Common use of EFFECTIVE AND BINDING AGREEMENT Clause in Contracts

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDC’s obligations under this IA based on a certification by DLDC 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 DLDC is relieved of its IA obligations, DLDC shall be required to notify OIG in writing at least 30 days in advance if DLDC 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 IA will be reactivated or modified.‌ D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDC’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 DLDC signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC EPIPG and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCEPIPG’s obligations under this IA based on a certification by DLDC EPIPG 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 DLDC EPIPG is relieved of its IA obligations, DLDC EPIPG shall be required to notify OIG in writing at least 30 days in advance if DLDC EPIPG 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDCEPIPG’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 DLDC EPIPG signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTSEL PASO INTEGRATED PHYSICIANS GROUP, P.A.‌ P.A.‌‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXXXxxxxx/ Dr. Xxxxxx Xxxxxx (on behalf of himself) DATE President, M.D. DATE Partner Digestive & Liver Disease ConsultantsEl Paso Integrated Physicians Group, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive and Accutrack Medical Claims Service, LLC Manager, Accutrack Medical Claims Service, LLC DATE and Accutrack Medical Claims Service, LLC Manager, Accutrack Medical Claims Service, LLC DATE Xxxxxx Xxxx Xxxxxx Xxxxxxxx & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY Xxx LLP DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌‌ Xxxx X. Re/ 10/2/17 XXXX X. RE Re DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX Xxxx X. XXXXXX Xxxxxxx DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D III.E of the IA. A. IRO Engagement‌ 1. DLDC EPIPG 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. E. Within 30 days after OIG receives the information identified in Section V.A.4 of the IA or any additional information submitted by DLDC EPIPG in response to a request by OIG, whichever is later, OIG will notify DLDC EPIPG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC EPIPG may continue to engage the IRO.‌ 2. If DLDC EPIPG 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, DLDC EPIPG 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 DLDC EPIPG at the request of OIG, whichever is later, OIG will notify DLDC EPIPG if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC EPIPG may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC FHG and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCFHG’s obligations under this IA based on a certification by DLDC FHG 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 DLDC FHG is relieved of its IA obligations, DLDC FHG shall be required to notify OIG in writing at least 30 days in advance if DLDC FHG 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDCFHG’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 DLDC FHG signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTSFHG‌ /Xxxxx Xxxx/ 5/4/17 Xx. Xxxxx Xxxx DATE Medical Director Fredericksburg Hospitalist Group, P.A.‌ P.C. /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX Xxxxxx/ 5/4/17 Xxxxxx X. XXXXXX. Xxxxxx, M.D. Esq. DATE Partner Digestive & Liver Disease ConsultantsXxxxxx Xxxxxx PLLC 0000 Xxxxxx Xxxxxxxxx Suite 430 Arlington, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE VA 22209 Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy FHG ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ /Xxxx X. Re/ 10/2/17 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 /Xxxxx 5/11/17 DATE /Xxxx X. Xxxxxx/ 9/28/17 XXXXX XXXX X. XXXXXX DATE Senior Counsel Office of Inspector General U. S. U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ 6/1/17 DATE /Xxxxxxx X. Xxxxxxxxx/ XXXXXXX X. XXXXXXXXX Associate 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxxx-JCA and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by prior written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCXxxxx-JCA’s obligations under this IA based on a certification by DLDC Xxxxx-JCA 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, interest in any entity that bills any Federal health care program. If DLDC Xxxxx-JCA is relieved of its IA obligations, DLDC Xxxxx-JCA shall be required to notify OIG in writing at least 30 days in advance if DLDC Xxxxx-JCA 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to to, and do not affect (1) DLDCXxxxx-JCA’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 DLDC signatories represent Xxxxx-JCA signatory represents and warrant warrants that they are it is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS/Xxxxx X. Xxxxx, P.A.