December 4, 2022

Volume XII, Number 338


December 02, 2022

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December 01, 2022

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The Proposed Cures 2.0 Act – What You Can Expect

On November 16, 2021, U.S. House Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the highly anticipated Cures 2.0 Act (H.R. 6000). Among other things, this 173-page bipartisan bill contain provisions to accelerate medical research, increase patient access to novel therapeutics, and remove current barriers to telehealth services.

This bill would also create a new agency called Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH). This agency would be tasked with developing novel treatments to challenging diseases such as cancer, diabetes, ALS, and Alzheimer’s. In a press release, DeGette and Upton said, “By creating ARPA-H, we will be bringing together some of 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.” The bill would provide $6.5 billion to ARPA-H through its first three years.

The Cures 2.0 bill contains numerous provisions that would impact the U.S. Food and Drug Administration (FDA).

FDA would have to:

  • establish at least two additional intercenter institutes;

  • provide grants for novel trial designs and other innovations in drug development;

  • submit a report to Congress with respect to cell and gene therapies; and

  • issue guidance on the use of real-world evidence in evaluating the safety and effectiveness of breakthrough devices and on the development and submission of chemistry, manufacturing, and controls information for products subject to one of FDA’s expedited regulatory pathways.

Additionally, the bill would accelerate the timeline for the designations of FDA’s breakthrough therapies and regenerative medicine advanced therapy (RMAT) therapies, allowing sponsors to request designations before or after a new drug application (NDA) or biologics license application (BLA) is submitted. Under the Cures 2.0 Act, FDA would also be required to meet with sponsors, device manufacturers, clinical research organizations, the technology community, and the patient community to discuss innovative approaches and incentives to adopt decentralized clinical trials.

Other provisions of this bill include reforms to Medicare reimbursement and coverage such as removing the condition that requires a patient to live in a rural area and to be in a physician’s office in order to qualify for telehealth services. The Centers for Medicare and Medicaid Services (CMS) would be able to grant greater flexibilities for healthcare providers to receive reimbursement from Medicare for telehealth services. Another key provision of this bill would allow CMS to temporarily cover products approved or cleared by the FDA under the breakthrough therapy pathway for up to four years. Recently, CMS issued a final rule that rescinded expedited Medicare coverage of breakthrough devices for up to four years once the product had been approved or cleared by the FDA. Additionally, this bill would require the Government Accountability Office to submit a report to Congress on recommendations to enhance Medicare coverage and reimbursement of innovative health technologies.

The provisions of the Cures 2.0 Act have the potential to significantly impact public health. By facilitating the investigation and development of novel therapies, we can expect that breakthroughs will result in the treatment of serious and debilitating diseases. Patients living in rural areas will be afforded greater access to healthcare through telehealth services. Finally, patients will get increased access to products that have received breakthrough designation as CMS can provide reimbursement for these life-saving products.

While Representatives DeGette and Upton had hoped to introduce the Cures 2.0 legislation earlier this year, it was stalled due to competing demands. At this point it is highly unlikely the legislation will be considered before Congress adjourns this year. However, it is expected to be a legislative priority in 2022, given the broad bipartisan support the first Cures bill enjoyed. We will continue to monitor the progress of the Cures 2.0 Act as it moves through Congress.

© 2022 Foley & Lardner LLPNational Law Review, Volume XI, Number 340

About this Author

Devaki Patel Healthcare Lawyer Foley and Lardner

Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist. Devaki is admitted to practice only in Maryland. She is practicing under the supervision of a member of the District of Columbia Bar.

Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern,...

David L. Rosen, Foley Lardner, FDA Regulatory Lawyer, Life Science Industry Attorney,

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was...

Jennifer F. Walsh, public affairs director, Foley law firm
Director, Public Affairs

Jennifer F. Walsh is a public affairs director with Foley & Lardner LLP. She has extensive experience in government affairs, including a lengthy career as a senior staffer in the U.S. Congress and the California Legislature, and as a vice president for Federal Government Affairs at a top 20 Fortune 500 health care company. Ms. Walsh has effectively advanced key issues before the United States Senate, House of Representatives and the Administration. She is a member of the firm’s Government & Public Policy Practice.

Jared Rifis Public Affairs Advisor Foley & Lardner
Public Affairs Advisor Sr

Jared Rifis is a senior public affairs advisor in the Washington, D.C. office of Foley & Lardner LLP. He represents clients and their legislative priorities before Congress and the Administration. Jared supports the firm’s Government Solutions Practice with research, analysis, and advocacy that advance each client’s public policy goals.

Prior to joining Foley, Jared served in various roles in Congress, most recently serving as a judiciary and commerce advisor to Senate Minority Leader Harry Reid. He was an effective advisor with a broad...