Disclosure Program. Prior to the Effective Date, Orthofix established a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with Orthofix’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas). The Disclosure Program shall emphasize a non-retribution, non-retaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) shall maintain a disclosure log, which shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Orthofix International N V)
Disclosure Program. Prior to the Effective Date, Orthofix Dignity Health has established a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, disclose to the Chief Corporate Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixDignity Health’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix Dignity Health shall continue to maintain this Disclosure Program for the duration of the CIA. Dignity Health shall continue to publicize appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas). The Disclosure Program shall continue to emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Corporate Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Corporate Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix Dignity Health shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Corporate Compliance Officer (or designee) shall maintain a disclosure log, which log and shall record each disclosure in the disclosure log within 48 hours of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Disclosure Program. Prior to the BIPI Effective Date, Orthofix BIPI established a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-the toll free compliance telephone lineEthics and Compliance Helpline) to enable individuals to disclose, to the Chief Compliance Officer CECO or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixBIPI’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix BIPI shall maintain such a Disclosure Program throughout the term of the CIA. BIPI publicizes, and shall continue to appropriately publicize publicize, the existence of the disclosure mechanism Disclosure Program and the Ethics and Compliance Helpline (e.g., via periodic e-mails to employees or employees, by posting the information in prominent common areas). , or through references in the Code of Conduct and during training.) The Disclosure Program shall emphasize a non-retributionnonretribution, non-retaliation policy, policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer CECO (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer CECO (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained obtains all of the necessary information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix BIPI shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) BIPI shall maintain maintain, a disclosure log, which shall include includes a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon request.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Disclosure Program. Prior to the Effective Date, Orthofix InterMune established a disclosure program designed to facilitate communications relating to compliance with Federal health care program and FDA requirements and with InterMune’s policies (Disclosure Program). To During the extent not already provided for in Orthofix’s term of this CIA, InterMune shall continue to maintain a Disclosure Program, it shall include Program that includes a mechanism (e.g., a the toll-free compliance telephone lineCode of Conduct Ethics Helpline) to to’ enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixInterMune’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix InterMune shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas). The Disclosure Program shall continue to emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall continue to include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix InterMune shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) shall continue to maintain a disclosure log, which shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. The disclosure log shall be made available to OIG upon request.
Appears in 1 contract
Disclosure Program. Prior to the Effective DateDate of this CIA, Orthofix CVS established a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixCVS’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix CVS shall continue to appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees employees, posting on CVS’s intranet or other internal website available to all Covered Persons, or by posting the information in prominent common areas). The Disclosure Program shall continue to emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall continue to include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix CVS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) shall maintain a disclosure log, which shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. The disclosure log shall be made available to OIG upon request.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Disclosure Program. Prior to Within 90 days after the Effective Date, Orthofix established PharMerica shall establish a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixPharMerica’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix PharMerica shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees Covered Persons, through a posting on PharMerica's intranet or other internal website available to all Covered Persons or by posting the information in prominent common areas). The Disclosure Program shall emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: :
(1) permits a determination of the appropriateness of the alleged improper practice; and and
(2) provides an opportunity for taking corrective action, Orthofix PharMerica shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-follow- up is conducted. The Chief Compliance Officer (or designee) shall maintain a disclosure log, which log and shall record each disclosure in the disclosure log within 48 hours of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Disclosure Program. Prior to the Effective Date, Orthofix established a Disclosure Program. To the extent not already provided for in Orthofix’s accomplished, within 120 days after the Effective Date, Endo shall establish a Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of commandreporting line, any identified issues or questions associated with OrthofixEndo’s policies, conduct, practices, or procedures with respect to a Federal health care program requirement or an FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix Endo shall appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the information in prominent common areas). Endo Pharmaceuticals Inc. Corporate Integrity Agreement The Disclosure Program shall emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: :
(1) permits a determination of the appropriateness of the alleged improper practice; and and
(2) provides an opportunity for taking corrective action, Orthofix Endo shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) shall maintain a disclosure log, which shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon request.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Disclosure Program. Prior to the Effective Date, Orthofix CVS Caremark established a Disclosure Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include Program that includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with OrthofixCVS Caremark’s policies, conduct, practices, or procedures with respect to a Federal health care program or FDA requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. Orthofix CVS Caremark shall continue to appropriately publicize the existence of the disclosure mechanism (e.g., via periodic e-mails to employees employees, through a posting on CVS Caremark’s intranet or other internal website available to all Covered Persons, or by posting the information in prominent common areas). The Disclosure Program shall continue to emphasize a non-retributionnonretribution, non-retaliation nonretaliation policy, and shall continue to include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Chief Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Chief Compliance Officer (or designee) shall make a preliminary, good-good faith inquiry into the allegations set forth in every disclosure to ensure that he or she has obtained all of the information necessary to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) permits a determination of the appropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, Orthofix CVS Caremark shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. The Chief Compliance Officer (or designee) shall maintain a disclosure log, which shall include a record and summary of each disclosure received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews.
Appears in 1 contract
Samples: Corporate Integrity Agreement