Lymphedema

CMS has called this meeting for the panel to discuss the adequacy of the available evidence that supports the diagnostic and treatment methods used in the management of secondary lymphedema. Medicare currently has a national coverage determination for the use lymphedema pumps related to the treatment of this condition.

Lymphedema occurs due to dysfunction of the lymphatic transport system. As a result of this abnormality, fluid (containing mostly water, protein, fatty acids, white blood cells, salts and debris/microorganisms) accumulates within the interstitial tissue of various areas of the body. The fluid accumulation can cause subclinical disease (that which cannot be seen on clinical examination) to gross enlargement of a body part. Complications of lymphedema include intradermal fibrosis, infection, pain and impaired functioning of the affected body part.

Lymphedema can be classified as either primary (due to abnormal development or growth of the lymphatic system) or secondary (due to injury to the lymphatic system). In the United States, the most common form of secondary lymphedema is that associated with the surgery and radiation of cancer treatment.

Strategies for the treatment of secondary lymphedema are directed at preventing or minimizing the fluid accumulation in the affected body parts, restoring any lost function and providing education to avoid the potential of anticipated complications.

October 1, 2009

October 5, 2009

November 2, 2009

November 17, 2009

November 30, 2009

January 19, 2010

February 16, 2010

Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 - 8:00 AM

8:00 - 8:15 AM

8:15 - 8:30 AM

8:30 - 9:15 AM

9:15 - 9:45 AM

9:45 - 10:15 AM

10:15 - 10:30 AM 

10:30 - 11:50 PM

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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.

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11:50 - 12:00 PM

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 - 2:45 PM  

2::45 - 3:45 PM

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

3:45 - 4:15 PM  

4:15 - 4:30 PM 

Download meeting minutes [PDF, 122KB]

1. How confident are you that there is sufficient evidence to determine if the listed diagnostic strategies can reliably identify and stratify the severity of secondary lymphedema, including subclinical disease? 

   1. Imaging techniques
      1. Lymphoscintigraphy/lymphangioscintigraphy
      2. MRI/CT
      3. Ultrasound
      4. (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan
   2. Quantitative techniques to determine limb volume/ skin elasticity
      1. Tissue tonometry
      2. Perometry
      3. Circumferential measurements
      4. Water displacement
      5. Bioimpedance
   3. Patient reported symptomatology
   4. Physical exam
   5. Other
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence



2. For only those items where the answer to Question 1 is at least in the Intermediate range (mean score ≥ 2.5 on Question 1), how confident are you that each of the listed diagnostic strategies reliably identifies and stratifies the severity of secondary lymphedema, including subclinical disease?  
   
   1. Imaging techniques
      1. Lymphoscintigraphy/lymphangioscintigraphy
      2. MRI/CT
      3. Ultrasound
      4. (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan
   2. Quantitative techniques to determine limb volume/ skin elasticity
      1. Tissue tonometry
      2. Perometry
      3. Circumferential measurements
      4. Water displacement
      5. Bioimpedance
   3. Patient reported symptomatology
   4. Physical exam
   5. Other
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence



3. How confident are you that secondary lymphedema can be classified into prognostic stages of severity, i.e., staging that is useful to guide choice of therapy or predict response to therapy?
   
   
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence




4. In clinical studies of treatment(s) for secondary lymphedema, how confident are you that there is sufficient evidence that an improvement in each of the following measures is, or is strongly associated with, an improved health outcome?

   1. Affected limb circumference
   2. Affected limb volume
   3. Symptom assessment
   4. Affected limb function (strength, endurance, range of motion, sensation, etc.)
   5. ADL (Activities of Daily Living) abilities
   6. Frequency of skin breakdown or ulceration
   7. Frequency of occurrence of local infection
   8. Quality of life assessment
   9. Other
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence




5. How confident are you that there is sufficient evidence to determine if each of the following treatment strategies produces clinically meaningful improved health outcomes for patients with secondary lymphedema?

   1. Pneumatic compression devices
   2. Exercise based activities
   3. Massage based treatment
   4. Compression bandaging/compression garments
   5. Psychosocial support
   6. Other
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence


Please answer Question 6 ONLY for those treatments where the panel had at least Intermediate range confidence (mean score ≥ 2.5 on Question 5) that there was sufficient evidence to address this issue.

6. How confident are you that each of the following treatment methods produces clinically meaningful improved health outcomes for patients with secondary lymphedema?

   1. Pneumatic compression devices
   2. Exercise based activities
   3. Massage based treatment
   4. Compression bandaging/compression garments
   5. Psychosocial support
   6. Other
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence




7. How confident are you that the conclusions regarding the diagnostic strategies as a group (Q2) and the treatment methods as a group (Q6) are generalizable to Medicare beneficiaries with secondary lymphedema? 

Diagnostic Strategies:
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

Treatment Methods:
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence




8. Please discuss any clinically important evidence gaps pertaining to the diagnosis and/or treatment of secondary lymphedema.  What trial designs would support the closure of such existing evidence gaps?

 

Download Scoresheet [PDF, 3MB]