Arrangements Transactions Review. The Arrangements Transactions Review shall consist of annual reviews by the IRO of the following categories of Focus Arrangements: (1) 25 Focus Arrangements of a similar type chosen by OIG (e.g., per diem contracts, contracts in a specific geographic region, or contracts with a specific long-term care facility chain), for which OIG may consider proposals submitted by CVS Health, internal risk assessment and audit work conducted by CVS Health or the IRO, and other information known to OIG; (2) 25 existing (performed under for at least one year) Focus Arrangements with long-term care facilities; (3) 25 new (entered into during the Reporting Period) Focus Arrangements with long-term care facilities; and (4) 25 Focus Arrangements relating to CVS Health’s IPS Operations that are not included in the previous three categories. The IRO shall randomly select the specific Focus Arrangements to be reviewed for each of the four categories listed above. The IRO shall assess whether CVS Health 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 CVS Health’s centralized tracking system in a manner that permits the IRO to identify the parties to the Focus Arrangement; the names and positions of the Arrangements Covered Persons involved in the original negotiations for all new or renewed Focus Arrangements, the Arrangements Covered Persons involved in the original negotiations for all existing Focus Arrangements if available, the Regional Vice President(s) with oversight over the Focus Arrangement, and the lawyer who reviewed and approved the Focus Arrangements; the relevant terms of the Focus Arrangement (i.e., the items or services to be provided; the amount of compensation; any discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, and aging of balances; the effective date; the expiration date; etc.); and the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, amount of payments, dates of payment, amounts owed, discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, aging of balances, etc.); 2. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and financial 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 subject to CVS’s policies and procedures for determining and documenting the fair market value of the remuneration, that remuneration is properly tracked, and that parties to the Focus Arrangement are complying with the terms of the Focus Arrangement;
Appears in 1 contract
Sources: Corporate Integrity Agreement
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of annual reviews a review by the IRO Monitor of the following categories of Focus Arrangements: (1) 25 100 randomly selected Focus Arrangements of a similar type chosen by OIG (e.g., per diem contracts, contracts in a specific geographic region, or contracts with a specific long-term care facility chain), for which OIG may consider proposals submitted by CVS Health, internal risk assessment and audit work conducted by CVS Health or the IRO, and other information known to OIG; (2) 25 existing (performed under for at least one year) Focus Arrangements with long-term care facilities; (3) 25 new (that were entered into or renewed by DaVita Dialysis during the Reporting Period) Focus Arrangements with long-term care facilities; and (4) 25 Focus Arrangements relating to CVS Health’s IPS Operations that are not included in the previous three categories. The IRO shall randomly select the specific Focus Arrangements to be reviewed for each of the four categories listed above. The IRO Monitor shall assess whether CVS Health DaVita Dialysis has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 Section III.D of the CIA, CIA with respect to the selected Focus Arrangements. The IROMonitor’s assessment with respect to each Focus Arrangement that is subject to review shall include:
1. a. verifying that the Health Care Provider(s) involved in the Focus Arrangement was selected consistent with DaVita Dialysis’s Selection Process and Selection Criteria (if applicable);
b. verifying that the Focus Arrangement is maintained in CVS HealthDaVita Dialysis’s centralized tracking system in a manner that permits the IRO Monitor to identify the parties to the Focus Arrangement; the names Arrangement and positions of the Arrangements Covered Persons involved in the original negotiations for all new or renewed Focus Arrangements, the Arrangements Covered Persons involved in the original negotiations for all existing Focus Arrangements if available, the Regional Vice President(s) with oversight over the Focus Arrangement, and the lawyer who reviewed and approved the Focus Arrangements; the relevant terms of the Focus Arrangement (i.e., the items or services items/services/equipment/space to be provided; , the amount of compensation; any discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, and aging of balances; the effective date; , the expiration date; etc.); and the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, amount of payments, dates of payment, amounts owed, discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, aging of balances, etc.);
2. c. verifying that the remuneration related to the Focus Arrangement was determined using the appropriate Valuation Methodology;
d. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and financial business review) and obtained the necessary approvals approvals, and that such review and approval is appropriately documented;; DaVita HealthCare Partners Inc. Corporate Integrity Agreement – Appendix C
3. e. verifying that the remuneration related to the Focus Arrangement is subject to CVS’s policies and procedures for determining and documenting the fair market value of the remuneration, that remuneration is properly tracked;
f. verifying that the services and activities are properly tracked and reviewed by DaVita Dialysis, and that the parties to the Focus Arrangement are complying performing the services required under the applicable Focus Arrangement (if applicable);
g. verifying that the use of leased space, medical supplies, medical devices, equipment, and other patient care items is properly monitored by DaVita Dialysis, and that such use is consistent with the terms of the applicable Focus Arrangement;Arrangement (if applicable); and
h. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.4 of the CIA.
