President Obama, in perhaps his last major legislative action, signed into law last week the 21st Century Cures Act. "Cures," as the 996 page legislation is known, affects all major components of healthcare including:

  • Healthcare providers such as acute care hospitals, physicians, long term care hospitals, ambulatory surgery centers, cancer centers and DME suppliers;
  • Medical device developers;
  • Pharmaceutical companies;
  • Electronic medical record vendors;
  • Health information exchanges; and
  • State public health agencies.

The Troutman Sanders Healthcare Practice has been following Cures for nearly a year as it worked its way through Congress. Government relations specialists from Troutman Sanders Strategies represented clients on the Hill to help educate key House and Senate staff on various aspects of the legislation. The law represents a legitimate bipartisan effort to leverage technology to improve access to, and the quality of, healthcare.

Some of the highlights of Cures include:

  • Promote Innovation:

    • Creates the National Institute of Health Innovation Account with $4.79 billion to support precision medicine, brain research, cancer research and clinical research for regenerative medicine
    • Creates a $1 billion fund within the U.S. Department of Health and Human Services (HHS) to support state programs to address the opioid abuse crisis
  • Streamline Regulatory Approval Processes:

    • Encourages expedited development of "breakthrough" technologies by modifying FDA approvals
    • Clarifies the definition of medical device to exclude certain types of medical software
    • Authorizes expedited development of medical countermeasures for biological or chemical agents that present a national security threat
    • Promotes inter-agency collaboration to identify and remove regulatory obstacles to innovation in healthcare
  • Increase Use of Electronic Medical Records and Tele-Health:

    • Reduces the regulatory and administrative burdens, such as documentation, associated with the use of electronic medical records
    • Approves the use of scribes by physicians
    • Requires EMR vendors to attest that they have not and will not engage in information blocking
    • Directs CMS to evaluate the value of tele-health services for Medicare-Medicaid "dual eligible's" and beneficiaries with chronic diseases
  • Health Information Exchange:

    • Directs the Office of the National Coordinator (ONC) to develop or support a "trusted exchange network" for health information exchange networks
    • Authorizes the HHS OIG to investigate data blocking complaints and impose sanctions including decertification of EHRs and fines up to $1 million per violation
  • Privacy of Health Information:

    • Directs HHS to develop training programs to help correct misunderstandings about HIPAA
    • Creates new privacy protocols for federally funded clinical research
    • Directs HHS to clarify when behavioral health and substance abuse records are accessed and shared
  • Access to Care:

    • Extends the Rural Community Hospital Demonstration Program for an additional 5 years
    • Adopts specific Medicare payment changes for Long Term Care Hospitals
    • Adopts sweeping programs and measures to enhance the availability of behavioral health and substance abuse services

It is difficult to overstate the breadth of Cures and its effect on the healthcare sector. Some of these impacts are immediately apparent, while others will take time to fully develop. Troutman Sanders is committed to keeping our clients informed about how Cures will affect them. Over the next several months, we will publish a series of e-alerts to talk about what Cures really means and how the healthcare sector is responding to this landmark legislation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.