Aegerion Pharmaceuticals: HoFH on the Form, High Cholesterol in the Pitch

The Aegerion Juxtapid fraud settlement required Aegerion Pharmaceuticals to pay $28.8 million to resolve allegations that it misled doctors, falsified reimbursement paperwork and used a foundation to cover patients’ copays. Former employees brought the case over a drug approved for a rare genetic disease. Their complaint describes a sales operation that allegedly avoided mentioning that disease to doctors, then insisted on putting it on the paperwork needed to get prescriptions approved. The alleged scheme put patients at risk and left taxpayers paying for prescriptions outside the approved population.

The Justice Department announced the civil settlement on September 22, 2017. Aegerion was a Cambridge, Massachusetts subsidiary of Novelion Therapeutics. This pharmaceutical fraud case connects decisions that employees in different departments could see: the sales message, the patient’s diagnosis, the information shared with the manufacturer and the route to a paid claim.

Juxtapid’s REMS Put the Diagnosis First

Juxtapid was approved to treat high cholesterol in patients with homozygous familial hypercholesterolemia, the rare genetic disease known as HoFH. The drug carried a warning about serious liver and stomach problems. Its Risk Evaluation and Mitigation Strategy tied access to a clinical or laboratory diagnosis consistent with HoFH.

The whistleblowers’ amended complaint describes the safety controls: prescribers had to enroll, undergo training and obtain certification. Each new prescription required an authorization form on which the prescriber affirmed that the patient had a qualifying diagnosis. The program also called for educating prescribers about liver risks and monitoring patients during treatment.

The diagnosis therefore did two jobs. It identified the population for which the Food and Drug Administration had accepted the drug’s risks, and it supplied information required to obtain the drug. Someone handling the authorization form was handling a patient-safety control as well as an access requirement.

That makes the alleged sales instructions especially striking. The condition that belonged on the form was the condition representatives were allegedly told to leave out of the conversation.

The Sales Pitch Left HoFH Out

The complaint alleges that Aegerion pushed off-label promotion by presenting Juxtapid as a treatment for difficult high-cholesterol cases. One representative described doctors returning her card when she explained that the drug treated HoFH. They told her they had no patients with the disease, and some said they had never seen one.

According to the complaint, the national sales director’s response was:

The representative was allegedly told to describe a breakthrough lipid treatment for patients whose high cholesterol resisted treatment, then invite interested doctors to lunch. The complaint also describes regional sales reviews that treated avoiding a definition of HoFH as a successful tactic.

The incentives were allegedly tied to prescriptions. The whistleblowers alleged a one-time $9,000 bonus for each new prescription, with an additional $3,500 for each new prescription shipped during a sales contest. The complaint put Juxtapid’s price at $311,000 per year of therapy. A prescription was valuable to both the company and the representative.

The pressure allegedly continued after a doctor reconsidered. The complaint describes a physician who reviewed four patients’ charts and concluded they did not have HoFH. Company personnel allegedly called repeatedly to change his mind. A sales director told the representative that the chief executive had already reported those prescriptions to Wall Street as revenue. In that account, the revenue expectation survived the doctor’s rejection of the diagnosis.

The Diagnosis Changed on the Payment Form

The civil settlement covered allegations that Aegerion employees altered or falsified medical-necessity statements and prior authorizations submitted to federal health care programs. The whistleblowers described changes designed to get Medicare and Medicaid to pay. The complaint makes this manufacturer-run prior authorization problem concrete through Compass, Aegerion’s in-house patient support program.

Compass assigned case managers to help enrolled patients with insurance reimbursement. The whistleblowers alleged that those managers expected the medical-necessity paperwork to carry a particular diagnosis code and wording about clinical signs and symptoms consistent with HoFH, even when that was not what the physician had written.

In one example, a doctor sent the patient’s complete record to the specialty pharmacy without filling out the required statement of medical necessity. The pharmacy could not process the prescription and contacted Compass. According to the complaint, a Compass case manager instructed the doctor’s staff to complete the form and change the diagnosis code from 272.9 to 272.0. The prescription went through. The doctor allegedly learned about the code change only when the sales representative later told him.

Elsewhere, the complaint identifies the replacement code as pure hypercholesterolemia and describes instructions to pair it with language about HoFH. Both the code and the accompanying words mattered to the alleged effort to obtain coverage. The employee who saw the original chart and the revised form could see how the diagnosis presented for payment had changed.

