Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III: a. a Compliance Officer; b. a Compliance Committee; c. the Board compliance obligations as required by Section III.A.3.; d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; e. written Policies and Procedures; f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements; h. a risk assessment and internal review process; i. a Disclosure Program; j. Ineligible Persons screening and removal requirements; k. notification of Government investigations or legal proceedings; l. policies and procedures regarding the repayment of Overpayments; and m. reporting of Reportable Events. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C. 6. A Stipulated Penalty of $1,500 for each day Progenity fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails to grant access.) 7. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A. 9. A Stipulated Penalty of $1,000 for each day Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity stating the specific grounds for its determination that Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity RMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity RMC fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;
k. i. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. j. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity RMC fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity RMC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity RMC fails to submit any Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 for each day Progenity RMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity RMC fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity RMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity RMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity RMC stating the specific grounds for its determination that Progenity RMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity RMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity RMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity GSK and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity GSK fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.obligations, including the resolution from the Board;
d. the management accountability and certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations;
e. a written Code of Conduct;
f. written Policies and Procedures;
f. the development of a written training plan and g. the training and education of Covered Persons, Arrangements Relevant Covered Persons, Management, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsMembers;
h. a risk assessment and internal review processTRACER program;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. an employee and executive incentive compensation and recoupment program as required by Section III.H and Appendix E;
l. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpaymentsproceedings as required by Section XXX.X; and
GlaxoSmithKline LLC Corporate Integrity Agreement m. reporting of Reportable Events.Events as required in Section III.J; n. notification of written communications with FDA as required by Section III.K; o. a program for FFMP as required by Section III.L; p. a program for Non-Promotional Monitoring Program as required by Section III.M; q. notifications to HCPs, HCIs, and Payers as required by Section III.N; and r. posting of any Payments as required by Section III.O.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity GSK fails to engage and use an IRO, IRO as required by in Section III.E, Appendix III.E and Appendices A, Appendix B, or Appendix -C.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity GSK fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Report to OIG in accordance with the requirements of Section V, V of the CIA or (c) a complete response to any request of Appendix D by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity GSK fails to submit any Arrangements IRO Review Report report (including the IRO Initial Report) in accordance with the requirements of Section Sections III.E and Appendix B.III.V and Appendices A-C.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity GSK fails to submit establish and implement any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails to grant access.)
7. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity stating the specific grounds for its determination that Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty following obligations as described in this Subsection shall not be demanded for any violation for which OIG has sought Section III of Appendix D:
a. a Stipulated Penalty under Subsections 1-8 GMS Compliance Officer;
b. a GMS Compliance Committee;
c. the Board compliance obligations, including the resolution from GlaxoSmithKline LLC Corporate Integrity Agreement the Board;
d. a written Code of this Section.Conduct;
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity KDMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity KDMC fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development training of a written training plan and the training and education of Covered Persons, Relevant Covered Persons, Arrangements Covered Persons, Board Members, and Board members;
Executive Management; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
Requirements described in Sections III.F.1 and III.F.2; h. a risk assessment and internal review process;
i. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. k. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity KDMC fails to engage and use an IRO, as required by in Section III.E, Appendix A, Appendix B, or and Appendix C.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity KDMC fails to timely submit (a) engage and use a complete Implementation Report or Annual ReportPeer Review Consultant, (b) a certification to OIG as required in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.III.D.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity KDMC fails to submit any Arrangements Review Report engage and use the Physician Executive(s), as required in accordance with the requirements of Section III.E and Appendix B.III.A.6.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity KDMC fails to engage and use a Medical Director of the Cardiac Catheterization Laboratory, as required in Section III.A.7.
6. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to engage and use the Board Compliance Expert, as required in Section III.A.4.
7. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Implementation Report or any Claims Annual Reports to OIG in accordance with the requirements of Section V by the deadlines for submission.
8. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Compliance Program Review Report, as required in Section III.A.4.a.v for the first, third, and fifth Reporting Periods.
9. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day KDMC fails to submit the Systems Review Report by the Peer Review Consultant, the annual Monitoring Reports by the Peer Review Consultant, the annual Interventional Cardiac Procedures Review Report, Arrangements Review Report, or Unallowable Cost Review Report in accordance with the requirements of Section III.D, Section III.E and Appendix Appendices B and C or fails to repay any Overpayment identified by the IRO as required by Appendix C.deadlines for submission.
610. A Stipulated Penalty of $1,500 for each day Progenity KDMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity KDMC fails to grant access.)
711. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity KDMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
912. A Stipulated Penalty of $1,000 for each day Progenity KDMC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity KDMC stating the specific grounds for its determination that Progenity KDMC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity KDMC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity KDMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 11 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Indivior and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Indivior fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. (a) a Compliance Officer;
b. (b) a Compliance Committee;
c. (c) the Board NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3.;
d. (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. (e) written Policies and Procedures;
f. (f) the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, Persons and Board NGC members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. (g) a risk assessment and internal review mitigation process;
i. (h) a Disclosure Program;
j. (i) Ineligible Persons screening and removal requirements;
k. (j) the Incentive Compensation Restriction and Financial Recoupment Programs;
(k) notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. (l) reporting of Reportable Events;
(m) notification of written communications with FDA;
(n) the FFMP;
(o) the NPMP;
(p) notification to HCPs and HCIs; and
(q) posting of any Payment-related information.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Indivior fails to engage and use an IRO, IRO as required by Section III.E, III.E and Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Indivior fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Indivior fails to submit any Arrangements IRO Review Report report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Indivior fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
87. A Stipulated Penalty of $2,500 for each day Progenity Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in required by Section III.E., III.E and for each day Progenity Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A; and
98. A Stipulated Penalty of $1,000 for each day Progenity Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Indivior stating the specific grounds for its determination that Progenity Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 7 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity the Friendship Entities and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails the Friendship Entities fail to establish, establish and implement or comply with any of the following obligations as described in Sections IIIIII and IV:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations;
e. a written Code of Conduct;
f. written Policies and Procedures;
f. g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsMembers;
h. a risk assessment and internal review processprocess as required by Section III.E;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and;
m. the repayment of Overpayments as required by Section III.I and Appendix B; n. reporting of Reportable Events; and
o. disclosure of changes to business units or locations.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails the Friendship Entities fail to engage and use an IRO, as required by Section III.EIII.D, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails the Friendship Entities fail to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails the Friendship Entities fail to submit any Arrangements Claims Review or Additional Items Review Report in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity fails the Friendship Entities fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails the Friendship Entities fail to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity the Friendship Entities as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity fails the Friendship Entities fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity the Friendship Entities stating the specific grounds for its determination that Progenity has the Friendship Entities have failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity the Friendship Entities shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives the Friendship Entities receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Good Shepherd and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Good Shepherd fails to establish, establish and implement or comply with any of the following obligations as described in Sections IIIIII and IV:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.management certification obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons, Arrangements and Relevant Covered Persons, and Board members;
; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review processprocess as required by Section III.E;
i. h. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. k. policies and procedures regarding the repayment of Overpayments;
l. the repayment of Overpayments as required by Section III.I; and
m. reporting of Reportable Events; and
n. disclosure of changes to business units or locations.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Good Shepherd fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Good Shepherd fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Good Shepherd fails to submit any Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 for each day Progenity Good Shepherd fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Good Shepherd fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Good Shepherd as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
87. A Stipulated Penalty of $2,500 10,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Good Shepherd fails to grant cooperate and otherwise satisfy any of the IRO access to all records obligations and personnel necessary to complete the reviews listed requirements as described in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.III.K.
