DEVICE, DRUG INDUSTRY EXCLUDED FROM ANTI-KICKBACK SAFE HARBOR

HHS is excluding device and drugmakers from a new protection from the anti-kickback statute designed to promote adoption of electronic health records, arguing that these sectors cannot be trusted to abide by the law.

The agency released a pre-publication copy of its rule Aug. 2 giving hospitals, group practices, prescription drug plan sponsors and Medicare Advantage organizations the ability to provide hardware, software or information technology and training services to healthcare professionals, pharmacies and pharmacists without violating federal anti-kickback law.

But HHS has explicitly excluded the device and pharmaceutical industries from this safe harbor. Not only do these sectors not provide healthcare items or services to patients or submit claims for those services involving eprescribing, but the agency does not trust these sectors not to exploit the safe harbor.

"Our enforcement experience demonstrates that unscrupulous manufacturers have offered remuneration in the form of free goods and services to induce referrals of their products," the agency said. "Given this enforcement history and the lack of a direct and central patient care role that justifies safe harbor protection for the provision of electronic health records technology, we are not including manufacturers as protected donors. We believe there is a substantial risk that, in many cases, manufacturers' primary interest in offering technology to potential referral sources would be to market their products."

The official version of the rule will be published in the Federal Register Aug. 8.

The prepublication version of the rule is available at oig.hhs.gov/authorities/docs/06/EHR, 8-01-06A.pdf (http://oig.hhs.gov/authorities/docs/06/EHR,%208-01-06A.pdf).