Common use of EFFECTIVE AND BINDING AGREEMENT Clause in Contracts

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ and OIG agree as follows: A. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. The undersigned ▇▇▇▇▇▇▇ signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌ 1. Lincare shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ 2. If Lincare engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare at the request of OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ A. All terms and OIG agree as follows: A. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent conditions of the parties to CIA not modified in this Amendment shall remain in effect for the remainder of the five-year period of compliance obligations that began on the CIA’s Effective Date. The Effective Date of this Amendment shall be the date the final signatory signs this Amendment (Amendment Effective Date). B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. The undersigned ▇▇▇▇▇▇▇ Signature signatories represent and warrant that they are authorized to execute this CIAAmendment. The undersigned OIG signatories represent that they are signing this CIA Amendment in their official capacities and that they are authorized to execute this CIAAmendment. D. C. This CIA Amendment may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAAmendment. Electronically transmitted copies Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAAmendment. U.S. /▇▇▇▇▇ ▇▇▇▇/ ▇▇▇▇▇ ▇▇▇▇ DATE CHIEF LEGAL OFFICER /▇▇▇▇ ▇. ▇▇/ ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌Engagement 1. Lincare Signature shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.7 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Signature in response to a request by OIG, whichever is later, OIG will notify Lincare Signature if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Signature may continue to engage the IRO.‌IRO. 2. If Lincare Signature engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Signature shall submit the information identified in Section V.A.8 V.A.7 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Signature at the request of OIG, whichever is later, OIG will notify Lincare Signature if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Signature may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌IRO.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ ‌ Lundbeck and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇Lundbeck’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. D. The undersigned ▇▇▇▇▇▇▇ Lundbeck signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA. D. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. ▇▇▇▇ ▇▇▇▇▇▇ DATE Vice President, Chief Compliance Officer Lundbeck LLC ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ESQ. DATE ▇▇▇▇▇▇ & ▇▇▇▇▇▇ Counsel for Lundbeck LLC ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services‌ U.S. Department Services ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Senior Counsel Office of Health and Human Services‌ Counsel to the Inspector General APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌ 1. Lincare Lundbeck shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.9 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Lundbeck in response to a request by OIG, whichever is later, OIG will notify Lincare Lundbeck if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Lundbeck may continue to engage the IRO.‌ 2. If Lincare Lundbeck engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Lundbeck shall submit the information identified in Section V.A.8 V.A.9 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Lundbeck at the request of OIG, whichever is later, OIG will notify Lincare Lundbeck if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Lundbeck may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims IRO Reviews who have expertise in the pharmaceutical industry and in Federal health care program requirements (including but not limited to, the Federal Anti-Kickback Statute and the False Claims Act) applicable to the claims Covered Functions being reviewed;‌ 2. assign individuals to design and select any samples for the Claims Review samples Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviewstechniques; and‌ 53. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌shall:‌‌‌‌ 1. perform each Claims component of the IRO Review in accordance with the specific requirements of the‌the CIA;‌ 2. follow all applicable Federal health care program requirements in making assessments in the IRO Review;‌ 3. request clarification from the appropriate authority (e.g., CMS), if in doubt of the application of a particular Federal health care program requirement;‌‌ 4. respond to all OIG inquires in a prompt, objective, and factual manner; and 5. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, PolyMedica and OIG agree as follows: A. This CIA constitutes shall be binding on the complete agreement between successors, assigns, and transferees of PolyMedica to the parties extent of the businesses and may not operations of PolyMedica that exist at the time of any transfer; POLYMEDICA CORPORATE INTEGRITY AGREEMENT B. This CIA shall become final and binding on the date the final signature is obtained on the CIA; C. Any modifications to this CIA shall be amended except by made with the prior written consent of the parties to this CIA.; B. All requirements and remedies set forth D. OIG may agree to a suspension of PolyMedica's obligations under the CIA in this CIA are the event of PolyMedica's cessation of participation in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable programs. If PolyMedica withdraws from participation in Federal health care program requirementsprograms and is relieved of its CIA obligations by OIG, PolyMedica shall notify OIG at least 30 days in advance of PolyMedica's intent to reapply as a participating provider or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CIA