Common use of Disclosure Program Clause in Contracts

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates established a Disclosure Program that includes a mechanism (the toll free “Integrity Helpline”) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and shall continue to appropriately publicize, the existence of the Disclosure Program and the Integrity Helpline (e.g., via periodic e-mails to employees, by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement The Disclosure Program shall emphasize a nonretribution, 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 Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains all necessary information 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, GSK and/or any applicable Affiliate shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK shall maintain, a disclosure log, which 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 4 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement

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Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Progenity shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated Progenity, Inc. Corporate Integrity Agreement with GSK’s or a GSK AffiliateProgenity’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Progenity shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Progenity’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Progenity. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Progenity shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Orthofix established a Disclosure Program that includes Program. To the extent not already provided for in Orthofix’s Disclosure Program, it shall include a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateOrthofix’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Orthofix shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretributionnon-retribution, 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 (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 it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Orthofix shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Orthofix International N V)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates established Gambro shall maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some Gambro Healthcare, Inc. Corporate Integrity Agreement other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateGambro’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Gambro shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails emails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Gambro shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG OIG, upon request.

Appears in 2 contracts

Samples: Integrity Agreement, Corporate Integrity Agreement (Davita Inc)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Indivior shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateIndivior’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential Indivior Corporate Integrity Agreement violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Indivior shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Indivior’s Covered Persons shall be expected to report suspected violations of any Federal health care program or FDA requirements to the Compliance Officer or other appropriate individual designated by Indivior. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Indivior shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil or administrative law related to Federal health care programs or FDA requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Genova shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateGenova’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Genova shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Genova’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Genova. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Genova shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to To the GSK extent not already accomplished, within 90 days after the Effective Date, GSK and its Affiliates established J&J shall ensure a Disclosure Program is established covering all J&J Pharmaceutical Affiliates that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer J&J CCO (or designee) or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSKJ&J’s or a GSK any J&J Pharmaceutical Affiliate’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its J&J and/or the J&J Pharmaceutical Affiliates publicize, and shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer J&J CCO (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer J&J CCO (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK J&J and/or any applicable Affiliate the J&J Pharmaceutical Affiliates shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The J&J CCO (or designee) shall maintain, maintain a disclosure log, which includes 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 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior AstraZeneca currently has a disclosure program that AstraZeneca represents is designed to facilitate communications relating to compliance with Federal health care program and FDA requirements and AstraZeneca’s policies (the GSK Effective Date“Disclosure Program”). During the term of the CIA, GSK and its Affiliates established AstraZeneca shall maintain a Disclosure Program that includes a mechanism (the toll a toll-free “Integrity Helpline”compliance telephone line and/or on-line electronic reporting) to enable individuals to disclose, to the U.S. Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateAstraZeneca’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and AstraZeneca shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails electronic communications to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretributionnonretaliation policy, 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 U.S. Compliance Corporate Integrity Agreement AstraZeneca Officer (or designee) shall gather all relevant information from the disclosing individual. The U.S. Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate AstraZeneca shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The U.S. Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.. Corporate Integrity Agreement AstraZeneca

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Extendicare shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateExtendicare’s policies, conduct, practices, or procedures with respect to quality of care or a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Extendicare shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees and by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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 conduct or practice; and (2) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate Extendicare shall conduct an internal review of the allegations set forth in the disclosure and ensure that corrective action is taken and proper follow-up is conducted. GSK If the inappropriate or improper conduct or practice places residents at risk of harm, then Extendicare will ensure that the conduct or practice ceases immediately and that appropriate action is taken. The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available sent to the Monitor not less than monthly unless otherwise agreed to in writing by OIG upon requestand the Monitor.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Post Acute Medical shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliatePost Acute Medical’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Post Acute Medical shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Post Acute Medical’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Post Acute Medical. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Post Acute Medical shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK conducted.‌ The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Kindred shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateKindred’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Kindred shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or RehabCare and Kindred - Corporate Integrity Agreement she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Kindred shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log for all disclosures directly or indirectly related to the provision of contract rehabilitation therapy services 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. This disclosure log shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Kindred Healthcare, Inc), Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established the U.S. Healthcare Supply DMEPOS Companies shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll- free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliatethe U.S. Healthcare Supply DMEPOS Companies’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and U.S. Healthcare Supply DMEPOS Companies shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by the U.S. Healthcare Supply DMEPOS Companies. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate the U.S. Healthcare Supply DMEPOS Companies shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 2 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement

