Extract to table

Specifically, the discount must be: (i) earned based on a buyer's purchases; (ii) properly disclosed by the seller to the buyer at the time of sale or, in the case of a rebate, at the time the rebate is paid; and (iii) the buyer must properly report the discount or reduction in price for purposes of federal healthcare program cost reporting

Importantly, the Escobar Court held that the noncompliance must be "material" to the government's payment decision

AKS Analysis — Personal Services and Management Contracts Safe Harbor The KOL consulting program must be structured to satisfy the requirements of the Personal Services and Management Contracts Safe Harbor, 42 C

The hourly rate range of $350 to $500 must be consistent with fair market value for physician consulting services in the cardiac rhythm management space

Consulting fees must be entirely decoupled from the consultant's ordering, prescribing, recommending, or referral patterns for the Pulsar™ CRM System

To mitigate this risk, the selection of each KOL consultant must be based on documented, legitimate criteria—including the physician's clinical expertise, research experience, academic standing, and publication record—and must be supported by a documented assessment of the specific business need that the engagement is designed to address