What Else is in the 21st Century Cures Act?

WASHINGTON — When most people think about the 21st Century Cures Act, they think about curing cancer and Alzheimer’s disease, and curbing the nation’s opioid epidemic. But the nearly 1,000-page healthcare spending bill, which President Obama signed in mid-December, also aims to reform the nation’s fragmented mental health system, improve access to electronic health data, and ensure that underrepresented individuals are included in important health research.

Mental Health

Approximately 13 million people in the U.S. have a serious mental illness or substance use disorder, according to the American Psychiatric Association (APA), which applauded the 21st Century Cures Act, calling its reforms to mental health a “huge step forward.”

The Cures Act included efforts to promote evidence-based treatments, strengthen mental health parity, and bolster the mental health workforce. The bill also established a grant program focused on early intervention for those showing warning signs of a potentially serious mental illness.

One almost immediate change the bill makes is to establish a new assistant secretary for Mental Health and Substance Abuse to oversee SAMHSA, explained Andrew Sperling, director of legislative advocacy for the National Alliance on Mental Illness.

The 21st Century Cures Act also designates a new Interdepartmental Serious Mental Illness Coordinating Committee, charged with summarizing advances in diagnosing and treating serious mental illness in a written report to congress. The committee — which includes members from SAMHSA, the Department of Defense, the Health Resources and Services Administration (HRSA), and other federal health agencies — will also be required to evaluate the impact of federal programs on important public health outcomes (i.e., rates of suicide, preventable emergency room visits, and homelessness).

Other key mental health-related provisions of the bill include the following:

Authorizing a grant program to enable local governments to improve crisis intervention among emergency responders, clinicians, and law enforcement and funding to build registries of available inpatient psychiatric beds;

Also, the Cures Act, while not amending the Health Insurance Portability and Accountability Act (HIPAA), does outline the circumstances by which clinicians can share information with family members when a loved one is in crisis. “We hope this will ease the chilling environment around disclosure of information to family members,” by providing clinicians with greater clarity regarding when they can disclose, Sperling said.

With regard to mental health parity — equal access and coverage from insurers for mental health issues compared with physical concerns — most states have not been aggressively auditing insurers, an APA representative told MedPage Today.

However, the Cures Act calls for a standardized approach to auditing, and, on a federal level, requires the Department of Labor to periodically publish reports to showcase the volume of cases the agency has pursued.

Efforts to ensure more consistency and transparency could produce a “sentinel effect,” said the APA official. The more that insurers believe they risk being audited, the more likely they are to take internal compliance seriously.

Electronic Health Records

The Cures Act also strengthens efforts to improve and enforce health information interoperability.

Beginning in January 2018, vendors’ relative interoperability will be evaluated, and by 2019, those not in compliance will lose certification, explained Mandy Long, chair of the Electronic Health Records Association (EHRA) Clinician Experience Workgroup for the Healthcare Information and Management Systems Society (HIMSS), speaking in a phone interview with MedPage Today during which a public relations official was present.

“There are real teeth to [the language in the bill], and [the penalties] grow over the course of a couple of years,” said Long, who is also vice president of product management at Modernizing Medicine, an EHR and practice management software company in Boca Raton, Fla.

She noted that vendors who engage in data blocking can be fined up to $1 million per violation.

Long, whose daughter has Turner syndrome, also spoke as the parent of an ill child about the challenge of keeping specialists in different hospitals current with her daughter’s health status and tests. “We call it the ‘patient’s Bible’ — that binder that patients create for themselves, or their parents create [of various medical records] — we lug it from visit to visit or, God forbid, if we end up in an emergency situation; it’s awful and frequently out of date.”

Long said she believes the bill’s requirements to promote a scalable integration structure will have benefits for patients as well as industry.

The College of Healthcare Information Management Executives (CHIME) offers more specifics on the health IT provisions of the bill related to information blocking, interoperability standards, and hardship exemptions for decertified EHRs.

Superbugs, Vaccinations, and Equity in Research

Other elements of the bill include provisions to fight superbug infections, such as allowing the FDA to require manufacturers or reusable medical devices to share their cleaning instructions and verify that such methods work. The Cures Act also creates new requirements for the National Institutes of Health to encourage scientists studying similar topics to collaborate, with the goal of increasing the volume of data on underrepresented populations (i.e., women, children, and minorities).

Finally, the bill aims to raise maternal vaccination rates through efforts to prevent vaccine shortages and by incentivizing drugmakers to develop new vaccines for pregnant women. In addition, the act encourages pediatric drug development by allowing products given a “rare pediatric disease designation” from the FDA before 2020 the chance to be considered for a voucher until 2022.