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 E, or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify OC and Xxxxxx in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. OC and Xxxxxx 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 OC and Xxxxxx regarding its IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify OC and Xxxxxx in writing that OC and Xxxxxx shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. OC and Xxxxxx 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 OC and Xxxxxx 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 CCH to engage a new IRO in accordance with Paragraph A of this Appendix. CCH must engage a new IRO within 60 days of termination of the IRO. Prior to requiring CCH to engage a new IRO, OIG shall notify CCH 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, CCH 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 CCH prior to requiring CCH to terminate the IRO. However, the final determination as to whether or not to require CCH 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 shall notify Arc in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Arc 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 Arc regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Arc in writing that Arc shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Xxx 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 Arc 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 Pentec in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Pentec 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 Pentec regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Pentec in writing that Pentec shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Pentec 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 Pentec 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 Indivior in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Indivior 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 Indivior regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Indivior in writing that Indivior shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Indivior 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 Indivior to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B INDEPENDENT REVIEW ORGANIZATION REVIEWS
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 Xxxx in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Xxxx 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 Xxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Sava in writing that Sava shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Xxxx 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 Xxxx to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX C SKILLED NURSING FACILITY CLAIMS 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 E or has failed to carry out its responsibilities as described in Paragraph C, OIG shall notify Amgen in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Amgen 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 Amgen regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Amgen in writing that Amgen shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. Amgen 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 Amgen to engage a new IRO shall be made at the sole discretion of OIG. CIA with Amgen Inc. Appendix B
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 SMMC in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. SMMC 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 SMMC regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify SMMC in writing that SMMC shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. SMMC 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 SMMC 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 the Provider to engage Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement - Appendix A a new IRO in accordance with Paragraph A of this Appendix. The Provider must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider to engage a new IRO, OIG shall notify the Provider 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, the Provider 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 the Provider prior to requiring the Provider to terminate the IRO. However, the final determination as to whether or not to require the Provider to engage a new IRO shall be made at the sole discretion of OIG. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement- Appendix B APPENDIX B CLAIMS REVIEW
