The U.S. House of Representatives today passed sweeping, bipartisan legislation, called the 21st Century Cures Act, comprised of a $6.3 billion package of medical innovation bills including $4.8 billion to the National Institutes of Health as well as $1 billion in state grants to fight opioid abuse. The legislation, which passed by a vote of 392-26, will now move to the Senate and could be voted on next week.
The legislation, which was included as an amendment to H.R. 34, also includes changes to the mental health system and could enact regulatory changes for drugs and medical devices.
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.
Rep. Erik Paulsen (R-MN) called the legislation “an innovation game-changer” during the debate prior to the House vote, noting that it “supports more NIH research, gives patients more input into the healthcare delivery process and important reforms to mental health.”
During the debate on the House floor, Rep. Pat Tiberi (R-Ohio) said the bill “provides regulatory relief to providers” and “gets America back in the driver’s seat with medical innovation.”
The legislation will provide $4.8 billion to NIH, including: $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. The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). The bill also includes $500 million in funding to the FDA over 10 years with the aim of moving drugs and medical devices to patients more quickly. Additionally, with 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.
As previously reported by Healthcare Informatics, House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25th. In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN) said the legislation will “advance President Obama’s personalized medicine initiative, Vice-President Biden’s cancer moonshot, Alzheimer’s research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors’ offices. It will address the needs of the one in five adult Americans who suffer mental illness.”
Regarding the health IT components of the bill, Jeffrey Smith, vice president of public policy at the American Medical Informatics Association (AMIA), said, “Essentially what this legislation does is give matching orders to both the public and the private sectors towards trying to improve the state of health IT and interoperability and usability.”
Smith continued, “One of the unknowns, heading into a new Administration and a new Congress, is the status of precision medicine, and the Cancer Moonshot, and the BRAIN initiative, in addition to the opioid and mental health legislation. I think that this legislation is incredibly important to try to assuage those who are concerned about the unknowns of the Trump administration, and the willingness of the 115th Congress, to fund what is really seen as a game of catch-up in terms of funding the NIH and research.”
The bill has many health IT-related provisions, including instructing the Secretary of HHS to work with healthcare providers, payers and vendors to reduce regulatory and administrative burdens relating to the use of electronic health records. The bill also authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking. The legislation would establish a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security to help providers better choose EHR products.
What is missing from the updated 21st Century Cures Act is the three-star grading system established in Sen. Bill Cassidy’s Trust IT Act (S. 2141). Earlier this week, before the House vote, Smith said, “The star rating system that was part of the Senate language, it was more of a report card approach to improving the performance of health IT and what this new language will do is essentially use a mechanism of transparency. Rather than grading each of the electronic health records (EHRs) on how they perform vis-à-vis usability, security and interoperability, this language just basically says they have to report on how they perform and then these would need to be made publicly available,” Smith says.
Smith added, “There are still some very consistent structural pieces in the legislation and how they define interoperability is more consistent with what the House is thinking. However, I think it remains to be seen exactly what impact the definition will have in a practical way.”
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