Common use of EFFECTIVE AND BINDING AGREEMENT Clause in Contracts

EFFECTIVE AND BINDING AGREEMENT. Progenity 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)

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EFFECTIVE AND BINDING AGREEMENT. Progenity Rehab 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. C. OIG may agree to a suspension of ProgenityRehab’s obligations under this CIA based on a certification by Progenity Rehab that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Rehab is relieved of its CIA obligations, Progenity shall Rehab will be required to notify OIG in writing at least 30 days in advance if Progenity Rehab plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Rehab 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx XxXxxxxx/ 5/11/15 XXXXXXX XXXXXXXX DATE Rehab Medical /Xxxxxxx Xxxxxxx, 2020 Xxxxxx Xxxxxxx XX/ 5/12/15 XXXXXXX XXXXXXX, XX. DATE General Counsel, Progenity /s/ Xxxxxxxx Xxxxx Xxxxx LLP /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx XxXxxxx/ 5/15/15 XXXXXX X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxxx X. Xxxxx/ 5-12-2015 XXXXXX X. XXXXX XXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Orbit 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. C. OIG may agree to a suspension of ProgenityOrbit’s obligations under this CIA based on a certification by Progenity Orbit that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity Orbit plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Orbit 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx Xxxxx/ 5/11/15 XXXXXXX XXXXX DATE Orbit Medical, 2020 Xxxxxx Xxxxxxx Inc. /Xxxxxxx Xxxxxxx, Xx./ 5/12/15 XXXXXXX XXXXXXX, XX. DATE General Counsel, Progenity /s/ Xxxxxxxx Xxxxx Xxxxx LLP /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx XxXxxxx/ 5/15/15 XXXXXX X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxxx X. Xxxxx/ 5-12-2015 XXXXXX X. XXXXX XXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Indivior 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityIndivior’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. E. D. The undersigned Progenity Indivior 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx X. Xxxxxx/ 7/24/2020 XXXXXXX (XXXXX) XXXXXX DATE Chief Integrity & Compliance Officer Indivior, 2020 Xxxxxx Xxxxxxx Inc. /Xxxxxx Xxxxxxxxx/ 7/24/2020 XXXXXX XXXXXXXXX DATE General CounselChief Legal Officer Indivior, Progenity /s/ Xxxxxxxx Inc. /Xxxxxx Xxxxxxx/ 7/24/2020 XXXXXXXX X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx XXXXXX DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx XXXXXX XXXXXXX XXXXX XXXXXXXX Xxxxx Lovells US LLP Counsel for Progenity /s/ Xxxx Indivior /Xxxx X. Re July 20, 2020 Re/ 7/23/2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21/Xxxx X. Xxxxxxx/ 7/24/2020 XXXX X. XXXXXXX, 2020 XXXXX XXXXXXX Senior Counsel DATE XXXXXXXX XXXXXX, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)

