Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: BRCA 1 Mutation

Treatment: Nerve Repair with Allograft (tissue graft from a donor) or Synthetic (produced by chemicals), Nipple-Sparing; billing code 64910

The insurer denied the nerve repair with allograft (tissue graft from a donor) or synthetic (produced by chemicals), nipple-sparing; billing code 64910.

The denial was upheld.

This is a female patient with a diagnosis of BRCA1 mutation. She is planned for bilateral nipple sparing mastectomy and immediate reconstruction with implants. The surgeon desires to perform a nerve graft with the breast reconstruction.

Some sensation to the breast returns after breast reconstruction, but recovery is variable and unpredictable. (Margarakis, et al.) 

"Without irradiation, skin overlying implants is associated with better sensation recovery than DIEP flap skin. However, with irradiation, DIEP flap skin had better sensation recovery than did skin over implants. Neurotization trended toward improvement in sensation in DIEP flaps." (Margarakis, M., et al, 2013)

"Overall, TRAM flaps are the most commonly performed type of flap reconstruction, partly because TRAM flap tissue is very similar to breast tissue and makes a good substitute. They also have been around for some time, and many surgeons know how to do them. However, the downside of TRAM flaps is that they do cut through muscle, while other types of flap reconstruction avoid this and are therefore "gentler" operations." (BreastCancer.org, 2019).

In regard to implant-based reconstruction, there is a single case series involving 16 patients reported by Peled and Peled which reported on nerve allografting for sensory innervation following immediate implant breast reconstruction. The references provided as support were also reviewed and mostly deal with prosthetic implants and not the proposed nerve allografting technique.  The article by Cornelissen is a retrospective study of 143 patients who underwent DIEP flap breast reconstruction.  Of these, 44 were considered eligible for completing a questionnaire.  Eighteen patients with and 14 without nerve coaptation responded (73%). While they found,  The breast Q score which as per the authors measures physical well being of the chest was not significant. (p=.09). The authors however claim improved sensation in the autologous reconstructed breast.  The limitations of this retrospective study are apparent. In addition this study used the 2nd and 3rd intercostal nerve and the letter by Dr. Valante proposes use of the 4th intercostal nerve.

The scientific evidence in the peer-reviewed literature does not support a result of improvement in health outcome. This is an unproven, controversial technique without demonstrated objective functional benefit.  There is inadequate evidence in the peer-reviewed medical literature to support the clinical effectiveness of nerve grafting after nipple sparing mastectomy as compared to standard implant-based reconstruction. The objective functional benefit of nerve grafting after nipple sparing mastectomy is under study. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. 
                                          
Based on the above, Nerve repair with allograft (tissue graft from a donor) or synthetic (produced by chemicals), nipple-sparing; billing code is upheld.