‌ X.X./ 5/9/13 Xxxxx X. Xxxxx, X.X. Xxxx Xxxxxxx Cardiology Associates /Xxxxxxx Xxxxxxxx/ 5/9/13 Xxxxxxx Xxxxxxxx Counsel for Xxxxx-JCA Date /Xxxxxx Xxxxx/ 9/26/17 ‌‌ X. XxXxxxx/ 6/3/13 XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 X. Xxxxx/ 6/4/2013 XXXXX X. XXXXXX XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Hanflink and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCHanflink’s obligations under this IA based on a certification by DLDC Hanflink 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 DLDC Hanflink is relieved of its his IA obligations, DLDC Hanflink shall be required to notify OIG in writing at least 30 days in advance if DLDC Hanflink 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCHanflink’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 DLDC signatories represent Hanflink signatory represents and warrant warrants that they are he is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS/Xxxxxx Xxxxxxxx/ XXXXXX XXXXXXXX, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX D.O. DATE Counsel for Digestive Xxxxxx Xxxxxxxx, D.O. Pietragallo Xxxxxx Xxxxxx Xxxxxx & Liver Disease ConsultantsXxxxxxxx, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY LLP DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXXXXXX XXXXX 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC Hanflink 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. E. Within 30 days after OIG receives the information identified in Section V.A.4 V.A.2 of the IA or any additional information submitted by DLDC Hanflink in response to a request by OIG, whichever is later, OIG will notify DLDC Hanflink if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Hanflink may continue to engage the IRO.‌ 2. If DLDC Hanflink 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, DLDC Hanflink shall submit the information identified in Section V.A.4 V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by DLDC Hanflink at the request of OIG, whichever is later, OIG will notify DLDC Hanflink if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Hanflink may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxxxxxx and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDC’s Xxxxxxxx’x obligations under this IA based on a certification by DLDC Klurfeld 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 DLDC Klurfeld is relieved of its IA obligations, DLDC Klurfeld shall be required to notify OIG in writing at least 30 days in advance if DLDC Klurfeld 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDCKlurfeld’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 DLDC Klurfeld signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS/Xxxx Xxxxxxxx/ 07/27/2020 Xxxx Xxxxxxxx, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXXon behalf of DATE Williamsburg Physical Therapy, M.D. P.C. and Euro Physical Therapy, P.C. /Xxxxx Xxxxxxxx/_ 07/27/2020_ Xxxxx Xxxxxxxx, on behalf of DATE Partner Digestive & Liver Disease ConsultantsFirst Plus Service, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX Inc. /Xxxx Xxxxxxxx/ 07/27/2020 Xxxx Xxxxxxxx DATE /Xxxxx Xxxxxxxx/_ 07/27/2020 Xxxxx Xxxxxxxx DATE /Xxxxx Xxxxxxx/_ 07/28/2020 Xxxxx Xxxxxxx DATE XXXXX DATE XXXXXXXX FLEXNER LLP Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ Klurfeld /Xxxxxx Xxxxxx/ 07/28/2020 Xxxxxx Xxxxxx DATE XXXXX XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE FLEXNER LLP Counsel for Xxxxxxxx Xxxxx Reddy Klurfeld /Xxxx X. Re/ 10/2/17 _ 08/13/2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX /Xxxxxx X. Xxxxxxxx/ _ 8/13/2020 XXXXXX 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.D III.E of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxx Clinic and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCXxxx Clinic’s obligations under this IA based on a certification by DLDC Xxxx Clinic 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 DLDC Xxxx Clinic is relieved of its IA obligations, DLDC Xxxx Clinic shall be required to notify OIG in writing at least 30 days in advance if DLDC Xxxx Clinic 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCXxxx Clinic’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 DLDC signatories represent Xxxx Clinic signatory represents and warrant warrants that they are he is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE XXXXX X. XXXX, O.D., DATE President and Owner XXXXX XXXX XXXX, O.D., PH.D., P.C., D/B/A XXXX EYE CLINIC /Xxxxx X. Day/ 9/15/2020_ XXXXX X. DAY DATE Xxxxx & LIVER DISEASE CONSULTANTSXxxxxxx, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX counsel for XXXXX XXXX XXXX, O.D., PH.D., P.C., D/B/A XXXX EYE CLINIC /Xxxxx Xxxx Xxxx/_ 9/4/2020 XXXXX X. XXXXXXXXX, M.D. O.D., DATE Partner Digestive President and Owner