Introduction of Bipartisan CURES 2.0 Bill

November 18, 2021

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) on Tuesday, November 16, introduced the CURES 2.0 bill, a sequel to the initial 21st Century Cures Act that passed Congress in 2015.

According to a statement released by DeGette, while the first CURES bill sought to improve how new drugs and treatments are researched and developed in the U.S., CURES 2.0 seeks to improve how those new treatments and therapies are delivered to patients.

CURES 2.0 includes, among other things, a breakthrough device payment pathway similar to the Medicare Coverage of Innovative Technology (MCIT) pathway that CMS recently repealed.The pathway proposed in CURES 2.0 would clarify that the HHS secretary can suspend or terminate coverage of a breakthrough device/diagnostic if it provides no clinical benefit or may cause serious harm to Medicare beneficiaries.

The new bill also authorizes $6.5 billion for an Advanced Research Projects Agency for Health, or ARPA-H, a priority for the Biden Administration. Under CURES 2.0, the new ARPA-H would be largely modeled after the military’s Defense Advanced Research Projects Agency, or DARPA, with the aim of accelerating medical research and breakthroughs in areas such as cancer, diabetes, Alzheimer’s and more.

While the 21st Century Cures Act sought to improve how new drugs and treatments are researched and developed in the U.S., CURES 2.0 seeks to improve how those new treatments and therapies are delivered to patients.

Other provisions in the legislation would:

• encourage the development of critically needed antimicrobials and antibiotics – and to ensure their appropriate use and domestic supply by including the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. 
• Increase diversity in clinical trials to ensure new drugs and treatments are both safe and effective for a greater majority of patients throughout the country.
• Require FDA to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches.
• Provide training and educational programs for caregivers – many of whom are often family members with no prior health care experience – to help improve the quality of care patients are provided at home, between clinical visits.
• Increase access to telehealth services for patients covered under Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make these services more accessible to more Americans.

CURES 2.0 could be considered as a legislative rider to MDUFA V.

View MDMA Statement HERE.

View AdvaMed Statement HERE.