On Sept. 16, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion 16-09, which stated that the OIG would not impose sanctions against a company (requestor) that proposed to provide physician offices with a computerized point-of-care vaccine storage and dispensing system free of charge, subject to certain other requirements (proposed arrangem). This advisory opinion is of significance because the OIG held that the proposed arrangement would not constitute grounds for the imposition of sanctions under the exclusion authority in Section 1128(b)(7) or the Social Security Act, of the civil monetary penalty provision of Section 1128A(a)(7), as those sections relate to the commission of acts described in Section 1128B(b), the Federal Anti-Kickback Statute (AKS).
AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a federal health care program, see Section 1128B(b) of the Social Security Act. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, AKS is violated. By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction. For purposes of AKS, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.
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