Common use of OIG Removal of IRO Clause in Contracts

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

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph BSection II, is not independent and objective as set forth in Paragraph DSection 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 Paragraph CSection III, OIG may, at its sole discretion, require the Provider KDMC to engage Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement - Appendix A a new IRO in accordance with Paragraph A Section I of this Appendix. The Provider KDMC must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider KDMC to engage a new IRO, OIG shall notify the Provider 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, the Provider 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 the Provider KDMC prior to requiring the Provider KDMC to terminate the IRO. However, the final determination as to whether or not to require the Provider KDMC 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 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 may, at its sole discretion, require the Provider CareAll Entities 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 CareAll Entities must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider the CareAll Entities to engage a new IRO, OIG shall notify the Provider CareAll Entities 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 CareAll Entities 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 CareAll Entities prior to requiring the Provider CareAll Entities to terminate the IRO. However, the final determination as to whether or not to require the Provider CareAll Entities 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 REVIEW‌REVIEW

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 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 the Provider InterMune 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 InterMune to engage a new IRO, OIG shall notify the Provider InterMune 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 InterMune may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. InterMune shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider InterMune prior to requiring the Provider InterMune to terminate the IRO. However, the final determination as to whether or not to require the Provider InterMune to engage a new IRO shall be made at the sole discretion of OIGOXX. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement- Appendix B APPENDIX B CLAIMS REVIEW‌Xxxxxxxx X to CIA for InterMune, Inc. Promotional and Product Services Engagement

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 the Provider DIG Entities 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 the DIG Entities must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider the DIG Entities to engage a new IRO, OIG shall notify the Provider DIG Entities 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 DIG Entities 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 DIG Entities prior to requiring the Provider DIG Entities to terminate the IRO. However, the final determination as to whether or not to require the Provider DIG Entities 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.

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 Harmony-Xxxxxx 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 Harmony-Xxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider Harmony-Xxxxxx to engage a new IRO, OIG shall notify the Provider Harmony-Xxxxxx 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 Harmony- Xxxxxx 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 Harmony-Xxxxxx prior to requiring the Provider Harmony-Xxxxxx to terminate the IRO. However, the final determination as to whether or not to require the Provider Harmony-Xxxxxx 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 REVIEW‌REVIEW

OIG Removal of IRO. In the event OIG has reason to believe the an IRO engaged by Xxxxxxxxxx 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 Xxxxxxxxxx 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 Xxxxxxxxxx must engage a new IRO within 60 days of termination of the an IRO. Prior to requiring a Provider Xxxxxxxxxx to engage a new IRO, OIG shall notify the Provider Xxxxxxxxxx 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 Xxxxxxxxxx may present additional information regarding the an IRO’s qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider Xxxxxxxxxx prior to requiring the Provider Xxxxxxxxxx to terminate the IRO. However, the final determination as to whether or not to require the Provider Xxxxxxxxxx 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 REVIEW‌B

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 Xx. Xxxxxxxx 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 Xx. Xxxxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider Xx. Xxxxxxxx to engage a new IRO, OIG shall notify the Provider Xx. Xxxxxxxx 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 Xx. Xxxxxxxx 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 Xx. Xxxxxxxx prior to requiring the Provider Xx. Xxxxxxxx to terminate the IRO. However, the final determination as to whether or not to require the Provider Xx. Xxxxxxxx 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 REVIEW‌REVIEW

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 DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Xx. Xxxxxxxx and Fleckner, at P.C. in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Xx. Xxxxxxxx and Fleckner, P.C. 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 sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require following OIG’s review of any information provided by Xx. Xxxxxxxx and Fleckner, P.C. regarding their IRO, OIG determines that the Provider IRO has not met the requirements of this Appendix, OIG shall notify Xx. Xxxxxxxx and Fleckner, P.C. in writing that Xx. Xxxxxxxx and Fleckner,‌ P.C. shall be required 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 Xx. Xxxxxxxx and Fleckner, P.C. must engage a new IRO within 60 days of termination receipt of the IROOIG’s written notice. 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 The final determination as to whether or not to require the Provider Xx. Xxxxxxxx and Fleckner, P.C. 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 QUARTERLY CLAIMS REVIEW‌REVIEW‌‌