98. A Stipulated Penalty of $1,000 for each day Progenity Good Shepherd fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Good Shepherd stating the specific grounds for its determination that Progenity Good Shepherd has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Good Shepherd shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Good Shepherd receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity eTEL-Rx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity eTEL-Rx fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:: eTEL-Rx Corporate Integrity Agreement
a. a Compliance Officer;
b. a Compliance Committeewritten Code of Conduct;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and d. the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. e. a Disclosure Program;
j. f. Ineligible Persons screening and removal requirements;
k. g. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. h. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity eTEL-Rx fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity eTEL-Rx fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity eTEL-Rx fails to submit any Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 for each day Progenity eTEL-Rx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity eTEL-Rx fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity eTEL-Rx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.. eTEL-Rx Corporate Integrity Agreement
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity eTEL-Rx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity eTEL-Rx stating the specific grounds for its determination that Progenity eTEL-Rx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity eTEL-Rx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity eTEL-Rx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxxxxxx-AFAS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Xx. Xxxxxxxxxx-AFAS and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to engage and use an IROdisclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, Appendix A, III.F and Appendix B, or Appendix C.; or f. report a Reportable Event in accordance with Section III.G. h. provide to OIG the certifications required by Section III.H relating to any third party xxxxxx engaged by Xx. Xxxxxxxxxx- AFAS during the term of the IA.
32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxxxxxx-AFAS fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxxxxxx-AFAS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Xx. Xxxxxxxxxx-AFAS fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxxxxxx-AFAS stating the specific grounds for its determination that Progenity Xx. Xxxxxxxxxx-AFAS has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xx. Xxxxxxxxxx-AFAS shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxxxxxx-AFAS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA (unless a timely written request for an extension has been submitted and approved in accordance with Section B below) may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 750 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxxx fails to to:
a. designate and maintain a Compliance Contact in accordance with the requirements of Section III.A;
b. establish and/or post a notice in accordance with the requirements of Section III.B;
c. implement, distribute, or update the procedures required by Section III.C;
d. establish and implement a training program in accordance with the requirements of Section III.D;
e. engage and use an IRO, as required by IRO in accordance with the requirements of Section III.E, Appendix A, and Appendix B;
f. submit the IRO’s annual Claims Review Report in accordance with the requirements of Section III.E and Appendix B;
g. obtain and maintain the following documentation: written procedures certifications in accordance with the requirements of Section III.C, training certification(s) in accordance with the requirements of Section III.D, and documentation of screening and disclosure requirements in accordance with the requirements of Section III.F;
h. screen Covered Persons in accordance with the requirements of Section III.F; or Appendix C.require Covered Persons to disclose if they are debarred, excluded, suspended or are otherwise considered an Ineligible Person in accordance with the requirements of Section III.F;
3i. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
j. provide to OIG the certifications required by Section III.J relating to any third party xxxxxx engaged by Xxxxxxx during the term of the IA; or
k. report a Reportable Event.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxxx fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
43. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 750 for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Xxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxxxx fails to grant access.)
74. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Xxxxxxx as part of its Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
85. A Stipulated Penalty of $2,500 750 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity Xxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xxxxxxx stating the specific grounds for its determination that Progenity Xxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity Xxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 4 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity MPG and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity MPG fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;
b. a Compliance Committee;complete the training required for MPG and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.;
d. the management certification obligations III.F and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;Appendix B; or
f. the development of report a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.Event in accordance with Section III.G.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MPG fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MPG fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MPG fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity MPG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity MPG fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity MPG and/or Xxxxxx Xxxx, M.D. as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity MPG fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity MPG fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity MPG fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity MPG stating the specific grounds for its determination that Progenity MPG has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the MPG shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity MPG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity CVS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity CVS fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Code of Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and e. the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. f. a Disclosure Program;
j. g. Ineligible Persons screening and removal requirements;; and CVS Caremark Corporate Integrity Agreement
k. notification h. Notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CVS fails to engage and use an IRO, as required by in Section III.E, III.D and Appendix A, Appendix B, or Appendix C.A.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CVS fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CVS fails to submit any Arrangements the annual Government Reimbursement Review Report in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity CVS fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity CVS fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity CVS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity CVS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity CVS, stating the specific grounds for its determination that Progenity CVS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity CVS shall take to comply with the this CIA. (This Stipulated Penalty shall begin to accrue 10 business ten (10) days after the date Progenity CVS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Hanflink and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Hanflink fails to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Hanflink and use an IROCovered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, III.F and Appendix A, Appendix B, or Appendix C.B;
3f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the certifications required by Section III.H relating to any third party xxxxxx engaged by Hanflink during the term of the IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Hanflink fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Hanflink fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Hanflink fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Hanflink fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Hanflink fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Hanflink as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Hanflink fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Hanflink fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Hanflink fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Hanflink stating the specific grounds for its determination that Progenity Hanflink has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Hanflink shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Hanflink receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Qamar fails to:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Qamar and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; and maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.F and Appendix B; or
f. report a Reportable Event in accordance with Section III.G.
g. engage and use an IRO, as ICC in accordance with the requirements of Section III.B;
h. provide to OIG the certifications required by Section III.E, Appendix A, Appendix B, or Appendix C.III.H relating to any third party xxxxxx engaged by Xxxxx during the term of the IA.
32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Qamar fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Qamar fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Qamar fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Qamar fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Qamar fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Qamar as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Xxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Qamar stating the specific grounds for its determination that Progenity Xxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Qamar shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Lundbeck and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Lundbeck fails to establish, establish, implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, Persons and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. h. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. k. reporting of Reportable Events.; and
l. the Independent Charity PAP policies, procedures, and practices required by Section XXX.X.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Lundbeck fails to engage and use an IRO, IRO as required by Section III.E, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Lundbeck fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Lundbeck fails to submit any Arrangements IRO Review Report report in accordance with the requirements of Section III.E and Appendix B.B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Lundbeck fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Lundbeck fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Lundbeck as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
87. A Stipulated Penalty of $2,500 for each day Progenity Lundbeck fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.E, and for each day Progenity Lundbeck fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Lundbeck fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Lundbeck stating the specific grounds for its determination that Progenity Lundbeck has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Lundbeck shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Lundbeck receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 7 of this Section.Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Rotech and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Rotech fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Code of Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and e. the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. f. a Disclosure Program;
j. g. Ineligible Persons screening and removal requirements;; and
k. h. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Rotech fails to engage and use an IRO, as required by in Section III.E, III.D and Appendix A, Appendix B, or Appendix C.A. Rotech Healthcare Inc. Corporate Integrity Agreement
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Rotech fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Rotech fails to submit any Arrangements the annual Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Rotech fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Rotech fails to grant access.)
76. A Stipulated Penalty of $50,000 20,000 for each false certification submitted by or on behalf of Progenity Rotech as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
87. A Stipulated Penalty of $2,500 for each day Progenity Rotech fails to grant comply with the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, Board of Directors resolution obligations as required by Section III.E and Appendix A.III.A.3;
98. A Stipulated Penalty of $1,000 for each day Progenity Rotech fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Rotech stating the specific grounds for its determination that Progenity Rotech has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Rotech shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Rotech receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Rotech Healthcare Inc)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Maximus and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Maximus fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Code of Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and e. the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. f. a Disclosure Program;
j. g. Ineligible Persons screening and removal requirements;; and
k. h. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Maximus fails to engage and use pay an IRO, invoice of OAS within 30 days of the receipt from OAS as required by in Section III.E, Appendix A, Appendix B, or Appendix C.III.D.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Maximus fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Maximus fails to submit any Arrangements Review Report notify affected parties of a Potential Problem with Consulting Contract in accordance with the requirements of Section III.E and Appendix B.III.H
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Maximus fails to submit any Claims the annual Consulting Contract Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.III.D.
