Common use of IRO Qualifications Clause in Contracts

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with pharmaceutical products and the Federal Anti-Kickback Statute and False Claims Act. 2. assign individuals to design and select the samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.

IRO Qualifications. ​ The IRO shall:: ​ 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with pharmaceutical products and the Federal Anti-Kickback Statute and False Claims Act.. ​ 2. assign individuals to design and select the samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; andand ​ 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.. ​ ​

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Reviews Claims Review who have expertise in the pharmaceutical industry billing, coding, claims submission, and in all applicable other Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing claims for items and promotional activities associated with pharmaceutical products and the Federal Anti-Kickback Statute and False Claims Act.services submitted by PALMS; 2. assign individuals to design and select the samples for the IRO Transactions Reviews Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques; 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements); and 34. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the Covered Promotional and Product Services Related Functions, including but not limited to expertise relating to marketing Clinical Investigation Related Functions, and promotional activities associated with pharmaceutical products and Reporting Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal Anti-Kickback Statute and False Claims Act.health care program(s) under which Spectranetics products are reimbursed; 2. assign individuals to design and select the samples for the IRO Transactions Transaction Reviews who are knowledgeable about the appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.. Spectranetics Corporate Integrity Agreement