HHS-OIG Says Anatomic Pathology Lab’s Purchased Service Arrangement Could Violate Anti-Kickback Statute

Highlights
U.S. Department of Health and Human Services issued an unfavorable opinion addressing an anatomic pathology laboratory that purchases services at fair market value from other labs, and bills commercial payors for such services
Even though the proposed arrangement carved out services reimbursed by Federal healthcare programs, the agency determined the arrangement posed a risk of fraud and abuse under the Anti-Kickback Statute
The opinion reiterates the HHS-OIG’s long-standing position against arrangements that “carve out” Federal healthcare program business, but still result in increased referrals of Federal healthcare program business outside of the arrangement
The Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG) issued Advisory Opinion No. 23-06 on Sept. 25, 2023, after reviewing a proposed arrangement whereby an anatomic pathology laboratory operator would purchase certain anatomic pathology services from other laboratories and then bill third-party commercial payors for those services.
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