Bausch + Lomb may engage a diverse range of Customers and Consumers—including independent healthcare professionals (HCPs), healthcare organizations (HCOs), patient advocacy groups, patients, and caregivers—to provide legitimate services that cannot be fulfilled using internal expertise or resources. These arrangements aim to ensure that the medicines we develop meet patient needs and remain accessible.
Bausch + Lomb may engage a diverse range of Customers and Consumers—including independent healthcare professionals (HCPs), healthcare organizations (HCOs), patient advocacy groups, patients, and caregivers—to provide legitimate services that cannot be fulfilled using internal expertise or resources. These arrangements aim to ensure that the medicines we develop meet patient needs and remain accessible.
This section outlines general principles applicable to service arrangements with Customers, including consulting services (such as providing knowledge, insight, or advice) or other services (such as speaker engagements) involving individual HCPs or patients/caregivers, marketing services with HCOs (including promotional opportunities), and data purchase agreements with HCOs.
All service arrangements must adhere to relevant laws and regulations, including, but not limited to, the Anti-Kickback Statute.
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Contractual Arrangement Discussions
Only Bausch + Lomb colleagues with job responsibilities specifically related to service agreements—and who have received appropriate training—are authorized to engage in discussions involving these arrangements. Such discussions may include the initiation, negotiation, or review of service agreements. These arrangements must be overseen by the designated Bausch + Lomb function and colleagues, in compliance with company policies outlined below.
Sales colleagues are prohibited from initiating, discussing, or negotiating service arrangement terms with Customers, including healthcare professionals (HCPs) and healthcare organizations (HCOs). If there is a business need to engage an HCP or HCO, the matter should be escalated to the appropriate Managed Markets, Marketing, or Commercial Operations colleague for evaluation.
Legitimate Business Need
Bausch + Lomb may enter into written fee-for-service agreements to obtain legitimate contractual services that address a documented business need identified prior to the commencement of services under the consulting arrangement.
Before engaging a Customer or Consumer for a specific service, appropriate consideration should be given to alternative options, and reasonable justification must be provided. The information or services requested must be limited to those that cannot be obtained through internal resources or expertise, are not already known to the company, and cannot be acquired through other methods (such as qualitative or quantitative market research).
Bausch + Lomb must not enter into any agreement intended to directly or indirectly influence the use of its products or to induce or reward purchasing, prescribing, or recommending Bausch + Lomb products.
For instance, service arrangements must not be used as opportunities to promote products or to present non-promotional (e.g., research) or off-label information to the contracted Customer, except when such information is specifically tailored and limited to the legitimate business purpose of the service.
Healthcare professionals (HCPs) should be engaged as Consultants solely to provide knowledge, insight, advice, or other information or services that fulfill a legitimate business need. Examples of legitimate needs include obtaining expertise on products, therapeutic areas, market dynamics, or patient needs.
Bausch + Lomb must not engage service providers based on the fact that the Customer is, or could become, a significant purchaser or prescriber of products.
Due Diligence and Eligibility
Thorough due diligence must be conducted on any healthcare organization (HCO) or healthcare professional (HCP) considered for a service arrangement to ensure they are capable of delivering the required services. This evaluation should be supported by appropriate documentation, such as written agreements, financial assessments, business case presentations, meeting minutes, or other relevant records. The extent of due diligence may vary depending on the nature of the arrangement and the service provider.
For example, when selecting or retaining HCPs as service providers, decisions should be based on established criteria including their education, medical expertise, reputation, knowledge, experience related to the subject matter, and overall competency to perform the specified services. Similarly, if Bausch + Lomb enters into a product discount agreement with a Specialty Pharmacy, due diligence must verify that the pharmacy can properly handle and store the products.
In certain cases, an evaluation of the provider’s current or previous performance related to the service may be necessary.
Bausch + Lomb colleagues or third parties acting on behalf of the company who engage HCOs or HCPs in service arrangements must possess the expertise to assess both the provider and their capability to fulfill the requested services.