Disclosure Program. Prior to ‌‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Greenway shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateGreenway’s policies, conduct, practices, or procedures with respect to (1) Health IT Software, (2) a Federal health care program program, including payment programs involving the use of health information technology and the regulations and other guidance related to these programs, or an FDA requirement (including as they relate to CGMP Activities3) the ONC Health IT Certification Program, believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Greenway shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Greenway’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements, including the requirements of payment programs involving the use of health information technology and the regulations and other guidance related to these programs, and/or ONC Health IT Certification Program requirements to the Compliance Officer or other appropriate individual designated by Greenway. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Greenway shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper appropriate follow-up and remediation is conducted. GSK If a Patient Safety Issue is identified as a result of any disclosure, the Compliance Officer (or designee) shall maintain, take immediate steps to mitigate any associated risk while the Patient Safety Issue is being corrected. The Compliance Officer (or designee) shall maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to ‌ To the GSK extent not already accomplished, within 90 days after the Effective Date, GSK and its Affiliates established CRMC shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateCRMC’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and CRMC shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of CRMC’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by CRMC. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate CRMC shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures (whether or not related to a potential violation of criminal, which includes civil, or administrative law related to the Federal health care programs) in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Xxxxxxxx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateXxxxxxxx’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Longwood shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Longwood’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Chief Compliance Officer or other appropriate individual designated by Xxxxxxxx. 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 it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Xxxxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established SDNA shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateSDNA’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and SDNA shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of SDNA’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by SDNA. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate SDNA shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to To the GSK extent not already accomplished, within 120 days after the Effective Date, GSK and its Affiliates established Spectranetics shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK Affiliate’s Spectranetics’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) requirements believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Spectranetics shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic “all-hands meetings,” newsletters and/or e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC ). Spectranetics Corporate Integrity Agreement The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Spectranetics shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Spectranetics Corp)

Disclosure Program. Prior Medco represents that it has established and shall continue to the GSK Effective Date, GSK and its Affiliates established maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateMedco’s policies, conduct, practices, or procedures with respect to a Covered Federal health care program or an FDA requirement (including as they relate to CGMP Activities) Program believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Medco shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, including on Medco’s intranet or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement internal website available to all employees). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosuredisclosure associated with Medco’s policies, conduct, practices or procedures with respect to any Covered Federal Program (each a “Disclosure”), the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information to determine whether a further review should be conducted. For any disclosure 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, GSK and/or any applicable Affiliate Medco shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK Medco CIA The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Medco Health Solutions Inc)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Sandoz shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Sandoz shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the disclosure Corporate Integrity Helpline Agreement Sandoz Inc. mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Sandoz’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Sandoz. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Sandoz shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established Gamma shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateGamma’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Gamma shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Gamma’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Gamma. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Gamma shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective DateDate of this CIA, GSK and its Affiliates PharMerica established a Disclosure Program that includes a mechanism (the toll toll-free “Integrity Helpline”) compliance telephone line to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliatePharMerica’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and PharMerica shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references ). PharMerica shall continue the Disclosure Program during the Term of the CIA as set forth in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement this Section III.F. The Disclosure Program shall emphasize emphasizes a nonretributionnon-retribution, non-retaliation policy policy, and shall include includes a reporting mechanism for anonymous communications for which appropriate confidentiality shall be is maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather gathers all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make makes a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: (1) reasonably permits a determination of the appropriateness of the alleged improper practice; practice and (2) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate shall conduct PharMerica conducts an internal review of the allegations set forth in the disclosure and ensure ensures that proper follow-up is conducted. GSK shall maintain, The Compliance Officer (or designee) maintains a confidential disclosure log, which 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 The disclosure log shall be made available to OIG upon written request but only as to those log entries that relate to allegations received concerning Federal health care programs or any alleged patient harm or abuse resulting from PharMerica’s practices. At such time as PharMerica makes the confidential disclosure log available for review by the OIG as specified above, it will also report to the OIG the following information (but only as it relates to those log entries other than those for Federal health care program allegations or patient harm allegations): the total number of disclosures received and included in the confidential disclosure log for such period, the general categories into which the disclosures fell (including, at a minimum, the following categories: human resources, loss prevention, controlled substance issues), the number of disclosures in each category, and a general description of how PharMerica followed up on the disclosures in each category. When PharMerica provides access to the confidential disclosure log to the OIG as specified in this Section, it shall provide the log to the OIG upon request and as soon as practicable, but not later than 10 business days from the date of the OIG request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Safari Holding Corp)

