University of Michigan.