Additionally, HCPs retained by Bausch + Lomb must undergo screening prior to engagement and annually thereafter against applicable debarment and exclusion lists.
You are required to notify the Compliance Department immediately if any positive screening matches are identified.
Compensation and Fee-for-Service Expenses
Bausch + Lomb must ensure that service fees align with Fair Market Value (FMV) for the services provided and are not influenced by the volume or value of business generated by the Customer. For healthcare professionals (HCPs) engaged as Consultants, including promotional speaker roles, the FMV tool should be used to determine appropriate compensation. For other agreements with HCPs or healthcare organizations (HCOs) that are outside the FMV tool’s scope, Bausch + Lomb colleagues should ensure payments are reasonable and customary, supported by benchmarking data where applicable.
All FMV or reasonable and customary determinations must be documented prior to contract execution. This documentation should be maintained by the designated personnel in accordance with the company’s document retention policy.
Royalty arrangements should only be considered if the HCP has made or is expected to make a novel or substantial contribution to the development of a product, technology, process, or method. Any Royalty Arrangements must undergo review and approval by the Legal Department.
Bausch + Lomb will reimburse Consultants for actual and reasonable travel-related expenses incurred while performing consulting services, provided that expenses are properly documented and comply with the company’s expense submission guidelines. Personal expenses (such as gift shop purchases or costs for the Customer’s spouse, partner, or guest) are not reimbursable. For further details, refer to the Bausch + Lomb U.S. HCP Travel and Expense Policy.
Additional guidelines related to fee arrangements are as follows:
Contractual Arrangement Discussions
Only Bausch + Lomb colleagues with job responsibilities specifically related to service agreements—and who have received appropriate training—are authorized to engage in discussions involving these arrangements. Such discussions may include the initiation, negotiation, or review of service agreements. These arrangements must be overseen by the designated Bausch + Lomb function and colleagues, in compliance with company policies outlined below.
Sales colleagues are prohibited from initiating, discussing, or negotiating service arrangement terms with Customers, including healthcare professionals (HCPs) and healthcare organizations (HCOs). If there is a business need to engage an HCP or HCO, the matter should be escalated to the appropriate Managed Markets, Marketing, or Commercial Operations colleague for evaluation.
Legitimate Business Need
Bausch + Lomb may enter into written fee-for-service agreements to obtain legitimate contractual services that address a documented business need identified prior to the commencement of services under the consulting arrangement.
Before engaging a Customer or Consumer for a specific service, appropriate consideration should be given to alternative options, and reasonable justification must be provided. The information or services requested must be limited to those that cannot be obtained through internal resources or expertise, are not already known to the company, and cannot be acquired through other methods (such as qualitative or quantitative market research).
Bausch + Lomb must not enter into any agreement intended to directly or indirectly influence the use of its products or to induce or reward purchasing, prescribing, or recommending Bausch + Lomb products.
For instance, service arrangements must not be used as opportunities to promote products or to present non-promotional (e.g., research) or off-label information to the contracted Customer, except when such information is specifically tailored and limited to the legitimate business purpose of the service.
Healthcare professionals (HCPs) should be engaged as Consultants solely to provide knowledge, insight, advice, or other information or services that fulfill a legitimate business need. Examples of legitimate needs include obtaining expertise on products, therapeutic areas, market dynamics, or patient needs.
Bausch + Lomb must not engage service providers based on the fact that the Customer is, or could become, a significant purchaser or prescriber of products.
Due Diligence and Eligibility
Thorough due diligence must be conducted on any healthcare organization (HCO) or healthcare professional (HCP) considered for a service arrangement to ensure they are capable of delivering the required services. This evaluation should be supported by appropriate documentation, such as written agreements, financial assessments, business case presentations, meeting minutes, or other relevant records. The extent of due diligence may vary depending on the nature of the arrangement and the service provider.
