Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following: a. meeting at least quarterly to review and oversee Ensign Group's Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee; b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and Federal health care program requirements; and c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign Group’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign Group’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the 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 Ensign Group. Ensign Group shall report to OIG, in writing, any changes in the composition of the Board and any such designated committee, 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 2 contracts
Samples: Corporate Integrity Agreement (Ensign Group, Inc), Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group KDMC (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's KDMC’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts reviewing the Peer Review Consultant’s Systems Review Report and implements policiesMonitoring Reports on the effectiveness of KDMC’s peer review, procedurescredentialing, and privileging practices designed to ensure compliance with for each Reporting Period of the requirements set forth CIA;
c. for the first, third, and fifth Reporting Periods, considering the results of the Compliance Program Reviews (as described in Section III.A.4.a.v of this CIA and Federal health care program requirementsCIA); and
c. d. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupKDMC’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupKDMC’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group KDMC has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupKDMC. Ensign Group KDMC shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Audit Committee of the Board of Directors UHS (or a committee Audit Committee of the Board) of Ensign Group (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 requirements, and the obligations professionally recognized standards of this CIAcare. The Audit Committee of the Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on Audit Committee of the Board and any such designated committee shall be readily available to the Compliance Officer and the Monitor required under Section III.D of this CIA to respond to any issues or questionsquestions that might arise. The Audit Committee of the Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramUHS’s compliance program, including including, but not limited to to, the performance of the Compliance Officer, the Behavioral Health Division Compliance Officer and the Compliance Committee;
b. reviewing the adequacy of UHS’s system of internal controls and quality assurance monitoring;
c. ensuring that Ensign Group UHS’s response to state, federal, internal, and external reports of quality of care problems is complete, thorough, and resolves the problem(s) identified;
d. ensuring that UHS adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and CIA, Federal health care program requirements, and professionally recognized standards of care;
e. reviewing and responding to the data analysis presented on the Dashboard and ensuring that UHS implements effective responses when the data indicates potential quality problems or that UHS is not meeting its established goals; and
c. f. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupUHS’s compliance with Federal health care program requirements and the obligations of this CIA, Federal health care program requirements, and professionally recognized standards of care. At a minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupUHS’s Compliance Program Program, including the performance of the Compliance Officer, Behavioral Health Division Compliance Officer and the Compliance 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, Ensign Group UHS has implemented an effective Compliance Program to meet the obligations of the CIA, Federal health care program requirements requirements, and the obligations professionally recognized standards of the Corporate Integrity Agreementcare.” 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 Ensign GroupUHS. Ensign Group UHS shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 2 contracts
Samples: Corporate Integrity Agreement (Universal Health Services Inc), Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group Dignity Health (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated (or a committee of the Board) must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committeea committee of the Board) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Dignity Health’s Compliance Program, including but not limited to the performance of the Corporate Compliance Officer and Compliance Oversight Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board (or a committee of the Board) summarizing its review and oversight of Ensign GroupDignity Health’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with Directors (or name of applicable committee of the assistance of its designated compliance committee, Board) has made a reasonable inquiry into the operations of Ensign GroupDignity Health’s Compliance Oversight Program including the performance of the Corporate Compliance Officer and the Compliance Oversight Committee. Based on its inquiry and review, the Board (or a committee of the Board) has concluded that, to the best of its knowledge, Ensign Group Dignity Health has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” If the Board (or a committee of the Board) is unable to provide such a conclusion in the resolution, the Board (or a committee of 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 Ensign GroupDignity Health. Ensign Group Dignity Health shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group Friendship Entities (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-non- executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance Programthe Friendship Entities’ compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign Group’s the Friendship Entities’ compliance with Federal health care program requirements and the obligations of this CIA; and
d. for each Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of the Friendship Entities’ Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to the Friendship Entities’ compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of the Friendship Entities’ compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by the Friendship Entities. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign Group’s the Friendship Entities’ Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group has the Friendship Entities have implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign Groupthe Friendship Entities. Ensign Group The Friendship Entities shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group Rehab (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Rehab’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupRehab’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupRehab’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Rehab has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupRehab. Ensign Group Rehab shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors of AstraZeneca PLC (Board), or a committee Committee of the Board) of Ensign Group (Board) , shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e.Board, non-executive) members. The individuals who serve on or a Committee of the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) Board, shall, at a minimum, be responsible for the following:
a. meeting The Board, or a Committee of the Board, shall meet at least quarterly to review and oversee Ensign Group's AstraZeneca’s U.S. Compliance Program, including but not limited to evaluating its effectiveness and receiving updates about the performance activities of the U.S. Compliance Officer and Compliance Committee;other compliance personnel.
