House Passes 21st Century Cures Act with Funding Allocation for NIH, FDA

On Dec. 2, the U.S. House of Representatives passed what is being called the biggest health reform bill since the Affordable Care Act. The 21st Century Cures Act passed the House by a vote of 392-26. The bill most notably invests $4.796 in the National Institutes of Health (NIH) over 10 years and $500 million to the Food and Drug Administration (FDA), although that funding would need to be released by congressional appropriators to be spent.
Outgoing House Energy and Commerce Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) have championed for nearly three years the cause of getting medical cures to patients faster, which has culminated in this legislation that President Obama has said he will sign into law if it passes the Senate. 

The cost of the bill is offset primarily by eliminating all future funding increases for the Prevention and Public Health Fund — a savings of $3.5 billion. An estimated $1 billion would come from a drawdown of the Strategic Petroleum Reserve. 

In addition to facilitating research and revising the FDA approval process, the bill makes some changes to Medicare, including creating an exception to the “site neutral” provision of the Bipartisan Budget Act  for hospital outpatient departments (HOPDs) that were “mid-build” prior to Nov. 2, 2015. “Mid-build” is defined as a provider that had a binding written agreement with an outside, unrelated party for the construction of the HOPD.

The legislation would also create more transparency around Medicare local coverage determinations (LCDs) by requiring each Medicare administrative contractor that develops a local coverage determination to make available at least 45 days before the effective date of such determination a summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence. 

Also included are a number of electronic health record (EHR)-related provisions, including a provision advocated by ASNC that encourages the exchange of health information between registries, including “clinician-led” registries, and EHR systems.  The legislation adopts a definition of a “clinician-led clinical data registry” supported by ASNC.

The bill had included a provision that would have made revisions to the current physician-industry transparency requirements, or “Sunshine Act,” to protect continuing medical education. Prior to the House vote, Sen. Chuck Grassley (,-R-IA), threatened to put a hold on the bill once it came over to the Senate unless the provisions were removed. Sen. Grassley led the fight in Congress for more transparency of relationships between physicians and industry.