BREAKING NEWS: 21st Century Cures Act Passes U.S. House of Representatives, Moves to Senate

July 10, 2015
On Friday, the U.S. House of Representatives passed the 21st Century Cures Act, a bill primarily focused on pharmaceutical innovation, but which would also promote interoperability in health IT

On Friday afternoon, July 10, the U.S. House of Representatives passed the 21st Century Cures Act, H.R. 6, by a vote of 344-77, sending it to the U.S. Senate. The main focus of the legislation is an attempt to remove regulatory roadblocks in the review process for new pharmaceuticals and medical devices on the part of the Food and Drug Administration (FDA). In addition, according to Congress.gov, the federal government’s official legislation tracking service, “Requirements are established [in the bill] for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.”

After the House’s passage of the bill, the Ann Arbor, Mich.-based College of Healthcare Information Management Executives (CHIME) released a statement attributed to Leslie Krigstein, interim vice president of public policy, praising the bill’s focus on interoperability.  “The 21st Century Cures Act is a landmark piece of legislation that will move our nation closer to a 21st Century healthcare system,” Krigstein said in the statement. “As recognized in this bill, health information technology will serve as the foundation to foster many of the ideologies in delivering lifesaving cures to patients more rapidly.”

Krigstein’s statement went on to say that “The Committee's choice to tackle the complex issue of interoperability is to be commended. Without nationwide interoperability, we will be unable to derive the value promised by the nation's $30 billion investment in electronic health records (EHRs). Expediting cures to patients will not be possible without a health information highway that allows providers and patients the data they need, when and where they need it.”

Krigstein added that “CHIME appreciates the Committee's recognition that harmonizing standards adoption will exponentially move interoperability forward. We agree that clear, enforceable standards are necessary to foster nationwide interoperability. The inclusion of increased testing requirements for certified products, including 'real world' testing, is a priority for CHIME members as a means to bring value to the certification program. We appreciate the Committee's inclusion of the need to ensure the information in one's EHR belongs to the patient. We hope that this language will begin a sincere dialogue on the need to address the ongoing patient safety and care coordination challenges arbitrarily imposed by the lack of a national approach to patient identification. Without a patient identity matching strategy, patient data matching errors and mismatches will become exponentially more problematic and dangerous.”

The CHIME statement concluded by stating that “We view this legislation as a starting point in the conversation on health IT reform. We hope to build on the language in 21st Century Cures Act to ensure the Meaningful Use Program, among other ongoing federal policy initiatives, enable the implementation and use of EHR systems to meaningfully improve patient care.”

Additional praise for the House of Representatives’ passage of the bill came from the Charlotte-based Premier healthcare alliance. Attributed to Blair Childs, Premier’s senior vice president of public affairs, it said, “Members of the Premier healthcare alliance commend House leadership for the passage of new health information technology (HIT) interoperability requirements within the 21st Century Cures legislation that passed overwhelmingly today. Requiring free and secure exchange of health information among disparate IT assets will improve patient care, reduce costs, and unlock “big data” in healthcare.  This is also an essential ingredient in enabling providers to improve the health of a defined population health across the care continuum.” That statement concluded by stating that “We are encouraged by the Senate’s equal focus on achieving interoperability among EHR systems.”

How did the legislation pass the House, and what are its chances in the Senate? Alex Lash, writing Friday in xconomy.com, wrote this: Passage in the House was due in no small part to the bill’s original sponsors, Reps. Diana DeGette (D-CO) (pictured) and Fred Upton (R-MI), whose work—appearances, town halls, info-gathering sessions—for more than a year leading up to the vote at times resembled a permanent campaign. But the Cures Act still must get through the Senate, where single opponents can often hold popular legislation hostage,” Lash noted. “And, despite the strong support in the House, critics are asking if the rush to approve new drugs might tilt away from traditional safeguards too much. Fiscal hawks will no doubt pick through the costs associated with the bill, as reported last month by the Congressional Budget Office.”

Healthcare Informatics will continue to update readers on this evolving story.

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