Federal Anti-Kickback Statute Safe Harbors

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Federal Anti-Kickback Statute Safe Harbors The OIG has adopted two safe harbors allowing for certain arrangements involving the donation of electronic prescribing and electronic health records (“EHR") technologies. The safe harbors reflect an attempt to encourage the donation of this technology in circumstances where the donations are unlikely to be constituted inducements or rewards for the generation of business payable by federal health care programs. Electronic Prescribing Items and Services The electronic prescribing safe harbor shields the donation of hardware, software, and information technology and training services by certain donors to certain recipients in connection with the Medicare Part D program. {Dunlop, 2007 #14} Specifically, the safe harbor only protects donations by: (1) a hospital to its medical staff; (2) a medical group to its members; and (3) a prescription drug plan (“PDP”) or a Medicare Advantage (“MA”) organization to prescribing health care professionals or in-network pharmacies and pharmacists.{Dunlop, 2007 #14} Donations of electronic prescribing technology must be documented by the parties in a signed writing specifying the donor’s costs for the technology provided. Donors cannot select recipients on the basis of the volume or value of referrals or other business generated between the parties, and recipients cannot condition doing business with potential donors on the provision of electronic prescribing technology.{Dunlop, 2007 #14} Furthermore, the donated technology must be compatible with other electronic prescribing and health records systems, and donors cannot restrict the recipient’s right or ability to use the technology for all patients, regardless of payor status. EHR Items and Servic... ... middle of paper ... ... “addressable.” A covered entity must implement a required implementation specification, but it need not implement an addressable specification if it has determined that the specification is not a reasonable and appropriate safeguard given the entity’s operating environment and the likely protective effect of the safeguard. If the implementation specification is determined not to be a reasonable and appropriate answer to the entity’s security needs, the entity must implement an equivalent alternative, if reasonable and appropriate. Where no reasonable and appropriate alternative exists, the entity need not implement any safeguard. However, in situations where an entity decides against implementation of an addressable specification, the entity must document the reasons for the determination that such implementation specification was unreasonable and inappropriate.

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