CMS and OIG Issue Proposed Changes to the Federal Stark Law Exception and Anti-Kickback Statute Safe Harbor for Electronic Health Records Donations

On April 10, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) published proposed rules that would extend the existing federal Stark Law exception (found at 42 CFR § 411.357[w]) and federal Anti-Kickback Statute safe harbor (found at 42 CFR § 1001.952[y]) that protect donations of electronic health record (EHR) items and services. 

Specifically, the proposed rules include both proposed changes to the current regulations, as well as several new proposals.  The main proposals include:

  • Extending the Sunset Date:  The proposed rules seek to extend the sunset date of the exception and safe harbor by three years  to December 31, 2016. As an alternative, the agencies are considering a sunset date of December 31, 2021, which corresponds to the end of the of the Medicaid EHR Incentive Program.  CMS and OIG are accepting comments on these two dates.
  • Changes to the Interoperability “Deeming” Requirement:  For EHR exception and safe harbor protection, the software must be deemed “interoperable” at the time it is provided to the recipient.  Under the current rules, this requires that a certifying body recognized by the Secretary certify the software within 12 months prior to the date it is provided to the recipient.  Under the proposed rules, CMS and OIG propose two changes: (1) changing the phrase “recognized by the Secretary” to “authorized by the National Coordinator for Health Information Technology” and (2) removing the 12 month period and instead requiring that the EHR software has been certified to any edition of ONC’s EHR certification criteria that is identified in the then applicable definition of Certified EHR Technology on the date it is provided to the recipient.
  • Removal of Electronic Prescribing Capability Requirement: The proposed rules seek to remove the current requirement that all donated software include electronic prescribing provisions.  These provisions which were originally included to encourage and incentivize electronic prescribing, but are now, according to CMS and OIG, no longer needed.

CMS and the OIG drafted the proposed rules in consultation in order to ensure that the two rules are as consistent as possible given the differences in the Stark Law and Anti-Kickback Statute.  Public comments on the proposed rules are being accepted through June 10, 2013. 

CMS’s proposed rule is available here

OIG’s proposed rule is available here.

~Submitted by J Finnegan

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