should be reactivated or modified. C. E. The undersigned ▇▇▇▇▇▇▇ PolyMedica signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacities capacity and that they are he is authorized to execute this CIA. POLYMEDICA CORPORATE INTEGRITY AGREEMENT ON BEHALF OF POLYMEDICA CORPORATION AND ITS SUBSIDIARIES /s/ Samuel L. Shanaman 11/08/04 --------------------------- ------------------- SAMUEL L. SHANAMAN DATE Chairman ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ation /s/ Alana Bloom Sullivan 11/04/2004 --------------------------- ------------------- ALANA BLOOM SULLIVAN DATE Chief Co▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇yMedica Corporation /s/ William B. Eck 11/03/2004 --------------------------- ------------------- WILLIAM B. ECK DATE Sr. Vice ▇▇▇▇▇▇▇▇▇ ▇▇▇ Deputy General Counsel PolyMedica Corporation /s/ Mark P. Schnapp 11/03/2004 --------------------------- ------------------- MARK P. SCHNAPP DATE Greenber▇ ▇▇▇▇▇▇▇, ▇. D. This CIA may be executed in counterparts, each ▇. POLYMEDICA CORPORATE INTEGRITY AGREEMENT ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ Larry J. Goldberg 11/3/04 --------------------------------------------- ------------- LARRY J. GOLDBERG DATE Assistan▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇al for Legal Affairs Office of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Inspector General U. S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ Services POLYMEDICA CORPORATE INTEGRITY AGREEMENT APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌ 1. Lincare shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ 2. If Lincare engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare at the request of OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ ‌ Astellas and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s Astellas’ responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. D. The undersigned ▇▇▇▇▇▇▇ Astellas signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA. D. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. ▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ DATE Vice President, Head of Ethics and Compliance Americas Astellas US LLC ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Esq. DATE ▇▇▇▇▇▇▇ ▇. ▇’▇▇▇▇▇▇, Esq. ▇▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ Counsel for Astellas ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services‌ U.S. Department Services ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Senior Counsel Office of Health and Human Services‌ Counsel to the Inspector General APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌ 1. Lincare Astellas shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.9 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Astellas in response to a request by OIG, whichever is later, OIG will notify Lincare Astellas if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Astellas may continue to engage the IRO.‌ 2. If Lincare Astellas engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Astellas shall submit the information identified in Section V.A.8 V.A.9 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Astellas at the request of OIG, whichever is later, OIG will notify Lincare Astellas if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Astellas may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ ‌ USWM and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇USWM’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements. C. D. The undersigned ▇▇▇▇▇▇▇ USWM signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities capacity and that they are authorized to execute this CIA.. Corporate Integrity Agreement – USWM D. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Corporate Integrity Agreement – USWM /▇▇▇ ▇. ▇▇▇▇/ ▇▇▇ ▇▇▇▇ COMPLIANCE OFFICER US WORLDMEDS, LLC DATE Counsel for US WorldMeds, LLC ▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ LLP Corporate Integrity Agreement – USWM ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services‌ Services ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services‌ Services Corporate Integrity Agreement – USWM APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌ 1. Lincare USWM shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ USWM in response to a request by OIG, whichever is later, OIG will notify Lincare USWM if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare USWM may continue to engage the IRO.‌ 2. If Lincare USWM engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ USWM shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare USWM at the request of OIG, whichever is later, OIG will notify Lincare USWM if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare USWM may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements applicable relating to the claims being reviewed;‌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 Claims Review samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviewstechniques; and‌ 53. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌shall:‌‌‌‌ 1. perform each Claims Review component of the IRO Reviews in accordance with the specific requirements of the‌the CIA;‌ 2. follow all applicable Federal health care program and FDA requirements in making assessments in the IRO Reviews;‌ 3. request clarification from the appropriate authority (e.g., CMS), if in doubt of the application of a particular Federal health care program requirement;‌ 4. respond to all OIG inquires in a prompt, objective, and factual manner; and 5. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA. D. USWM Responsibilities‌ USWM shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.E of this CIA and that all records furnished to the IRO are accurate and complete.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ EPI and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. The undersigned ▇▇▇▇▇▇▇ Endo signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA. D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ Endo Pharmaceuticals Inc. Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌Engagement 1. Lincare EPI shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. D. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.9 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ EPI in response to a request by OIG, whichever is later, OIG will notify Lincare EPI if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare EPI may continue to engage the IRO.‌IRO. 2. If Lincare EPI engages a new IRO during the term of the CIA, that this IRO must shall also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ EPI shall submit the information identified in Section V.A.8 V.A.9 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare EPI at the request of OIG, whichever is later, OIG will notify Lincare EPI if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare EPI may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌IRO.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, Vencor and OIG agree as follows: A. This CIA constitutes shall be binding on the complete agreement between successors, assigns, and transferees of Vencor except that the parties obligations of this CIA shall not apply to facilities, business units or locations that Vencor or a Vencor successor does not own or operate as a result of an asset sale to an unrelated third party; B. This CIA shall become final and may not binding on the date the final signature is obtained on the CIA and shall incorporate by reference any other Corporate Integrity Agreements obligating Vencor or any of its facilities, business units or locations at the time of execution of this CIA; C. Any modifications to this CIA shall be amended except by made only with the prior written consent of the parties to this CIA.; and B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. D. The undersigned ▇▇▇▇▇▇▇ Vencor signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent signatory represents that they are he is signing this CIA in their his official capacities capacity and that they are he is authorized to execute this CIA. D. This CIA may be executed in counterparts. On Behalf of Vencor ------------------------------------------------ ------------------------- ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ DATE President, each of which constitutes an original Chairman, and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌ 1. Lincare shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Chief Executive Officer ------------------------------------------------ ------------------------- ▇▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable▇. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ 2. If Lincare engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 DATE Vice President and Compliance Officer On behalf of the CIA to OIG within 30 days Office of engagement Inspector General of the IRODepartment of Health and Human Services ------------------------------------------------ ------------------------- ▇▇▇▇▇ ▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services EXHIBIT A --------- VENCOR MONITOR TASK LIST ------------------------ THIS DOCUMENT IS DESIGNED TO PROVIDE GUIDANCE TO THE MONITOR; IT MAY BE AMENDED AT ANY TIME CONSISTENT WITH THE TERMS OF THE CORPORATE INTEGRITY AGREEMENT ("CIA"). Within 30 days after OIG receives this information or any additional information submitted by Lincare at the request of OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌NOTHING IN THIS TASK LIST SHOULD BE INTERPRETED TO LIMIT THE TERMS AND CONDITIONS OF THE CIA. B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions I. Analysis of the Claims Reviews who have Quality Compliance Infrastructure A. Board of Directors: Existence of the Board level committee with a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌quality improvement function.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ Arthrex and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇Arthrex’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements. C. D. The undersigned ▇▇▇▇▇▇▇ Arthrex signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities capacity and that they are authorized to execute this CIA. D. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌ 1. Lincare Arthrex shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Arthrex in response to a request by OIG, whichever is later, OIG will notify Lincare Arthrex if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Arthrex may continue to engage the IRO.‌ 2. If Lincare Arthrex engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Arthrex shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Arthrex at the request of OIG, whichever is later, OIG will notify Lincare Arthrex if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Arthrex may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims IRO Reviews who have expertise in the medical device industry and in all applicable Federal health care program and FDA requirements applicable relating to the claims being reviewed;‌Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with medical devices and the Federal Anti-Kickback Statute and False Claims Act.‌ 2. assign individuals to design and select the Claims samples for the IRO Transactions Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviewstechniques; and‌ 53. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review component of the IRO Reviews in accordance with the specific requirements of the‌the CIA;‌ 2. follow all applicable Federal health care program and FDA requirements in making assessments in the IRO Reviews;‌ 3. respond to all OIG inquires in a prompt, objective, and factual manner; and 4. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA. D. Arthrex Responsibilities‌ Arthrex shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.E of this CIA and that all records furnished to the IRO are accurate and complete.

