Washington, DC – Today, Congresswoman Elise Stefanik (R-NY-21) helped the House pass the Senate Amendment to the 21st Century Cures Act. This critical, bipartisan legislation is designed to help accelerate the discovery, development, and delivery of promising new treatments and cures for patients with diseases ranging from Alzheimer’s to Lyme while maintaining our nation’s standing as the biomedical innovation capital of the world.

“Whether it is a child caring for an elderly parent who is suffering, a spouse receiving disheartening news about the health of their loved one, or a parent tearfully listening to devastating news about their child's diagnosis, every single family in our district has faced health challenges,” said Congresswoman Stefanik. “This problem stems from the staggering reality that while there are over 10,000 known diseases, we only have cures and treatments for about 500 of them. This leaves those afflicted by diseases ranging from Alzheimer’s to Parkinson’s to cancer hoping for medical breakthroughs and cures that will improve their standards of living.

“This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics,” added Stefanik. “I am also pleased that this legislation includes a measure that Congressman Chris Gibson and I worked on called the Tick-Borne Disease Research Accountability and Transparency Act, in addition to a needed update to our nation’s mental health laws and treatment capabilities.”

 “Clarkson University applauds Congresswoman Stefanik’s advocacy of the 21st Century Cures Bill which brings acute attention to the critical need for biotechnology research and innovation to support cures, treatments and vaccinations for some of the most pressing health issues of our time,” said Anthony G. Collins, President of Clarkson University.  “Clarkson and its research partners, including the Trudeau Institute in Saranac Lake, NY, are working diligently to safely accelerate the time between research discovery and getting cures into the marketplace to help the people who need these solutions."

Summary: The legislation includes an updated 21st Century Cures Act, Helping Families in Mental Health Crisis Reform Act, Increasing Choice, Access, and Quality in Health Care for Americans, and Family First Prevention Services Act of 2016. The bill provides $4.8 billion in discretionary funding for NIH, $1 billion for grants to states to fight Opioid abuse, and $500 million to FDA to speed up bringing drugs and devices to market. The legislation is fully offset on a year-by-year bases which include rescissions from the ACA public health and prevention fund, unused funds from territories for ACA exchanges, reductions in overpayments in Medicare/Medicaid, and sales from the strategic petroleum reserve. Specifically, the legislation includes:

21st Century Cures:

21st Century Cures is designed to help accelerate the discovery, development, and delivery of promising new treatments and cures for patients and maintain our nation’s standing as the biomedical innovation capital of the world. There are 10,000 known diseases, but we only have cures and treatments for 500 of them. The bill would help patients suffering from those diseases by:

  • Streamlining and improving the FDA’s review of life-saving drugs for patients
  • Modernizing clinical trials and removing regulatory uncertainty for the development of new medical apps
  • Supporting and investing in the next generation of Scientists

The bill provides $4.8 billion over 10 years to the National Institutes of Health (NIH) for:

·         The Precision Medicine Initiative

·         The Brain Research Through Advancing Innovative Neurotechnologies Initiative

·         Cancer research

·         Regenerative medicine using adult stem cells

Additionally, the bill provides:

  • $500 million to the Food and Drug Administration (FDA) over 10 years to move drugs and medical devices to patients more quickly
  • $1 billion over 2 years for grants to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs and implementing prevention

Discretionary Funding & Offsets: The funding in this legislation is discretionary and, thus subject to annual appropriation. In addition, the dedicated funding in the bill is fully offset on a year-by-year basis, rather than spending now and saving later.

Helping Families in Mental Health Crisis Reform Act:

The legislation, a similar form of which passed the House in July 2016, helps individuals and their families in mental health crisis, as well as addressing the needs of those Americans with a substance use disorder. The bill:

  • Establishes an Assistant Secretary for Mental Health and Substance Use (Assistant Secretary) to head the Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Creates a coordinating committee to evaluate federal programs related to Serious Mental Illness (SMI) and provide recommendations to better coordinate mental health services for people with SMI. The committee terminates after six years.
  • Gives states additional flexibility to use Community Mental Health Services (CMHS) block grant funding to provide community mental health services for adults with SMI and children with Serious Emotional Disturbances (SED)
  • Reauthorizes and makes technical updates to develop and implement programs to divert individuals with a mental illness from the criminal justice system to community-based services
  • Reauthorizes and makes updates to grants for states to provide services to homeless individuals who are potentially suffering from serious mental illness
  • Reauthorizes grants to institutions of higher education or accredited professional training programs to support the recruitment and education of mental health care providers
  • Provides a Sense of Congress that clarification is needed regarding existing permitted uses and disclosures of health information under the Health Information Portability and Accountability Act (HIPAA) by health care professionals to communicate with caregivers of adults with SMI to facilitate treatment
  • Directs the Secretary to clarify circumstances when a health care provider or covered entity may use or disclose protected health information related to the treatment of an adult with a mental or substance use disorder