b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and Federal health care program requirements; and
c. for For each Reporting Period Period, the Board, or a Committee of the CIABoard, adopting shall adopt a resolution, and the resolution or a statement of concurrence with the resolution shall be signed by each individual member of the Board or the Committee, summarizing its review and oversight of Ensign Groupmatters relating to AstraZeneca’s compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with Directors [or a Committee of the assistance of its designated compliance committee, Board] has made a reasonable inquiry into the operations of Ensign GroupAstraZeneca LP and AstraZeneca Pharmaceuticals LP’s Compliance Program for the Corporate Integrity Agreement AstraZeneca period , including but not limited to evaluating its effectiveness and receiving updates about the performance activities of the its U.S. Compliance Officer and the Compliance Committeeother compliance personnel. Based on its inquiry and reviewinquiry, the Board [or the Committee] has concluded that, to the best of its knowledge, Ensign Group has AstraZeneca LP and AstraZeneca Pharmaceuticals LP have implemented an effective U.S. Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity Agreement.” If the Board Board, or the Committee of the Board, is unable to provide such a conclusion in the resolution, the Board or the Committee 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 assure implementation by AstraZeneca of an effective U.S. Compliance Program at Ensign GroupAstraZeneca. Ensign Group AstraZeneca shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeor the Committee of the Board, or any actions or changes that would affect the Board's or the Committee’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Board of Directors Compliance Obligations. The A Committee of the Board of Directors (or a committee of the Board) of Ensign Group (BoardCommittee) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) Committee shall, at a minimum, be responsible for the following:
a. meeting The Committee shall meet at least quarterly to review and oversee Ensign Group's Lilly’s Compliance Program, including but not limited to evaluating its effectiveness and receiving updates about the activities of the Chief Compliance Officer and other compliance personnel.
b. The Committee shall consist of at least three members, all of whom shall be independent directors. The Chief Compliance Officer is required to make at least four reports a year to the Committee or more often, if requested by the Committee or the Chief Compliance Officer.
c. The Committee shall arrange for the performance of a review on the effectiveness of Lilly’s Compliance Program (Compliance Program Review) for each Reporting Period of the CIA and shall review the results of the Compliance Officer Program Review as part of the review and assessment of Lilly’s Compliance Committee;Program. A copy of the Compliance Program Review Report shall be provided to OIG in each Annual Report submitted by Lilly. Corporate Integrity Agreement Xxx Xxxxx Company
b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and Federal health care program requirements; and
c. for d. For each Reporting Period of the CIA, adopting the Committee shall adopt a resolution, signed by each individual member of the Board Committee, summarizing its review and oversight of Ensign GroupLilly’s compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The [insert name of Committee] Committee of the Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupLilly’s Compliance Program Program, including but not limited to evaluating its effectiveness and receiving updates about the performance activities of the its Chief Compliance Officer and other compliance personnel. The Board also has arranged for the performance of, and reviewed the result of, the Compliance CommitteeProgram Review. Based on its inquiry and reviewinquiry, the Board Committee has concluded that, to the best of its knowledge, Ensign Group Lilly has implemented an effective Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity AgreementCIA.” If the Board Committee is unable to provide such a conclusion in the resolution, the Board Committee 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 assure implementation by Lilly of an effective Compliance Program at Ensign GroupLilly. Ensign Group Lilly shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeCommittee, or any actions or changes that would affect the BoardCommittee’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change. The Board of Directors may by resolution reserve to itself the powers and responsibilities assigned to the Committee under this CIA. In that event, all references in this CIA to the Committee shall be deemed to be references to the Board of Directors.
Appears in 1 contract
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group 21st Century (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance Program21st Century’s compliance program, including but not limited to the performance of the Chief Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign Group21st Century’s compliance with Federal health care program requirements and the obligations of this CIA.
d. for the first Reporting Period of the CIA, the Board shall continue to retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of 21st Century’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to 21st Century’s compliance program. During the first Reporting Period, the Board shall review the Compliance Program Review Report as part of its review and oversight of 21st Century’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in the first Annual Report submitted by 21st Century. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign Group21st Century’s Compliance Program including the performance of the Chief Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group 21st Century has implemented and maintained an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign Group21st Century. Ensign Group 21st Century shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 (21st Century Oncology Holdings, Inc.)
Board of Directors Compliance Obligations. The Board CRCC of Directors (or a committee of the Board) of Ensign Group (Board) Amgen shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee CRCC must include independent (i.e., non-executive) members. members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) CRCC shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Xxxxx’s Compliance Program, including but not limited to the performance of the Chief Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board CRCC, summarizing its review and oversight of Ensign GroupAmgen’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Corporate Responsibility and Compliance Committee (CRCC) has made a reasonable inquiry into the operations of Ensign GroupXxxxx’s Compliance Program including the performance of the Chief Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board CRCC has concluded that, to the best of its knowledge, Ensign Group Amgen has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” If the Board CRCC is unable to provide such a conclusion in the resolution, the Board CRCC 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 Ensign GroupAmgen. Ensign Group Amgen shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeCRCC, or any actions or changes that would affect the BoardCRCC’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 Regulatory and Compliance Committee of the Pfizer Board of Directors (or a committee of the Board) of Ensign Group (BoardRCC) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee RCC must include independent (i.e., non-executive) members. members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) RCC shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Pfizer’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each individual member of the Board RCC, summarizing its review and oversight of Ensign GroupPfizer’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Regulatory and Compliance Committee of the Pfizer Board of Directors, with the assistance of its designated compliance committee, Directors (RCC) has made a reasonable inquiry into the operations of Ensign GroupPfizer’s Compliance Program during the preceding twelve-month period including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board RCC has concluded that, to the best of its knowledge, Ensign Group Pfizer has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” If the Board RCC is unable to provide such a conclusion in the resolution, the Board RCC 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 Ensign GroupPfizer. Ensign Group Pfizer shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeRCC, or any actions or changes that would affect the BoardRCC’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 Ensign Group PGS (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramPGS’ compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign Group’s PGS’ compliance with Federal health care program requirements and the obligations of this CIA.
