21st Century Cures

By Andrew Pike, Ph.D.

On December 13, 2016, former President Barack Obama signed a bill known as the “21st Century Cures Act” into law. The bill had strong bipartisan support and passed both houses of congress with nearly unanimous consent. This bill covers a broad range of health related topics from tackling the opioid crisis and encouraging novel drug discovery to increasing access to mental health care. Many of these changes had been under consideration for some time, and address long-standing health care issues. Others, such as the “Cancer Moonshot” and “BRAIN Initiative” have appeared more recently and represent the projects spearheaded by Vice-President Joe Biden and President Obama, respectively.

While the bill had support from most members of congress, there were representatives and senators who voiced their opposition to the bill. One major issue they cited was the amount of lobbying done by pharmaceutical companies and other groups that stood to benefit from the bill. The final version of the bill also earmarked less money for the National Institutes of Health (NIH) than some earlier versions. This funding must be appropriated each year and is, therefore, not guaranteed. However, the overall impact of the bill should be to increase spending on research and the availability of quality health care.

The bill is divided into three major sections: “Innovation Projects and State Responses to Opioid Abuse”, “Helping Families in Mental Health Crisis”, and “Increasing Choice, Access and Quality in Health Care for Americans”. The first section includes allocation of large sums of money to the NIH and Food and Drug Administration (FDA) for innovative research in specified areas. The NIH will receive the bulk of these funds to increase investment in precision medicine, neuroimaging and cancer research. There is also $1 billion allocated for individual states to implement programs to combat the nationwide opioid epidemic as outlined in the 2016 Comprehensive Addiction and Recovery Act. These funds are in addition to the normal budgets of the NIH and FDA, and the bill sets the level of NIH funding for the next three years. Oil from the Strategic Petroleum Reserve will be sold off to fund some of these initiatives, reducing the overall financial impact of these increased expenditures.

This section also contains the controversial sections accelerating the approval processes for new drugs and medical devices. Drugs may now be approved for treatment based on “real-world outcomes” instead of full clinical trials. Similarly, so called “breakthrough” medical devices that represent a significant advancement over previous devices will have an expedited approval process. The pharmaceutical and medical device companies stand to benefit greatly by having their products reach consumers more quickly, but argue that this will also increase patient access to therapies that can greatly improve their quality of life. The ability of pharmaceutical companies to advertise drugs for off-label treatments may lead to greater access to life-saving care, as will increased access to experimental drugs, both of which are provided for in this law. Finally, the FDA is given new hiring and retention policies to encourage the best and brightest scientists to work at the FDA, which will be necessary to supervise these new activities.

The next major section, concentrating on mental health, is a massive, and greatly needed, expansion of mental health care in America. The availability of quality mental health services in this country has been lacking, and this bill contains a number of directives aimed at solving this problem. Numerous subsections address this and, if properly implemented, should go far toward this goal. The section begins by identifying some changes that should help both mental and general health care. Steps such as encouraging the use of electronic records, increasing transparency in medical records to protect patient privacy, and boosting research on health issues affecting women and underrepresented minorities will improve health care for all. Additional sections address saving money in the health system by improvements in various aspects of Medicare, which is always a commendable goal, as the health care expenditures of this country are extremely high.

This section continues by addressing numerous issues with the mental health system in the United States and our approaches to treating substance abuse. Part of the issues stems from a lack of countrywide leadership, and the bill establishes both individuals and councils to oversee the nationwide mental health system and fill this void. A policy laboratory will also be created to monitor novel treatments as they arise and promote their use among practitioners. This will ensure that people are constantly getting the best care available, as slow-uptake of new treatments often impedes progress in all areas of medicine. These novel treatments will be monitored to ensure that they are based on evidence and that data are shared between researchers to encourage innovation. The federal government will also be decreasing liability in mental health volunteer workers, clarifying HIPAA rules, and increasing mental health training for various groups in order to promote mental health involvement and access.

While this is a national law, many of the mental health and substance abuse initiatives must happen at the state level. The bill expands access to grants to facilitate the creation of state and local service providers to ensure access to quality mental health care. These grants are targeted at both community mental health and substance abuse prevention programs, and should have a large impact on these issues. By targeting local providers, these initiatives will operate at the small scale necessary to address mental health and substance abuse problems. The US government is too large to address them directly, and by providing these grants, individual providers can provide the necessary care to make an impact on these issues.

