21st Century Cures Act

The 21st Century Cures Act has the potential to accelerate innovation, boost research, streamline drug and device approvals, and enhance interoperability and telemedicine, all of which will improve patient care exponentially. It passed the House Energy and Commerce Committee with a vote of 51 – 0 on Thursday, May 21, 2015. The bill's goal is to hasten the development and delivery of new therapies by streamlining regulatory processes, investing in research, and advancing more targeted treatment options.

Key Sections:

  • Putting patients first by incorporating their perspectives into the regulatory process and addressing unmet needs
  • Building the foundation for 21st Century medicine, including helping young scientists
  • Streamlining clinical trials
  • Accelerating the discovery, development, and delivery cycle and supporting continued innovation at NIH, FDA, CDC, and CMS
  • Modernizing medical product regulation

The current bill provides $10 billion to the National Institutes of Health (NIH) over 5 years as well as $550 million to the FDA over five years to help the FDA fulfill new duties created by the bill. Those include development of new "biomarkers" to gauge drug effectiveness, enhanced incorporation of patient perspective into approval decisions, and grants to study so-called continuous drug manufacturing that could reduce production costs. In addition, the amendment would exempt from budget sequestration the user fees paid by drug and device makers to support FDA reviews and inspections. Sequestration only kicks in if spending caps are exceeded, but the Cures bill now provides peace of mind for companies that complained about private money being locked away in 2013 because of political spending fights.

Other substantive provisions were notable for their omission, including possible changes to dial back use of the 340B drug discount program by hospitals and clinics. Other substantive changes in the amendment are geared toward fully covering the legislation's price tag. One provision would delay so-called reinsurance subsidies that go to health insurance plans in Medicare Part D in order to partly offset the costs of unusually expensive policyholders. The proposal stems from a 2013 inspector general's report that found delays of certain advance payments would allow Medicare to generate more interest income — roughly $110 million in 2009 alone.