Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Nov. 16 introduced the bipartisan 21st Century Cures 2.0 package, which builds on progress since the 2016 21st Century Cures Act was signed into law. The 173-page bill is “designed to revolutionize how the U.S. provides care to patients” and includes “several provisions aimed at speeding up the delivery of groundbreaking, new – and potentially lifesaving – cures, treatments and innovations to those who need them most.”

The legislation includes many provisions of interest to ACC members, including:

• Telehealth
  • Expands telehealth flexibilities and improves telehealth access for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries
• Creates generally accepted standard for electronic prescribing
  • Tasks the U.S. Department of Health and Human Services (HHS) with establishing a standardized process for electronic prescribing and electronic prior authorization for Part D drugs
• Innovation
  • Mandates HHS report to Congress on alignment across the U.S. Food and Drug Administration regarding digital health technology regulation
  • Requires the Government Accountability Office to study efforts to enhance Medicare coverage and reimbursement for innovative health technologies
  • Creates new Advanced Research Projects Agency for Health to transform and improve health
  • Provides $25 billion in federal research money to independent facilities and universities
• Includes the Meaningful Access to Federal Health Plan Claims Data Act, which ACC staff, along with the Society of Thoracic Surgeons, worked to introduce. 
  • Provides clinician-led clinical data registries with access to Medicare claims data for purposes of research to improve quality and cost efficiency
• COVID-19 pandemic funding
  • Explores effects of long COVID-19
  • Development of testing and response strategy for future pandemics
  • Vaccine and immunization education and capacity enhancements
• Efforts to increase diversity in clinical trials
• Includes the Precision Medicine Answers for Kids Today Act
  • Increases access to diagnostic testing by providing federal support for the use of genetic and genomic testing for pediatric patients with rare diseases

ACC Advocacy staff is reviewing the legislation and will post additional updates on ACC.org.

Read more in a joint press release from DeGette and Upton or review a section-by-section summary of the bill.

Clinical Topics: Cardiovascular Care Team, COVID-19 Hub, Prevention

Keywords: ACC Advocacy, Immunization, Genetic Testing, Registries, Vaccines, Telemedicine, Biomedical Technology, Medicare, United States Food and Drug Administration, Pandemics, Electronic Prescribing, Prior Authorization, Children's Health Insurance Program, Medicaid, COVID-19

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