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established ABC shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”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 GSK’s or a GSK AffiliateABC’s policies, conduct, practices, or procedures with respect to a Federal health care program program, FDA, or an FDA DEA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and ABC shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of ABC’s Covered Persons shall be expected to report suspected violations of any Federal health care program, FDA, or DEA requirements to the Chief Compliance Officer or other appropriate individual designated by ABC. 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 it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate ABC shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK APM, Park Center, and its Affiliates established Xxxxxx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s APM’s, Park Center’s, and Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicizeAPM, Park Center, and Xxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of APM’s, Park Center’s, and Xxxxxx’x Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by APM, Park Center, and Xxxxxx. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate APM, Park Center, and Xxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-follow- up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Vibra has an established a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateVibra’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees Vibra shall continue to maintain this Disclosure Program for the duration of third party suppliers that contract with GSKthe CIA. GSK and its Affiliates publicize, and Vibra shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall continue to emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Vibra’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Vibra. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Vibra shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established Providence shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or or‌ some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateProvidence’s policies, conduct, practices, or procedures with respect to quality of care or a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Providence shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Providence’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Providence. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he/she/they has/have obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Providence shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK If the inappropriate or improper practice places patients at risk of harm, then Providence will ensure that the practice ceases immediately and that appropriate action is taken. The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Progenity shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateProgenity’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Progenity shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Progenity’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Progenity. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Progenity shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Xxxxxxx Lutheran shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateXxxxxxx Lutheran’s policies, conduct, practices, or procedures Xxxxxxx Lutheran Corporate Integrity Agreement with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Xxxxxxx Lutheran shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Xxxxxxx Lutheran shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-follow- up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 To the GSK extent not already accomplished, within 90 days after the Effective Date, GSK and its Affiliates established Mylan shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, disclose to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, command any identified issues or questions associated with GSK’s or a GSK AffiliateMylan’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Mylan shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Mylan’s Covered Persons shall be expected to report Mylan Corporate Integrity Agreement suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Mylan. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains all necessary information 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, GSK and/or any applicable Affiliate Mylan shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Mylan N.V.)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established United Therapeutics shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s United Therapeutics’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and United Therapeutics shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of United Therapeutics’ Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by United Therapeutics. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains all necessary information 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, GSK and/or any applicable Affiliate United Therapeutics shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (UNITED THERAPEUTICS Corp)

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established the GIS Parties shall establish a Disclosure Program that includes a mechanism (the toll e .g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s the GIS Parties’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and GIS Parties shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of the GIS Parties’ Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by the GIS Parties. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate the GIS Parties shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates King established a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateKing’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) Health Care Program Requirement believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and King shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas), or through references in and King shall maintain the Code Disclosure Program during the term of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement the CIA. The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosuredisclosure that relates to a Federal Health Care Program Requirement, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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 inappropriateness of the alleged improper practice; and (2) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate King shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes shall include a record and summary of each disclosure received that relates to a Federal Health Care Program Requirement (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This The disclosure log shall be made available to OIG upon request.. Corporate Integrity Agreement King Pharmaceuticals, Inc.

Appears in 1 contract

Samples: Corporate Integrity Agreement (King Pharmaceuticals Inc)

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Amgen shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”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 GSK’s or a GSK AffiliateAmgen’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Amgen shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Amgen’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Chief Compliance Officer or other appropriate individual designated by Amgen. 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 it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Amgen shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established BPMC shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateBPMC’s policies, conduct, practices, or procedures with respect to a Federal health care award program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and BPMC shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of BPMC’s Covered Persons shall be expected to report suspected violations of any Federal award program requirements to the Compliance Officer or other appropriate individual designated by BPMC. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate BPMC shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal award programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Recipient Compliance Agreement

Disclosure Program. Prior Zimmer represented to the GSK OIG that, prior to the Effective DateDate of this CIA, GSK and its Affiliates it established a Disclosure Program. Zimmer shall maintain a Disclosure Program that includes a mechanism (the toll e.g., toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Zxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Zxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be is maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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; practice and (2) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate the Compliance Officer (or designee) shall conduct an internal review of the allegations set forth in the that disclosure and ensure that proper follow-up is conducted. GSK Zxxxxx’x Compliance Officer (or designee) shall maintain, maintain a disclosure log, which Corporate Integrity Agreement between OIG-HHS and Zxxxxx, Inc. 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 The disclosure log shall be made available to OIG OIG, upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Zimmer Holdings Inc)

