Four years after the 21st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) recently circulated a discussion draft of their proposed Cures 2.0 legislation, setting the stage for negotiations on the legislative package. In addition to proposing new programs and enhancements for the FDA and CMS, the draft bill would create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H) the Biden administration called for in its 2022 budget proposal.
More on Draft
“The federal government has amazing resources at its disposal,” said DeGette and Upton in a press release. “Now is the time to put the full weight of those resources to use to cure some of the world’s most devastating diseases, such as cancer, diabetes, Alzheimer’s, and more. Developing and delivering new lifesaving cures is a mission that must unite all of us.”
This discussion draft presents stakeholders a platform for raising important issues. As a draft, the legislation may change and is open to suggestions from stakeholders. However, the bill’s future in going through the markup process and ultimately receiving any vote is not certain. Certain items from the bill may ultimately be packaged into other legislative vehicles based on committee and leadership interest, stakeholder input, and the needs of members.
Specifics
There are many interesting parts of this discussion draft. Regarding, ARPA-H, the bill includes bare-bones legislation to authorize the agency. It 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 further directs HHS to conduct a national survey of long COVID patients to determine what type of health care coverage they have. It also directs HHS to set up a learning collaborative around long COVID between plans, providers, researchers, patient advocates, and more. The bill would additionally require 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.
The discussion draft also 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.
The bill additionally 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 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. Furthermore, The bill 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.