Board of Directors Compliance Obligations. The Board shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA. The Board shall, at a minimum, be responsible for the following: a. The Board shall meet at least quarterly to review and oversee GSK’s Compliance Program, including but not limited to the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements. b. For each Reporting Period of the CIA, the Board shall adopt a resolution, signed by each individual member of the Board, summarizing its review and oversight of GSK’s compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSK’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIA. The Board has concluded that, to the best of its knowledge, GSK has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, and the obligations of the CIA.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSK. GlaxoSmithKline LLC Corporate Integrity Agreement GSK shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 4 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors of CHSI shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. The Board of Directors must include independent (i.e., non-executive) members. The Board of Directors shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSKCHSI’s Compliance Program, including but not limited to the performance of the Corporate Compliance and Privacy Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Corporate Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.Work Group; and
b. For for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board of Directors summarizing its review and oversight of GSKCHSI’s compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors of the Board of Directors has made a reasonable inquiry into the operations of GSKCHSI’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Corporate Compliance and Privacy Officer and the compliance personnel who are Covered Persons under this CIACorporate Compliance Work Group. The Based on its inquiry and review, the Board of Directors has concluded that, to the best of its knowledge, GSK CHSI has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, requirements and the obligations of the CIA.” Community Health Systems, Inc. Corporate Integrity Agreement If the Board of Directors is unable to provide such a conclusion in the resolution, the Board of Directors shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKCHSI. GlaxoSmithKline LLC Corporate Integrity Agreement GSK CHSI shall report to OIG, in writing, any changes in the composition of the BoardBoard of Directors, or any actions or changes that would affect the Board's Board of Directors’ ability to perform the duties necessary to meet the obligations in this CIA, within 15 30 days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Quorum Health Corp), Corporate Integrity Agreement (Community Health Systems Inc)
Board of Directors Compliance Obligations. The Board of Directors (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. The individuals who serve on the Board of Directors Committee shall be readily available to the Compliance Officer to respond to any issues or questions that might arise. The Board shall, at a minimum, be responsible for the following:: Xxxxxxx Lutheran Corporate Integrity Agreement
a. The Board shall meet meeting at least quarterly to review and oversee GSKXxxxxxx Lutheran’s Compliance Program, including but not limited to the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate Compliance Committee;
b. reviewing the effectiveness adequacy of Xxxxxxx Lutheran’s system of internal controls, quality assurance monitoring, and resident care;
c. ensuring that Xxxxxxx Lutheran’s response to state, federal, internal, and external reports of quality of care issues is complete, thorough, and resolves the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer issue(s) identified;
d. ensuring that Xxxxxxx Lutheran adopts and other compliance personnel and updates about adoption and implementation of implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program requirements;
e. reviewing and FDA requirements.responding to the Dashboard and ensuring that Xxxxxxx Lutheran implements effective responses when potential quality problems are indicated on the Dashboard or when quality indicators show that Xxxxxxx Lutheran is not meeting its established goals; and
b. For f. for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board summarizing its review and oversight of GSKXxxxxxx Lutheran’s compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSKXxxxxxx Lutheran’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIACompliance Committee. The Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Xxxxxxx Lutheran has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, requirements and the obligations of the CIA.” Xxxxxxx Lutheran Corporate Integrity Agreement If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKXxxxxxx Lutheran. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Xxxxxxx Lutheran shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a Committee of the Board) of Shire plc (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, requirements and FDA requirements, requirements and the obligations of this CIA. The Board must include independent (i.e., non-executive) members. The Board (or a Committee of the Board) shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSKShire’s U.S. Compliance Program, including but not limited to the performance of the CCRO and U.S. Compliance Officer and other compliance personnel. The Board shall evaluate Committee;
b. evaluating the effectiveness of the U.S. Compliance Program, including, including at a minimum, by receiving updates about the activities of the Compliance Officer CCRO and other compliance personnel and updates about the adoption and implementation of policies, procedures, and practices designed to ensure compliance with Shire North American Group, Inc. Corporate Integrity Agreement the requirements set forth in this CIA and with applicable Federal health care program requirements and FDA requirements.; and
b. For c. for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board or Committee of the Board summarizing its review and oversight of GSKShire’s compliance with Federal health care program requirements, requirements and FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors [or a Committee of the Board] has made a reasonable inquiry into the operations of GSKShire’s U.S. Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer CCRO and the compliance personnel who are Covered Persons under this CIAU.S. Compliance Committee. The Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Shire has implemented an effective Compliance Program to meet Federal health care program requirements, requirements and FDA requirements, requirements and the obligations of the CIA.” If the Board Board, or a Committee of the Board, is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective U.S. Compliance Program at GSKShire. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Shire shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet at least quarterly to review and oversee GSKABCs’s Compliance Program, including but not limited to the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.