While local mental health programs will provide an important set of care options to many individuals, the bill also increases federal mental health and substance abuse programs. Funding for grants to allow homeless individuals and those in jail to seek mental health care is provided, including ways to help these people re-enter productive society. A national suicide prevention hotline will be created, as will programs specifically targeting teen and adult suicide, hopefully reducing the tragedy of suicide at all ages. Limiting underage drinking is also specifically targeted through grants to encourage pediatricians to screen youths for alcohol use and intervene when needed. Mental health in children and on college campuses is addressed by creating working groups to study ways to improve access to and quality of mental health care for children and on college campuses. Educating college employees and providing better outreach and availability will also help improve mental health in our highly vulnerable youth. Finally, the law aims to improve overall community mental health by increasing the availability of mental health screening and treatment in the judicial system. This will encourage the rehabilitation and treatment of those who commit crimes instead of simply locking them away. The aim of this is to decrease the prison population, while increasing community safety by separating those who could benefit from improved mental health care from other criminals.

The last major section, “Increasing Choice, Access and Quality in Health Care for Americans”, contains a number of changes to Medicare laws in order to ensure that people get the best possible medical care. Rules governing which hospitals are eligible for Medicare funding and under what circumstances will be altered in order to increase health care access. For instance, rural hospitals and long-term care hospitals will see increased funding and simplified regulations to increase the availability of necessary treatments. Similarly, access to outpatient treatment and medical equipment will be increased by permitting Medicare coverage of these services under specified circumstances. New Medicare providers will have a period of full coverage and some that would have been shut down will be allowed to stay open, again increasing access to care. Finally, many small employers will benefit by being allowed to offer health reimbursements for health insurance purchased by their employees instead of having to provide group health insurance. This was a major sticking point of the Affordable Care Act of 2010, better known as Obamacare, and should ease the financial burden that law imposed on small businesses.

This large law contains many changes, but there are a few important takeaway points. First, congress is investing heavily in healthcare related science. A lot of ink has been spilled in the last decade or so about how dismal prospects are in the sciences, but this bill signals a shift. When adjusted for inflation, 2016 marked the first year in over a decade that science funding increased and 2017 will continue this real funding increase. As a young researcher, I can certainly say that times are tough. Most faculty spend their time searching for grant money rather than performing science. This constant search for funding leads some people exaggerating, or outright fabricating, results. The job market for young PhDs is terrible. The increased funding provided by this bill may ease the funding crunch, at least a little. However, not all problems young researchers face can be solved by throwing more money at the NIH. Loans need to be repaid, which this law helps address for some researchers by increasing the NIH Loan Repayment Program. Older faculty need to retire in order to open up slots for young researchers. Universities need to encourage promotion instead of allowing indefinite post-doctoral and junior faculty tenures. These, and many other, issues remain to be addressed.

Second, mental health care in this country is receiving a big boost, which has been a long time coming. Discussions of mental health issues and substance abuse have long been considered taboo in America, but only by addressing these issues head on can we provide the help that people need. Access to mental health screening and treatment programs will be increased nationwide, and at many levels. These interventions will be available at low cost and in areas previously devoid of any mental health facilities. This should certainly improve our ability to help those in need. The law does not solve every problem, but it is a solid step in the right direction.

Finally, drug companies and medical device manufacturers will certainly benefit from the new law. While the drug companies did not get everything they wanted, as early versions of the bill included a provision to increase the period before generic drugs are available on the market, the faster approval process and reduced clinical trials will increase their profits. There are legitimate concerns that this will put patient life in danger, but it could equally increase access to necessary treatments, which is a worthy goal. The final effects of this portion of the law will take time to observe, but there are certainly some potential good effects of loosening the extremely strict regulations that control medical products.

Overall, this massive bill seeks to address a number of issues facing American health care. Increased funding for research will help keep the United States at the forefront of medical innovation and spur the next great advances in health treatment. While in the past the mental health landscape in this country was limited and shoddy at best, this law contains many provisions to improve our mental health and substance abuse care, helping to tackle this important issue. Similarly, our massive health care costs each year cause problems to many citizens, but increased options with Medicare will help provide care to some in need. Parts of the bill represent incremental steps forward, while others are larger leaps. All of it, however, is moving toward the goal of improving access to and quality of American health care. Despite its flaws, I would have sided with those who voted “yea” on this bill to improve health care, and create cures, in the 21st century.