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 Xxxxxxx-Xxxxxx 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 Xxxxxxx-Xxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring a Provider Xxxxxxx-Xxxxxx to engage a new IRO, OIG shall notify the Provider Xxxxxxx-Xxxxxx 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 Xxxxxxx- Xxxxxx 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 Xxxxxxx-Xxxxxx prior to requiring the Provider Xxxxxxx-Xxxxxx to terminate the IRO. However, the final determination as to whether or not to require the Provider Xxxxxxx-Xxxxxx 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 REVIEW‌REVIEW

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 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 the Provider WellCare 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 WellCare to engage a new IRO, OIG shall notify the Provider WellCare 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 WellCare may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. WellCare Appendix A to Corporate Integrity Agreement WellCare Health Plans, Inc. shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider WellCare prior to requiring the Provider WellCare to terminate the IRO. However, the final determination as to whether or not to require the Provider WellCare to engage a new IRO shall be made at the sole discretion of OIG. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Appendix A to Corporate Integrity Agreement- Appendix B Agreement WellCare Health Plans, Inc. APPENDIX B CLAIMS REVIEW‌REIMBURSEMENT FUNCTIONS REVIEWS

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph Section B, is not independent and objective as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph Section C, OIG shall notify Novartis in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. OIG may, at its sole discretion, require the Provider Novartis to engage Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement - Appendix A a new IRO in accordance with Paragraph Section A of this Appendix. The Provider Novartis must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring a Provider Novartis to engage a new IRO, OIG shall notify the Provider Novartis 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 Novartis may present additional information regarding the IRO’s qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider Novartis prior to requiring the Provider Novartis to terminate the IRO. However, the final determination as to whether or not to require the Provider Novartis 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 REVIEW‌C

OIG Removal of IRO. In the event OIG has reason to believe the IRO does IRO(s) do 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 Allegiance to engage Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement - Appendix A a new IRO IRO(s) in accordance with Paragraph A of this Appendix. The Provider Allegiance must engage a new IRO IRO(s) within 60 days of termination of the IRO. Prior to requiring a Provider Allegiance to engage a new IROIRO(s), OIG shall notify the Provider Allegiance 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 Allegiance may present additional information regarding the IRO’s IRO(s)’ qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO IRO(s) with the Provider Allegiance prior to requiring the Provider Allegiance to terminate the IROIRO(s). However, the final determination as to whether or not to require the Provider Allegiance to engage a new IRO IRO(s) shall be made at the sole discretion of OIG. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Corporate Integrity Agreement- Appendix B APPENDIX B CLAIMS REVIEW‌CARDIAC CATHETERIZATION PROCEDURES 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 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 the Provider Gambro 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 Gambro to engage a new IRO, OIG shall notify the Provider Gambro 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 Gambro may present additional information regarding request a meeting with Gambro Healthcare, Inc. OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Gambro shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider Gambro prior to requiring the Provider Gambro to terminate the IRO. However, the final determination as to whether or not to require the Provider Gambro to engage a new IRO shall be made at the sole discretion of OIG. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Gambro Healthcare, Inc. Corporate Integrity Agreement- Agreement Appendix B C C-2 GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX B D CLAIMS REVIEW‌REVIEW

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 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 the Provider Gambro 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 Gambro to engage a new IRO, OIG shall notify the Provider Gambro 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 Gambro may present additional information regarding request a meeting with Gambro Healthcare, Inc. OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Gambro shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with the Provider Gambro prior to requiring the Provider Gambro to terminate the IRO. However, the final determination as to whether or not to require the Provider Gambro to engage a new IRO shall be made at the sole discretion of OIG. Alliance/Active/Xxxxx/Xxxx/Xxxxxx Gambro Healthcare, Inc. Corporate Integrity Agreement- Agreement Appendix B C GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX B D CLAIMS REVIEW‌REVIEW