HHS information blocking final rule amends monetary penalties, increases maximums

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The Department of Health and Human Services has issued a final rule that amends civil money penalties for information blocking related to HHS grants, contracts and other agreements.

Maximum penalties for certain violations are increased under the final rule.

The Office of the Inspector General enforcement will focus on information blocking allegations that pose risk to patients, providers and healthcare programs.

However, HHS said that in response to commentators' inquiries, the OIG does not intend to use its authority to investigate information blocking for potential noncompliance with CMS requirements, including those under the Promoting Interoperability Program for eligible hospitals and critical access hospitals and the Merit-Based Incentive Program (MIPS) promoting interoperability performance category for clinicians. These are distinct from the information blocking provisions of the Public Health Service Act, HHS said.

If investigations into alleged information blocking suggest a healthcare provider may be out of compliance with CMS programmatic requirements, OIG may refer such matters to CMS, HHS said. 

WHY THIS MATTERS: PENALTIES

For contracted vendors and others, the financial penalties encompass not more than $10,000 for each specified claim; not more than $50,000 for each false statement, omission or misrepresentation of a material fact; $50,000 for each false record or statement; and not more than $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay. 

The OIG may impose a penalty of not more than $1,000,000 per violation that constitutes information blocking, HHS said. In considering the factors, the OIG will take into account the nature and extent of the information blocking, the number of patients affected and the number of providers affected, the number of days the information blocking persisted and the resulting harm.

THE LARGER TREND

This final rule implements the 21st Century Cures Act, authorizing the Office of the Inspector General to investigate claims of information blocking and giving the HHS secretary authority to impose civil monetary penalties. 

On May 1, 2020, the Office of the National Coordinator published the ONC final rule, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. The ONC final rule put forward the information blocking regulations defining information blocking and establishing exceptions to that definition.

The Cures Act established new authorities related both to information blocking and to fraud and other prohibited conduct involving HHS grants, contracts, and other agreements.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org