6. A Stipulated Penalty of $1,500 for each day Progenity Maximus fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Maximus fails to grant access.)
7. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Maximus as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity Maximus fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Maximus stating the specific grounds for its determination that Progenity Maximus has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Maximus shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Maximus receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity HOTC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity HOTC fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;
k. i. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. j. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOTC fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOTC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOTC fails to submit any Arrangements Eligibility Review Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity HOTC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity HOTC fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity HOTC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity HOTC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity HOTC stating the specific grounds for its determination that Progenity HOTC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity HOTC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity HOTC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity CHSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity CHSI fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Corporate Compliance and Privacy Officer;, Corporate Compliance Directors, and/or Facility Compliance Officers;
b. a Corporate Compliance Committee;Work Group; and/or Facility Compliance Committees;
c. the Board of Directors compliance obligations as required by Section III.A.3.;obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;Code of Conduct;
e. written Policies and Procedures;Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board members;Members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;a Disclosure Program;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;requirements;
k. i. notification of Government investigations or legal proceedings;; and
l. policies and procedures regarding the repayment of Overpayments; and
m. j. reporting of Reportable Events.Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to engage and use an IRO, as required by in Section III.E, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to submit any Claims Review Report, Unallowable Cost Review Report, or Arrangements Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.C.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity CHSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity CHSI fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity as part of its Implementation Report, any Annual Report, certification additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity CHSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity CHSI stating the specific grounds for its determination that Progenity CHSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity CHSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity CHSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity CHSI and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity CHSI fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Corporate Compliance and Privacy Officer, Corporate Compliance Directors, and/or Facility Compliance Officers;
b. a Corporate Compliance CommitteeWork Group; and/or Facility Compliance Committees;
c. the Board of Directors compliance obligations as required by Section III.A.3.;obligations; Community Health Systems, Inc. Corporate Integrity Agreement, Amended
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;
k. i. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. j. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to engage and use an IRO, as required by in Section III.E, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CHSI fails to submit any Claims Review Report, Unallowable Cost Review Report, or Arrangements Review Report in accordance with the requirements of Section III.E III.E, Appendix B, and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
65. A Stipulated Penalty of $1,500 for each day Progenity CHSI fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity CHSI fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity CHSI as part of its Implementation Report, any Annual Report, Community Health Systems, Inc. Corporate Integrity Agreement, Amended additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity CHSI fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity CHSI stating the specific grounds for its determination that Progenity CHSI has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity CHSI shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity CHSI receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Community Health Systems Inc)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity UHS and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity UHS fails to establish, implement implement, or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. a Quality of Care Review Program;
e. a Dashboard;
f. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. g. written Policies and Procedures;
f. h. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, Persons and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirementsi. retention of a Monitor;
h. j. a risk assessment and internal review process;
i. k. a Disclosure Program;
j. l. Ineligible Persons screening and removal requirements;
k. m. notification of Government investigations or legal proceedings;
l. n. policies and procedures regarding the repayment of Overpayments; and
m. o. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity UHS fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity UHS fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a Annual Reports, or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 1,500 for each day UHS fails to grant access as required in Section VII (which This Stipulated Penalty shall begin to accrue on the day after the date the obligation became due) for each day Progenity UHS fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.grant access.).
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity UHS fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
6. A Stipulated Penalty of $1,500 for each day Progenity fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails to grant access.)
7. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity UHS as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
7. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day UHS fails to pay a Monitor, as required in Section III.D.5.
8. A Stipulated Penalty of $2,500 for each day Progenity UHS fails to comply fully and adequately with any of its obligations with respect to the Monitor, including but not limited to the obligation to grant the Monitor access, as set forth in Section III.D.2, and the obligation to adequately and timely respond to any written recommendation of the Monitor, as set forth in Section III.D.6. OIG shall provide notice to UHS stating the specific grounds for its determination that UHS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps UHS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after UHS receives this notice from OIG of the failure to comply.)
9. A Stipulated Penalty of $2,500 for each day UHS fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.E, and for each day Progenity UHS fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
910. A Stipulated Penalty of $1,000 for each day Progenity UHS fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity UHS stating the specific grounds for its determination that Progenity UHS has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity UHS shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity UHS receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 9 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Universal Health Services Inc)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Aegerion and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Aegerion fails to establish, implement implement, or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board Board’s compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4obligations;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirementsa RAMP;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. k. reporting of Reportable Events.;
l. notification of written communications with FDA as required by Section III.K;
m. the FFMP required by Section III.L;
n. the NPMP required by Section III.M;
o. notification to HCPs and HCIs as required by Section III.N;
p. posting of any Payment-related information as required by Section III.O; and
q. implementation of the other requirements described in Section III.P.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Aegerion fails to engage and use an IRO, IRO as required by Section III.E, Appendix A, Appendix B, or Appendix C.III.E and Appendices A and B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Aegerion fails to timely submit (a) a complete Implementation Report, Annual Report or Annual Report, (b) a any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Aegerion fails to submit any Arrangements IRO Review Report report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Aegerion fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Aegerion fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Aegerion as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Aegerion fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Aegerion stating the specific grounds for its determination that Progenity Aegerion has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Aegerion shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Aegerion receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Orthofix and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Orthofix fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Chief Compliance Officer;
b. a Compliance Committee;
c. the Board Audit Committee compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written all training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board membersrequirements pursuant to Section III.C;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsRequirements described in Sections III.D.2 and III.D.3;
h. a risk assessment and internal review processDisclosure Program pursuant to Section III.E;
i. a Disclosure Programan Internal Monitoring Program and Consultant Monitoring pursuant to Section III.J;
j. Ineligible Persons screening and removal requirementsrequirements pursuant to Section III.F;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpaymentsproceedings pursuant to Section III.G; and
m. l. reporting of Reportable Events.Events pursuant to Section III.I.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Orthofix fails to engage and use an IRO, as required by in Section III.E, Appendix III.D and Appendices A, Appendix B, or Appendix -C.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Orthofix fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Orthofix fails to submit any Claims Review Report or annual Arrangements Review Report in accordance with the requirements of Section III.E III.D.1, Appendix B, and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
65. A Stipulated Penalty of $1,500 for each day Progenity Orthofix fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Orthofix fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Orthofix as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Orthofix fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Orthofix stating the specific grounds for its determination that Progenity Orthofix has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Orthofix shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Orthofix receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Orthofix International N V)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity DaVita and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity DaVita fails to establish, establish and implement or comply with any of the following obligations as described in Sections IIIIII and IV:
a. a Chief Compliance Officer;
b. a Management Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.;obligations; DaVita HealthCare Partners Inc. Corporate Integrity Agreement
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board membersMembers;
g. the Selection Process and Selection Criteria, Valuation Methodologies, Focus Arrangements Procedures Procedures, and/or Focus Arrangements RequirementsRequirements described in Section III.D;
h. a risk assessment the Notice to Joint Venture Partners and internal review processMedical Directors;
i. the unwinding of the Subject Joint Venture Clinics, except to the extent covered by a Monitor’s certification as described in Section III.F.3;
j. the Executive Financial Recoupment Program;
k. the Compliance Input on Executive Compensation;
l. a Disclosure Program;
j. m. Ineligible Persons screening and removal requirements;
k. n. notification of Government government investigations or legal proceedingsproceedings in the United States;
l. policies and procedures regarding the o. repayment by DaVita Dialysis of Overpayments; and;
m. p. reporting of Reportable Events; and
q. disclosure of changes to business units or locations.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity DaVita fails to engage and use an IROa Compliance Advisor, as required by in Section III.E, III.A.3 and Appendix A, Appendix B, or Appendix C.A.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity DaVita fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an Independent Monitor, (b) a certification to OIG as required in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.III.G and Appendix C. DaVita HealthCare Partners Inc. Corporate Integrity Agreement
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity DaVita fails to submit the Implementation Report or any Arrangements Review Report Quarterly Response Reports or Annual Reports to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity DaVita fails to submit any Claims a Compliance Program Review Report in accordance with the requirements of Section III.E III.A.3 and Appendix C or A.
6. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day the Independent Monitor fails to repay any Overpayment identified by submit a Quarterly or Annual Report in accordance with the IRO as required by requirements of Section III.G and Appendix C.
67. A Stipulated Penalty of $1,500 for each day Progenity DaVita fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity DaVita fails to grant access.)
78. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity DaVita as part of its Implementation Report, any Quarterly Response Report, Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity DaVita fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity DaVita stating the specific grounds for its determination that Progenity DaVita has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity DaVita shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity DaVita receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1–8 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Davita Healthcare Partners Inc.)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxxxx and Fleckner, P.C. and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Xx. Xxxxxxxx and use an IROFleckner, P.C. and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.E; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.E; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.E;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.F;
e. repay any Overpayments as required by Section III.EIII.G and Appendix B;
f. report a Reportable Event in accordance with Section III.H;
g. provide to OIG the certifications required by Section III.I relating to any third party xxxxxx engaged by Xx. Xxxxxxxx and Xxxxxxxx, Appendix A, Appendix B, or Appendix C.P.C. during the term of the IA.
32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.D, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to submit a complete Implementation Report, Annual Report, Quarterly Drug Inventory Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxxxx and Xxxxxxxx, P.C. fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxxxx and Xxxxxxxx, P.C. as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.D, and for each day Progenity fails Xx. Xxxxxxxx and Xxxxxxxx, P.C. fail to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity fails Xx. Xxxxxxxx and Fleckner, P.C. fail to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxxxx and Fleckner, P.C. stating the specific grounds for its determination that Progenity has Xx. Xxxxxxxx and Fleckner, P.C. have failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity shall take to comply with the CIAXx. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.Xxxxxxxx and Fleckner,
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Xx. Xxxxxx fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;
b. a Compliance Committee;complete the training required for Xx. Xxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.;III.F and Appendix B;
d. f. report a Reportable Event in accordance with Section III.G; and
g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.H relating to any third-party xxxxxx engaged by Xx. Xxxxxx during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Xx. Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxx fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxx as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xx. Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xx. Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xx. Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxx stating the specific grounds for its determination that Progenity Xx. Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and the steps Progenity Xx. Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Txxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Txxxx fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Chief Compliance Officer;
b. a Regional Compliance Officers;
c. Hospital Compliance Officers;
d. Ethics and Compliance Department;
e. Clinical Quality Department;
f. Corporate Compliance Committee;
c. g. Regional and Hospital Compliance Committees;
h. Quality, Compliance, and Ethics Committee of the Board compliance obligations as required by Section III.A.3.of Directors;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. i. written Policies and Procedures;
f. the development ; j. training of a written training plan Covered Persons, Billing and the training and education of Reimbursement Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. Clinical Quality Covered Persons; k. a Disclosure Program;
j. l. Ineligible Persons screening and removal requirements;; and
k. notification m. Notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Txxxx fails to engage and use an IRO, as required by in Section III.E, Appendix III.D and Appendices A, Appendix B, or Appendix C.-E.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Txxxx fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Txxxx fails to submit any Arrangements the IRO Review Report Reports in accordance with the requirements of Section III.E III.D and Appendix B.Appendices A-E.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Txxxx fails to grant access to the information or documentation as required in Section VIIVII or any other provision under the CIA. (This Stipulated Penalty shall begin to accrue on the date Progenity Txxxx fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Txxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Txxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Txxxx, stating the specific grounds for its determination that Progenity Txxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Txxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Txxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Tenet Healthcare Corp)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity LCPCC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LCPCC fails to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for LCPCC and use an IROCovered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, Appendix A, III.F and Appendix B, or Appendix C.; or
3f. report a Reportable Event in accordance with Section III.G.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LCPCC fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LCPCC fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LCPCC fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity LCPCC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity LCPCC fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity LCPCC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity fails LCPCCfails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity stating the specific grounds for its determination that Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.in
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity XXX and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOK fails to engage and use an IROestablish, implement or comply with any of the following obligations as described in Section III:
a. appoint a Compliance Officer as required by Section III.EIII.A;
b. written Policies and Procedures required by Section III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the training required for Covered Persons and maintain training records, Appendix Ain accordance with the requirements of Section III.D;
e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;
f. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
g. establish policies and procedures regarding the repayment of Overpayments;
h. repay any Overpayments as required by Section III.H and Appendix B, or Appendix C.; or
3i. report a Reportable Event in accordance with Section III.I.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOK fails to timely submit (a) a complete Implementation Report engage and use an IRO, as required by Section III.E, Appendix A or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOK fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity HOK fails to submit any Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity HOK fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity HOK fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity HOK as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity HOK fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.E, and for each day Progenity HOK fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity HOK fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity HOK stating the specific grounds for its determination that Progenity HOK has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the HOK shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity HOK receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Golden and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Golden fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. appoint a Compliance Officer;
b. Officer and a Compliance Committee;
c. the Board compliance obligations Chief Clinical Officer as required by Section III.A.3.;III.A;
d. the management certification obligations b. written Policies and the development and implementation of a written process for Certifying Employees, as Procedures required by Section III.A.4;III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the training required for Covered Persons and maintain training records, in accordance with the requirements of Section III.D;
e. written Policies and Procedures;screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;
f. the development notify OIG of a written training plan and government investigation or legal proceeding, in accordance with the training and education requirements of Covered Persons, Arrangements Covered Persons, and Board members;Section III.G;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. establish policies and procedures regarding the repayment of OverpaymentsOverpayments;
h. repay any Overpayments as required by Section III.H and Appendix B;
i. report a Reportable Event in accordance with Section III.I; andor
m. reporting j. provide to OIG the certifications required by Section III.J relating to any third-party xxxxxx engaged by Golden during the term of Reportable Events.the IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Golden fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, A or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Golden fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Golden fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Golden fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Golden fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Golden as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Golden fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.E, and for each day Progenity Golden fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Golden fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Golden stating the specific grounds for its determination that Progenity Golden has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Golden shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Golden receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Klurfeld fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. appoint a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations Officer as required by Section III.A.3.III.A;
b. written Policies and Procedures required by Section III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the management certification obligations training required for Covered Persons and maintain training records, in accordance with the development and implementation requirements of a written process for Certifying Employees, as required by Section III.A.4III.D;
e. written Policies and Proceduresscreen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;
f. the development notify OIG of a written training plan and government investigation or legal proceeding, in accordance with the training and education requirements of Covered Persons, Arrangements Covered Persons, and Board membersSection III.G;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. establish policies and procedures regarding the repayment of Overpayments;
h. repay any Overpayments as required by Section III.H and Appendix B; and
m. reporting of or i. report a Reportable Events.Event in accordance with Section III.I.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Klurfeld fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, A or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Klurfeld fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Klurfeld fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxxxxx fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Klurfeld as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xxxxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity stating the specific grounds for its determination that Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.in
