Arrangements Systems Review. The Arrangements Systems Review shall be a review of Progenity’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following: 1. Progenity’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System; 2. Progenity’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements; 3. Progenity’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable; 4. Progenity’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) involved with the fair market value determination(s); 5. Progenity’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable); 6. Progenity’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable); 7. Progenity’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement; 8. Progenity’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by Progenity, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law; 9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, Progenity’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures; 10. Progenity’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and 11. Progenity’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 3 contracts
Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement, Corporate Integrity Agreement (Progenity, Inc.)
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityCHN’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityCHN’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new existing, new, and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityCHN’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityCHN’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityCHN’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) involved with the fair market value determination(s);
5. ProgenityCHN’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityCHN’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityCHN’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityCHN’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityCHN, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityCHN’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityCHN’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityCHN’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityFlower Mound’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityFlower Mound’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityFlower Mound’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityFlower Mound’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityFlower Mound’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityFlower Mound’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityFlower Mound’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityFlower Mound’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityFlower Mound’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityFlower Mound, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityFlower Mound’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityFlower Mound’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityFlower Mound’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityRadeas’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityRadeas’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityRadeas’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityRadeas’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityRadeas’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) involved with the fair market value determination(s);
5. ProgenityRadeas’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityRadeas’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityRadeas’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityRadeas’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityRadeas, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityRadeas’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityRadeas’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityRadeas’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityCRMC’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityCRMC’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityCRMC’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityCRMC’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityCRMC’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityCRMC’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityCRMC’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityCRMC’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityCRMC’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityCRMC, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityCRMC’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityCRMC’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityCRMC’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityNorthwell’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityNorthwell’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityNorthwell’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityNorthwell’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityNorthwell’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and and positions of the Arrangements Covered Person(s) involved with the fair market value determination(s);determination(s);
5. ProgenityNorthwell’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityNorthwell’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityNorthwell’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityNorthwell’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by Progenityor on behalf of Lenox Hill, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityNorthwell’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityNorthwell’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityNorthwell’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityProvider’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityProvider’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and existing, new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityProvider’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityProvider’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityProvider’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityProvider’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityProvider’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityProvider’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityProvider’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityProvider, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityProvider’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityProvider’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityProvider’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityPost Acute Medical’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityPost Acute Medical’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityPost Acute Medical’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityPost Acute Medical, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityPost Acute Medical’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Anti- Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityPost Acute Medical’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityRockport ’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityRockport ’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and existing, new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityRockport ’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityRockport ’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityRockport ’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. ProgenityRockport ’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityRockport ’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityRockport ’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityRockport ’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityRockport , the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityRockport ’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityRockport ’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityRockport ’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityVision Quest’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityVision Quest’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new existing, new, and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityVision Quest’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityVision Quest’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityVision Quest’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) involved with the fair market value determination(s);
5. ProgenityVision Quest’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityVision Quest’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityVision Quest’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityVision Quest’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityVision Quest, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityVision Quest’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityVision Quest’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityVision Quest’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityGSMC’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityGSMC’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityGSMC’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityGSMC’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityGSMC’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityGSMC’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityGSMC’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityGSMC’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityGSMC’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityGSMC, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityGSMC’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityGSMC’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityGSMC’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of Progenity’s ofAvanti's systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of ArrangementsofArrangements. Specifically, the IRO shall review the following:following:
1. Progenity’s Avanti's systems, policies, processes, and procedures with respect re_spect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Fpcus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. Progenity’s Avanti's systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. Progenity’s Avanti's systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. Progenity’s Avanti's systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or .or entities that determined the fair market value amount or range, and the names and positions of the Arrangements oftheeArrangeme11ts Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. Progenity’s determination(s); Avanti CIA - Appendix B 1 5 Avanti's systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. Progenity’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. Progenity’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. Progenity’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by Progenity, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, Progenity’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. Progenity’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. Progenity’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityProvider’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityProvider’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new existing, new, and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityProvider’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, review and approval of all Focus Arrangements;Arrangements;
3. ProgenityProvider’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements Arrangements, to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityProvider’s systems, policies, processes processes, and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityProvider’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityProvider’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityProvider’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityProvider’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityProvider, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee Chief Executive Officer on the Focus Arrangements Tracking System, ProgenityProvider’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;procedures;
10. ProgenityProvider’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andand
11. ProgenityProvider’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 III.E.2 of the CIA.IA.
Appears in 1 contract
Samples: Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenitySOS’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenitySOS’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenitySOS’s systems, policies, processes, and procedures for tracking documenting the names and positions of the Arrangements Covered Person(s) involved involving in the negotiation, review, review and approval of all Focus Arrangements;
3. ProgenitySOS’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements Arrangements, to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenitySOS’s systems, policies, processes processes, and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. ProgenitySOS’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenitySOS’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenitySOS’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenitySOS’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenitySOS, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee Chief Executive Officer on the Focus Arrangements Tracking System, ProgenitySOS’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenitySOS’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenitySOS’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 III.E.2 of the CIAIA.
