Regulatory and Health Industry
New Federal Rule Establishes Penalties for Information Blocking
An individual or entity who commits information blocking may face penalties up to a $1 million per violation, according to a new federal rule.
The Department of Health and Human Services, Office of Inspector General (HHS-OIG), on June 27 issued its final rule implementing information blocking penalties for health information exchanges, health information networks, and developers of certified health IT. The rule spells out penalties created by the 21st Century Cures Act and outlines the process for investigating information blocking claims, but it does not impose new information blocking requirements.
Despite gaining clarity on the investigation process, providers covered under information blocking remain in limbo as they await the release of the Office of the National Coordinator for Health Information Technology (ONC) proposed rule for provider disincentives this fall.
“HHS-OIG is committed to using its information blocking enforcement authority to help improve the flow of health care data,” says Andrew VanLandingham, senior counselor for HHS-OIG. “Patients, their family members, health care practitioners, and many others depend on the timely access, exchange, and use of this data to make critical decisions about their health. HHS-OIG’s investigations will prioritize conduct that jeopardizes patients’ health or interferes with a provider’s ability to care for their patients.”
VanLandingham added that the agency is encouraging healthcare entities to proactively comply with the final rule to avoid any harm to patients and costly fines.
OIG says that it incorporated regulations published by the ONC as the basis for enforcing information blocking penalties. OIG expects enforcement to help improve interoperability in healthcare.
How OIG Will Conduct Investigations
OIG will investigate complaints by gathering facts, conducting interviews, and making document requests, and it may consult with ONC to assess facts and information blocking regulations. Entities will be given an opportunity to discuss the investigation and appeal any penalties. Complaints about possible information blocking can be made online at the ONC Information Blocking Portal or the OIG Hotline.
Source: Department of Health and Human Services, Office of Inspector General
OIG says it likely will receive more complaints than it can investigate. The agency will prioritize cases to investigate based on issues such as the impact on a provider’s ability to care for patients and financial loss caused to federal healthcare programs. Penalty amounts will be based on factors such as the harm to patients that resulted from information blocking.
The rule has been submitted to the Office of the Federal Register for publication, yet has not yet been officially published. Enforcement of penalties will start 60 days after publication of the final rule in the Federal Register.
“The final rule provides some welcome clarity to information blocking covered actors by detailing how the investigation process will function and the types of activities OIG will prioritize investigating,” says AHIMA Director of Regulatory Affairs Andrew Tomlinson. “AHIMA will use the time between the final rule's official release and its effective date to understand the rule provisions and educate our members in preparation for the investigation process to begin.”
OIG says the information blocking rule does not establish healthcare provider disincentives. HHS is developing a separate rule to create those disincentives.
“We look forward to ONC’s release of the proposed rule on the provider actor disincentives in the fall and providing comments to help shape one of the final phases of information blocking implementation,” Tomlinson says.
Damon Adams is content production editor for AHIMA.