On November 20, 2020, the Department of Health and Human Service’s Office of Inspector General’s (OIG) issued a final rule that revises some of the regulatory “safe harbors” from liability under the federal Anti-Kickback Statute. WLF had filed comments focused on the proposed rule’s attempt to remove regulatory barriers to care coordination and value-based care. Consistent with WLF’s comments, the final rule categorized device manufacturers as “value-based enterprises” eligible for some safe harbors, and it also created a limited pathway for makers of durable medical equipment, prosthetics, orthotics, and supplies to benefit from safe harbors. Unfortunately, the final rule retained the proposed rule’s conclusion that pharmaceutical manufacturers and laboratories cannot qualify for value-based-care safe harbors. WLF’s comments dissected OIG’s faulty reasoning that justified such a categorical exclusion, and urged the agency not to discriminate against those industries.
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