d. for each Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of PGS’ Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to PGS’ compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of PGS’ compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by PGS. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to OIG upon request.] At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign Group’s PGS’ Compliance Program Program, including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group PGS has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupPGS. Ensign Group PGS shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group PCMC (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramPCMC’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupPCMC’s compliance with Federal health care program requirements and the obligations of this CIA.
d. for each Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of PCMC’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to PCMC’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of PCMC’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by PCMC. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupPCMC’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group PCMC has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign Group. Ensign Group PCMC. PCMC shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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.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 Ensign Group Good Shepherd (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramGood Shepherd’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupGood Shepherd’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupGood Shepherd Hospice, Mid America, Inc.’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Good Shepherd Hospice, Mid America, Inc. has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupGood Shepherd. Ensign Group Good Shepherd shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Aegerion’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the Compliance Program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each individual member of the Board Board, summarizing its review and oversight of Ensign GroupAegerion’s compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupAegerion’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Aegerion has implemented an effective Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the 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 Ensign GroupAegerion. Ensign Group Aegerion shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 (Novelion Therapeutics Inc.)
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group (Board) Compliance Committee shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include Compliance Committee is currently comprised solely of independent (i.e., non-executive) members. The individuals who serve on members and shall continue to be comprised solely of independent members for the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questionsCIA Period. The Board (or Compliance Committee has now and shall maintain for the CIA Period the ability to retain, at its designated committee) sole discretion, outside compliance counsel. The Board Compliance Committee shall, at a minimum, be responsible for the following:
a. meeting The Board Compliance Committee shall meet at least quarterly to review and oversee Ensign Group's DaVita Dialysis’s DaVita HealthCare Partners Inc. Corporate Integrity Agreement Compliance Program, including including, but not limited to to, the performance of the Chief Compliance Officer and Officer, Management Compliance Committee;, and the Compliance Department.
b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance The Board Compliance Committee shall meet at least quarterly in executive session with the requirements Chief Compliance Officer.
c. The Board Compliance Committee shall, within 90 days of the second anniversary of the Effective Date, retain a person or entity who meets the qualifications set forth in this CIA Appendix A as its Compliance Advisor. Beginning with the third Reporting Period of the CIA, the Compliance Advisor shall review the effectiveness of DaVita Dialysis’s Compliance Program and Federal health care program requirements; andRisk Assessment and Mitigation Process for DaVita Dialysis (Compliance Program Review) and provide the Board with a Compliance Program Review Report for the remaining Reporting Periods of the CIA. The Board shall consider the Compliance Program Review Report as part of its review and assessment of DaVita Dialysis’s Compliance Program.
c. d. The Board Compliance Committee shall, for each Reporting Period of the CIA, adopting adopt a resolution, signed by each member of the Board Compliance Committee summarizing its review and oversight of Ensign GroupDaVita Dialysis’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Compliance Committee of the Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupDaVita Dialysis’s Compliance Program including the performance of the Chief Compliance Officer and the Management Compliance Committee. Based on its inquiry and review, the Board Compliance Committee has concluded that, to the best of its knowledge, Ensign Group DaVita Dialysis has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” If the Board Compliance Committee is unable to provide such a conclusion in the resolution, the Board Compliance Committee 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 Ensign GroupDaVita Dialysis. Ensign Group DaVita HealthCare Partners Inc. Corporate Integrity Agreement DaVita shall report to OIG, in writing, any changes in the composition or leadership of the Board and any such designated committeeCompliance Committee, or any actions or changes that would affect the BoardBoard Compliance Committee’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 (Davita Healthcare Partners Inc.)
