On Dec. 13, President Obama signed into law the 21st Century Cures Act; the signing follows votes overwhelmingly in favor of the bipartisan, bicameral legislation in the House (392 – 26) and the Senate (95 – 4). The ACC was closely engaged with committees in both House and Senate as they worked to create this legislation.

21st Century Cures includes a number of ACC’s advocacy priorities. The following provisions are of special interest to the profession of cardiology:

• Provides $4.8 billion (subject to appropriations) over ten years in funding to the National Institutes of Health (NIH) for the Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research and regenerative medicine using adult stem cells. Increased funding for NIH has been a legislative conference talking point and a key item on ACC’s advocacy agenda for the 114th Congress.
• Provides $500 million over ten years to the U. S. Food and Drug Administration (FDA) to move drugs and medical devices to patients more quickly, while maintaining the same standard for safety and effectiveness.
• Facilitates faster marketing of drugs and medical devices at lower cost by making needed reforms to the FDA, including:

FDA/NIH Reforms

• Creates a “Next Generation of Researchers Initiative” in the Office of the Director at the NIH to coordinate, develop, modify and prioritize policies and programs to improve opportunities for new researchers. Increases the maximum yearly loan repayment amount from $35,000 to $50,000.
  • Establishes a “Research Policy Board” charged with making recommendations on how to modify and harmonize regulations related to federal research requirements and policies to minimize administrative burdens.
  • Strikes the requirement that a sponsor of a medical device trial always use a local institutional review board allowing the use of centralized methods.
• Establishes a program to evaluate the potential use of “real world evidence” (including data from clinical data registries) to help support the approval of new drugs (not devices) and satisfy post-approval study requirements.
• Establishes expedited review for breakthrough devices; increases patient involvement in drug approval process.
• Encourages the National Institute of Minority Health and Health Disparities at NIH to include ways to increase representation of underrepresented populations in clinical trials in its strategic plan.

Health IT Reforms

• Establishes much needed definitions of “interoperability” and “information blocking”.
• Provides authority for the Health and Human Services (HHS) Office of the Inspector General to investigate claims of information blocking and assign penalties for practices found to be interfering with the lawful sharing of electronic health records (EHRs).
• Requires HHS to defer to health information technology standards developed in the private sector.
• Encourages the exchange of health information between registries and EHR systems by establishing a definition of “clinician-led clinical data registry”.
• Requires the Government Accountability Office to conduct a study on methods for securely matching patient records to the correct patient.

Medicare Part A Reforms

• Requires an adjustment for socioeconomic status under the Hospital Readmission Program, including the clarification that the proxy should only apply to a hospital’s Medicare population.

Medicare Part B Reforms (Site-Neutrality)

• Provides an exception to section 603 of the Bipartisan Budget Act of 2015 (BBA ’15) for those hospital outpatient departments that were defined as “mid-build” prior to Nov. 2, 2015.
• Provides that Prospective Payment System (PPS)-exempt cancer hospitals are not included in the payment changes under section 603 of the BBA ’15, ensuring that these facilities’ payments continue under their existing separate system, as opposed to the inpatient and outpatient PPS system.

Miscellaneous

• Increases transparency around the Local Coverage Determination process and brings greater accountability to those contracting with Centers for Medicare and Medicaid Services to manage the Medicare program.

The budgetary offsets used to pay for this bill include $3.5 billion from the Affordable Care Act’s Prevention and Public Health Fund and a drawdown of the Strategic Petroleum Reserve. 

Keywords: Cancer Care Facilities, Centers for Medicare and Medicaid Services, U.S., Drug Approval, Electronic Health Records, Ethics Committees, Research, Medicaid, Minority Health, National Institutes of Health (U.S.), Patient Participation, Patient Protection and Affordable Care Act, Patient Readmission, Pharmaceutical Preparations, Prospective Payment System, Public Health, Regenerative Medicine, Registries, United States Food and Drug Administration, Cardiology Magazine, ACC Publications