At PreciouStatus, our mission has always been to connect individuals during life’s most important moments. This is especially true of our work in healthcare, where an update from a caregiver can be an essential component of recovery. Which is why we were thrilled to see that after three years of work sponsored by Representative Fred Upton of Michigan, the Republican chairman of the House Energy and Commerce Committee, and Representative Diana DeGette of Colorado, a liberal Democrat on the committee, the 21st Century Cures Act was signed into law by President Obama on December 13th, 2016. The bill, which is being hailed as a landmark achievement for the mental health community, was a diligent, overwhelmingly bipartisan effort of legislation, the kind to which many members of both parties have longed to return. Following a 392-26 vote in the House, the bill passed with a 94-5 vote in the Senate. Upon receiving the news of the bill’s passage in the legislative branch, President Obama remarked “The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors. . . . This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.” The bill, which not only reforms federal policy on mental health care, but also boosts funding for medical research and eases regulations for experimental treatments, will give patients who had previously been unable to access or receive treatment a hope for the cure.
Of the bills many provisions (which you can read in its entirety, here), some of the most significant include funding to combat the opioid addiction epidemic that has been sweeping the country, strengthening mental health parity laws to require insurance companies to recognize and treat mental illnesses in the same fashion as medical conditions, modifications to the FDA’s drug approval process and the allocation of billions of dollars in funding to combat cancer and further research for brain diseases like Alzheimer’s. It total, it will provide over $6 billion in much needed capital to a myriad of programs that benefit public health. Chief among them? The expedition of research into new medical devices and disease-curing drugs. By helping to remove the barriers that often impede and delay clinical trials and drug/device approvals, biomedical innovation will be encouraged to continue to grow. “Those changes will last for decades after the money is spent,” DeGette said in an interview. “It’s really not just bringing devices and drugs to market more quickly, but it’s also being able to expedite the basic research behind the way we’re developing these devices.”
For the 44 million individuals in the United States living with mental illness, the Cures Act’s passage couldn’t come soon enough. Senator Chris Murphy, one of the bill’s co-creators understands the urgency “I’d heard too many devastating stories of people struggling with serious mental illness and addiction whose lives were forever changed because they couldn’t get the care they need,” Murphy says. “I’d seen up close the heartbreak and frustration that families suffered trying to find care for a loved one — care that seemed impossible to find and even harder to pay for.” In many ways, the bill is the most significant piece of mental health legislation to pass since 2008. This is largely due to the bill’s emphasis on pushing states to adopt an approach to treatment that includes early intervention for psychosis. Generally, a minimum of ten percent of the state’s mental health block grant will need to be allocated to a model known as coordinated specialty care.
Coordinated specialty care utilizes a team approach to treatment – specialists who provide medication, psychotherapy, education and support work in tandem with the individual and the individual’s family to develop and executive an effective plan. Research from the National Institutes of Health shows that people who receive this kind of care stay in treatment longer; have greater improvement in their symptoms, personal relationships and quality of life; and are more involved in work or school compared to people who receive standard care. For individuals with serious mental illnesses, like schizophrenia, the bill has also created a $5 million grant program to support the implementation of assertive community treatment. The service model has been identified as one of the most successful strategies to help cope with more serious conditions. By shifting the focus to early detection and treatment, more individuals will be able to get help at the right time, resulting in a lessened impact on their lives – fewer missed work or school days and the increased opportunity to overcome or successfully cope with the condition. Early treatment and engagement of loved ones will also help to mitigate some of the more devastating side effects of untreated mental illness, including homelessness, incarceration, and suicide.
The focus on early treatment echoes a sentiment which can be found in many of the bill’s provisions – a shift in focus to the perspective of the patient and significant investment into precision medical initiatives. By definition, precision medicine is changing the approach to treatment from a one-size-fits-all for the “average” patient to a unique treatment that is tailored to the individual on a genetic level, while simultaneously taking into account lifestyle and environmental factors. It also requires taking a more personalized approach to communication with the patient, as one-size-fits all treatments, like writing a prescription (i.e., take one pill twice daily), fails to take a fully holistic view of the patient’s situation. As President Obama observed when he first announced the Precision Medicine Initiative in early 2015, “Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type — that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?”. The Cures Act hopes to allow doctors to do just that. Currently, the system is broken for an individual with a life-threatening disease, but it has the potential to be completely revolutionized.
