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Saturday, December 28, 2024

Senator Cassidy seeks clarity from Biden administration on health info-blocking regulation delays

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Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot

Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot

WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, has called on the Biden administration to clarify delays in implementing and enforcing regulations designed to prevent health information blocking. Information blocking refers to practices that hinder the access, exchange, or use of electronic health information.

“It is imperative that the Administration fully implement the statutory prohibition on information blocking that Congress established in 2016. Without data, we cannot have an informed patient population, find cures, or drive down costs – the goals of the law we passed nearly a decade ago,” wrote Dr. Cassidy. “This process has taken years to implement and it is still not clear whether OIG and ONC’s actions have actually reduced cases of information blocking.”

The 21st Century Cures Act, passed in 2016, directed the Office of the National Coordinator for Health Information Technology (ONC) to publish rules prohibiting health data information blocking. The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) was also tasked with creating an enforcement framework for this prohibition.

OIG did not issue a proposed rule outlining information blocking enforcement until 2021 and finalized this rule only in July 2023. Additionally, a proposed rule to prohibit information blocking by providers was published earlier this year. Despite these delays, ONC has received 1,052 claims of information blocking since 2021; 982 were found to be potentially valid claims. It remains unclear how ONC resolved these claims without proper regulations in place.

Dr. Cassidy's letter addressed both Inspector General Grimm and Dr. Tripathi:

“Congress directed the Office of the National Coordinator for Health Information Technology (ONC) in the 21st Century Cures Act to publish rules to prohibit health data information blocking... Eight years later, we still receive reports of information blocking.”

The letter continues:

“OIG did not issue a proposed rule outlining information blocking enforcement until 2021 and did not finalize this proposed rule until July 2023... Despite this multi-year delay, ONC has received 1,052 claims of information blocking; 982 were found to be potentially valid claims.”

Dr. Cassidy emphasized that full implementation is crucial for achieving an informed patient population and reducing healthcare costs.

“This process has taken years to implement and it is still not clear whether OIG and ONC’s actions have actually reduced cases of information blocking,” he stated.

Dr. Cassidy requested detailed responses by July 24, 2024:

- How do ONC and OIG conduct audits and monitor compliance with the prohibition?

- Examples of enforcement actions taken by OIG.

- Criteria used by OIG to prioritize investigations.

- Collaboration between OIG and ONC regarding allegations prior to September 1, 2023.

- Clarification on penalty assessments by OIG.

- Consideration of ONC’s FAQs when evaluating allegations.

- Educational resources planned by ONC and OIG for entities subject to the prohibition.

- Metrics used to evaluate regulation effectiveness.

For more updates from HELP Republicans, visit their website or Twitter at @GOPHELP.

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