Beating the deadline by mere days, CMS and the OIG released their final rules related to the Stark Law exception/Anti-Kickback safe harbor for EHR donation arrangements. The new rules extend the donation arrangement exception until December 31, 2021.
The new rules become effective 90 days after publication, with the exception of the extension, which is effective on December 31, 2013. These new rules permit existing donation arrangements to continue to operate beyond December 31, 2013, provided they remain in compliance with the Stark exception and Anti-Kickback safe harbor.
Highlights of this new rule (other than the very important extension to 2021) include:
- The items/EHR are provided by a company (i.e. a hospital) that is not a laboratory.
- Software is deemed interoperable if it has been certified as “certified EHR technology” as that term is used by the ONC for the meaningful use/EHR Incentive Program.
- Elimination of the requirement that the EHR software contain eRx capabilities in order to qualify for the exception.
- Clarification that the donor cannot limit the interoperability of the donated software with other eRx and EHR systems, which CMS interprets more broadly by providing a non-exclusive list of the types of technologies that are included in this restriction: “health information technology applications, products, or services.”
To view the HIMSS statement on the extension click here.