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 department released a pre-publication copy Aug. 2 of its rule allowing hospitals, group practices, prescription drug plan sponsors and Medicare Advantage organizations 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 department does not trust them not to exploit the provision.

"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 department said.