Rep. Kelly Supports 21st Century Cures Act

Nov 30, 2016 Issues: Health Care

House passes patient-centered bill to boost health care innovation

Includes Kelly legislation to improve Medicare transparency

WASHINGTON — U.S. Representative Mike Kelly (R-PA) – a member of the House Ways and Means Committee – issued the following statement today in support of the House Amendment to Senate Amendment to H.R. 34, the 21st Century Cures Act, which was passed by the House of Representatives this evening by a bipartisan vote of 392-26. The legislation, sponsored by House Energy & Commerce Chairman Fred Upton (R-WI), is a medical innovation package to improve patient treatments by promoting advancements in technology, eliminating regulations that stifle competition, providing resources to combat the growing opioid epidemic, ensuring critical support for those struggling with mental health, and supporting cutting-edge research and the next generation of scientists. The package includes H.R. 2505, the Medicare Advantage Coverage Transparency Act of 2015, which Rep. Kelly introduced on May 21, 2015, and which was passed unanimously by the House on June 17, 2015. The bill requires the Department of Health and Human Services (HHS) to provide an annual report on the program's enrollment data to Congress, and is co-sponsored by Rep. Ron Kind (D-WI) and Rep. Gus Bilirakis (R-FL).

“The Cures Act is wide in its reach and dramatic in its impact yet squarely focused on a singular goal: helping American patients beat their diseases and become healthy again. Thanks to this historic package, the future of American health care and medical innovation is brighter than ever. Our moms and dads and sons and daughters who face illnesses, along with the family members who care for them, can take heart that their fight just received brand new life-changing and, we pray, life-saving support.

“I am particularly proud that this powerful legislation includes my House-passed bill to make Medicare Advantage coverage more transparent for the benefit of our nation’s seniors. This bill will bring key Medicare enrollment details into public view and equip lawmakers with important information so that we may make better decisions on behalf of our elderly constituents. I am also very glad to see my friend Rep. Murphy’s transformational mental health reforms included in this package and applaud him for his tireless work in helping carry it past the finish line.”

NOTE: The 21st Century Cures Act achieves the following:

Catalyzes cutting-edge research and personalized drug development.

  • Authorizes innovation prize competitions to advance biomedical science for diseases that are serious and represent a significant burden. (Section 2002)
  • Establishes the Precision Medicine Initiative to help researchers develop medicines tailored to individuals, rather than one-size-fits-all treatments. (Section 2011)
  • Provides opportunities for new researchers and promotes earlier research independence. (Section 2021)
  • Supports high-risk, high-reward research that has the potential to transform the scientific field. (Section 2036) 
  • Expedites the development and review of drugs for subgroups of rare disease patients by authorizing FDA to rely on data submitted in previously approved applications involving similar gene targeting technology. (Section 3012)
  • Reauthorizes the pediatric priority review voucher program incentivizing the development of drugs for rare pediatric diseases. (Section 3013)

Modernizes clinical treats and evidence development.

  • Directs FDA to provide clarity to drug developers about incorporating novel clinical trial designs into drug development. (Section 3021)
  • Supports the utilization of real-world evidence in regulatory decision-making. (Section 3022)
  • Harmonizes various regulations protecting patients in clinical trials to avoid duplication and unnecessary delays that researchers face on a daily basis. (Section 3023)
  • Authorizes FDA to rely upon qualified data summaries to support the approval of supplemental applications. (Section 3031)
  • Establishes an alternative approval pathway for sorely needed antimicrobial drugs intended for limited patient populations. (Section 3042)

Brings the FDA into the 21st century.

  • Removes the silos at FDA by transitioning the agency towards a disease-centric approach. (Section 3073)
  • 966Codifies a structured framework at FDA for the submission, review, and qualification of biomarkers that can be used to evaluate the safety and effectiveness of a product earlier in the process. (Section 3011)
  • Fosters development and utilization of incredibly promising approaches to regenerative medicine. (Sections 3033 - 3036)
  • Reforms the flawed combination product review process to provide certainty to manufacturers developing these complex therapies and technologies. (Section 3038)
  • Provides long-overdue clarification regarding how medical product manufacturers can discuss the value of therapies and technologies with insurers and formulary committees. (Section 3037)

Improves the medical device review process and reduces unnecessary regulation.

  • Empowers FDA to apply efficient and flexible approaches to expedite the development and review of new medical technologies like the breakthrough path for drugs that Congress made law four years ago. (Section 3051)
  • Streamlines medical device and diagnostic regulations and ensures FDA uses the least burdensome approaches necessary. (Sections 3052-3059)
  • Exempts certain software and personal health apps from FDA regulation. (Section 3060)

Empowers patients to participate in research and development activities.

  • Ensures that patients can voluntarily provide hospitals and research institutions authorization to use their personal health data for future research purposes. (Section 2063)
  • Puts patients at the center of the drug development and FDA review process, requiring the FDA to routinely incorporate patient input and experiences into their regulatory decision-making. (Sections 3001-3004)

Incentivizes the development of medical countermeasures and vaccines.

  • Establishes a priority review voucher program that encourages the development of drugs and vaccines to protect Americans against agents that present a national security threat, like a bioterror attack. (Section 3086)
  • Provides current and potential vaccine manufacturers with more predictable CDC timeframes. (Section 3091-3093)

Fosters interoperable health records.

  • Expedites the interoperability of electronic health record systems to help make good on the $30 billion taxpayer investment and benefit patients, providers, and researchers. (Sections 4003-4006)

The mental health reforms included in the revised 21st Century Cures Act are based largely on H.R. 2646, the Helping Families in Mental Health Crisis Act, authored by Rep. Tim Murphy (R-PA), which passed the House in July by a vote of 422-2. This legislative effort represents the most significant reforms to the mental health system in more than a decade.

These landmark reforms will:

  • Create a new Assistant Secretary for Mental Health and Substance Use to replace the Administrator at SAMHSA and coordinate mental health programs across the federal government.
  • Establish the National Mental Health and Substance Use Policy Lab to drive evidence-based grant making within SAMHSA.
  • Direct the Secretary of HHS to undertake guidance to clarify when communication can take place under HIPAA to help ensure communication among providers, families, and patients to improve mental health treatment.
  • Improve mental health care for children with serious emotional disturbance, or adults with serious mental illness, through targeted authorizations and reauthorizations, including expansion of Assisted Outpatient Treatment.
  • Strengthen the nation’s mental health workforce.
  • Reduce government spending by $5 million according to a preliminary analysis from the Congressional Budget Office.