Common use of EFFECTIVE AND BINDING AGREEMENT Clause in Contracts

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ and OIG agree as follows: A. This CCA shall be binding on the successors, assigns, and transferees of Coram; B. This CCA shall become final and binding on the date the final signature is obtained on the CCA; C. This CCA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCA; D. ▇▇▇ may agree to a suspension of C▇▇▇▇’▇ obligations under this CCA in the event of C▇▇▇▇’▇ cessation of participation in Federal health care programs. If C▇▇▇▇ withdraws from participation in Federal health care programs and is relieved of its CCA obligations by OIG, Coram shall notify OIG at least 30 days in advance of Coram’s intent to reapply as a participating provider or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA should reactivated or modified. E. The undersigned Coram signatories represent and warrant that they are authorized to execute this CCA. The undersigned OIG signatory represents that he is signing this CCA in his official capacity and that he is authorized to execute this CCA. F. This CCA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CCA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCA. /S/ 8/21/07 M▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Corporate Compliance Officer Senior Vice President, Quality, Ethics and Compliance /S/ 8/21/07 J▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Assistant Inspector General for Legal Affairs Office of Inspector General United States Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of Coram, Inc. and has personal knowledge of the facts stated herein. The following describes the compliance program (Program) currently in place at Coram.

Appears in 1 contract

Sources: Certification of Compliance Agreement (Apria Healthcare Group Inc)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ AtriCure, Inc. and OIG agree as follows: A. This CCA CIA shall be binding on the successors, assigns, and transferees of CoramAtriCure, Inc.; B. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA; C. This CCA CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCACIA; D. ▇▇▇ OIG may agree to a suspension of C▇▇▇▇’▇ AtriCure, Inc.’s obligations under this CCA the CIA in the event of C▇▇▇▇’▇ AtriCure, Inc.’s cessation of participation in Federal health care programs. If C▇▇▇▇ withdraws from participation AtriCure, Inc. ceases participating in Federal health care programs and is relieved of its CCA CIA obligations by OIG, Coram AtriCure, Inc. shall notify OIG at least 30 days in advance of CoramAtriCure, Inc.’s intent to reapply resume participating as a participating provider or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA CIA should be reactivated or modified. E. The undersigned Coram AtriCure, Inc. signatories represent and warrant that they are authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCACIA. F. This CCA CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CCACIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCACIA. /S/ 8/21/07 MCORPORATE INTEGRITY AGREEMENT ATRICURE, INC. ON BEHALF OF ATRICURE, INC. /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 2/1/2010 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE Chief Executive Officer AtriCure, Inc. /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇Corporate Compliance Officer Senior Vice President1/20/2010 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ & Green, QualityP.C. CORPORATE INTEGRITY AGREEMENT ATRICURE, Ethics and Compliance /S/ 8/21/07 JINC. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ 1/27/2010 ▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General United States U. S. Department of Health and Human Services The declarant is currently CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. This Appendix contains the Corporate Compliance Officer of Coram, Inc. and has personal knowledge requirements relating to the Independent Review Organization (IRO) required by Section III.D of the facts stated herein. The following describes the compliance program (Program) currently in place at CoramCIA. A. IRO Engagement