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Prime shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliatePrime’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Prime shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline (disclosure mechanism ( e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Prime’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Prime. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Prime shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure. the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon request.review.‌‌

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Mallinckrodt shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateMallinckrodt’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Mallinckrodt shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Mallinckrodt’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Mallinckrodt. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant Mallinckrodt plc Corporate Integrity Agreement information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Mallinckrodt shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil or administrative law related to Federal health care programs or FDA requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates UMHS has established a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateUMHS’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees UMHS shall continue to maintain this Disclosure Program for the duration of third party suppliers that contract with GSKthe CIA. GSK and its Affiliates publicize, and UMHS shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate UMHS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established Xxxxxx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Xxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Xxxxxx’x Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Xxxxxx. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Xxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established Insys shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateInsys’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Insys shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Insys’s Covered Persons shall be expected to report suspected violations of any Federal health care program or FDA requirements to the Compliance Officer or other appropriate individual designated by Insys. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Insys shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.reviews.‌‌

Appears in 1 contract

Samples: Corporate Integrity Agreement and Conditional

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Apria shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateApria’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Apria shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Apria’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Apria. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Apria shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK Apria - Corporate Integrity Agreement The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil, or administrative law related to the Federal health care programs, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Apria, Inc.)

Disclosure Program. Prior to the GSK Effective DateDate of this CIA, GSK and its Affiliates Walgreens established a Disclosure Program that includes includes, among other things, a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateWalgreens’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Walgreens shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails posting on Walgreens’s intranet or other internal website available to employeesall Covered Persons, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall continue to emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall continue to include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosuredisclosure with respect to a Federal health care program, the Compliance Officer (or designee) shall attempt to gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every such disclosure to ensure that it obtains he or she has obtained all of the information reasonably available and necessary information to determine whether a further review should be conducted. For any such 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, GSK and/or any applicable Affiliate Walgreens shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes shall include a record and summary of each disclosure with respect to a Federal health care program received (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This 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 GSK Effective Date, GSK and its Affiliates established Xxxxxxx-Xxxxxx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Xxxxxxx-Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Xxxxxxx-Xxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Xxxxxxx-Xxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-follow- up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 Within 90 days after the GSK Effective Date, GSK and its Affiliates established Cordant shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateCordant’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Cordant shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Cordant’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Cordant. