The U.S. House of Representatives is scheduled to vote Wednesday on the 21st Century Cures Act, a $6.3 billion package of medical innovation bills that now includes $4.8 billion to the National Institutes of Health as well as $1 billion in state grants to fight opioid abuse.
House and Senate health committee leaders released a final version of the legislation over the holiday weekend, on Friday, Nov. 25th. A section-by-section summary of the bill can be found here.
As previously reported by Healthcare Informatics, there had been concerns that the legislation would not pass during the lame duck session of Congress as Democrats on the House Energy and Commerce Committee wanted the bill to include policies to address high drug prices. Additionally, finding a way to pay for new mandatory funding for medical research at NIH has been an obstacle as well.
Healthcare stakeholders have touted the health IT provisions of the bill, particularly regarding the Food and Drug Administration’s oversight of the sector, as well as encouraging interoperability of electronic health records (EHRs) and patient access to health data, and discouraging information blocking.
In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN) said, “It is time to vote on 21st Century Cures, mental health legislation, and help fund the fight against opioid abuse. The House vote on Wednesday will be an extraordinary opportunity to help almost every American family. It 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.”
“What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in Fiscal 2017,” Upton and Alexander said in the statement.
Senate Majority leader Mitch McConnell has described the Cures bill as "the most important legislation Congress will consider this year” and said that, after the House acts, the Senate will act before the end of December.
Matthew Weinstock, spokesperson for the College of Healthcare Information Management Executives (CHIME), said in a statement that while CHIME members are still reviewing the bill, he praised “improvements in language surrounding transparency, security, interoperability and usability of certified health IT.” Additionally, he stated, “We are encouraged by language that would instruct HHS [U.S. Department of Health and Human Services] to examine, and, hopefully reduce, the reporting burden on providers.”
Earlier this year, CHIME launched its $1 million National Patient ID Challenge and Weinstock also noted the language in the bill specifically requiring the Government Accountability Office (GAO) to conduct a study, within one year of the bill’s passage, on methods for securely matching patient records to the correct patient.
“We are pleased to see that the bill retained language instructing GAO to investigate and report on patient matching. We’d prefer a shorter timeframe for GAO to come back to Congress, but believe that this represents a growing recognition that we must address the serious issues of patient identification and patient matching,” he said. “While patient ID and patient matching are slightly different topics, we are very encouraged that lawmakers and policymakers are paying attention and looking for solutions.”
Here is a breakdown of the health IT-related provisions of the 21st Century Cures Act:
Innovation Projects and State Responses to Opioid Abuse
The legislation will provide $4.8 billion to NIH, including: $1.4 billion for President Obama’s Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; $1.8 billion for Vice President Biden’s "Cancer Moonshot” to speed research; and $1.6 billion for the BRAIN initiative to improve research into diseases like Alzheimer's and speed diagnosis and treatment.
The legislation also included $500 million to the Food and Drug Administration (FDA) over 10 years with the aim of moving drugs and medical devices to patients more quickly. And the bill provides $1 billion over two years for grants to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs).
EHR Requirements and Interoperability
In a section titled “Delivery,” 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 instructs HHS to develop a strategy for meeting this goal within one year of the legislation’s passage.
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.
The legislation defines interoperability as “health information technology that enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user and allows for complete access, exchange, and use of all electronically accessible health information for authorized users,” and “does not constitute information blocking.”
With regard to certification for EHR developers, under the bill, developers will be required to attest that they will use open application programming interfaces (APIs), have successfully tested the real-world use of the technology for interoperability and will not take any action that is constituted as information blocking or restricts communication.
And, the bill calls for ONC, working with the National Institute for Standards and Technology (NIST), to develop a voluntary model framework and common agreement for the secure exchange of health information. Within six months of the bill’s passage, ONC must work with public and private stakeholders to develop or support a trusted exchange framework for exchange between health information networks. And, the bill calls for ONC, within a year, to publish the trusted exchange framework and common agreement, and ONC also is instructed to publish the names of networks that use the trust framework.
Within two years of the bill’s passage, ONC must create a digital health care provider directory to facilitate exchange.
Additionally, under the legislation ONC would be allowed to create a voluntary EHR certification program for medical specialties for which no certified technology exists, such as pediatrics. And, the bill’s provisions would exclude ambulatory surgical centers from meaningful use penalties for three years or until ONC creates an EHR certification program for them.
HIT Advisory Committee – Under the 21st Century Cures bill, the separate HIT Policy and Standards Advisory Committees within ONC would be consolidated into one HIT Advisory Committee to specifically address issues related to interoperability, privacy, and security.
Information Blocking – The bill defines information blocking as “a practice that is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.” And, the bill authors provided examples, such as “practices that restrict authorized access, exchange or use of such information for treatment and other permitted purposes such as transitions between certified health information technologies,” and “implementing health information technology in nonstandard ways that are likely to increase the complexity or burden of accessing, exchanging or using electronic health information.”
The bill would establish authority for the 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.
Leveraging EHRs to improve patient care – The bill encourages the exchange of health information between registries and electronic health record systems. Additionally, the bill adds developers of health information technology to patient safety organizations to help improve the safety of HIT products for patients.
Medical Devices and Software
According to a press release about the bill, provisions in the bill will help bring drugs and devices to market more quickly and at less cost by making needed reforms to the FDA, including: expedited review for breakthrough devices, increased patient involvement in the drug approval process, a streamlined review process for combination products that are both a drug and device, and freedom from red tape for software like Fitbit or calorie counting apps. The bill clarifies that technology software such as EHRs and clinical decision support tools are exempted from FDA regulation.