b. For each Reporting Period of the CIA, the Board shall adopt a resolution, signed by each individual member of the Board, summarizing its review and oversight of GSKxxx’s compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSKxxx’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIA. The Board has concluded that, to the best of its knowledge, GSK xxx has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, and the obligations of the CIA.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSK. GlaxoSmithKline LLC Corporate Integrity Agreement GSK shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Spring Gate (Board) shall be responsible for the review and oversight of matters related to compliance with the requirements and obligations of this CIA, Federal health care program requirements, FDA requirementsand professionally recognized standards of care. The Board must include independent (i.e., non-executive) members. The Board shall be readily available to the Compliance Officer and the obligations Monitor required under Section III.D of this CIACIA to respond to any issues or questions that might arise. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSKSpring Gate’s Compliance Programcompliance program, including including, but not limited to to, the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Compliance ProgramCommittee;
b. reviewing the adequacy of Spring Gate’s system of internal controls, includingquality assurance monitoring, at a minimumand resident care;
c. ensuring that Spring Gate’s response to state, by receiving updates about federal, internal, and external reports of quality of care problems is complete, thorough, and resolves the activities of the Compliance Officer problem(s) identified;
d. ensuring that Spring Gate adopts and other compliance personnel and updates about adoption and implementation of implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable CIA, Federal health care program requirements, and FDA requirements.professionally recognized standards of care;
b. For e. reviewing and responding to the Dashboard and ensuring that Spring Gate implements effective responses when potential quality problems are indicated on the Dashboard or when quality indicators show that Spring Gate is not meeting its established goals; and
f. for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board summarizing its review and oversight of GSKSpring Gate’s compliance with the obligations of this CIA, Federal health care program requirements, FDA requirements, and the obligations professionally recognized standards of this CIAcare. At a minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSKSpring Gate’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period]Program, including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIACompliance Committee. The Board has also provided oversight on quality of care issues. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Spring Gate has implemented an effective Compliance Program to meet the obligations of the CIA, Federal health care program requirements, FDA requirements, and the obligations professionally recognized standards of the CIAcare.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKSpring Gate. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Spring Gate shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Xxxxxxxxxx Regional (Board) shall be Xxxxxxxxxx Regional Medical Center Corporate Integrity Agreement responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. The Board must include independent (i.e., non-executive) members. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSK’s Xxxxxxxxxx Regional's Compliance Program, including but not limited to the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.Committee; and
b. For for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board summarizing its review and oversight of GSKXxxxxxxxxx Regional’s compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSKXxxxxxxxxx Regional’s Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIACompliance Committee. The Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Xxxxxxxxxx Regional has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, requirements and the obligations of the CIA.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKXxxxxxxxxx Regional. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Hutchinson Regional shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.. Xxxxxxxxxx Regional Medical Center Corporate Integrity Agreement
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Xxxxxxxx (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. The Board must include independent (i.e., non-executive) members. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSK’s Xxxxxxxx'x Compliance Program, including but not limited to the performance of the Compliance Officer and other compliance personnel. The Board shall evaluate the effectiveness of the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.Committee; and
b. For for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board summarizing its review and oversight of GSK’s Xxxxxxxx’x compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSK’s Xxxxxxxx’x Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIACompliance Committee. The Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Xxxxxxxx has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, requirements and the obligations of the CIA.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKXxxxxxxx. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Xxxxxxxx shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board (or a committee of the Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. The Board must include independent (i.e., non-executive) members. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSKMylan’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. submitting to OIG a description of the documents and other compliance personnel. The Board shall evaluate materials it reviewed, as well as any additional steps taken, such as the effectiveness engagement of an independent advisor or other third party resources, in its oversight of the Compliance Program, including, at a minimum, by receiving updates about Program and in support of making the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.resolution described below during each Reporting Period; and
b. For c. for each Reporting Period of the CIA, the Board shall adopt adopting a resolution, signed by each individual member of the Board, summarizing its review and oversight of GSKMylan’s compliance with Federal health care program requirements, FDA requirements, requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors (or a committee thereof) has made a reasonable inquiry into the operations operation of GSKMylan’s Compliance Program as applicable to during the CIA (including its Appendices) for the time preceding twelve-month period [insert time period], including the performance of the Compliance Officer and the compliance personnel who are Covered Persons under this CIACompliance Committee. The Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, GSK Mylan has implemented an effective Compliance Program to meet Federal health care program requirements, FDA requirements, requirements and the obligations of the CIACorporate Integrity Agreement.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program at GSKMylan. GlaxoSmithKline LLC Corporate Integrity Agreement GSK Mylan shall report to OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 1 contract
Board of Directors Compliance Obligations. The Board shall be responsible for the review and oversight of matters related to compliance with cGMP Activities, applicable Federal health care program requirements, applicable FDA requirements, and the obligations of this CIAAppendix. The Board shall, at a minimum, be responsible for the following:
a. The Board shall meet meeting at least quarterly to review and oversee GSKGMS’s Compliance Program, including but not limited to the performance of the GMS Compliance Officer and other GMS compliance personnel. The Board shall evaluate the effectiveness of the Compliance Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and other compliance personnel and updates about adoption and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with applicable Federal health care program and FDA requirements.;
b. For for each Reporting Period of the CIAthis Appendix, the Board shall adopt adopting a resolution, signed by each individual member of the Board, Board summarizing its review and oversight of GSKGMS’s compliance with cGMP Activities, applicable Federal health care program requirements, applicable FDA requirements, and the obligations of this CIAAppendix. At minimum, the resolution shall include the following language: “The Board of Directors has made a reasonable inquiry into the operations of GSK’s the GMS Compliance Program as applicable to the CIA (including its Appendices) for the time period [insert time period], including the performance of the GMS Compliance Officer and the compliance personnel who are Covered Persons under this CIAOfficer. The Board has concluded that, to the best of its knowledge, GSK has implemented an effective Compliance Program Program, including a program that is effective to meet applicable Federal health care program requirements, applicable FDA requirements, and the obligations of this Appendix D to the CIA.” If the Board is unable to provide such a conclusion in the resolution, the Board shall include in the resolution a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective GMS Compliance Program at GSKProgram. GlaxoSmithKline LLC Corporate Integrity Agreement GSK shall report to the OIG, in writing, any changes in the composition of the Board, or any actions or changes that would affect the Board's ’s ability to perform the duties necessary to meet the obligations in this CIAAppendix, within 15 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement