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Product Discount and/or Rebate Arrangements

Bausch + Lomb routinely enters into product discount and rebate agreements with healthcare organizations (HCOs), including but not limited to commercial and government health plans, pharmacy benefit managers, government healthcare programs, group purchasing organizations, integrated delivery networks, hospitals, and other providers, as well as individual practice purchasers. These agreements offer rebates and price concessions on Bausch + Lomb products purchased by the Customer or, in the case of pay-for-performance arrangements, used by the PByFr’s members.

This section outlines the general requirements for product discount and rebate arrangements to ensure all agreements comply with applicable laws and regulations, including but not limited to the federal Anti-Kickback Statute (AKS), the Personal Services Safe Harbor, and the AKS Discount Safe Harbor.

Quick Tips:

  • Product discount and/or rebate arrangements must be for a legitimate business need and documented by a written agreement.
  • Only appropriately trained Bausch + Lomb Colleagues may initiate and have discussions related to product discount arrangements.
  • Bausch + Lomb Colleagues must ensure the appropriate Functions, including Managed Markets and Legal and Finance, review and approve the arrangement as well as the required written agreements.

General Guidelines

Contractual Arrangement Discussions by appropriate Bausch + Lomb Colleagues
Only specific Bausch + Lomb colleagues with responsibilities related to product contractual agreements—and who have received appropriate training—may engage in discussions involving these contracts. Such discussions may include initiating, negotiating, or reviewing contractual arrangements.

Authorized personnel, such as Corporate and National Account Managers and Trade Directors, are the only individuals permitted to negotiate discounts, price concessions, and related pricing matters with healthcare organizations (HCOs) such as retail, long-term care, or specialty pharmacies. These negotiations must align with pre-approved pricing ranges established by the Pricing Governance Committee.

Colleagues without designated contractual responsibilities or training must refrain from discussing these topics with Customers. All contractual arrangements must be handled by the appropriate department and adhere strictly to company policies.

When pricing discussions occur, they must comply with all applicable laws and regulations, including the Anti-Kickback Statute (AKS), the AKS discount safe harbor, and government price reporting rules.

For example, no discussions should involve grants, charitable contributions, sponsorships, service agreements (including consulting, speaking, or data purchase), collaborations, patient access programs, clinical trials, or any “off-invoice” items or transfers of value during product contracting negotiations.

 

Due Diligence and Eligibility
Proper due diligence must be conducted when entering into product discount arrangements with HCOs or Customers, documented through financial assessments, business case materials, meeting minutes, or other relevant records. The extent of due diligence depends on the arrangement type.

For agreements involving administrative fees, colleagues must determine whether the fee corresponds to bona fide services consistent with the AKS personal services safe harbor and government price reporting requirements. Compliance should be consulted for guidance as necessary.

Only designated Managed Markets colleagues are authorized to perform return on investment (ROI) analyses related to Customer performance under product discount contracts.

Bausch + Lomb must not engage a Customer as a service provider solely because they are, or could become, a significant purchaser or prescriber of products.

Written Agreements
All product discount and rebate arrangements must include:

  • Clear pricing and rebate terms, including payment details and schedules where applicable.
  • Appropriate representations and warranties affirming compliance with applicable laws, including the AKS.
  • Provisions addressing bona fide service fees and ensuring physician independence related to medical and formulary decisions, if applicable.

Invoicing
For direct purchase agreements, Bausch + Lomb’s invoices must accurately reflect all known discounts at the point of sale (i.e., upfront discounts) and include language informing Customers of their potential obligation to report these discounts to government agencies in cost or charge claims.

Review and Approval
Before engaging in discount arrangements with Customers, Bausch + Lomb colleagues must first consult Managed Markets and the Legal Department. All product discount contracts require review and approval by relevant departments, including Managed Markets, Legal, Compliance, Finance, and Pricing. Discounts and concessions must be approved per company policy.

The Pricing and Governance Committee oversees all strategic, operational, and regulatory matters regarding pricing and contracting for Bausch + Lomb products. This committee regularly updates Pricing and Governance Policies to ensure compliant price management.

The committee may review and approve changes such as contractual terms, administrative fees, pricing outside approved guidelines, or agreement modifications during the contract term. Refer to the Pricing and Governance Committee process for details.

 

Records Retention
All documentation supporting product discount arrangements must be maintained by the designated personnel in compliance with Bausch + Lomb’s document retention policies. Responsibility for retaining and managing documentation rests with the department overseeing the Customer relationship.

Pricing Guidelines

When contracting with specific Customers (e.g., group purchasing organizations, payors), colleagues should consult the Contracts and Analytics team and Legal Department as appropriate.

Below are general pricing guidelines. Please refer to the Bausch + Lomb Pricing and Governance Policies and Procedures for additional guidance.

  • Prohibiting improper incentives such as samples, free products, illegitimate fees, or service arrangements. Product warranties and personal services cannot be offered as discounts.
  • Discounts cannot involve supplying products or services free or at a reduced rate to induce purchasing of others unless all items are reimbursed under the same federal healthcare program via the same methodology and disclosed properly.
  • Discounts may not be given as cash or cash equivalents, except rebates which may be paid by check.
  • Discounts and multi-product rebates must comply with applicable laws, including the AKS.

Discounts, as well as bundled or multi-product rebates, should be structured to conform to all applicable laws and regulations including the Anti-Kickback Statute.

Price Reporting
Pricing negotiations must comply with all internal approval processes and applicable government reporting obligations. Government organizations must receive accurate and complete information regarding prices and concessions offered to pharmacy Customers.

When reporting “Best Price,” all cash discounts, promotional free goods, volume discounts, and rebates (outside of Medicaid Drug Rebate Program rebates) must be included. Additionally, free or reduced-price services, grants, or other benefits offered to encourage sales may also be considered pricing terms.

Administrative Fees and Services
Occasionally, Bausch + Lomb pays administrative fees to Customers for legitimate services related to rebate administration or contract management. Such fees must:

  • Be bona fide payments for legitimate, itemized services were actually performed on behalf of Bausch + Lomb—services that the company would otherwise conduct or contract out.
  • For payor and group purchasing organization arrangements, fees must not exceed Fair Market Value (FMV), and Customers must represent compliance with applicable safe harbors.
  • For arrangements with PayFrs and group purchasing organizations, Customers must represent they are in compliance with relevant and applicable safe harbors.

All price concessions and administrative fees must comply with government price reporting requirements, including reporting average sales price, average manufacturer price, and Best Price to the Centers for Medicare & Medicaid Services.

Antitrust and Competition Laws

Bausch + Lomb values fair competition based on product quality and merit, adhering strictly to competition laws globally. To comply with U.S. antitrust laws, employees must never discuss pricing, pricing strategies, profits, costs, promotional or business plans, bidding policies, or intentions related to research or contracts with competitors or multiple Accounts.

Antitrust laws prohibit differential pricing for similarly situated competing Customers that could harm competition, requiring Bausch + Lomb to offer comparable prices and discounts unless legally justified.