Two years after beginning work on a follow up to the 21st Century Cures Act, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) introduced their Cures 2.0 bill in November. The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid services (CMS), as well as create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H).
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“Diseases such as cancer, diabetes, Alzheimer’s and ALS don’t care if you’re a Democrat or Republican. They affect all of us the same. By creating ARPA-H, we will be bringing together some our nation’s greatest minds to help find cures to these devastating diseases. And we will – for the first time – be putting the full weight of the federal government behind the ongoing efforts to end these terrible illnesses as we know them – which is a mission that all of us should be able to get behind,” Upton and DeGette said.
The bill includes bare-bones legislation to authorize ARPA-H, which would be a new agency to speed innovation in health research. The agency would be tasked with tackling challenges in health care that require large scale and sustained coordination; creating new capabilities such as data resources and disease models; and supporting research with significant financial risk.
The legislation also directs the Department of Health and Human Services (HHS) to conduct a national survey of long COVID patients to determine what type of health care coverage they have. It further directs HHS to set up a learning collaborative around long COVID between plans, providers, researchers, patient advocates, and more. In terms of public health, the legislation requires the development of a national testing and response strategy for future pandemics, create an education program relating to vaccines, and strengthen the capacity of the Immunization Information System (IIS).
The discussion draft with the bill includes Reps. Buddy Carter’s (R-GA) and Lisa Blunt Rochester’s (D-DE) Telehealth Modernization Act, which would permanently remove geographic and originating site restrictions from the Medicare telehealth benefit and to allow HHS to expand the types of health care providers that may offer telehealth services for Medicare reimbursement. The discussion draft would also require the development of guidance and strategies for states to better integrate telehealth into Medicaid and CHIP programs.
Furthermore, the bill includes several provisions to address clinical trials. It would require HHS to conduct activities to improve diversity in clinical trials, require the collection and reporting of patient experience data as part of clinical trials, allow Medicare to cover beneficiaries’ costs in PCORI-funded clinical trials, and provide for grants to build on novel clinical trial designs. In addition, it would require the Food and Drug Administration (FDA) to outline approaches to expand the use of real-world evidence (RWE) and to establish a task force to develop recommendations on ways to involve patients in RWE generation. For accelerated approval drugs, it would allow the use of patient registries or other RWE to fulfill phase 4 study requirements.
The bill also includes Reps. Suzan DelBene’s (D-WA) and Gus Bilirakis’ (R-FL) Ensuring Patient Access to Critical Breakthrough Products Act, which requires Medicare to cover newly approved breakthrough products for a three-year period while a permanent coverage determination is made. The legislation also includes provisions to direct HHS to enter into subscription-like contracts with manufacturers to spur antimicrobial innovation. Furthermore, the bill would allow for manufacturers to request an accelerated approval designation for a new drug either before or after an investigational new drug (IND) application.