August 10, 2016
MEDCAC and AHRQ Find Evidence Is Insufficient to Support Interventional Treatments of Lower-Extremity Chronic Venous Disease
August 10, 2016—The score sheet on panelist voting from the July 20 Centers for Medicare & Medicaid Services (CMS) Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on treatment strategies for patients with lower extremity chronic venous disease (LECVD) is now available on the CMS website here. Overall, the MEDCAC panelists expressed low confidence in the sufficiency of evidence to support a recommendation for national CMS coverage of interventions to treat LECVD.
Voting on a scale of 1 (lowest or no confidence) to 5 (high confidence), participants were asked to gauge their confidence in the sufficiency of evidence that intervention will improve symptoms for (1) adults with varicose veins and/or other clinical symptoms or signs of chronic venous insufficiency; and (2) adults with chronic venous thrombosis and venous obstruction (including individuals with post-thrombotic syndrome).
In the first category (varicose veins), the average score (3.33) of the voting-member MEDCAC panelists indicated an intermediate level of confidence that treatment will improve the immediate/near-term health outcomes in patients presenting with symptoms. However, in patients presenting without symptoms but with physical signs, the average confidence level for improved short-term outcomes was only 2.00. Regarding the long-term health outcomes in patients presenting with symptoms, the panel’s average confidence level was 2.56; and for patients without symptoms but physical signs, it was 1.33.
In the second category (chronic venous thrombosis and venous obstruction), the average confidence level was low (at 2.11) that intervention would improve immediate/near-term outcomes in patients presenting with symptoms. The average confidence was only 1.44 in patients presenting without symptoms but physical signs. For long-term outcomes, the average level of confidence that intervention would lead to improvement was 1.56 in patients with symptoms and 1.22 in patients without symptoms.
In addition to the MEDCAC panel meeting, on June 28 the US Agency for Healthcare Research and Quality (AHRQ) issued a draft Technology Assessment (TA) on LECVD for public review and commentary by stakeholders. The draft document is available on AHRQ website at www.ahrq.gov.
The AHRQ assessment concluded:
The available evidence for treatment of patients with LECVD is limited by heterogeneous studies that provide comparisons of multiple treatment options, varied outcomes measured, and disparate timepoints of outcome assessment. Very little comparative effectiveness data has been generated to study new and existing diagnostic testing modalities for patients with LECVD. Several advances in care in endovenous interventional therapy have not been rigorously tested, and very few studies on conservative measures (eg, lifestyle modification, compression therapy, exercise training) exist in the contemporary literature. Additionally, the potential additive effects of many of these therapies are unknown. The presence of significant clinical heterogeneity of these results makes conclusions for clinical outcomes uncertain and provides an impetus for further research to improve the care of patients with LECVD.
On August 3, the representatives of the Venous Care Partnership provided commentary on the draft TA in a letter available online here addressed to the AHRQ Task Officers Aysegul Gozu, MD, and Elise Berliner, PhD. The letter outlined general and specific concerns of the TA, including its methods and findings, stating:
In summary, although the authors have conducted an extensive review within the limitations required of them, this document may have hindered interpretation of the totality of the evidence, thus diminishing its ability to effectively inform policy decisions. The exclusion of publications prior to the year 2000, the focus on patient conditions without description, broad and overlapping questions, and stringent study inclusion criteria have provided a subjective portrayal of the scientific evidence upon which modern venous treatment is based.
The Venous Care Partnership is composed of representatives appointed from ten specialty societies and associations: Alliance for Wound Care Stakeholders, American College of Cardiology, American College of Phlebology, American College of Radiology, American Heart Association, Society for Vascular Medicine, Society of Interventional Radiology, Society for Cardiovascular Angiography and Intervention, US Compression Alliance, and Vascular Interventional Advances.