Are you ready to respond to a federal subpoena from the HHS Office of Inspector General (OIG) asking for documents and interviews related to a complaint that has been filed against you for engaging in “information blocking”?
If you are involved in the exchange of electronic health information in any capacity, you may be considered an HIE/HIN which is one category of organizations, Actors, that must comply with the federal Information Blocking Rule. If you develop or offer certified health IT, then you are also an Actor who must comply with the rule. Penalties can be up to $1M per violation and multiple violations can result from an Actor’s practices. Healthcare providers also face enforcement actions but the penalties are not yet final.
You should know that the OIG will enforce the Information Blocking Rule. The OIG has 70 offices across the US with over 1,550 staff, all of whom are experts in healthcare. The OIG has very broad authority to investigate all types of healthcare fraud and abuse, Stark, Anti-kickback cases and, now, information blocking cases. OIG investigators can issue subpoenas for individuals and for documents. If you receive an OIG subpoena, you must take this very seriously and consult with legal counsel who understand the information blocking rule.
Enforcement is just now ramping up, so now is the time to get ready for how you will respond to an OIG investigation. At HIMSS24, the OIG told us that its investigations will focus on the conduct that an Actor engaged in and the intent of the Actor. In other words, what specific activities did an Actor engage in that interfered with the access, exchange or use of Electronic Health Information (EHI). And, did the Actor know, or should they have known using reasonable care, that these activities were likely to interfere with such access, exchange or use of EHI.
You should have already started working towards compliance with the Information Blocking Rule! The first step is educating your team on what, exactly, the Information Blocking Rule requires. Next, conduct a risk assessment to identify the specific activities that put your organization at risk for enforcement. Gravely Group is working with many HIE/HINs, and others, to do exactly this. Check out our website for free resources that can help get you started.
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