Legislation introduced last year to help small device companies collect data to accelerate the process of gaining reimbursement for new technologies by letting patients pay for procedures was highlighted at a House hearing this week.
AIM Act Touted As One Solution To Device Reimbursement Woes
The Accelerating Innovation in Medicine Act, introduced last year with some bipartisan support, was touted at the latest House 21st Century Cures hearing as a self-pay path for seniors to get access to newly-approved devices not yet covered under Medicare, and to give manufacturers time to collect needed data to support reimbursement.
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.