21st Century Cures Act
The 21st Century Cures Act, enacted in December 2016, introduced significant reforms to the American healthcare system aimed at accelerating medical innovation and improving patient care. A key aspect of the legislation was the relaxation of testing requirements for new medical products, which proponents argue facilitates quicker access to potentially life-saving treatments. The act also prioritized funding for critical health issues, allocating substantial resources for cancer research, mental health initiatives, and combating opioid addiction. Notably, the National Institutes of Health received the majority of this funding to enhance research efforts, including a high-profile "cancer moonshot" initiative.
Additionally, the act revised regulations surrounding patient information sharing, allowing healthcare providers to communicate more effectively about patients' needs while still maintaining privacy protections. While the 21st Century Cures Act was largely supported by various stakeholders, including healthcare advocates and legislators, concerns were raised about the implications of reduced drug testing and the potential for unsafe products to reach the market. Critics also pointed to challenges in the implementation of the act's provisions, particularly regarding the timely enhancement of health data access. Overall, the 21st Century Cures Act reflects a complex interplay of efforts to modernize healthcare while addressing longstanding systemic issues.
21st Century Cures Act
The 21st Century Cures Act is legislation passed in the United States in December 2016 that changes many aspects of the American healthcare system. One of the main reforms involves lowering the requirements for medical testing needed for new products to be approved and marketed to patients. Another reform relates to the means by which patient information can be shared between healthcare providers to provide more comprehensive care. The 21st Century Cures Act also provides extensive new funding for cancer research and opioid treatment as well as mental-health initiatives.
Background
In the twentieth and twenty-first centuries, medical science experienced enormous breakthroughs. However, it also faced some serious and mounting challenges such as the rising cost of health care, complications in the ways in which new products are developed and introduced, and inefficient policies relating to the distribution of care. Critics of the healthcare system contended such problems were inhibiting the creation and use of new medications and procedures that could help millions of people in need.
These concerns brought a call for change that ultimately led to the drafting of new legislation that would become the 21st Century Cures Act, first introduced to Congress in January 2015. The act contained funding boosts, policy reforms, and regulation alterations that would change much of the national healthcare system. When the act came up for voting in December 2016, it was met with widespread approval. Many lawmakers called it a clear message that the time had come to overhaul the medical establishment and make full use of modern science to help American families.
However, the praise was tempered by significant criticism from legislators such as Senators Bernie Sanders and Elizabeth Warren, who felt that the bill gave too much leeway to pharmaceutical companies looking to pass new products through drug-approval procedures. That fast-tracking of new products could lead to new drugs that are insufficiently tested and potentially unsafe.
Despite the debates, the 21st Century Cures bill passed by a vote of 392 to 26 in the House of Representatives and then made another impressive showing in the Senate, passing by a vote of 94 to 5. President Barack Obama, already a vocal supporter of the bill, signed it into law on December 13, 2016. Explaining his support for the act, Obama said that he believed the new legislation would ultimately help to find cures for ongoing health problems such as cancer, Alzheimer's disease, and opioid addictions.
Overview
The adoption of the 21st Century Cures Act in December 2016 brought many changes to the healthcare system. A main change was in the area of medical product research and development. Whereas traditionally new drugs and devices would be required by law to undergo extensive testing prior to government approval, the 21st Century Cures Act significantly reduced these requirements. Proponents of the act believed that loosening such testing would allow new medical innovations to more easily reach the market and help patients.
This part of the 21st Century Cures Act seeks to make the medical establishment more patient-friendly, an ongoing goal of the Food and Drug Administration (FDA), the government organization that evaluates medical drugs for safety and effectiveness. The act further aims to help patients by increasing funding for clinical trials, which are methods of testing new medical products. Clinical trials are important for determining the safety of drugs and can help to identify important new innovations in medicine.
One of the main medical fields targeted by the 21st Century Cures reforms is cancer research, with some $1.8 billion in funding going to a National Institutes of Health program to accelerate studies into cancer and its possible cures. This effort has been referred to as the “cancer moonshot” to emphasize both its importance and its scope. Joe Biden, vice president under Obama, added his support and a personal touch to the act. The cancer moonshot was named after Beau Biden, son of the vice president, who died in 2015 of a brain tumor.
Another main initiative of the act, supported by an earmarked budget of $1.6 billion, was to advance mental health care in the United States. Mental health reforms carried in the bill placed higher expectations on healthcare providers to offer their patients multifaceted treatments that can treat the mind and body. One of the primary mental illnesses to be explored and treated in new ways was Alzheimer’s disease, a disorder mainly occurring in older people that involves degenerated memory and thinking capacity along with behavioral changes. Funding through the act is also channeled to states to fight opioid addiction.
A third main facet of the 21st Century Cures Act relates to reforms in patient information access and privacy policies. The Health Insurance Portability and Accountability Act of 1996, better known as HIPAA, was revised under the 21st Century Cures Act to allow medical caregivers to more easily share critical information about their patients, specifically those mentally or physically unable to make their own decisions about their privacy. Sharing this information can help families and caregivers in a variety of locations become aware of critical health concerns and potentially provide better and more integrated service. Part of this increase in information accessibility relates to new networking systems between healthcare providers, a “trusted exchange framework” that can internally share pertinent patient information while still protecting it from unauthorized use.
Despite the adoption of the act, criticism continued in some quarters. Opponents reinforced their concerns that weakening the testing procedures for new drugs could allow inefficient or even potentially harmful drugs or devices to enter widespread use. Other criticism arrived in the coming years, mainly stemming around charges of inefficiency. Critics have claimed that the administrators empowered to carry out the act are taking too long to implement changes. In particular, the Office of the National Coordinator for Health IT (Information Technology) has been criticized for its slow progress in updating and improving health data access and sharing.
Bibliography
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Sullivan, Thomas. “21st Century Cures Act: Implementation Update.” Policy & Medicine, 17 Feb. 2019, www.policymed.com/2019/02/21st-century-cures-act-implementation-update.html. Accessed 5 Nov. 2019.
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21st Century Cures Act. U.S. Food and Drug Administration, 29 March 2018, www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act. Accessed 5 Nov. 2019.