Appears in 1 contract
Samples: Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityBioReference’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityBioReference’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and existing, new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityBioReference’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityBioReference’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityBioReference’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. ProgenityBioReference’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityBioReference’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityBioReference’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityBioReference’s systems, policies, processes, and procedures for the internal review and approval of existing, new new, and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityBioReference, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityBioReference’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityBioReference’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityBioReference’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityResMed’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:following:
1. ProgenityResMed’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;System;
2. ProgenityResMed’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
3. ProgenityResMed’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;reasonable;
4. ProgenityResMed’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);determination(s);
5. ProgenityResMed’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);applicable);
6. ProgenityResMed’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);applicable);
7. ProgenityResMed’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;Arrangement;
8. ProgenityResMed’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityResMed, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;Statute;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityResMed’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;, and the Pricing Protocol;
10. ProgenityResMed’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; andappropriate;
11. ProgenityResMed’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 III.D.3 of the CIA.CIA;
12. ResMed’s systems, policies, processes and procedures with respect to creating and maintaining a centralized system that reflects the single base price for each product subject to Invoiced Sales (Base Price List) and with respect to creating and maintaining a centralized system for tracking all Invoiced Sales with prices that reflect a discount from the Base Price List (Discounted Price List), including a description of the information captured in the Base Price List and the Discounted Price List; and
13. ResMed’s systems, policies, processes and procedures for establishing a written review and approval for offering any discounted prices for Invoiced Sales (Pricing Protocol), including the process for ensuring that the Pricing Protocol is subject to legal review by counsel with expertise in the Anti- Kickback Statute and that all Invoiced Sales are subject to the Pricing Protocol.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Arrangements Systems Review. The Arrangements Systems Review shall be a review of ProgenityCordant’s systems, processes, policies, and procedures relating to the initiation, review, approval, and tracking of Arrangements. Specifically, the IRO shall review the following:
1. ProgenityCordant’s systems, policies, processes, and procedures with respect to creating and maintaining a centralized tracking system for all existing and new and renewed Focus Arrangements (Focus Arrangements Tracking System), including a detailed description of the information captured in the Focus Arrangements Tracking System;
2. ProgenityCordant’s systems, policies, processes, and procedures for documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
3. ProgenityCordant’s systems, policies, processes, and procedures for tracking all remuneration to and from all parties to Focus Arrangements to ensure that the parties are complying with the financial terms of the Focus Arrangements and that the Focus Arrangements are commercially reasonable;
4. ProgenityCordant’s systems, policies, processes and procedures for documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) of completion of the fair market valuation(s), the individuals or entities that determined the fair market value amount or range, and the names and positions of the Arrangements Covered Person(s) who received or were otherwise involved with the fair market value determination(s);
5. ProgenityCordant’s systems, policies, processes, and procedures for tracking service and activity logs to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
6. ProgenityCordant’s systems, policies, processes, and procedures for monitoring the use of leased space, medical supplies, medical devices, equipment, or other patient care items to ensure that such use is consistent with the terms of the applicable Focus Arrangement(s) (if applicable);
7. ProgenityCordant’s systems, policies, processes, and procedures for initiating Arrangements, including those policies that identify the individuals with authority to initiate an Arrangement and that specify the business need or business rationale required to initiate an Arrangement;
8. ProgenityCordant’s systems, policies, processes, and procedures for the internal review and approval of existing, new and renewed Focus Arrangements, including those policies that identify the individuals required to approve each type or category of Focus Arrangement entered into by ProgenityCordant, the internal controls designed to ensure that all required approvals are obtained, the processes for determining and documenting the business need or business rationale for all Focus Arrangements, the processes for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement, and the processes for ensuring that all Focus Arrangements are subject to a legal review by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law;
9. the Compliance Officer’s annual review of and reporting to the Compliance Committee on the Focus Arrangements Tracking System, ProgenityCordant’s internal review and approval process, and other Focus Arrangements systems, process, policies, and procedures;
10. ProgenityCordant’s systems, policies, processes, and procedures for implementing effective responses when suspected violations of the Anti-Kickback Statute and Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments when appropriate; and
11. ProgenityCordant’s systems, policies, processes, and procedures for ensuring that all new and renewed Focus Arrangements comply with the Focus Arrangements Requirements set forth in Section III.D.2 of the CIA.
Appears in 1 contract
Samples: Corporate Integrity Agreement