Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following: a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System); b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements; c. 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; d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s); e. 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); f. 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); g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement; h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above; i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity CHSI shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;; Community Health Systems, Inc. Corporate Integrity Agreement
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Corporate Compliance and Privacy Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance CommitteeBoard of Directors; and
j. g. 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 pursuant to Sections III.I and III.J and III.K when appropriate.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Quorum Health Corp), Corporate Integrity Agreement (Community Health Systems Inc)
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Post Acute Medical shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity CHN shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Avanti shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered .Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Paksn shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity the GIS Parties shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;Arrangements;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. g. implementing effective responses when suspected violations of the Anti-Kickback Statute and and/or Xxxxx Law are discovered, including disclosing Reportable Events and quantifying and repaying Overpayments pursuant to Sections Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Vascular Access Centers shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.bIII.D.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);amount
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;Section
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.and
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Provider shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.Arrangement;
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity Radeas shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity APM, Park Center, and Xxxxxx shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity CII shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity SPD shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes that statute (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Anti- Kickback Statute and Xxxxx LawStatute, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity WBH shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Rockport shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement Arrangements does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity CHSI shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Corporate Compliance and Privacy Officer to review the Focus Arrangements Tracking System, internal Community Health Systems, Inc. Corporate Integrity Agreement, Amended review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance CommitteeBoard of Directors; and
j. g. 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 pursuant to Sections III.I and III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Community Health Systems Inc)
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity Greenway shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, and guidance related to these statutes this statute (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.bIII.E.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Northwell shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Vision Quest shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and the Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and the Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity CVS Health shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes this statute (Focus Arrangements Procedures). These procedures shall include include, but are not limited to, the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and using financial databases to track financial transactions and the information specified in Sections III.D.1.b-f g below for each existing and new or renewed Focus Arrangement (“Focus Arrangements Tracking SystemDatabase”);
b. documenting tracking the names and positions of the Arrangements Covered Person(s) Persons involved in the negotiationoriginal negotiations for all new or renewed Focus Arrangements, reviewthe 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 approval the lawyer who reviewed and approved the Focus Arrangements (the names and positions of all the Arrangements Covered Persons involved with financial aspects of the of the Focus ArrangementsArrangement shall be made available to OIG or the IRO upon request);
c. 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;
d. documenting tracking all fair market value determination(s) for discounts (e.g., prompt pay discounts, electronic payment discounts), write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements related to any Focus Arrangement, including the fair market value amount or range and corresponding time period(s), the date(s) aging 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s)balances;
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Xxxxx shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;Arrangements;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. g. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within In addition to the Valuation Methodologies, within 90 days after the Effective Date, Progenity Date DaVita Dialysis shall create examine its procedures and evaluate whether the procedures are reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback DaVita HealthCare Partners Inc. Corporate Integrity Agreement Statute and/or the Xxxxx Law or and the regulations and guidance related to these statutes the Anti-Kickback Statute (Focus Arrangements Procedures), and shall revise those procedures as necessary. These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. tracking all remuneration to and from all parties to Focus Arrangements;
c. tracking investments made by and estimated rates of return received during the CIA Period by all parties to all Partial Acquisition and Partial Divestiture transactions between DaVita Dialysis and a Health Care Provider (if applicable), to ensure except for those transactions that the parties are complying with the financial terms part of the Focus Arrangements conduct released by the Settlement Agreement entered into between the United States and that the Focus Arrangements are commercially reasonableDaVita contemporaneously with this CIA;
d. documenting all fair market value determination(s) for any Focus Arrangement, including the fair market value amount or range tracking services 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. tracking service and activity logs activities to ensure that parties to the Focus Arrangement are performing the services required under the applicable Focus Arrangement(s) (if applicable);
f. e. 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);
g. f. establishing and implementing a written review and approval process for all Focus Arrangements, except Business Courtesies, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx LawStatute, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx LawStatute, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. g. requiring the Chief Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval DaVita HealthCare Partners Inc. Corporate Integrity Agreement process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Board Compliance Committee; and
j. h. 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 pursuant to Sections III.J III.O and III.K III.P when appropriate. Notwithstanding the foregoing, DaVita shall have until the end of the first Reporting Period to identify and enter in the Focus Arrangements Tracking System all existing Focus Arrangements except (i) center transaction agreements; (ii) Medical Director agreements, (iii) leases, and (iv) consulting agreements; and to enter all data for items or services provided under the existing Focus Arrangements on or after the Effective Date. DaVita is not required to include in its Focus Arrangements Tracking System historical remuneration or performance data for items or services provided under the existing Focus Arrangements prior to the Effective Date.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Davita Healthcare Partners Inc.)
