Frequently Asked Questions From Health Insurance Providers
Question 1
Based on the findings of the National Institutes of Health (NIH) study, why not provide compression sleeves prophylactically to all patients following breast surgery?
Response 1
Generally, a medical diagnosis of disease, or impairment, is necessary prior to the implementation of any medical intervention or treatment. In the case of secondary lymphedema following primary medical treatment (surgery, chemotherapy and/or radiation) the overall incidence of lymphedema has been estimated to be 20-25%. As such, if one were to provide compression sleeves to all patients following treatment, 75-80% of these patients may be inappropriately treated for a non-diagnosed condition.
In the absence of a diagnosis, patients are less likely to be compliant with a medical intervention over a long period, such as the 36 months of highest risk following their primary treatment. Compliance with a short interval of intervention, as demonstrated in a study conducted by the NIH (Cancer, June 2008) [1] is more likely to be successful.
Improper fitting or wear of compression sleeves provided prophylactically to all patients could actually promote constriction of the arm and subsequent swelling and other vascular complications.
Fitting such sleeves to all patients could subject them to unnecessary cosmetic and comfort issues.
Lastly, the cost of these sleeves (2 per year) could be significant to the patients or health insurance provider over time.
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Bioimpedance Spectroscopy (BIS) was not used in the NIH study. Can I be confident it can work as effectively as perometry did in the study?
Response 2
Although BIS was not used in the NIH study, other published studies have demonstrated high correlation between perometry and BIS. [2,3] Additionally, BIS has been independently validated in the peer-reviewed literature and shown capable of assisting physicians in the clinical assessment of early onset of lymphedema, up to 10 months prior to total limb volume changes. [4]
One should note the measurement differences between perometry and BIS. Optoelectronic volumetry (Perometry) represents an indirect measurement of the volume based on the formula for a truncated cone using girth and distance between points of measure. In essence, it includes all tissues (e.g.: bone, skin, muscle) in the establishment of a volume estimate.
BIS is a direct measurement of the resistance (ohms) of the extracelluar fluid in the arm. Excess extracelluar fluid is the principal component responsible for the early and late development of secondary lymphedema. Several clinical studies by Cornish et al have established high levels of sensitivity and specificity in the ability to identify and monitor lymphedema over time.[4]
Additionally, BIS has regulatory clearance in the United States to “support the measurement of extracellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women.” Breast surgeons throughout the United States have adopted BIS technology and have been utilizing these devices in accordance with the prospective or pre-emptive model described in the NIH study.
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Isn’t BIS considered experimental?
Response 3
According to the definitions provided by the American Medical Association (AMA), BIS is considered “emerging technology” and not experimental. The first publication describing BIS occurred in 1992. Subsequently there has been 17 years of further clinical and research study which has resulted in the publication a number of scientific articles in peer-reviewed medical and scientific journals. (Please see Published Papers and Clinical References/Lymphedema:
http://www.impedimed.com/knowledge-center/pulished-papers-and-clinical-references/lymphedema.htm). As previously stated, over 120 surgeons nationwide have incorporated this technology into their routine practice for the assessment and surveillance of their breast cancer patients. The clinical utility of BIS has been translated from research into clinical practice, a key element of the demonstration of comparative effectiveness.
Question 4
The surgeons in our plan don’t see Lymphedema anymore and believe Sentinel Lymph Node Biopsy (SLNB) has eliminated Lymphedema. Is this true?
Response 4
Unfortunately, the incidence of secondary lymphedema following sentinel lymph node biopsy still exists and is established in the literature. Depending on the article cited, rates range from 4-17%. [5,6,7] While it is true that rates of lymphedema in those patients receiving SLNB-only procedures have been reduced, it still remains a significant adverse effect and risk for the general population of patients.
In addition, approximately 1 in 4 SLNB procedures will result in a positive finding, necessitating further axillary clearance or removal of additional lymph nodes through axillary dissection. Further identification of additional positive nodes would also require irradiation of the area, placing the patient at further potential risk of the development of lymphedema.
One of current dilemmas for health care providers is that all patients that have received some form of surgery, chemotherapy and/or radiation are at relative risk of developing secondary lymphedema during their years of survivorship. Unfortunately, there are no absolute risk or prediction methods to identify patients at greatest risk. As such, based on the findings of the NIH study and other associated publications, the most prudent and possibly effective method to identify and treat this impairment early would require a pre-surgical assessment of the limb, followed by periodic surveillance to ensure timely and appropriate intervention.
Question 5
What factors suggest that patients will be more compliant with a shorter interval of intervention (ie., 30 days) than having to wear a compression garment for a much longer interval (such as years)?
Response 5
Data from the NIH study demonstrated that intervention with a compression sleeve and gauntlet over an average 4.4 weeks was effective at reducing swelling in the affected limb to nearly that of the un-affected limb.
