During a Senate Health, Education, Labor and Pensions committee hearing Tuesday, Senate leaders pressed officials with the U.S. Department of Health and Human Services (HHS) on the progress being made to implement the health IT provisions in the 21st Century Cures Act, which was signed into law December 2016.
The law, considered to be landmark healthcare legislation, 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 aimed at improving interoperability and electronic health information exchange, as well as reducing the burden on providers using electronic health records (EHRs).
Leaders from three agencies within HHS—the Office of the National Coordinator for Health IT (ONC), the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG), all of which are involved with implementing health IT provisions in the Cures Act—testified during the hearing.
Senator Lamar Alexander (R-Tenn.), chairman of the Senate HELP committee, said during the hearing, “The goal of the health IT provisions in Cures was to make it easier for patients to access their health records and for doctors and hospitals to get the information they need to treat patients. The law set clear deadlines for the administration to meet.”
However, Senator Patty Murray (D-Wash.), ranking member of the committee, expressed concerns that the legislation’s health IT provisions are not being implemented as intended by Congress. “I am concerned, for one, that [President] Trump has asked Congress to slash ONC’s operating budget, that will not help our efforts today,” Murray said, referring to President Trump’s fiscal year 2018 budget request for ONC for $38 million, down from $60 million in 2017.
Murray continued, “And Trump didn’t include anything in his budget for information blocking, requested by ONC and Office of the Inspector General which helps certify and protect health information. We need to make sure the agencies involved have access to the funding they need.”
Jon White, M.D., ONC’s deputy national coordinator for health information technology, testified, “Under the current budget proposal, we’re expecting to meet all the requirements of the Cures Act, with the exception of the EHR reporting program. As you know, there was $15 million that was authorized in the Cures Act but not appropriated,” White testified. He was referring to the provision of the Cures Act that authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking by establishing a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security.
Information Blocking Enforcement
21st Century Cures establishes authority for the HHS OIG 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.
James A. Cannatti III, HHS OIG’s senior counselor for health information technology, testified that information blocking is a practice that inappropriately impedes the flow or use of information.
“OIG historically had no authority that allowed us to investigate or take enforcement action based solely on acts of information blocking, rather, we look to leverage existing authority to hold wrong doers accountable. With the passage of Cures, Congress empowered OIG to directly address information blocking problems,” Cannatti said,
The Cures Act directs the HHS Secretary to first identify “necessary and reasonable activities” that do not constitute information blocking. “ONC has been tasked with that rule making. ONC’s final rule will provide the legal basis that OIG will use to assess conduct during investigations and enforcement activities,” Cannatti said, adding, "We are engaged in preparing, so when the rule making is complete, we’re ready to enforce.”
He continued, “In the meantime, OIG has been preparing for effective, efficient and fair enforcement. Our goal is to protect patients and the health system to stop information blocking. We aim to leverage our new authorities to change behaviors in the industry. We believe this can be accomplished with clear rules of the road and targeted enforcement against those who choose to break it.”
Cannatti also noted that the Cures Act information blocking provision covers a broad range of conduct and arrangements. “It covers from large health IT providers and developers to individual physicians, and the information blocking landscape is complex; it combines highly technical issues with a breadth of business arrangements.” He also said that stakeholder engagement is critical to gaining a deep understanding of the complex landscape. “We have held a dozen stakeholder meetings with representatives from a wide cross section of healthcare and tech communities, and the insights gained will help us as we begin enforcement.”
When pressed by Senate committee members as to the timeline on ONC rule making on information blocking, ONC’s White was evasive about providing a timeline. “My counsel told me not to report on rulemaking in progress,” he said. White also made the case that information blocking is a “complex issue,” and noted, “it’s important to distinguish inappropriate actions from appropriate actions.”
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