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The commenter noted that their company is not operating as an Independent Diagnostic Testing Facility (IDTF) but rather entering into contractual agreements with facilities to offer e-Lung as a software-as-a-medical-device (SaMD) for which the hospitals will then submit claims as the provider

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Under this alternative pathway, devices that are granted an FDA Breakthrough Device designation are not evaluated in terms of the current substantial clinical improvement criterion at 419.66(c)(2) for the purposes of determining device pass-through payment status, but do need to meet the other requirements for pass-through payment status in our regulation at 419.66

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