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Cordant shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures (whether or not related to a potential violation of criminal, which includes civil, or administrative law related to the Federal health care programs) in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior Boston Scientific currently has a disclosure program that Boston Scientific represents is designed to facilitate communications relating to compliance with Federal health care program requirements and Boston Scientific’s policies (the GSK Effective Date“Disclosure Program”). During the term of this CIA, GSK and its Affiliates established Boston Scientific shall continue to maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line and/or online electronic reporting) 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 GSK’s or a GSK AffiliateGuidant/CRM’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Boston Scientific shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Boston Scientific shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a confidential disclosure loglog pertaining to Guidant/CRM, which includes shall include a record and summary of each disclosure received that is related to Guidant/CRM (whether anonymous or not), the Boston Scientific Corp. Corporate Integrity Agreement status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This The confidential disclosure log as to allegations involving Guidant/CRM shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Boston Scientific Corp)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Harmony-Xxxxxx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Harmony-Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Harmony-Xxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Harmony-Xxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-follow- up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 Within 90 days after the GSK Effective Date, GSK and its Affiliates established UHS shall ensure that it has a Disclosure Program that includes complies with the following requirements: a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateUHS’s policies, conduct, practices, or procedures with respect to quality of care or a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and UHS shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of UHS’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by UHS. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate UHS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK If the inappropriate or improper practices places patients at risk of harm, then UHS will ensure that that practice ceases immediately and that appropriate action is taken. The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This The disclosure log shall be made available sent to OIG upon request.the Monitor required under Section III.D of this CIA not less than monthly. Universal Health Services, Inc. Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Universal Health Services Inc)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates The University has established a Disclosure Program that includes Program, including a mechanism (the toll free “Integrity Helpline”) to enable hotline, for named or anonymous individuals to disclose, to the Compliance Officer report, or some other person who is not in the disclosing individual’s chain of commandrequest advice on, at a minimum, any identified issues or questions associated related to compliance with GSK(i) the Athletics Department’s or a GSK Affiliate’s policiesand/or relevant University Policies and Procedures, (ii) the NCAA Constitution, Bylaws, and the principles regarding institutional control, responsibility, ethical conduct, practicesand integrity reflected in the NCAA Constitution and Bylaws or (iii) the Big Ten Handbook and the principles regarding institutional control, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by responsibility, ethical conduct and integrity reflected in the individual to be a potential violation of criminal, civil, or administrative lawBig Ten Handbook. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK University shall appropriately and its Affiliates publicize, and shall continue to appropriately publicize, widely publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references ). The University may use its existing hotline and disclosure policies and procedures if they comply with the requirements in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement this section. The Disclosure Program shall emphasize a nonretributionnon-retribution, non-retaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosuredisclosure within the job responsibilities of the Athletics Integrity Officer, the Compliance Athletics Integrity Officer (or designee) shall gather all relevant information from the disclosing individual, to the extent possible. The Compliance Athletics Integrity Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information to determine whether a further review should be conducted. For any disclosure that is sufficiently specific so that it reasonably: the Athletics Integrity Officer (1or designee) permits a determination in good faith determines requires further inquiry, the University (under the oversight of the appropriateness of the alleged improper practice; and (2Athletics Integrity Council) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The procedures described above in this Section III D regarding the preliminary inquiry by the Athletics Integrity Officer or review by the Athletics Integrity Council must be done in a manner that does not interfere with any relevant criminal investigation and must be done in a manner that is consistent with all laws and any and all University policies relating to: mandatory reporting; the proper handling of criminal misconduct; proper handling of student misconduct; or the proper handling of health and safety issues. Any University policies promulgated after the date hereof shall maintain, be developed in good faith with due consideration given to the processes described in this Section. The Athletics Integrity Officer (or designee) shall provide regular updates to the Athletics Integrity Council of any reports received by the Athletics Integrity Officer. The Athletics Integrity Officer (or designee) shall maintain a disclosure log, which includes shall include a record and summary of each disclosure received received, regardless of how general or unsubstantiated the information is ultimately viewed (whether anonymous or not), the status of the respective internal reviews, and any corrective action taken in response to the internal reviewsreview. This disclosure log shall be made available Nothing in this Section is intended to OIG upon requestreplace any of the existing procedures at the University to address disclosures. The University may follow such other procedures in addition to the process described above, for any particular disclosure.

