June 13, 2018, marked 18 months since the signing of the 21st Century Cures Act (P.L. 114-255). FasterCures continues to assess its effect on the biomedical innovation system, and we are pleased to see progress on implementing Cures Act provisions. At FasterCures we talk about saving lives by saving time, and the Cures Act continues to succeed in that mission.  

2018 YTD Implementation Highlights

There are several recent deadlines that we’ve eyed with excitement. We would like to congratulate the U.S. Department of Health and Human Services (HHS) for completing and sharing key deliverables with the community.

Sec. 3021. Novel clinical trial designs.

• The U.S. Food and Drug Administration (FDA) was required to host a public meeting by June 11, 2018, to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications. The FDA hosted this public meeting, "Promoting the Use of Complex Innovative Designs in Clinical Trials," on March 20, 2018.

Sec. 3002. Patient-focused drug development guidance.

• The FDA is directed to release at least one draft guidance within 18 months of enactment and a plan for issuance of the PFDD guidances.
• On June 12, 2018, the FDA released draft guidance on “Patient-Focused Drug Development Collecting Comprehensive and Representative Input.” Concerning the public docket for the draft guidance, electronic or written comments can be submitted by September 11, 2018.
• Additionally, FDA held a public workshop on Dec. 18, 2017, on "Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input” including discussion documents. FDA held an additional workshop on March 19, 2018, “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.”

Sec. 3072. Hiring authority for scientific, technical, and professional personnel.

• The FDA submitted a required report on workforce needs and planning to Congress on June 12, 2018.

Sec. 4008. Government Accountability Office (GAO) study on patient access to health information.

• The GAO was required within 18 months of enactment to publish a study on patient access to health information. The GAO published GAO-18-386 on May 5, 2018 (full report available here).

Sec. 4012. Telehealth services in Medicare.

• The Centers for Medicare & Medicaid Services (CMS) was required by Dec. 13, 2017, to provide information to Congress on use of telehealth services by Medicare. CMS built upon its 2017 work by publishing an updated Medicare Learning Network Booklet on Telehealth Services. Of note, Congress also included landmark support for telemedicine in Medicare in the Bipartisan Budget Act, with specific sections on the topic:
• Sec. 50323. Increasing convenience for Medicare Advantage enrollees through telehealth.
• Sec. 50324. Providing accountable care organizations the ability to expand the use of telehealth.
• Sec. 50325. Expanding the use of telehealth for individuals with stroke.

Sec. 3086. Encouraging treatments for agents that present a national security threat.

• The section establishes a Priority Review Voucher program at FDA to incentivize the development of medical countermeasures. FDA issued draft guidance for industry, “Material Threat Medical Countermeasure Priority Review Vouchers," on Jan. 17, 2018.

Looking Ahead to Other 2018 Deadlines

National Institutes of Health (NIH)

Sec. 2031. National Institutes of Health strategic plan.

• Develop and publish the NIH Strategic Plan.

Sec. 2038. Collaboration and coordination to enhance research.

• Develop and disseminate appropriate measures related to reporting health information about sexual and gender minority populations.
• Release of triennial report for inclusion of information regarding number of women and minorities included as research subjects.

FDA

Sec. 3011. Qualification of drug development tools.

• Host a public meeting to solicit input on a new qualification process for biomarkers and other drug development tools.
• Publish taxonomy on drug development tools for public comment.

Sec. 3022. Real world evidence.

• Develop and begin to implement a framework to evaluate the use of real-world evidence to support the approval of a new indication for a previously approved drug or post-approval study requirements.

Office of the National Coordinator for Health Information Technology

Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients.

• Adopt certification criteria for a voluntary program for health IT use in pediatric settings.
• Issue a strategy and recommendations for improving patient care and reducing the administrative burden of electronic health record use by medical professionals.

Sec. 4004. Information blocking.

• Determine activities that do not constitute information blocking and therefore are not subject to penalties established by this section.

21st Century Cures Tracker

For more information on upcoming statutory deadlines and completed products, we invite you to visit our 21st Century Cures Tracker, which monitors the implementation of the 114 sections in Division A, which include the key provisions relevant to biomedical research and innovation. The tracker seeks to measure impact, highlight progress, and identify areas where more resources may be needed. While we are pleased with Cures Act implementation to date, we know that there is much still to be done and look forward to seeing more progress this year.