On December 2, 2021, the Physician Clinical Registry Coalition (“PCRC”) submitted a letter to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) commending them for including Section 411 in the Cures 2.0 Act, which would ensure 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.  This legislation would allow clinician-led clinical data registries to link their outcomes data with claims data in a way that would help ascertain the value of new medical technologies and therapies and assist in the development of effective alternative payment models (“APMs”).

PCRC also applauded Representatives DeGette and Upton for including Section 309 in the Cures 2.0 Act, 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.

Click here to read the full letter.