The 21st Century Cures Act, or H.R. 6, reauthorizes the National Institutes of Health (NIH) and provides other funding to the agency through FY 2020. We are walking away from disease treatments and actively searching for cures — methods to resolve the root problem. New efforts rip off the band-aids of temporary relief to unmasking problems. Lifesaving and life-improving therapies have the potential to transform our quest for faster cures.
Genesis of the bill
To accelerate the discovery, development and delivery of 21st-century cures is the bill’s goal. Said another way, the goal of this bill is to save lives.
The 21st Century Cures Act, introduced by Rep. Fred Upton (R-Michigan), was overwhelmingly passed by the House. Here’s a timeline of its journey to the president’s desk:
- May 19, 2015: Rep. Fred Upton introduces bill.
- Nov. 30, 2016: The House passes the bill.
- Dec. 7, 2016: The Senate passes the bill.
- Dec. 13, 2016: President Barack Obama signs it into law.
The act has three pillars: discovery, development and the delivery of cures.
1. Discovery ensures that the NIH is provided with a total of $4.8 billion in new funding. This monetary injection includes $1.5 billion to advance the Precision Medicine Initiative to drive research into genetic, lifestyle and environment variations of disease plus $1.8 billion to fuel Vice President Joe Biden’s Cancer Moonshot initiative and support the BRAIN (Brain Research Through Advancing Innovative Neurotechnologies) initiative to improve our understanding of diseases like Alzheimer’s.
2. Development addresses the fact that while advancements of human genome mapping have been impressive, translating this into FDA-approved treatments has proved difficult. Modernizing clinical trials (analyzing the safety and efficacy of data), utilization of biomarkers (to assess how a therapy is working), and empowering the FDA to utilize flexible approaches to reviewing medical devices. This section also provides the FDA with $500 million for regulatory modernization to retain the best and brightest scientists, doctors and engineers.
3. Delivery helps to put newly tested and approved drugs into the hands of patients, at the right time. Interoperability of electronic health records systems for a seamless patient experience is the essence of delivery. Patients need access to their complete health profile (longitudinal medical record) to fully realize the benefits of a learning healthcare system. Rounding out the bill is healthcare provider education to empower seniors with the latest medical technology.
The bill is lengthy: It has 25 sections and runs to 996-pages. The Energy and Commerce Committee of the House of Representatives published a helpful section summary that carved out the intent while omitting the exact letter of the bill. Our discussion will concentrate on interoperability covered under “Title IV: Delivery” where interoperability is addressed in multiple sections:
- Sec. 4001. Assisting Doctors and Hospitals in Improving Quality of Care for Patients: encourages certification of health information technology for specialty providers.
- Sec. 4002. Transparent Reporting on Usability, Security, and Functionality: Calls for the creation of reporting system to gather information about electronic health record (EHR) usability and interoperability.
- Sec. 4003. Interoperability: Supports the creation of a digital healthcare directory (a voluntary model framework and common agreement) to facilitate exchange and requires the HHS to defer to the private sector on health IT standards development.
- Sec. 4004. Information Blocking: Grants the HHS Office of the Inspector General authority to assign penalties for practices that block the sharing of electronic health records.
- Sec. 4005. Leveraging Electronic Health Records to Improve Patient Care: Encourages the exchange of health information between registries and EHR systems.
- Sec. 4006. Empowering Patients and Improving Patient Access to their Electronic Health Information: Certification of patient-centered electronic medical records and promotion of health information exchanges to promote patient access.
- Sec. 4007. GAO Study on Patient Matching: GAO study of methods for securely matching patient records to the correct patient.
- Sec. 4008. GAO Study on Patient Access to Health Information: Authorizes the GAO to review barriers to access, healthcare complications and patient methods for requesting their health information.
- Sec. 4009. Streamlining Transfers Used for Educational Purposes: Physicians are now exempt from reporting income received for the purpose of speaking or preparing materials for educational presentations on medical topics.
- Sec. 4010. Improving Medicare Local Coverage Determinations: Decisions by a medicare administrative contractor (MAC) about whether to cover a particular service must be public on the website.
- Sec. 4011. Medicare Pharmaceutical and Technology Ombudsman: Establishment of a new role to address problems relating to coverage of new and life-saving technologies.
- Sec. 4012. Medicare Site-of-Service Price Transparency: Requires the public availability on a website of Medicare services for estimates of items and services and beneficiary liability (cost to the beneficiary).
- Sec. 4013. Telehealth Services in Medicare: Establishes a bipartisan working group focusing on telemedicine to explore improvements for dually eligible conditions (Medicare, Medicaid and chronic conditions) that might improve with telehealth.
A future connected
The Energy and Commerce Committee published a useful fact sheet reviewing the bill’s goals of helping patients through biomedical innovation. The progressive pace of scientific advancements must get better at translating discoveries into cures for patients. H.R. 6 champions the quest for faster cures by doing the following:
- Removing barriers to increased research collaboration.
- Incorporating the patient perspective into the drug development and regulatory review process.
- Measuring success and identifying diseases earlier through personalized medicine.
- Modernizing clinical trials.
- Removing regulatory uncertainty for the development of new medical apps.
- Providing new incentives for the development of drugs for rare diseases.
- Helping the entire biomedical ecosystem coordinate more efficiently to find faster cures.
- Investing in 21st-century science and next-generation investigators.
- Helping to keep and create jobs in the United States.
- Reducing the deficit by over $500 million.
Feb. 17, 2017, will mark nine years since the $35 billion HITECH Act (Health Information Technology for Economic and Clinical Health Act) was passed. What has HITECH accomplished? It’s accepted that adoption of electronic health records is more prolific and that market competition dynamics have improved. Sharing of patient lab results, radiology reports and summary of care records on average improved 48.5 percent since HITECH passed.
The 21st Century Cures Act amends the HITECH Act by requiring providers of healthcare services to establish goals, strategies and recommendations by Dec. 13, 2017. Acknowledgment that patient-focused drug development is required is a positive start to finding better cures in 2017.