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group ION (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include at least two independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramION’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupION’s compliance with Federal health care program requirements and the obligations of this CIA; and
d. in Reporting Periods one, three, and five of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of ION’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to ION’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of ION’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by XXX. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to OIG upon request. At minimum, the resolution required by Section III.A.4.c shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupXXX’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group ION has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupION. Ensign Group XXX shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group Envision’s parent company – Envision Healthcare Inc. (Board) - shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramEnvision’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupEnvision’s compliance with Federal health care program requirements and the obligations of this CIA; and
d. for the first, third and fourth Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of Envision’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Envision’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Envision Corporate Integrity Agreement 5 Envision’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by Envision. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupEnvision’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Envision has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupEnvision. Ensign Group Envision shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 (Envision Healthcare Corp)
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group CareMed (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services requirements and the obligations of this CIA. The Board and any such designated committee must may include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's CareMed’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG in Annual Reports a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupCareMed’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupCareMed’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group CareMed has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupCareMed. Ensign Group CareMed shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, or any actions actions, or changes that would affect the Board’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 business days after such a change.. Corporate Integrity Agreement between the Office of Inspector General and Sorkin’s Rx Ltd. d/b/a CareMed Pharmaceutical Services
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Board of Directors (or a committee or subcommittee of the Board) of Ensign Group EHS (Board) shall be responsible for the review and oversight of matters related to Endo’s compliance with Federal health care program and FDA requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:: Endo Pharmaceuticals Inc. Corporate Integrity Agreement
a. meeting at least quarterly to review receive reports from the Compliance Officer regarding Xxxx’s Compliance Program;
b. reviewing and oversee Ensign Groupoverseeing Xxxx's Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts c. evaluating the effectiveness of the Compliance Program, including at a minimum, by receiving updates about the activities of the Compliance Officer and implements other compliance personnel and updates about the 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 requirements, and FDA requirements; and
c. d. for each Reporting Period of the CIA, adopting a resolutionresolution (for which the Board may rely on (without diminishing their obligations under law to provide adequate oversight) independent outside experts engaged to assist the Board with a review of the Compliance Program), signed by each member of the Board summarizing its review and oversight of Ensign GroupEndo’s and EPI’s compliance with Federal health care program requirements and FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with Directors [or a Committee or subcommittee of the assistance of its designated compliance committee, Board] has made a reasonable inquiry into the operations of Ensign GroupXxxx’s Compliance Program for [insert a description of the time period reviewed] including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board [or Committee or subcommittee] has concluded that, to the best of its knowledge, Ensign Group Endo has implemented an effective Compliance Program to meet Federal health care program and FDA requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Endo Pharmaceuticals Inc. Corporate Integrity Agreement Program at Ensign GroupEndo. Ensign Group EPI shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group LCCA (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include an independent (i.e., non-executive) members. The individuals member who serve on must be named within 120 days of the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:Effective Date.
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramLCCA’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG pursuant to Section V.B a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupLCCA’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, ; and
d. for the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign Group’s Compliance Program including the performance first and third Reporting Periods of the Compliance Officer and the Compliance Committee. Based on its inquiry and reviewCIA, the Board has concluded that, to the best of its knowledge, Ensign Group has implemented shall retain an effective Compliance Program to meet individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of LCCA’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to LCCA’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of LCCA’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by LCCA. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the obligations of the Corporate Integrity AgreementBoard, shall be made available to OIG upon request.” 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 Ensign Group. Ensign Group shall report to OIG, in writing, any changes in the composition of the Board and any such designated committee, 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 Ensign Group Health Quest (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramHealth Quest’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupHealth Quest’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupHealth Quest’s Compliance Program Program, including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Health Quest has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupHealth Quest. Ensign Group Health Quest shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 A Committee of the Board of Directors (or a committee of the Board) of Ensign Group (BoardCommittee) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) Committee shall, at a minimum, be responsible for the following:
a. meeting The Committee shall meet at least quarterly to review and oversee Ensign Group's AtriCure, Inc.’s Compliance Program, including but not limited to evaluating its effectiveness and receiving updates about the performance activities of the Compliance Officer and Compliance Committee;other compliance personnel.
b. ensuring that Ensign Group adopts and implements policiesThe Committee shall consist of at least three members, proceduresat least one of whom shall be an independent director. The Compliance Officer is required to make at least four reports a year to the Committee or more often, and practices designed to ensure compliance with if requested by the requirements set forth in this Committee or the Compliance Officer.
c. The Committee shall arrange for the performance of a review on the effectiveness of AtriCure, Inc.’s Compliance Program (Compliance Program Review) for each Reporting Period of the CIA and Federal health care program requirements; andshall review the results of the Compliance Program Review as part of the review and assessment of AtriCure, Inc.’s Compliance Program. A copy of the Compliance Program Review Report shall be provided to OIG in each Annual Report submitted by AtriCure, Inc.
