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The US regulator has not only taken a proactive role in exploring the current and future applications of RWD, but also published the framework for its Real-World Evidence Program in 2018, which launched through the 21st Century Cures Act. This can require new processes, technologies and an organisation mind shift.”.
Making available more specific information about total costs and coverage will ensure that all consumers have comprehensive information to help them make smart health care decisions. These resources should aim to clarify insurance terms and concepts, aiding consumers in navigating the complexities of selecting a health plan.
Too often the formal notice and comment process does not reach these marginalized communities and federal agencies must actively work to seek their input in non-traditional ways. This process respects their autonomy by involving them in decision-making to the extent that they are able.
As these technologies become increasingly integral to patient care, it is essential for CMS to develop clear and consistent guidelines for the payment and coverage of AI-enabled services. Providing clear guidance, technical assistance, and streamlined processes can help facilitate the adoption of this innovative care model.
16 We encourage CMS to continue refining these data collection processes to ensure they capture meaningful and actionable information. We believe this process is crucial for adapting the payment system to evolving clinical practices and emerging medical technologies.
3 Establishing a feedback loop with stakeholders during this monitoring process will provide additional safeguards against adverse effects. Engaging stakeholders in transparent decision-making processes is critical to the success of risk adjustment model updates.
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