Sponsors and supporters said the "Cures 2.0" legislation would revolutionize medical research. The lawmakers also said it would speed up the development of novel therapies.
Healthcare and research advocates are cheering the introduction of a new bill that supporters say will spur new cures and therapies and expand telehealth access.
U.S. Reps. Diana DeGette, D-Colo., and Fred Upton, R-Mich., introduced the “Cures 2.0” bill Tuesday. The measure would create the new federal research agency proposed by President Joe Biden: the Advanced Research Projects Agency for Health, or ARPA-H.
The bill would offer $6.5 billion to finance the agency for three years, the amount the White House requested.
The agency is designed to undertake novel, groundbreaking research to help lead to breakthroughs in treatments for cancer, diabetes, Alzheimer’s disease and other illnesses. In a news release, the lawmakers said the new research agency would be overseen by a small group of managers and they would have the freedom to pursue “high risk, high reward” research projects.
The lawmakers, crossing party lines to craft the bill, offered bold predictions about the potential of the new research agency and other provisions in the bill designed to speed up cures.
“It will completely reshape the future of biomedical research in this country,” DeGette said in a joint statement with Upton shown on Twitter.
“This legislation is a once-in-a-lifetime opportunity to push our country’s research potential beyond what we ever could have imagined,” Upton said.
Several research and healthcare advocacy groups came out in support of the legislation and are urging Congress to approve it.
Mary Woolley, president and CEO of Research!America, said in a statement the bill “would dramatically strengthen our nation’s R&D architecture.”
The new research agency is the centerpiece of the bill. However, the lawmakers said the measure aims to invest more in telehealth, COVID-19 research, training for caregivers and a host of other areas.
“It will make healthcare more accessible,” DeGette said. “It will make breakthrough therapies available to patients sooner. And it will help us better understand the effects we don’t even know enough about, such as COVID.”
The lawmakers are just introducing the bill, so it still must clear both the House and Senate before landing on the president's desk.
Here’s a rundown of some key components of the bill.
The lawmakers said the bill would expand access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program. It would eliminate Medicare's geographic restrictions which require patients to live in a rural area and be physically in a doctor's office or clinic to use telehealth services.
The measure would offer research grants to study the long-term effects of COVID-19 in kids and adults. It would also finance studies to determine disparities among those with long-COVID. The bill would also call for a learning collaborative on COVID-19 and improved education and outreach efforts on the importance of vaccines.
The measure calls for a national strategy to look at other pandemics, including testing, vaccine distribution and how to ensure an adequate supply of medical supplies for future public health emergencies.
Faster drug approvals
The measure would offer grants to develop innovations in the clinical trials of drugs. It would also allow Medicare to cover and pay for breakthrough devices. The legislation also calls for more communication between the Food and Drug Administration and the Centers for Medicare & Medicaid Services on breakthrough drugs.
The bill would provide money for education programs and training for caregivers to help provide care for loved ones at home.
Diversity in drug trials
The FDA would be required to provide updates to Congress on what it’s doing to get participants from more diverse backgrounds in drug trials. The Government Accountability Office would be required to do a study on barriers to participating in clinical trials.
Here is a summary with more details on the bill and a link to a copy of the 173-page legislation.
Lawmakers are also working on the 2022 federal budget, which could offer big increases for health and research programs.