U.S. Senate Joins House to Pass 21st Century Cures Act

Dec. 7, 2016
The U.S. Senate today, in a 94-5 vote, passed the 21st Century Cures Act, sweeping, bipartisan legislation that largely focuses on medical research, but also includes a number of health IT provisions. The bill now moves to President Obama's desk.

The U.S. Senate today, in a 94-5 vote, passed the 21st Century Cures Act, sweeping, bipartisan legislation that largely focuses on medical research and changing the approval process for new drugs and medical devices but also includes a number of health IT provisions. Last week, the legislation passed in the U.S. House of Representatives by a vote of 392-26.

The legislation, which was two years in the making, was passed by both chambers of Congress during a lame duck session and will now head to President Barack Obama’s desk to be signed into law.

On Monday during consideration of the bill on the Senate floor, Senator Susan Collins (R-Maine) said that the legislation is the product of years of bipartisan work on the Senate health committee and has earned the support of more than 300 organizations. “It very well may be the most important, far reaching legislation that we pass this year for its benefits to families across the nation,” she said.

Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s (FDA) oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.  

As previously reported by Healthcare Informatics, the bill would establish authority for the U.S. Department of 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 EHRs. Organizations that are found to have committed information blocking face civil monetary penalties up to $1 million.

The College of Healthcare Information Management Executives (CHIME) published a crosswalk of the health IT provisions from last week’s House-passed bill, the 21st Century Cures legislation that first passed the House in July 2015, juxtaposed to those approved by the Senate Committee on Health, Education, Labor and Pensions (HELP), which can be found here.

The $6.3 billion package of medical innovation bills contained in the 21st Century Cures Act includes $4.8 billion to the National Institutes of Health (NIH) as well as $1 billion in state grants to fight opioid abuse. Within the $4.8 billion to NIH, funding includes $1.4 billion for President Obama’s Precision Medicine Initiative; $1.8 billion for Vice President Biden’s Cancer Moonshot; and $1.6 billion for the BRAIN initiative.

On Monday, Senate Majority Leader Mitch McConnell (R-Ky.) announced during his speech on the Senate floor that NIH’s cancer initiatives in the legislation would be renamed “Beau Biden Cancer Moonshot and NIH Innovation Projects,” in honor of Vice President Joe Biden’s son, Beau, who died of brain cancer in 2015.

The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). Additionally, the bill  includes $500 million in funding to the FDA over 10 years with the aim of moving drugs and medical devices to patients more quickly. Withh regard to mental health, the bill aims to strengthen the enforcement of the mental health parity law, which requires insurers to cover mental illness as they would treatment for other diseases.

Senator Elizabeth Warren (D-Mass.), who has been an outspoken critic of the bill, was one of three Democrats who voted against it, as well as independent Vermont Senator Bernie Sanders and Republican Mike Lee (Utah). Critics say the bill lowers standards for drug and medical device approvals. In remarks last week, Sen. Warren said the bill had been “hijacked by the pharmaceutical industry.” While Warren said that she is a strong proponent of “significant, meaningful funding for NIH,” she said the current legislation doesn’t fulfill that promise.

“I support most of these proposals, I worked on them and if this bill becomes law, there is no question that it will contain some real legislative accomplishments, but I cannot vote for this bill because I know the difference between compromise and extortion,” Warren said.

A number of health IT industry organizations have expressed strong support for the legislation, specifically the focus on EHR interoperability and efforts to improve patient records matching.

Samantha Burch, senior director of congressional affairs at the Chicago-based Healthcare Information and Management Systems Society (HIMSS), says, broadly, the legislation clearly recognizes the role of health IT as foundational to healthcare delivery and medical research, noting that health IT appears in 30 different sections of the bill. Burch says key provisions in the bill include efforts to reduce reporting burdens on healthcare providers and recognizing the critical role of private sector initiatives in advancing interoperability

In addition, Burch says the legislation is a step forward in addressing and studying solutions to increase the accuracy of patient data matching. The legislation directs the Government Accountability Office (GAO) to review methods used for secure patient matching, including methods used in the private sector, and report its findings to Congress.

“The GAO study on patient matching was improved during the negotiations between the House and Senate and it was made stronger. We’re hoping that this will be a launching pad to really achieving an understanding and recognition to clarify HHS being a partner to work with the private sector in this area,” she says.

Since 1999, the federal government has been prohibited from spending public funds on the development of a national patient identifier. As such, Burch says, “HHS is not engaging in the patient matching issue in any meaningful way. They need to be at the table. We’re moving towards some House Labor report language, which also addresses this issue, and I think we’re moving toward an understanding in Congress of the impact of the ban and the need to clarify and study this issue and move forward,” she says, referencing a House Appropriations Committee subcommittee on Labor, Health and Human Services, and Education bill that clarifies that the restrictions on HHS “does not prohibit HHS from examining the issues around patient matching.”

In a statement, Blair Childs, Premier senior vice president of public affairs, said today’s passage of the 21st Century Cures Act “represents a big leap forward in health innovation.”

“In particular, we believe the law’s interoperability roadmap will advance free and secure health IT exchange that will improve patient care, reduce costs and prevent data silos in healthcare—progress that should take us forward in efforts to deliver next-generation healthcare. We are also pleased to see important changes to the Medicare hospital readmissions program, which will finally recognize and adjust the performance measures for socio-economic status and other factors that can affect patient outcomes. In addition, members of Premier support provisions that will modernize the FDA approval process to advance the entry of new drugs and devices to the market, thereby creating a more competitive market,” Childs said in the statement. 

In a statement issued last week when the House passed the bill, Russell Branzell, president and CEO of the College of Healthcare Information Management Executives (CHIME), applauded the health IT provisions in the 21st Century Cures Act. Branzell said the “landmark legislation” would “significantly improve the ability of hospitals and other providers to exchange accurate patient data and advance personalized care.”

“CHIME is especially encouraged that in a number of sections the bill addresses the critical issues of accurately identifying patients and matching them to their health records. The absence of national solutions for patient identification and patient matching not only pose serious risks to patient safety, but also lead resources being wasted on cleaning up duplicative medical records, as well as creating other inefficiencies. We believe that accurate patient identification is central to improving patient matching,” Branzell said.

CHIME has provided an outline of the timelines for the various directives that the legislation provides HHS, the Office of the National Coordinator for Health Information Technology (ONC) and the GAO.