Appears in 1 contract

Samples: Athletics Integrity Agreement

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Sanofi shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateSanofi’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Sanofi shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Sanofi’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Sanofi. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Sanofi shall Sanofi Corporate Integrity Agreement conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK conducted.‌‌ The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established HealthNet shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateHealthNet’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and HealthNet shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of HealthNet’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by HealthNet. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate HealthNet shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK conducted.‌‌ The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Baxano Surgical established a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”Compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateBaxano Surgical’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees Baxano Surgical shall maintain such a Disclosure Program throughout the term of third party suppliers that contract with GSKthe CIA. GSK and its Affiliates publicize, and Baxano Surgical shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline Compliance telephone line (e.g., via periodic e-mails to employees, employees and/or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, 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 Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all necessary information 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, GSK and/or any applicable Affiliate Baxano Surgical shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, a disclosure log, which 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 (Baxano Surgical, Inc.)

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Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established a SUN shall establish Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateSUN’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and SUN shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of SUN’s Covered Persons shall be expected to report suspected violations of any Federal health care program or FDA requirements to the Compliance Officer or other appropriate individual designated by SUN. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure SUN Corporate Integrity Agreement that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate SUN shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil or administrative law related to Federal health care programs or FDA requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior Exactech currently has a disclosure program that Exactech represents is designed to facilitate communications relating to compliance with Federal health care program requirements and Exactech’s policies (the GSK Effective Date, GSK and its Affiliates established (Disclosure Program”). Exactech shall continue to maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateExactech’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Exactech shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Exactech shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.. Exactech, Inc. - Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Exactech Inc)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Shire established a Disclosure Program that meets the requirements of this Section III.F and shall maintain the Disclosure Program throughout the term of this CIA. The Disclosure Program includes a mechanism (the toll free “Integrity Compliance Helpline) to enable individuals to disclose, to the Compliance Officer CCRO or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateShire’s policies, conduct, practices, or procedures with respect to a Federal health care program requirement or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicizeShire publicizes, and shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Compliance Helpline (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct Ethics and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer CCRO (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer CCRO (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Shire shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The CCRO (or designee) shall maintain, maintain a disclosure log, which includes 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 ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established ResMed shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateResMed’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and ResMed shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of ResMed’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by ResMed. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate ResMed shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK conducted.‌ The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures (whether or not related to a potential violation of criminal, which includes civil, or administrative law related to the Federal health care programs) in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to To the GSK extent not already accomplished, within 90 days after the Effective Date, GSK and its Affiliates established WellCare shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK Affiliate’s WellCare's policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and WellCare shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate WellCare shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a confidential disclosure log, which includes 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 The confidential disclosure Corporate Integrity Agreement WellCare Health Plans, Inc. log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Wellcare Health Plans, Inc.)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Xxxxx established a Disclosure Program that meets the requirements of this Section III.F and shall maintain the Disclosure Program throughout the term of this CIA. The Disclosure Program includes a mechanism (the toll free “Integrity Compliance Helpline) to enable individuals to disclose, to the Compliance Officer CCRO or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateShire’s policies, conduct, practices, or procedures with respect to a Federal health care program requirement or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicizeShire publicizes, and shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Compliance Helpline (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct Ethics and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer CCRO (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer CCRO (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Shire shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The CCRO (or designee) shall maintain, maintain a disclosure log, which includes 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 Within 90 days after the GSK Effective Date, GSK and its Affiliates established Aegerion shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateAegerion’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Aegerion shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Aegerion’s Covered Persons shall be expected to report suspected violations of any Federal health care program and/or FDA requirements to the Compliance Officer or other appropriate individuals designated by Aegerion. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all information necessary information 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, GSK and/or any applicable Affiliate Aegerion shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, log which 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 The Compliance Officer (or designee) shall record each disclosure in the disclosure log shall be made available to OIG upon requestwithin two business days of receipt of the disclosure.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established CSI shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateCSI’s policies, conduct, practices, or procedures with respect to a Federal health care program or an any FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and CSI shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of CSI’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by CSI. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate CSI shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Cardiovascular Systems Inc)

Disclosure Program. Prior Hill-Rom has established a disclosure program designed to facilitate communications relating to compliance with Federal health care programs and Hill- Rom’s Policies and Procedures (“Disclosure Program”). During the GSK Effective Dateterm of the CIA, GSK and its Affiliates established Hill Rom shall maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Chief Compliance Hill-Rom Corporate Integrity Agreement Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateHill-Rom’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Hill-Rom shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, employees or by posting the information in prominent common areas). To the extent not already accomplished, or through references Hill-Rom’s Disclosure Program shall incorporate the elements described in this Section III.E within 90 days after the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement Effective Date. The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Hill-Rom shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established Respironics shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated associated‌ with GSK’s or a GSK Affiliate’s Respironics’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Respironics shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-e- mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Respironics’ Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Respironics. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Respironics shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil or administrative law related to Federal health care program requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established WCH shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateWCH’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and WCH shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of WCH’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by WCH. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate WCH shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established RMS shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateRMS’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and RMS shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of RMS’s Covered Persons shall be expected to report suspected violations of any Federal health care program or FDA requirements to the Compliance Officer or other appropriate individual designated by RMS. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate RMS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures, which includes whether or not related to a record and potential violation of criminal, civil or administrative law related to Federal health care programs or FDA requirements, in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Ra Medical Systems, Inc.)

Disclosure Program. Prior Hill-Rom has established a disclosure program designed to facilitate communications relating to compliance with Federal health care programs and Hill-Rom’s Policies and Procedures (“Disclosure Program”). During the GSK Effective Dateterm of the CIA, GSK and its Affiliates established Hill Rom shall maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateHill-Rom’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Hill-Rom shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas). To the extent not already accomplished, or through references Hill-Rom’s Disclosure Program shall incorporate the elements described in this Section III.E within 90 days after the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement Effective Date. The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Hill-Rom shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 (Hill-Rom Holdings, Inc.)