XXXX EYE CLINIC /Xxxxx X. Day/ 9/15/2020_ XXXXX X. DAY DATE Xxxxx & Liver Disease ConsultantsXxxxxxx, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX counsel for XXXXX DATE Counsel for Digestive & Liver Disease ConsultantsX. XXXX, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 O.D. XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC LFAC and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCLFAC’s obligations under this IA based on a certification by DLDC LFAC 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 DLDC LFAC is relieved of its IA obligations, DLDC LFAC shall be required to notify OIG in writing at least 30 days in advance if DLDC LFAC 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCLFAC’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 DLDC LFAC signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx /Xxxxxxx X. Xxxxx/ 9/26/17 ‌‌ XXXXXX 04-30-2020 XXXXXXX X. XXXXX, M.D. DPM DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX /Xxxxxx Xxxxxx/_ 4-30-20 XXXXXX X. XXXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy LFAC /Xxxx X. Re/ 10/2/17 05/01/2020 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX /Xxxxxxx X. XXXXXX Xxxxxxx/ 4-29-2020 XXXXXXX X. 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Practitioner and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCPractitioner’s obligations under this IA based on a certification by DLDC Practitioner 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 DLDC Practitioner is relieved of its his IA obligations, DLDC Practitioner shall be required to notify OIG in writing at least 30 days in advance if DLDC 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCPractitioner’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 DLDC signatories represent Practitioner signatory represents and warrant warrants that they are he is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS/Xxxxxxx Xxxx/ 6/24/2020_ XXXXXXX X. XXXX, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXXMD DATE /Xxxxxxx Xxxx/___ 6/24/2020_ XXXXXXX X XXXX, M.D. MD DATE Partner Digestive & Liver Disease ConsultantsPresident Medscan, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy PSC /Xxxx X. Re/ 10/2/17 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 /Xxxxx Xxxxxx/ 9/28/17 Xxxxxxx/ 6 July 2020 XXXXX X. XXXXXX 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Dr. Uradu and UTC and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCDr. Uradu and UTC’s obligations under this IA based on a certification by DLDC Dr. Uradu and UTC 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 DLDC is Dr. Uradu and UTC are relieved of its their IA obligations, DLDC Dr. Uradu and UTC shall be required to notify OIG in writing at least 30 days in advance if DLDC plans Dr. Uradu and/or UTC 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCDr. Uradu and UTC’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 DLDC signatories represent Dr. Uradu and warrant UTC signatory represents and warrants that they are she is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx DR. URADU AND UTC‌‌ /Xxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX XXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultantsa/k/a Xxxxxxxxxx Xxxx Uradu Personally and on behalf of Ultimate Care Medical Services, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX LLC d/b/a Ultimate Treatment Center XXXXXX XXXXXXX DATE Counsel for Digestive & Liver Disease Consultantsfor: Xxxx X. Xxxxx, P.A /Xxxxxxxx M.D. a/k/a Xxxxxxxxxx Xxxx Uradu and Ultimate Care Medical Services, LLC d/b/a Ultimate Treatment Center 0000 Xxxxxxxxx Xxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 Xxxx 0 Xxxxxxxxxx, XX 00000 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 /Xxxxx Xxxxxx/ 9/28/17 XXXXX XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Administrative and Civil Remedies Branch 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC Dr. Uradu and UTC 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. E. Within 30 days after OIG receives the information identified in Section V.A.4 V.A.2 of the IA or any additional information submitted by DLDC Dr. Uradu and UTC in response to a request by OIG, whichever is later, OIG will notify DLDC Dr. Uradu and UTC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Dr. Uradu and UTC may continue to engage the IRO.‌ 2. If DLDC Dr. Uradu and UTC 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, DLDC Dr. Uradu and UTC shall submit the information identified in Section V.A.4 V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by DLDC Dr. Uradu and UTC at the request of OIG, whichever is later, OIG will notify DLDC Dr. Uradu and UTC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Dr. Uradu and UTC 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.

