HHS OIG says “Ditto” to HHS Blanket Stark Waivers for Purposes of the Anti-Kickback Statute
On April 3, the Department of Health and Human Services Office of the Inspector General (HHS OIG) released a policy statement to align its enforcement of the federal Anti-Kickback Statute (AKS) with HHS’s recent Blanket Waivers of Stark (Blanket Waivers) during the COVID-19 pandemic. As previously reported, HHS issued the Blanket Waivers to allow for certain arrangements necessary to give hospitals and providers additional flexibility in providing care during the pandemic. The HHS OIG notes that “some financial relationships that implicate the physician self-referral law also may implicate, and potentially violate, the Federal anti-kickback statute.” Given the “unique circumstances of the COVID-19 outbreak,” HHS “OIG will not impose administrative sanctions . . . [for] the commission of acts described in the Federal anti-kickback statute, with respect to remuneration that is covered by section II.B.(1)-(11) of the Blanket Waivers.” This effectively aligns AKS enforcement with the relevant portions of the Stark Blanket Waivers during this period of public health emergency.
The HHS OIG stressed that its policy statement is intended to avoid the need any “separate legal review under the Federal anti-kickback statute for arrangements protected by the Blanket Waivers.” Thus, it does not apply to “arrangements that implicate the Federal anti-kickback statute that are not covered by the Blanket Waivers (e.g., … direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved).” But “where an arrangement is covered by a Blanket Waiver, this Policy Statement extends to remuneration that relates to referrals for services furnished to all Federal health care program beneficiaries pursuant to the covered arrangement.”
Notably, the policy statement does not automatically extend protection to all of the types of arrangements described in the Blanket Waivers. The HHS OIG still wants parties to submit inquires with additional details for the arrangements numbered 12-17 in the Blanket Waivers. And, for arrangement number 18—which provides a waiver of the requirement of a written agreement or signature—the policy statement says nothing.