Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve bioimpedance spectroscopy (BIS), extracellular fluid analysis for 
lymphedema assessment(s) (93702x4). 
 
You asked the Plan to pre-approve bioimpedance spectroscopy. You say that you disagree with the denial. The 
Plan denied your request. The Plan says that experimental and investigational procedures are not covered by 
Medicare. The use of bioimpedance spectroscopy for lymphedema is unproven and not medically necessary 
due to insufficient evidence of safety and/or efficacy. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 bioimpedance spectroscopy. Our 
reviewer says that the requested items/services are considered medically reasonable and necessary in this case. 
Our physician reviewer found his study compared rates of progression to chronic breast cancer-related 
lymphedema (defined as = 10% arm volume change from baseline requiring complex decongestive 
physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by 
bioimpedance spectroscopy (BIS) or by tape measurement (TM). This stratified, randomized, international trial 
enrolled new breast cancer patients undergoing mastectomy/partial mastectomy, axillary treatment (dissection, 
sentinel lymph node biopsy [SLNB] >6 nodes or radiation), radiation therapy (chest wall/breast, 
supraclavicular fossa), or taxane-based chemotherapy. Following postsurgery eligibility reassessment, 
centralized, 1:1 randomization to prospective surveillance by BIS or TM occurred. S-BCRL detection triggered 
a 4-week, 12-hour per day, compression sleeve, and gauntlet intervention. The primary outcome (n = 209), 
rates of postintervention progression to CDP, was assessed over 3 years. Between June 24, 2014, and 
September 11, 2018, 1200 patients were enrolled, 963 randomized (BIS n = 482; TM n = 481) and 879 
analyzed (BIS n = 442; TM n = 437). Median follow-up was 32.9 months (interquartile range = 22, 35). BIS 
patients triggered an intervention at a lower rate than TM patients (20.1%, n = 89 vs. 27.5%, n = 120, p = 
0.011). Median months to trigger were longer with BIS than TM (9.7; 95% confidence interval [CI], 8.2-12.6 
vs. 3.9; 95% CI, 2.8-4.5, p = 0.001). Overall, 14.4% (n = 30) progressed post-intervention, with reduced 
likelihood for BIS patients than TM patients (7.9%, n = 7 vs. 19.2%, n = 23; relative risk = 0.41; 95% CI, 0.13-
0.81; absolute reduction 11.3%; 95% CI, 2.3-20.3; p = 0.016). Compared to TM, BIS provides a more precise 
identification of enrollees likely to benefit from an early compression intervention. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of bioimpedance spectroscopy have been met. Therefore, we decided that the Plan 
has to pre-approve bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema 
assessment(s) (93702x4).  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.