HHS' Office of Inspector General and CMS have released final rules that revise the Anti-Kickback Statute safe harbor and Stark Law exception, respectively, for certain arrangements involving the donation of electronic health records.
The donation of an item with the value of an EHR program would normally raise fraud and abuse concerns, but exemptions to the Stark Law and AKS were crafted to encourage widespread implementation of EHRs and allow smaller provider groups to accept gifts of EHR software without violating the law and statute. The Stark exemption and AKS safe harbor both permit EHR donations if certain safeguards are met.
When the agencies' final rules go into effect, they will extend the Stark Law exception and the Anti-Kickback safe harbor until Dec. 31, 2021, eliminate the electronic prescribing requirement for EHR systems and update the "interoperability'' requirements to conform with the current Office of the National Coordinator for Health Information Technology's certification program.
The rules also exclude laboratory companies as protected donors for EHR items and services, effective March 27, 2014.
The final rules revise the final rules CMS and the OIG adopted in 2006. Both will be published in the Federal Register on Dec. 27.
Read the OIG final rule and CMS final rule in full.
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