c. for d. For each Reporting Period of the CIA, adopting the Committee shall adopt a resolution, signed by each individual member of the Board Committee, summarizing its review and oversight of Ensign GroupAtriCure, Inc.’s compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. “The [insert name of Committee] Committee of the Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupAtriCure, Inc.’s Compliance Program Program, including but not limited to evaluating its effectiveness and receiving updates about the performance activities of the its Compliance Officer and other compliance personnel. The Board also has arranged for the performance of, and reviewed the results of, the Compliance CommitteeProgram Review. Based on its inquiry and reviewinquiry, the Board Committee has concluded that, to the best of its knowledge, Ensign Group AtriCure, Inc. has implemented an effective Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity AgreementCIA.” If the Board Committee is unable to provide such a conclusion in the resolution, the Board Committee 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 assure implementation by AtriCure, Inc. of an effective Compliance Program at Ensign GroupProgram. Ensign Group AtriCure, Inc. shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeCommittee, or any actions or changes that would affect the BoardCommittee’s ability to perform the duties necessary to meet the obligations in this CIA, within 15 days after such a change. The Board of Directors may by resolution reserve to itself the powers and responsibilities assigned to the Committee under this CIA. In that event, all references in this CIA to the Committee shall be deemed to be references to the Board of Directors.
Appears in 1 contract
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group Sava LLC (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 requirements, and the obligations professionally recognized standards of this CIAcare. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer and the Monitor required under Section III.D of this CIA to respond to any issues or questionsquestions that might arise. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramSava’s compliance program, including including, but not limited to to, the performance of the Compliance Officer and the Compliance Committee;
b. ensuring that Ensign Group reviewing the adequacy of Sava’s system of internal controls, quality assurance monitoring, and resident care;
c. reviewing the adequacy of Sava’s response to state, federal, internal, and external reports of quality of care problems;
d. determining whether Sava adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and CIA, Federal health care program requirements, and professionally recognized standards of care;
e. reviewing and responding to the data analysis presented on the Dashboard and determining whether Sava implements effective responses when the data indicates potential quality problems or that Sava is not meeting its established goals; and
c. f. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupSava’s compliance with Federal health care program requirements and the obligations of this CIA, Federal health care program requirements, and professionally recognized standards of care. The above described Board responsibilities are not intended to suggest that the Board is responsible for the day-to-day operations of Sava or the Sava Facilities. At a minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupSava’s Compliance Program Program, including the performance of the Compliance Officer and the Compliance 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, Ensign Group Sava has implemented an effective Compliance Program to meet the obligations of the CIA, Federal health care program requirements requirements, and the obligations professionally recognized standards of the Corporate Integrity Agreementcare.” 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 Ensign GroupSava. Ensign Group Sava shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group Envision’s parent company – Envision Healthcare Inc. (Board) - shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. members. The Board (or its designated committee) shall, at a minimum, be responsible for the following:: Envision Corporate Integrity Agreement
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramEnvision’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupEnvision’s compliance with Federal health care program requirements and the obligations of this CIA; and
d. for the first, third and fourth Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of Envision’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Envision’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Envision’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by Envision. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: Envision Corporate Integrity Agreement “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupEnvision’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Envision has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupEnvision. Ensign Group Envision shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group CVS Health (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on CVS Health’s Board of Directors currently has, and shall maintain during the term of the CIA, an Audit Committee (“Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questionsCommittee”). The Board (or its designated committee) Committee shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's CVS Health’s Compliance Program, including but not limited to the performance of the Chief Compliance Officer, the Compliance Officer for IPS Operations, and the Compliance Committee;
b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and Federal health care program requirements; and
c. b. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board Committee summarizing its review and oversight of Ensign GroupCVS Health’s compliance with Federal health care program requirements and the obligations of this CIA. For the duration of the CVS Caremark CIA the Board Committee may adopt a single resolution summarizing its review and oversight as required by both the CVS Caremark CIA and this CIA. Each individual member of the Board Committee shall sign a statement indicating that he/she agrees with the resolution. At minimum, the resolution shall include the following language: “The Board Committee of Directors, with the assistance Board of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupCVS Health’s Compliance Program for IPS Operations including the performance of the Chief Compliance Officer, the Compliance Officer for IPS Operations, and the Compliance Committee. Based on its inquiry and review, the Board Committee has concluded that, to the best of its knowledge, Ensign Group CVS Health has implemented an effective Compliance Program to meet for IPS Operations and CVS Health’s IPS Operations are in compliance with the Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” In support of making the resolution above during each Reporting Period, the Board Committee shall submit to the OIG a description of the documents and other materials it reviewed, as well as any additional steps taken, such as the engagement of third party resources, in its oversight of CVS Health’s compliance with the Federal health care program requirements and the obligations of this CIA. If the Board Committee is unable to provide such a conclusion in the resolution, the Board Committee 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 ensure that CVS Health implements an effective Compliance Program at Ensign GroupProgram. Ensign Group CVS Health shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeCommittee, 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 Ensign Group Signature Healthcare, LLC (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:program
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramSignature’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupSignature’s compliance with Federal health care program requirements and the obligations of this CIA; and
d. for the first and third Reporting Periods of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of Signature’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Signature’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Signature’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by Signature. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupSignature’s Compliance Program Program, including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Signature has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity Agreement.” 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 Ensign GroupSignature. Ensign Group Signature shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 of Forest Laboratories, Inc. (Board), or a committee Committee of the Board) of Ensign Group (Board) , shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e.Board, non-executive) members. The individuals who serve on or a Committee of the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) Board, shall, at a minimum, be responsible for the following:
a. meeting The Board, or a Committee of the Board, shall meet at least quarterly to review and oversee Ensign GroupForest's Compliance Program, including but not limited to the performance of the Compliance Officer and other Compliance Committee;personnel.
