Common use of IRO Qualifications The IRO shall Clause in Contracts

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and have expertise in all applicable Federal health care program and FDA requirements relating to Covered Functions and the RAMP Program. The assigned individuals shall be experienced in risk identification and mitigation in relation to pharmaceutical product marketing and promotion. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Government Reimbursed Products are reimbursed;

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and have expertise in all applicable Federal health care program and FDA requirements relating to Covered Promotional Functions and the RAMP Programto Product Related Functions. The assigned individuals also shall be experienced in risk identification and mitigation in relation to pharmaceutical product marketing and promotion. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Government Reimbursed Products are reimbursed;

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews Systems Review and Transactions Review who have expertise in the pharmaceutical medical device industry and have expertise in all applicable Federal health care program and FDA requirements relating to the Covered Functions and the RAMP Program. The assigned individuals shall be experienced (as defined in risk identification and mitigation in relation to pharmaceutical product marketing and promotion. The assigned individuals shall also be knowledgeable about the general requirements Section II.C of the Federal health care program(sCIA), including but not limited to expertise relating to the preparation and submission of Premarket Approval Applications (PMAs) under which Government Reimbursed Products are reimbursed;to the FDA; and

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and have expertise in all applicable Federal health care program and FDA state pharmacy requirements relating as they pertain to Covered Claims Related Functions (including claims for drugs that require pre- dispensing authorization from health plans), and Restocking Related Functions. As such, the RAMP Program. The assigned individuals shall be experienced in risk identification and mitigation in relation to pharmaceutical product marketing and promotion. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under from which Government Reimbursed Products are reimbursed;CareMed seeks reimbursement; Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and have expertise in all applicable Federal health care program and FDA requirements relating to the Covered Functions Functions, including but not limited to expertise relating to marketing and promotional activities associated with pharmaceutical products and the RAMP Program. The assigned individuals shall be experienced in risk identification Federal Anti-Kickback Statute and mitigation in relation False Claims Act and relating to pharmaceutical product marketing the collection, calculation, verification and promotion. The assigned individuals shall also be knowledgeable about the general requirements reporting of information for such products for purposes of the Federal health care program(s) under which Government Reimbursed Products are reimbursedMedicaid Drug Rebate Program, the Medicare Program and the 340B Drug Pricing Program;

IRO Qualifications The IRO shall. 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and have expertise in all applicable Federal health care program and FDA requirements relating to Covered Functions Pricing and the RAMP Program. The assigned individuals shall be experienced in risk identification and mitigation in relation to pharmaceutical product marketing and promotion. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Government Reimbursed Products are reimbursedContracting Functions;