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity LHMC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity LHMC fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officernotice in accordance with the requirements of Section III.A;
b. a Compliance Committeecomplete the training required for LHMC and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.III.F and Appendix B;
d. f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.H relating to any third-party xxxxxx engaged by LHMC during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable EventsIA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LHMC fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LHMC fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity LHMC fails to submit any Arrangements Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity LHMC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity LHMC fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity LHMC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity LHMC fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity LHMC fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity LHMC fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity LHMC stating the specific grounds for its determination that Progenity LHMC has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the LHMC shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity LHMC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Medco and HHS-OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Medco fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Code of Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures; Medco CIA
e. the training of Covered Persons;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsRequirements described in Sections III.D.l and III.D.2;
h. a risk assessment and internal review process;
i. g. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;; and
k. notification i. Notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Medco fails to engage and use an IRO, as required by in Section III.E, III.E and Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Medco fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Medco fails to submit any the annual Focus Arrangements Review Report and Unallowable Cost Review Report, if applicable, in accordance with the requirements of Section III.E and Appendix B.III.E.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Medco fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Medco fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Medco as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Medco fails to comply fully and adequately with any obligation of this CIA. HHS-OIG shall provide notice to Progenity Medco, stating the specific grounds for its determination that Progenity Medco has failed to comply fully Medco CIA and adequately with the CIA obligation(s) at issue and steps Progenity Medco shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Medco receives this notice from HHS-OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which HHS-OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Medco Health Solutions Inc)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity InterMune and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity InterMune fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Code of Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and e. the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. f. a Disclosure Program;
j. g. Ineligible Persons screening and removal requirements;
k. notification h. Notification of Government investigations or legal proceedings;
l. policies and procedures i. notification of communications regarding the repayment of Overpaymentsoff-label related matters; and
m. reporting j. a review of Reportable Eventsrecords reflecting the content of detailing sessions.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity InterMune fails to engage and use an IRO, as required by in Section III.E, Appendix A, Appendix B, or Appendix C.III.D and Appendices A and B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity InterMune fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity InterMune fails to submit the annual Report associated with any Arrangements Review Report of the Reviews in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity InterMune fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity InterMune fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity InterMune as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity InterMune fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity InterMune, stating the specific grounds for its determination that Progenity InterMune has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity InterMune shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity InterMune receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Xxxxx fails to establish, establish and implement or comply with any of the following obligations as described in Sections IIIIII and IV:
a. a Compliance Officer;Officer;
b. a Compliance Committee;Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.;obligations;
d. the management certification obligations obligations;
e. a written Code of Conduct;
f. written Policies and Procedures;
g. the development and and/or implementation of a written process Training Plan for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;Members;
g. h. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;Requirements described in Sections III.D.1 and III.D.2;
h. i. a risk assessment and internal review process;process as required by Section III.F;
i. j. a Disclosure Program;Program;
j. k. Ineligible Persons screening and removal requirements;requirements;
k. l. notification of Government investigations or legal proceedings;proceedings;
l. m. policies and procedures regarding the repayment of Overpayments; andOverpayments;
m. n. the repayment of Overpayments as required by Section III.J and Appendix B;
o. reporting of Reportable Events.; and
p. disclosure of changes to business units or locations.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Xxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxx fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Xxxxx fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Xxxxx stating the specific grounds for its determination that Progenity Xxxxx has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Xxxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxx Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Xxxxx Pharmacy fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officernotice in accordance with the requirements of Section III.A;
b. a Compliance Committeecomplete the training required for Xxxxx Pharmacy and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.III.F and Appendix B;
d. f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.H relating to any third-party xxxxxx engaged by Xxxxx Xxxxxxxx during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable EventsIA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx Pharmacy fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx Pharmacy fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxx Pharmacy fails to submit any Arrangements Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Xxxxx Pharmacy fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxx Pharmacy fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xxxxx Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xxxxx Pharmacy fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xxxxx Pharmacy fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xxxxx Pharmacy fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xxxxx Pharmacy stating the specific grounds for its determination that Progenity Xxxxx Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xxxxx Pharmacy shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxx Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Xxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to engage disclose if they are excluded in accordance with the requirements of Section III.D; and use an IROmaintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, Appendix A, III.F and Appendix B, or Appendix C.; or
3f. report a Reportable Event in accordance with Section III.G.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxxx fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xxxxxx stating the specific grounds for its determination that Progenity Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Ho Medical and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA (unless a timely written request for an extension has been submitted and approved in accordance with Section B below) may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 750 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Ho Medical fails to to:
a. designate and maintain a Compliance Contact in accordance with the requirements of Section III.A;
b. establish and/or post a notice in accordance with the requirements of Section III.B;
c. implement, distribute, or update the procedures required by Section III.C;
d. establish and implement a training program in accordance with the requirements of Section III.D;
e. engage and use an IRO, as required by IRO in accordance with the requirements of Section III.E, Appendix A, and Appendix B;
f. submit the IRO’s annual Claims Review Report in accordance with the requirements of Section III.E and Appendix B;
g. obtain and maintain the following documentation: written procedures certifications in accordance with the requirements of Section III.C, training certification(s) in accordance with the requirements of Section III.D, and documentation of screening and disclosure requirements in accordance with the requirements of Section III.F;
h. screen Covered Persons in accordance with the requirements of Section III.F; or Appendix C.require Covered Persons to disclose if they are debarred, excluded, suspended or are otherwise considered an Ineligible Person in accordance with the requirements of Section III.F;
3i. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
j. provide to OIG the certifications required by Section III.J relating to any third party xxxxxx engaged by Ho Medical during the term of the IA; or
k. report a Reportable Event.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Ho Medical fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
43. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 750 for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Ho Medical fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Ho Medical fails to grant access.)
74. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Ho Medical as part of its Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
85. A Stipulated Penalty of $2,500 750 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity Ho Medical fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Ho Medical stating the specific grounds for its determination that Progenity Ho Medical has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Ho Medical shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Ho Medical receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 4 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity APM, Park Center, Xxxxxx, and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails APM, Park Center, and Xxxxxx fail to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.management certification obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. e. the development of a written training plan and the training and education of Covered Persons, and Arrangements Covered Persons, and Board members;
g. f. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;Requirements;
h. g. a risk assessment and internal review process;process;
h. a Disclosure Program;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;requirements;
k. j. notification of Government investigations or legal proceedings;proceedings;
l. k. policies and procedures regarding the repayment of Overpayments; andand
m. l. reporting of Reportable Events.Events
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails APM, Park Center, and Xxxxxx fail to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C.C.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails APM, Park Center, and Xxxxxx fail to timely submit (a) a complete Implementation Report or Report, Annual Report, (b) a or any certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIG.submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails APM, Park Center, and Xxxxxx fail to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails APM, Park Center, and Xxxxxx fail to submit any Claims Review Report in accordance with the requirements of Section Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity fails APM, Park Center, and Xxxxxx fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails APM, Park Center, and Xxxxxx fail to grant access.)access.)
7. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity APM, Park Center, and Xxxxxx as part of its their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails APM, Park Center, and Xxxxxx fail to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails APM, Park Center, and Xxxxxx fail to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
9. A Stipulated Penalty of $1,000 for each day Progenity fails APM, Park Center, and Xxxxxx fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity APM, Park Center, and Xxxxxx stating the specific grounds for its determination that Progenity has APM, Park Center, and Xxxxxx have failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity APM, Park Center, and Xxxxxx shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives APM, Park Center, and Xxxxxx receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity FHG and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity FHG fails to engage and use an IROestablish, implement or comply with any of the following obligations as described in Section III:
a. appoint a Compliance Officer as required by Section III.EIII.A;
b. written Policies and Procedures required by Section III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the training required for Covered Persons and maintain training records, in accordance with the requirements of Section III.D;
e. screen Covered Persons in accordance with the requirements of Section III.F or require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; and maintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.F;
f. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
g. establish policies and procedures regarding the repayment of Overpayments;
h. repay any Overpayments as required by Section III.H and Appendix A, Appendix B, or Appendix C.B;
3i. report a Reportable Event in accordance with Section III.I; or
j. provide to OIG the certifications required by Section III.J relating to any third party xxxxxx engaged by FHG during the term of the IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity FHG fails to timely submit (a) a complete Implementation Report engage and use an IRO, as required by Section III.E, Appendix A or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity FHG fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity FHG fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity FHG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity FHG fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity FHG as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity FHG fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity FHG stating the specific grounds for its determination that Progenity FHG has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the FHG shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity FHG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxx Clinic and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Xxxx Clinic fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officernotice in accordance with the requirements of Section III.A;
b. a Compliance Committeecomplete the training required for Xxxx Clinic and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.;
d. the management certification obligations III.F and the development and implementation of Appendix B; or f. report a written process for Certifying Employees, as required by Reportable Event in accordance with Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.III.G.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxx Clinic fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxx Clinic fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxx Clinic fails to submit any Arrangements Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Xxxx Clinic fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxx Clinic fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xxxx Clinic as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xxxx Clinic fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xxxx Clinic fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xxxx Clinic fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xxxx Clinic stating the specific grounds for its determination that Progenity Xxxx Clinic has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xxxx Clinic shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxx Clinic receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity I&L and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity I&L fails to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for I&L and use an IROCovered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, III.F and Appendix A, Appendix B, or Appendix C.B;
3f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the certifications required by Section III.H relating to any third party xxxxxx engaged by I&L during the term of the IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity I&L fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity I&L fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity I&L fails to submit any Quarterly Claims Review Report or Quarterly Drug Inventory Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity I&L fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity I&L fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity I&L as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity I&L fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity I&L fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity I&L fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity I&L stating the specific grounds for its determination that Progenity I&L has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the I&L shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity I&L receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA (unless a timely written request for an extension has been submitted and approved in accordance with Section B below) may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 750 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to to:
a. designate and maintain a Compliance Contact in accordance with the requirements of Section III.A;
b. establish and/or post a notice in accordance with the requirements of Section III.B;
c. implement, distribute, or update the procedures required by Section III.C;
d. establish and implement a training program in accordance with the requirements of Section III.D;
e. engage and use an IRO, as required by IRO in accordance with the requirements of Section III.E, Appendix A, and Appendix B;
f. submit the IRO’s annual Claims Review Report in accordance with the requirements of Section III.E and Appendix B;
g. obtain and maintain the following documentation: written procedures certifications in accordance with the requirements of Section III.C, training certification(s) in accordance with the requirements of Section III.D, and documentation of screening and disclosure requirements in accordance with the requirements of Section III.F;
h. screen Covered Persons in accordance with the requirements of Section III.F; or Appendix C.require Covered Persons to disclose if they are debarred, excluded, suspended or are otherwise considered an Ineligible Person in accordance with the requirements of Section III.F;
3i. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
j. provide to OIG the certifications required by Section III.J relating to any third party xxxxxx engaged by Xx. Xxxxxxxx during the term of the IA; or
k. report a Reportable Event.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
43. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 750 for each day Progenity fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5Xx. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxxxx fails to grant access.)
74. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxxxx as part of its Implementation Report, any Annual ReportReports, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
85. A Stipulated Penalty of $2,500 750 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9Xx. A Stipulated Penalty of $1,000 for each day Progenity Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxxxx stating the specific grounds for its determination that Progenity Xx. Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 4 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Biovail and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Biovail fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Chief Compliance Officer;
b. a U.S. Healthcare Compliance Policy Committee;
c. the Risk and Compliance Committee of the Board compliance obligations as required by Section III.A.3.of Director’s resolution;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Persons and Relevant Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;
k. ; L notification of Government investigations or legal proceedings;
l. policies and procedures regarding i. notification of Government investigations of legal proceedings;
j. notification of communications with the repayment FDA as specified in Section III.I;
k. posting of OverpaymentsPayment information as required by Section III.J; and
m. reporting l. a review of Reportable Events.records reflecting the content of detailing sessions as required by Section III.K.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Biovail fails to engage and use an IRO, as required by in Section III.E, III.D and Appendix A, Appendix B, or Appendix C.A.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Biovail fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Biovail fails to submit any Arrangements the annual IRO Review Report Report(s) in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Biovail fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Biovail fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Biovail as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Biovail fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Biovail stating the specific grounds for its determination that Progenity Biovail has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Biovail shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Biovail receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Biovail Corp International)
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity EPIPG and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity EPIPG fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. appoint a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations Officer as required by Section III.A.3.;III.A;
d. the management certification obligations b. written Policies and the development and implementation of a written process for Certifying Employees, as Procedures required by Section III.A.4;III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the training required for Covered Persons and maintain training records, in accordance with the requirements of Section III.D;
e. written Policies and Procedures;screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;
f. the development notify OIG of a written training plan and government investigation or legal proceeding, in accordance with the training and education requirements of Covered Persons, Arrangements Covered Persons, and Board members;Section III.G;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. establish policies and procedures regarding the repayment of OverpaymentsOverpayments;
h. repay any Overpayments as required by Section III.H and Appendix B; andor
m. reporting of i. report a Reportable Events.Event in accordance with Section III.I.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity EPIPG fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, A or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity EPIPG fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity EPIPG fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity EPIPG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity EPIPG fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity EPIPG as part of its Implementation Report, any Annual Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity EPIPG fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.E, and for each day Progenity EPIPG fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity EPIPG fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity EPIPG stating the specific grounds for its determination that Progenity EPIPG has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the EPIPG shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity EPIPG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity ResMed and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity ResMed fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;Officer;
b. a Compliance Committee;Committee;
c. the Board compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3.;III.A.3;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.4;
e. written Policies and Procedures;Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;members;
g. the Focus Arrangements Procedures, Invoiced Sales Procedures and/or Focus Arrangements Requirements;Requirements;
h. a risk assessment and internal review process;process;
i. a Disclosure Program;Program;
j. Ineligible Persons screening and removal requirements;requirements;
k. notification of Government investigations or legal proceedings;; and
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.Events
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity ResMed fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity ResMed fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity ResMed fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity ResMed fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity ResMed fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity ResMed as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
87. A Stipulated Penalty of $2,500 for each day Progenity ResMed fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.D, and for each day Progenity ResMed fails to furnish to the IRO accurate and complete records to the IROrecords, as required by Section III.E and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity ResMed fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity ResMed stating the specific grounds for its determination that Progenity ResMed has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity ResMed shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity ResMed receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Practitioner and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Practitioner fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officernotice in accordance with the requirements of Section III.A;
b. a Compliance Committeecomplete the training required for Practitioner and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.;III.F and Appendix B; or
d. f. report a Reportable Event in accordance with Section III.G.
g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.H relating to any third-party xxxxxx engaged by Practitioner during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable EventsIA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Practitioner fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Practitioner fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Practitioner fails to submit any Arrangements Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Practitioner fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Practitioner fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Practitioner as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Practitioner fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Practitioner fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity Practitioner fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Practitioner stating the specific grounds for its determination that Progenity Practitioner has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Practitioner shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Practitioner receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Prime fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Corporate Compliance Officer;Officer or Deputy Compliance Officers;
b. a Compliance Committee;Committee;
c. the Board compliance obligations obligations, the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3.;III.A.4.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;III.A.5;
e. written Policies and Procedures;Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;Requirements;
h. a risk assessment and internal review process;process;
i. a Disclosure Program;Program;
j. Ineligible Persons screening and removal requirements;requirements;
k. notification of Government investigations or legal proceedings;proceedings;
l. policies and procedures regarding the repayment of Overpayments; andand
m. reporting of Reportable Events.Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Prime fails to engage and use an IRO, as required by Section III.E, Appendix A, Appendix B, or Appendix C.and Appendices A through D.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Prime fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Prime fails to submit any Arrangements Review Report in accordance with the requirements of Section III.E and Appendix B.B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Prime fails to submit any Claims Review Report or Inpatient Medical Necessity Review Report in accordance with the requirements of Section III.E and Appendix Appendices C and D, respectively, or fails to repay any Overpayment identified by the IRO as required by Appendix C.Appendices C and D.