As part of the effort to more broadly introduce precision medicine, the new legislation associated with the Cures Act will enable the FDA to modernize their approach to evaluating new treatments, including incorporating more patient input and improving patient access to new drugs. As a point of reference to understand the current scope of the public health field, there are approximately 7,000 identified “rare diseases”, i.e. a disease that affects fewer than 200,000 Americans at any given time. For those 7,000 rare diseases, there are 400 available treatments. In the climate prior to the bill’s passage, the clinical trials required to develop additional treatments were considered to be in many ways, infeasible, given that they required collecting a sufficient number of patients in each condition to perform the tests. This was complicated further by that knowledge that even if the numbers were available, the distance to the nearest trial site combined with the cost of travel made it unlikely that patients would be willing or able to attend. By allowing for greater flexibility in the design of clinical trials, as will be permitted under the Cures Act, more people will have access to precision medicine drugs that could potentially save their lives.
Although the goal of the legislation was to remove some of the bureaucratic red tape that has resulted in our current predicament for health conditions, which is that it takes anywhere from twenty to forty years for scientific discoveries to trickle down and benefit lives in a meaningful way, the provisions for research and funding were partially driven by Vice President Biden’s moonshot initiative, to end cancer as we know it. The $1.8 billion in funding earmarked for cancer research specifically has come at an opportune time – many oncologists believe that we are at a pivotal moment with cancer research, one which will be able to start to translate scientific information into survival advantages. President Obama agreed – in his remarks when signing the bill, he stated “In this effort, Joe Biden has rallied not just Congress, but he has rallied a tremendous collection of researchers and doctors, philanthropists, patients. He’s showing us, that with the right investment and the ingenuity of the American people, to quote him, there isn’t anything we can’t do.”
Less altruistically, the impact of the Cures Act has the potential to keep the United States at the forefront of medical innovation, attracting the best doctors and researchers in the world. According to the National Science Foundation, the United States is still the world leader in medical innovation, though that position is tenuous as Southeast, East, and South Asia continue to rapidly ascend in the fields of engineering and science. Health is like an ecosystem and by providing the best players, we’re positioning ourselves to have the greatest chance for saving lives and improving the conditions of those living with debilitating diseases.
At first blush, drug companies and research organizations may appear to have most benefitted by the bill’s passage, given the immediate effect that they will have on their respective industries. However, the Cures Act is also opening doors for digital health, which may ultimately lead to healthcare IT absolutely exploding. As you can imagine, cutting edge technology is a critical component to conducting research. As such, major investments in upgrading and implementing new IT systems will be made to continue to support the new developments. This will also give rise to an influx of digital health apps, which promote patient engagement. For the treatment of opioid dependency and substance abuse, the use of health apps that will allow care providers to interact with their patients will be a key component of recovery. The new attention to this space will also provide bolt of digitally focused innovation to the substance abuse and mental health fields. As was previously discussed, coordinated specialty care is perhaps the most effective strategy to combatting mental health issues. For teens especially, this may be best achieved through apps which allow digital communication via texting or a proprietary communication platform like PreciouStatus.
Beyond facilitating treatment, healthcare IT will also play an important role in helping doctors to better implement precision medicine-based treatment programs. Given that doctors must consider the combination of genetics, behavior, and environment when prescribing a personalized disease prevention or treatment option, it is impossible to believe that the process would not be aided by an app that would both prompt a patient to an action (i.e. taking pills each day at a specified time) or serving as a means for recording daily progress (such as vitals, overall wellbeing, diet, exercise, sleep, etc.). Healthcare IT could also be instrumental in one of the more unique provisions of the legislation – allowing the FDA to consider real-world evidence in lieu of Phase III trials when approving treatments, drugs and medical devices. The instances where this could be utilized are few and far between, but exist when the gold-standard for testing of the medical community, randomized controlled trials (RCT’s), are logistically, ethically, or operationally impossible, such as the 2014 Ebola outbreak or the current Zika epidemic. Digital health apps could provide the repository for observations and findings by doctors in those scenarios to begin to accumulate data.
Overall, the 21st Century Cures Act is a much needed piece of legislation that will greatly benefit the American public. From recognizing mental illnesses as a medical condition that must be supported by insurance companies to a degree commensurate with breaking your arm, to ensuring that American public has access to the best possible drugs and treatments, to maybe even finding a cure for cancer once and for all, the legislation will somehow impact every household one way or another. The immense bipartisan support of the bill is also a positive indication of what can happen when needs of the American people are put in the forefront of the issue. In short, as President Obama remarked when he signed the bill, “We are bringing to reality the possibility of new breakthroughs to some of the greatest health challenges of our time”. As we continue to move into 2017, we are looking forward to watching the impact of the bill on patients and research alike as we seize every opportunity to find cures as soon as possible. The essence of the 21st Century Cures act, to connect more individuals, echoes our mission as an organization and we’re proud of the collaborative efforts of all parties to benefit the American people.