Dear Representatives DeGette and Upton:
The undersigned members of the Physician Clinical Registry Coalition (“Coalition”) write to express our strong support for the inclusion of Section 411 in the Cures 2.0 Act,
ensuring that clinician-led clinical data registries have meaningful access to Medicare,
Medicaid, and State Children’s Health Insurance Program claims data to better track
patient outcomes over time, expand their ability to assess the safety and effectiveness of
medical treatments, and provide them with the information necessary to assess the cost-effectiveness of therapies. We also applaud the inclusion of Section 309, which seeks to
increase the use of real-world evidence and support the use of data from clinical care data
repositories and patient registries to fulfill post-approval study requirements for products
regulated by the Food and Drug Administration.
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