Common use of IRO Qualifications Clause in Contracts

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursed; 2. assign individuals to design and select the samples for the 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.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review Reviews who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory to Product Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products Allergan’s Government Reimbursed Products are reimbursed; 2. assign individuals to design and select the samples for the 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.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Quarterly Claims Review who have expertise in all the Medicare and state Medicaid program requirements and applicable Federal health care program state Board of Pharmacy requirements applicable to the pharmacy claims being reviewed and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements collection or waiver of the Federal health care program(s) under which Forest products are reimbursedcost-sharing amounts for pharmacy claims; 2. assign individuals to design and select the samples for the Transaction Reviews Quarterly Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews required by the CIA IA on a timely basis.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review Reviews who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional Functions and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest BIPI products are reimbursed; 2. assign individuals to design and select the samples for the 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.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Claims Review who have expertise in all applicable the Federal health care program and FDA requirements relating applicable to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedclaims being reviewed; 2. assign individuals to design and select the samples for the Transaction 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 Prescription Review who have expertise in the Federal and state requirements for dispensing Controlled Substances, including all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedControlled Substances Act requirements; 2. assign individuals to design and select the samples for the Transaction Reviews Prescription Review sample 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 Review Government Pricing and Medicaid Drug Rebate Engagement who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedHealth Care Program Requirements; 2. assign individuals to design and select the samples for the Transaction Reviews who are knowledgeable about the appropriate statistical sampling techniquestechniques and select the samples required for the Government Pricing and Medicaid Drug Rebate Engagement; 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 Record Review who have expertise in all applicable the Federal health care program requirements applicable to the records and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimburseddata being reviewed; 2. assign individuals to design and select the samples for the Transaction Reviews Record Review sample who are knowledgeable about the appropriate statistical sampling techniques; 3. assign individuals to conduct the coding review portions of the Record Review who are certified coders and who are experienced in risk adjustment data validation, and the review of a variety of medical record layouts, electronic medical record entries, and handwritten medical record documentation; 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 Review Reviews who have expertise in the medical device industry and have expertise in all applicable Federal health care program and FDA requirements relating to Promotional Covered Functions, including but not limited to expertise relating to marketing and Product Related Functions promotional activities associated with medical devices and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedAnti-Kickback Statute and False Claims Act; 2. assign individuals to design and select the samples for the Transaction 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 Review Review(s) who have expertise in all applicable Federal health care program and FDA requirements relating related to Promotional and Product Related Functions and Regulatory Related Functionsthe Reviews. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest Biovail products are reimbursed; 2. assign individuals to design and select the samples for the Transaction Reviews Review sample(s) 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 Promotional and Product Services Review who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Services Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest Cephalon products are reimbursed; 2. assign individuals to design and select the samples for the 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.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review Reviews who have expertise in all applicable the pharmaceutical industry and in Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of (including but not limited to, the Federal health care program(sAnti-Kickback Statute and the False Claims Act) under which Forest products are reimbursedapplicable to the Covered Functions being reviewed; 2. assign individuals to design and select the any samples for the Transaction 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 Review Reviews who have expertise in the medical device industry and have expertise in all applicable Federal health care program and FDA requirements relating to Promotional Covered Functions, including but not limited to expertise relating to marketing and Product Related Functions promotional activities associated with medical device products and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursed;Anti-Kickback Statute and the False Claims Act. 2. assign individuals to design and select the samples for the Transaction 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 Program Report Review, Bid Submissions Systems Review, and Unallowable Cost Review engagements who have expertise in all applicable Federal health the reimbursement involving managed care program organizations and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about in the general requirements of the State and Federal health care program(s) under from which Forest products are reimbursedWellCare seeks reimbursement; 2. assign individuals to design and select the samples for the Transaction Reviews who are knowledgeable about the appropriate reporting and bid submission processes and about statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews Reviews required by the CIA on a timely basis.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review Review(s) who have expertise in all applicable Federal health care program and FDA requirements relating related to Promotional and Product Related Functions and Regulatory Related Functionsthe Reviews. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest Boston Scientific products are reimbursed; 2. assign individuals to design and select the samples for the Transaction Reviews Arrangements Review sample(s) who are knowledgeable about the appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews Reviews required by the CIA on a timely basis.. Boston Scientific Corporation CIA Appendix A

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Claims Review and Quarterly Drug Inventory Review and who have expertise in all applicable the Federal health care program requirements and FDA state Board of Pharmacy requirements relating applicable to Promotional the claims being reviewed and Product Related Functions the dispensing and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedbilling for prescription drugs; 2. assign individuals to design and select the samples for the Transaction Reviews Claims Review sample and Quarterly Drug Inventory Review sample who are knowledgeable about the appropriate statistical sampling techniques; and 3. have sufficient staff and resources to conduct the reviews required by the CIA IA on a timely basis.

IRO Qualifications. The IRO shall: 1. assign individuals to conduct the IRO Review Reviews who have expertise in all applicable the pharmaceutical industry and in Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of (including but not limited to, the Federal health care program(sAnti-Kickback Statute and the False Claims Act) under which Forest products are reimbursedapplicable to the reviews being conducted; 2. assign individuals to design and select the samples for the Transaction 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 Arrangements Review and, if applicable, Unallowable Cost Review engagements who have expertise in all applicable Federal health care program the requirements of the reviews being performed and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about in the general requirements of the applicable Federal health care program(s) under which Forest products are reimbursed); 2. assign individuals to design and select the samples for the Transaction Reviews Arrangements Review sample 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 Review Reviews who have expertise in all applicable Federal health care program and FDA requirements relating to Promotional and Product Related Functions and Regulatory Related Advice Functions performed; and for the Advice Functions. The assigned , assign individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedwho have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements); 2. assign individuals to design and select the samples for the Transaction Reviews Encounters Review sample 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 Claims Review who have expertise in all applicable the Federal health care program and FDA requirements relating applicable to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursedretail pharmacy claims being reviewed; 2. assign individuals to design and select the samples for the Transaction Reviews Claims Review sample 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:shall:‌‌ 1. assign individuals to conduct the IRO Review Reviews who have expertise in all applicable Federal health care program program, FDA, and FDA DEA requirements relating applicable to Promotional and Product Related Functions and Regulatory Related Functions. The assigned individuals shall also be knowledgeable about the general requirements of the Federal health care program(s) under which Forest products are reimbursed;reviews being conducted;‌ 2. assign individuals to design and select the samples for the Transaction 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.basis.‌