Establishes a Value-Based Insurance Design Model for Medicare, covering AI-driven wearable medical devices and assistive telehealth. Limits demonstration to 25 plans, promoting rural access, and requires demographic data for reimbursement. Allocates funding for state Medicaid telehealth programs.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
This is a binding federal statute establishing a Medicare demonstration program with mandatory requirements, specific payment structures, enforcement through reimbursement eligibility, and clear regulatory authority delegated to the Secretary of Health and Human Services.
The document has minimal coverage of AI risk domains, with limited focus on privacy (2.1) and system safety (7.3). The document primarily addresses healthcare delivery mechanisms and payment structures rather than AI-specific risks. Coverage is concentrated in privacy concerns related to demographic data collection and potential system reliability issues with AI-driven medical devices.
The document primarily governs the Health Care and Social Assistance sector through Medicare and Medicaid programs. It also has secondary coverage of the Information sector through telecommunications and telehealth services requirements.
The document primarily addresses the Deploy and Operate and Monitor stages of the AI lifecycle for medical devices. It establishes coverage and payment mechanisms for AI-driven wearable devices and SaMD technologies that have already been approved by the FDA, focusing on their deployment in Medicare Advantage plans and ongoing monitoring through independent evaluation.
The document explicitly mentions AI systems (wearable patient monitoring devices with AI), machine learning, and software as a medical device (SaMD). It does not mention frontier AI, general purpose AI, foundation models, or compute thresholds. The focus is on task-specific AI applications in medical diagnostics and monitoring.
United States Congress
This is federal legislation enacted by Congress, as indicated by the document title 'Advanced Safe Testing at Residence Telehealth Act of 2023' and the legislative structure amending the Social Security Act.
Secretary of Health and Human Services, Centers for Medicare & Medicaid Services, Deputy Administrator and Director of the Center for Medicare and Medicaid Innovation, Food and Drug Administration (for device approval)
The Secretary of Health and Human Services has primary enforcement authority through payment mechanisms, reimbursement eligibility requirements, and program administration. The FDA maintains approval authority for covered medical devices.
Independent third-party evaluator (to be designated), Secretary of Health and Human Services, Congress (receives reports)
The statute mandates independent third-party evaluation of the demonstration program with specific evaluation objectives and reporting requirements to Congress.
Eligible MA organizations (Medicare Advantage organizations), physicians and practitioners using AI-driven wearable medical devices and SaMD technologies, State Medicaid programs
The document targets Medicare Advantage organizations that deploy AI-driven medical devices and telehealth systems, as well as developers of medical devices incorporating AI, machine learning, and software as a medical device (SaMD) technologies.
3 subdomains (3 Minimal)