Disclosure Program. Prior Elan currently has a disclosure program that is designed to facilitate communications relating to compliance with Federal health care program and FDA requirements and Elan’s policies (the GSK Effective Date“Disclosure Program”). During the term for the CIA, GSK and its Affiliates established Elan shall maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateElan’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Elan shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretributionnonretaliation policy, 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 it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Elan shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Elan Corp PLC)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established VITAS shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s VITAS’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and VITAS shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of VITAS’ Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by VITAS. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate VITAS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received VITAS Corporate Integrity Agreement (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 Within 90 days after the GSK Effective Date, GSK and its Affiliates established Health Quest shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateHealth Quest’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Health Quest shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Health Quest’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Health Quest. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Health Quest shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established eTEL-Rx shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateeTEL-Rx’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and eTEL-Rx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the eTEL-Rx Corporate Integrity Agreement allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate eTEL-Rx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 To the GSK extent not already accomplished, within 90 days after the Effective Date, GSK and its Affiliates established Biovail shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”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 GSK’s or a GSK AffiliateBiovail’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Biovail shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate BiovaiI shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Biovail Corp International)

Disclosure Program. Prior Allina has represented to the GSK Effective Date, GSK and its Affiliates OIG that it has established a Disclosure Program confidential disclosure program (“Integrity Line”), that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the 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 GSK’s or a GSK AffiliateAllina’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) program, believed by the individual to be a potential violation of criminal, civil, civil or administrative law. The Allina shall maintain the Integrity Helpline may be used by employees Line for the term of third party suppliers that contract with GSKthis CIA. GSK and its Affiliates publicize, and Allina shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline Line (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate ). The Integrity Agreement The Disclosure Program Line shall emphasize a nonretributionnon-retribution, non-retaliation policy policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall will be maintained. Upon receipt of a disclosure, the Corporate Compliance Officer (or his/her designee) shall gather all relevant information from the disclosing individual. The Corporate Compliance Officer (or his/her designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information to determine whether a further review should be conducted. For any disclosure related to a Federal health care program or abuse or neglect of patients 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, GSK and/or any applicable Affiliate Allina shall conduct an internal review of the allegations set forth in the such a disclosure and ensure that proper follow-up is conducted. GSK The Corporate Compliance Officer (or his/her designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG OIG, upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established VITAS shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s 's chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s VITAS' policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and VITAS shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of VITAS' Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by VITAS. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate VITAS shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.Vitas Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Chemed Corp)

Disclosure Program. Prior to To the GSK extent not already implemented, within 90 days after the Effective Date, GSK and its Affiliates established CVS Health shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll- free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Chief Compliance Officer, Compliance Officer for IPS Operations, or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateCVS Health’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and CVS Health shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, through a posting on CVS Health’s intranet or other internal website available to all Covered Persons, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy 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 faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he/she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate CVS Health shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Chief Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established Encore shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateEncore’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Encore shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Encore’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Encore. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Encore shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record all disclosures in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received Encore Rehabilitation Services, LLC Corporate Integrity Agreement (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established AtriCure, Inc. shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateAtriCure, Inc.’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicizeAtriCure, and Inc. shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information to determine whether a further review should be CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. 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, GSK and/or any applicable Affiliate AtriCure, Inc. shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (AtriCure, Inc.)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Primex shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateXxxxxx’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Primex shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Primex’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Primex. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Primex shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This 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 GSK Effective Date, GSK and its Affiliates established OCOM shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateOCOM’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and OCOM shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of OCOM’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by OCOM. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate OCOM shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure loglog and shall record all disclosures (whether or not related to a potential violation of criminal, which includes civil, or administrative law related to the Federal health care programs) in the disclosure log within two business days of receipt of the disclosure. The disclosure log shall include a record and summary of each disclosure received (whether anonymous or not), the individual or department responsible for reviewing the disclosure, the status of the respective internal reviewsreview, and any corrective action taken in response to the internal reviews. This disclosure log shall be made available to OIG upon requestreview.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK Odyssey Hospice established and its Affiliates established shall maintain for the term of the CIA a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateOdyssey Hospice’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, Odyssey Hospice has and shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Odyssey Hospice shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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.Odyssey Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Gentiva Health Services Inc)

Disclosure Program. Prior to ‌ Within 90 days after the GSK Effective Date, GSK and its Affiliates established PCMC shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliatePCMC’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and PCMC shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement areas).‌‌ The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of PCMC’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by PCMC. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate PCMC shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior Biomet represented to the GSK OIG that, prior to the Effective DateDate of this CIA, GSK and its Affiliates it established a Disclosure Program, which applies to Biomet Orthopedics Biomet shall maintain a Disclosure Program that includes a mechanism (the toll e.g., toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSKBiomet’s or a GSK Affiliate’s and Biomet Orthopedics’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Biomet shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be is maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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; practice and (2) provides an opportunity for taking corrective action, GSK and/or any applicable Affiliate the Compliance Officer (or designee) shall conduct an internal review of the allegations set forth in the that disclosure and ensure that proper follow-up is conducted. GSK Biomet’s Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG OIG, upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Biolectron, Inc.)

