21st Century Cures Act brings provisions for EHRs, interoperability, precision medicine and more
The U.S. House of Representatives passed the long-awaited 21st Century Cures Act on Wednesday by a vote of 392 to 26. It will now head to the Senate for further debate, before it makes it to the President's desk.
The bill, the largest healthcare-focused legislation since the Patient Protection and Affordable Care Act, contains $6.3 billion in provisions that will fund federal agencies as they work to speed the arrival of diagnostic tools and disease therapies, improve mental health treatment and bolster the fight against the ongoing opioid crisis.
Notably, it would provide the National Institutes of Health with $4.8 billion to help advance President Barack Obama's Precision Medicine Initiative (aimed at driving technology-enabled personalized medicine), the "Cancer Moonshot" spearheaded by Vice President Joe Biden and Obama's BRAIN initiative, which is meant to improve understanding of diseases such as Alzheimer's and dementia.
Specific to health IT, the Cures bill has provisions concerning the use and regulation of EHRs.
"The development of new drugs and devices is meaningless unless they are delivered to the right patients at the right time," according to a House statement. "Cures will help improve delivery by: ensuring electronic health record systems are interoperable for seamless patient care and help fully realize the benefits of a learning health care system.
The bill aims to create a reporting system to tap into stakeholder opinions about EHR usability, interoperability and security; drive better interoperability by, among other things, setting up a provider directory to facilitate data exchange and favoring exchange standards developed in the private sector.
Cures would take aim at several policy changes, such as combining ONC's Health IT Policy and Standards Advisory Committees, giving authority for HHS's Office of the Inspector General to investigate and penalize information blocking and requiring HHS to educate providers about data sharing misunderstandings that could be hindering better interoperability.
"Setting interoperability standards, and requiring free and secure health IT exchange among disparate assets will improve patient care, reduce costs and unlock data silos in healthcare," said Blair Childs, senior vice president of public affairs at Premier, in a statement.
The White House, meanwhile, lauded the bill for taking steps to "improve mental health, including provisions that build on the work of the President's Mental Health and Substance Use Disorder Parity Task Force. "Like all comprehensive legislation, the bill is not perfect. But the legislation offers advances in health that far outweigh these concerns."
The bill would disburse $1 billion to states to fight opioid abuse, and give an additional $500 million to the FDA to do the same on a national level.
But despite the wide margin of approval, some of the bill's provisions – especially the deregulation of the FDA's approval process, have drawn criticism.
Some opponents, such as the nonprofit Public Citizen, called the act a "threat to FDA standards." The provision has been also opposed by Democrats such as Elizabeth Warren, D-Massachusetts and Bernie Sanders, I-Vermont.
"For more than two years, Congress has been working on legislation to help advance medical innovation in the United States," Warren said November 28. But "this final deal has only a tiny fig leaf of funding for NIH and for the opioid crisis. And most of that fig leaf isn't even real. … Most of the money won't really be there unless future Congresses pass future bills in future years to spend those dollars."
Sanders opposed the lack of provisions to combat rising drug prices and the inclusion of "corporate giveaways that will make drug companies even richer," he said in a statement. He also opposed the $1 billion cuts to Medicare and Medicaid funding.
Despite those objections, however, the large margin of the bipartisan House vote suggests the bill will pass the Senate.
For its supporters, the bill provides needed relief for medical research, product development and support to the mental health system.
"It can take more than ten years and $2 billion for new drugs and other therapies to get to market," said Janet Marchibroda, director of health innovation at the Bipartisan Policy Center, in a statement. "This new legislation will help accelerate the discovery, development, and delivery of life-saving, safe, and effective cures for patients."
House Chief Deputy Whip Patrick McHenry, R-North Carolina, said in a statement that the bill is a bipartisan effort "aimed at improving the lives of Americans" afflicted by disease, and said the House vote "provides hope more cures are within reach."
"The real winners today are American families whose lives stand to be improved by the Cures legislation," said Senate Health Committee Chairman Lamar Alexander, R-Tennessee, co-sponsor of the bill. "This bipartisan legislation … will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors' offices and patients' medicine cabinets around the country."