COMMENTARY

An Extraordinary Legislative Gain for Mental Health Care

Jeffrey A. Lieberman, MD

Disclosures

December 06, 2016

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Hello. This is Dr Jeffrey Lieberman of Columbia University in New York City, speaking to you today for Medscape.

In my last video blog, I was feeling irritable and worried about whether I was becoming too much of a curmudgeon. I felt this way because of some recent developments that seemed to reinforce my impressions of how mental health care, psychiatry, and mental illness get short shrift and continue to be neglected. Then we had the presidential election and the tumultuous change that it promises to bring, for better or for worse.

But the week after Thanksgiving, something totally unexpected happened that has almost restored my faith in government. Congress has orchestrated a visionary, clever legislative process to push some sweeping legislation over the goal line. This legislation will affect healthcare, biomedical research, and drug and device development and review in the United States, something that could be not only beneficial but actually transformative.

Parallel Legislations, Protracted Negotiations

Let me put this in context. During the past year, several legislative efforts have been underway in parallel in Congress. The one most familiar to me is the Helping Families in Mental Health Crisis Act (HR 2646), which was introduced in November 2013 in the aftermath of the terrible Sandy Hook tragedy. This legislation was initiated by Congressman Tim Murphy of Pennsylvania and Congresswoman Eddie Bernice Johnson of Texas, and was quite promising in terms of its potential impact in the way the federal government supports mental health services. The legislation fought its way through the legislative process for 3 years before finally being passed in July 2016 with a near unanimous vote in the House of Representatives. That happened at the end of July with the congressional recess approaching. The parallel Senate bill, the Mental Health Reform Act (S 2680), was sponsored by Senators Lamar Alexander of Tennessee and Chris Murphy of Connecticut, but it was a far cry from the House bill in terms of the measures that were included. As of August, the Senate bill had not been passed, and if it were passed, it would have to have been reconciled in conference with the House bill.

In addition, Senator John Cornyn from Texas had introduced the Mental Health and Safe Communities Act (S 2002), a bill that was occasioned by recent mass-violence incidents that have been perpetrated by individuals who were mentally ill and not receiving proper treatment. This bill also was undergoing a protracted legislative negotiation and consideration process.

At the same time, Congressman Fred Upton from Michigan and Congresswoman Diana DeGette from Colorado brought forward a more ambitious, broad measure called the 21st Century Cures Act (HR 6). This bill aimed to augment the funding for the National Institutes of Health (NIH) so that the NIH could target priority areas of scientific research and public health need. The bill also contained sweeping measures that would improve the resources and efficiency of operations of the US Food and Drug Administration (FDA) for development of drugs and therapeutic devices.

All of these bills were moving forward in parallel, facing various types of obstacles and resistances in the Congress as the clock was ticking and time was running out. August came and Congress recessed. Legislators returned in September but did not act on these before the election. The aftermath of the election brought a tectonic change in expectations that could have completely derailed any possibility that these bills would be addressed during the lame duck session, and if that were the case, everything would have had to start over again in the new Congress after January 2017.

An Amazing Bipartisan Effort

That is when an amazing thing happened. In a bipartisan effort, the leaders determined that the best way to accomplish their ends with respect to all of these bills was to integrate them. Measures from the Helping Families in Mental Health Crisis Act and the Mental Health Reform Act were incorporated into the 21st Century Cures bill. This was no easy task because the House and Senate versions were very different. Even before a vote was taken in the Senate to approve their counterpart bill, discussions essentially reconciled the two and incorporated many, if not most, of the important elements from the House bill.

Of course, much more than I understand went into making this happen, but the point is that the leaders of the Senate and the House joined together and deftly found a way to extract what was the best of the three bills and prepared the legislation so that it could be voted on in early December. President Obama has already signaled his intent to sign the bill, which means that it could become law by the end of the year. This is an extraordinary turn of events that I did not foresee or believe could be orchestrated. It shows how Congress can do good things ingeniously when it wants to.

Inside the Legislation

Why am I so excited about this? The 21st Century Cures bill includes a provision that adds half a billion dollars a year for the next 10 years to the NIH budget, specifically to fund precision medicine, brain research, cancer research, and regenerative medicine using stem cells. In addition, the FDA will receive half a billion dollars over the next 10 years to implement policies that will move drugs and medical devices through the approval process more quickly. A billion dollars in grants will be given over 2 years to states to address the opiate addiction crisis. Another provision directs the NIH to give grants that will support innovation. Another directive supports young, emerging scientists and authorizes the director of the NIH to coordinate, develop, modify, and prioritize policies and programs to improve the opportunities for new researchers who, in this dire funding climate, have been struggling to get funding to launch their careers.

