Ordinarily, the donation of Electronic Health Record (EHR) technology, services or training to a provider would raise fraud and abuse concerns and potentially implicate the Stark law and Anti-kickback Statute. In order to encourage the use of EHR technology, in August of 2006, CMS and OIG published companion rules creating an exception to the Stark law and a safe harbor for the Anti-kickback Statute that protects arrangements involving the provision of EHR technology, services, and training to providers. The rules were scheduled to expire on December 31, 2013.
On December 27, 2013, CMS and OIG published final rules in the federal register extending the exception and safe harbor until December 31, 2021. The new rule also:
1. Updates the requirement that donated software be interoperable. The rule now states that if the software has been certified by an agency authorized by the National Coordinator for Health Information Technology to meet EHR certification criteria when it is given to the provider, the software will be deemed interoperable.
2. Deletes the requirement that donated software contain an electronic prescribing component. The purpose of this requirement was to encourage the use of electronic prescribing but CMS and OIG have determined that the requirement is no longer necessary, as many other policies are now in existence that support the adoption of electronic prescribing.
3. Excludes laboratory companies from the types of entities that may donate EHR items and services. Donations by laboratories have been the subject of many complaints and are considered more likely to be motivated by a purpose of securing future business rather than better coordinating care for beneficiaries.
4. Clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services by adding a non-exhaustive list of some of the forms of technologies that would be prohibited under the regulation.
You can find the CMS Final Rule here: http://www.gpo.gov/fdsys/pkg/FR-2013-12-27/pdf/2013-30923.pdf
You can find the OIG Final Rule here: http://oig.hhs.gov/authorities/docs/2013/2013-30924.pdf
If you have questions about these final rules or any other Stark or Anti-kickback issues, please contact any member of the Benesch Health Care Department.