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The  21st Century Cures Act

Barry RosenNow that President Trump has declared the opioid crisis a public health emergency, it is useful to revisit one of the last laws signed by President Obama, namely the 21st Century Cures Act, which, among other things, addressed the growing opioid crisis.

The act was signed into law at the end of 2016, and garnered bipartisan support for its primary goals (1) to expedite the “discovery, development and delivery” of new treatments and cures for diseases, and (2) to help combat mental health and substance use disorders.

The act allocated $4.8 billion to the National Institutes of Health; $1 billion in grants to states over two years to improve access to mental health programs and to combat opioid drug abuse; $1.8 billion for former Vice President Joe Biden’s “Cancer Moonshot;” $1.4 billion for the Precision Medicine Initiative concerning genetic information: and $1.5 billion for the Brain Research through Advancing Innovative Neurotechnologies initiative, or BRAIN.

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Leslie M. Cumber

The act also modified several Food and Drug Administration approval pathways for drugs and medical devices, and made changes to electronic health records, Medicare, and Medicaid.

The NIH programs

All three of the NIH programs that received funding involve research. The Precision Medicine Initiative will collect genetic and health data that will be used to enable health care providers to tailor treatment and prevention strategies to people’s unique characteristics.

The BRAIN initiative increased neuroscience research dollars going to treat, prevent and cure brain disorders, such as Alzheimer’s disease. And, the Cancer Moonshot funded research to cancer causes and cures, with the hope that such research will lead to better prevention and earlier detection of cancer.

Drugs and devices

The act streamlined the approval process for drugs and medical devices by creating new approval pathways, and by easing review burdens that should result in bringing products to market more quickly.

For example, the act allows the FDA to grant prior review and accelerated approval to drugs or biologics the FDA designates as regenerative advanced therapies.  And, the act required the FDA to establish a program to expedite developing and reviewing devices that provide for more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.

The act also authorized an additional $400 million over 10 years to an FDA Innovation Account to help the agency cover the cost of implementing the act.  On June 9, 2017, the FDA delivered to Congress a final work plan that shows how the FDA would use the funding.

Mental health reforms

In addition to the allocation of $1 billion in grant funding to states for addressing opioid abuse and addiction, the act provided for several incentive grants for promoting the integration of mental health services with primary care services.

The act also established programs that provide training to law enforcement, corrections officers, and first responders on identifying and effectively addressing individuals with mental illnesses, and gave the Attorney General authority to create mental health and drug treatment alternatives to incarceration.

Electronic health records

The act required the Department of Health and Human Services to develop a strategy for reducing the regulatory and administrative burdens of using EHRs. The act also allowed providers to delegate EHR documentation requirements to scribes.

Certain changes, such as new interoperability standards for certification by the Office of the National Coordinator for Health Information Technology, the creation of an EHR reporting system designed to help providers choose EHR products, and a new requirement that the Government Accountability Office study barriers to patient access, should improve patient access and EHR interoperability.

Medicare and Medicaid

The act included a number of Medicare and Medicaid changes, including reimbursement changes and notice changes. The act moved the implementation of the Medicaid reimbursement limitation for durable medical equipment forward to Jan. 1, 2018, meaning Medicaid reimbursement for durable medical equipment will be capped at Medicare amounts as of Jan. 1, 2018, instead of Jan. 1, 2019.

The act also required Medicare administrative contractors to publish local coverage determinations and explanations at least 45 days before such decisions go into effect, and, in an effort to improve price transparency, required HHS to publish the prices of items and services available in hospital outpatient departments and ambulatory surgical centers.

Conclusion

The 21st Century Cures Act is a weighty new law of which health care facilities, durable medical equipment suppliers, and all other providers of health care services need to be aware.

Barry F. Rosen is the chairman & CEO of the law firm of Gordon Feinblatt LLC, heads the firm’s health care practice group and can be reached at 410-576-4224 or brosen@gfrlaw.com.  Leslie M. Cumber is an associate in the firm’s health care practice group and can be reached at 410-576-4248 or lcumber@gfrlaw.com.

 

 

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