EFFECTIVE AND BINDING AGREEMENT. Progenity CCH 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. C. OIG may agree to a suspension of ProgenityCCH’s obligations under this CIA based on a certification by Progenity CCH that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity CCH is relieved of its CIA obligations, Progenity shall CCH will be required to notify OIG in writing at least 30 days in advance if Progenity it plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modifiedmodified as to CCH. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity signatories for CCH 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxx Xxxxxxx/ 1-26-15 XXXXXX XXXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx Chief Executive Officer /Xxxxxx Xxxx/ 1/26/15 XXXXXX XXXX DATE Member /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx XxXxxxx/ 1/30/15 XXXXXX X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxxxxx X. Xxxx/ 1/27/15 XXXXXXX X. XXXX DATE Senior Associate Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Amedisys Inc), Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity KDMC 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. C. OIG may agree to a suspension of ProgenityKDMC’s obligations under this CIA based on a certification by Progenity KDMC that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity KDMC is relieved of its CIA obligations, Progenity shall KDMC will be required to notify OIG in writing at least 30 days in advance if Progenity KDMC plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity KDMC 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxxx Xxxxxxxxx/ XXXXXXX XXXXXXXXX President/CEO of King’s Daughters Health System DATE General Counsel, Progenity /s/ Xxxxxxxx 5/16/14 /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Xxxx/ XXXXXX XXXX Counsel for Progenity /s/ Xxxx King’s Daughters Medical Center Xxxxxx & Xxxxxxxx, PLLC DATE 5/16/14 /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 5/27/14 XXXXXX X. RE DATE XXXXXXX Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE /Xxxx Xxxxxx/ XXXX XXXXXX‌ Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services DATE 5/21/14 APPENDIX A INDEPENDENT REVIEW ORGANIZATIONS This Appendix contains the requirements relating to the Independent Review Organization Organizations (IROIROs) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity CHSI 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. C. OIG may agree to a suspension of ProgenityCHSI’s obligations under this CIA based on a certification by Progenity CHSI that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity CHSI is relieved of its CIA obligations, Progenity shall CHSI will be required to notify OIG in writing at least 30 days in advance if Progenity CHSI plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity CHSI 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Community Health Systems, Inc. Corporate Integrity Agreement /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 2123, 2020 Xxxxxxxx X. 2014 Xxxxxx Xxxxxxxx DATE X. Sr. Vice President, Corporate Compliance and Privacy Officer /s/ Xxxxxxx Day Xxxxxx July 23, 0000 Xxxxxxx Xxxxxx, Xxxx & Xxxxxxxx LLP Esq. DATE Counsel for Progenity CHSI Community Health Systems, Inc. Corporate Integrity Agreement /s/ Xxxx Xxxxxx X. Re XxXxxxx July 2028, 2020 XXXX 2014 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx X. Xxxxxx July 2124, 2020 XXXXX 2014 XXXXXXX X. XXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Community Health Systems, Inc. Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Quorum Health Corp), Corporate Integrity Agreement (Community Health Systems Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity Halifax 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. C. OIG may agree to a suspension of ProgenityHalifax’s obligations under this CIA based on a certification by Progenity Halifax that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity Halifax is relieved of its CIA obligations, Progenity shall Halifax will be required to notify OIG in writing at least 30 days in advance if Progenity Halifax plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Halifax 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxx Xxxxxx/ 3/10/14 XXXX XXXXXX DATE President & Chief Executive Officer Halifax Health /Xxxxx Xxxxxxxx/ 3/10/14 XXXXX XXXXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx Counsel Halifax Hospital Medical Center /X. Xxxx Xxxxxxxx/ 3/10/14 X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx XXXX XXXXXXXX DATE X. Xxxxxxx Day Xxxxxx, Xxxx XxXxxxxxx Will & Xxxxxxxx Xxxxx LLP Counsel for Progenity /s/ Halifax Health /Xxxx Xxxxxx/ 3/10/14 XXXX XXXXXX DATE President & Chief Executive Officer Halifax Health /X. Xxxx Xxxxxxxx/ 3/10/14 X. Re July 20, 2020 XXXX XXXXXXXX DATE XxXxxxxxx Will & Xxxxx LLP Counsel for Halifax Health /Xxxxxx X. RE XxXxxxx/ 3/10/14 XXXXXX X. XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxxx/ 3/9/2014 XXXXX XXXXXXX X. XXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services /Xxxxx X. Xxxxxxxx/ 3/7/2014 XXXXX X. XXXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services /Xxxxxxx X. Xxxx/ 3/10/2014 XXXXXXX X. XXXX DATE Associate Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Legal Independent Review Organization (Legal IRO) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Each Provider 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. C. OIG may agree to a suspension of Progenitya Provider’s obligations under this CIA based on a certification by Progenity the Provider that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity the Provider is relieved of its CIA obligations, Progenity shall the Provider will be required to notify OIG in writing at least 30 days in advance if Progenity the Provider plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Provider 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Alliance/Active/Xxxxx/Xxxx/Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Parkland and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Parkland. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. OIG X. XXX may agree to a suspension of ProgenityParkland’s obligations under this CIA based on a certification by Progenity Parkland that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Parkland is relieved of its CIA obligations, Progenity shall Parkland will be required to notify OIG in writing at least 30 days in advance if Progenity Parkland plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Parkland 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxx X. Xxxxx/ 5/24/13 XXXXXX X. XXXXX DATE Interim Chief Executive Officer Parkland Health and Hospital System /Xxxx X. Xxxxxxx/ 5/24/13 XXXX X. XXXXXXX, 2020 Xxxxxx Xxxxxxx MS, CPA, CHC DATE Sr. Vice President/Chief Compliance and Ethics Officer Parkland Health and Hospital System /Xxxx X. Xxxxxx/ 5/24/13 XXXX X. XXXXXX DATE General CounselCounsel Parkland Health and Hospital System /Xxxxx X. Xxxxxxx/ 5/28/13 XXXXX X. XXXXXXX DATE Xxxxxx and Xxxxxxx, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Parkland /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 5/30/13 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxx X. Xxxxxx Berlin/ 5/28/13 XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains /Xxxxxxxxx Xxxxx/ 5/28/13 XXXXXXXXX XXXXX DATE Associate Counsel Office of Inspector General U. S. Department of Health and Human Services A. Billing IRO Engagement 1. Parkland shall engage a Billing IRO that possesses the requirements relating qualifications set forth in Paragraph B, below, to perform the Independent Review Organization (responsibilities in Paragraph C, below. The Billing IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.14 of the CIA or any additional information submitted by Parkland in response to a request by OIG, whichever is later, OIG will notify Parkland if the IRO is unacceptable. Absent notification from OIG that the Billing IRO is unacceptable, Parkland may continue to engage the Billing IRO) required by Section III.E . 2. If Parkland engages a new Billing IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new Billing IRO is engaged, Parkland shall submit the information identified in Section V.A.14 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 Parkland at the request of OIG, whichever is later, OIG will notify Parkland if the IRO is unacceptable. Absent notification from OIG that the Billing IRO is unacceptable, Parkland may continue to engage the IRO.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity RMC and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of RMC. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. D. OIG may agree to a suspension of ProgenityRMC’s obligations under this CIA based on a certification by Progenity RMC that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity RMC is relieved of its CIA obligations, Progenity shall RMC will be required to notify OIG in writing at least 30 days in advance if Progenity RMC plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity RMC 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxxxxxxxx Xxxxxx/ XXXXXXXXXXX XXXXXX Senior Vice President and General Counsel Rural/Metro Corporation 6/14/12 DATE /Xxxxxxx Xxxxxxx/ XXXXXXX XXXXXXX Xxxxxx Xxxxxxx July 21Xxxxx & Xxxxxxxxxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Rural/Metro Corporation 6/14/12 DATE /Xxxxxxx X. Re July 20XxXxxxxx/ 6/14/12 XXXXXXX X. XXXXXXXX Xxxxxx Xxxxxxx Xxxxx & Xxxxxxxxxxx, 2020 XXXX LLP Counsel for Rural/Metro Corporation DATE /Xxxxxxx X. RE DATE Assistant Xxxxxx/ XXXXXXX X. XXXXXX Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 216/15/12 DATE /Xxxxxx X. Xxxxxxxx/ XXXXXX X. XXXXXXXX Associate Counsel 6/15/12 DATE Rural/Metro Corporation Corporate Integrity Agreement May 9, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services 2012 This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Dignity Health 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. C. OIG may agree to a suspension of ProgenityDignity Health’s obligations under this CIA based on a certification by Progenity Dignity Health that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Dignity Health is relieved of its CIA obligations, Progenity Dignity Health shall be required to notify OIG in writing at least 30 days in advance if Progenity Dignity Health plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Dignity Health 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx Xxxxxxx/ 10.29.14 XXXXXXX XXXXXXX DATE Sr. Executive Vice President Chief Financial Officer Dignity Health /Raja X.X. Xxxxxxx/ 29 October 2014 RAJA X.X. XXXXXXX DATE V.P. & Associate General Counsel for Regulatory Affairs Dignity Health /Xxxxxxxx Xxxxxxxxx/ 10/29/14 XXXXXXXX XXXXXXXXX DATE Corporate Compliance Officer Dignity Health /Xxxx Xxx Xxxxxxx/ Oct. 29, 2020 Xxxxxx Xxxxxxx 2014 XXXX XXX XXXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Dignity Health /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 10/30/2014 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxxxx X. Xxxxx/ 10-29-2014 XXXXXXX X. XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement 1. Dignity Health 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.11 of the CIA or any additional information submitted by Dignity Health in response to a request by OIG, whichever is later, OIG will notify Dignity Health if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Dignity Health may continue to engage the IRO. 2. If Dignity Health engages a new IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, Dignity Health shall submit the information identified in Section V.A.11 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 Dignity Health at the request of OIG, whichever is later, OIG will notify Dignity Health if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Dignity Health may continue to engage the IRO.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity J&J and OIG XXX agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of J&J. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity J&J 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx THIS PAGE IS INTENTIONALLY LEFT BLANK. /Xxxx X. Xxxxxx/ 10/31/13 XXXX X. XXXXXX DATE Chief Compliance Officer Xxxxxxx July 21, 2020 Xxxxxx & Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day /Xxxx Xxxxxx, Xxxx Esq./ 10/31/13 XXXX XXXXXX, ESQ. DATE King & Xxxxxxxx Spalding LLP Counsel for Progenity /s/ Xxxx Xxxxxxx & Xxxxxxx /Xxxxxxxxxxx X. Re July 20Xxxx, 2020 XXXX Esq./ 10/31/13 XXXXXXXXXXX X. RE XXXX, ESQ. DATE King & Spalding LLP Counsel for Xxxxxxx & Xxxxxxx /Xxxxxx Xxxxx, Esq./ 10/31/13 XXXXXX XXXXX, ESQ. DATE King & Spalding LLP Counsel for Xxxxxxx & Xxxxxxx ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ /Xxxxxx X. XxXxxxx/ 10/31/13 XXXXXX XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxx X. Xxxxxxx/ 10/31/13 XXXX X. XXXXXXX DATE Senior Counsel Office of the Inspector General U.S. Department /Xxxxx X. Xxxxxx/ 10-31-2013 _ XXXXX X. XXXXXX DATE Senior Counsel Office of Health and Human Services the Inspector General This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Aegerion 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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 affect: (1) ProgenityAegerion’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 and FDA requirements. E. D. The undersigned Progenity Aegerion 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21Xxxx 9/18/17 XXXXXXX XXXX DATE President and Chief Accounting Officer Aegerion Pharmaceuticals, 2020 Xxxxxx Inc. /s/ Xxxxx Xxxxxxx 9/18/2017 XXXXX XXXXXXX DATE General CounselVice President, Progenity Ethics and Compliance Officer Aegerion Pharmaceuticals, Inc. /s/ Xxxxxxxx Xxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx 9/18/2017 XXXXXX X. Xxxxxxxx XXXX DATE XXXXX X. Xxxxxxx Day Xxxxxx, XXXXXXXX Ropes & Xxxx & Xxxxxxxx LLP Counsel for Progenity Aegerion Pharmaceuticals, Inc. /s/ Xxxx X. Re July 20, 2020 9/22/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxx X. Xxxxxxx July 21, 2020 XXXXX 9/22/17 XXXX X. XXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ PCMC 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. C. OIG may agree to a suspension of ProgenityPCMC’s obligations under this CIA based on a certification by Progenity PCMC that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity PCMC is relieved of its CIA obligations, Progenity PCMC shall be required to notify OIG in writing at least 30 days in advance if Progenity PCMC plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityPCMC’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. E. The undersigned Progenity PCMC 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxxx Xxxxxxx/ XX. XXXXXXX XXXXXXX Chief Executive Officer Pine Creek Medical Center 11-9-17 DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxx Xxxxx/ XXXX X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, XXXXX Xxxx Xxxx & Xxxxxxxx XxXxxx, LLP Counsel for Progenity /s/ Xxxx Pine Creek Medical Center, LLC 11/9/17 DATE /Xxxx X. Re July 20, 2020 Re/ 11/15/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxxxx/ 11/16/2017 XXXXX XXXXXXX X. XXXXXXXX DATE Senior Counsel Office of Inspector General U.S. 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.E of the CIA. A. IRO Engagement‌ 1. PCMC 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by PCMC in response to a request by OIG, whichever is later, OIG will notify PCMC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PCMC may continue to engage the IRO.‌ 2. If PCMC 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, PCMC 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 PCMC at the request of OIG, whichever is later, OIG will notify PCMC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PCMC may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Mallinckrodt 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityMallinckrodt’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. E. D. The undersigned Progenity Mallinckrodt 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx /Xxxx Xxxxx/ March 3, 2022 XXXX XXXXX DATE Executive Vice President and Chief Legal Officer Mallinckrodt plc /Xxxx X. Dunn/ March 3, 2022 XXXX X. DUNN DATE XXXXXXXX X. XXXXX Skadden, Arps, Slate, Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, & Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Mallinckrodt plc /Xxxx X. Re July 20, 2020 Xx/ 02/07/2022 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxx X. Xxxxxxx/ 3/3/2022 XXXX X. XXXXXXX DATE XXXXXXXX X. XXXXXX Senior Counsel Office of Counsel to the Inspector General U.S. Department Office of Health and Human Services Inspector General This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Allegiance and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Allegiance. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. D. OIG may agree to a suspension of ProgenityAllegiance’s obligations under this CIA based on a certification by Progenity Allegiance that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Allegiance is relieved of its CIA obligations, Progenity shall Allegiance will be required to notify OIG in writing at least 30 days in advance if Progenity Allegiance plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Allegiance 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx Xxxxxxxx/ 4/23/13 XXXXXXX XXXXXXXX President and Chief Executive Officer Allegiance Health DATE /Xxxxx X. Xxxxxx/ 4/25/2013 XXXXX X. XXXXXX DATE Xxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx Xxxxxxx, Xxxxx & Xxxxxxxx LLP Counsel Xxxxx, X.X. Xxxxxxx for Progenity /s/ Xxxx Allegiance Health /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 6/5/13 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 6/14/2013 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization Organization(s) (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, Rotech and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Rotech; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. This C. Any modifications to this CIA constitutes shall be made with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of Progenity’s Rotech's obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of Rotech's cessation of participation in Federal health care program and it does not have any ownership or control interest, as defined programs. If Rotech withdraws from participation in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity programs and is relieved of from its CIA obligationsobligations by the OIG, Progenity shall be required Rotech agrees to notify OIG in writing at least 30 days in advance if Progenity plans of Rotech's intent to resume providing health care items reapply as a participating Rotech or services that are billed to any supplier with the Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care programprograms. At Upon receipt of such timenotification, OIG shall will evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity Rotech 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. F. This CIA may be executed in counterparts, each . Rotech Corporate Integrity Agreement On Behalf of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Rotech Medical Corporation /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx X. Xxxxxxx 2/11/02 -------------------------- ------- Xxxxxxx X. Xxxxxxx DATE General Counsel, Progenity President and CEO Rotech Medical Corporation /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE Xxxxx X. Xxxxxxx Day Xxxxxx, Xxxx 1/7/02 -------------------------- ------- Xxxxx X. Xxxxxxx DATE Xxxxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE Xxxxxxx Rotech Corporate Integrity Agreement On Behalf of the Office of Inspector General Of the Department of Health and Human Services --------------------------------------------- ---- XXXXX XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.Rotech Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Rotech Healthcare Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity The Providers and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s the Providers’ obligations under this CIA IA based on a certification by Progenity any of the Providers that it is they are no longer providing health care items or services that will be billed to any Federal health care program programs and it does they do not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, interest in any entity that bills any Federal health care program. If Progenity is any of the Providers are relieved of its CIA their IA obligations, Progenity the Provider shall be required to notify OIG in writing at least 30 days in advance if Progenity the Provider plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, the OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to to, and do not affect (1) Progenity’s the Providers’ 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. E. The undersigned Progenity Provider signatories represent represents and warrant warrants that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxxxx X. Xxxx, M.D./ 4/9/14 Xxxxxx Xxxxxxx July 21X. Xxxx, 2020 Xxxxxx Xxxxxxx DATE General CounselX.X. Xxxx [Address] /Xxxxxxxx Xxxxx, Progenity /s/ M.D./ 4/9/14 Xxxxxxxx Xxxxx, X.X. Xxxx [Address] Xxxx Xxxxxxxx, Esq. Date /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx XxXxxxx/ 4/22/14 XXXXXX X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxxxx X. Xxxxxx/ 4/11/2014 XXXXXXXX X. XXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Ocean Dental 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 prior written consent of the parties to this CIA. C. OIG may agree to a suspension of ProgenityOcean Dental’s obligations under this CIA based on a certification by Progenity Ocean Dental that it is no longer providing health care items or services that will be billed to any Federal health care program programs and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity Ocean Dental is relieved of its CIA obligations, Progenity Ocean Dental shall be required to notify OIG in writing at least 30 days in advance if Progenity Ocean Dental plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, the 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 to, and do not affect (1) ProgenityOcean Dental’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. E. The undersigned Progenity Ocean Dental 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxx Xxxxxxx/ 10-6-14 Xxxx Xxxxxxx Date President Ocean Dental, P.C. /Xxxxxx XxXxxxxxxx/ 10/13/14 Xxxxxx XxXxxxxxxx Date Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Ocean Dental /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 10/24/14 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxxx/ 10/15/14 XXXXX XXXXXXX X. XXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxxxxxxx and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Orthofix; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityOrthofix’s obligations under this CIA based on a certification by Progenity Orthofix that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Orthofix is relieved of its CIA obligations, Progenity shall Orthofix will be required to notify OIG in writing at least 30 days in advance if Progenity Orthofix plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Orthofix signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent represents that they are signing this CIA in their official capacities capacity and that they are authorized to execute this CIA. