Mid-Atlantic Health Law TOPICS

The 21st Century Cures Act (Act), which was signed into law at the end of 2016, garnered bipartisan support for its primary goal — to expedite the “discovery, development and delivery” of new treatments and cures. 

The Act allocates $4.8 billion to the National Institutes of Health (NIH); $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 (BRAIN) initiative.

The Act also modifies several Food and Drug Administration (FDA) approval pathways for drugs and medical devices and makes changes to electronic health records (EHRs), Medicare, and Medicaid.

A.  The NIH Programs

All three of the NIH programs that are receiving 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 aims to increase neuroscience research dollars going to treat, prevent and cure brain disorders, such as Alzheimer’s disease. And, the Cancer Moonshot will dedicate research to cancer causes and cures in the hopes that such research will lead to better prevention and earlier detection of cancer.

B.  Drugs and Devices

The Act aims to streamline 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 requires 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.

C.  Mental Health Reforms

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

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

D.  Electronic Health Records

The Act requires that the Department of Health and Human Services (HHS) develops a strategy for reducing the regulatory and administrative burdens of using EHRs. The Act also allows providers to delegate EHR documentation requirements to scribes. 

The Act also aims to improve patient access and EHR interoperability through 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.

E.  Medicare and Medicaid

The Act includes a number of Medicare and Medicaid changes, including reimbursement and notice changes. The Act moves the implementation of the Medicaid reimbursement limitation for durable medical equipment (DME) forward to January 1, 2018, meaning Medicaid reimbursement for DME will be capped at Medicare amounts as of January 1, 2018, instead of January 1, 2019. 

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

F.  Conclusion

The 21st Century Cures Act garnered strong bipartisan support, meaning, similar to the Medicare Access and CHIP Reauthorization Act, it is unlikely to be affected by the American Health Care Act, whatever form it is in, if it becomes law. Therefore, health care facilities, DME suppliers and any other provider of health care services ought to get comfortable with this weighty new law.

Barry Rosen
(410) 576-4224 • brosen@gfrlaw.com

A version of this article was published in The Daily Record on November 29, 2017.