On April 10, 2013, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that would revise the exception to the physician self-referral prohibition (the “Stark Law”) for certain arrangements involving the donation of electronic health records (EHR) and related services. The U.S. Department of Health and Human Services Office of Inspector General (OIG) published its proposed changes to the anti-kickback statute EHR safe harbor, which are nearly identical to those proposed by CMS, in the same issue of the Federal Register.

Specifically, CMS and OIG propose the following changes:

  • Extending the exception and safe harbor to December 31, 2016. The EHR exception and safe harbor are currently set to expire on December 31, 2013. The proposed changes would extend that date to at least December 31, 2016 to correspond with the last year in which a healthcare provider may receive a Medicare electronic health record incentive payment and the last year in which a healthcare provider may initiate participation in the Medicaid electronic health record incentive program.
  • Revising the parameters around the term “interoperable.” The current EHR exception and safe harbor provide, in relevant part, that any donated software must be certified as “interoperable” within no more than 12 months prior to the time it is provided to the physician. The proposed rules bring the certification provisions in line with Office of the National Coordinator for Health Information Technology (ONC) certification program for EHR technology by removing the 12-month timeframe and allowing any software that meets the ONC’s definition of Certified EHR Technology in 45 CFR part 170.
  • Removing the electronic prescribing requirement.

In addition, CMS and OIG are proposing to limit the scope of protected donors. Currently, the exception and safe harbor apply to any individual or entity who donates EHR items or related services to a physician. However, out of a concern for potential abuse, CMS and OIG are considering limiting the exception and safe harbor to only those donors originally mandated under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: hospitals, group practices, prescription drug plan sponsors, and Medicare Advantage organizations.

The deadline for comments on these proposed rules is June 10, 2013.