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity BioReference shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new existing, new, or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new existing, new, or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Prime shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity PCMC shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. g. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 120 days after the Effective Date, Progenity Mercy shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. g. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity SOS shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.bIII.E.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity CRMC shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Flower Mound shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. 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 pursuant to Sections III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity GSMC shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity ResMed shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes this statute (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Anti- Kickback Statute and Xxxxx LawStatute, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. 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 pursuant to Sections III.J and III.K when appropriate.Events.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity OCOM shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity KRHS shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 and/or were otherwise involved with the fair market value determination(s);determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, Law and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Healthquest, Inc. shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.bIII.E.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity WCH shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations regulations, directives, and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;Arrangements;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. c. 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);
f. d. 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);
g. e. establishing and implementing a written review and approval process for all Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. f. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; andand
j. g. 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 pursuant to Sections III.I and III.J and III.K when appropriate.appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity ION shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and other guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include include, but are not limited to, the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.bSection III.D.2.b-f k below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System). The Focus Arrangements Tracking System shall include a Financial Tracking Report of Arrangements that continually tracks account balances, debts, and profit distributions with Health Care Providers, Cancer Centers, and ION Physician-Investors;
b. documenting tracking the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of original negotiations for all Focus Arrangements, tracking the Arrangements Covered Person(s) with oversight over the Focus Arrangement, tracking the names and positions of the Arrangements Covered Person(s) involved with financial aspects of the Focus Arrangement, and verifying that an attorney reviewed and approved the Focus Arrangement;
c. 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 reasonableArrangement;
d. documenting tracking all investments made by all parties to all Ownership Arrangements during the term of the CIA and tracking all actual rates of return received by all parties to all Ownership Arrangements during the term of the CIA;
e. tracking all discounts (e.g., prompt pay discounts, electronic payment discounts), write-offs, debt forgiveness, short-pays, accounts receivable, collection efforts, settlements related to any Focus Arrangement, and aging of balances;
f. tracking the fair market value determination(s) for any determination of remuneration specified in the 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)range, 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 and/or were otherwise involved with the fair market value determination(s)determination;
e. g. 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);
f. h. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Cordant shall create procedures reasonably designed to ensure that each existing and new or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Respironics shall create procedures reasonably designed to ensure that identify each existing and new or Focus Arrangement and ensure that each existing, new, and renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes that statute (Focus Arrangements Procedures). These procedures shall include the following:
a. creating and maintaining a centralized tracking system for all existing and new or renewed Focus Arrangements and the information specified in Sections III.D.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;Arrangements;
c. 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;
d. 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 Covered Person(s) Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Focus Arrangements Procedures. Within 90 days after the Effective Date, Progenity Provider shall create procedures reasonably designed to ensure that each existing and new existing, new, or renewed Focus Arrangement does not violate the Anti-Kickback Statute and/or the Xxxxx Law or the regulations and guidance related to these statutes (Focus Arrangements Procedures). These procedures shall include the following:following:
a. creating and maintaining a centralized tracking system for all existing and new existing, new, or renewed Focus Arrangements and the information specified in Sections III.D.1.bIII.E.1.b-f below for each existing and new or renewed Focus Arrangement (Focus Arrangements Tracking System);
b. documenting the names and positions of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of all Focus Arrangements;
c. 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;
d. 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 Covered Person(s) who received and/or were otherwise involved with the fair market value determination(s);
e. 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);
f. 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);
; g. establishing and implementing a written review and approval process for Focus Arrangements, the purpose of which is to ensure that all new and existing and new or renewed Focus Arrangements do not violate the Anti-Kickback Statute and Xxxxx Law, and that includes at least the following: (i) a legal review of all Focus Arrangements by counsel with expertise in the Anti-Kickback Statute and Xxxxx Law, ; (ii) a process for specifying and documenting the business need or business rationale for all Focus Arrangements, ; and (iii) a process for determining and documenting the fair market value of the remuneration specified in the Focus Arrangement;
h. ensuring that all existing Focus Arrangements are subject to the review and approval process described in Section III.D.1.g above;
i. requiring the Compliance Officer to review the Focus Arrangements Tracking System, internal review and approval process, and other Focus Arrangements Procedures on at least an annual basis and to provide a report on the results of such review to the Compliance Committee; and
j. 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 pursuant to Sections III.J and III.K when appropriate.
Appears in 1 contract
Samples: Integrity Agreement