For example, when selecting or retaining HCPs as service providers, decisions should be based on established criteria including their education, medical expertise, reputation, knowledge, experience related to the subject matter, and overall competency to perform the specified services. Similarly, if Bausch + Lomb enters into a product discount agreement with a Specialty Pharmacy, due diligence must verify that the pharmacy can properly handle and store the products.
In certain cases, an evaluation of the provider’s current or previous performance related to the service may be necessary.
Bausch + Lomb colleagues or third parties acting on behalf of the company who engage HCOs or HCPs in service arrangements must possess the expertise to assess both the provider and their capability to fulfill the requested services.
Additionally, HCPs retained by Bausch + Lomb must undergo screening prior to engagement and annually thereafter against applicable debarment and exclusion lists.
You are required to notify the Compliance Department immediately if any positive screening matches are identified.
Compensation and Fee-for-Service Expenses
Bausch + Lomb must ensure that service fees align with Fair Market Value (FMV) for the services provided and are not influenced by the volume or value of business generated by the Customer. For healthcare professionals (HCPs) engaged as Consultants, including promotional speaker roles, the FMV tool should be used to determine appropriate compensation. For other agreements with HCPs or healthcare organizations (HCOs) that are outside the FMV tool’s scope, Bausch + Lomb colleagues should ensure payments are reasonable and customary, supported by benchmarking data where applicable.
All FMV or reasonable and customary determinations must be documented prior to contract execution. This documentation should be maintained by the designated personnel in accordance with the company’s document retention policy.
Royalty arrangements should only be considered if the HCP has made or is expected to make a novel or substantial contribution to the development of a product, technology, process, or method. Any Royalty Arrangements must undergo review and approval by the Legal Department.
Bausch + Lomb will reimburse Consultants for actual and reasonable travel-related expenses incurred while performing consulting services, provided that expenses are properly documented and comply with the company’s expense submission guidelines. Personal expenses (such as gift shop purchases or costs for the Customer’s spouse, partner, or guest) are not reimbursable. For further details, refer to the Bausch + Lomb U.S. HCP Travel and Expense Policy.
Additional guidelines related to fee arrangements are as follows:
All service arrangements must be documented in a signed written agreement between the service provider and Bausch + Lomb before any services begin. At a minimum, the agreement should include the following:
Review and Approval
Bausch + Lomb colleagues must ensure that all written Consultant Agreements with independent healthcare professionals (HCPs) are reviewed and approved by the appropriate functions, such as Procurement, Legal, and Marketing Operations, in accordance with Bausch + Lomb’s Contract Review and Procurement Policies.
Service arrangements involving healthcare organizations (HCOs) must be reviewed by the relevant functions, including Managed Markets, Legal, Compliance, and Finance.
Proof of Performance
Written agreements for service arrangements must clearly define the expected deliverables and include a requirement for proof of performance. The acceptable form of proof may vary depending on the type of engagement. Examples of valid proof for arrangements with HCPs include final agendas, sign-in sheets, meeting minutes, summary reports, teleconference records, meeting invitations, detailed feedback notes, and other work products produced by the Customer. Bausch + Lomb colleagues should only authorize payment after receiving appropriate proof of performance. Please note that pre-meeting agendas and invoices alone do not qualify as acceptable proof.
All service arrangements must be documented in a signed written agreement between the service provider and Bausch + Lomb before any services begin. At a minimum, the agreement should include the following:
Review and Approval
Bausch + Lomb colleagues must ensure that all written Consultant Agreements with independent healthcare professionals (HCPs) are reviewed and approved by the appropriate functions, such as Procurement, Legal, and Marketing Operations, in accordance with Bausch + Lomb’s Contract Review and Procurement Policies.
Service arrangements involving healthcare organizations (HCOs) must be reviewed by the relevant functions, including Managed Markets, Legal, Compliance, and Finance.
