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We discussed our review of these codes and our rationale for finalizing the current values extensively in the CY 2019 PFS final rule (83 FR 59517), and CY 2021 PFS final rule (85 FR 84602)

Decentralizing clinical trial operations allows trial participation from home, which can be implemented using digital health technologies, including wearable devices, mobile health apps, and platforms for telemedicine

FDA has taken additional steps to support decentralized clinical trials (DCTs) and in May 2023 released draft guidance providing recommendations for their use

Healthcare providers must stay updated on insurance requirements and guidelines to maximize reimbursement for their services