Appears in 1 contract

Sources: Corporate Integrity Agreement (AtriCure, Inc.)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ Spectranetics and OIG agree as follows: A. This CCA CIA shall be binding on the successors, assigns, and transferees of CoramSpectranetics; B. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA; C. This CCA CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCACIA; D. ▇▇▇ OIG may agree to a suspension of C▇▇▇▇’▇ Spectranetics’ obligations under this CCA the CIA in the event of C▇▇▇▇’▇ Spectranetics’ cessation of participation in Federal health care programs. If C▇▇▇▇ withdraws from participation Spectranetics ceases participating in Federal health care programs and is relieved of its CCA CIA obligations by OIG, Coram Spectranetics shall notify OIG at least 30 days in advance of Coram’s Spectranetics’ intent to reapply resume participating as a participating provider or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA CIA should be reactivated or modified. E. The undersigned Coram Spectranetics signatories represent and warrant that they are authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCACIA. F. This CCA CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CCACIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCACIA. /S/ 8/21/07 MSpectranetics Corporate Integrity Agreement By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ Dated: 12/18/2009 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ Chief Executive Officer Spectranetics Corporation By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Dated: 12/18/2009 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Spectranetics Corporation Vice President, General Counsel & Secretary Vice President, Human Resources By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Dated: 12/18/2009 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP Counsel for the Spectranetics Corporation Spectranetics Corporate Compliance Officer Senior Vice President, Quality, Ethics and Compliance /S/ 8/21/07 JIntegrity Agreement /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ 12/22/09 ▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General United States U. S. Department of Health and Human Services The declarant is currently the Spectranetics Corporate Compliance Officer of Coram, Inc. and has personal knowledge of the facts stated herein. The following describes the compliance program (Program) currently in place at Coram.Integrity Agreement

Appears in 1 contract

Sources: Corporate Integrity Agreement (Spectranetics Corp)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ 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 CCA 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 Coram;Gambro; Gambro Healthcare, Inc. Corporate Integrity Agreement B. C. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA; C. This CCA constitutes D. Any modifications to this CIA 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 CCACIA; D. ▇▇▇ E. OIG may agree to a suspension of C▇▇▇▇’▇ Gambro’s obligations under this CCA the CIA in the event of C▇▇▇▇’▇ Gambro’s cessation of participation in Federal health care programs. If C▇▇▇▇ Gambro withdraws from participation in Federal health care programs and is relieved of its CCA CIA obligations by OIG, Coram Gambro shall notify OIG at least 30 days in advance of CoramGambro’s intent to reapply as a participating provider Gambro or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA CIA should be reactivated or modified.; and E. F. The undersigned Coram Gambro signatories represent and warrant that they are authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCA. F. This CCA may be executed in counterpartsCIA. ON BEHALF OF GAMBRO HEALTHCARE, each of which constitutes an original and all of which constitute one and the same CCAINC. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCA. /S/ 8/21/07 M/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Corporate Compliance Officer Senior Vice President, Quality, Ethics and Compliance /S/ 8/21/07 J▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, H▇▇▇▇& H▇ 11/29/04 ▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇Assistant Senior Vice President & Chief Compliance Officer Gambro Healthcare, Inc. DATE /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ 11/29/04 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, ESQ. ▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP Counsel for 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/ ▇▇▇▇▇ ▇▇▇▇▇▇ 11/30/04 ▇▇▇▇▇ ▇▇▇▇▇▇ Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General United States U.S. Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of CoramDATE Gambro Healthcare, Inc. Corporate Integrity Agreement GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX A INSTRUCTIONS FOR ARRANGEMENTS REVIEW Gambro shall review and has personal knowledge evaluate all Relevant Arrangements to ensure that each Relevant Arrangement does not violate Anti-Kickback Statute. A. Relevant Arrangements consist of the facts stated hereinfollowing: 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. ▇. ▇▇▇▇▇▇ 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 GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX B HEIGHTENED ARRANGEMENT REVIEW I. The following describes the compliance program (Program) currently in place at Coram.Arrangement Samples

