Next Cures Medical Research Bill Builds on Biden’s Past Support

Dec 11, 2020
In The News

President-elect Joe Biden’s shepherding of a landmark biomedical innovation law bodes well for a second effort to improve access to digital health and reform the Medicare agency.

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) said a draft version of Cures 2.0, the followup to the 21st Century Cures law, will come out early next year, with the aim of passing it next year. Biden, whose cancer moonshot initiative was part of the 2016 law (Pub. L. 114-255), presided over the Senate when it passed that chamber.

“Hopefully by the spring, we’ll be well on our way to getting Cures 2.0 done,” Upton said Tuesday during the Milken Institute’s Future of Heath Summit. House members will be sworn in Jan. 3 according to the House Majority Leader’s calendar, and Upton said it’s going to take a little while for the 117th congress to get organized.

The original law passed with overwhelming bipartisan support, and movement in the next session could be a win for both lawmakers and the incoming Biden administration in a Congress fractured along party lines.

The incoming Biden administration is well aware of Cures 2.0, said DeGette, who had a number of conversations with incoming White House Chief of Staff Ron Klain before the election.

While the 2016 law focused on reforming the National Institutes of Health and the Food and Drug Administration, Cures 2.0 will focus more on restructuring the Centers for Medicare & Medicaid Services, DeGette said.

Gene therapy products have already come onto the market along with more than 900 investigational new drug applications for ongoing clinical studies. But with price tags running into seven figures for one dose of these potentially curative therapies, insurers have grappled with how to pay for the treatments.

“If you’re going to expedite cures through the process, you have to be able to provide them to the patients,” DeGette said.

She also acknowledged the 2016 law was “light on digital health services.”

“This is not an easy issue to crack,” she said, because of so many different digital platforms. “As we’ve learned in the pandemic there are so many barriers to electronic medical records and to preserving data and privacy and so on. And so those are some of the areas we’re really trying to tackle.”

The lawmakers released a concept paper in April and staff for Upton and DeGette are combing through more than 500 comments to inform a discussion draft they expect to release early next year, they said.

The Cures lawmakers are still aiming to insert their pandemic preparedness provisions into future virus relief funding, which they mentioned this past spring. Those provisions include improving surveillance and testing as well as more support for developing new antimicrobials.