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxxx X. Xxxxxx/ XXXXXX X. XXXXXX President and Chief Executive Officer Orthofix International, N.V. 5/31/2012 DATE /Xxxxx X. O’Connor/ BRIEN X. X’XXXXXX XXXXXXX X. XXXXX XXXXXXX X. XXXXXXX Ropes & Gray LLP Prudential Tower, 000 Xxxxxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx XX 00000-0000 5/31/2012 DATE /X. Xxxxx XxXxxxxx/ X. XXXXX XXXXXXXX Senior Vice President and Chief Financial Officer Orthofix, Inc 5/31/2012 DATE /Xxxxx X. O’Connor/ BRIEN X. X’XXXXXX XXXXXXX X. XXXXX XXXXXXX X. XXXXXXX Ropes & Gray LLP Prudential Tower, 000 Xxxxxxxx Xxxxxx Xxxxxx, XX 00000-0000 5/31/2012 DATE /Xxxxxxx X. Xxxxxx/ XXXXXXX X. XXXXXX General Counsel and Secretary Blackstone Medical Inc. 5/31/2012 DATE /Xxxxx X. O’Connor/ BRIEN X. X’XXXXXX XXXXXXX X. XXXXX XXXXXXX X. XXXXXXX Ropes & Gray LLP Prudential Tower, 000 Xxxxxxxx Xxxxxx Xxxxxx, XX 00000-0000 5/31/2012 DATE /Xxxxxxx X. Xxxxxx/ XXXXXXX X. XXXXXX Chief Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant to the Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 216/6/2012 DATE /Xxxxxx X. Xxxxxx Berlin/ XXXXXX X. XXXXXX BERLIN Senior Counsel Office of Inspector General U. S. Department of Health and Human Services 6/5/2012 DATE /Xxxxx X. Xxxxxx/ June 5, 2020 2012 XXXXX XXXXXXX DATE X. XXXXXX Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE This Appendix contains the requirements relating to the Independent Review Organization Organization(s) (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity CVS Health 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. C. OIG may agree to a suspension of ProgenityCVS Health’s obligations under this CIA based on a certification by Progenity CVS Health that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity CVS Health is relieved of its CIA obligations, Progenity CVS Health shall be required to notify OIG in writing at least 30 days in advance if Progenity CVS Health plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityCVS Health’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. E. The undersigned Progenity CVS Health 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxxxxx Xxxxxxxx/ 10/11/2016 XXXXXXXXX X. XXXXXXXX DATE Deputy General Counsel, Progenity /s/ Xxxxxxxx Counsel CVS Health Corporation /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ 10/11/2016 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxx Xxxx/ 10/7/2016 XXXXX XXXX XXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxx/ 10/7/2016 XXXXX XXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services /Xxxx Xxxxxxx/ 10/7/2016 XXXX X. XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.F of the CIA. A. IRO Engagement 1. CVS Health 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.10 of the CIA or any additional information submitted by CVS Health in response to a request by OIG, whichever is later, OIG will notify CVS Health if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, CVS Health may continue to engage the IRO. 2. If CVS Health 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, CVS Health shall submit the information identified in Section V.A.10 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 CVS Health at the request of OIG, whichever is later, OIG will notify CVS Health if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, CVS Health may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Essilor 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityEssilor’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. E. D. The undersigned Progenity Essilor 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxx Xxxxx/ 2/25/22 _ XXXXX X. XXXXX, 2020 Xxxxxx Xxxxxxx ESQ. DATE General CounselCounsel Essilor of America, Progenity /s/ Xxxxxxxx Inc., and Esssilor Laboratories of America, Inc. /Xxxxxxxx Xxxxxx/ April 1, 2022_ XXXX XXXXXXXXX, ESQ. DATE XXXXXXXX X. Xxxxxxxx July 21XXXXXX, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx ESQ. Dentons US LLP Counsel for Progenity /s/ Xxxx Essilor of America, Inc., and Esssilor Laboratories of America, Inc. /Xxxx X. Re July 20, 2020 Xx/ _ 03/07/2022 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21/Xxxxxxx Xxxxxx/_ April 4, 2020 XXXXX 2022_ XXXXXXX X. XXXXXX DATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement‌ 1. Essilor 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 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 Essilor in response to a request by OIG, whichever is later, OIG will notify Essilor if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Essilor may continue to engage the IRO.‌ 2. If Essilor 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, Xxxxxxx 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 Xxxxxxx at the request of OIG, whichever is later, OIG will notify Essilor if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Essilor may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity 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 shall be binding on the successors, assigns, and transferees of PolyMedica to the extent of the businesses and 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.; B. This C. Any modifications to this CIA constitutes shall be made with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of Progenity’s PolyMedica's obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of PolyMedica's cessation of participation in Federal health care program programs. If PolyMedica withdraws from participation in Federal health care programs and it does not have any ownership 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 control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity 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. F. This CIA may be executed in counterparts. POLYMEDICA CORPORATE INTEGRITY AGREEMENT ON BEHALF OF POLYMEDICA CORPORATION AND ITS SUBSIDIARIES /s/ Samuel L. Shanaman 11/08/04 --------------------------- ------------------- SAMUEL L. SHANAMAN DATE Chairman XxxxXxxxxx Xxxxxxation /s/ Alana Bloom Sullivan 11/04/2004 --------------------------- ------------------- ALANA BLOOM SULLIVAN DATE Chief Coxxxxxxxx Xxxxxxx XxxyMedica Corporation /s/ William B. Eck 11/03/2004 --------------------------- ------------------- WILLIAM B. ECK DATE Sr. Vice Xxxxxxxxx xxx Deputy General Counsel PolyMedica Corporation /s/ Mark P. Schnapp 11/03/2004 --------------------------- ------------------- MARK P. SCHNAPP DATE Greenberx Xxxxxxx, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. X.X. POLYMEDICA CORPORATE INTEGRITY AGREEMENT ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx Larry J. Goldberg 11/3/04 --------------------------------------------- ------------- LARRY J. GOLDBERG DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General Assistanx Xxxxxxxxx Xxxxxal for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services POLYMEDICA CORPORATE INTEGRITY AGREEMENT APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Polymedica Corp)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Envision Corporate Integrity Agreement Envision 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. C. OIG may agree to a suspension of ProgenityEnvision’s obligations under this CIA based on a certification by Progenity Envision that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Envision is relieved of its CIA obligations, Progenity Envision shall be required to notify OIG in writing at least 30 days in advance if Progenity Envision plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityEnvision’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. E. The undersigned Progenity Envision 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Envision Corporate Integrity Agreement /Xxxxx Xxxxxx/ 12/15/17 Xxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General CounselCounsel /Xxxx Xxxxx/ 12/15/17 Xxxx Xxxxx DATE Chief Compliance Officer /Xxxxx X. Xxxxxx// 12/15/17‌ Xxxxx Xxxxxx DATE Xxxxxxx Xxxxxx & Xxxxx, Progenity /s/ Xxxxxxxx P.C. Counsel to Envision, Inc. Envision Corporate Integrity Agreement /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ 12/15/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxxx Xxxx Xxxxx/ 12/15/2017 XXXXXX XXXX XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Envision Corporate Integrity Agreement This Appendix contains the requirements relating to the Legal Independent Review Organization (Legal IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Amedisys 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. C. OIG may agree to a suspension of ProgenityAmedisys’s obligations under this CIA based on a certification by Progenity Amedisys that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Amedisys is relieved of its CIA obligations, Progenity shall Amedisys will be required to notify OIG in writing at least 30 days in advance if Progenity Amedisys plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Amedisys 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.. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement /s/ Xxxxxx Xxxxxxx July 21X. XxXxxxx 4.22.14 XXXXXX X. XXXXXXX DATE President and Interim Chief Executive Officer On behalf of Amedisys, 2020 Inc. /s/ Xxxx X. Xxxxxx Xxxxxxx 4.22.14 XXXX X. XXXXXX DATE General CounselKing & Spalding, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity Amedisys, Inc. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement /s/ Xxxxxx X. XxXxxxx 4.22.14 XXXXXX X. XXXXXXX DATE President and Interim Chief Executive Officer On behalf of Amedisys Holding, LLC /s/ Xxxx X. Re July 20, 2020 Xxxxxx 4.22.14 XXXX X. RE XXXXXX DATE King & Spalding, LLP Counsel for Amedisys Holding, LLC Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL /s/ Xxxxxx X. XxXxxxx 4.22.14 XXXXXX X. XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx X. Xxxxxxx July 21, 2020 4.22.14 XXXXX X. XXXXXXX DATE Senior Associate Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Amedisys Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ CBHA and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityCBHA’s obligations under this CIA IA based on a certification by Progenity CBHA that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity CBHA is relieved of its CIA IA obligations, Progenity CBHA shall be required to notify OIG in writing at least 30 days in advance if Progenity CBHA plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect (1) ProgenityCBHA’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. E. The undersigned Progenity CBHA signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA.‌‌ ON BEHALF OF‌‌ DR. /s/ Xxxxxx BASSAM AWWA DATE President Connecticut Behavioral Health Associates, P.C. XXX XXXXXXX DATE Xxx Xxxxxxx July 21& Associates, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP P.C. Counsel for Progenity /s/ Connecticut Behavioral Health Associates, P.C. /Xxxxxx Awwa/ 3/5/2019 ‌‌ DR. BASSAM AWWA DATE /Xxx Xxxxxxx/ 3/5/19 ‌‌ XXX XXXXXXX DATE Xxx Xxxxxxx & Associates, P.C. Counsel for Xx. Xxxxxx Xxxx X. Re July 20, 2020 ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Office of Inspector General U.S. 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.E III.D of the CIAIA. A. IRO Engagement‌ 1. CBHA 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 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.4 of the IA or any additional information submitted by CBHA in response to a request by OIG, whichever is later, OIG will notify CBHA if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, CBHA may continue to engage the IRO.‌ 2. If CBHA engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, CBHA shall submit the information identified in Section V.A.4 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by CBHA at the request of OIG, whichever is later, OIG will notify CBHA if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, CBHA may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity GSK and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of GSK; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.; GlaxoSmithKline LLC Corporate Integrity Agreement D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity GSK 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ GlaxoSmithKline LLC Corporate Integrity Agreement ON BEHALF OF GLAXOSMITHKLINE LLC /Xxxxxxx Xxxxxxxx/ XXXXXXX XXXXXXXX President GlaxoSmithKline LLC 6-28-2012 DATE /Xxxxxxx X. Xxxx/ XXXXXXX X. XXXX Vice President & Compliance Officer North America Pharmaceuticals GlaxoSmithKline LLC 6/28/2012 DATE /Xxxxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxxx/ XXXX X. XXXX XXXXXXX XXXXXX XXXXXXX XXXXXX X. XXXX Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx Xxxxxx LLP Counsel for Progenity /s/ Xxxx GlaxoSmithKline LLC 6/28/2012 DATE GlaxoSmithKline LLC Corporate Integrity Agreement ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /Xxxxxxx X. Re July 20, 2020 XXXX Xxxxxx/ XXXXXXX X. RE DATE Assistant XXXXXX Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX 6/22/12 DATE /Xxxx X. Xxxxxxx/ XXXX X. XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services 6/28/2012 DATE /Xxxxxxxxx X. XxXxxxxx/ XXXXXXXXX X. XXXXXXXX Senior Counsel Office of Inspector General U. S. Department of Health and Human Services June 28, 2012 DATE GlaxoSmithKline LLC Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Monos, Ltd., Xxxxxxxx, and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s obligations Monos, Ltd., 215, and Xxxxxxxx’x requirements under this CIA IA based on a certification by Progenity Monos, Ltd., 215, and Xxxxxxxx‌ that it is it/he is/are no longer providing health care items or services that will be billed to any Federal health care program and it it/he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.program.‌‌ D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s Monos, Ltd., 215, and Xxxxxxxx’x 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. E. The undersigned Progenity signatories represent Monos, Ltd., 215, and warrant Xxxxxxxx signatory represents and warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ ON BEHALF OF XXXXXXXX & XXXXX MEDICAL GROUP, LLP D/B/A MONOS HEALTH‌‌ /Xxxxx Xxxxxxxx/ 12/21/2021 ON BEHALF OF XXXXXX X. XXXXXXXX, M.D., LTD.‌‌ /Xxxxx Xxxxxxxx/ ON BEHALF OF 215 SURGERY CENTER, LLC‌‌ 12/23/2021 12/21/2021 ON BEHALF OF XX. XXXXXX XXXXXXXX‌‌ /Xxxxx Xxxxxxxx/ ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ /Xxxxxx X. Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Berlin/ 12/26/2021 APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA. A. IRO Engagement‌ 1. Monos, Ltd., 215, and Xxxxxxxx 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 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.2 of the IA or any additional information submitted by Monos, Ltd., 215, and Xxxxxxxx in response to a request by OIG, whichever is later, OIG will notify Monos, Ltd., 215, and Xxxxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Monos, Ltd., 215, and Xxxxxxxx may continue to engage the IRO.‌ 2. If Monos, Ltd., 215, and Xxxxxxxx engage a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Monos, Ltd., 215, and Xxxxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Monos, Ltd., 215, and Xxxxxxxx at the request of OIG, whichever is later, OIG will notify Monos, Ltd., 215, and Xxxxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Monos, Ltd., 215, and Xxxxxxxx may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Quarterly Claims Review who have expertise in the Medicare, Medicare Managed Care, Medicaid, and Medicaid Managed Care program requirements applicable to the claims being reviewed; 2. assign individuals to design and select the Quarterly Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Quarterly Claims Review 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 professional acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Quarterly Claims Review; and‌ 5. have sufficient staff and resources to conduct the reviews required by the IA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌ 1. perform each Quarterly Claims Review in accordance with the specific requirements of the IA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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 IA. X. Xxxxx, Ltd., 215, and Xxxxxxxx Responsibilities‌‌ Monos, Ltd., 215, and Xxxxxxxx shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in Section III.C of this IA and that all records furnished to the IRO are accurate and complete.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Good Shepherd 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. C. OIG may agree to a suspension of ProgenityGood Shepherd’s obligations under this CIA based on a certification by Progenity Good Shepherd that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Good Shepherd is relieved of its CIA obligations, Progenity shall Good Shepherd will be required to notify OIG in writing at least 30 days in advance if Progenity Good Shepherd plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Good Shepherd 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxx Xxxxxxxx/ 1/29/2015 XXXXX XXXXXXXX DATE President Good Shepherd Hospice, Mid America, Inc. /Xxxxxx Xxxxxx/ 1/29/15 Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxx Xxxxxx Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Xxxxxx PLLC Counsel for Progenity /s/ Xxxx Good Shepherd Hospice, Mid America, Inc. /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 2/6/15 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 1-29-15 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity XXXX and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of BIPI; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity BIPI 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx ON BEHALF OF BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. /Xxxxxxx Xxxxx/ XXXXXXX XXXXX President and Chief Executive Officer Boehringer Ingelheim Pharmaceuticals, Inc. 10-22-12 DATE /Xxxxxxxxxx X. Hawthorne/ XXXXXXXXXX X. HAWTHORNE Chief Ethics and Compliance Officer Boehringer Ingelheim Pharmaceuticals, Inc. 10-22-12 DATE /X. Xxxxxxx July 21Xxxxxxx III/ 10-22-12 X. XXXXXXX XXXXXXX III DATE King & Spalding LLP Counsel for Boehringer Ingelheim Pharmaceuticals, 2020 Xxxxxx Xxxxxxx Inc. /Xxxx X. Xxxxxx/ 10-22-12 XXXX X. XXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Boehringer Ingelheim Pharmaceuticals, Inc. /Xxxxxxxxx X. Xxxxx/ 10-22-12 XXXXXXXXX X. XXXXX DATE Xxxx & Xxxxxxxx LLP Counsel for Boehringer Ingelheim Pharmaceuticals, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /Xxxxxxx X. Re July 20, 2020 XXXX Xxxxxx/ 10/17/12 XXXXXXX X. RE XXXXXX DATE Assistant Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxx X. Xxxxxxx/ 10/22/12 XXXX X. XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services /Xxxxx X. Xxxxxx/ 10/18/12 XXXXX X. XXXXXX DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Prime 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. C. OIG may agree to a suspension of ProgenityPrime’s obligations under this CIA based on a certification by Progenity Prime that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Prime is relieved of its CIA obligations, Progenity Prime shall be required to notify OIG in writing at least 30 days in advance if Progenity Prime plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityPrime’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.requirements.‌ E. The undersigned Progenity Prime 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx ON BEHALF OF PRIME‌‌ /Xxxxxxx Xxxxxx/ 7/31/18 ‌‌ ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Re/ 8/01/2018 /Xxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Xxxxxx/ 8/3/18 APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. Prime shall engage an IRO(s) that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.9 of the CIA or any additional information submitted by Prime in response to a request by OIG, whichever is later, OIG will notify Prime if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Prime may continue to engage the IRO.‌ 2. If Prime 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, Prime shall submit the information identified in Section 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 Prime at the request of OIG, whichever is later, OIG will notify Prime if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Prime may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIAIA. C. OIG X. XXX may agree to a suspension of ProgenityQin’s obligations under this CIA IA based on a certification by Progenity Xxx that it he is no longer providing health care items or services that will be billed to any Federal health care program programs and it he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, interest in any entity that bills any Federal health care program. If Progenity Xxx is relieved of its CIA his IA obligations, Progenity Qin shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, the OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to to, and do not affect (1) ProgenityXxx’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. E. The undersigned Progenity signatories represent Xxx signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxx Xxx, M.D./ April 29, 2015 Xxxx Xxx, M.D. DATE /Xxxx X. Xxxxxx/ 4/29/15 Counsel for Qin DATE Xxxx X. Xxxxxx Xxxxxxx July 21, 2020 Xxxxxxx & Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx PLLC /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx XxXxxxx/ 4/27/15 Xxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XxXxxxx DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services /s/ /Xxxxxx X. Xxxxx/ 4/29/2015 Xxxxxx X. Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxx 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. C. OIG may agree to a suspension of ProgenityArc’s obligations under this CIA based on a certification by Progenity Arc that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Arc is relieved of its CIA obligations, Progenity Arc shall be required to notify OIG in writing at least 30 days in advance if Progenity Arc plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityArc’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. E. The undersigned Progenity Arc 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx 4/17/18 /Xxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx/ XXXXXXX X. Xxxxxxxx DATE XXXXXX 4-18-18 /Xxxx X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Re/ 4/23/18 /Xxxxxxxxx Xxxxx/ 4-18-18 This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. Xxx 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by Arc in response to a request by OIG, whichever is later, OIG will notify Arc if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arc may continue to engage the IRO.‌ 2. If Xxx 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, Arc shall submit the information identified in Section 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 Xxx at the request of OIG, whichever is later, OIG will notify Arc if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arc may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Alaska Medicaid program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have expertise in the Alaska Medicaid coding requirements applicable to the claims being reviewed;‌ 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 Review; 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 CIA;‌ 2. follow all applicable Alaska Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority if in doubt of the application of a particular Alaska Medicaid program policy or regulation;‌ 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.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Tenet and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Tenet. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. This C. Any modifications to this CIA constitutes shall be made with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA. C. D. OIG may agree to a suspension of Progenity’s Txxxx’x obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of Txxxx’x cessation of participation in Federal health care program programs. If Tenet withdraws from participation in Federal health care programs and it does not have any ownership is relieved of its CIA obligations by OIG, Tenet shall notify OIG at least 30 days in advance of Txxxx’x intent to reapply as a participating provider or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity Tenet 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Txxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx 9/27/06 TXXXXX XXXXXX DATE General Counsel, Progenity Chief Executive Officer Txxxx Healthcare Corporation /s/ Xxxxxxxx Sxxxxx X. Xxxxxxxx July 219/27/06 SXXXXX X. XXXXXXXX DATE Senior Vice President, 2020 Xxxxxxxx X. Xxxxxxxx DATE Ethics and Compliance and Chief Compliance Officer Txxxx Healthcare Corporation /s/ Rxxxx X. Xxxxxxx Day Xxxxxx, Xxxx 9/27/06 RXXXX X. XXXXXXX DATE Lxxxxx & Xxxxxxxx Wxxxxxx LLP Counsel for Progenity Txxxx Healthcare Corporation /s/ Xxxx Gxxxxxx X. Re July 20, 2020 XXXX Xxxxxx 9/27/06 GXXXXXX X. RE XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.Services

