Tuesday, May 31, 2016

CMS to Hold MEDCAC on Chronic Venous Disease (July 20, 2016)

On May 6, 2016, CMS announced it will hold a July 20, 2016, MedCAC on chronic venous disease of the lower extremities.  Webpage for the meeting here.  The deadline for meeting registration and/or PowerPoint submissions for presentations is June 13, 2016.  Federal Register announcement, here.

CMS abstract for the meeting, below the break.  This summer's meeting follows a MEDCAC last summer on peripheral arterial disease (here).

AHRQ has a current evidence collection on "Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease" June 9-July 9, here.   Earlier, AHRQ also posted a March 2016 protocol for the review of this topic, here.

Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
Lower Extremity Chronic Venous Disease

July 20, 2016

This MEDCAC meeting will 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. This meeting will also identify evidence gaps that exist related to lower extremity chronic venous disease. Lower extremity chronic venous disease is distinct from lower extremity peripheral artery disease as it is characterized by a different pathophysiology, epidemiology, set of clinical manifestations, and outcomes. Lower extremity chronic venous disease includes heterogeneous disorders that encompasses a variety of primary etiologies. Nevertheless, common to most of these venous conditions is a permanent alteration in venous structure and function, which leads to altered venous hemodynamics.

Causes of altered venous blood flow include venous dilation and venous valvular reflux (venous valvular incompetence or “chronic venous insufficiency”) or venous obstruction (from prior venous thrombosis or mechanical compression).  Patients with any of these venous structural alterations may be asymptomatic or symptomatic, suffering from mild pain to severe discomfort, with or without edema.  Chronic venous disease can lead to major decrements in quality of life, and be associated with quality-of-life altering physical stigmata, including telangiectasias and varicose veins.  Venous obstruction, venous insufficiency, and post-thrombotic syndrome patients may suffer from significant dependent edema and loss of ambulatory function.  When venous insufficiency is associated with untreated (sustained) venous hypertension, the skin may be permanently damaged with initial and recurrent skin ulceration.

Existing therapies to improve outcomes for individuals with lower extremity chronic venous disease are grouped into four main categories:

  1. medical therapy, 
  2. lifestyle interventions (including exercise, smoking cessation, and weight reduction), 
  3. mechanical compression therapies (support garments, bandaging and pneumatic compressive devices), and 
  4. invasive procedures (endovascular techniques including venous angioplasty, stenting and ablation; and surgical interventions, including venous thrombectomy, venous bypass, venous ligation, and venous excision).

Clinical outcomes of interest to the Medicare program include:
reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and avoidance of repeat interventions and harms from the interventions.