Ariel Seeley

Ariel Seeley

Morgan Lewis

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Latest Posts › Centers for Medicare & Medicaid Services (CMS)

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How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

5/27/2025  /  Algorithms , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Digital Health , FDA Approval , Health Technology , Medical Devices , Medicare , Proposed Legislation , Reimbursements

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025  /  Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements
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