Appears in 1 contract

Samples: Corporate Integrity Agreement (Tenet Healthcare Corp)

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxxxxxx 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. C. OIG may agree to a suspension of Progenity’s Xxxxxxx’x obligations under this CIA based on a certification by Progenity Xxxxxxx that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxxx is relieved of its CIA obligations, Progenity Xxxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’s Xxxxxxx’x 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. E. The undersigned Progenity Xxxxxxx 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. 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 or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21Chief Financial Officer DATE Xxxxx, 2020 Xxxxxx Xxxxxxxx & Xxxxxxx, P.C. Counsel for Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Eastern Iowa Dermatology 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 IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. B. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityEastern Iowa Dermatology’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. E. C. The undersigned Progenity signatories represent Eastern Iowa Dermatology signatory represents and warrant warrants that they are [he/she] is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. D. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxxxx Xxxxx, MD/_ 7/20/2022 Xxxxxx Xxxxxxx July 21X. Xxxxx, 2020 MD DATE Owner of Eastern Iowa Dermatology, PLC Eastern Iowa Dermatology, PLC _/Xxxxxx Xxxxx, MD/_ 7/20/2022 Xxxxxx Xxxxxxx X. Xxxxx, MD DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ 7/21/2022 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx /Xxxxx Xxxxxxx/ __July 21, 2020 2022 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx 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. C. OIG may agree to a suspension of Progenity’s Xxxxxxxxxx-Xxxxxxx Xxxxxx’x obligations under this CIA based on a certification by Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx is relieved of its CIA obligations, Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement in any entity that bills any Federal health care program. 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) Progenity’s Xxxxxxxxxx-Xxxxxxx Xxxxxx’x 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. E. The undersigned Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement DATE 000 Xxxx Xxxxxxx July 21Xxxxxxx Xxxxxxxxxxx, 2020 XX 00000 DATE 000 Xxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxx, XX 00000 DATE Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx Xxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20Xxxxxxxxxx-Xxxxxxx Xxxxxx DATE Xxxxxx Moscou Faltischek, 2020 P.C. Counsel for Xxxxxxxxxx-Xxxxxxx Xxxxxx DATE Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services XXXXXX X. XXXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Post Acute Medical 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. C. OIG may agree to a suspension of ProgenityPost Acute Medical’s obligations under this CIA based on a certification by Progenity Post Acute Medical that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Post Acute Medical is relieved of its CIA obligations, Progenity Post Acute Medical shall be required to notify OIG in writing at least 30 days in advance if Progenity Post Acute Medical plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityPost Acute Medical’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. E. The undersigned Progenity Post Acute Medical 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx X. Xxxxxxxx/ 8/13/18 ‌‌ XXXXXXX X. XXXXXXXX DATE Manager of Post Acute Medical Principal, 2020 Xxxxxx Xxxxxxx DATE General CounselPresident, Progenity /s/ Xxxxxxxx and CEO, Post Acute Medical, LLC /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ 8/10/2018 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxx/ 8/13/18 XXXXX XXXXXXX X. XXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Tri-County 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 prior written consent of the parties to this CIA. C. OIG may agree to a suspension of ProgenityTri-County’s obligations under this CIA based on a certification by Progenity Tri-County that it is no longer providing health care items or services that will be billed to any Federal health care program programs and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity Tri-County is relieved of its CIA obligations, Progenity Tri- County shall be required to notify OIG in writing at least 30 days in advance if Progenity Tri- County plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, the 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 to, and do not affect (1) ProgenityTri-County’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. E. The undersigned Progenity Tri-County 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxxx Xxxxxx/ 6-16-14 Xxxxxx Xxxxxxx July 21Xxxxxx Date Owner, 2020 Tri-County Ambulance /Xxxxx Xxxxxx/ 6-16-14 Xxxxx Xxxxxx Xxxxxxx DATE General CounselDate Owner, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Tri-County Ambulance /Xxxx Xxxxxx/ 6-16-14 Xxxx & Xxxxxxxx LLP Xxxxxx Date Counsel for Progenity /s/ Xxxx Tri-County /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 7/25/14 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxxx/ 7-14-14 XXXXX XXXXXXX X. XXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Ensign Group and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Ensign Group. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. D. OIG may agree to a suspension of ProgenityEnsign Group’s obligations in whole or in part under this CIA based on a certification by Progenity Ensign Group that it is no longer providing health care items or services that will be billed directly or indirectly to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Ensign Group is relieved of its CIA obligations, Progenity shall Ensign Group will be required to notify OIG in writing at least 30 days in advance if Progenity Ensign Group plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Ensign Group 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ ON BEHALF OF THE ENSIGN GROUP, INC. /Xxxxxxx X. Xxxxxx/ 10/1/13 XXXXXXX X. XXXXXX DATE Chief Compliance Officer The Ensign Group, Inc. /Xxxxxxxxxxx X. Xxxxxxxxxxx/ 10/1/2013 XXXXXXXXXXX X. XXXXXXXXXXX DATE President and Chief Executive Officer The Ensign Group, Inc. /Xxxxx X. Xxxxxxx/ 10/1/13 XXXXX X. XXXXXXX DATE Xxxxxx & Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx The Ensign Group, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 9/27/13 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxx Xxxx/ 9/27/2013 XXXXX XXXXXXX XXXX XXXX DATE Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Biomet, Biomet Orthopedics and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Biomet and Biomet Orthopedics; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityBiomet’s or Biomet Orthopedics’ obligations under this the CIA based on a certification by Progenity that it is no longer providing health care in the event of Biomet’s or Biomet Orthopedics’ cessation of the delivery, sale, marketing, or furnishing of items or services that will be billed to reimbursed by any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care programprograms. If Progenity such cessation occurs and Biomet or Biomet Orthopedics is relieved of its CIA obligationsobligations by OIG, Progenity Biomet or Biomet Orthopedics shall be required to notify OIG in writing at least 30 days in advance if Progenity plans of the date on which Biomet or Biomet Orthopedics intends to resume providing health care begin delivering, selling, marketing, or furnishing items or services that are billed to reimbursed by any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care programprograms. At Upon receipt of such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity Biomet and Biomet Orthopedics 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. ON BEHALF OF BIOMET, INC. AND BIOMET ORTHOPEDICS, INC. /s/ Xxxxxxx X. Xxxxxx 9/27/07 XXXXXXX X. XXXXXX DATE President and Chief Executive Officer Biomet, Inc. and Biomet Orthopedics, Inc. /s/ Xxxxxxxxxx X. Xxxxx 9/27/07 XXXXXXXXXX X. XXXXX DATE Vice President & Corporate Compliance Officer Biomet, Inc. /s/ Xxxxxxx July 21X. Xxxxxx 9/27/07 XXXXXXX X. XXXXXX DATE Xxxxx & Xxxxxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity Biomet, Inc. and Biomet Orthopedics, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ Xxxx Xxxxxxx X. Re July 20, 2020 XXXX Xxxxxx 9/27/07 XXXXXXX X. RE XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Office of Counsel to the Inspector General U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.Services

Appears in 1 contract

Samples: Corporate Integrity Agreement (Biolectron, Inc.)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ TEN 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ProgenityTEN’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. E. C. The undersigned Progenity TEN 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. F. 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-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx /Xxxxxxx Xxxxxxxxx/ _7-17-23 Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx Xxxxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx Chief Executive Officer TEN Healthcare /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Re/ 07/24/23 ‌‌ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Services‌ /Xxxxx X. Xxxxxxxxx/ 07/25/2023 ‌‌ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX X. Xxxxxxxxx DATE Senior Counsel Administrative and Civil Remedies Branch Office of Inspector General U.S. Department of Health and Human Services Services‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. TEN 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 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.6 of the CIA or any additional information submitted by TEN in response to a request by OIG, whichever is later, OIG will notify TEN if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, TEN may continue to engage the IRO.‌ 2. If TEN 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, TEN shall submit the information identified in Section V.A.6 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 TEN at the request of OIG, whichever is later, OIG will notify TEN if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, TEN may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity SMMC 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. C. OIG may agree to a suspension of ProgenitySMMC’s obligations under this CIA based on a certification by Progenity SMMC that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity SMMC is relieved of its CIA obligations, Progenity SMMC shall be required to notify OIG in writing at least 30 days in advance if Progenity SMMC plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenitySMMC’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. E. The undersigned Progenity SMMC 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. 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 or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ ON BEHALF OF THE COUNTY OF SAN MATEO – SAN MATEO MEDICAL CENTER (SMMC)‌ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office Xxxxxx County Counsel County of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services San Mateo 7/29/2021 APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. SMMC 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 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.7 of the CIA or any additional information submitted by SMMC in response to a request by OIG, whichever is later, OIG will notify SMMC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, SMMC may continue to engage the IRO.‌ 2. If SMMC 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, SMMC shall submit the information identified in Section 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 SMMC at the request of OIG, whichever is later, OIG will notify SMMC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, SMMC may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 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 Review; 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 CIA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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. SMMC Responsibilities‌ SMMC 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Baptist 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. C. OIG may agree to a suspension of ProgenityBaptist’s obligations under this CIA based on a certification by Progenity Baptist that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Baptist is relieved of its CIA obligations, Progenity shall Baptist will be required to notify OIG in writing at least 30 days in advance if Progenity Baptist plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Baptist 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. F. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. ElectronicallyFacsimiles or e-transmitted copies or facsimiles mails of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx /Xxxxxxxx X. Xxxxxxx/ 2/11/15 Xxxxxxxx X. Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx Corporate Compliance and Privacy Officer Baptist Health /Xxxx Xxxxx/ 2/11/2015 Xxxx Xxxxx DATE Baptist Health Chief Executive Officer /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx/ 2/9/15 Xxxx X. Xxxxxxxx Xxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Baptist Health /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 2/20/15 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxxxxx Xxxxxxxxxxxx/ 02-12-15 XXXXXXX XXXXXXXXXXXX DATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity AtriCure, Inc. and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of AtriCure, Inc.; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityAtriCure, Inc.’s obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of AtriCure, Inc.’s cessation of participation in Federal health care program programs. If AtriCure, Inc. ceases participating in Federal health care programs and it does not have any ownership is relieved of its CIA obligations by OIG, AtriCure, Inc. shall notify OIG at least 30 days in advance of AtriCure, Inc.’s intent to resume participating as a provider or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity AtriCure, Inc. 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. ON BEHALF OF ATRICURE, INC. /s/ Xxxxx Xxxxxxxx 2/1/2010 XXXXX XXXXXXXX DATE Chief Executive Officer AtriCure, Inc. /s/ Xxxxxx X. Xxxxxx 1/20/2010 XXXXXX X. XXXXXX DATE Xxxxxxx July 21Xxxxxx & Green, 2020 P.C. CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ Xxxxxxx X. Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx 1/27/2010 XXXXXXX X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21CORPORATE INTEGRITY AGREEMENT ATRICURE, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services INC. This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement

Appears in 1 contract

Samples: Corporate Integrity Agreement (AtriCure, Inc.)

