'Cures' Placeholders: LDTs, Precision Medicine, Device Coverage, Company Communication

The 21st Century Cures draft bill, which one industry attorney describes as including “More Proposals Than You Can Shake a Stick At,” also includes placeholders for key sections that are still being worked out, including provisions addressing CMS coverage of breakthrough devices, company communication about drugs and devices, precision medicine, regulation of laboratory developed tests, and health technology interoperability. “The 21st Century Cures Act is chock-full of proposals, some of which are new and some of which are old (i.e.,...