Appears in 1 contract
Sources: Corporate Integrity Agreement (Davita Healthcare Partners Inc.)
Arrangements Transactions Review. The Arrangements Transactions Review shall consist of annual reviews a review by the IRO of the following categories of Focus Arrangements: (1) 25 50 randomly selected Focus Arrangements of a similar type chosen by OIG (e.g., per diem contracts, contracts in a specific geographic region, or contracts with a specific long-term care facility chain), for which OIG may consider proposals submitted by CVS Health, internal risk assessment and audit work conducted by CVS Health or the IRO, and other information known to OIG; (2) 25 existing (performed under for at least one year) Focus Arrangements with long-term care facilities; (3) 25 new (that were entered into or renewed by ResMed during the Reporting Period) Focus Arrangements with long-term care facilities; and (4) 25 Focus Arrangements relating to CVS Health’s IPS Operations that are not included in the previous three categories. The IRO shall randomly select the specific Focus Arrangements to be reviewed for each of the four categories listed above. The IRO shall assess whether CVS Health ResMed has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 III.D.1, III.D.2, and III.D.2 III.D.3 of the CIA, with respect to the selected Focus ArrangementsArrangements. 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:
1. a. for Focus Arrangements that are not Invoiced Sales, verifying that the Focus Arrangement is maintained in CVS HealthResMed’s centralized tracking system in a manner that permits the IRO to identify identify: (i) the parties to the Focus Arrangement; , (ii) the names name(s) and positions position(s) of the Arrangements Covered Persons Person(s) involved in the original negotiations for all new or renewed Focus Arrangementsnegotiation, the Arrangements Covered Persons involved in the original negotiations for all existing Focus Arrangements if availablereview, the Regional Vice President(s) with oversight over and approval of the Focus Arrangement, and the lawyer who reviewed and approved the Focus Arrangements; (iii) the relevant terms of the Focus Arrangement (i.e., the items items, services, equipment, or services space to be provided; , the amount of compensation; any discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, and aging of balances; the effective date; , the expiration date; , etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, amounts owedetc.);
b. for Invoiced Sales, discounts, write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements, aging of balances, etc.);verifying that information about Invoiced Sales with prices that reflect a discount from the Base Price List are accurately reflected in the Discounted Price List;
2. c. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and financial business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented (or, in the case of Invoiced Sales, that it was subject to the Pricing Protocol);
3. d. verifying that the remuneration related to the Focus Arrangement is subject to CVShas been determined in accordance with ResMed’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;Arrangement (if applicable);
e. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ResMed’s policies and procedures (if applicable);
f. verifying that the service and activity logs are properly completed and reviewed (if applicable);
g. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and
h. verifying that the Focus Arrangement satisfies the applicable requirements of Section III.D. of the CIA.
2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.
3. If the IRO cannot verify compliance with all of the applicable requirements specified in Section C.1 above for at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to ResMed and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies ResMed and its IRO that an Additional Transactions Review will be required.
Appears in 1 contract
Sources: Corporate Integrity Agreement