Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a Bioimpedance spectroscopy (BIS), extracellular fluid 
analysis for lymphedema assessment (93702). 
 
You asked the Plan to pre-approve a BIS assessment. You say that the use of lmpediMed's L-Dex device is 
medically necessary. The Plan denied your request. The Plan says Medicare does not cover experimental and 
investigational procedures. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
 
 
 
 
 
 
 
 
 We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve a BIS assessment. Our reviewer says 
that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found Bioimpedance spectroscopy measures the differential impedance (resistance) to low 
level electrical current to evaluate changes in body fluid composition that occur in conditions such as 
lymphedema. Body composition assessment has been used to evaluate clinical interventions in research trials 
and has the potential to improve patient care in the clinical setting. Body cell mass (BCM) is an important 
indicator of nutrition status; however, its measurement in the clinic has been limited. BCM can be estimated by 
the measurement of intracellular water (ICW). The assessment of extracellular water (ECW) is also important 
because many clinical populations undergo alterations in fluid distribution, particularly individuals with 
wasting, those receiving dialysis, and obese individuals. Bioimpedance spectroscopy (BIS) is a unique 
bioimpedance approach that differs in underlying basis from the more readily recognized single-frequency 
bioelectrical impedance analysis (SF-BIA) in that it does not require the use of statistically derived, population-
specific prediction equations. It has the potential advantage of not only measuring total body water (TBW), as 
does SF-BIA, but also offering the unique capacity to differentiate between ECW and ICW and, thus, to 
provide an estimate of BCM. This literature review was conducted to compare available BIS devices to 
multiple dilution for measuring fluid compartments or BCM in a number of populations. Variable results 
regarding the ability of BIS to measure absolute volumes, as well as the observation of wide limits of variation, 
make BIS problematic for individual assessment in the clinic, particularly in populations with abnormal fluid 
distribution or body geometry. BIS has been found to be more accurate for measuring changes in fluid volumes 
or BCM, particularly in post-surgical and human immunodeficiency virus (HIV)-infected individuals. It is 
certainly possible that population-specific adjustments may improve the accuracy of BIS for assessing 
individuals in the clinical setting; however, additional research and development is needed before the method 
can be accepted for routine clinical use. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of a BIS assessment have not been met. Therefore, we decided that the Plan does 
not have to pre-approve a Bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema 
assessment (93702).