Final Rules Amend and Extend Protections of the EHR Stark Law Exception and Anti-Kickback Statute Safe Harbor

December 24, 2013

On December 23, 2013, the Centers for Medicare & Medicaid Services (CMS) released a final rule that revises the exception to the federal physician self-referral prohibition (Stark Law) for certain arrangements involving the donation of electronic health records (EHR) items and services (the Stark Exception). The Office of Inspector General of the Department of Health and Human Services (OIG) simultaneously released a companion rule revising the safe harbor regulation concerning EHR items and services under the Federal Anti-Kickback Statute (the Safe Harbor). The rules amended the final rules adopted by CMS and the OIG in 2006, which constituted an effort by the federal government to encourage the adoption of costly EHR systems. Both final rules will be published in the Federal Register on Dec. 27, 2013.

Following are five key points regarding the final rules:

  1. The final rules extend the Stark Law exception and the Safe Harbor until Dec. 31, 2021;
  2. After March 27, 2014, laboratory companies will no longer be protected donors;
  3. The software is deemed interoperable if, on the date the software is provided to a physician, a certifying body authorized by the National Coordinator for Health Information Technology certifies that the software meets the then-applicable EHR certification criteria;
  4. The rule clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services; and
  5. The electronic prescribing capability requirement is removed.

McGuireWoods regularly advises healthcare organizations on compliance with the electronic health records exception and Safe Harbor. A more comprehensive analysis of the final rules will follow this e-newsletter. If you would like to discuss your company’s compliance with these statutes and regulations, please contact one of the authors.