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On Tuesday, the HHS’ Office of inspector General (OIG) proposed a rule that amends civil monetary penalty rules to also cover information blocking.
“When implemented, the new CMPs for information blocking will be an important tool to ensure program integrity and the promised benefits of technology and data,” said Christi A. Grimm, OIG Principal Deputy Inspector General.
OIG understands that during the COVID-19 public health emergency, healthcare organizations are focused on providing treatment and follow-up care to patients. OIG is fulfilling its obligations by publishing the new rule but is also trying to be as flexible as possible to minimize the burden on healthcare organizations on the front line dealing with the COVID-19 pandemic. OIG is seeking comment from healthcare organizations and industry stakeholders on when information blocking enforcement should begin.
OIG explained that all entities and individuals required to comply with the new information blocking regulations will be given time to achieve compliance before enforcement begins. OIG has proposed the earliest date for enforcement is the compliance date of the ONC Final Rule published on March 9, 2020 but has proposed a 60-day delay to enforcement due to the COVID-19 pandemic.
The proposed rule does not introduce any new requirements concerning information blocking, instead OIG will be incorporating the regulations published by the National Coordinator for Health Information Technology (ONC) in March, and will be using that rule as the basis for enforcing information blocking CMPs.
OIG said civil monetary penalties will only be imposed on entities and individuals when there have been intentional information blocking violations. OIG will not impose civil monetary penalties on entities and individuals in cases where innocent mistakes have been made. In order to determine intent, OIG will work closely with both the ONC and the HHS’ Office for Civil Rights. The proposed rule also explains the basis for determining whether there have been single or multiple violations of information blocking provisions of the ONC rule.
ONC explained that it will prioritize investigations where conduct has or has potential to cause harm, when information blocking has significantly impacted a provider’s ability to provide care for patients, cases involving information blocking over a long period of time, deliberate information blocking, and when conduct has caused financial loss to Federal healthcare programs or other government or private entities.
The proposed rule also makes changes in two other areas. There are new authorities for civil monetary penalties, assessments, and exclusions related to HHS grants, contracts and other agreements in relation to fraud, and the maximum penalties for certain violations will be increased in accordance with changes made by the Bipartisan Budget Act of 2018.
The OIG proposed rule has been published in the federal register and can be viewed on this link. Comments on proposed rule will be accepted for 60 days from the date of publication in the federal register.