Although intuitive that patients would be better compliant to a shorter interval of treatment with compression, other Quality of Life factors which may be considered include:
a. Patients in warm, humid climates may find long term compliance to be more difficult due to comfort and appearance.
b. Many women after primary treatment of their breast cancer express the desire to “move on with her life” and put cancer behind them. Wearing a sleeve for a longer interval of time would be a constant reminder to them of their breast cancer.
c. Wearing of a compression sleeve could identify the woman publicly as a breast cancer survivor, hence a shorter interval of care might be preferred rather than extended periods of months or years.
Question 6
Are there clinical outcomes (studies, data) supporting the successful use of BIS?
Response 6
Numerous peer-reviewed and published studies cite the ability of BIS to assist a clinician in the detection of early stage lymphedema. Other published reports support the importance of early identification and early intervention.
(see http://www.impedimed.com/knowledge-center/pulished-papers-and-clinical-references/lymphedema.htm)
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Question 7
How does Bioimpedance Spectroscopy (BIS) compare to other assessment methods in the assessment of lymphedema?
Response 7
BIS provides an objective, standardized metric for the assessment of lymphedema. It provides a measure directly related but inversely proportion to the accumulation of fluid in a limb.
Other methods for assessment include visualization, tape measure, water displacement and perometry. All of these methods are based on an increase in total limb volume (muscle, fat, bone and fluid) rather than specifically assessing extracellular fluid. Each of these other methods have issues related to sensitivity, reproducibility and practicality in a clinical setting. These methods may also be confounded by changes in weight and fat or muscle mass.
Please see the Published Papers and Clinical References- Lymphedema for papers comparing various methods for assessment of lymphedema:
( http://www.impedimed.com/knowledge-center/pulished-papers-and-clinical-references/lymphedema.htm)
Question 8
Should the use of BIS be considered a medical necessity in the assessment and treatment of all breast cancer patients?
Response 8
Physicians typically establish a clinical diagnosis of lymphedema after visible changes in girth and volume of the patient’s arms are apparent and as confirmed by a 2 centimeter circumferential girth measurement difference using a tape measure. While the tape measure provides a gross and indirect measure of total limb volume change, there are issues related to measurement time, reproducibility, accuracy and standardization that negatively impact on the use and quality of the measure.
Recent published advances in science and technology have resulted in the capability to detect secondary lymphedema at an earlier, less severe stage. If the condition is diagnosed and treated with an off-the-shelf compression sleeve early in the course of its progression, better functional outcomes are possible. Additionally, utilization and need for other more costly covered services such as complex decongestive therapy (CDT), pneumatic compression pumps and static compression sleeves would decrease resulting in significant overall cost savings and improved health economics. Failure to diagnose or treat this condition in a timely fashion may result in progression to a more chronic and irreversible stage.
BIS provides sensitive and objective measurement of changes in extracellular fluid indicative of early physiological signs of lymphedema. BIS provides a direct measure of electrical resistance through extracellular fluid and provides patient specific values which are compared between limbs and over time. The values obtained represent the ratio of impedance in the normal limb compared to that of the at-risk limb. Using this approach, Cornish et al (2001)[4] predicted the onset of lymphedema in a cohort of breast cancer patients up to 10 months before the condition was clinically diagnosed. Recently, BIS has been proposed as the new gold standard for the detection of early stage lymphedema based on its specificity, accuracy, precision, repeatability both within and between testing centers, limits of detection, sensitivity, practicability and applicability under normal conditions of use. [8] BIS devices are cleared within the US for the assessment of extracellular fluid volume differences between limbs.
BIS allows providers the ability to identify early, abnormal shifts in extracelluar fluid well in advance of current methods used to detect subclinical lymphedema.
Lymphedema is a common co-morbidity of cancer treatment. (See Question 4 above). BIS should, therefore, be considered “medically necessary” due to the relatively high risk of lymphedema in patients following primary treatment.
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Question 9
What distinguishes the application of bioimpedance spectroscopy (BIS) in assessment of lymphedema from bioimpedance analysis (BIA) used in body composition assessment?
Response 9
BIS provides a direct measure of extracellular fluid in a patient’s limb by calculating impedance at a theoretical zero frequency (R0). Impedance is inversely proportional to fluid volume. Hence, as a patient begins to accumulate excess extracellular fluid in their at-risk limb, impedance (as measured in ohms) is reduced. BIS compares the impedance of the unaffected limb to that of the potentially affected limb and reports this comparison in the form of an impedance ratio (L-Dex®).
Bioimpedance analysis (BIA) as used in single and multiple frequency devices for body composition assessment rely on prediction equations or algorithms to arrive at estimates of fat mass, fat-free mass and fluid status based on comparisons to a studied population of generally healthy individuals. BIA devices for body composition typically measure at frequencies of 50 kHz or higher where the current passes through both intracellular and extracellular fluid. BIA works on the assumption that the subject being measured is similar to the population from which the algorithm or prediction equation was derived.