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Amedisys has established a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateAmedisys’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Amedisys shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall continue to emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall continue to include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Amedisys shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 (Amedisys Inc)

Disclosure Program. Prior Xxxxxx currently has a disclosure program that Xxxxxx represents is designed to facilitate communications relating to compliance with Federal health care program requirements and Xxxxxx’x policies (the GSK Effective Date, GSK and its Affiliates established (Disclosure Program”). Xxxxxx shall continue to maintain a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Xxxxxx’x policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Xxxxxx shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Xxxxxx shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes 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 The disclosure log shall be made available to OIG upon request.. Xxxxxx Medical Technology, Inc. — Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Wright Medical Group Inc)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Walgreens shall establish a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance and Ethics Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK Affiliate’s Walgreens’ policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Walgreens shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, employees or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which Walgreen Co. - Corporate Integrity Agreement appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Walgreens’ Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance and Ethics Officer or other appropriate individual designated by Walgreens. Upon receipt of a disclosure, the Compliance and Ethics Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance and Ethics Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Walgreens shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance and Ethics Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement

Disclosure Program. Prior to the GSK Effective Date, GSK and its Affiliates Pediatrix certifies that it has established a Disclosure Program that includes a mechanism (the toll e.g., a toll-free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliatePediatrix’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Pediatrix shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, through compliance training or by posting the information in prominent common areas, or through references in ). Pediatrix hereby agrees to maintain such a Disclosure Program during the Code term of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement this CIA The Disclosure Program shall emphasize a nonretribution, non-retaliation policy nonretaliation policy, and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individualinformation. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Pediatrix shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK Pediatrix certifies that its Compliance Officer (or designee) maintains, and shall maintaincontinue to maintain during the term of the CIA, a disclosure log, which includes a record and summary of each disclosure received (whether anonymous or not). As of the Effective Date, the disclosure log shall also include the status of the respective internal reviews, and any corrective action taken in response to the internal reviews. This The disclosure log shall be made available to the OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Pediatrix Medical Group Inc)

Disclosure Program. Prior to Within 90 days after the GSK Effective Date, GSK and its Affiliates established Jazz shall establish a Disclosure Program that includes a mechanism (the e.g., a toll free “Integrity Helpline”compliance telephone line) to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual’s chain of command, any identified issues or questions associated with GSK’s or a GSK AffiliateJazz’s policies, conduct, practices, or procedures with respect to a Federal health care program or an FDA requirement (including as they relate to CGMP Activities) believed by the individual to be a potential violation of criminal, civil, or administrative law. The Integrity Helpline may be used by employees of third party suppliers that contract with GSK. GSK and its Affiliates publicize, and Jazz shall continue to appropriately publicize, publicize the existence of the Disclosure Program and the Integrity Helpline disclosure mechanism (e.g., via periodic e-mails to employees, or by posting the information in prominent common areas, or through references in the Code of Conduct and during training.) GlaxoSmithKline LLC Corporate Integrity Agreement ). The Disclosure Program shall emphasize a nonretribution, non-retaliation nonretaliation policy and shall include a reporting mechanism for anonymous communications for which appropriate confidentiality shall be maintained. The Disclosure Program also shall include a requirement that all of Jazz’s Covered Persons shall be expected to report suspected violations of any Federal health care program requirements to the Compliance Officer or other appropriate individual designated by Jazz. Upon receipt of a disclosure, the Compliance Officer (or designee) shall gather all relevant information from the disclosing individual. The Compliance Officer (or designee) shall make a preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure that it obtains he or she has obtained all of the information necessary information 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, GSK and/or any applicable Affiliate Jazz shall conduct an internal review of the allegations set forth in the disclosure and ensure that proper follow-up is conducted. GSK The Compliance Officer (or designee) shall maintain, maintain a disclosure log, which includes log and shall record each disclosure in the disclosure log within two business days 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. This disclosure log shall be made available to OIG upon request.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Jazz Pharmaceuticals PLC)

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