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ ‌ Pfizer and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇Pfizer’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. D. The undersigned ▇▇▇▇▇▇▇ Pfizer signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities capacity and that they are authorized to execute this CIA. D. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇ ▇▇▇▇▇▇▇/ ▇▇▇▇ ▇▇▇▇▇▇▇ Executive Vice President and Chief Compliance and Risk Officer Pfizer Inc. Counsel for Pfizer Inc. DLA Piper Counsel for Pfizer Inc. Ropes & ▇▇▇▇ ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services‌ U.S. Department Services ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Senior Counsel Office of Health and Human Services‌ Counsel to the Inspector General APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the CIA. A. IRO Engagement‌ 1. Lincare Pfizer shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. D. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.9 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Pfizer in response to a request by OIG, whichever is later, OIG will notify Lincare Pfizer if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Pfizer may continue to engage the IRO.‌ 2. If Lincare Pfizer engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Pfizer shall submit the information identified in Section V.A.8 V.A.9 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Pfizer at the request of OIG, whichever is later, OIG will notify Lincare Pfizer if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Pfizer may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ Walgreens and OIG agree as follows: A. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. C. OIG may agree to a suspension of Walgreens’ obligations under this CIA based on a certification by Walgreens that it is no longer performing Covered Functions and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that performs Covered Functions. If Walgreens is relieved of its CIA obligations, Walgreens shall be required to notify OIG in writing at least 30 days in advance if Walgreens plans to resume performing Covered Functions or to obtain an ownership or control interest in any entity that performs Covered Functions. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s Walgreens’ responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. E. The undersigned ▇▇▇▇▇▇▇ Walgreens signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA. D. F. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Walgreen Co. - Corporate Integrity Agreement DATE Counsel to Walgreen Co. DATE Walgreen Co. - Corporate Integrity Agreement ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services‌ Services ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ DATE Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ Services Walgreen Co. - Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌ 1. Lincare shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ 2. If Lincare engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare at the request of OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews who have expertise in the Federal health care program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ ‌ Gold Coast and OIG agree as follows: A. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇Gold Coast’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. C. The undersigned ▇▇▇▇▇▇▇ Gold Coast signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA.CIA.‌ D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services‌ U.S. Department of Health and Human Services‌ ON BEHALF OF VENTURA COUNTY MEDI-CAL MANAGED CARE COMMISSION D/B/A GOLD COAST HEALTH PLAN‌‌ APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA. A. IRO Engagement‌ 1. Lincare Gold Coast shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 V.A.7 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ Gold Coast in response to a request by OIG, whichever is later, OIG will notify Lincare Gold Coast if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Gold Coast may continue to engage the IRO.‌ 2. If Lincare Gold Coast engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ Gold Coast shall submit the information identified in Section V.A.8 V.A.7 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare Gold Coast at the request of OIG, whichever is later, OIG will notify Lincare Gold Coast if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare Gold Coast may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Reviews Medical Loss Ratio (MLR) Element Review who have expertise in the Federal health care program medical loss ratio standards and calculations required by 42 C.F.R. § 438.8 and the applicable medical loss ratio calculation and reporting requirements applicable to of the claims being reviewed;‌California Department of Health Care Services; and 2. assign individuals to design and select the Claims Review samples who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Reviews who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professionals acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Claims Reviews; and‌ 5. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌basis. C. IRO Responsibilities The IRO shall:‌‌‌shall:‌‌ 1. perform each Claims MLR Element Review in accordance with the specific requirements of the‌the CIA;‌ 2. follow all applicable Medicaid program requirements as well as the terms of Gold Coast’s contract with the California Department of Health Care Services (DHCS) in making assessments in the MLR Element Review;‌ 3. request clarification from the Medicaid program or DHCS if in doubt of the application of a particular program policy or regulation or contractual provision;‌ 4. respond to all OIG inquires in a prompt, objective, and factual manner; and 5. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA. D. Gold Coast Responsibilities‌ Gold Coast shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.D of this CIA and that all records furnished to the IRO are accurate and complete.