Healthcare providers that prevent authorized users from accessing electronic health records data face new consequences under a final rule the Health and Human Services Department published Monday.
The regulation to discourage so-called information blocking emerged from the 21st Century Cures Act of 2016 and applies to providers including hospitals, physicians and accountable care organizations.
Related: HHS proposes crackdown on EHR 'information blocking' by providers
Providers that HHS determines knowingly prevented others from appropriate use of EHR data would be subject to Medicare reimbursement cuts under the rule, which HHS, the Centers for Medicare and Medicaid Services and Office of the National Coordinator for Health Information Technology proposed in October.
The new regulation complements an HHS Office of Inspector General final rule issued last July that levies fines up to $1 million for technology companies and health information exchanges found to have engaged in information blocking.
"With this action, HHS is taking a critical step toward a healthcare system where people and their health providers have access to their electronic health information," HHS Secretary Xavier Becerra said in a news release. “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the healthcare system to better serve patients."
HHS will assess penalties differently between hospitals, medical practices and ACOs determined to have committed information blocking.
- Hospitals, including critical access hospitals, will have their EHR "meaningful use" status and payment incentives revoked for the year in which CMS reports them to the OIG. Hospitals that are not meaningful users will be ineligible to achieve that status, except for critical access hospitals, which will get a 1 percentage point cut to their Medicare reimbursements.
- Physicians and other clinicians subject to the Medicare Merit-based Incentive Payment System likewise will lose their meaningful use designation and payment incentives. MIPS providers that are not meaningful users will receive a zero score on the program's Promoting Interoperability metric, which could lead to lower reimbursements.
- ACOs and ACO participants could be barred from the Medicare Shared Savings Program for a year and may lose shared savings revenue.
Most of these policies will take effect 30 days after the regulation appears in the Federal Register, except the Medicare Shared Savings Program provisions, which will not be in force until at least Jan. 1. HHS will issue additional rules spelling out further penalties, the news release said.
The ONC logged 1,035 information blocking complaints from April 5, 2021-May 31, 2024, 79% of which identified healthcare providers as the "potential actor," according to the agency. Patients and their representatives lodged 69% of the complaints, the ONC data show.
The agency established two standards for what constitutes information blocking under the 21st Century Cures Act. For certified health IT developers, health information exchanges and health information networks, the standard is whether those parties know, or should know, that a practice is likely to interfere with the access, exchange or use of electronic health information. For providers, the standard is whether they know that a practice is unreasonable and is likely to interfere with the access, exchange or use of electronic health information.
