June 25, 2024 - The U.S. Department of Health and Human Services (HHS) on Monday released a final rule that establishes disincentives for health care providers that have committed information blocking. This final rule exercises the Secretary’s authority under the 21st Century Cures Act (Cures Act) to establish “disincentives” for health care providers who engage in practices that the health care providers knew were unreasonable and were likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information (EHI), except as required by law or covered by a regulatory exception.

“This final rule is designed to ensure we always have access to our own health information and that our care teams have the benefit of this information to guide their decisions. With this action, HHS is taking a critical step toward a health care system where people and their health providers have access to their electronic health information,” said HHS Secretary Xavier Becerra. “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the health care system to better serve patients. But we must always take the necessary actions to ensure patient privacy and preferences are protected – and that’s exactly what this rule does.”

HHS has established the following disincentives for health care providers found by the HHS Office of Inspector General (OIG) to have committed information blocking and referred by OIG to the Centers for Medicare & Medicaid Services (CMS):

• Under the Medicare Promoting Interoperability Program, an eligible hospital or critical access hospital (CAH) that has committed information blocking and is referred to CMS by OIG will not be a meaningful electronic health record (EHR) user during the calendar year of the EHR reporting period in which OIG refers its determination to CMS.  If the eligible hospital is not a meaningful EHR user, the eligible hospital will not be able to earn three quarters of the annual market basket increase they would have been able to earn for successful program participation; for CAHs, payment will be reduced to 100 percent of reasonable costs instead of 101 percent. This disincentive will be effective 30 days after publication of the final rule.
• Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), a MIPS eligible clinician (including a group practice) who has committed information blocking will not be a meaningful EHR user during the calendar year of the performance period in which OIG refers its determination to CMS. If the MIPS eligible clinician is not a meaningful EHR user, then they will receive a zero score in the MIPS Promoting Interoperability performance category. The MIPS Promoting Interoperability performance category score is typically a quarter of an individual MIPS eligible clinician’s or group’s total final score in a performance period/MIPS payment year, unless an exception applies and the MIPS eligible clinician is not required to report measures for the performance category. CMS has modified its policy for this disincentive to clarify that if an individual eligible clinician is found to have committed information blocking and is referred to CMS, the disincentive under the MIPS Promoting Interoperability performance category will only apply to the individual, even if they report as part of a group. This disincentive will be effective 30 days after publication of the final rule.
• Under the Medicare Shared Savings Program, a health care provider that is an Accountable Care Organization (ACO), ACO participant, or ACO provider or supplier who has committed information blocking may be ineligible to participate in the program for a period of at least one year. Consequently, the health care provider may not receive revenue that they might otherwise have earned through the Shared Savings Program. CMS also finalized in this rule that it will consider the relevant facts and circumstances (e.g. time since the information blocking conduct, the health care provider’s diligence in identifying and correcting the problem, whether the provider was previously subject to a disincentive in another program, etc.) before applying a disincentive under the Shared Savings Program. This disincentive will be effective 30 days after publication of the final rule; however, any disincentive under the Shared Savings Program would be imposed after January 1, 2025.
• Additional disincentives may be established through future rulemaking.

This HHS final rule complements OIG’s final rule from June 2023 that established penalties for information blocking actors other than health care providers, as identified in the Cures Act (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks). If OIG determines that any of these individuals or entities committed information blocking, they may be subject to a civil monetary penalty of up to $1 million per violation.

The Office of the National Coordinator for Health Information Technology (ONC) and CMS will host a joint information session about the final rule on June 26, 2024 at 2pm ET. More information can be found at healthit.gov/informationblocking and via ONC’s X account, @ONC_HealthIT .
Source: HHS