House and Senate health committee leaders have negotiated a compromise on the 21st Century Cures Act. The final version, released Nov. 25, combines innovation-measurement and mental health reforms to create a single medical innovation package along with a grab bag of partly unrelated items like provisions for telehealth and streamlining clinical research. The House passed the bill Wednesday, and the Senate is slated to take up the measure next week.
The AHA highlighted several key provisions of the bill that would have an impact on hospitals in its letter of support to Congress
The medical innovation element essentially aims to expedite the Food and Drug Administration's approval of new drugs and devices. It authorizes $4.8 billion in funding throughout the course of 10 years for research at the National Institutes of Health, a compromise from an earlier proposed budget of $8.75 billion. Of particular focus are regenerative medicines for advanced therapies and medical devices that feature breakthrough technologies and engineering.
The mental health portion updates programs for the first time in a decade and includes new funding for state grants to fight opioid abuse, the establishment of new chief medical officer and assistant secretary for mental health roles in the Department of Health and Human Services, and other programs.
Each of these is an important improvement in the health system. Each has the potential to improve the quality of care via new drugs, devices, technologies and attention to the menacing epidemic of mental health in our country. But these proposals aren’t new in health care: Laws aimed at accelerating the drug approval process have been on the books since 1992, and recent approvals for specialty drugs have driven drug prices sky-high.
Similarly, mental health has received attention (as in the Mental Health Parity and Addiction Equity Act of 2008), but passage and implementation has proceeded at a snail’s pace. In the aftermath of the Sandy Hook shooting in 2012 in Connecticut, lawmakers — led primarily by U.S. Rep. Tim Murphy (R-Pa.), chairman of the Oversight and Investigations Committee and a clinical psychologist by training — turned their attention to reforms that would expand access, coordinate services and increase funding. Murphy called for mental health to receive serious attention in a $3 trillion health care system, which, he says, “does little but bear witness to rising rates of suicide, homelessness, and incarcerations.” He then reintroduced the Helping Families in Mental Health Crisis Act, but not much changed.
For hospital leaders, the likely passage of the new 21st Century Cures bill could be a big deal. It might change how many new drugs and devices enter the market, or how mental health is diagnosed and treated. For hospitals, however, there remain many unknowns.
Focusing on the basics of the 21st Century Cures Bill
In the context of these two domains — drugs and devices, and mental health — it’s clear that hospitals must stay focused on the basics while the dust settles. Here are some major points to keep in mind:
- Formulary design and medication management policies and procedures need constant review so that competing compounds can find their way readily into a hospital’s prescribing patterns. And the hospital’s interaction with retail pharmacies should enable shared knowledge about new and emerging classes and compounds that offer the same efficacy and effectiveness at a lower rate.
- Medical device utilization, purchasing, and measures of effectiveness and safety need closer scrutiny. Of particular note are two areas where compliance risk is quite strong: the financial relationships between physicians and hospitals and manufacturers, and the safety associated with devices. Notably, the FDA has cracked down on manufacturers, forcing higher standards of scientific evidence in their approval process and stronger proof that a supposed “essential equivalent” is different or not.
- Medical directors must be proactive. Pharmacists should be included in care coordination teams across the organization. Most are treated as prescription-drug fulfillment staff. They’re much more. And mental health professionals — psychiatrists, clinical psychologists, counselors — should be fully integrated in every care guideline: Mood, stress and anxiety disorder, dual personality disorders, and other mental health conditions require serious attention. In the case of those that can treated in a primary care setting, these providers should be skilled in screening. For those more serious, an adequate panel of specialists should be accessible.
- Mental health professionals should be recruited to the clinical community. In many communities, recruiting mental health professionals takes a back seat to recruiting surgeons and others who drive higher revenue to the hospital. According to the Health Resources Services Administration, there are 3,669 "Mental Health, Health Professional Shortage Areas" that touch 91 million people in the U.S. today. The shortage is acute: It would take 1,846 psychiatrists and 5,931 other practitioners to fill the needed slots.
- The diagnostic tests inclusive of mental and physical health signs, symptoms, risk factors, and comorbidities should be updated and hardwired into clinical decision support systems that prompt, alert and remind clinicians to make definitive diagnoses. A hospital’s assurance of quality and safety should not be compromised by inadequate screening for mental health problems.
- Employers should be educated about workforce health and stress. That starts with the employees of the hospital itself: It’s a stressful environment in the best of times. The hospital’s human resource personnel should lead the charge to address mental health as aggressively and discreetly as any other condition. The same principle can be extended to local employers who wrestle with the costs of absenteeism, productivity and presenteeism gaps that are the direct result of mental health issues. Simply offering an employee assistance program that allows an employer to check a box isn’t good enough. Not addressing bullies and narcissism in the workplace is destructive to the company’s bottom line, damaging to its reputation and harmful to employee health. Treating mental health — stress, mood, anxiety, substance abuse, obsessive disorders, etc. — is as important as treating obesity and diabetes.
- Private insurance plans should be reviewed for adequacy and appropriateness of mental health screening and treatment. Mental health services, in order to be adequate, must be covered in the same ways as physical medicine: no exceptions.
- Hospital CEOs and board chairs should initiate an open conversation with their community to destigmatize mental health. The clergy, educators and community leaders should be engaged frankly and urgently. These maladies affect virtually every family. They can be treated if they’re diagnosed and treatment — medical, therapeutic, holistic — is made available.
The 21st Century Cures Act of 2016 was a long time coming, and no one knows for sure how its implementation will play out. It’s huge: 996 pages in its final version with a shopping cart full of goodies. What we know for sure is it calls attention to two major areas: expeditious access to new drugs and devices, and effective and accessible access to mental health services. They’re both important. That’s why the new legislation is potentially a big deal for hospitals.
Paul H. Keckley, Ph.D. (email@example.com), does independent health research and policy analysis and is managing editor of The Keckley Report. He is a member of Health Forum’s Speakers Express.
The opinions expressed by the author do not necessarily reflect the policy of the American Hospital Association.