Federal Regulations

Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP

This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for emerging direct-to-consumer ("DTC") sales programs established by pharmaceutical manufacturers, including those that will be available through TrumpRx.