OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph E, or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify Provider in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Provider shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, independence or performance of its responsibilities in order to resolve the concerns identified by OIG. If, following OIG’s review of any information provided by Provider regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Provider in writing that Provider shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Provider must engage a new IRO within 60 days of its receipt of OIG’s written notice. The final determination as to whether or not to require Provider to engage a new IRO shall be made at the sole discretion of OIG.
OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the final determination as to whether or not to require GSK to engage a new IRO shall be made at the sole discretion of OIG. Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other sys...
OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require Xxxxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. Xxxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring Xxxxxxx to engage a new IRO, OIG shall notify Xxxxxxx of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, Xxxxxxx may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with Xxxxxxx prior to requiring Xxxxxxx to terminate the IRO. However, the final determination as to whether or not to require Xxxxxxx to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B CLAIMS REVIEW
OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph E or has a prohibited relationship as set forth in paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify CHN in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. CHN shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, independence, relationship to CHN or performance of its responsibilities in order to resolve the concerns identified by OIG. If, following OIG’s review of any information provided by CHN regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify CHN in writing that CHN shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. CHN must engage a new IRO within 60 days of its receipt of OIG’s written notice. The final determination as to whether or not to require CHN to engage a new IRO shall be made at the sole discretion of OIG.
OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Section II, is not independent and objective as set forth in Section IV (or that the Legal IRO has a relationship to KDMC prohibited under Section IV), or has failed to carry out its responsibilities as described in Section III, OIG may, at its sole discretion, require KDMC to engage a new IRO in accordance with Section I of this Appendix. KDMC must engage a new IRO within 60 days of termination of the IRO. Prior to requiring KDMC to engage a new IRO, OIG shall notify KDMC of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, KDMC may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with KDMC prior to requiring KDMC to terminate the IRO. However, the final determination as to whether or not to require KDMC to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B INTERVENTIONAL CARDIAC PROCEDURES REVIEW
OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify the Friendship Entities in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. The Friendship Entities shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, independence or performance of its responsibilities in order to resolve the concerns identified by OIG. If, following OIG’s review of any information provided by the Friendship Entities regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify the Friendship Entities in writing that the Friendship Entities shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. The Friendship Entities must engage a new IRO within 60 days of their receipt of OIG’s written notice. The final determination as to whether or not to require the Friendship Entities to engage a new IRO shall be made at the sole discretion of OIG. Corporate Integrity Agreement - Appendix A 3 APPENDIX B CLAIMS REVIEW AND ADDITIONAL ITEMS REVIEW
OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require SpecialCare to engage a new IRO in accordance with Paragraph A of this Appendix. SpecialCare must engage a new IRO within 60 days of termination of the IRO. Prior to requiring SpecialCare to engage a new IRO, OIG shall notify SpecialCare of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, SpecialCare may present additional information regarding the IRO’s qualifications, independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with SpecialCare prior to requiring SpecialCare to terminate the IRO. However, the final determination as to whether or not to require SpecialCare to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B ARRANGEMENTS REVIEW The Arrangements Review shall consist of two components: a systems review and a transactions review. The IRO shall perform all components of each Arrangements Review. If there are no material changes to SpecialCare’s systems, processes, policies, and procedures relating to Arrangements, the Arrangements Systems Review shall be performed for the first and fourth Reporting Periods. If SpecialCare materially changes the Arrangements systems, processes, policies, and procedures, the IRO shall perform an Arrangements Systems Review for the Reporting Period in which such changes were made in addition to conducting the systems review for the first and fourth Reporting Periods. The Arrangements Transactions Review shall be performed annually and shall cover each of the five Reporting Periods.
OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require Xxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. Xxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring Xxxxx to engage a new IRO, OIG shall notify Xxxxx of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, Xxxxx may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with Xxxxx prior to requiring Xxxxx to terminate the IRO. However, the final determination as to whether or not to require Xxxxx to engage a new IRO shall be made at the sole discretion of OIG.
OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph E, or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify Monos, Ltd., 215, and Xxxxxxxx in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Monos, Ltd., 215, and Xxxxxxxx shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, independence or performance of its responsibilities in order to resolve the concerns identified by OIG. If, following OIG’s review of any information provided by Monos, Ltd., 215, and Xxxxxxxx regarding its IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Monos, Ltd., 215, and Xxxxxxxx in writing that Monos, Ltd., 215, and Xxxxxxxx shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Monos, Ltd., 215, and Xxxxxxxx must engage a new IRO within 60 days of receipt of OIG’s written notice. The final determination as to whether or not to require Monos, Ltd., 215, and Xxxxxxxx to engage a new IRO shall be made at the sole discretion of OIG.
OIG Removal of IRO. In the event OIG has reason to believe the IRO does not possess the qualifications described in Paragraph B, is not independent and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require Good Shepherd to engage a new IRO in accordance with Paragraph A of this Appendix. Good Shepherd must engage a new IRO within 60 days of termination of the IRO. Prior to requiring Good Shepherd to engage a new IRO, OIG shall notify Good Shepherd of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, Good Shepherd may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with Good Shepherd prior to requiring Good Shepherd to terminate the IRO. However, the final determination as to whether or not to require Good Shepherd to engage a new IRO shall be made at the sole discretion of OIG.
