H.R. 6000, the 21st Century Cures Act 2.0, was introduced on November 17, 2021 by Diane DeGette (D-CO-1) and Fred Upton (R-MI-6), and currently has 63 cosponsors. The bill addresses several topics relevant to telehealth and digital health, including breakthrough devices.
Title I of the bill addresses various public health initiatives, including study of long covid, and Title II would expand programs for patients and caregivers. Title III incorporates several initiatives affecting the Food and Drug Administration (FDA), including expanding the use of real-world evidence (RWE); requiring communication between the FDA and the Centers for Medicare and Medicaid Services (CMS); and accelerating the timeline for breakthrough and regenerative medicine advanced therapy (RMAT) designation. Title IV, dealing with CMS, would incorporate concepts advanced in several other bills, including increasing access to telehealth under Medicaid and the Children's Health Insurance Programs (H.R. 1397, the Telehealth Improvement for Kids' Essential Services (TIKES) Act; extending the Medicare telehealth flexibilities beyond the expiration of the covid public health emergency (H.R. 1332, the Telehealth Modernization Act); providing for coverage of breakthrough devices (H.R. 4043, the Ensuring Patient Access to Critical Breakthrough Products Act); and expanding access to genetic testing (H.R. 5989, the Precision Medicine Answers for Kids Today Act). Title V provides additional funding for health research.