EFFECTIVE AND BINDING AGREEMENT. Progenity Good Shepherd 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. C. OIG may agree to a suspension of ProgenityGood Shepherd’s obligations under this CIA based on a certification by Progenity Good Shepherd that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Good Shepherd is relieved of its CIA obligations, Progenity shall Good Shepherd will be required to notify OIG in writing at least 30 days in advance if Progenity Good Shepherd plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Good Shepherd 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxx Xxxxxxxx/ 1/29/2015 XXXXX XXXXXXXX DATE Manager Good Shepherd Hospice, Springfield, L.L.C. /Xxxxxx Xxxxxx Xxxxxxx July 21, 2020 1/29/15 XXXXXX XXXXXX DATE Xxxx Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Xxxxxx PLLC Counsel for Progenity /s/ Xxxx Good Shepherd Hospice, Springfield, L.L.C. /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 2/6/15 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 1/29/15 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ LCPCC and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityLake Country Pharmacy and Compounding Center’s obligations and/or Xxxxxxxxxxx X. Xxxxxxx’x obligations and/or Xxxxx X. Xxxxxxx’x obligations under this CIA IA based on a certification by Progenity LCPCC, Xxxxxxxxxxx X. Xxxxxxx, or Xxxxx X. Xxxxxxx that it it/he/she is no longer providing health care items or services that will be billed to any Federal health care program and it program. It/he/she must also certify that it/he/she does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Lake Country Pharmacy and Compounding Center, Xxxxxxxxxxx X. Xxxxxxx, and/or Xxxxx X. Xxxxxxx is relieved of its CIA IA obligations, Progenity it/he/she shall be required to notify OIG in writing at least 30 days in advance if Progenity it/he/she plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. . All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s LCPCCs 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. E. D. The undersigned Progenity signatories represent LCPCC signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. E. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx ON BEHALF OF LAKE COUNTRY PHARMACY AND COMPOUNDING CENTER‌ /Xxxxx Xxxxxxx/ Xxxxx X. Xxxxxxx July 21, 2020 Xxxxxx Lake Country Pharmacy And Compounding Center DATE X.X. Xxxxx Counsel for LCPCC DATE /Xxxxxxxxxxx X. Xxxxxxx/ 6/6/19 ‌‌ Xxxxxxxxxxx X. Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE /X.X. Xxxxx/ 6/7/19 ‌‌ Counsel for Xxxxxxxxxxx X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP DATE /Xxxxx X. Xxxxxxx/ 6/6/19 ‌‌ Xxxxx X. Xxxxxxx DATE /X.X. Xxxxx/ 6/7/19 ‌‌ Counsel for Progenity /s/ Xxxx Xxxxx X. Re July 20, 2020 Xxxxxxx DATE ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services XXXXXXXXX X. XXXXXXXX DATE Senior Counsel Office of Inspector Generl U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. LCPCC 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 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.2 of the IA or any additional information submitted by LCPCC in response to a request by OIG, whichever is later, OIG will notify LCPCC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, LCPCC may continue to engage the IRO.‌ 2. If LCPCC engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged LCPCC shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by LCPCC at the request of OIG, whichever is later, OIG will notify LCPCC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, LCPCC may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity XXX 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. C. OIG may agree to a suspension of ProgenityION’s obligations under this CIA based on a certification by Progenity ION that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity ION is relieved of its CIA obligations, Progenity ION shall be required to notify OIG in writing at least 30 days in advance if Progenity ION plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityXXX’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. E. The undersigned Progenity ION 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxxxxx Xxxxxxx/ /Xxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx/ /Xxxx Xxxxxxx/ /Xxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Xxxxxxx/ This Appendix A contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.F of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx 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. C. OIG may agree to a suspension of Progenity’s Xxxxxxxxxx-Xxxxxxx Xxxxxx’x obligations under this CIA based on a certification by Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx is relieved of its CIA obligations, Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement in any entity that bills any Federal health care program. 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) Progenity’s Xxxxxxxxxx-Xxxxxxx Xxxxxx’x 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. E. The undersigned Progenity Xxxxxxxxxx-Xxxxxxx Xxxxxx 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement DATE 000 Xxxx Xxxxxxx July 21Xxxxxxx Xxxxxxxxxxx, 2020 XX 00000 DATE 000 Xxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxx, XX 00000 DATE Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx Xxxxxx LLP Counsel for Progenity /s/ Xxxx Xxxxxxxxxx-Xxxxxxx Xxxxxx DATE Xxxxxx Moscou Xxxxxxxxxx, X.X. Xxxxxxx for Xxxxxxxxxx-Xxxxxxx Xxxxxx DATE Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement /Xxxx X. Re July 20, 2020 Re/ 10/26/16 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services /Xxxxxx X. Xxxxxxxx/ 11/1/16 XXXXXX X. XXXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxxxxxxx–Zwanger Xxxxxx – Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ PANF and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityPANF’s obligations under this CIA IA based on a certification by Progenity PANF that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined engaging in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care programPatient Assistance Related Functions. If Progenity PANF is relieved of its CIA IA obligations, Progenity PANF shall be required to notify OIG in writing at least 30 days in advance if Progenity PANF plans to resume providing health care items or services that are billed to any Federal health care program Patient Assistance Related Functions or to obtain an ownership or control interest in any entity that bills any Federal health care programengages in Patient Assistance Related Functions. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect (1) ProgenityPANF’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. This IA does not supersede OIG’s rights as set forth in 42 C.F.R. 1008.45 in connection with conduct other than the Covered Conduct or conduct that occurs on or after the Effective Date of the Settlement Agreement described above in the Preamble. E. The undersigned Progenity PANF signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxxxx X. Xxxxx/ Xxxxxx X. Xxxxx President and Chief Executive Officer Patient Access Network Foundation Date Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day & Xxxxxx, Xxxx PLLC Counsel for PANF Date Drinker Xxxxxx & Xxxxxxxx Xxxxx LLP Counsel for Progenity /s/ Xxxx PANF Date /Xxxx X. Re July 20, 2020 Xx/ XXXX X. RE DATE XX Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.G of the CIAIA. A. IRO Engagement‌ 1. PANF 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 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.6 of the IA or any additional information submitted by PANF in response to a request by OIG, whichever is later, OIG will notify PANF if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PANF may continue to engage the IRO.‌ 2. If PANF engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, PANF shall submit the information identified in Section V.A.6 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by PANF at the request of OIG, whichever is later, OIG will notify PANF if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PANF may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity MMW and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityMMW’s obligations under this CIA IA based on a certification by Progenity MMW that it [he/she] is no longer providing health care items or services that will be billed to any Federal health care program and it [he/she] does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity MMW is relieved of its CIA [his/her] IA obligations, Progenity MMW shall be required to notify OIG in writing at least 30 days in advance if Progenity MMW plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityMMW’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. E. The undersigned Progenity signatories represent MMW signatory represents and warrant warrants that they are [he/she] is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxxx Xxxxx/ Xxxxx X. Xxxxx 3/28/2017 DATE /Xxxxxx Xxxxxx/ Xxxxxx Xxxxxxx July 21Xxxxxx Partner, 2020 Xxxxx Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Xxxxx X. Re July 20Xxxxx 5/1/17 DATE /Xxxxx Xxxxx/ Xxxxx X. Xxxxx Mobility Metabolism and Wellness, 2020 P.C. 3/28/2017 DATE /Xxxxxx Xxxxxx/ Xxxxxx Xxxxxx Partner, Xxxxx Xxxxxx LLP Counsel for Mobility Metabolism and Wellness, P.C. DATE /Xxxx X. Re/ 5/8/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 5/2/2017 XXXXX XXXXXXX X. XXXXX DATE Senior Associate Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Parkland and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Parkland. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. D. OIG may agree to a suspension of ProgenityParkland’s obligations under this CIA based on a certification by Progenity Parkland that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Parkland is relieved of its CIA obligations, Progenity shall Parkland will be required to notify OIG in writing at least 30 days in advance if Progenity Parkland plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Parkland 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ ON BEHALF OF PARKLAND /Xxxxxx X. Xxxxx/ 5/24/13 XXXXXX X. XXXXX DATE Interim Chief Executive Officer Parkland Health and Hospital System /Xxxx X. Xxxxxxx/ 5/24/13 XXXX X. XXXXXXX, MS, CPA, CHC DATE Sr. Vice President/Chief Compliance and Ethics Officer Parkland Health and Hospital System /Xxxx X. Xxxxxx/ 5/24/13 XXXX X. XXXXXX XXXX General Counsel Parkland Health and Hospital System /Xxxxx X. Xxxxxxx/ 5/28/13 XXXXX X. XXXXXXX DATE Xxxxxx Xxxxxxx July 21and Xxxxxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Parkland ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 5/30/13 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxx X. Xxxxxx Berlin/ 5/28/13 XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains /Xxxxxxxxx Xxxxx/ 5/28/13 XXXXXXXXX XXXXX DATE Associate Counsel Office of Inspector General U. S. Department of Health and Human Services APPENDIX A BILLING INDEPENDENT REVIEW ORGANIZATION A. Billing IRO Engagement 1. Parkland shall engage a Billing IRO that possesses the requirements relating qualifications set forth in Paragraph B, below, to perform the Independent Review Organization (responsibilities in Paragraph C, below. The Billing IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.14 of the CIA or any additional information submitted by Parkland in response to a request by OIG, whichever is later, OIG will notify Parkland if the IRO is unacceptable. Absent notification from OIG that the Billing IRO is unacceptable, Parkland may continue to engage the Billing IRO) required by Section III.E . 2. If Parkland engages a new Billing IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new Billing IRO is engaged, Parkland shall submit the information identified in Section V.A.14 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 Parkland at the request of OIG, whichever is later, OIG will notify Parkland if the IRO is unacceptable. Absent notification from OIG that the Billing IRO is unacceptable, Parkland may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxx Pharmacy and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityXxxxx Pharmacy’s obligations under this CIA IA based on a certification by Progenity Xxxxx Pharmacy that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxx Pharmacy is relieved of its CIA IA obligations, Progenity Xxxxx Pharmacy shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxx Pharmacy plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect (1) ProgenityXxxxx Pharmacy’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.requirements.‌‌ E. The undersigned Progenity Xxxxx Pharmacy signatories represent and warrant that they are authorized to execute this CIAthis. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ ON BEHALF OF Xxxxx Pharmacy‌‌ /Xxxx Xxxx/ XXXXXX XXXXX PROFESSIONAL‌ PHARMACY, INC. 9-20-18 ‌ DATE /Xxxx Xxxx/ XXXX XXXX‌ Co-Owner, Xxxxxx Xxxxxxx July 21Xxxxx Professional Pharmacy, 2020 Inc. 9-20-18 ‌ DATE /Xxxxxx Xxxxxxx/ XXXXXX X. XXXXXXX‌ Co-Owner, Xxxxxx Xxxxxxx Xxxxx Professional Pharmacy, Inc. 9-20-18 ‌ DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX X. XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E 111.D of the CIAIA. A. IRO Engagement‌ 1. Xxxxx Pharmacy 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 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.4 of the IA or any additional information submitted by Xxxxx Pharmacy in response to a request by OIG, whichever is later, OIG will notify Xxxxx Pharmacy if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxx Pharmacy may continue to engage the IRO.‌ 2. If Xxxxx Pharmacy engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxx Pharmacy shall submit the information identified in Section V.A.4 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Xxxxx Pharmacy at the request of OIG, whichever is later, OIG will notify Xxxxx Pharmacy if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxx Pharmacy may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ South Miami Hospital 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. C. OIG may agree to a suspension of ProgenitySouth Miami Hospital’s obligations under this CIA based on a certification by Progenity South Miami Hospital that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.U.S.C. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ProgenitySouth Miami Hospital’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. E. The undersigned Progenity South Miami Hospital 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx /Lincoln X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx/ 11/29/16 /Xxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ 12/1/16 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxxxxx X. Xxxxxx/ 12/5/2016 XXXXXXX X. XXXXXX DATE Senior Counsel Office of Inspector General 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.E III.D of the CIA. A. IRO Engagement‌ 1. South Miami Hospital 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by South Miami Hospital in response to a request by OIG, whichever is later, OIG will notify South Miami Hospital if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, South Miami Hospital may continue to engage the IRO.‌ 2. If South Miami Hospital 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, South Miami Hospital shall submit the information identified in Section 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 South Miami Hospital at the request of OIG, whichever is later, OIG will notify South Miami Hospital if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, South Miami Hospital may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Medicare, state Medicaid, and TRICARE program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 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 Review; 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 CIA;‌ 2. follow all applicable Medicare, state Medicaid, and TRICARE program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare, state Medicaid, and TRICARE program policy or regulation;‌‌ 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ICH 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. C. OIG may agree to a suspension of ProgenityICH’s obligations under this CIA based on a certification by Progenity ICH that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity ICH is relieved of its CIA obligations, Progenity shall ICH will be required to notify OIG in writing at least 30 days in advance if Progenity ICH plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity ICH 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Seslee X. Xxxxxxx/ 1-16-15 SESLEE X. XXXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx the Hospital Authority of Xxxxx County /Xxx Xxxxxx/ 1-12-15 XXX XXXXXX Administrator/CEO for Xxxxx County Hospital DATE /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 1/16/15 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxx Xxxxxx/ 1/16/15 XXXX XXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement 1. ICH 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.9 of the CIA or any additional information submitted by ICH in response to a request by OIG, whichever is later, OIG will notify ICH if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ICH may continue to engage the IRO. 2. If ICH engages a new IRO during the term of the CIA, this IRO shall also meet the requirements of this Appendix. If a new IRO is engaged, ICH shall submit the information identified in Section 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 ICH at the request of OIG, whichever is later, OIG will notify ICH if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ICH may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s Xxxxxx’x obligations under this CIA IA based on a certification by Progenity Xxxxxx that it she is no longer providing health care items or services that will be billed to any Federal health care program and it she does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxx is relieved of its CIA her IA obligations, Progenity Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s Xxxxxx’x 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. E. The undersigned Progenity Xxxxxx signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /Xxxxxx Xxxxxx/ XXXXXX XXXXXX, RPH DATE Xxxxx Xxxxxx Xxxxxxx July 21, 2020 – Attorneys at Law Counsel for Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx RPH DATE /Xxxx X. Re July 20, 2020 Re/ 7/31/2019 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxx/ 7/31/2019 XXXXX XXXXXXX X. XXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xxxxxx 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 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.2 of the IA or any additional information submitted by Xxxxxx in response to a request by OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌ 2. If Xxxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xxxxxx at the request of OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxx Xxxxxx 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. C. OIG may agree to a suspension of Progenity’s Mid Xxxxxx’x obligations under this CIA based on a certification by Progenity Mid Xxxxxx that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity Mid Xxxxxx is relieved of its CIA obligations, Progenity shall Mid Xxxxxx will be required to notify OIG in writing at least 30 days in advance if Progenity Mid Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Mid Xxxxxx 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx M.D./ 4/28/2014 XXXXXX X. XXXXXX, M.D. DATE President & Xxxxxxxx LLP Chief Executive Officer Mid Xxxxxx Medical Group, P.C. /Xxxxxx X. Xxxxxxxx, Esq./ 4/29/14 XXXXXX X. XXXXXXXX, ESQ. DATE Garfunkel Wild, P.C. Counsel for Progenity /s/ Xxxx Mid Xxxxxx Medical Group, P.C. /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 5/9/14 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxxxxx X. Xxxx/ 5/6/14 XXXXXXX X. XXXX DATE Senior Associate Counsel Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Family Dermatology 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. C. OIG may agree to a suspension of ProgenityFamily Dermatology’s obligations under this CIA based on a certification by Progenity Family Dermatology that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Family Dermatology is relieved of its CIA obligations, Progenity shall Family Dermatology will be required to notify OIG in writing at least 30 days in advance if Progenity Family Dermatology plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Family Dermatology 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. /Xxxxx Xxxxxxxx/ 4.21.15 Xxxxx Xxxxxxxx DATE X. Xxxxxxx Day On behalf of himself and Family Dermatology, P.C., Family Dermatology of Pennsylvania, P.C., and Family Dermatology of Delaware, P.A. /Dr. Xxxxx Xxxxxx/ 4.21.15 Dr. Xxxxx Xxxxxx DATE On behalf of himself and Family Dermatology, P.C., Family Dermatology of Pennsylvania, P.C., and Family Dermatology of Delaware, P.A. /Xxxx Xxxxxx, Esq./ 4.21.15 Xxxx & Xxxxxxxx LLP Xxxxxx, Esq. DATE Counsel for Progenity /s/ Xxxx Family Dermatology, P.C., Family Dermatology of Pennsylvania, P.C., and Family Dermatology of Delaware, P.A. /Xxxxxxx X. Re July 20, 2020 XXXX Xxxxxx for RKD/ 4/20/15 Xxxxxx X. RE XxXxxxx DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ /Xxxxx X. Xxxxxxxx/ 4/16/15 Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX X. Xxxxxxxx DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services /Xxxxxx Xxxxxxxx/ 4/16/15 Xxxxxx Xxxxxxxx DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Cordant 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. C. OIG may agree to a suspension of ProgenityCordant’s obligations under this CIA based on a certification by Progenity Cordant that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Cordant is relieved of its CIA obligations, Progenity Cordant shall be required to notify OIG in writing at least 30 days in advance if Progenity Cordant plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityCordant’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. E. The undersigned Progenity Cordant 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx /Xxx Xxxxxx/ 7-13-2020_ XXX XXXXXX DATE President Sterling Healthcare Opco, LLC d/b/a Cordant Health Solutions /Xxxxxxx Xxxxx/_ July 2113, 2020 Xxxxxx Xxxxxxx XXXXXXX X. XXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Cordant /Xxxx X. Re July 20, 2020 Xx/ _ 07/16/2020_ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services /Xxxxxxxxx Xxxxx/ 14 July 2020_ XXXXXXXXX XXXXX DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Exactech and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Exactech; B. This CIA shall become final and binding on the later of (1) the date the final signature is obtained on the CIA.; or (2) the date the Civil Settlement Agreement becomes effective. Exactech, Inc. - Corporate Integrity Agreement B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityExactech’s obligations under this CIA based on a certification by Progenity Exactech that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Exactech is relieved of its CIA obligations, Progenity shall Exactech will be required to notify OIG in writing at least 30 days in advance if Progenity Exactech plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Exactech 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21Exactech, 2020 Xxxxxx Xxxxxxx Inc. - Corporate Integrity Agreement ON BEHALF OF EXACTECH /S/ XXXXXXX XXXXX December 2, 2010 XXXXXXX XXXXX DATE General CounselChief Executive Officer Exactech, Progenity /s/ Xxxxxxxx Inc. /S/ XXXXXXX X. Xxxxxxxx July 21XXX December 3, 2020 Xxxxxxxx 2010 XXXXXXX X. Xxxxxxxx XXX DATE X. Xxxxxxx Day XxxxxxXxxxxxxxx Xxxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity Exactech, Inc. Exactech, Inc. - Corporate Integrity Agreement ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ Xxxx XXXXXXX X. Re July 20, 2020 XXXX XXXXXX 12/7/2010 XXXXXXX X. RE XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXX X. XXXXXXX 12/7/2010 XXXXXX X. XXXXXXX DATE Senior Counsel Office of Counsel to the Inspector General U.S. Office of Inspector General U. S. Department of Health and Human Services Exactech, Inc. - Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Exactech Inc)

