Akash Jha, Healthcare Consultant and Diptarka Biswas, Healthcare Consultant on Jan 12, 2017
The 21st Century Cures Act (the Act) is said to be the most important legislation passed since the Affordable Care Act (ACA). The bill seeks to modernize clinical trials; streamline new drug and medical device approvals; provide funding for medical innovations, mental health, opioid prevention and treatment; and mandates increased interoperability in health IT.
Through the Act, more than $4.8 billion is earmarked for the National Institute for Health over the next 10 years for research under various domains. These include the BRAIN initiative to study brain diseases which include Alzheimer’s ($1.6 billion), cancer research ($1.8 billion), Precision Medicine ($1.5 billion) and regenerative medicine ($30 million) – all of which will be tracked through annual reports. In addition, the FDA will receive $500 million over 10 years to streamline drug approval processes while maintaining the same standard of safety and effectiveness. The Act also looks into prevention of opioid abuse by establishing a $1 billion grant over the course of two years for states to implement preventive and treatment activities.
Enhancing the FDA
The Act includes various provisions to streamline FDA approvals for medical devices, drugs and software. The FDA can now use real-world evidence and qualified data summaries to approve a previously approved drug for a new medical use. An example of this would be Aspirin which was found to have other beneficial effects than its original intent. Patient experience data may also be used to consider approval of a new drug.
The FDA has also approved the use of a new approach for antimicrobial drugs treating life threatening conditions. For such drugs, the FDA can provide approval based on a limited population set and the drug labels can carry the same information. The FDA can also rely on testimonials from third party experts regarding a drug’s use and indicated application.
In terms of medical devices, iterating on the existing Expedited Access Pathway (EAP), the FDA is required to establish a ‘Breakthrough Device’ pathway program for accelerated device approvals. The Act provides guidance to the FDA on handling the approvals of combination products – which contain both the drug and the device. The criterion for humanitarian device exception is also enhanced to 8,000 individuals.
In addition, the FDA will exempt five categories of low-risk software from being regulated as medical devices. These are classified as “posing no serious threat” to the patient. The FDA will also approve accessories based on usage rather than the device they are being used with.
For regenerative medicine, regenerative therapeutic products are classified as moderate risk and the FDA is allowed to conduct accelerated approvals. The FDA is also required to update their guidance and regulation, as well as establish standards, with the help of the National Institute of Standards and Technology.
Health IT impact
The 21st Century Cures Act intends to increase the adoption and interoperability of Electronic Health Records (EHRs) by reducing regulatory and administrative burdens on the use of EHRs, establishing standards for interoperability and all subsequent application and approval processes.
The ONC will require a continuous maintenance of EHR certification, requiring the technology to demonstrate its “capabilities” on measures which will be published by the Department of Health and Human Services (HHS). The reporting of these measures will be handled by third parties pursuant to the health IT reporting grants program established in the Act. The HHS will maintain a list of all EHR products on its site to help users choose according to their requirement. EHR products can also be decertified and/ or penalized based on complaint or unsatisfactory reporting.
Information blocking is strongly discouraged in any form unless legally required with penalties provided in the legislation. Health IT developers will be required to make health data available using APIs and publish the same content on their website.
To promote interoperability, the Act suggests establishments of a Trusted Exchange Framework which will be a common agreement for exchange among all health information networks on a national level. This agreement may have a common method of authentication, a common set of rules for exchange and policies which enable the exchange. Furthermore, a national Provider Digital Index will be published and maintained by the HHS which will give centralized access to all relevant information for all providers.
The HIT Policy and Standards Advisory Committee will also be streamlined to create a new HIT Advisory Committee. This committee will prioritize and advise on new standards and implementation specifications for Health IT as well as review and phase out any outdated standards.
The Act also asks the HHS to clarify on the permitted exchange of protected health data for mental and substance abuse patients.
The 21st Century Cures Act will undoubtedly have a large impact on health IT and the industry as a whole. It will be interesting to see what long term impact it can have on how drugs are tested and brought to the market. While the regulation on EHRs should make the whole market more competitive and result in much more informed choices by customers, it remains to be seen if initiatives to increase interoperability like the Trusted Exchange Framework will bear fruit.
“21st Century Cures Act” Senate. (November 25th, 2016). Retrieved from http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf
“21st Century Cures Act” House summary. (October 7th, 2015). Retrieved from https://rules.house.gov/sites/republicans.rules.house.gov/files/114/PDF/114-SAHR34-Sxs.pdf
The Energy and Commerce committee on 21st century cures. Retrieved from https://energycommerce.house.gov/cures
Senator Susan Collins. “Senate Passes 21st Century Cures Act with 5 Provisions”. (July 12th, 2016). Retrieved from https://www.collins.senate.gov/newsroom/senate-passes-21st-century-cures-act-5-provisions-authored-senator-collins
FDA home page. Retrieved from http://www.fda.gov/default.htm
Sarah Faulkner. “How the 21st Century Cures Act will affect medical devices”. (December 8th, 2016). Retrieved from http://www.massdevice.com/21st-century-cures-act-will-affect-medical-devices/