6. A Stipulated Penalty of $1,500 for each day Progenity Prime fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Prime fails to grant access.)access.)
7. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Prime as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity Prime fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity Prime fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.A.
9. A Stipulated Penalty of $1,000 for each day Progenity Prime fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Prime stating the specific grounds for its determination that Progenity Prime has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Prime shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Prime receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Khanna and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Khanna fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officernotice in accordance with the requirements of Section III.A;
b. a Compliance Committeecomplete the training required for Khanna and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. create and maintain a Prescription Tracking System, in accordance with the Board compliance obligations requirements of Section III.C;
d. screen Covered Persons in accordance with the requirements of Section III.E; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.E; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.E;
e. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.F;
f. repay any Overpayments as required by Section III.A.3.III.G and Appendix B;
d. g. report a Reportable Event in accordance with Section III.H; or
h. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.I relating to any third party xxxxxx engaged by Khanna during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable EventsIA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Khanna fails to engage and use an IRO, as required by Section III.EIII.D, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Khanna fails to timely submit submit
(a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Khanna fails to submit any Arrangements Quarterly Claims Review Report or Prescription Review Report in accordance with the requirements of Section III.E III.D and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Khanna fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Khanna fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Khanna as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIAIA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Khanna fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.D, and for each day Progenity Khanna fails to furnish accurate and complete records to the IRO, as required by Section III.E III.D and Appendix A.
98. A Stipulated Penalty of $1,000 for each day Progenity Khanna fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Khanna stating the specific grounds for its determination that Progenity Khanna has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Khanna shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Khanna receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxxxx and OIG hereby agree that failure to to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Xx. Xxxxxxxx fails to establish, implement or comply with any of the following obligations as described in Sections Section III:
a. post a Compliance Officer;notice in accordance with the requirements of Section III.A;
b. a Compliance Committee;complete the training required for Xx. Xxxxxxxx and Covered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the Board compliance obligations requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.A.3.;III.F and Appendix B;
d. f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the management certification obligations and the development and implementation of a written process for Certifying Employees, as certifications required by Section III.A.4;
e. written Policies and Procedures;
f. III.H relating to any third-party xxxxxx engaged by Xx. Xxxxxxxx during the development term of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to engage and use an IRO, as required by Section III.EIII.C, Appendix A, Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.OIG.
4. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to submit any Arrangements Quarterly Claims Review Report in accordance with the requirements of Section III.E Section III.C and Appendix B or fails to repay any Overpayment identified by the IRO, as required by Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6Xx. A Stipulated Penalty of $1,500 for each day Progenity Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxxxx fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xx. Xxxxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xx. Xxxxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xx. Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxxxx stating the specific grounds for its determination that Progenity Xx. Xxxxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Covered Persons and use an IROmaintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, Appendix A, III.F and Appendix B, or Appendix C.; or
3f. report a Reportable Event in accordance with Section III.G.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxx fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity fails Xx. Xxxxxx or MRA fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity fails Xx. Xxxxxx or MRA fail to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xx. Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xx. Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xx. Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxx stating the specific grounds for its determination that Progenity Xx. Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xx. Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity XXXX and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity MCCG fails to establish, establish and implement or comply with any of the following obligations as described in Sections IIIIII and IV:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Management Certification obligations;
e. a written Code of Conduct;
f. written Policies and Procedures;
f. g. the development and/or implementation of a written training plan and Training Plan for the training and education of Covered Persons, Arrangements Covered Persons, Persons and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsMembers;
h. a risk assessment and internal review processmitigation process as required in Section III.E;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and;
m. the repayment of Overpayments as required by Section III.I; n. reporting of Reportable Events; and
o. disclosure of changes to business units or locations.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MCCG fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, Appendix B, or and Appendix C.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MCCG fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity MCCG fails to submit any Arrangements Claims Review Report or Inpatient Medical Necessity and Appropriateness Review Report in accordance with the requirements of Section III.E III.D, Appendix B, and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
65. A Stipulated Penalty of $1,500 for each day Progenity MCCG fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity MCCG fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity MCCG as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity MCCG fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity MCCG stating the specific grounds for its determination that Progenity MCCG has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity MCCG shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity MCCG receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xx. Xxxxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Xx. Xxxxxxxx and Covered Persons and maintain training certifications, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; or require Covered Persons to engage disclose if they are debarred, excluded, or suspended in accordance with the requirements of Section III.D; and use an IROmaintain documentation of screening and disclosure requirements in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, III.F and Appendix A, Appendix B, B;
f. report a Reportable Event in accordance with Section III.G.; or
g. disclose any changes to locations or Appendix C.business under Section IV.
32. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xx. Xxxxxxxx fails to submit the Implementation Report, any Arrangements Quarterly Claims Review Report or any Annual Report to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) 1,000 for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6Xx. A Stipulated Penalty of $1,500 for each day Progenity Xxxxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xx. Xxxxxxxx fails to grant access.)access.)
75. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xx. Xxxxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
96. A Stipulated Penalty of $1,000 for each day Progenity Xx. Xxxxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xx. Xxxxxxxx stating the specific grounds for its determination that Progenity Xx. Xxxxxxxx has failed failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xx. Xxxxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xx. Xxxxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 5 of this Section.
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxx Xxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Kai Heart fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. h. Ineligible Persons screening and removal requirements;
k. i. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. j. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Kai Heart fails to engage and use an IRO, as required by in Section III.EIII.D, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Kai Heart fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Kai Heart fails to submit any Arrangements Claims Review Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E III.D and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Kai Heart fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Kai Heart fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Kai Heart as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Kai Heart fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Kai Heart stating the specific grounds for its determination that Progenity Kai Heart has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Kai Heart shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxx Xxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity PHC and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity PHC fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
Members; g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
Requirements described in Sections III.D.1 and III.D.2; h. a risk assessment and internal review process;
i. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. k. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity PHC fails to engage and use an IRO, as required by in Section III.E, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity PHC fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity PHC fails to submit any the annual Arrangements Review Report or Unallowable Cost Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity PHC fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity PHC fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity PHC as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity PHC fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity PHC stating the specific grounds for its determination that Progenity PHC has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity PHC shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity PHC receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity CBHA and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CBHA fails to engage and use an IROestablish, implement or comply with any of the following obligations as described in Section III:
a. appoint a Compliance Officer as required by Section III.EIII.A;
b. written Policies and Procedures required by Section III.B;
c. post a notice in accordance with the requirements of Section III.C;
d. complete the training required for Covered Persons and maintain training records, Appendix Ain accordance with the requirements of Section III.D;
e. screen Covered Persons in accordance with the requirements of Section III.F; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.F; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.F;
f. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.G;
g. establish policies and procedures regarding the repayment of Overpayments;
h. repay any Overpayments as required by Section III.H and Appendix B, or Appendix C.; or
3i. report a Reportable Event in accordance with Section III.I.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CBHA fails to timely submit (a) a complete Implementation Report engage and use an IRO, as required by Section III.E, Appendix A or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CBHA fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity CBHA fails to submit any Quarterly Claims Review Report in accordance with the requirements of Section III.E III.D and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity CBHA fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity CBHA fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity CBHA and/or Xx. Xxxxxx Xxxx as part of its the Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity CBHA fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
9. A Stipulated Penalty of $1,000 for each day Progenity fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity stating the specific grounds for its determination that Progenity has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 of this Section.in
Appears in 1 contract
Samples: Integrity Agreement
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Amedisys and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Amedisys fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board of Directors and Covered Administrators compliance obligations as required by Section III.A.3.obligations;
d. the management certification obligations and the development and implementation of a written process for Certifying EmployeesCode of Conduct; Amedisys, as required by Section III.A.4;Inc. and Amedisys Holding, LLC Corporate Integrity Agreement
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Relevant Covered Persons, and Board membersMembers;
g. the Focus Arrangements Procedures and/or Focus Arrangements RequirementsREM Program;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. i. Ineligible Persons screening and removal requirements;
k. j. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. k. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Amedisys fails to engage and use an IRO, as required by in Section III.E, Appendix A, and Appendix B, or Appendix C.B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Amedisys fails to timely submit (a) a complete the Implementation Report or any Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Amedisys fails to submit any Arrangements Claims Review Report, the REM Program Review Report, or Unallowable Cost Review Report in accordance with the requirements of Section III.E and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Amedisys fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Amedisys fails to grant access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Amedisys as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Amedisys fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Amedisys stating the specific grounds for its determination that Progenity Amedisys has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Amedisys shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Amedisys receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 1- 6 of this Section.