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EFFECTIVE AND BINDING AGREEMENT. Progenity Par and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Par. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA. B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA. C. D. OIG may agree to a suspension of ProgenityPar’s obligations under this CIA based on a certification by Progenity Par that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Par is relieved of its CIA obligations, Progenity shall Par will be required to notify OIG in writing at least 30 days in advance if Progenity Par plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Par 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Par Corporate Integrity Agreement /Xxxx Xxxxxxxxxx/ Xxxx Xxxxxxxxxx Chief Executive Officer Par Pharmaceutical Companies, Inc. 2/28/2013 DATE /Xxxx Xxxxxxxx, III/ Xxxx Xxxxxxxx, III Counsel Par Pharmaceutical Companies, Inc. 2/28/2013 DATE Par Corporate Integrity Agreement /Xxxxxx XxXxxxx/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE XxXxxxx Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX 3/1/2013 DATE /Xxxxxxxxx X. XxXxxxxx/ Xxxxxxxxx X. XxXxxxxx Senior Counsel Office of the Inspector General U.S. Department 3/4/2013 DATE /Xxxxxxx Xxxxxxxxx/ 3/4/2013 Xxxxxxx Xxxxxxxxx Associate Counsel Office of Health and Human Services the Inspector General DATE Par Corporate Integrity Agreement This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Avanti 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. C. OIG may agree to a suspension of Progenity’s Avanti's obligations under this CIA based on a certification by Progenity Avanti that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Avanti is relieved of its CIA obligations, Progenity Avanti shall be required to notify OIG in writing at least 30 days in advance if Progenity Avanti plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’s Avanti's responsibility to follow all applicable Federal health care program requirements or (2) the government’s 's right to impose appropriate remedies for failure to follow applicable Federal health care program requirements. E. The undersigned Progenity Avanti 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxx Xxxxxxxxxx/ 11-7-18 ‌‌ XXXX XXXXXXXXXX DATE Interim Chief Executive Officer Avanti Hospitals, 2020 Xxxxxx Xxxxxxx LLC /Xxxxx Xxxxx/ 11/15/18 ‌‌ XXXXX XXXXX DATE General CounselChief Executive Officer Gardena Hospital, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx L.P. /Xxxxxxx Xxxxxxx/ 11/20/18 ‌‌ XXXXXXX XXXXX DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP XXXXXXX XXXXXXX Counsel for Progenity /s/ Xxxx Gardena Hospital, L.P. and Avanti Hospitals, LLC /Xxxx X. Re July 20, 2020 Re/ 11/05/2018 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxxx/ 11/1/2018 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the ill.E ofthe CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity CareMed 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. C. OIG may agree to a suspension of ProgenityCareMed’s obligations under this CIA based on a certification by Progenity CareMed that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity CareMed is relieved of its CIA obligations, Progenity shall CareMed will be required to notify OIG in writing at least 30 days in advance if Progenity CareMed plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity CareMed 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services /Nuaman Tyyeb/ 11/24/2014 NUAMAN TYYEB DATE President, 2020 Xxxxxx Xxxxxxx Sorkin’s RX Ltd. As the Executor of the Estate of Muhammad Tyyeb /Xxxxxx X. Xxxxxxxx/ 11/24/14 XXXXXX X. XXXXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx CareMed Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 11/21/14 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 12/1/2014 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity OC, Xxxxxx, and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s OC or Xxxxxx’x obligations under this CIA IA based on a certification by Progenity OC and Xxxxxx that it it/he is no longer providing health care items or services that will be billed to any Federal health care program and it it/he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is OC or Xxxxxx are relieved of its CIA their IA obligations, Progenity OC or Xxxxxx (as applicable) shall be required to notify OIG in writing at least 30 days in advance if Progenity OC or Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s OC and Xxxxxx’x 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. E. The undersigned Progenity OC and Xxxxxx signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ _/Xxxxxx X. Xxxxxx, MD/ _ 4/29/2020 DR. XXXXXX XXXXXX DATE Individually, and on behalf of Ophthalmic Consultants, P.A. /Xxxx X. Xxxxxxxx/ May 5, 2020 XXXX X. XXXXXXXX DATE Counsel for Ophthalmic Consultants, P.A. and Dr. Xxxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx P.A. 0000 X. Re July 20Xxx Xxxxx Xxxxxxxxx, 2020 Xxxxx 0000 Xxxxx, Xxxxxxx 00000-0000 /Xxxx X. Xx/_ 04/30/2020_ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxx X. Xxxxxx Berlin/ 6/29/2020_ XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Administrative and Civil Remedies Branch Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxxxx 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 IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. B. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityBalotin’s and any Owned or Controlled Entity’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. E. C. The undersigned Progenity signatories represent Xxxxxxx signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. D. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21ON BEHALF OF XXXXXXX X. XXXXXXX‌ 6/9/23 June 14, 2020 Xxxxxx Xxxxxxx 2023 DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xxxxxxx 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 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.2 of the IA or any additional information submitted by Xxxxxxx in response to a request by OIG, whichever is later, OIG will notify Balotin if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Balotin may continue to engage the IRO.‌ 2. If Xxxxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xxxxxxx at the request of OIG, whichever is later, OIG will notify Balotin if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Balotin may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Federal health care program requirements and State Board of Pharmacy requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 4. assign licensed nurses or physicians with relevant education, training and specialized expertise (or other licensed health care professional acting within their scope of practice and specialized expertise) to review and ensure that all ingredients in each prescription for a compounded medication or cream were authorized by the prescriber and for each‌ 5. have sufficient staff and resources to conduct the reviews required by the IA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌ 1. perform each Claims Review in accordance with the specific requirements of the‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Xxxxx Xxxxxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityXxxxx Pharmacy’s obligations under this CIA IA based on a certification by Progenity Xxxxx Xxxxxxxx that he/it is no longer providing health care items or services that will be billed to any Federal health care program and he/it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxx Pharmacy is relieved of his/its CIA IA obligations, Progenity Xxxxx Pharmacy shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxx Pharmacy plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityXxxxx Pharmacy’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. E. The undersigned Progenity signatories represent Xxxxx Pharmacy signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxxxxxxx Xxxxx/ XXXXXXXXXXX XXXXX 3/27/2020_ DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxxxxxxxxx Xxxxx /Xxxxxxxxxxx Xxxxx/ 3/27/2020 Xxxxxxxxxxx Xxxxx DATE Chief Executive Officer Xxxx Square Pharmacy, Inc. /Xxxxx Xxxxxxxxxx/ 3/27/2020 Xxxxx Xxxxxxxxxx DATE Counsel for Xxxx Square Pharmacy, Inc. /Xxxx X. Re July 20, 2020 Xx/ _ 03/30/2020_ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxx Xxxxxxxxxx/ _ 3/30/2020_ XXXXXX X. XXXXXXXXXX DATE Senior Associate Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Good Shepherd 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. C. OIG may agree to a suspension of ProgenityGood Shepherd’s obligations under this CIA based on a certification by Progenity Good Shepherd that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Good Shepherd is relieved of its CIA obligations, Progenity shall Good Shepherd will be required to notify OIG in writing at least 30 days in advance if Progenity Good Shepherd plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Good Shepherd 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxx Xxxxxxxx/ 1/29/2015 XXXXX XXXXXXXX DATE Manager Good Shepherd Hospice, Wichita, L.L.C. /Xxxxxx Xxxxxx/ 1/29/2015 XXXXXX XXXXXX DATE Xxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP PLLC Counsel for Progenity /s/ Xxxx Good Shepherd Hospice, Wichita, L.L.C. /Xxxxxx X. Re July 20, 2020 XXXX XxXxxxx/ 2/6/15 XXXXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 1-29-15 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity CSI 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. C. OIG may agree to a suspension of ProgenityCSI’s obligations under this CIA based on a certification by Progenity CSI that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity CSI is relieved of its CIA obligations, Progenity CSI shall be required to notify OIG in writing at least 30 days in advance if Progenity CSI plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityCSI’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. E. The undersigned Progenity CSI 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. _/s/ Xxxxx Ward____________________ __6/28/16___________________ XXXXX XXXX DATE Chairman of the Board, Interim Chief Executive Officer and President _/s/ Xxxxxxx Loucks________________ __6/28/16___________________ XXXXXXX X. XXXXXX DATE Skadden, Arps, Slate, Xxxxxxx & Xxxx, LLP __/s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Deconti______________ ____6/23/16____________ XXXXXX X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services _/s/ Xxxxx Xxxxxxx July 21, 2020 X. Ellis________________________ _____6/24/16___________ XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Cardiovascular Systems Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIA.IA.‌‌ B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s Xxxxxx’x obligations under this CIA IA based on a certification by Progenity Xxxxxx that it he is no longer providing health care items or services that will be billed to any Federal health care program and it he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxx is relieved of its CIA his IA obligations, Progenity Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s Xxxxxx’x 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. E. The undersigned Progenity signatories represent Xxxxxx signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ ON BEHALF OF XXXXXX XXXXXX AND INTEGRATIVE SPINE CARE LLC‌‌ /Xxxxxx Xxxxxx/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP M.D. Owner Integrative Spine Care LLC and MSPC /Xxxxx Xxxxxx/ Xxxxx Xxxxxx Xxxxxxxxxx PC DATE Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Xxxxxx Xxxxxx and Integrative Spine Care LLC ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX DATE Senior Counsel Office of Counsel to the Inspector General 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xxxxxx 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by Xxxxxx in response to a request by OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌ 2. If Xxxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xxxxxx at the request of OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity PRMC and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of PRMC; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityPRMC’s obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of PRMC’s cessation of participation in Federal health care program programs. If PRMC withdraws from participating in Federal health care programs and it does not have any ownership is relieved of its CIA obligations by OIG, PRMC shall notify OIG at least 30 days in advance of PRMC’s intent to reapply as a participating provider or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity PRMC 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxxxxx X. Xxxxxxx/ Xxxxxxxx (Xxxxx) X. Xxxxxxx, DR.M President/CEO Date August 2, 2011 /Xxxxxxx X. Xxxxxx/ Xxxxxxx X. Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ 8/9/11 Date /Xxxxx X. Xxxxxx/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE X. Xxxxxx Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services 8/8/11 Date This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Mylan 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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 affect: (1) ProgenityMylan’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for the failure to follow applicable Federal health care program requirements. E. D. The undersigned Progenity Mylan 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxxxx X. Xxxxxxx/ 8/15/17 Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx X. Xxxxxxx DATE General CounselHead of Global Compliance Operations and Chief Compliance Officer, Progenity /s/ North America Mylan Inc. /Xxxxxxxx X. Xxxxxx/ 8/16/17 Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx Xxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx Xxxxx Xxxxx Lovells US LLP Counsel for Progenity /s/ Xxxx Mylan Inc. and Mylan Specialty L.P. DATE OF THE DEPARTMENT OF HEALTH AND-HUMAN SERVICES /Xxxx X. Re July 20, 2020 Re/ 8/16/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX /Xxxx X. Xxxxxxx/ 8/16/17 XXXX X. XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE /Xxxxxx Xxxxxx/ 8/14/17 XXXXXX XXXXXX Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Mylan N.V.)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ XXX and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityHOK’s obligations under this CIA IA based on a certification by Progenity HOK that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity HOK is relieved of its CIA IA obligations, Progenity HOK shall be required to notify OIG in writing at least 30 days in advance if Progenity HOK plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect (1) ProgenityHOK’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. E. The undersigned Progenity HOK signatories represent and warrant that they are authorized to execute this CIAIA [change to singular if only one signatory]. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxx Xxxxxx/ XXXXX XXXXXX Chief Executive Officer DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Hospice of Kona DATE /Xxxx X. Re July 20, 2020 Xx/ XXXX X. RE DATE XX Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services DATE APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIAIA. A. IRO Engagement‌ 1. HOK 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 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.4 of the IA or any additional information submitted by HOK in response to a request by OIG, whichever is later, OIG will notify HOK if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, HOK may continue to engage the IRO.‌ 2. If HOK engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, HOK shall submit the information identified in Section V.A.4 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by HOK at the request of OIG, whichever is later, OIG will notify HOK if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, HOK may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ APM, Park Center, Xxxxxx, 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. C. OIG may agree to a suspension of Progenity’s APM, Park Center, and Xxxxxx’x obligations under this CIA based on a certification by Progenity APM, Park Center, and Xxxxxx that it is they are no longer providing health care items or services that will be billed to any Federal health care program and it does do not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is APM, Park Center, and Xxxxxx are relieved of its their CIA obligations, Progenity APM, Park Center, and Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity plans APM, Park Center, and Xxxxxx plan to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’s APM, Park Center, and Xxxxxx’x 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. E. The undersigned Progenity APM, Park Center, and Xxxxxx 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21XX. XXXXXXXX XXXXXX DATE Principal, 2020 Xxxxxx Xxxxxxx Advanced Pain Management And Spine Specialists, P.A. XXXXXX XXXXXX XXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20Advanced Pain Management Specialists, 2020 P.A., d/b/a Advanced Pain Management & Spine Specialists /Xxxxxxxx Xxxxxx/ 12/13/18 ‌‌ XX. XXXXXXXX XXXXXX DATE Principal, Park Center for Procedures, LLC /Xxxxxx Xxxxxx Xxxx/ 12/13/18 ‌‌ XXXXXX XXXXXX XXXX DATE Counsel for Park Center for Procedures, LLC /Xxxxxxxx Xxxxxx/ XXXXXXXX XXXXXX M.D. DATE /Xxxxxx Xxxxxx Xxxx/ XXXXXX XXXXXX XXXX Counsel for Xxxxxxxx Xxxxxx M.D. DATE XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement‌ 1. APM, Park Center, and Xxxxxx shall each engage an IRO to perform the Claims Review that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO(s) shall conduct the Claims Review in a professionally independent and objective fashion, as set forth in Paragraph E.‌ 2. APM, Park Center, and Xxxxxx shall each engage an IRO to perform the Arrangements Review that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO(s) shall not have a prohibited relationship to APM, Park Center, and Xxxxxx as set forth in Paragraph F.‌ 3. Within 30 days after OIG receives the information identified in Section‌ V.A.8 of the CIA or any additional information submitted by APM, Park Center, and Xxxxxx in response to a request by OIG, whichever is later, OIG will notify APM, Park Center, and Xxxxxx if the IRO(s) is/are unacceptable. Absent notification from OIG that an IRO is unacceptable, APM, Park Center, and Xxxxxx may continue to engage the IRO. 4. If APM, Park Center, and Xxxxxx engage 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, APM, Park Center, and Xxxxxx 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 APM, Park Center, and Xxxxxx at the request of OIG, whichever is later, OIG will notify APM, Park Center, and Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, APM, Park Center, and Xxxxxx may continue to engage the IRO. B. IRO Qualifications Each IRO shall:‌‌ 1. assign individuals to conduct the Arrangements Review who are knowledgeable in the requirements of the Anti-Kickback Statute and the Xxxxx Law and the regulations and other guidance documents related to these statutes;‌ 2. possess expertise in fair market valuation issues or have the ability to associate a valuation firm to assist in conducting the transactions review component of the Arrangements Review;‌ 3. assign individuals to conduct the Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;‌ 4. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 5. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 6. 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 Review; and‌ 7. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities Each IRO shall:‌‌ 1. perform each Arrangements Review and Claims Review in accordance with the specific requirements of the CIA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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 and Appendix C (as applicable) to the CIA. D. APM, Park Center, and Xxxxxx Responsibilities‌ APM, Park Center, and Xxxxxx shall ensure that the IRO(s) has/have access to all records and personnel necessary to complete the reviews listed in Section III.E of this CIA and that all records furnished to any IRO are accurate and complete.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, Gambro and OIG agree as follows: A. This CIA shall be applicable only to those operations of Gambro that are subject to United States laws and regulations; B. This CIA shall be binding on the successors, assigns, and transferees of Gambro; Gambro Healthcare, Inc. Corporate Integrity Agreement 33 C. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. This D. Any modifications to this CIA constitutes shall be made with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA.; C. E. OIG may agree to a suspension of ProgenityGambro’s obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of Gambro’s cessation of participation in Federal health care program programs. If Gambro withdraws from participation in Federal health care programs and it does not have any ownership is relieved of its CIA obligations by OIG, Gambro shall notify OIG at least 30 days in advance of Gambro’s intent to reapply as a participating Gambro or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified.; and D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. F. The undersigned Progenity Gambro 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. F. This CIA may be executed in counterparts. ON BEHALF OF GAMBRO HEALTHCARE, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAINC. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx Xxxxxxxxxxx X. Xxxxxxxx July 2111/29/04 XXXXXXXXXXX X. XXXXXXXX Senior Vice President & Chief Compliance Officer Gambro Healthcare, 2020 Xxxxxxxx Inc. DATE /s/ Xxxxxx X. Xxxxxxxx DATE Xxxxx 11/29/04 XXXXXX X. XXXXX, ESQ. Xxxxx & Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity Gambro Healthcare, Inc. DATE Gambro Healthcare, Inc. Corporate Integrity Agreement ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Xxxxx Xxxxxx 11/30/04 XXXXX XXXXXX Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21DATE Gambro Healthcare, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health Inc. Corporate Integrity Agreement 35 GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX A INSTRUCTIONS FOR ARRANGEMENTS REVIEW Gambro shall review and Human Services This Appendix contains the requirements relating evaluate all Relevant Arrangements to the Independent Review Organization (IRO) required by Section III.E ensure that each Relevant Arrangement does not violate Anti-Kickback Statute. A. Relevant Arrangements consist of the CIAfollowing: 1. All Arrangements with physicians; 2. Lease Agreements with potential sources of patient referrals; 3. Joint Ventures; 4. Pharmaceutical Vendors; 5. Stat Lab Agreements; 6. Management Agreements; and 7. Dialysis Transfer Agreements with nursing homes. X. Xxxxxx shall create a database, which shall contain the information Gambro considers necessary to evaluate the Relevant Arrangement’s compliance with the Anti-Kickback Statute including, at a minimum, the following: 1. each party involved in the Arrangement (e.g., physician, Gambro subsidiary); 2. the relationship(s) between or among the parties (e.g., physician employment contract, medical directorship, lease agreement); 3. the term of the Arrangement, including start and expiration dates (including any automatic renewal provisions); 4. the nature and material terms of the Arrangement, including the subject of the contract and type of service or supplies provided; 5. the methodology for determining compensation, including fair market value, and the means by which compensation is paid (e.g., bonus, salary, services); and 6. potentially applicable safe harbor(s). Gambro Healthcare, Inc. Corporate Integrity Agreement Appendix A A-1 GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX B HEIGHTENED ARRANGEMENT REVIEW I. The Arrangement Samples

