Does RTM require the usage of medical devices? Who can get ABA?

Julie Markova, Supervisor of the Medical Billing Department

RTM requires to use medical devices as defined under the federal Food, Drug, and Cosmetics Act (not merely a wellness device).

In the final CMS rule, it was denoted that self-reported/entered data may be part of the non-physiologic data for purposes of RTM codes. See 86 FR 64995, 65116 (Nov 19, 2021) (“Reportedly, RTM data can be patient-reported, as well as digitally uploaded, while RPM requires that data be physiologic and be digitally uploaded.”). According to CMS, self-reported RTM data via a smartphone app or online platform classified as Software as a Medical Device (SaMD) may qualify for reimbursement, whereas RTM codes still require the device used to meet the FDA’s definition of a medical device. That is the difference between them and the RPM codes that require the device to digitally (automatically) record and upload patient physiologic data that cannot be self-recorded, self-reported or entered manually into the device by the patient.

Is ABA only covered by Medicaid?