An Introduction to the 21st Century Cures Act

Join us for a lively discussion about the 21st Century Cures Act, an expansive law that encompasses major reforms, funding, and regulatory changes of significant interest to healthcare providers and pharmaceutical and medical device manufacturers. Our program will bring you quickly up to speed on the key provisions of the bill, including insights regarding opportunities and challenges and why some of the innovations are controversial. We will address:

• A brief overview of the legislative history and reasons for bipartisan support, including the provision over ten years of $4.8 billion to the NIH to support initiatives in precision medicine, the "cancer moonshot," the BRAIN initiative, and regenerative medicine, as well as over $500 million to FDA.
• The provision of over $1 billion over two years in grants available to states to prevent and treat opioid abuse and enhance mental health services, and how healthcare providers face new opportunities and risks as a result.
• Major reforms in federally-regulated clinical investigations and protection of human subjects, including, among other things, informed consent, the collection of patient experience data and "real world evidence" to support drug development, compassionate use policies for investigational drugs, and IRB requirements for medical device trials.
• A streamlined FDA approval process, with provisions related to increased patient involvement in the drug approval process, biomarkers, accelerated approval for regenerative therapeutic products, expedited approval for breakthrough medical devices, and many other new developments. We will also discuss reforms regarding the provision of healthcare economic information (HCEI) to payors.
• Key reforms in Medicare Part A and Part B that will affect healthcare providers, including changes to the CMS Hospital Readmission Reduction Program and immediate changes in the methodology for calculation of Medicare payments for Part B infused drugs. We will also briefly address reforms relating to hospital outpatient departments , telemedicine, and long-term care hospitals.

We plan a future webinar that will focus on the reforms in the new law that will affect electronic medical records and compliance with HIPAA.

You do not have to be a client to attend, and there is no charge.

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Questions

If you have questions concerning this Roundtable Webinar, e-mail lifesciences-healthcare@kslaw.com.