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityHanora’s obligations under this CIA IA based on a certification by Progenity Xxxxxx that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxx is relieved of its CIA IA obligations, Progenity Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityHanora’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. E. The undersigned Progenity Xxxxxx signatories represent and warrant warrants that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ IA.‌‌ ON BEHALF OF XXXXXX MEDICAL CENTER, P.L.L.C., AND XXXXXXXX X. XXXX, M.D.‌‌ /Xxxxxxxx Xxxx/__ Xxxxxx Medical Center, P.L.L.C. Date Date G. Xxxx Xxxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Date ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Date Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE X. Xxxxxxxxx Date Senior Counsel Office of Inspector General U.S. 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xxxxxx 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 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.2 of the IA or any additional information submitted by Xxxxxx in response to a request by OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌ 2. If Xxxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xxxxxx at the request of OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xxxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s Xxxxxx’x obligations under this CIA IA based on a certification by Progenity Xxxxxx that it is they are no longer providing health care items or services that will be billed to any Federal health care program and it does they do not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xxxxxx is relieved of its CIA their IA obligations, Progenity Xxxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xxxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s Xxxxxx’x 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.requirements.‌‌ E. The undersigned Progenity Xxxxxx signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21ON BEHALF OF SERBIN‌‌ /Xxxxxxx Xxxxxx/ 10/10/18 ‌‌ XXXXXXX X. XXXXXX, 2020 Xxxxxx Xxxxxxx M.D. DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx Xxxxxx/ 10/10/18 ‌‌ XXXXXXXX X. Xxxxxxxx XXXXXX DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX X. XXXXXX DATE Senior Counsel Office of Inspector General 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xxxxxx 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by Xxxxxx in response to a request by OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌ 2. If Xxxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by at the request of OIG, whichever is later, OIG will notify Xxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xxxxxx may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Lan Apothecary and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityLan Apothecary’s obligations requirements under this CIA IA based on a certification by Progenity Lan Apothecary that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Lan Apothecary is relieved of its CIA obligationsIA requirements, Progenity Lan Apothecary shall be required to notify OIG in writing at least 30 days in advance if Progenity Lan Apothecary plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityLan Apothecary’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. E. The undersigned Progenity signatories represent Lan Apothecary signatory represents and warrant warrants that they are she is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxxx Xxxx/ XXXXXXX (XXXXXXX) X. XXXX, 2020 Xxxxxx Xxxxxxx RPH Individually and on behalf of Lan Apothecary, Inc. DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Xxxxxxx (Xxxxxxx) X. Re July 20Xxxx, 2020 RPH and Lan Apothecary, Inc. DATE /Xxxx X. Re/ 12/10/2021_ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxx/ 12/10/2021_ XXXXX XXXXXXX X. XXXX DATE Senior Counsel Affirmative Litigation Branch Office of Inspector General U.S. 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.E III.C of the CIAIA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Practitioner and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.IA.‌‌ C. OIG may agree to a suspension of ProgenityPractitioner’s obligations requirements under this CIA IA based on a certification by Progenity Practitioner that it Practitioner is no longer providing health care items or services that will be billed to any Federal health care program and it Practitioner does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Practitioner is relieved of its CIA obligationsPractitioner’s IA requirements, Progenity Practitioner shall be required to notify OIG in writing at least 30 days in advance if Progenity Practitioner plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityPractitioner’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. E. The undersigned Progenity signatories represent Practitioner signatory represents and warrant warrants that they are she is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ _/Xxxx Xxxxxxxxx/ 7-23-21 ‌‌ XXXX XXXXXXXXX DATE /Xxxxxxx Xxxxxxxxxx Xxxxxxx/ _ _ 7/23/21 _ XXXXXXX XXXXXXXXXX XXXXXXX DATE‌‌ Xxxxxx Xxxxxxx July 21Xxxxxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Xxxxxxxxx _/Xxxx Xxxxxxxxx/ XXXX XXXXXXXXX Owner _/Xxxxxxx Xxxxxxxxxx Xxxxxxx/ XXXXXXX XXXXXXXXXX XXXXXXX Xxxxxx Xxxxxxx, LLP Counsel for L.A. Vision LLC DATE ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ _/Xxxx X. Re July 20, 2020 Xx/ 8/06/2021 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE _/Xxxx X. X’Xxxxx/_ _ 08/03/2021 _ XXXX X. X’XXXXX XXXX Senior Counsel Office of Inspector General U.S. 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. Practitioner 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 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.2 of the IA or any additional information submitted by Practitioner in response to a request by OIG, whichever is later, OIG will notify Practitioner if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Practitioner may continue to engage the IRO.‌ 2. If Practitioner engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Practitioner shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Practitioner at the request of OIG, whichever is later, OIG will notify Practitioner if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Practitioner may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Spectranetics and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Spectranetics; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of Progenity’s Spectranetics’ obligations under this the CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any in the event of Spectranetics’ cessation of participation in Federal health care program programs. If Spectranetics ceases participating in Federal health care programs and it does not have any ownership is relieved of its CIA obligations by OIG, Spectranetics shall notify OIG at least 30 days in advance of Spectranetics’ intent to resume participating as a provider or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills supplier with any Federal health care program. If Progenity is relieved Upon receipt of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such timenotification, OIG shall evaluate whether the CIA will should be reactivated or modified. D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Progenity’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. E. The undersigned Progenity Spectranetics 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Spectranetics Corporate Integrity Agreement By: /s/ Xxxxxx Xxxxx Xxxxxxxxxxxx Dated: 12/18/2009 XXXXX XXXXXXXXXXXX Chief Executive Officer Spectranetics Corporation By: /s/ Xxxxx Xxxxxxxxxx Dated: 12/18/2009 XXXXX XXXXXXXXXX Spectranetics Corporation Vice President, General Counsel & Secretary Vice President, Human Resources By: /s/ Xxxxxxx July 21, 2020 Xxxxxx X. Xxxxx Dated: 12/18/2009 XXXXX X. XXXXXXX XXXXXXX X. XXXXX Xxxxx & Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity the Spectranetics Corporation Spectranetics Corporate Integrity Agreement /s/ Xxxx Xxxxxxx X. Re July 20, 2020 XXXX Xxxxxx 12/22/09 XXXXXXX X. RE XXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.Spectranetics Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Spectranetics Corp)

EFFECTIVE AND BINDING AGREEMENT. Progenity Genova 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. C. OIG may agree to a suspension of ProgenityGenova’s obligations under this CIA based on a certification by Progenity Genova that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Genova is relieved of its CIA obligations, Progenity Genova shall be required to notify OIG in writing at least 30 days in advance if Progenity Genova plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityGenova’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. E. The undersigned Progenity Genova 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. 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 or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ /Xxxx Xxxxxxx/_ _ 13APR20 XXXX XXXXXXX DATE Chief Executive Officer Genova Diagnostics /Xxxxxx X. Xxxxx/ 4/17/20 XXXXXX X. XXXXX DATE Counsel for Xxxxxx Xxxxxxx July 21Xxxxxx Green 000 Xxxx Xxxxxx Xxx Xxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx XX 00000 /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Re/ _ 4/17/20 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX /Xxxxxx X. Xxxxxx Berlin/ 4/15/2020 XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Administrative and Civil Remedies Branch Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity CHSI 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. C. OIG may agree to a suspension of ProgenityCHSI’s obligations under this CIA based on a certification by Progenity CHSI that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity CHSI is relieved of its CIA obligations, Progenity shall CHSI will be required to notify OIG in writing at least 30 days in advance if Progenity CHSI plans to resume providing health care items or services that are billed to any Federal health care program or to Community Health Systems, Inc. Corporate Integrity Agreement, Amended obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity CHSI 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. F. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. Community Health Systems, Inc. Corporate Integrity Agreement, Amended /s/ Xxxx Xxxxxxxx September 20, 2018 Xxxx Xxxxxxxx DATE CHSI Senior Vice President, Corporate Compliance and Privacy Officer /s/ Xxxxxxx X. Xxxxxx Xxxxxxx July September 21, 2020 2018 Xxxxxxx X. Xxxxxx DATE Counsel for XXXX Xxxxxxx, Russell, Englert, Orseck, Untereiner & Sauber LLP /s/ Xxxxxxx X. Xxxxxxx September 21, 2018 Xxxxxxx X. Xxxxxxx DATE General CounselCounsel for XXXX Xxxxxxx, Progenity Russell, Englert, Orseck, Untereiner & Sauber LLP /s/ Xxxxxxxx X. Xxxxxxxx July Xxxx Re September 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 2018 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxxx Xxxx Xxxxx Xxxxxxx July September 21, 2020 2018 XXXXXX XXXX XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Service This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Community Health Systems Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ ResMed 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. C. OIG may agree to a suspension of ProgenityResMed’s obligations under this CIA based on a certification by Progenity ResMed that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity ResMed is relieved of its CIA obligations, Progenity ResMed shall be required to notify OIG in writing at least 30 days in advance if Progenity ResMed plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityResMed’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. E. The undersigned Progenity ResMed 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. 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-transmitted copies or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxx Xxxxxxxxx/ XXXXX XXXXXXXXX Secretary DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Xxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 ResMed Corp. DATE XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement‌ 1. ResMed 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 not have a prohibited relationship to ResMed as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.9 of the CIA or any additional information submitted by ResMed in response to a request by OIG, whichever is later, OIG will notify ResMed if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ResMed may continue to engage the IRO.‌ 2. If ResMed 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, ResMed shall submit the information identified in Section 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 ResMed at the request of OIG, whichever is later, OIG will notify ResMed if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, ResMed may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Novartis 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’s Novartis’ 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. E. D. The undersigned Progenity Novartis 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21/Xxxxxx X. Xxxxxxx/ _ June 30, 2020 Xxxxxx XXXXXX X. XXXXXXX DATE President, Novartis Corporation U.S. Country President /Xxxxxx Xxxxx/_ 6-30-20 XXXXXX XXXXX DATE Vice President & Chief Compliance Officer, Novartis Pharmaceuticals Corporation U.S. Country Head, Ethics, Risk & Compliance /Xxxxx Xxxxxxxx/ _6/30/20 XXXXX XXXXXXXX, Esq. DATE XXXXXXX X. X’XXXXXX, Esq. Xxxxxxxxx & Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx Novartis Pharmaceuticals Corporation ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ /Xxxx X. Re July 20, 2020 Re/ 6/30/2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21/Xxxx X. Xxxxxxx/ 6/30/2020 _ XXXX X. XXXXXXX, 2020 XXXXX XXXXXXX SENIOR COUNSEL DATE Senior Counsel XXXXXXXX XXXXXX, ASSOCIATE COUNSEL Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx /Xxxxxx Xxxxxxx/_ July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 /Xxxxxxxx Xxxxxxxx/_ 7/21/20 _ Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, King and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of King; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. This C. Any modifications to this CIA constitutes shall be made with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity signatories King 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.; and F. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAagreement. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptableCorporate Integrity Agreement King Pharmaceuticals, binding signatures for purposes of this CIAInc. /s/ Fxxxxxxx Xxxxxxxxxxx, Xx. 10/31/05 Fxxxxxxxx Xxxxxxxxxxx, Xx. Corporate Compliance Officer DATE /s/ Xxxxxx Xxxxxxx July 21Mxxx X. Xxxxxxxxx 10/31/05 Mxxx X. Xxxxxxxxx, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Esq. Counsel for Progenity King Pharmaceuticals, Inc. DATE Corporate Integrity Agreement King Pharmaceuticals, Inc. /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Lxxxx Xxxxxx 10/28/05 Lxxxx Xxxxxx Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21DATE Corporate Integrity Agreement King Pharmaceuticals, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services Inc. This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. Capitalized terms used in this Appendix A and not defined herein have the meanings assigned to them in the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement (King Pharmaceuticals Inc)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Xx. Xxxxx and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG X. XXX may agree to a suspension of Progenity’s Xx. Xxxxx’x obligations under this CIA IA based on a certification by Progenity Xx. Xxxxx that it he is no longer providing health care items or services that will be billed to any Federal health care program and it he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Xx. Xxxxx is relieved of its CIA his IA obligations, Progenity Xx. Xxxxx shall be required to notify OIG in writing at least 30 days in advance if Progenity Xx. Xxxxx plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) Progenity’s Dr, Xxxxx’x or the Cancer Centers’ 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. E. The undersigned Progenity signatories represent signatory on behalf of Xx. Xxxxx and warrant the Cancer Centers represents and warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxxxx Xxxxx/ DR. XXXXXXX XXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Xx. Xxxxx and the Cancer Centers Ice Xxxxxx DATE XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA. A. IRO Engagement‌ 1. Xx. Xxxxx 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by Xx. Xxxxx in response to a request by OIG, whichever is later, OIG will notify Xx. Xxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xx. Xxxxx may continue to engage the IRO.‌ 2. If Xx. Xxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xx. Xxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xx. Xxxxx at the request of OIG, whichever is later, OIG will notify Xx. Xxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Xx. Xxxxx may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Quarterly Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Quarterly Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Quarterly Claims Review 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 professional acting within their scope of practice and specialized expertise) to make the medical necessity determinations required by the Quarterly Claims Review; and‌ 5. have sufficient staff and resources to conduct the reviews required by the IA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌ 1. perform each Quarterly Claims Review in accordance with the specific requirements of the IA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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 IA.