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxx, Village and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCXxxx’x or Village’s obligations under this IA based on a certification by DLDC Xxxx or Village that he/it is is/are 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 DLDC is Xxxx or Village are relieved of his/its IA obligations, DLDC Xxxx or Village (as applicable) shall be required to notify OIG in writing at least 30 days in advance if DLDC plans Xxxx or Village (as applicable) 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 IA will be reactivated or modified.‌modified with respect to Xxxx or Village (as applicable). D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCthe Practice’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 DLDC signatories for the Practice represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTSXX. XXX XXXXX XXXXXX XXXX AND VILLAGE DERMATOLOGY AND COSMETIC SURGERY, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ L.L.C.‌‌ XX. XXX XXXXX XXXXXX XXXX DATE on behalf of himself and on behalf of Village Dermatology and Cosmetic Surgery, LLC XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX XXXXXXX DATE Counsel for Digestive & Liver Disease ConsultantsXx. Xxx Xxxxx Xxxxxx Xxxx and Village Dermatology and Cosmetic Surgery, P.A /Xxxxxxxx LLC Xxxxxx Xxxxxxx 100 S.E. 0xx Xxxxxx, Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 0000 Xxxx Xxxxxxxxxx, XX 00000 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 /Xxxxx Xxxxxx/ 9/28/17 XXXXX XXXXXX X. XXXXXX BERLIN DATE Senior Counsel Administrative and Civil Remedies Branch 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC The Practice 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. E. Within 30 days after OIG receives the information identified in Section V.A.4 V.A.2 of the IA or any additional information submitted by DLDC the Practice in response to a request by OIG, whichever is later, OIG will notify DLDC the Practice if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC the Practice may continue to engage the IRO.‌ 2. If DLDC the Practice 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, DLDC the Practice shall submit the information identified in Section V.A.4 V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by DLDC the Practice at the request of OIG, whichever is later, OIG will notify DLDC the Practice if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC the Practice 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. D. The Practice Responsibilities‌ The Practice 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.

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDC’s obligations under this IA based on a certification by DLDC 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 DLDC is relieved of its IA obligations, DLDC shall be required to notify OIG in writing at least 30 days in advance if DLDC 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 IA will be reactivated or modified.‌ D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDC’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 DLDC signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE X.X. XXXX Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Dia-Foot and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCDia-Foot’s obligations requirements under this IA based on a certification by DLDC Dia-Foot 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 DLDC Dia-Foot is relieved of its IA obligationsrequirements, DLDC Dia-Foot shall be required to notify OIG in writing at least 30 days in advance if DLDC Dia-Foot 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDCDia-Foot’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 DLDC Dia-Foot signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTSXXXXXX XXXXXX, P.A.‌ DPM AND FOOT CARE STORE, INC.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ Xxxxxx/ XXXXXX X. XXXXXXXXXXX, M.D. DPM DATE Partner Digestive & Liver Disease ConsultantsPresident, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX Foot Care Store, Inc. d/b/a Dia-Foot DATE Counsel for Digestive Dia-Foot Brown & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY Xxxxxxxxx DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 12/29/21 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 Xxxxxxxxx/_ 12-30-21 XXXXX X. XXXXXX XXXXXXXXX DATE Senior Counsel Administrative and Civil Remedies Branch Office of Counsel to the 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.D III.E of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC LFAC and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCLFAC’s obligations under this IA based on a certification by DLDC LFAC 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 DLDC LFAC is relieved of its IA obligations, DLDC LFAC shall be required to notify OIG in writing at least 30 days in advance if DLDC LFAC 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDCLFAC’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 DLDC LFAC signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxxxxx and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDCSkyline’s obligations under this IA based on a certification by DLDC Skyline 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 DLDC Skyline is relieved of its IA