Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3 
 
A  46-year-old  female  enrollee  has  requested  authorization  and  coverage  for  bone  marrow 
aspiration (38220). The Health Insurer has denied this request and reported that the requested 
services are investigational for the treatment of the enrollees medical condition. The physician 
reviewer found that according to Thurairajah and colleagues, published scientific data on bone 
marrow aspirate therapy for human nonunion has been available since 1986, but to date there is no 
Level I nor Level II evidence in publication. A retrospective study involving 26 patients by Lin 
and colleagues was designed to compare bone marrow aspirate concentrate with cancellous 
allograft to iliac crest bone graft in the treatment of nonunions. No significant difference was found 
in union rate for long bone nonunions treated with to iliac crest bone graft or bone marrow aspirate 
concentrate with allograft. The authors noted, Bone marrow aspirate concentrate and allograft led 
to 75% successful healing in this series. Given the heterogeneity of the control group, further 
prospective investigation should be conducted to more rigorously compare bone marrow aspirate 
concentrate to iliac crest bone graft for nonunion treatment. Autologous cancellous bone grafting 
often involves donor site morbidities and complications. The purpose of the study by Thua and 
colleagues was to evaluate the initial outcome of the percutaneous injection of autologous bone 
marrow after concentration for the treatment of delayed union or nonunion. The authors noted,  The result of this study is encouraging. Percutaneous autologous bone marrow implantation could 
be an effective and safe option for the treatment of delayed or nonunion fractures. However, more 
studies are needed for definitive conclusions. The objective of a systematic review and meta-
analysis by Palombella and colleagues was to assess the current evidence for the efficacy of bone 
marrow-derived cell-based approaches associated or not with bone scaffolds for the treatment of 
nonunions. A total of 27 studies were analyzed. The authors noted, The results indicate that 
marrow aspirate concentrate or marrow aspirate concentrate/scaffold might be considered as the 
primary choice to treat nonunions with a successful healing rate at a midterm follow-up. Moreover, 
this meta-analysis highlighted that the presence of a scaffold positively influences the healing rate 
at a long-term follow-up. More case-control studies are still needed to support the clinical 
improvement of cell-based therapies against autografts, up to now considered as the gold standard 
for the treatment of nonunions. In sum, percutaneous bone marrow aspirate for the treatment of 
delayed or nonunion fractures is encouraging and could be an effective and safe option. However, 
at this time, there is a lack of Level I or Level II evidence in publication supporting its use. More 
studies  are still  needed  to  support  the  clinical  improvement  of  cell-based  therapies  against 
autografts. Therefore, the requested bone marrow aspiration (38220) is not likely to be more 
beneficial than any other available standard treatments for the enrollees medical condition.