Appears in 1 contract
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Cephalon and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Cephalon fails to establish, implement implement, or comply with accomplish any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.resolution;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4Code of Conduct;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirementsa Disclosure Program as required by Section III.E;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. i. notification of Government investigations or legal proceedings;
j. notification of communications with FDA regarding off-label matters;
k. Message Recall Studies (or alternative information permitted by Section III.J);
l. policies and procedures regarding the repayment of Overpayments; anda program for FFMP;
m. reporting notification to any health care providers or entities as required by Section III.L; or
n. posting of Reportable Events.any Payments as required by Section III.M.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Cephalon fails to engage and use an IRO, as required by in Section III.E, Appendix III.D and Appendices A, Appendix B, or Appendix C.-B.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Cephalon fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Cephalon fails to submit any Arrangements the annual IRO Review Report Report(s) in accordance with the requirements of Section III.E Sections III.D and V.B.6 and Appendix B.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Cephalon fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Cephalon fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Cephalon as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Cephalon fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Cephalon, stating the specific grounds for its determination that Progenity Cephalon has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Cephalon shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Cephalon receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
Appears in 1 contract
Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Gambro and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity Gambro fails to establish, establish and implement or comply with any of the following obligations as described in Sections Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.a written Standards of Business Conduct;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and e. the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. f. a Disclosure Program;
j. g. Ineligible Persons screening and removal requirements;; and
k. notification h. Notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Gambro fails to engage and use an IRO, as required by in Section III.EIII.E and Appendix X. Xxxxxx Healthcare, Appendix A, Appendix B, or Appendix C.Inc. Corporate Integrity Agreement
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Gambro fails to timely submit (a) a complete the Implementation Report or the Annual Report, (b) a certification Reports to OIG in accordance with the requirements of Section V, or (c) a complete response to any request V by the deadlines for information from OIGsubmission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Gambro fails to submit any the annual Claims Review Report, the Unallowable Cost Review Report, the annual Stat Labs Billing Review Report, or the annual Heightened Arrangements Review Report in accordance with the requirements of Section III.E Sections III.D and Appendix B.E and Appendixes B, C, D, and E.
5. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity fails to submit any Claims Review Report in accordance with the requirements of Section III.E and Appendix C or fails to repay any Overpayment identified by the IRO as required by Appendix C.
6. A Stipulated Penalty of $1,500 for each day Progenity Gambro fails to grant access to the information or documentation as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Gambro fails to grant access.)
76. A Stipulated Penalty of $50,000 5,000 for each false certification submitted by or on behalf of Progenity Gambro as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA.
8. A Stipulated Penalty of $2,500 for each day Progenity fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E., and for each day Progenity fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A.
97. A Stipulated Penalty of $1,000 for each day Progenity Gambro fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Progenity Gambro, stating the specific grounds for its determination that Progenity Gambro has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Progenity Gambro shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Gambro receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 6 of this Section.
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Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractual remedy, Progenity Xxxxxx and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA IA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions.
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Progenity fails to establish, implement or comply with any of the following obligations as described in Sections III:
a. a Compliance Officer;
b. a Compliance Committee;
c. the Board compliance obligations as required by Section III.A.3.;
d. the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4;
e. written Policies and Procedures;
f. the development of a written training plan and the training and education of Covered Persons, Arrangements Covered Persons, and Board members;
g. the Focus Arrangements Procedures and/or Focus Arrangements Requirements;
h. a risk assessment and internal review process;
i. a Disclosure Program;
j. Ineligible Persons screening and removal requirements;
k. notification of Government investigations or legal proceedings;
l. policies and procedures regarding the repayment of Overpayments; and
m. reporting of Reportable Events.
2. A Stipulated Penalty of $2,500 1,000 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to engage establish, implement or comply with any of the following obligations as described in Section III:
a. post a notice in accordance with the requirements of Section III.A;
b. complete the training required for Xxxxxx and use an IROCovered Persons and maintain training records, in accordance with the requirements of Section III.B;
c. screen Covered Persons in accordance with the requirements of Section III.D; require Covered Persons to disclose if they are excluded in accordance with the requirements of Section III.D; or maintain copies of print screens from search results to demonstrate the required screening has been performed in accordance with the requirements of Section III.D;
d. notify OIG of a government investigation or legal proceeding, in accordance with the requirements of Section III.E;
e. repay any Overpayments as required by Section III.E, III.F and Appendix A, Appendix B, or Appendix C.B;
3f. report a Reportable Event in accordance with Section III.G; or
g. provide to OIG the certifications required by Section III.H relating to any third party xxxxxx engaged by Xxxxxx during the term of the IA.
2. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to timely submit (a) a complete Implementation Report or Annual Reportengage and use an IRO, (b) a certification to OIG in accordance with the requirements of as required by Section VIII.C, Appendix A, or (c) a complete response to any request for information from OIG.Appendix B.
43. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to submit a complete Implementation Report, Annual Report, or any Arrangements Review Report certification to OIG in accordance with the requirements of Section III.E and Appendix B.V by the deadlines for submission.
54. A Stipulated Penalty of $2,500 1,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Progenity Xxxxxx fails to submit any Quarterly Claims Review Report or Quarterly Drug Inventory Review Report in accordance with the requirements of Section III.E III.C and Appendix C B or fails to repay any Overpayment identified by the IRO IRO, as required by Appendix C.B.
65. A Stipulated Penalty of $1,500 1,000 for each day Progenity Xxxxxx fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Progenity Xxxxxx fails to grant access.)access.)
76. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Progenity Xxxxxx as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or as otherwise required by this CIA.IA.
87. A Stipulated Penalty of $2,500 1,000 for each day Progenity Xxxxxx fails to grant the IRO access to all records and personnel necessary to complete the reviews listed in Section III.E.III.C, and for each day Progenity Xxxxxx fails to furnish accurate and complete records to the IRO, as required by Section III.E III.C and Appendix A.A.
98. A Stipulated Penalty of $1,000 for each day Progenity Xxxxxx fails to comply fully and adequately with any obligation of this CIAIA. OIG shall provide notice to Progenity Xxxxxx stating the specific grounds for its determination that Progenity Xxxxxx has failed to comply fully and adequately with the CIA IA obligation(s) at issue and steps Progenity the Xxxxxx shall take to comply with the CIAIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Progenity Xxxxxx receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1-8 7 of this Section.Section.
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Samples: Integrity Agreement