Proof of Performance
Written agreements for service arrangements must clearly define the expected deliverables and include a requirement for proof of performance. The acceptable form of proof may vary depending on the type of engagement. Examples of valid proof for arrangements with HCPs include final agendas, sign-in sheets, meeting minutes, summary reports, teleconference records, meeting invitations, detailed feedback notes, and other work products produced by the Customer. Bausch + Lomb colleagues should only authorize payment after receiving appropriate proof of performance. Please note that pre-meeting agendas and invoices alone do not qualify as acceptable proof.
Service providers engaged by Bausch + Lomb for promotional or non-promotional activities must perform their duties in accordance with the company’s policies and procedures, representing Bausch + Lomb in alignment with our values and Code of Conduct. When applicable, these providers must receive relevant training to ensure compliance with Bausch + Lomb’s standards. The required training should correspond to the nature of the services provided. Training topics may include areas such as Adverse Event reporting, patient privacy, and regulatory considerations related to promotional contexts.
All Speaker Training Meetings must adhere to the logistical policies outlined previously. Bausch + Lomb colleagues are prohibited from providing training on Off-Label uses or indications. All Speaker and Professional Education Training Meetings must include HCP training on compliance with relevant FDA regulations, delivered by a representative from Bausch + Lomb’s Compliance Department or a designated delegate. Please contact the Compliance Department for additional information.
Service providers engaged by Bausch + Lomb for promotional or non-promotional activities must perform their duties in accordance with the company’s policies and procedures, representing Bausch + Lomb in alignment with our values and Code of Conduct. When applicable, these providers must receive relevant training to ensure compliance with Bausch + Lomb’s standards. The required training should correspond to the nature of the services provided. Training topics may include areas such as Adverse Event reporting, patient privacy, and regulatory considerations related to promotional contexts.
All Speaker Training Meetings must adhere to the logistical policies outlined previously. Bausch + Lomb colleagues are prohibited from providing training on Off-Label uses or indications. All Speaker and Professional Education Training Meetings must include HCP training on compliance with relevant FDA regulations, delivered by a representative from Bausch + Lomb’s Compliance Department or a designated delegate. Please contact the Compliance Department for additional information.
Bausch + Lomb must ensure that all documentation supporting a service arrangement is managed by the appropriate personnel and maintained according to the company’s document retention policies. The department responsible for managing the Customer relationship must record and preserve all documentation as outlined throughout this policy.
Bausch + Lomb must ensure that all documentation supporting a service arrangement is managed by the appropriate personnel and maintained according to the company’s document retention policies. The department responsible for managing the Customer relationship must record and preserve all documentation as outlined throughout this policy.
All Consultants engaged by Bausch + Lomb are required to fully disclose their relationship with the company to any formulary or pharmacy and therapeutics committees, or similar bodies involved in treatment protocol development, of which they are members or affiliates. This disclosure obligation extends for at least two years after the termination of any Consultant Agreement. Additionally, Consultants must comply with any disclosure rules imposed by healthcare institutions, medical committees, or scientific organizations with which they are affiliated.
All Consultants engaged by Bausch + Lomb are required to fully disclose their relationship with the company to any formulary or pharmacy and therapeutics committees, or similar bodies involved in treatment protocol development, of which they are members or affiliates. This disclosure obligation extends for at least two years after the termination of any Consultant Agreement. Additionally, Consultants must comply with any disclosure rules imposed by healthcare institutions, medical committees, or scientific organizations with which they are affiliated.
Data Purchase Arrangements
Bausch + Lomb occasionally purchases data from Customers or healthcare organizations (HCOs) to support legitimate business functions, such as outcomes research, market research, or other appropriate activities. These data purchases typically involve information that enhances understanding of scientific, clinical, or business-related issues relevant to our products or therapeutic areas, which is not otherwise accessible to Bausch + Lomb.
