Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 randomly selected Focus Arrangements that were entered into or renewed by Progenity during the Reporting Period. The IRO shall assess whether Progenity has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.
1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
a. verifying that the Focus Arrangement is maintained in Progenity’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);
b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;
c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;
d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s policies and procedures;
e. verifying that the service and activity logs are properly completed and reviewed (if applicable);
f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and
g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.
2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requi...
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by Xxxxxxxx during the Reporting Period. The IRO shall assess whether Xxxxxxxx has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
1. verifying that the Focus Arrangement is maintained in Xxxxxxxx’x centralized tracking system in a manner that permits the IRO to identify the parties to the Focus Arrangement and the relevant terms of the Focus Arrangement (i.e., the items/services/equipment/space to be provided, the amount of compensation, the effective date, the expiration date, etc.)
2. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;
3. verifying that the remuneration related to the Focus Arrangement is properly tracked;
4. verifying that the service and activity logs are properly completed and reviewed (if applicable);
5. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and
6. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the Legal IRO of 75 Focus Arrangements that were entered into or renewed by Halifax during the Reporting Period with: (1) physicians or other health care professionals; or (2) entities owned or controlled, in whole or in part, by physicians or other health care professionals. The Legal IRO shall select its sample of Focus Arrangements for review in consultation with OIG. The Legal IRO shall assess whether Halifax has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA with respect to the selected Focus Arrangements. The Legal IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
1. verifying that the Focus Arrangement is maintained in Halifax’s centralized tracking system in a manner that permits the Legal IRO to identify the parties to the Focus Arrangement and the relevant terms of the Focus Arrangement (i.e., the items/services/equipment/space to be provided, the amount of compensation, the effective date, the expiration date, etc.);
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of all Focus Arrangements that were entered into or renewed by WCH during the Reporting Period. The IRO shall assess whether WCH has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by ResMed during the Reporting Period. The IRO shall assess whether ResMed has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1, III.D.2, and III.D.3 of the CIA, with respect to the selected Focus Arrangements. In OIG’s discretion, OIG may specify the categories of Focus Arrangements from which the IRO shall select the random sample for purposes of the Arrangements Transactions Review and notify ResMed and the IRO of its selection of such categories at least 30 days prior to the end of each Reporting Period. At least 90 days prior to the end of each Reporting Period, ResMed shall submit to OIG a description of the different categories of Focus Arrangements it has entered into or renewed during the preceding Reporting Period. ResMed, or its IRO on behalf of ResMed, may submit proposals identifying suggestions for the categories of Focus Arrangements from which the random sample of Focus Arrangements shall be selected at least 60 days prior to the end of each Reporting Period. In connection with limiting the categories of Focus Arrangements to be reviewed as part of the Arrangements Transactions Review, OIG may consider (1) proposals submitted by ResMed or its IRO or (2) information furnished to OIG regarding the results of ResMed’s risk assessment and internal review process. The determination of whether, and in what manner, to limit the Focus Arrangements subject to the Arrangements Transactions Review shall be made at the sole discretion of OIG.
1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
a. for Focus Arrangements that are not Invoiced Sales, verifying that the Focus Arrangement is maintained in ResMed’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e, items or services actually provided, equipment or space actually ...
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the Legal IRO of 75 Focus Arrangements that were entered into or renewed by KDMC during the Reporting Period with: (1) physicians or other health care professionals; or (2) entities owned or controlled, in whole or in part, by physicians or other health care professionals. The Legal IRO shall select its sample of Focus Arrangements for review in consultation with OIG. The Legal IRO shall assess whether KDMC has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.F.1 and III.F.2 of the CIA, with respect to the selected Focus Arrangements. The Legal IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by Mercy during the Reporting Period with: (1) physicians or other health care professionals; or (2) entities owned or controlled, in whole or in part, by physicians or other health care professionals. The IRO shall assess whether Xxxxx has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by Cordant during the Reporting Period. The IRO shall assess whether Cordant has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.
1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
a. verifying that the Focus Arrangement is maintained in Cordant’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement;
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by PCMC during the Reporting Period. The IRO shall assess whether PCMC has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
1. verifying that the Focus Arrangement is maintained in PCMC’s centralized tracking system in a manner that permits the IRO to identify the parties to the Focus Arrangement and the relevant terms of the Focus Arrangement (i.e., the items/services/equipment/space to be provided, the amount of compensation, the effective date, the expiration date, etc.);
2. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;
3. verifying that the remuneration related to the Focus Arrangement is properly tracked;
4. verifying that the service and activity logs are properly completed and reviewed (if applicable);
5. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and
6. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 50 randomly selected Focus Arrangements that were entered into or renewed by SDNA during the Reporting Period. The IRO shall assess whether SDNA has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include:
1. verifying that the Focus Arrangement is maintained in SDNA’s centralized tracking system in a manner that permits the IRO to identify the parties to the Focus Arrangement and the relevant terms of the Focus Arrangement (i.e., the items/services/equipment/space to be provided, the amount of compensation, the effective date, the expiration date, etc.);