b. ensuring that Ensign Group adopts and implements policiesThe Board, proceduresor a Committee of the Board, and practices designed to ensure compliance with shall arrange for the requirements set forth in this CIA and Federal health care program requirements; and
c. performance of a review of the effectiveness of Forest's Compliance Program (Compliance Program Review) by the Compliance Expert (described below) for each Reporting Period of the CIA. The Board, adopting or a Committee of the Board, shall review the Compliance Program Review Report (described below) as part of its review and assessment of Forest's Compliance Program. A copy of the Compliance Program Review Report shall be provided to OIG in each Annual Report submitted by Forest.
c. The Board, or a Committee of the Board, shall retain an independent individual or entity with expertise in compliance with Federal health care program and FDA requirements (Compliance Expert). The Compliance Expert shall create a work plan for the Compliance Program Review, oversee the performance of the Compliance Program Review, and prepare a written report about the Compliance Program Review and the results of the review. The written report (Compliance Program Review Report) shall include a description of the review and shall include recommendations with respect to the Compliance Program. This report shall also include a certification that the Compliance Expert has evaluated its professional independence and objectivity, as appropriate to the nature of the engagement with regard to the Compliance Program Review and concluded that it is, in fact, independent and objective. Corporate Integrity Agreement Forest Laboratories, Inc.
d. For each Reporting Period of the CIA, the Board, or a Committee of the Board, shall adopt a resolution, signed by each individual member of the Board or the Committee, summarizing its review and oversight of Ensign Group’s Forest's compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with Directors [or a Committee of the assistance of its designated compliance committee, Board] has made a reasonable inquiry into the operations of Ensign Group’s Forest's Compliance Program including Program, including, but not limited to, evaluating its effectiveness and receiving updates about the performance of the Compliance Officer and other Compliance personnel for the time period [insert time period]. In addition, the Board [or a Committee of the Board] has retained a Compliance Expert with expertise in compliance with the Federal health care program and FDA requirements to support the Board's responsibilities. The Board [or a Committee of the Board] also has arranged for the performance of, and reviewed the results of, the Compliance CommitteeProgram Review, including the Compliance Program Review Report. Based on its inquiry and reviewall of these steps, the Board [or a Committee of the Board] has concluded that, to the best of its knowledge, Ensign Group Forest has implemented an effective Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity AgreementCIA.” If the Board Board, or a Committee of the Board, is unable to provide such a conclusion in the resolution, the Board or the Committee 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 Ensign GroupForest. Ensign Group Forest shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeor the Committee of the Board described above, or any actions or changes that would affect the ability of the Board’s ability , or the Committee of the Board 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 BoardBoard that includes independent (i.e., non-executive) members) of Ensign Group PharMerica (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramPharMerica’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupPharMerica’s compliance with Federal health care program and Controlled Substances Act requirements and the obligations of this CIA; and
d. for the first and second Reporting Periods of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program and Controlled Substances Act requirements (Compliance Expert) to perform a review of PharMerica’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review, and any recommendations with respect to PharMerica’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of PharMerica’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in the Annual Reports for the first and second Reporting Periods submitted by PharMerica. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign GroupPharMerica’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group PharMerica has implemented an effective Compliance Program to meet Federal health care program and Controlled Substances Act requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupPharMerica. Ensign Group PharMerica shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Mallinckrodt (or a committee of the Board) of Ensign Group (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-employee and non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Mallinckrodt’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirements; andresolution below during each Reporting Period;
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board Board, summarizing its review and oversight of Ensign GroupMallinckrodt’s compliance with Federal health care program requirements and the obligations of this CIA; and
d. for the second and fourth Reporting Periods of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program and Food and Drug Administration (FDA) requirements (Compliance Expert) to perform a review of the effectiveness of Mallinckrodt’s Compliance Program (Compliance Program Review). The Compliance Expert shall prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Mallinckrodt’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Mallinckrodt’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each applicable Annual Report submitted by Mallinckrodt. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign GroupMallinckrodt’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Mallinckrodt has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the 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 Ensign GroupMallinckrodt. Ensign Group Mallinckrodt shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 business 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 Ensign Group Kindred (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramKindred’s compliance program for RehabCare, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupRehabCare’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupKindred’s Compliance Program for RehabCare including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Kindred has implemented an effective Compliance Program for RehabCare to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign Groupfor RehabCare. Ensign Group Kindred shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group Hebrew Homes (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramHebrew Homes’ compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to the OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign Group’s Hebrew Homes’ compliance with Federal health care program requirements and the obligations of this CIA.
