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The Medicare Prescription Drug Improvement and Modernization Act of 2003

Client Alert | 1 min read | 01.01.04

The President has signed into law the Medicare Prescription Drug Improvement and Modernization Act of 2003. The Act is a far-reaching recasting of the Medicare law, most notably in the creation of a new drug benefit. It also makes major changes to the Medicare coordinated care plan program, now to be called Medicare Advantage, radically restructures the Medicare intermediary contracting program, changes provider reimbursement, creates a new form of health savings account with potentially significant tax advantages, and changes many other aspects of the almost 40-year old program.

Click here to download Crowell & Moring's summary of the Medicare Prescription Drug Improvement and Modernization Act of 2003 [doc].

Insights

Client Alert | 6 min read | 09.03.26

FDA Seeks Input for Regulating GenAI-Powered Medical Devices

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. ...