BIS is, therefore, both patient specific and indicated for use in disease or at-risk populations. BIA for body composition would be clinically inappropriate in lymphedema assessment and will not provide a direct, limb specific assessment of extracellular fluid due to reliance on algorithms and predictive equations.
Question 10
Are there Randomized Control Trials (RCT) using your product?
Response 10
The efficacy of medical practice procedures is best served through evidence based literature and publication of peer-reviewed, randomized controlled trials that demonstrate better outcomes when compared to a control group. Unfortunately such RCT evidence to prove efficacy is substantially lacking, in part due to the difficulty and ethics of comparing a control group (usual care) where the investigator would wait to diagnose lymphedema until it was visibly apparent to an experimental group provided an earlier diagnosis of “subclinical lymphedema”. One recent European study [9] used a RCT design to investigate the effectiveness of early intervention and education versus education alone. Results demonstrated significantly lower rates of lymphedema in the early intervention arm of the trial.
In addition, the explanation of the consent form to potential subjects by the investigator explaining that subjects may be randomized to a group requiring a visible change in the volume and size of their arm before treatment could be initiated may present the investigator a significant challenge in recruitment and compliance.
In the absence of RCTs, there are a number of peer-reviewed published articles which address the science, technology and practice related to the use of bioimpedance in the study of lymphedema. Most of the clinical trials employed either prospective, retrospective, observational or cohort designs. In addition, there are a number of review articles describing current incidence, assessment and intervention practiced in treatment of lymphedema. Consideration of the robustness of these articles under the guise of best-evidence literature is often weighed in assessment and appraisal of non-pharmaceutical research where RCTs are not available. The current body of evidence supporting two major tenants of a pre-emptive model are compelling:
1.) Importance and effectiveness of the early assessment and management of lymphedema.
2.) Use of newer, sensitive and objective measurement tools such as BIS to enable earlier diagnosis of lymphedema.
Question 11
Is a pre-emptive model of surveillance and early intervention cost effective?
Response 11
The diagnosis of lymphedema often requires referral for specialized and protracted treatment by physical therapists including complex decongestive therapy (CDT), compression bandages and custom fitted sleeves and in some cases, procurement of expensive pneumatic compression devices or pumps. The cost of these interventions is significant to patient and payer (government and third party). A recent study published in the Journal of Clinical Oncology of 1877 breast cancer patients by Shih, et al (2009) identified an $14,877 to $23,167 increased overall cost of medical treatment for those patients with a documented history of lymphedema compared to those without lymphedema over a two year period. The study employed an economic analysis method based on medical claims reviewed.
Further, as there is no current “cure” for chronic lymphedema, intensive care and associated cost must be maintained for the remainder of the survivor’s life. For this reason, early assessment of lymphedema and early treatment appears to be a more highly desirable option to the current method of assessment and care of patients at risk for lymphedema.
ImpediMed can provide interested health care insurance providers with a model based on US breast cancer statistics and published health economic reports. Additionally, payers are encouraged to conduct their own internal analysis based on CPT and ICD-9 codes identified in the study by Shih, et al.
Question 12
Is BIS safe and effective?
Response 12
The actual amount of electrical current passed through the body is imperceptible to most patients, is applied non-invasively and is applied over a brief period (less than 1 second). As previously described, BIS has regulatory clearance within the United States to “support the measurement of extracelluar fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women.”
References
[1] Gergich, et al, Preoperative Assessment Enables the Early Diagnosis and Successful Treatment of Lymphedema, Cancer, Volume 112, Issue 12, Pages 2809-2819, 15 June 2008
[2] Czerniec, et al, Assessment of Breast Cancer-Related Arm Lymphedema—Comparison of Physical Measurement Methods and Self-Report, Cancer Investigation, 28:54–62, 2010
[3] Ward, et al, Operational Equivalence of Bioimpedance Indices and Perometry for the Assessment of Unilateral Arm Lymphedema, Lymphatic Research and Biology, Volume 7, Number 2, 2009, pp 81-85
[4] Cornish, et al, Early diagnosis of lymphedema using MFBIA, Lymphology, 34: 2-11 2001
[5] Veronesi, et al, A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer. N Engl J Med Volume 349;6:546-553 August 7, 2003
[6] Francis, et al, Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg 2006;192(5):636-9.
[7] Wilke, et al, Annals of Surg Oncology 2006 -Z10 Surgical Complications Associated With Sentinel Lymph Node Biopsy Results From a Prospective International Cooperative Group Trial
[8] Ward, Is BIS Ready for Prime Time?, Journal of Lymphology, Vol 4, No 2, 2009
[9] Lacomba, et al, Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial, BMJ 2010;340:b5396