The 21st Century Cures Act ("Cures Act"), touted by Congressional leaders as a "once-in-a-generation, transformational opportunity to change the way we treat disease," was signed into law on December 13, 2016. The Cures Act is aimed at modernizing and personalizing healthcare by encouraging innovation and streamlining the process for discovery, development, and delivery of new treatments and technologies to those suffering from illness. Importantly, the legislation provides for significant funding to advance these goals, to the tune of $4.8 billion to the National Institutes of Health ("NIH"), $500 million to the Food & Drug Administration ("FDA"), and $1 billion in grants to states for opioid abuse prevention and treatment. This article will provide an overview of key components of the Cures Act and highlight implications for the future of healthcare.
Precision Medicine Initiative
One of the most interesting aspects of the Cures Act is the Precision Medicine Initiative (funded at $1.45 billion), a long-term research effort among NIH and other research centers to understand how an individual's genetics, lifestyle, and environment can impact disease prevention and treatment decisions. The "All of Us" program is one aspect of the Precision Medicine Initiative, with the goal of collecting genomic data from at least one million people for purposes of accelerating research to improve health. The Cures Act requires grant recipients under the Precision Medicine Initiative to share the data that is generated from their research. But notably, the Act increases privacy protections for research volunteers, prohibiting researchers from being compelled to disclose an individual's sensitive information.
Look for the Precision Medicine Initiative to play a key role in the shift to patient-centered, value-based healthcare. As precision medicine evolves to allow treatments and interventions targeted specifically to a particular individual's genetic makeup and environment, healthcare outcomes overall should improve. At the same time, treatments judged likely to be ineffective based on a particular individual's genomic and environmental factors will be discarded as an option in favor of those more likely to achieve the desired result, meaning cost of care should be reduced.
Many Americans outside of the healthcare industry are well aware of the Cancer Moonshot, due in large part to former Vice President Joe Biden's leadership in advocating for cancer research after the loss of his son to cancer. The Cancer Moonshot, funded at $1.8 billion, will accelerate cancer research, increase availability of cancer therapies, and aim to improve cancer prevention and detection at an early stage. A "Blue Ribbon Panel of Experts" has already issued a report setting forth ten recommendations for making a decade's worth of progress on cancer treatment and prevention in five years' time. Recommendations include, among others, engaging patients to contribute their tumor profile data to aid research, building a national cancer data ecosystem, developing guidelines for monitoring and managing patient-reported symptoms and side effects of treatment, and mining past patient data to predict future outcomes. Grant funding opportunities are available to implement these recommendations.
With both the Precision Medicine Initiative and the Cancer Moonshot, data - including Patient Generated Health Data ("PGHD") of the type collected by remote monitoring devices and platforms - is king. Look for the rise and use of Artificial Intelligence and Machine Learning technologies to analyze patient data and make accurate predictions regarding efficacy of treatments for individuals with specific disease states.
Streamlining FDA Regulations for Medical Technologies and Treatments
The Cures Act provides $500 million in funding to the Food and Drug Administration over ten years for streamlining the process of getting new drugs, treatments, and technologies to patients while maintaining standards for safety. A portion of this funding will go to recruiting and retaining the best scientists, engineers, and doctors to FDA to develop, review, and regulate new drugs and medical devices. The Act requires the FDA to establish a program to evaluate the use of "Real World Evidence" -- defined as "data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than clinical trials" -- in the drug and device approval process. This Real World Evidence may take the form of Patient Experience Data collected by the patient, caregivers, family, providers, research foundations, and drug manufacturers. Patient Experience Data is intended to provide information about the impact of a disease and the patient's preferences for treatment. The FDA is required to report any Patient Experience Data that was used to support a drug's approval.
Streamlining FDA regulations is a process in and of itself. The FDA is holding public workshops to inform the guidance it will issue per the requirements of the Act. For example, in January 2018, the FDA convened a public workshop on patient-focused drug development to collect input from a range of stakeholders on how best to collect patient experience data. Keep your eye out for a host of new mobile medical apps and technologies aimed at collecting and aggregating Patient Generated Health Data and Patient Experience Data from a variety of sources.
National data sharing
The Cures Act encourages collaboration and data sharing among researchers and healthcare professionals. In some cases, the law goes so far as to mandate the formation of national networks for gathering and sharing clinical data to facilitate and expedite the development of treatments. The Act includes a number of provisions aimed at improving data sharing, including support for EHR interoperability and health information exchange. The Cure Act's emphasis on collection and use of Patient Experience Data, EHR data, Real World Evidence, and other clinical data to facilitate drug and device approvals and improve outcomes will require a robust privacy and security infrastructure to protect patient privacy and confidential information. Look for health information technology platforms and mHealth apps that make ease of interoperability and privacy protections a major selling point for their products.
Contact us to learn more about how the Cures Act may impact your healthcare company or practice.