The information gap between a clinical record and a dispensing transaction also appears in the 2018 Managed Care article Indication-Specific Drug Pricing–Simple in Theory, Complex in Reality. Discussing the difficulty of pricing drugs by the condition treated, it quotes an industry expert:

A pharmacy can receive the information needed to process a prescription without the payment transaction carrying the full clinical account behind it. In Aegerion’s case, the whistleblowers alleged that the manufacturer helped change that information.

Patient Names Became Sales Leads

The civil complaint also alleges that Aegerion obtained identifiable patient information before patients consented to its release. It describes doctors or nurses giving the company patient names, and sales representatives using those names to start discussions about Juxtapid, physician certification and prescription authorization.

The alleged access went beyond receiving a completed form. Representatives allegedly participated in electronic medical-record searches and chart reviews at doctors’ offices, seeing patient information without names removed. They also allegedly supplied doctors with forms already populated with patient data. The complaint describes access to information about people who had not yet consented and people who never consented.

The complaint gives a specific example at a cardiology practice. A doctor allegedly provided a sales representative with a laptop and a conference room, ran queries with him, then left him alone to review electronic charts for findings consistent with HoFH. The search allegedly produced eight candidates, none with a clinical diagnosis or genetic test indicating HoFH. The company allegedly circulated the exercise in emails to the sales force as a success.

A useful parallel is QOL Medical’s use of free diagnostic testing to generate sales leads. The government’s account of QOL’s testing program describes a laboratory sending results to the company as well as to providers. QOL passed positive results to its sales force and tracked whether follow-up calls produced Sucraid prescriptions.

The connection is the commercial use of clinical information.

Copay Assistance Turned Free Drug Into Paid Claims

The government alleged that Aegerion covered patients’ Juxtapid copays by funneling funds through Patient Services Inc. in violation of the Anti-Kickback Statute. In the settlement announcement, the foundation was described as promoting its ability to create a “reimbursement vehicle” for Aegerion from patients who otherwise would have received free drug.

That comparison explains the money. Giving a patient free drug leaves the manufacturer supplying the medicine. Covering the patient’s copay can instead allow a claim for the rest of the price to reach the insurer, at taxpayers’ expense when a government program pays. The alleged benefit to Aegerion was the reimbursed prescription that the assistance made possible.

This is the commercial logic behind copay charity kickback allegations. Patient assistance can remove the patient’s immediate cost while preserving the manufacturer’s revenue from the payer. The government tied Aegerion’s alleged assistance arrangement to Juxtapid claims, alongside the separate allegations about diagnosis and authorization paperwork.

The Settlement Required Controls Around Promotion and Assistance

The resolution required changes to Aegerion’s commercial operations as well as a civil payment. Aegerion agreed to a separate civil consent decree with the FDA addressing failures to follow the Juxtapid REMS requirements and labeling that lacked adequate directions for the drug’s intended uses.

It also entered a five-year corporate integrity agreement with the Department of Health and Human Services’ Office of Inspector General. That agreement required measures governing promotion and interactions with outside patient-assistance programs, independent reviews, and compliance certifications from executives and board members.

What Evidence Is Needed to Prove Fraud?

In a case like Aegerion’s, the evidence connects sales instructions and patient information to the diagnosis presented for coverage and the resulting government-paid prescription. We work with you to connect the clinical account, authorization paperwork and payment history, and establish who directed any changes.

The complaint shows why an insider’s account can matter. A sales representative may know what managers instructed the field force to say. A case manager may know why an authorization was changed. Someone handling patient information may know when the company first received it and what consent accompanied it. Patient-assistance staff may understand why a person was routed toward a copay program rather than free drug.

Those are different views of the same prescription. Our work with pharmaceutical whistleblowers connects what they saw inside the business to the claims the government paid.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

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

In the Aegerion case, the Justice Department announced a combined $4.7 million reward for three former employees who brought the qui tam case, from the federal civil settlement proceeds.

You Saw How the Prescription Got Approved

If you saw a sales instruction become a diagnosis on a form, or patient assistance become a route to reimbursement, tell our whistleblower experts what happened inside the business. We build the case with you and bring in pharmaceutical fraud whistleblower lawyers who understand manufacturer promotion, reimbursement and copay arrangements. We stay beside you as the people, paperwork and payments become a case for recovering public money.