d. for each Reporting Period of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of Hebrew Homes’ Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Hebrew Homes’ compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Hebrew Homes’ compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by Hebrew Homes. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to the OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign Group’s Hebrew Homes’ Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Hebrew Homes has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupHebrew Homes. Ensign Group Hebrew Homes shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Audit Committee of the Board) of Ensign Group (Board) Board shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Audit Committee of the Board and any such designated committee must include independent (i.e., non-executive) members. Walgreen Co. - Corporate Integrity Agreement The individuals who serve on Audit Committee of the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramWalgreens’ compliance program, including but not limited to the performance of the Compliance and Ethics Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the Walgreens compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Audit Committee of the Board summarizing its review and oversight of Ensign Group’s Walgreens’ compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Audit Committee of the Board of DirectorsDirectors of Walgreens Boots Alliance, with the assistance of its designated compliance committee, Inc. has made a reasonable inquiry into the operations of Ensign Group’s Walgreens’ Compliance Program Program, including the performance of the Compliance and Ethics Officer and the Compliance Committee. Based on its inquiry and review, the Audit Committee of the Board has concluded that, to the best of its knowledge, Ensign Group Walgreens has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” If the Audit Committee of the Board is unable to provide such a conclusion in the resolution, the Audit Committee of 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 Ensign GroupWalgreens. Ensign Group Walgreens shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeAudit Committee of the Board, or any actions or changes that would affect the Audit Walgreen Co. - Corporate Integrity Agreement Committee of 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 of Forest Laboratories, Inc. (Board), or a committee Committee of the Board) of Ensign Group (Board) , shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e.Board, non-executive) members. The individuals who serve on or a Committee of the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) Board, shall, at a minimum, be responsible for the following:
a. meeting The Board, or a Committee of the Board, shall meet at least quarterly to review and oversee Ensign Group's Forest’s Compliance Program, including but not limited to the performance of the Compliance Officer and other Compliance Committee;personnel.
b. ensuring that Ensign Group adopts and implements policiesThe Board, proceduresor a Committee of the Board, and practices designed to ensure compliance with shall arrange for the requirements set forth in this CIA and Federal health care program requirements; and
c. performance of a review of the effectiveness of Forest’s Compliance Program (Compliance Program Review) by the Compliance Expert (described below) for each Reporting Period of the CIA. The Board, adopting or a Committee of the Board, shall review the Compliance Program Review Report (described below) as part of its review and assessment of Forest’s Compliance Program. A copy of the Compliance Program Review Report shall be provided to OIG in each Annual Report submitted by Forest.
c. The Board, or a Committee of the Board, shall retain an independent individual or entity with expertise in compliance with Federal health care program and FDA requirements (Compliance Expert). The Compliance Expert shall create a work plan for the Compliance Program Review, oversee the performance of the Compliance Program Review, and prepare a written report about the Compliance Program Review and the results of the review. The written report (Compliance Program Review Report) shall include a description of the review and shall include recommendations with respect to the Compliance Program. This report shall also include a certification that the Compliance Expert has evaluated its professional independence and objectivity, as appropriate to the nature of the engagement with regard to the Compliance Program Review and concluded that it is, in fact, independent and objective.
d. For each Reporting Period of the CIA, the Board, or a Committee of the Board, shall adopt a resolution, signed by each individual member of the Board or the Committee, summarizing its review and oversight of Ensign GroupForest’s compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with Directors [or a Committee of the assistance of its designated compliance committee, Board] has made a reasonable inquiry into the operations of Ensign GroupForest’s Compliance Program including Program, including, but not limited to, evaluating its effectiveness and receiving updates about the performance of the Compliance Officer and other Compliance personnel for the time period [insert time period]. In addition, the Board [or a Committee of the Board] has retained a Compliance Expert with expertise in compliance with the Federal health care program and FDA requirements to support the Board’s responsibilities. The Board [or a Committee of the Board] also has arranged for the performance of, and reviewed the results of, the Compliance CommitteeProgram Review, including the Compliance Program Review Report. Based on its inquiry and reviewall of these steps, the Board [or a Committee of the Board] has concluded that, to the best of its knowledge, Ensign Group Forest has implemented an effective Compliance Program to meet Federal health care program requirements requirements, FDA requirements, and the obligations of the Corporate Integrity AgreementCIA.” If the Board Board, or a Committee of the Board, is unable to provide such a conclusion in the resolution, the Board or the Committee 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 Ensign GroupForest. Ensign Group Forest shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeor the Committee of the Board described above, or any actions or changes that would affect the ability of the Board’s ability , or the Committee of the Board 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 (Forest Laboratories Inc)
Board of Directors Compliance Obligations. The Board of Directors (or a committee of the Board) of Ensign Group Memorial Health (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramMemorial Health’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, procedures, as well as any additional steps taken in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; and
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupMemorial Health’s compliance with Federal health care program requirements and the obligations of this CIA.
