Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors are still engaging in conduct that the rules were intended to discourage, in part due to the lack of enforcement rules.
Attendees of the panel expressed a number of concerns and practical issues they are encountering with information blocking compliance implementation:
- Lack of Incentives to Comply. Attendees were concerned that, with the enforcement rules pending, some actors are continuing to engage in information blocking. Labs feel that they are stuck in the middle between having to comply with the rules and needing to protect themselves against those still engaging in information blocking, with limited resources. Attendees asked what, if anything, they can do now to discourage information blocking and protect their rights. Industry stakeholders do have some options, including: reporting HIPAA right of access violations to the HHS Office for Civil Rights; ensuring their contracts prohibit information blocking; and leveraging available claims for tortious business interference, unfair competition, defamation or breach of contract.
- Added Complexity of State Laws. Attendees were also concerned with recently passed state laws that contribute to the complexity of information blocking compliance, and having to shoulder the cost of this increased complexity. For example, the Kentucky Disclosure of Lab Results Act requires that certain clinical laboratory, pathology and radiology tests and reports not be disclosed to a patient for 72 hours after they are finalized, unless a health care provider otherwise directs the release. Given that anything required by law is excepted from the definition of information blocking, information blocking actors within the scope of this Kentucky law must comply with it. In addition, California enacted its own information blocking law in 2021, the California Data Exchange Framework, which imposes additional obligations on certain actors in California. Providers and other actors must monitor for state laws that could change or add to their information blocking obligations.
Industry stakeholders’ concerns regarding the lack of enforcement rules may be addressed this fall. HHS recently reiterated that it is developing a proposed rule to implement information blocking enforcement against providers. That rule is scheduled to be released this September. Whether the proposed rule will be released by then remains to be seen—the HHS OIG failed to publish its final rule for information blocking enforcement by either of the fall 2022 or spring 2023 dates proposed in the regulatory agenda.
For assistance with information blocking questions and compliance, please contact a member of the Sheppard Mullin Healthcare Team.