Also included is a provision that authorizes NIH's National Center for Advancing Translational Sciences to support clinical trials that extend through phase 2 of testing, which is the all-important proof-of-concept stage of drug development. An additional directive establishes a review pathway at the FDA to develop biomarkers and other objective measures that are surrogate endpoints of therapeutic efficacy, which are important in the process of facilitating development of therapeutics. The bill also requires that pharmaceutical companies have publicly accessible compassionate-use policies for drugs that are being developed for serious or life-threatening conditions. This means that patients who participate in a clinical trial during one of the phase 2 or 3 studies for FDA approval, including patients in the placebo group, will have a chance to receive the active drug after the study is completed. Another measure allows the FDA to grant accelerated approval for regenerative medicine therapeutic products, something that is badly needed for people with degenerative diseases and traumatic brain injury.

Enriched Partnership Among Mental Health Care Agencies

The Helping Families in Mental Health Crisis Act is also embedded within the 21st Century Cures bill. The Act provides, first and foremost, a consolidation of authority over all the federal agencies that have anything to do with mental health care and addiction. It does so by establishing the position of assistant secretary for mental health and substance abuse in the Department of Health and Human Services. That will be an assistant secretary at the cabinet level focusing on mental health and addiction. The bill also proposes that there must be a chief medical officer appointed within the Substance Abuse and Mental Health Services Administration (SAMHSA), the biggest federal agency to support mental health care and substance abuse treatment in the United States, with funding of $3.6 billion. Candidates for both of these positions are required to be experienced, research-sophisticated, doctoral-level professionals, either MDs or PhDs in psychology, to carry this out.

The legislation also requires that the advisory council to SAMHSA and other federal agencies concerned with mental illness and drug abuse include as ex officio members the directors of the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA), which is meant to provide scientific heft to those advisory bodies. The bill also establishes the National Mental Health and Substance Use Policy Laboratory. This laboratory will annually advise SAMHSA and other federal agencies on the latest research that may be ready to translate into clinical practice and should be encouraged, incentivized, and supported by these agencies. This laboratory will provide guidance that encourages evidence-based, proven, effective practices to be supported with federal funds and with federal incentives. There is also a stipulation that block grants given to the states be tied to specific public mental health and substance abuse needs, and to methodologies that have been proved, in NIH funded studies, to be effective prevention strategies. Substantial amounts of money are available through these mechanisms, from SAMHSA and the other agencies. In the aggregate, they will deliver more than $6 billion a year to states for funding these mental health initiatives.

Addressing Mental Health in Diverse Populations

The provisions from the Mental Health Reform Act and the Mental Health and Safe Communities Act that were incorporated into the larger bill are geared toward trying to address mental health on college campuses, among the homeless, in jails, among pediatric patients, among expectant mothers, and in perinatal clinics. They also include guidance that attempts to modify the HIPAA guidelines to allow clinicians to communicate medical information about mentally impaired individuals to other health professionals even without permission. This measure did not make it through as it was initially composed because of controversy over confidentiality, but there is language that aims to develop means that do not compromise confidentiality but still allow health professionals to communicate.

Also included is language that supports funding to states that encourage assisted outpatient and assertive community treatment, and language that eliminates the Medicaid prohibition against allowing separate payment for mental health care and primary care services provided on the same day. Previously, Medicaid would not pay for two different services performed on the same day, even when they were given for entirely different reasons. Finally, although there is no elimination of the notorious Institutions for Mental Diseases exclusion (the IMD exclusion prohibits Medicaid reimbursement for care provided in mental health and substance use disorder residential treatment facilities larger than 16 beds), there is language that requires the impact of this on patient care to be studied to determine whether this policy needs to be modified.

An Extraordinary Development, With a Caveat

All in all, this is an extraordinary piece of legislation, the likes of which I cannot recall since the Mental Health Parity Act in 1996. This new bill is broad in its scope and potential impact and includes many good things that will not just be rhetorical but will actually have traction in how healthcare is delivered to and accessed by patients. To have the federal agencies such as SAMHSA work more closely with the NIH institutes that are developing the research for the newer, hopefully better treatments will be remarkable. Best of all, it consolidates the authority for these undertrained professionals who have sophisticated knowledge in clinical care and research. Joining this to the 21st Century Cures legislation, which provides a significant infusion of resources and increased discretionary capability to the NIH and the FDA, is a marvelous synergy of good legislation.

The bill has not yet passed and is not yet signed, but it is an extraordinarily positive development occurring in the context of what has been a very tumultuous and oftent stressful year politically in terms of healthcare. One cautionary note: As good as all of this is and as much as it will mean, it could be completely altered if there are sweeping changes in our country's healthcare laws, specifically the Affordable Care Act (ACA). If Obamacare is repealed or dismantled in a significant way, whereby the millions of people who have gained coverage now lose that coverage, this will negate much of the benefit that this legislation would have, because among the people who lacked insurance before the ACA was a disproportionate number of individuals who suffer from mental disorders. We do not know what President-elect Trump or his Health and Human Services Secretary nominee are going to do. We hope it will not adversely affect the way healthcare is currently financed in the United States and negate the good work that our Congress has just done.

I give my heartfelt thanks and congratulations to the congressional leaders. I have not said many kind things about them in the past. In this case they have ingeniously come through in a way that I admire and for which am deeply grateful.

Thank you for listening. I am Dr Jeffrey Lieberman at Columbia University, speaking to you today for Medscape.

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