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The Novartis physician speaker kickback settlement required the company to pay $591,442,008 in federal False Claims Act damages and $48,151,273 to states over alleged payments to induce prescriptions. Novartis admitted paying doctors for events that never happened, arranging repeated dinners with rotating paid speakers, and using prescribing data to select doctors whose prescriptions it wanted to keep or increase. For someone who handled the invitations, expenses or sales reports, this case reaches well beyond what happened at dinner.
The Justice Department announced the settlement on July 1, 2020. The government alleged that Novartis used physician speaker programs from 2002 through 2011 to induce prescribing of cardiovascular and diabetes drugs reimbursed by federal health care programs. A whistleblower brought the case, and the government joined it against the manufacturer. The U.S. Attorney’s Office for the Southern District of New York credited investigative work by the FBI, the Department of Health and Human Services Office of Inspector General, and the Defense Criminal Investigative Service.
Novartis admitted that its sales force used prescribing data to identify high-volume prescribers and track their prescriptions over time. Some representatives selected doctors as speakers with the intention that their fees would induce continued or increased prescribing. The government’s complaint further alleged that representatives pressured speakers to increase prescriptions and dropped doctors who failed to do so. Novartis admitted paying more than $320,000 in honoraria to one doctor who wrote more than 8,000 prescriptions for the covered drugs.
The settlement’s admitted facts describe who controlled the operation. Sales representatives organized most programs, picked the venues, selected speakers and decided whom to invite. Company policy called for a trained speaker to deliver medically relevant slides and answer questions about a Novartis product. Novartis paid the speaker an honorarium and covered attendees’ meals and alcohol at restaurant events.
Management supplied a reason to keep booking. Novartis admitted that many managers directed representatives to spend their entire promotional budgets, and that underspending could count against a representative in an annual review. Bonuses rewarded growth in local drug market share. The dinner budget and the prescription target sat inside the same sales operation.
That relationship matters more than the label on an invoice. The 2020 Journal of Forensic and Investigative Accounting paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud explains that kickback arrangements can involve economic relationships more complex than a simple payment for services. In Novartis’s admitted account, the payment, the speaker selection and the prescribing reports were parts of one commercial relationship.
Novartis admitted that many paid speakers gave no presentation or clicked through slides in minutes, leaving most of the event for dinner and socializing. It also admitted paying honoraria for purported events that never took place. On Long Island, a sales representative arranged fake restaurant receipts, used the budgeted money to buy gift cards for high-prescribing doctors, and had doctors paid for supposedly speaking at those events.
Repeat attendance kept the benefits circulating. Novartis admitted paying for groups of colleagues or friends to dine together repeatedly, sometimes rotating who served as speaker and received the fee. A group of five doctors in Harrisburg cycled through more than 100 events over five years, with some or all attending and one taking a turn as the paid speaker. The company also admitted holding programs at fishing trips, sporting events, wineries and golf clubs.
Its own meal limits did little to contain the spending. Novartis admitted that more than 12,000 programs and roundtables substantially exceeded those limits. At one Maryland steakhouse event, the audience consisted of a single doctor, while food and alcohol cost $448 per person and the speaker received a $1,000 honorarium. We see a sales budget buying repeated access to prescribers, with the educational purpose disappearing from the room.
The government complaint described ways the event paperwork could make hospitality look cheaper than it was. One was an accounting category for spending above the company’s per-person allowance. The complaint explained it through an illustrative calculation:
In practice these limits could be avoided through attributing amounts over those caps to what Novartis termed an “unmet minimum,” which was the difference between a restaurant’s minimum spend for an event and the per person charge for the event. For example, if a restaurant had a minimum charge of $2,000 for an event, but only four people attended it, a sales representative could attribute $1,500 of the costs of the program, the amount exceeding the $125 per capita cost for four people, to the “unmet minimum” for the program.
In that example, the restaurant’s bill stays the same. Moving part of it into another category changes how the expense appears against the cap. Separately, Novartis admitted that some employees falsified records to understate food and alcohol spending per doctor. An expense report and the underlying restaurant bill could tell different stories about the same program.
Other complaint allegations put the claimed work itself in doubt. A physician allegedly received speaking fees and ground transportation expenses for events purportedly held in her own office. Another doctor allegedly received payment for dinners he never attended at restaurants he had never heard of. Those are discrepancies a person processing payments or arranging programs could recognize without seeing the company’s entire sales strategy.
The government alleged that Novartis’s own data showed more than $65 million spent on over 38,000 programs for Lotrel, Starlix and Valturna from January 2002 through November 2011. It alleged that honoraria or lavish meals and entertainment reached at least 26,997 doctors through those programs.
The settlement covered those drugs as well as Diovan, Diovan HCT, Exforge, Exforge HCT, Tekturna, Tekturna HCT and Tekamlo. Novartis marketed the covered products for hypertension or diabetes, tying the speaker payments to prescribing in those practices.
Novartis admitted that its marketing science group measured program return on investment using new prescriptions written by attendees. An internal analysis put the return for Lotrel roundtables at 1,200% for doctors who attended more than one. We see a company measuring the prescriptions its dinners bought, not what doctors learned.
The government’s complaint connected that business to public payments. It alleged that a doctor in East Orange, New Jersey, wrote $39,793 in Medicare-reimbursed prescriptions for the promoted drugs after Novartis began paying her as a speaker. The government also alleged that Medicaid, TRICARE and Veterans Affairs paid for prescriptions induced by the payments. The claimed physician kickbacks put company money into the relationship with the prescriber and left public programs paying the drug bills.
Novartis admitted that it lacked enough compliance staff to investigate potential violations, leaving a backlog that meant some misconduct was never investigated. It did not conduct a comprehensive field audit until 2008, after approximately 90% of the events at issue had already occurred. Before that audit, sales representatives typically received advance notice that their programs would be checked.
Even when someone watched, the government’s complaint alleged violations of the meal policy at 44 of 107 monitored programs. In another investigation, it alleged that the only recommended discipline for the representative was verbal coaching about controlling alcohol expenses. Monitoring could produce a finding without producing a serious change in the sales operation.
Novartis also admitted what its chief compliance officer said in training presentations:
If you don’t have to write it, don’t. Consider using the phone.
We would expect compliance training to confront the purchase of prescriptions. Here, the admitted advice directed attention toward avoiding a written record. For an insider, what management said about documenting a payment can explain as much as the payment’s approved description.
The 2020 settlement incorporated restrictions from a five-year corporate integrity agreement with the Department of Health and Human Services Office of Inspector General. It required paid external speakers to appear remotely, apart from every audience member, and barred restaurant venues and alcohol at the programs.
Industry warnings about speaker programs focus on weak educational substance and sales-driven selection. This case makes the connections between records concrete. Speaker selection reports show which prescribing histories mattered, attendance records show who repeatedly appeared, and invoices show what the company paid for. Inside a physician practice, you may know whether the doctor actually attended the dinner or whether a paid office presentation happened at all. That knowledge can connect a speaking fee to the work the doctor actually did.
A whistleblower brought the Novartis case to the government through a False Claims Act complaint. A later court order set the federal whistleblower reward at approximately $109.4 million. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.
If you handled speaker payments in a physician practice, organized the dinners or saw prescribing used to decide who got invited back, speak to one of our whistleblower experts about what the program bought. We work beside you to build your strongest pharmaceutical kickback whistleblower case around what you witnessed and bring in healthcare fraud whistleblower lawyers who understand pharmaceutical payment schemes. From the first conversation through the pursuit of a recovery, you have partners who understand why the event record and the prescription report belong together.