CMS panel tepid on interventions for patients with chronic venous disease

A panel of the Medicare Evidence Development and Coverage Advisory Committee of the CMS voted that it has moderate confidence that there is sufficient evidence for intervention that improves health outcomes for certain adults with chronic venous disease.

The moderate-confidence vote applied to patients who have varicose veins and/or other indicators of chronic venous insufficiency and who present with symptoms.

However, the panel voted that it has low confidence of adequate evidence for an intervention for members of that cohort presenting without symptoms but with signs.

The panel also voted that it has low confidence of sufficient evidence for intervention that improves both immediate/near-term and long-term health outcomes for adults with chronic venous thrombosis — including individuals with post-thrombotic syndrome — who present with signs or symptoms.

Panelist John Jeffrey Carr, MD, professor of radiology, bioinformatics and cardiovascular medicine at Vanderbilt University, said lack of outcomes data drove the vote.

“What was the missing piece?” Carr asked. “It was patient-centered outcomes.”

Other panel members agreed that reliable data was lacking.

“Just about everything has an evidence gap for people over the age of 65,” Diana Zuckerman, PhD, president of the National Center for Health Research Cancer Prevention and Treatment Fund, said. “What we need are some good studies that are specific. That way, we can pursue effective, affordable outcomes.”

Committee chair and nonvoting member Rita Redberg, MD, MSC, professor of medicine at University of California, San Francisco, and a member of the Cardiology Today Editorial Board, said, “What was most striking to me were the evidence gaps. [For this vote] my tendency is to think more conservatively than invasively.”

Rita Redberg

Presenters often discussed the lack of quality-of-life issues included in data studies. K. Francis Lee, MD, PC, medical director of Advanced Vein Care Center in Springfield, Massachusetts, said, “These [studies] do not adequately address what patients care about. They care about their pain. What about the single mothers who are waitresses and can’t keep their jobs because it’s too painful to stand on their feet all day?”

The purpose of the meeting was to examine the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease interventions that aim to improve health outcomes in the Medicare population, according to the CMS.

It also sought to identify evidence gaps that exist related to lower extremity chronic venous disease, including heterogeneous disorders that encompasses a variety of primary etiologies.

But, according to the CMS, common to most of these venous conditions is a permanent alteration in venous structure and function, which leads to altered venous hemodynamics. – by James Clark

Disclosure: The standing members of the MEDCAC panel report no relevant financial disclosures.