Reimbursement Promises and Excess Samples: When a Manufacturer Removes the Buyer’s Risk

A reimbursement promise becomes a kickback when a manufacturer offers to cover a buyer’s reimbursement shortfall to induce purchases billed to government health care programs. The buyer gets protection against a denied claim or a payment below the drug’s purchase cost. Excess free samples can add another benefit: enough product to treat patients whose insurance will not cover it. For someone in market access or a surgery center’s reimbursement office, the question is what the manufacturer offered to make the next order happen.

EyePoint Pharmaceuticals sold DEXYCU, an injectable drug for ocular inflammation following cataract surgery. The Justice Department alleged that EyePoint used both its Assurance Program and excessive free samples to induce ambulatory surgery centers to purchase and dispense the drug. The promise and the product each changed what the center stood to lose by choosing DEXYCU.

Two Benefits in the Same Sale

The reimbursement promise addresses the purchased drug. Under the alleged EyePoint Assurance Program, the manufacturer would reimburse or compensate a center when an insurer denied its DEXYCU claim or paid less than the center’s purchase cost. The center could buy with the expectation that the manufacturer would absorb that shortfall.

Free product addresses another expense. The EyePoint whistleblower complaint alleged that samples subsidized surgeries for patients whose coverage did not reimburse DEXYCU, encouraging continued purchases for patients covered by government programs. A free unit used in a commercially insured surgery could therefore help sell a purchased unit used in a Medicare surgery.

That is why the recipient matters. The alleged benefit went to the business buying and using the drug. A promise to protect that business from loss, or product it could use without paying, could influence the next order as directly as a payment.

What Is a Pharmaceutical Kickback?

A pharmaceutical kickback is a payment or other benefit knowingly and willfully offered or paid to induce referrals, purchases or orders covered by a federal health care program. The Anti-Kickback Statute reaches benefits supplied indirectly and in goods or services, as well as cash. Claims for items or services resulting from a violation are false claims under the False Claims Act.

For this arrangement, the benefit is the expense or risk the manufacturer takes off the purchaser’s hands. In the alleged arrangement, taxpayers funded the purchased doses while free product helped steer the center’s choice of supplier. The EyePoint complaint alleged that free product for one group of patients encouraged purchases for another group whose drugs the government would pay for.

When Reimbursement Support Removes the Buyer’s Risk

The HHS Office of Inspector General’s 2003 pharmaceutical manufacturer guidance specifically addressed reimbursement support coupled with a promise that eliminates normal financial risk. It identified the combination as raising kickback concerns, including an arrangement under which a buyer pays for ordered products only if a federal health care program reimburses it.

The guidance addressed reimbursement support with no substantial independent value to the purchaser when it came with a separate financial benefit: protection against the purchase going unpaid. The support service helps with the claim. The promise changes who bears the loss if the claim fails.

That distinction puts the contract and the sales pitch beside each other. What loss did the manufacturer agree to cover? Who could receive the benefit? Was the promise tied to purchases or continued use? In the EyePoint allegations, the relevant events were concrete: a denied claim or reimbursement below purchase cost, alongside excess samples supplied to purchasers.

The Purchase Price and the Payer’s Payment

When a manufacturer’s reimbursement promise covers payment below acquisition cost, the kickback allegation turns on why the manufacturer offered to absorb the gap. Acquisition cost is what the buyer paid for the drug. The insurer’s reimbursement is a separate transaction, and the program terms determine when the manufacturer steps in.

The historical payment setting helps explain the sales problem. The EyePoint complaint filed in 2021 described DEXYCU and competing DEXTENZA as separately payable Medicare Part B drugs during their temporary pass-through period. It also described uneven commercial insurance coverage. A center could receive a separate drug payment for one patient and have to absorb the cost for another.

According to the complaint, ophthalmologists preferred using a single drug across patients because it simplified billing and supported uniformity of outcomes. Gaps in coverage discouraged purchases even for patients whose insurance would pay. The alleged sample offer addressed that obstacle across the center’s patient population.

For reimbursement staff, this is the difference between a published payment benchmark and the economics of a particular surgery. The invoice shows the purchase expense. The payer response shows the allowed payment or denial. A manufacturer credit or compensation payment shows whether the promised protection reached the center.

Excess Samples Can Sell the Purchased Doses

Excess samples can subsidize the buyer’s work and encourage future government-paid purchases. The EyePoint complaint alleged that the company supplied free DEXYCU with purchased prescriptions so physicians could use the drug for patients whose insurers did not cover it. It connected that subsidy to continued purchases for Medicare, Medicaid and TRICARE patients.

The whistleblower’s complaint quoted an email from a surgery center’s nurse administrator asking a competing supplier whether it offered the same arrangement:

A customer was asking the rival to match the sample deal. The complaint also alleged that an operating-room whiteboard identified patients receiving DEXYCU samples. That observation connected the commercial offer to particular procedures.

The alleged incentive reached beyond the free unit. The complaint argued that even a purchased dose could generate a false claim when the free-product arrangement induced its purchase. The relevant trail therefore includes the samples used for privately insured patients and the purchased doses billed to government programs.

Free Samples Billed to Medicare

Free samples billed to Medicare create a separate claim problem: the provider seeks reimbursement for product it received without charge. TAP Pharmaceutical Products’ 2001 Lupron case included an indictment charging that practice, alongside allegations that TAP marketed the profit between discounted drug purchases and Medicare reimbursement.

In that historical arrangement, the government alleged that TAP used a higher reported average wholesale price to increase reimbursement while selling the drug to physicians at a discount. The difference became part of the sales pitch. The buyer’s actual cost and the amount used for reimbursement told different stories about the same drug.

Those allegations show why both the unit and the broader sales arrangement matter. A billing review follows the free sample into a claim. The EyePoint complaint’s inducement theory also follows the benefit into subsequent purchases. Looking only for a claim submitted for a free unit would leave that second connection unexplored.

The Records That Connect the Promise to the Claim

We work with reimbursement and market-access insiders to connect the manufacturer’s promise to the center’s costs, free product and government claims. The written terms and sales emails show what the buyer was offered. Purchase invoices, payer responses and manufacturer credits show whether the promised protection reached the center.

Sample shipments, allocation records and procedure records connect free inventory to its use. The operating-room whiteboard described in the EyePoint complaint shows how an insider could recognize that connection. We compare the program’s terms with the services and product it actually supplied, then follow the benefit into claims and later orders.

A manufacturer can cause a false claim that a provider submits. Someone who worked on the offer, the sample allocation or the reimbursement support may hold a consequential part of a healthcare fraud case even if another business handled the billing. The EyePoint allegations connected a commercial insurance problem to government-paid sales through the same purchasing decision.

What Happened in the EyePoint Case?

In July 2026, EyePoint agreed to pay the United States $4,657,463 to resolve the False Claims Act allegations involving its Assurance Program and excessive samples. The government described conduct from 2019 through 2023. The resolution paired the federal payment with a five-year corporate integrity agreement with the HHS Office of Inspector General and separate payments to participating states.

The civil settlement resolved claims brought by a corporate whistleblower and provided for a whistleblower reward. Its complaint identified its managing members as people who had worked for a competing ophthalmic drug manufacturer. Their account connected what customers said about the offer with how the free product was used inside surgery centers.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know What Secured the Order

If you know how a reimbursement promise or excess samples secured drug purchases, talk with our whistleblower experts about the offer and the resulting claims. We work beside you throughout the case and bring in pharmaceutical kickback whistleblower lawyers who understand reimbursement arrangements. Together, we build your strongest case around the manufacturer’s terms, the center’s actual costs and the government-paid business.