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CMS and OIG Issue Final Rules Revising the EHR Donation Stark Law Exception and Anti-Kickback Statute Safe Harbor.

The Centers for Medicare & Medicaid Services issued a final rule updating certain aspects of the electronic health records (EHR) donation exception to the Stark Law.  The Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule extending the same revisions to the EHR safe harbor under the Anti-Kickback Statute.  The final rules make the following changes to the EHR donation exception and safe harbor:

  • Extends the expiration date for the exception and safe harbor to December 31, 2021 (the end of the Medicaid incentive program);
  • Excludes laboratory companies from the types of entities that may donate EHR items and services;
  • Updates the provision under which EHR software is deemed interoperable;
  • Removes the electronic prescribing capability requirement; and
  • Clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services.

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The final rules establish that EHR software is deemed to be interoperable if, on the date that it is provided to the physician, it has been certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the EHR certification criteria, based on the definition of Certified EHR Technology in the Medicare and Medicaid EHR Incentive Program regulations.  For example, in 2013, the applicable definition of Certified EHR Technology includes both the 2011 and 2014 editions of the EHR certification criteria.  Therefore, software in 2013 certified to meet either the 2011 or the 2014 edition would meet the new requirements. 

The final rule related to the EHR donation exception revisions is available at:

The final rule related to the EHR donation safe harbor revisions is available at:

Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements, Final Rule; 78 Fed. Reg. 249, 78751, 78769 (Dec. 27, 2013).

Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute; Final Rule, 78 Fed. Reg. 249, 79202, 79220 (Dec. 27, 2013).