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Gamma 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. C. OIG may agree to a suspension of ProgenityGamma’s obligations under this CIA based on a certification by Progenity Gamma that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Gamma is relieved of its CIA obligations, Progenity Gamma shall be required to notify OIG in writing at least 30 days in advance if Progenity Gamma plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityGamma’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. E. The undersigned Progenity Gamma 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. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx /Xxxxxx Xxxxxx/ XXXXXX XXXXXX President of Gamma Healthcare, Inc. DATE Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Xxxxxxxxxxxx Counsel for Progenity /s/ Xxxx Gamma Healthcare, Inc. DATE /Xxxx X. Re July 20, 2020 Re/ 04/09/2018 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx X. Xxxxx/ 4/3/2018 XXXXX XXXXXXX X. XXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. Gamma 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by Gamma in response to a request by OIG, whichever is later, OIG will notify Gamma if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Gamma may continue to engage the IRO.‌ 2. If Gamma 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, Gamma shall submit the information identified in Section 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 Gamma at the request of OIG, whichever is later, OIG will notify Gamma if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Gamma may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Oglethorpe 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. C. OIG may agree to a suspension of ProgenityOglethorpe’s obligations under this CIA based on a certification by Progenity Oglethorpe that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Oglethorpe is relieved of its CIA obligations, Progenity Oglethorpe shall be required to notify OIG in writing at least 30 days in advance if Progenity Oglethorpe plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityOglethorpe’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. E. The undersigned Progenity Oglethorpe 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. 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 or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx 1/26/21 /A. Xxx Xxxxxxx July 21, 2020 Xxxxxx III/ Xxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services 1/26/2021 This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. Oglethorpe 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 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.7 of the CIA or any additional information submitted by Oglethorpe in response to a request by OIG, whichever is later, OIG will notify Oglethorpe if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Oglethorpe may continue to engage the IRO.‌ 2. If Oglethorpe 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, Oglethorpe shall submit the information identified in Section 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 Oglethorpe at the request of OIG, whichever is later, OIG will notify Oglethorpe if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Oglethorpe may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained‌ 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 Review; 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 CIA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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. X. Xxxxxxxxxx Responsibilities‌ Oglethorpe 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ Arora 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 IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. B. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityArora’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. E. C. The undersigned Progenity signatories represent Xxxxx signatory represents and warrant warrants that they are he is authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. D. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21ON BEHALF OF XXXX XXXXX, 2020 Xxxxxx Xxxxxxx MD‌‌‌ /Xxxx Xxxxx/ 9/11/23 ‌‌ XXXX XXXXX, MD DATE General Counsel/Xxxxxx Xxx Xxxxxx/ 9/11/23 ‌‌ XXXXXX X. DEL GIORNO DATE Garfunkel Wild, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP P.C. Counsel for Progenity /s/ Xxxx X. Re July 20Xxxxx, 2020 MD /Xxxx Re/ 2023.09.20 ‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General General‌ U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxxx/ 2023.09.20 ‌ XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General General‌ 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. Arora 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 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.2 of the IA or any additional information submitted by Arora in response to a request by OIG, whichever is later, OIG will notify Arora if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arora may continue to engage the IRO.‌ 2. If Xxxxx engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Xxxxx shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by Xxxxx at the request of OIG, whichever is later, OIG will notify Arora if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arora may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityUSWM’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. E. D. The undersigned Progenity 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 F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Corporate Integrity Agreement – USWM /Xxx X. Xxxx/ XXX XXXX COMPLIANCE OFFICER US WORLDMEDS, LLC DATE Counsel for US WorldMeds, LLC Xxxxxx Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Corporate Integrity Agreement – USWM XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXXX XXXX XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human 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.E of the CIA. A. IRO Engagement‌ 1. 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 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 USWM if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, USWM may continue to engage the IRO.‌ 2. If 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 USWM at the request of OIG, whichever is later, OIG will notify USWM if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, USWM may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the IRO Reviews who have expertise in the pharmaceutical industry and in all applicable Federal health care program and FDA requirements relating to the 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 samples for the IRO Transactions Reviews who are knowledgeable about the appropriate statistical sampling techniques; and‌ 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌‌ 1. perform each component of the IRO Reviews in accordance with the specific requirements of the 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Agendia 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. C. OIG may agree to a suspension of ProgenityAgendia’s obligations under this CIA based on a certification by Progenity Agendia that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Agendia is relieved of its CIA obligations, Progenity Agendia shall be required to notify OIG in writing at least 30 days in advance if Progenity Agendia plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityAgendia’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. E. The undersigned Progenity Agendia 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. 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 or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx /Xxxxxxx Xxxxxxx/ _ XXXXXXX X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services 01/11/2021 APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement‌ 1. Agendia 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 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.7 of the CIA or any additional information submitted by Agendia in response to a request by OIG, whichever is later, OIG will notify Agendia if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Agendia may continue to engage the IRO.‌ 2. If Agendia 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, Agendia shall submit the information identified in Section 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 Agendia at the request of OIG, whichever is later, OIG will notify Agendia if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Agendia may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Claims Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims being reviewed;‌ 2. assign individuals to design and select the Claims Review sample who are knowledgeable about the appropriate statistical sampling techniques;‌ 3. assign individuals to conduct the coding review portions of the Claims Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements);‌‌ 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 Review; 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 CIA;‌ 2. follow all applicable Medicare and state Medicaid program rules and reimbursement guidelines in making assessments in the Claims Review;‌ 3. request clarification from the appropriate authority (e.g., Medicare contractor), if in doubt of the application of a particular Medicare or state Medicaid program policy or regulation;‌‌ 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. Agendia Responsibilities‌ Agendia 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.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ I&L and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityI&L Pharmacy’s, Xxxxxxxxx’x, and/or Babchinetskaya’s obligations under this CIA IA based on a certification by Progenity I&L Pharmacy, Xxxxxxxxx, and/or Babchinetskaya that it it/she is no longer providing health care items or services that will be billed to any Federal health care program and it it/she does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity I&L Pharmacy, Xxxxxxxxx, and/or Babchinetskaya is relieved of its CIA its/her IA obligations, Progenity I&L Pharmacy, Xxxxxxxxx, and/or Babchinetskaya shall be required to notify OIG in writing at least 30 days in advance if Progenity plans I&L Pharmacy, Xxxxxxxxx, and/or Babchinetskaya plan to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityI&L’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. E. The undersigned Progenity I&L signatories represent represents and warrant warrants that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx Individually and on behalf of I&L Express Pharmacy LLC DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Welsh & Xxxxxx, Xxxx & Xxxxxxxx LLP P.C. Counsel for Progenity /s/ Xxxx I&L Express Pharmacy LLC and Xxxxx Xxxxxxxxx, RPH DATE Individually and on behalf of I&L Express Pharmacy LLC DATE Xxxxx Xxxxxxxx, P.C. Counsel for Xxxxxx Xxxxxxxxxxxxxx DATE /Xxxx X. Re July 20, 2020 Re/ _5/03/2018 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. U. S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 _/Xxxxx X. Xxxx/ 5/30/2018 XXXXX XXXXXXX X. XXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.C of the CIAIA. A. IRO Engagement‌ 1. I&L 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.2 of the IA or any additional information submitted by I&L in response to a request by OIG, whichever is later, OIG will notify I&L if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, I&L may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Orthofix and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees of Orthofix; B. This CIA shall become final and binding on the date the final signature is obtained on the CIA.; B. C. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.; C. D. OIG may agree to a suspension of ProgenityOrthofix’s obligations under this CIA based on a certification by Progenity Orthofix that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity Orthofix is relieved of its CIA obligations, Progenity shall Orthofix will be required to notify OIG in writing at least 30 days in advance if Progenity Orthofix plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity Orthofix signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent represents that they are signing this CIA in their official capacities capacity and that they are authorized to execute this CIA. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21X. Xxxxxx 5/31/2012 XXXXXX X. XXXXXX DATE President and Chief Executive Officer Orthofix International, 2020 Xxxxxx Xxxxxxx N.V. /s/ Brien X. X’Xxxxxx 5/31/2012 BRIEN X. X’XXXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx XXXXXXX X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.X. XXXXXXX Ropes & Xxxx LLP Prudential Tower, 800 Boylston Street Boston, MA 02199-3600 /s/ R. Xxxxx XxXxxxxx 5/31/12

Appears in 1 contract

Samples: Corporate Integrity Agreement (Orthofix International N V)

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ PSI and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIAIA. C. OIG may agree to a suspension of ProgenityPSI’s obligations under this CIA IA based on a certification by Progenity PSI that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined engaging in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care programPatient Assistance Related Functions. If Progenity PSI is relieved of its CIA IA obligations, Progenity PSI shall be required to notify OIG in writing at least 30 days in advance if Progenity PSI plans to resume providing health care items or services that are billed to any Federal health care program Patient Assistance Related Functions or to obtain an ownership or control interest in any entity that bills any Federal health care programengages in Patient Assistance Related Functions. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect (1) ProgenityPSI’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 requirementsrequirements during the IA or thereafter. This IA does not supersede OIG’s rights as set forth in 42 C.F.R. 1008.45 in connection with conduct other than the Covered Conduct or conduct that occurs on or after the Effective Date of the Settlement Agreement described above in the Preamble. E. The undersigned Progenity PSI signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ /X. Xxxxxx Xxxx/ 1/17/2020 X. Xxxxxx Xxxx Date Chief Executive Officer Patient Services, Inc. /Xxxxxxx Xxxxxxxxx/ 1/17/2020 Xxxxxxx July 21, 2020 X. Xxxxxxxxx Date Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx Xxxxxx Xxxxxx LLP Counsel for Progenity /s/ Patient Services, Inc. /Xxxx X. Xx/ 01/17/2020 Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx /Xxxx X. Xxxxxxx/ 01/17/2020 Xxxx X. Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General 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.E III.G of the CIAIA. A. IRO Engagement‌ 1. PSI 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 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.6 of the IA or any additional information submitted by PSI in response to a request by OIG, whichever is later, OIG will notify PSI if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PSI may continue to engage the IRO.‌ 2. If PSI engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, PSI shall submit the information identified in Section V.A.6 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by PSI at the request of OIG, whichever is later, OIG will notify PSI if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, PSI may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ MPG and OIG agree as follows: A. This CIA IA shall become final and binding on the date the final signature is obtained on the CIAIA. B. This CIA IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.IA.‌‌ C. OIG may agree to a suspension of ProgenityMPG’s obligations under this CIA IA based on a certification by Progenity MPG that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity MPG is relieved of its CIA IA obligations, Progenity MPG shall be required to notify OIG in writing at least 30 days in advance if Progenity MPG plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA IA will be reactivated or modified. D. All requirements and remedies set forth in this CIA IA are in addition to and do not affect affect: (1) ProgenityMPG’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. E. The undersigned Progenity MPG signatories represent and warrant that they are authorized to execute this CIAIA. The undersigned OIG signatories represent that they are signing this CIA IA in their official capacities capacity and that they are authorized to execute this CIAIA. F. This CIA IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIAIA. Electronically-Electronically transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAIA. /s/ Xxxxxx Xxxxxxx July 21ON BEHALF OF MICHIGAN PHYSICIANS GROUP, 2020 Xxxxxx Xxxxxxx P.C., AND XXXXXX XXXX, M.D.‌‌ /Xxxxxx Xxxx/_ Michigan Physicians Group, P.C. DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxx & Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx P.C. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ /Xxxx X. Re July 20, 2020 Re/ 2/11/2021 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 /Xxxxx Xxxxxxxxx/__ 2/11/2021_ XXXXX XXXXXXX X. XXXXXXXXX DATE Senior Associate Counsel Office of Inspector General 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.E III.C of the CIAIA. A. IRO Engagement‌ 1. MPG 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 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.2 of the IA or any additional information submitted by MPG in response to a request by OIG, whichever is later, OIG will notify MPG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, MPG may continue to engage the IRO.‌ 2. If MPG engages a new IRO during the term of the IA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, MPG shall submit the information identified in Section V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information, or any additional information submitted by MPG at the request of OIG, whichever is later, OIG will notify MPG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, MPG may continue to engage the IRO.‌

Appears in 1 contract

Samples: Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity Merit 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityMerit’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. E. D. The undersigned Progenity Merit 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. F. 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-transmitted copies or facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21XXXX XXXXXXXXXXXX DATE Chief Executive Officer Merit Medical Systems, 2020 Xxxxxx Xxxxxxx Inc. XXXX X. XXXXX DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP XXXXXXX XXXXX Counsel for Progenity /s/ Xxxx X. Re July 20Merit Medical Systems, 2020 Inc. King & Spalding LLP ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX XXXXXXXX X. XXXXXX DATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity ‌ FHS and Xxxxx Xxxxxxxx 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. C. OIG may agree to a suspension of Progenity’s FHS obligations under this CIA based on a certification by Progenity FHS that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity FHS is relieved of its CIA obligations, Progenity FHS shall be required to notify OIG in writing at least 30 days in advance if Progenity FHS plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified. D. X. XXX may agree to a suspension of Xxxxx Xxxxxxxx’x obligations under this CIA based on a certification by Xxxxx Xxxxxxxx that he does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care programs. If Xxxxx Xxxxxxxx is relieved of his CIA obligations, he shall be required to notify OIG in writing at least 30 days in advance if he plans to obtain an ownership or control interest in any entity that bills any Federal health care programs. At such time, OIG shall evaluate whether the CIA shall be reactivated or modified. E. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ProgenityFHS’s and/or Xxxxx Xxxxxxxx’x 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. E. F. The undersigned Progenity FHS and/or Xxxxx Xxxxxxxx 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. F. G. 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 or facsimiles of Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx DATE General Counsel, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services ‌‌‌‌‌‌‌‌‌‌‌ ‌‌‌‌‌‌‌‌‌‌‌‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement‌ 1. FHS 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 review in a professionally independent and objective fashion, as set forth in Paragraph D. Within 30 days after OIG receives the information identified in Section V.A.7 of the CIA or any additional information submitted by FHS in response to a request by OIG, whichever is later, OIG will notify FHS if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, FHS may continue to engage the IRO.‌ 2. If FHS 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, FHS shall submit the information identified in Section 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 FHS at the request of OIG, whichever is later, OIG will notify FHS if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, FHS may continue to engage the IRO.‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity UMHS 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. C. OIG may agree to a suspension of ProgenityUMHS’s obligations under this CIA based on a certification by Progenity UMHS that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §§ 1320a-3, in any entity that bills any Federal health care program. If Progenity UMHS is relieved of its CIA obligations, Progenity UMHS shall be required to notify OIG in writing at least 30 days in advance if Progenity UMHS plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) ProgenityUMHS’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. E. The undersigned Progenity UMHS 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. 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-transmitted copies or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /s/ Xxxxxx Xxxxxxx July 21XXXXX XXXXXXX DATE Vice President for Finance and Chief Financial Officer University of Missouri System The Curators of the University of Missouri, 2020 Xxxxxx Xxxxxxx DATE General Counselacting on behalf of the University of Missouri Health System _/Xxxxx X. Xxxxxxxxxx/ XXXXX XXXXXXXXXX, Progenity /s/ Xxxxxxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, ESQ. Norton Xxxx & Xxxxxxxx Xxxxxxxxx US LLP Counsel for Progenity /s/ Xxxx The Curators of the University of Missouri DATE XXXXXX X. Re July 20, 2020 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.Services

Appears in 1 contract

Samples: Corporate Integrity Agreement

EFFECTIVE AND BINDING AGREEMENT. Progenity A. All terms and OIG agree as follows: A. This conditions of the CIA not modified in this Amendment shall become final and binding 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 signature is obtained on the CIAsignatory signs this Amendment (Amendment Effective Date). 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. C. OIG may agree to a suspension of Progenity’s obligations under this CIA based on a certification by Progenity that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Progenity is relieved of its CIA obligations, Progenity shall be required to notify OIG in writing at least 30 days in advance if Progenity plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. 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) Progenity’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. E. The undersigned Progenity 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. F. 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 or facsimiles Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIAAmendment. /s/ Xxxxxx Xxxxxxx July 21, 2020 Xxxxxx Xxxxxxx /Xxxxx Xxxx/ XXXXX XXXX DATE General Counsel, Progenity /s/ Xxxxxxxx CHIEF LEGAL OFFICER /Xxxx X. Xxxxxxxx July 21, 2020 Xxxxxxxx X. Xxxxxxxx DATE X. Xxxxxxx Day Xxxxxx, Xxxx & Xxxxxxxx LLP Counsel for Progenity /s/ Xxxx X. Re July 20, 2020 Xx/ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /s/ Xxxxx Xxxxxxx July 21, 2020 XXXXX XXXXXXX DATE Senior Counsel Office of Inspector General U.S. U. S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E III.D of the CIA. A. IRO Engagement 1. 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 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.7 of the CIA or any additional information submitted by Signature in response to a request by OIG, whichever is later, OIG will notify Signature if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Signature may continue to engage the IRO. 2. If 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.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 Signature at the request of OIG, whichever is later, OIG will notify Signature if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Signature may continue to engage the IRO.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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