The Office of the Inspector General (OIG) for the Department of Health and Human Services announced and solicited comments to proposed rule changes to the Electronic Health Records Safe Harbor (EHRSH) under the federal Anti-Kickback Statute in the Social Security Act. The safe harbor at issue aims to protect arrangements involving interoperable electronic health record (EHR) software or services relating to information technology and training.

The safe harbor became final on August 8, 2006, and is scheduled to expire on December 31, 2013. The proposed amendments would:

  • Extend the current 12-month period for certifying that donated EHR software is interoperable
  • Remove the electronic prescription capability requirement
  • Extend the 2013 sunset provision of the safe harbor

The Anti-Kickback Statute imposes civil and criminal penalties on individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration to induce or reward the referral of business subject to reimbursement under any of the federal health care programs. EHRSH, however, excludes donations from protected donors of EHR software or services from the statute’s prohibition.

The OIG proposes removing the current requirement that donated software be certified for interoperability within 12 months of its donation.  Rather, the proposed amendment imposes a two-year time frame for certification, which correlates with the certification process for EHR technology established by the Office of the National Coordinator for Health Information and Technology.

The OIG also proposes eliminating the electronic prescription capability requirement of donated software. Citing the medical industry’s gains in the rate of electronic prescription use and federal statutory and regulatory incentives, the OIG found this requirement is no longer necessary. 

Finally, the OIG proposes extending the EHRSH’s sunset provision until December 31, 2016, to correspond with both the conclusion of payments under Medicare’s EHR incentive payment program and the closure of the enrollment period under Medicaid’s corresponding incentive program. Alternatively, the OIG is considering a sunset date of December 31, 2021, to correspond with the conclusion of payments under Medicaid’s incentive program.

In addition to the proposed rule changes, the OIG also solicited comments on limiting the definition of protected donors, the conditions of interoperability, and the clarity of covered software.

Ballard Spahr attorneys in the Health Care and White Collar/Investigations Groups have extensive experience advising clients on anti-kickback compliance. For more information, please contact Health Care Practice Leader Jean C. Hemphill at 215.864.8539 or hemphill@ballardspahr.com, Dee Spagnuolo at 215.864.8312 or spagnuolod@ballardspahr.com, or the Ballard Spahr attorney with whom you work.


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