d. for the First, Third, and Fifth Reporting Periods of the CIA, the Board shall retain an individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of Memorial Health’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to Memorial Health’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of Memorial Health’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by Memorial Health. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the Board, shall be made available to OIG upon request. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, Directors has made a reasonable inquiry into the operations of Ensign GroupMemorial Health’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group Memorial Health has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the Corporate Integrity AgreementCIA.” 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 Ensign GroupMemorial Health. Ensign Group Memorial Health shall report to OIG, in writing, any changes in the composition of the Board and any such designated committeeBoard, 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 Ensign Group NAHC (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:members.
a. meeting at least quarterly to review and oversee Ensign Group's Compliance ProgramNAHC’s compliance program, including but not limited to the performance of the Compliance Officer and Compliance Committee;Committee;
b. ensuring that Ensign Group adopts submitting to OIG a description of the documents and implements policiesother materials it reviewed, proceduresas well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and practices designed to ensure compliance with in support of making the requirements set forth in this CIA and Federal health care program requirementsresolution below during each Reporting Period; andand
c. for each Reporting Period of the CIA, adopting a resolution, signed by each member of the Board summarizing its review and oversight of Ensign GroupNAHC’s compliance with Federal health care program requirements and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign Group’s Compliance Program including the performance CIA.
d. for each Reporting Period of the Compliance Officer and the Compliance Committee. Based on its inquiry and reviewCIA, the Board has concluded that, to the best of its knowledge, Ensign Group has implemented shall retain an effective Compliance Program to meet individual or entity with expertise in compliance with Federal health care program requirements (Compliance Expert) to perform a review of the effectiveness of NAHC’s Compliance Program (Compliance Program Review). The Compliance Expert shall create a work plan for the Compliance Program Review and prepare a written report about the Compliance Program Review. The written report (Compliance Program Review Report) shall include a description of the Compliance Program Review and any recommendations with respect to NAHC’s compliance program. The Board shall review the Compliance Program Review Report as part of its review and oversight of NAHC’s compliance program. A copy of the Compliance Program Review report shall be provided to OIG in each Annual Report submitted by NAHC. In addition, copies of any materials provided to the Board by the Compliance Expert, along with minutes of any meetings between the Compliance Expert and the obligations of the Corporate Integrity Agreement.” If the Board is unable Board, shall be made available 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 Ensign Group. Ensign Group shall report to OIG, in writing, any changes in the composition of the Board and any such designated committee, 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.OIG upon request.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Board of Directors Compliance Obligations. The Novartis Board of Directors (or a committee of the Board) of Ensign Group (Board) shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. The Board and any such designated committee must include independent (i.e., non-executive) members. The individuals who serve on the Board and any such designated committee shall be readily available to the Compliance Officer to respond to any issues or questions. The Board (or its designated committee) shall, at a minimum, be responsible for the following:
a. meeting The Board shall meet at least quarterly to review and oversee Ensign Group's Novartis' Compliance Program, including but not limited to the performance of the Chief Compliance Officer and Compliance Committee;other compliance personnel.
b. ensuring that Ensign Group adopts and implements policies, procedures, and practices designed to ensure compliance with The Board shall arrange for the requirements set forth in this CIA and Federal health care program requirements; and
c. performance of a review of the effectiveness of Novartis' Compliance Program (Compliance Program Review) by a Compliance Expert (described below) for each Reporting Period of the CIA. The Board shall review the Compliance Program Review Report (described below) as part of its review and assessment of Novartis’ Compliance Program. A copy of the Compliance Program Review Report shall be provided to OIG in each Annual Report submitted by Novartis.
c. The Board shall retain an independent individual or entity with expertise in compliance with Federal health care program and FDA requirements (Compliance Expert). The Compliance Expert shall create a work plan for the Compliance Program Review, adopting oversee the performance of the Compliance Program Review, and prepare a written report about the Compliance Program Review and the results of the review. The written report (Compliance Program Review Report) shall include a description of the review and shall include recommendations with respect to the Compliance Program. This report shall also include a certification that the Compliance Expert has evaluated its professional independence and objectivity, as appropriate to the nature of the engagement with regard to the Compliance Program Review and concluded that it is, in fact, independent and objective.
d. For each Reporting Period of the CIA, the Board shall adopt a resolution, signed by each individual member of the Board Board, summarizing its review and oversight of Ensign Group’s Novartis’ compliance with Federal health care program requirements requirements, FDA requirements, and the obligations of this CIA. At minimum, the resolution shall include the following language: “The Board of Directors, with the assistance of its designated compliance committee, has made a reasonable inquiry into the operations of Ensign Group’s Compliance Program including the performance of the Compliance Officer and the Compliance Committee. Based on its inquiry and review, the Board has concluded that, to the best of its knowledge, Ensign Group has implemented an effective Compliance Program to meet Federal health care program requirements and the obligations of the 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 Ensign Group. Ensign Group shall report to OIG, in writing, any changes in the composition of the Board and any such designated committee, 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