Lawmakers Seek Expanded Stark Exception, Anti-Kickback Safe Harbor for EHRs

Wednesday, July 17, 2013

By Alex Ruoff

Two lawmakers urged regulators to expand the physician self-referral law exception and anti-kickback statute safe harbor for electronic health records to prohibit the intentional limiting of interoperability among all health information technologies.

The rules could be expanded to expressly prohibit the limitation or restriction of interoperability of health information systems donated to health care providers by hospitals, Reps. Diane Black (R-Tenn.) and Michael Honda (D-Calif.) said in a July 11 joint letter to the heads of the Centers for Medicare & Medicaid Services and the Office of the National Coordinator for Health IT.

In their letter, the lawmakers also asked ONC, through its EHR certification program, to combat “information blocking,” a business practice of designing health IT tools to not be interoperable.

Joel White, executive director for the Health IT Now Coalition, a collection of patient and physician advocacy groups, told BNA such an expansion would combat the industry practice of purposefully inhibiting interoperability across different vendor platforms to control market share.

“One of the rules of the road should be that you can’t block information from moving. If you’re donating this technology, it has to be interoperable.”
— –Joel White, Health IT Now Coalition

“One of the rules of the road should be that you can’t block information from moving,” he said. “If you’re donating this technology, it has to be interoperable.”

White said health IT vendors often require users of their products to agree not to exchange information with users of other vendor products in exchange for donated technologies. He said he did not know how often this occurs.

The physician self-referral law, known commonly as the Stark law, generally prohibits physicians from accepting money or items of value from referral sources. Exceptions, such as the one that protects donations of EHRs, require physicians to meet all conditions of the provision to ensure the activities do not run afoul of the law.

CMS and the Department of Health and Human Services Office of Inspector General April 8 released proposed rules extending the anti-kickback statute safe harbor and Stark law exception for EHR arrangements to Dec. 31

Health IT tools hold the promise to improve the coordination of health care between health care providers only if they are capable of communicating electronically, the Honda-Black letter said. Interoperability is defined as the ability to electronically exchange information among disparate IT systems.

“To reach this shared goal, all providers, health systems, hospitals, and patients must have access to real-time, accurate, and actionable health information … unfortunately some have created obstacles to achieving interoperability, which must be eliminated,” the letter said.

CMS and OIG April 8 modified the anti-kickback safe harbor and Stark law exception so that they do not apply to EHRs that are not interoperable with other systems, White said. In their letter, Honda and Black asked for these provisions to be extended to all health IT tools.

HHS should add language to the anti-kickback safe harbor statute that states “neither the donor nor donee can take any actions to limit the interoperability of donated health information technology,” the letter said.

HHS should also require vendors to expressly agree to this condition.

The letter can be found at