Contents
In the Cephalon Medicaid rebate settlement, Cephalon agreed to pay $7.5 million to resolve allegations that it improperly deducted wholesaler service fees from average manufacturer price, reducing rebates owed to Medicaid. The government alleged a calculation choice a pricing employee would recognize: money paid for distribution services entered the calculation as a reduction in the price of the drugs. That choice allegedly left the manufacturer owing less to a public health care program.
The Justice Department announced the settlement on July 6, 2015. Cephalon, a Teva subsidiary, agreed to pay approximately $4.3 million to the United States and the remainder to participating states. A pharmacist brought the whistleblower lawsuit behind the resolution.
The Cephalon AMP wholesaler fee rebate settlement concerned payments that allegedly made the company’s reported drug prices too low. Under the Medicaid Drug Rebate Program, manufacturers pay quarterly rebates to states in exchange for coverage of their drugs. Average manufacturer price helps determine those rebates. A higher reported average manufacturer price means a larger rebate.
The government alleged that Cephalon underreported average manufacturer price for a number of its drugs by improperly deducting fees paid to wholesalers. It said that states consequently received smaller rebates and that the United States paid too much toward the states’ Medicaid costs. State and federal taxpayers bore the alleged shortfall.
A qualifying bona fide service fee stays outside the price calculation. Treating the payment as a price concession instead reduces the price used in that calculation. The commercial payment can remain the same while its treatment changes the rebate bill.
In the government’s account, paying the wholesaler for services also became a way to pay Medicaid less.
A pharmaceutical wholesaler buys and distributes drugs, and can also receive payment from the manufacturer for services. Product moves from manufacturer to wholesaler to dispenser. Money also moves back from the manufacturer to the wholesaler under the service arrangement. That second direction is where this case’s allegation begins.
Distribution work can include inventory management, stocking and administrative services. A contract employee may know the promised work, a distribution employee may know whether it happened, and a pricing analyst may know how the fee entered average manufacturer price. Each sees a different part of the same commercial arrangement.
For a wholesaler-fee case, we examine the service arrangement alongside the calculation that produced the reported average manufacturer price. An insider may know what the manufacturer bought, while the government sees the number the company reported.
A distribution-services agreement identifies the work the manufacturer agreed to purchase. The fee schedule shows what it agreed to pay. When the contract promises inventory management or administrative work, we look at the work delivered alongside the payment assigned to it.
The AMP misreporting question is what happened to the payment after finance recorded it. In Cephalon’s case, the government alleged that fees paid for wholesaler services became deductions from drug prices. The contract describes the purchase; the calculation shows how the company used it to determine what Medicaid was owed.
Manufacturers submit their price reports to the Centers for Medicare & Medicaid Services. An authorized officer or directly delegated individual certifies them. That connects the transaction inside the business to the number the government uses for this public healthcare program.
We read the assumptions and any later price restatements with the underlying transaction. Written assumptions can explain why the company treated a payment one way. We work through that reasoning with an insider who knows why a particular payment lowered average manufacturer price.
An outside estimate can combine payments that an internal pricing calculation has to distinguish. The 2020 USC Schaeffer Center white paper The Association Between Drug Rebates and List Prices estimated the gap between list and net prices using company revenue and third-party sales-volume data. Its method shows how much can sit inside a single label:
Rebates to PBMs likely account for most of this difference, but other contributors include manufacturer payments and discounts to other intermediaries including wholesalers and pharmacies. For simplicity, we refer to the entire difference as “rebates.”
The Association Between Drug Rebates and List Prices, USC Schaeffer Center White Paper Series, 2020
The paper describes most drug-price and rebate information as confidential. An insider’s knowledge can explain what that broad estimate cannot: what a particular wholesaler payment bought and how the manufacturer treated it in the government calculation.
Yes. A pharmacist brought the False Claims Act qui tam lawsuit that led to Cephalon’s settlement. The case concerned a manufacturer’s treatment of wholesaler payments and the resulting Medicaid rebates, an issue that reaches beyond what happens at the dispensing counter.
The same lawsuit also produced AstraZeneca’s separate $46.5 million settlement, announced the same day. The government alleged a similar wholesaler-fee deduction mechanism against both companies.
For a pharmacist or another pharmaceutical whistleblower, knowing the transaction can be the starting point. We work with the person who can explain the mismatch between the service arrangement and the reported price, and connect that account to the calculation and the company’s decisions.
A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
Bristol-Myers Squibb agreed to a separate $75 million settlement announced on April 1, 2021. The same pharmacist brought that case. Alongside allegedly improper wholesaler-fee deductions, it concerned additional value the manufacturer allegedly received under price-appreciation provisions in its wholesaler contracts and excluded from average manufacturer price.
Price appreciation begins with inventory bought before a manufacturer raises its price. A wholesaler can sell that stock at the higher price, and the contract can return some of the increase to the manufacturer. The later allegation concerned that value coming back into the business, as well as fees going out.
Another drugmaker, the same pharmacist, and another allegation that Medicaid received too little. These cases show how pharmaceutical fraud settlements can turn on different payments within the same kind of commercial arrangement.
If you know how a wholesaler’s service payment became an AMP deduction, talk with our whistleblower experts about the calculation you saw. We build your strongest case around your knowledge of the contract and the pricing decisions, bring in pharmaceutical pricing whistleblower lawyers who understand Medicaid rebate disputes, and stand beside you throughout the case.