Lower Extremity Chronic Venous Disease

On July 20, 2016, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC).  The MEDCAC panel will examine the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease treatments 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.

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.   

By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about Medicare coverage for interventions related to lower extremity peripheral venous disease.  MEDCAC panels do not make coverage determinations, but CMS often benefits from their advice.

May 6, 2016

July 13, 2016

July 22, 2016

September 6, 2016

• Webcast of meeting
• Registration
• Information about visiting CMS
• Driving directions to CMS
• Recommended hotels

Rita Redberg, MD, Committee Chair
Art Sedrakyan, MD, Acting Committee Vice Chair
Lori Ashby, MA, Director, Division of Medical and Surgical Services, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AM

8:00 – 8:15 AM

8:15 - 8:25 AM

8:25 – 8:45 AM

8:45 – 9:35 AM

9:35 – 9:55 AM 

9:55 – 10:05 AM 

10:05 – 10:15 AM  

10:15 – 11:50 AM

(Refer to Speaker List)

Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

11:50 – 12:00 AM

Public Attendees who wish to address the panel will be given that opportunity

12:00 - 1:00 PM

1:00 – 2:00 PM

2:00 – 3:00 PM

3:00 – 4:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

4:00 – 4:20 PM

4:20 – 4:30 PM

Download scoresheet.

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: medical therapy, lifestyle interventions (including exercise, smoking cessation, and weight reduction), mechanical compression therapies (support garments, bandaging and pneumatic compressive devices), and 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.

For each voting question, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence and 5 representing high confidence.

1. For adults with varicose veins and/or other clinical symptoms or signs of chronic venous insufficiency, how confident are you that there is sufficient evidence for an intervention that improves:
   1. Immediate/near-term health outcomes in patients presenting with symptoms?  In patients presenting without symptoms but with physical signs?
   2. Long-term health outcomes in patients presenting with symptoms?  In patients presenting without symptoms but with signs?

Discussion:

• If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s).
• Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention.

2. For adults with chronic venous thrombosis and venous obstruction (including individuals with post-thrombotic syndrome), how confident are you that there is sufficient evidence for an intervention that improves:
   1. Immediate/near-term health outcomes in patients presenting with symptoms?  In patients presenting without symptoms but with signs?
   2. Long-term health outcomes in patients presenting with symptoms?  In patients presenting without symptoms but with signs?

Discussion:

• If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s).
• Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention.
  1. Immediate/near-term health outcomes?
  2. Long-term health outcomes?

Additional Discussion Topics

3. Discuss important venous disease evidence gaps that have not been previously or sufficiently addressed.


4. Discuss any current venous disease treatment disparities and how they may affect the health outcomes of Medicare beneficiaries.


5. Discuss any mechanisms that might be supported by CMS that would more quickly generate an improved evidence base that would underpin improved care for the Medicare population affected by lower extremity chronic venous diseases.

Table 1. Definitions of Terms

Abbreviations:

CEAP = Clinical, Etiologic, Anatomic, Pathophysiologic
DVT = deep vein thrombosis
LE = lower extremity