obligations, DLDC Skyline shall be required to notify OIG in writing at least 30 days in advance if DLDC Skyline 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect (1) DLDCSkyline’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 DLDC Skyline signatories represent and warrant that they are authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xxxxxxx and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDC’s Xxxxxxx’x obligations under this IA based on a certification by DLDC 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 DLDC Xxxxxxx is relieved of its IA obligations, DLDC Xxxxxxx shall be required to notify OIG in writing at least 30 days in advance if DLDC 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDC’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 DLDC signatories represent Xxxxxxx signatory represents and warrant warrants that they are it is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS/Xxxxx Xxxxxxx/ 6/29/16 ‌‌ Xxxxx X. Xxxxxxx, P.A.‌ X.X. XXXX /Xxxxx Xxxxxxx/ 6/29/16 ‌‌ Xxxxx X. Xxxxxxx, X.X. XXXX /Xxxxxx Xxxxx/ 9/26/17 ‌‌ X. XxXxxxx/ 7/5/16 XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE XXXXXXX DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX X. XXXXXX Xxxxxxx for Xxxxxxx Xxxxxxx/ 7/14/16 XXXXXXX XXXXXXX 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.D III.C of the IA. A. IRO Engagement‌ 1. DLDC 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 reviews 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.4 V.A.2 of the IA or any additional information submitted by DLDC Xxxxxxx in response to a request by OIG, whichever is later, OIG will notify DLDC Xxxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Xxxxxxx may continue to engage the IRO.‌ 2. If DLDC 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, DLDC Xxxxxxx shall submit the information identified in Section V.A.4 V.A.2 of the IA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information information, or any additional information submitted by DLDC Xxxxxxx at the request of OIG, whichever is later, OIG will notify DLDC Xxxxxxx if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC Xxxxxxx may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the Quarterly Claims Review and Dermatology Treatment Schedule Review who have expertise in the Medicare and state Medicaid program requirements applicable to the claims and documentation being reviewed;‌ 2. assign individuals to design and select the Quarterly Claims Review sample and the Dermatology Treatment Schedule 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 and the Dermatology Treatment Schedule Review who have a nationally recognized coding certification and who have maintained this certification (e.g., completed applicable continuing education requirements); and‌‌ 4. 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 and Dermatology Treatment Schedule 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 Quarterly Claims Review and the Dermatology Treatment Schedule 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.

EFFECTIVE AND BINDING AGREEMENT. ‌ DLDC Xx. Xxxxxxxx and OIG agree as follows: A. This IA shall become final and binding on the date the final signature is obtained on the IA. B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA. C. OIG may agree to a suspension of DLDC’s Xx. Xxxxxxxx’x obligations under this IA based on a certification by DLDC Xx. Xxxxxxxx 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 DLDC Xx. Xxxxxxxx is relieved of its his IA obligations, DLDC Xx. Xxxxxxxx shall be required to notify OIG in writing at least 30 days in advance if DLDC Xx. Xxxxxxxx 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 IA will be reactivated or modified.‌modified. D. All requirements and remedies set forth in this IA are in addition to and do not affect affect: (1) DLDC’s Xx. 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.requirements.‌‌ E. The undersigned DLDC signatories represent Xx. Xxxxxxxx signatory represents and warrant warrants that they are he is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA. F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically-transmitted copies Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this IA. ON BEHALF OF DIGESTIVE & LIVER DISEASE CONSULTANTS, P.A.‌ /Xxxxxx Xxxxx/ 9/26/17 ‌‌ XXXXXX X. XXXXX, M.D. DATE Partner Digestive & Liver Disease Consultants, P.A. /Xxx Xxxxx/ 9/26/17 ‌‌ XXX XXXXX DATE Counsel for Digestive & Liver Disease Consultants, P.A /Xxxxxxxx Xxxxx Reddy/ 9/26/17 ‌ XXXXXXXX XXXXX REDDY DATE /Xxx Xxxxx/ _9/26/17 ‌‌ XXX XXXXX DATE Counsel for Xxxxxxxx Xxxxx Reddy /Xxxx X. Re/ 10/2/17 XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /Xxxxx Xxxxxx/ 9/28/17 XXXXX 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.D of the IA. A. IRO Engagement‌ 1. DLDC 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.4 of the IA or any additional information submitted by DLDC in response to a request by OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌ 2. If DLDC 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, DLDC 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 DLDC at the request of OIG, whichever is later, OIG will notify DLDC if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, DLDC may continue to engage the IRO.‌