In the closing days of his administration, President Barack Obama signed the 21st Century Cures Act, which was a sweeping bill of nearly 1,000 pages and the result of three years of work by legislators and lobbyists.
The bill touched upon many areas in healthcare and received overwhelming support in both houses of Congress. It sought to change FDA processes to quicken medical research and treatments; enhance health IT interoperability; improve mental health services; provide $1 billion for states to fund opioid abuse prevention and treatment; and spend $4.8 billion on cancer research and the BRAIN Initiative.
Though seen as a major achievement at the time, the Cures Act quickly fell into the background as the Donald Trump Administration took office, and a flurry of activity followed.
In the early days of the Trump Administration, the president signed two executive orders that implemented a 90-day hiring freeze on executive branch positions and required that lawmakers and policymakers cut two regulations for every new one implemented.
Supporters of the Cures Act worried the two executive orders would slow implementing the Cures Act. For instance, a major piece of the legislation includes revamping the FDA processes, which will take staffing. Not being able to create new regulations, which was the point of one of the executive orders, could hamper progress.
However, in a blog post, Hughes Hubbard & Reed partner Seth D. Rothman and counsel Jessica Studness wrote that the hiring freeze order allows for wiggle room for positions needed for “public safety,” which could include the FDA. The regulation order could also get sidestepped because FDA process changes could lead to “lifesaving medicines.” That said, they still warned that the two executives orders could stall the law.
“The only certainty is that the act is going to take longer to implement than had originally been anticipated,” they wrote.
David Harlow, principal of The Harlow Group, a healthcare law and consulting company, told Healthcare Dive he shares concerns about what the executive orders — and the Trump Administration — may do to the process. “The Cures Act is not part of Obamacare, and enjoyed bipartisan support in Congress, but it is hard to predict what the current administration may do when it comes to implementing anything that may be construed as part of the legacy of the previous administration,” said Harlow.
Dr. Scott Gottlieb, commissioner of the FDA, tried to allay those fears in a recent blog post. Gottlieb said the FDA will soon unveil improvements to the regulatory processes “so that safe and effective new technologies can reach patients in a timely fashion.”
It has been seven months since Obama signed the legislation. Here's a look at how the Cures Act provisions are progressing in Health IT interoperability, FDA changes and mental health.
Health IT interoperability
The health IT operability portion of the 21st Century Cures Act charged the Office of the National Coordinator (ONC) to create a framework that would allow for greater interoperability between healthcare stakeholders and also asked HHS to educate providers about health information exchanges.
ONC is still in the early stages of rulemaking under the act. The agency has held listening sessions to get feedback from the industry with the hope of getting a proposed regulation out by the end of the year. The FDA also plans a public workshop to discuss changing digital health in January.
The FDA recently released its Digital Health Innovation Action Plan, which is a blueprint for the upcoming improvements. The plan includes issuing new guidance on health IT, reimagining how the FDA approaches digital health medical devices and growing the FDA’s expertise in the area of health IT.
What kind of impact will these changes have on healthcare? Many health IT leaders said that interoperability was already happening in the industry before the law. In a recent blog post, Harlow said some worry that the Cures Act may actually slow down the process of greater interoperability.
Harlow said the government’s challenge is to advance rulemaking in the interoperability realm that is flexible enough to allow for technological advances and make sure that health organizations already working on interoperability aren't considered non-compliant.
“In general, it is challenging for the government to regulate technology at a granular level because technology changes faster than the regulatory machinery can move,” Harlow told Healthcare Dive. “One of the greatest concerns about a federal interoperability rule is that technology and industry standards may advance in such a way that the state of the art does not fall within the four corners of the rule.”
Larger healthcare organizations are already using interoperability solutions to manage population health. They use a combination of expensive commercial off-the-shelf and custom solutions. Harlow said the goal should be to ensure that interoperability is available to all providers so they and their patients are “on an equal footing when it comes to reaping the benefits of technology.”
Harlow’s biggest concern about the rulemaking process is that it might take too long. The rule may not be finalized for a year, and then the industry will need to retool to comply, he said.
The FDA portion of the law seeks to accelerate new medical treatments by removing potential FDA barriers, speeding up FDA processes and investing $500 million to make those improvements. The law also removes the FDA from regulating low-risk medical devices, such as FitBits.
