Hospital Drug Discount Fraud: Buying the Prescription That Follows

Whistleblower Justice Network

Hospital drug discounts tied to outpatient prescriptions become fraud when manufacturers knowingly conceal reportable concessions from Medicaid. In the Merck and Wyeth cases, the government alleged that cheap hospital drugs helped secure business after discharge while the discounts disappeared from government pricing. If you negotiated the hospital deal or prepared the Best Price report, you may know how a discount used to win the account was kept out of the number sent to Medicaid.

The commercial opportunity extends beyond the hospital’s purchase. A manufacturer can accept less for the drug used during a hospital stay to gain the prescriptions that follow the patient home. The Merck and Wyeth allegations put that opportunity beside a second financial benefit: paying Medicaid less in rebates by leaving the hospital concession out of the calculation.

Where 340B Fits in Hospital Drug Pricing

The 340B program sets a ceiling on what eligible providers pay for covered outpatient drugs. The ceiling comes from the preceding quarter’s average manufacturer price minus the Medicaid unit rebate amount. When a hidden hospital concession reduces the Medicaid rebate, it also raises the calculated 340B ceiling. The manufacturer’s pricing report can shortchange Medicaid and leave safety-net providers facing a higher price cap.

The rules connect to Best Price through specific exclusions. The Medicaid Best Price regulation excludes prices charged to qualifying covered entities, including inpatient prices charged to specified hospitals.

Where the Discount Reaches the Government

Medicaid rebate reporting asks what price the manufacturer made available to qualifying buyers after applicable discounts and other concessions. Manufacturers report their prices, while states report drug utilization. A concealed concession can leave the reported Best Price too high and the rebate too low.

For a hospital contracting employee, the useful connection may be the promise behind the price: preferred use, a volume commitment or a condition tying one product’s discount to another. For the government-pricing employee, it may be the decision that left that concession outside the reported number. The same agreement can explain both sides.

Merck’s Pepcid Discount Followed the Patient Home

Merck allegedly reduced Pepcid prices for hospitals that agreed to use it primarily instead of a competitor’s drug. The government said the company sought the business that followed discharge, when patients continued buying Pepcid outside the hospital.

The Justice Department’s February 7, 2008 announcement described Merck’s alleged use of the nominal-price exception to exclude hospital discounts from the prices it reported to the government.

The hospital discount had a job to do. It encouraged the hospital to favor the drug, giving Merck an opportunity to keep the patient as a customer afterward. According to the government’s allegations, the company used that commercial advantage while excluding the discounted price from Medicaid reporting as nominal.

A physician brought the Pepcid whistleblower case, which Merck agreed to resolve for $250 million. A separate $399 million settlement covered a former employee’s allegations about unreported Zocor and Vioxx hospital discounts and physician payments. Those hospital discounts allegedly depended on using large quantities in place of competing brands. Both cases put a hospital’s drug choice beside the price Merck reported to Medicaid.

Wyeth Linked the Oral Drug to the IV Discount

Wyeth allegedly bundled discounts on Protonix Oral and Protonix IV to win hospital use of the oral drug, then left the bundled concessions out of Medicaid pricing. The government’s account of the Protonix deal explains why the connection mattered: competing oral drugs were priced competitively and considered at least as effective and safe. Hospitals otherwise had little incentive to choose Protonix Oral.

The government alleged that discharged patients were likely to remain on the oral drug for long periods while payers, including Medicaid, paid nearly full price. In that alleged arrangement, the hospital got the discount, while taxpayers kept paying nearly full price after discharge.

The Best Price issue crossed the formulations. The government alleged that Wyeth hid the bundled discounts on both oral and intravenous Protonix. An analysis confined to either product’s invoice would miss the condition linking the two.

The bundled-sale rule addresses that connection. It treats a concession conditioned on another purchase or performance requirement as part of the arrangement, regardless of how the products are packaged. Discounts are allocated in proportion to the total dollar value of the drugs or products sold under the bundle. That puts the terms of the whole deal into the pricing analysis.

Wyeth and Pfizer agreed to a $784.6 million settlement, announced on April 27, 2016, over allegations that the hidden discounts avoided hundreds of millions of dollars in Medicaid rebates from 2001 through 2006. Two whistleblowers brought the allegations, and the settlement provided a combined federal and state whistleblower share of approximately $98 million.

Merck’s alleged exclusion depended on treating the hospital price as nominal. Wyeth’s alleged omission concerned discounts linked across products. The commercial destination was similar, but the pricing treatment that kept the concession out of Medicaid was different.

What Nominal Means in Medicaid Pricing

Nominal pricing has both a price threshold and a recipient requirement. The price must be less than 10 percent of the average manufacturer price for the same quarter, and the buyer must fall within an eligible category.

Those categories include covered entities in the 340B program, specified care facilities, qualifying family-planning providers, and certain nonprofit or state entities serving the same populations as covered entities. The hospital’s status is therefore part of the exclusion decision. A pricing employee may know both the amount charged and the basis used to treat the recipient as eligible.

Congress narrowed the eligible-recipient categories through the Deficit Reduction Act of 2005. The Merck settlements describe the government’s allegations about using the exception to omit hospital discounts. The recipient restriction adds a specific question to the price comparison: which eligible category did the buyer belong to?

What Evidence Is Needed to Prove Fraud?

The evidence must connect the hospital’s deal, the actual concession and the manufacturer’s price report to Medicaid. We work with insiders to establish that connection and build the case around what the manufacturer knew.

A separate whistleblower complaint against Astellas over pediatric promotion of Mycamine shows how explicit a hospital-use condition can be. The whistleblower alleged:

In order to obtain a substantial discount in excess of 45%, Defendants required children’s hospitals to sign marketshare (exclusivity) contracts with Astellas. This required the hospital to use Mycamine at least 80% of the time and penalized the hospital through pricing if the hospital were noncompliant.

Whistleblower’s complaint, United States ex rel. Smith v. Astellas Pharma, US Inc. et al., paragraph 65

That allegation identifies the bargain in terms a hospital buyer would recognize: a required share of use and a pricing consequence for missing it.

The payment record matters beyond the invoice. The Best Price regulation includes applicable cash and volume discounts, purchase-linked free goods, chargebacks, incentives and other concessions. It also requires adjustments when later rebates change the available price. That makes the original sale and the later rebate part of the same inquiry.

A senior officer or directly delegated individual must certify the manufacturer’s price report. That gives the reported number someone inside the company who has to stand behind it.

The USC Schaeffer Center’s 2020 paper, The Association Between Drug Rebates and List Prices, found a positive association between rebates and list prices. A large discount tells only part of the pricing story.

The People Who Know What the Discount Bought

Hospital contracting, pharmacy, market-access and government-pricing staff can see different parts of the same bargain. Someone may know why a hospital chose the drug. Someone else may know how the discount was coded, excluded or allocated. The connection between those decisions is what makes their knowledge valuable in a pharmaceutical whistleblower case.

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

You Know What Was Promised to the Hospital

If you know the hospital’s deal and how the manufacturer reported it, speak with our whistleblower experts about the discount and the prescriptions it bought. We build a case strategy around the transaction and bring in pharmaceutical whistleblower lawyers who understand Medicaid pricing and hospital contracts. We stay with you as partners through the case, connecting your knowledge of the bargain to the decisions behind the reported price.

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