Appears in 1 contract

Sources: Corporate Integrity Agreement (Davita Inc)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is entered, and into which this CIA is incorporated, Mariner and the OIG agree as follows: A. This CCA CIA shall be binding on the successors, assigns, and transferees of CoramMariner except that the obligations of this CIA shall not apply to facilities, business units or locations that Mariner or a Mariner successor does not own or operate as a result of an asset sale to an unrelated third party; B. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA and approved by the Bankruptcy Court, and shall incorporate by reference any other Corporate Integrity Agreements obligating Mariner or any of its facilities, business units or locations at the time of execution of this CIA; C. This CCA constitutes Any modifications to this CIA shall be made only with the complete agreement between the parties and may not be amended except by prior written consent of the parties to this CCA;CIA; and D. ▇▇▇ may agree to a suspension Nothing in this CIA precludes Mariner from lawfully contesting the legality, enforceability or applicability of C▇▇▇▇’▇ obligations under this CCA in the event of C▇▇▇▇’▇ cessation of participation in Federal health care programs. If C▇▇▇▇ withdraws from participation in Federal health care programs and is relieved of its CCA obligations by OIG, Coram shall notify OIG at least 30 days in advance of Coram’s intent to reapply as a participating provider or supplier with any Federal health care programprogram requirement; and E. This CIA is for the benefit of the Parties hereto, and creates no rights or remedies beyond those expressly created herein. Upon receipt of such notification, OIG shall evaluate whether the CCA should reactivated or modifiedNothing in this CIA is intended to confer any benefits on any third-party. E. F. The undersigned Coram signatories represent Mariner signatory represents and warrant warrants that they are he is authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCA. F. This CCA may be executed in counterpartsCIA. ON BEHALF OF MARINER HEALTH CARE, each of which constitutes an original and all of which constitute one and the same CCAINC. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCA. /S/ 8/21/07 MDATED: BY: -------------- --------------------------------------------- Susan Thomas Whittle General Counsel ▇▇▇ E▇▇▇▇▇▇▇▇ ▇. ▇▇▇- President Mariner Post-Acute Network, Inc. Mariner Health Group, Inc. DATED: BY: -------------- --------------------------------------------- Thomas C. Fox Scot T. Hasselman Reed Smith LLP Counsel for Mariner P▇▇▇-▇▇▇▇▇ Corporate Compliance Officer Senior Vice PresidentNetwork, QualityInc. Counsel for Mariner Health Group, Ethics and Compliance /S/ 8/21/07 J▇Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ------------------------- ------------------------------------- DATED: LEWIS MORRIS Assistant Ins▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Assistant Inspector General al for Legal Affairs Office of Inspector General United States U. S. Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of Coram, Inc. and has personal knowledge MONITOR TASK LIST THIS DOCUMENT IS DESIGNED TO PROVIDE GUIDANCE TO THE MONITOR; IT MAY BE AMENDED AT ANY TIME CONSISTENT WITH THE TERMS OF THE CORPORATE INTEGRITY AGREEMENT ("CIA"). NOTHING IN THIS TASK LIST SHOULD BE INTERPRETED TO LIMIT THE TERMS AND CONDITIONS OF THE CIA. I. Analysis of the facts stated herein. The following describes Quality Compliance Infrastructure A. Board of Directors: Existence of the compliance program (Program) currently in place at CoramBoard level committee with a quality improvement function.