Opponents to the bill, including Senators Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), spoke out about removing FDA protections, but Gottlieb emphasized in a recent blog post the importance he sees in eliminating regulatory barriers.
Gottlieb and the FDA have been working on implementing the numerous FDA-related aspects of the Cures Act. The FDA posted Cures deliverables recently so people could track the progress and submitted a final work plan to Congress, which was required by the law.
One way the FDA is hoping to streamline approval processes is by allowing silico tools in clinical trials “for improving drug development and making regulation more efficient.”
Silico clinical trials use computer models and simulations to evaluate devices and drugs. This program “enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials,” Gottlieb said.
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development,” said Gottlieb.
So, the FDA has knocked off a few from its Cures to-do list despite concerns about the president’s executive orders.
The mental health portion of the Cures Act didn't have the billions of dollars and resources found in other portions of the bill, such as for cancer and brain research and opioid abuse. There also isn’t a lengthy planning process, which is the case with the FDA changes and IT interoperability.
Instead, the mental health portion of the Cures Act was a cobbled together effort of other pieces of legislation that were in the pipeline, such as the Helping Families in Mental Health Crisis Act of 2016, the Mental Health Reform Act of 2016, the Mental Health and Safe Communities Act of 2015 and the Comprehensive Justice and Mental Health Act.
One of the major pieces involves creating an assistant secretary of mental health and substance abuse position in HHS. Ronald Honberg, senior policy advisor for the National Alliance on Mental Illness (NAMI), told Healthcare Dive the position might not sound like much, but an assistant secretary will have the ear of the HHS director. In the past, mental health has been pretty far down in the pecking order at HHS, he said.
“Creating an assistant secretary position, in theory at least, elevates the importance of these areas within HHS,” said Honberg.
The assistant secretary will coordinate the various agencies that deal with mental health, including Substance Abuse and Mental Health Service Administration (SAMHSA), National Institute of Mental Health and the CMS. Honberg said there hasn't been coordination or a coherent federal strategy addressing mental health needs. That should change once an assistant secretary is in place.
The Trump Administration nominated Elinore McCance-Katz of Rhode Island for the position in April, but the Senate hasn't acted on the appointment yet. The nomination isn’t without controversy. U.S. Rep. Tim Murphy (R-Penn.), who proposed the assistant secretary position in the Cures Act, spoke out about the nomination because McCance-Katz served with SAMHSA when the department “was incapable and unwilling to work with me and my colleagues in Congress to deliver the transformative changes needed," said Murray.
The New York Times reported in May that there is also a larger debate in the mental health community around the nomination. The issue revolves around McCance-Katz’s support of the “medical model of psychiatry, which emphasizes drug and hospital treatment” instead of supporting a psychosocial approach with more emphasis on community care and support structures.
While the nomination remains stuck in the Senate, there is movement in other parts of the mental health portion of the Cures Act. The law extends demonstration programs for states to create outpatient treatment programs. That program was ending before the Cures Act extended it through 2022. The law also reauthorized mental health collaborations with criminal justice organizations to divert people into mental health treatment and services rather than incarceration.
Both of those measures were in the fiscal year 2017 appropriations bill, so that work is ongoing, but mental health advocates need to advocate for the funding each year, said Honberg.
Honberg said another important piece of the legislation is requiring that states spend 10% of money from federal block grants on mental health, which is an increase from 5%. “These programs are quite effective preventing hospitalizations, homelessness and really bad things we see with untreated schizophrenia.”
Overall, Honberg said NAMI has seen “promising signs, but it’s really too early to tell” about the Cures Act. Beyond the Cures Act, Honberg said keeping mental health front of mind in the current political climate is important.
Despite the steps forward, Honberg said the president’s proposed budget cuts would undo work being done in mental health. The president’s budget, which will likely have little influence on the final budget approved on Capitol Hill, would cut $600 billion from Medicaid over 10 years, $356 million from the National Institute on Mental Health and $400 million from SAMHSA programs (including $116 million from the mental health services block grant). The budget proposal would also cut $854 million from the FDA and $22 million from ONC, which play key roles in implementing the Cures Act.
Honberg said mental health advocates will have a better idea on the state of mental health programs once the final budget is approved.
“We don’t understand that at all. It’s so counterproductive,” said Honberg about the proposed cuts. “Medicaid is the greatest and largest source of funding for mental health services in the country." He added: "Cures was one step forward. Medicaid cuts would be 10 steps back.”