Regeneron: Eylea Copays, Card Fees and the Medicare Bill

The Regeneron Eylea False Claims Act case concerns separate allegations that the drugmaker used a copay foundation to support Eylea sales and left credit-card fee payments out of the price reports that determine Medicare reimbursement. Both concern money spent outside the drug invoice that allegedly made Eylea more attractive to the physicians buying it. For someone in patient assistance, distributor contracting or government pricing, the important decisions happened before a Medicare claim arrived: who received the benefit, who approved it, and how the company accounted for it.

The Justice Department filed the copay case itself in 2020. In its April 2024 announcement of the separate pricing complaint, the Justice Department said it had joined a case prompted by whistleblower allegations. These pharmaceutical fraud cases concern different payments and different decisions inside the same business.

Eylea Copay Funding and the Cost of an Injection

Eylea is a physician-administered drug used to treat wet age-related macular degeneration, a condition that impairs vision. In the buy-and-bill arrangement described in the complaints, retina practices buy the drug through distributors, administer it, and bill Medicare Part B. They also collect the patient’s share. The doctor prescribing Eylea is therefore also the customer purchasing it.

The government’s amended copay complaint describes patients generally responsible for a 20% share after the deductible, unless supplemental insurance covers it. It alleges that Regeneron used the Chronic Disease Fund to remove that expense for Eylea patients and spare physicians the job of collecting it. For an approved patient, the physician could bill the foundation after administering the injection, and the foundation paid the physician directly.

A Higher Launch Price With Help for the Copay

The complaint places copay assistance inside the launch-price decision. Before Eylea went on sale in late 2011, Regeneron considered a price between $1,500 and $1,950 per injection. The government alleges that it chose $1,850 because paying more into a foundation could absorb the higher copay for patients and physicians. Its pricing consultant had projected that the additional revenue would outweigh the additional foundation expense.

That arrangement could reverse the price comparison the patient saw. The complaint describes Genentech’s Avastin as a much cheaper alternative used off-label in eye treatment, yet says the foundation covered Eylea and Lucentis while excluding Avastin. With assistance, the expensive drugs could cost the patient less. The government’s allegation is that Regeneron could preserve a high drug price while removing the out-of-pocket expense that might otherwise push the patient and physician toward a cheaper choice.

The Donation Followed Eylea Patients

The government alleges that Regeneron funneled tens of millions of dollars through the Chronic Disease Fund, with funding calculations tied to how many Eylea patients it would support. The government says senior management wanted assistance tied to the company’s own drug and wanted a return on the money. Its amended complaint describes the calculation:

In the government’s account, the arrangement kept the patient’s bill down while leaving taxpayers to fund the high-priced drug. The foundation’s projections allegedly traveled into the manufacturer’s budget process. The complaint describes a spreadsheet estimating Eylea patients, renewals and funding needs, followed by internal discussions about potential lost sales if assistance fell short. Reimbursement and market-access staff, financial planning and commercial leadership all appear in that account. The alleged donation budget was being evaluated as a sales investment.

The Email Changed Before the Auditors Saw It

The government alleges that Regeneron’s commercial chief altered an email before forwarding it to internal audit. Auditors had asked how the company determined its payments and whether it received reports on how the foundation spent the money. By then, according to the complaint, the commercial team had already used Eylea-specific patient and funding projections to plan its contributions.

The change described in the complaint turned a reluctance to provide existing documentation into a reluctance to ask for it:

The government says the altered message made it appear that the company would have needed to request data it already possessed.

Copay Foundation Independence and Product-Specific Data

An independent foundation decides whom to help without letting a manufacturer’s sales interests decide the answer. The HHS Office of Inspector General’s patient-assistance safeguards call for assistance independent of donor control, awarded without regard to the donor’s product interests, and based on a consistent measure of financial need. They also address the information moving back to the donor: product-specific data can let a manufacturer match its contributions to subsidized prescriptions.

The Regeneron complaint alleges that employees circulated the government’s guidance while continuing to obtain and use Eylea-specific information. A fund could cover more than one manufacturer’s drug while still sending each donor the information needed to calculate support for its own sales. In this case, the government’s account turns on what the manufacturer learned from the foundation and what it did with those numbers.

A similar funding-and-data connection appeared in Teva’s Copaxone case. In October 2024, Teva agreed to pay $425 million to resolve the copay allegations. The government alleged that Teva worked with assistance foundations and a specialty pharmacy to direct funding to Copaxone patients.

Advanced Care Scripts separately acknowledged relaying foundation spending data to Teva and giving it updates about patients awaiting assistance. The pharmacy said an employee understood that Teva would use the waiting-patient counts to help determine its next payment. When funds reopened, the pharmacy sent batch files of applications consisting almost entirely of Copaxone patients.