Appears in 1 contract

Sources: Corporate Integrity Agreement (Mariner Health Care Inc)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ Biomet, Biomet Orthopedics and OIG agree as follows: A. This CCA CIA shall be binding on the successors, assigns, and transferees of CoramBiomet and Biomet Orthopedics; B. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA; C. This CCA CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCACIA; D. ▇▇▇ OIG may agree to a suspension of C▇▇▇▇’▇ Biomet’s or Biomet Orthopedics’ obligations under this CCA the CIA in the event of C▇▇▇▇’▇ Biomet’s or Biomet Orthopedics’ cessation of participation in the delivery, sale, marketing, or furnishing of items or services reimbursed by any Federal health care programs. If C▇▇▇▇ withdraws from participation in Federal health care programs such cessation occurs and Biomet or Biomet Orthopedics is relieved of its CCA CIA obligations by OIG, Coram Biomet or Biomet Orthopedics shall notify OIG at least 30 days in advance of Coram’s intent the date on which Biomet or Biomet Orthopedics intends to reapply as a participating provider begin delivering, selling, marketing, or supplier with furnishing items or services reimbursed by any Federal health care programprograms. Upon receipt of such notification, OIG shall evaluate whether the CCA CIA should be reactivated or modified. E. The undersigned Coram Biomet and Biomet Orthopedics signatories represent and warrant that they are authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCACIA. F. This CCA CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CCACIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCACIA. /S/ 8/21/07 MON BEHALF OF BIOMET, INC. AND BIOMET ORTHOPEDICS, INC. /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ 9/27/07 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE President and Chief Executive Officer Biomet, Inc. and Biomet Orthopedics, Inc. /s/ ▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ 9/27/07 ▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ DATE Vice President & Corporate Compliance Officer Senior Vice PresidentBiomet, Quality, Ethics and Compliance /S/ 8/21/07 JInc. /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ 9/27/07 ▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇ & ▇▇▇▇▇▇▇, LLP Counsel for Biomet, Inc. and Biomet Orthopedics, Inc. ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ 9/27/07 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General United States Office of Counsel to the Inspector General U. S. Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of Coram, Inc. and has personal knowledge of the facts stated herein. The following describes the compliance program (Program) currently in place at Coram.Services

Appears in 1 contract

Sources: Corporate Integrity Agreement (Biolectron, Inc.)

EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ 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 CCA 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 Coram;Gambro; Gambro Healthcare, Inc. Corporate Integrity Agreement 33 B. C. This CCA CIA shall become final and binding on the date the final signature is obtained on the CCACIA; C. This CCA constitutes D. Any modifications to this CIA 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 CCACIA; D. ▇▇▇ E. OIG may agree to a suspension of C▇▇▇▇’▇ Gambro’s obligations under this CCA the CIA in the event of C▇▇▇▇’▇ Gambro’s cessation of participation in Federal health care programs. If C▇▇▇▇ Gambro withdraws from participation in Federal health care programs and is relieved of its CCA CIA obligations by OIG, Coram Gambro shall notify OIG at least 30 days in advance of CoramGambro’s intent to reapply as a participating provider Gambro or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA CIA should be reactivated or modified.; and E. F. The undersigned Coram Gambro signatories represent and warrant that they are authorized to execute this CCACIA. The undersigned OIG signatory represents that he is signing this CCA CIA in his official capacity and that he is authorized to execute this CCA. F. This CCA may be executed in counterpartsCIA. ON BEHALF OF GAMBRO HEALTHCARE, each of which constitutes an original and all of which constitute one and the same CCAINC. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCA. /S/ 8/21/07 M/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Corporate Compliance Officer Senior Vice President, Quality, Ethics and Compliance /S/ 8/21/07 J▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, H▇▇▇▇& H▇ 11/29/04 ▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇Assistant Senior Vice President & Chief Compliance Officer Gambro Healthcare, Inc. DATE /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ 11/29/04 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, ESQ. ▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP Counsel for 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/ ▇▇▇▇▇ ▇▇▇▇▇▇ 11/30/04 ▇▇▇▇▇ ▇▇▇▇▇▇ Chief Counsel to the Inspector General for Legal Affairs Office of Inspector General United States U.S. Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of CoramDATE Gambro Healthcare, Inc. Corporate Integrity Agreement 35 GAMBRO HEALTHCARE, INC. CORPORATE INTEGRITY AGREEMENT APPENDIX A INSTRUCTIONS FOR ARRANGEMENTS REVIEW Gambro shall review and has personal knowledge evaluate all Relevant Arrangements to ensure that each Relevant Arrangement does not violate Anti-Kickback Statute. A. Relevant Arrangements consist of the facts stated hereinfollowing: 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. ▇. ▇▇▇▇▇▇ 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 following describes the compliance program (Program) currently in place at Coram.Arrangement Samples

Appears in 1 contract

Sources: Corporate Integrity Agreement