In the face of sweeping Medicare changes for 2025, millions of seniors face the challenge of navigating a complex landscape of new options, increased costs, and altered benefits. Innovative technologies are emerging as crucial tools for both patients and healthcare providers, offering detailed cost comparisons, network analyses, and benefit breakdowns.
Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high as the US prices.
Congress must decide the future of the Acute Hospital Care at Home (AHCAH) program, an initiative of the Centers for Medicare & Medicaid Services (CMS) that, without legislative action, will expire on December 31, 2024. To ensure beneficiaries can receive various levels of care in their preferred settings, this brief provides immediate–term federal policy reform recommendations for the potential reauthorization of the AHCAH model while outlining key issues for policymakers to consider when further research and data emerge.
As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.
Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.
Study reveals limitations of large language AI models in medical coding.
Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
“We are honored to have Dr. Lace, who is widely recognized as one of the industry’s most trusted reimbursement experts, leading our new division. He will also support all our services as our CMO.”
Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring (RPM) and Hospital at Home programs. The software platform and algorithms tasked with integrating and evaluating data must identify the data that matters, when it matters.