Non-patient identified prescriber data is utilized to facilitate efficient communication with HCPs and support activities such as sharing important safety updates, conducting research, targeting sales and marketing efforts, and monitoring adverse events. Any agreement for non-patient identified data must include assurances that the data comply with HIPAA de-identification standards.
In rare cases, Bausch + Lomb may purchase patient-identified prescriber and treatment data. Both non-patient identified, and patient-identified data are handled responsibly, in compliance with applicable laws, and with respect for confidentiality. Questions about the use of non-patient identified data should be directed to the data’s business owner within Bausch + Lomb and Compliance as needed. Furthermore, requests from HCPs to withhold their prescriber data from Bausch + Lomb sales representatives must be honored.
Data purchases must be based on a legitimate, documented business need, and the scope of data acquired should be limited to what is necessary to fulfill that need. Agreements for data purchases must be documented in a written contract, signed by both parties, with a term of at least one year unless otherwise approved by the Legal Department. The agreement should clearly describe the data to be provided and specify a Fair Market Value (FMV) fee for the purchase. FMV determinations should consider fees for comparable data and must be properly documented and retained.
Before finalizing a data purchase, Bausch + Lomb should ensure the data is not already accessible from other sources, such as third-party vendors or other customers. If the necessary data can be obtained from a third-party vendor (e.g., IMS Health), that option should be preferred over purchasing directly from a customer.
The Bausch + Lomb colleague managing the data purchase should ensure timely delivery of data in the agreed format. They should also assess the treatment of associated fees under government price reporting laws and whether these fees must be reported under the federal Physician Payment Sunshine Act or applicable state laws. For guidance, consult Managed Markets, Financial Operations, or Compliance.
Prohibited Data Purchases Include:
Data Purchase Arrangements
Bausch + Lomb occasionally purchases data from Customers or healthcare organizations (HCOs) to support legitimate business functions, such as outcomes research, market research, or other appropriate activities. These data purchases typically involve information that enhances understanding of scientific, clinical, or business-related issues relevant to our products or therapeutic areas, which is not otherwise accessible to Bausch + Lomb.
Non-patient identified prescriber data is utilized to facilitate efficient communication with HCPs and support activities such as sharing important safety updates, conducting research, targeting sales and marketing efforts, and monitoring adverse events. Any agreement for non-patient identified data must include assurances that the data comply with HIPAA de-identification standards.
In rare cases, Bausch + Lomb may purchase patient-identified prescriber and treatment data. Both non-patient identified, and patient-identified data are handled responsibly, in compliance with applicable laws, and with respect for confidentiality. Questions about the use of non-patient identified data should be directed to the data’s business owner within Bausch + Lomb and Compliance as needed. Furthermore, requests from HCPs to withhold their prescriber data from Bausch + Lomb sales representatives must be honored.
Data purchases must be based on a legitimate, documented business need, and the scope of data acquired should be limited to what is necessary to fulfill that need. Agreements for data purchases must be documented in a written contract, signed by both parties, with a term of at least one year unless otherwise approved by the Legal Department. The agreement should clearly describe the data to be provided and specify a Fair Market Value (FMV) fee for the purchase. FMV determinations should consider fees for comparable data and must be properly documented and retained.
Before finalizing a data purchase, Bausch + Lomb should ensure the data is not already accessible from other sources, such as third-party vendors or other customers. If the necessary data can be obtained from a third-party vendor (e.g., IMS Health), that option should be preferred over purchasing directly from a customer.
The Bausch + Lomb colleague managing the data purchase should ensure timely delivery of data in the agreed format. They should also assess the treatment of associated fees under government price reporting laws and whether these fees must be reported under the federal Physician Payment Sunshine Act or applicable state laws. For guidance, consult Managed Markets, Financial Operations, or Compliance.
Prohibited Data Purchases Include:
The discussion of data purchase arrangements should be separate from the negotiation of discount arrangements and independently meet the requirements set forth in this guidance.
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