By Beth Neal Pitman
This article is Part 1 of a two-part series on the information blocking disincentives for healthcare providers that took effect on Aug. 1, 2024, following publication of the final rule in July by the U.S. Department of Health and Human Services (HHS).
HHS Access Initiative
Since 2000, with the implementation of the first Health Insurance Portability and Accountability Act (HIPAA) Privacy Rules, HHS has been committed to ensuring access to healthcare and has focused on the impact that access to health records has on an individual’s quality of care.
The broad umbrella of access initiatives has included healthcare information technology (Health IT) interoperability with the 2009 introduction of the electronic medical record (EMR) Meaningful Use incentive program (through the HITECH Act) intended to encourage healthcare provider implementation of electronic health records. The Meaningful Use program was transitioned by the Centers for Medicare & Medicaid Services (CMS) to the Medicare Access and CHIP Reauthorization Act (MACRA) Merit-Based Incentive Payment System (MIPS) program, Promoting Interoperability program and Affordable Care Organizations (ACO) shared savings program. The HHS Office for Civil Rights (OCR) access initiative was announced in 2019, with its aggressive enforcement activity followed by the 21st Century Cures Act (Cures Act) regulations setting interoperability standards and prohibiting information blocking practices.
As emphasized by HHS Secretary Xavier Becerra, “[w]hen 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.”
Interoperability and Access
The Cures Act, enacted in 2016, established provisions to promote interoperability and patient access to electronic health information (EHI). A critical component of the Cures Act is the prohibition of information blocking, which refers to practices that interfere with the access, exchange or use of EHI. The Office of the National Coordinator for Health Information Technology (ONC) issued regulations defining information blocking and establishing permissible exceptions. These regulations, effective April 5, 2021, were amended in December 2023 through the HTI-1 Rule, and HHS has proposed further amendments in the July 10, 2024 HTI-2 Rule. An enforcement structure for Health IT developers and Health Information Exchanges was finalized June 27, 2023, with enforcement against these Information Blocking Actors underway since Sept. 1, 2023.
Continuing HHS’ commitment to encourage permitted access to and exchange of EHI, the final rule specifically focuses on establishing disincentives for healthcare providers found by the HHS Office of Inspector General (OIG) to have committed information blocking. Importantly, the Cures Act definition of healthcare providers is not limited to HIPAA-regulated providers and includes both individual providers and their group practices, hospitals or other organizations through which an individual renders services.
Finalized Disincentives
HHS has finalized three categories of disincentives applicable to healthcare providers determined by the OIG to have engaged in information blocking. These disincentives primarily target three major programs:
1. Medicare Promoting Interoperability Program
An attestation of no information blocking is a foundational requirement for the Promoting Interoperability program.
Under this program, eligible hospitals and critical access hospitals (CAHs) reporting Promoting Interoperability and found by OIG to have committed information blocking will be excluded from being considered meaningful electronic health record (EHR) users.
This exclusion may lead to significant financial penalties, including a reduction of 75 percent of the annual market basket increase for eligible hospitals and a decrease in payment to 100 percent of reasonable costs for CAHs (from 101 percent).
The exclusion applies to the reporting period during which the information blocking practice occurred.
2. Merit-Based Incentive Payment System (MIPS)
Eligible clinicians and groups who are Medicare Part B providers and are determined by OIG to have engaged in information blocking will be denied the meaningful user status within MIPS. The final rule amends the MIPS definition of Meaningful User to exclude an information blocker.
This denial will result in a zero score in the Promoting Interoperability performance category, significantly impacting the overall MIPS score and potential payment adjustments.
Denials apply to the performance reporting period during which the information blocking practice occurred.
Groups that are not information blockers will not be penalized for an individual clinician’s information blocking actions, but will be required to submit MIPS reporting without the data from that individual clinician.
3. Affordable Care Organizations
Medicare providers that are an ACO, ACO participant, or ACO provider or supplier found by OIG to have committed information blocking may be ineligible to participate in the CMS Shared Savings Program for at least one year.
This will result in loss of revenue from the Shared Savings Program.
These finalized disincentives aim to encourage compliance with information blocking regulations and foster a culture of data sharing and interoperability in healthcare. Although enforcement disincentives became effective on Aug. 1, 2024, the ACO disincentive will not be imposed until the 2025 contracting year (Jan. 1, 2025).
Coming Up Next Month
Part 2 of Holland & Knight’s series will look at the implications for healthcare providers and best practices for consideration under the information blocking disincentive.
Beth Neal Pitman is a partner in the Birmingham, Alabama, office of Holland & Knight.
