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We also proposed to assign status indicator N to CPT codes 97007 and 97009 to align with our current packaging policies generally, and specifically with regard to our current packaging of CPT code 0663T

Background The intent of transitional device pass-through payment, as implemented at 42 CFR 419.66, is to facilitate access for beneficiaries to the advantages of new and truly innovative devices by allowing for adequate payment for these new devices while the necessary cost data is collected to incorporate the costs for these devices into the procedure APC rate (66 FR 55861)

Randomized, double-blind, placebo-controlled trial of ISC 17536, an oral inhibitor of transient receptor potential ankyrin 1, in patients with painful diabetic peripheral neuropathy: Impact of preserved small nerve fiber function

Another factor is location: Both Jupiter Systems and CFIUS are located in the United States, so communication can be expedited, which has been advantageous in this unique 120-day timeline