Regeneron Eylea Credit Card Fee ASP Allegations

The Regeneron Eylea credit card fee ASP allegations concern payments to distributors that allegedly lowered customers’ purchasing costs without lowering the average sales price reported to Medicare. The Justice Department says Regeneron paid the processing fees so that retina and ophthalmic practices could use credit cards while retaining the lower cash price. Practices could also receive cash back and other card rewards.

Medicare uses manufacturer-reported average sales price to set payment rates. The complaints describe the usual Part B formula as 106% of ASP before payment reductions and patient cost sharing. Price concessions reduce the reported average. The government alleges that leaving out the fee payments kept Eylea’s reported price, and therefore Medicare reimbursement, too high.

That price report is assembled from a manufacturer’s quarterly sales and unit totals. A senior company official certifies its accuracy. A credit-card benefit booked elsewhere in the company can therefore matter even when the invoice price looks unchanged. The alleged reporting failure sits between those records: what the company paid to help the customer buy Eylea, and what its certified report told Medicare the drug had sold for.

The commercial benefit ran through the distributor. A practice could get the lower purchase price, avoid a card fee and still collect reimbursement calculated from an allegedly overstated benchmark. That is the average sales price fraud allegation: the benefit reached the customer while the price report failed to reflect it.

The scale explains why a processing fee matters here. The Justice Department put total Medicare payments for Eylea at more than $25 billion from 2012 through 2023. It alleged hundreds of millions of dollars in inflated reimbursements from the reporting conduct.

The Whistleblowers’ View of Distributor Discounts

The original whistleblower complaint gives a closer view of the sales pitch. Filed in 2020, it alleged that Regeneron subsidized discounts and card-fee waivers through Besse Medical. The whistleblowers said those benefits encouraged practices to switch both their drug purchases to Eylea and their distribution business to Besse Medical.

Their complaint describes a drug-profitability spreadsheet used in sales discussions. It allegedly showed how a practice could increase its margin through discounts that left the reimbursement benchmark untouched. The filing identifies an Amex rebate entry as the subsidized card-fee waiver and says reimbursement business managers used the calculations with practice office managers:

The same complaint says official presentation notes prohibited reimbursement managers from discussing product profitability based on ASP or comparing Eylea’s rate with another drug’s. The alleged gap between the approved presentation and the spreadsheet used with customers makes the internal sales materials especially revealing.

Why the Service-Fee Label Mattered

Calling a payment a bona fide service fee affects whether it reduces the reported price. Such a fee must pay fair market value for an itemized service performed for the manufacturer, a service the manufacturer would otherwise perform or purchase. The benefit must also stay with the service provider rather than pass to its customer.

The Justice Department alleges that Regeneron tried to classify the card payments as service fees despite knowing they did not qualify. The practical issue is what the distributor received payment to do and who ultimately benefited. Paying a distributor to absorb its customer’s card expense changes the customer’s purchase terms, even though the manufacturer pays the distributor.

This is why the invoice alone can miss the economics. The USC Schaeffer Center’s 2020 paper The Association Between Drug Rebates and List Prices found that increases in rebates were associated with increases in list prices across branded drugs. In Regeneron’s case, the government identifies a particular payment it says the reported average omitted.

The Records Behind the Payment Decision

The copay account supplies unusually concrete examples: foundation projections, donation approvals, expected sales returns, audit questions and different versions of an email. We examine how those records fit together and what they show about the people making the decision.

A foundation report showing Eylea patients has a different significance when the same report is used to approve the next contribution. An audit response has a different significance when an earlier message shows that the commercial team already possessed the information it denied receiving. The government’s complaint alleges both connections. Patient-support and finance employees may recognize the decision process even if they never handle a Medicare claim.

On the pricing side, distributor agreements and fee payments show who bore the card expense. Customer terms and sales spreadsheets show the benefit offered to the practice. The government alleges that the company’s ASP reports omitted the fee payments. The practice’s purchase, the manufacturer’s calculation and Medicare’s reimbursement are different parts of that chain.

The original pricing complaint identifies whistleblowers with responsibilities in reimbursement support, commercial sales management and analytics. Those roles covered helping offices secure reimbursement, reviewing sales and customer data, and measuring Eylea’s performance. The case shows why pharmaceutical whistleblowers can contribute different pieces of the same transaction. Our work with an insider is to connect that view of the business to the payments the government made.

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

You Saw the Payment Decision

If you worked with foundation funding, distributor fees or Eylea price reports, talk with our whistleblower experts about the decisions you saw. We build the case with you and bring in pharmaceutical pricing and kickback whistleblower lawyers who understand how those payments reach Medicare. We stay beside you from the first conversation through the pursuit of a recovery.