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Pharmaceutical Kickbacks are Violations of Federal Law
The Anti-kickback Statute (AKS) is violated when a person or entity makes or accepts payment for referring, recommending or arranging for federally-funded medical items or services, including items or services provided under the Medicare, Medicaid, and TRICARE programs. Violations of the AKS are per se violations of the federal False Claims Act, the government’s primary pharmaceutical fraud-fighting weapon.
Dishonest drug companies have skirted the AKS, knowing their illegal payments will influence prescribing habits and, in turn, often result in the provision of pharmaceutical products that are not medically necessary and are harmful to a vulnerable patient population.
Study Findings: The Payment-For-Prescription Effect
In 2019, the esteemed public watchdog ProPublica conducted an extensive analysis of the 50 most prescribed brand name drugs in Medicare for which drug makers had made payments to doctors in 2016. The analysis revealed that for a staggering 46 out of the 50 drugs analyzed, doctors who received payments wrote many more prescriptions for said drug that doctors who did not receive payments. For some drugs, such as for Restasis, used to treat dry eyes, doctors who received payments wrote 141% more prescriptions that doctors who did not receive payments from the manufacturer. Payments were made to doctors directly by the drug manufacturer for such things as speaking engagements and paying for meals.
The analysis revealed that doctors who prescribed more of a drug received higher payments from pharmaceutical companies than doctors who did not prescribe it as much. Depending on the drug, payments were 2 to 4 times higher to high prescribing physicians.
When presented with this information, drug companies said that prescribing data was not used to target physicians for promotional interactions.
The analysis showed that for common drugs that are household names, it was even more common for prescribing physicians to receive a payment than not. For some common drugs, such as Breo, used to treat asthma, more than half of physicians who prescribed the drug received payments from the manufacturer. Similar results were found for other commonly prescribed drugs. As pharmaceutical companies increased their spending on drug promotion, payments received by physicians sometimes totaled tens of thousands of dollars per physician and were often spread out between different pharmaceutical companies and drugs.
While the review did not include an analysis of whether payments to physicians by pharmaceutical companies actually changed physician behavior or if patients received inferior care from physicians who received payments from drug makers, industry experts did not think that such arrangements between physicians and pharmaceutical companies were beneficial to the patient. Even more, these types of payments are sometimes a violation of Healthcare Fraud laws and related laws, including a violation of the False Claims Act and Anti-Kickback Laws.
Common Types of Pharmaceutical Kickbacks
Pharmaceutical manufacturers that provide items of value to patients may also be in violation of the anti-kickback law, and thereby expose themselves to whistleblower lawsuits arising from such Medicare Fraud. There is ample precedence from the Office of Inspector General (OIG) Bulletins, Guidance, and Alerts describing scenarios involving kickbacks to patients.
Patients, Prescriptions and Fraud
Where patients are influenced, they are offered valuable benefits in exchange for selecting particular devices, medical equipment or prescription drug brands. As patients can and do influence physician selection of products in certain circumstances, the OIG has expressed concerns that these benefits would interfere with the traditional roles of the physician and pharmacist to provide treatments and recommend products in the best interest of the patient.
The OIG also noted that “indirect marketing or promotional efforts or informal channels of information dissemination, such as ‘word of mouth’ promotion by practitioners and patient support groups,” coupled with unlawful kickbacks, can and do unlawfully influence prescribing.
But, the devil is always in the details. At the end of last year, the OIG issued an opinion (OIG Advisory Opinion No. 20-09) in response to a drug company’s request about its program of providing money for patients’ travel, lodging, and other expenses. The OIG ultimately found that the company’s specific program was not illegal under existing law, as the program was limited in scope and unlikely to influence prescribing.
Speaking Engagements, Training Sessions & Pharmaceutical Kickbacks
For decades, one of the most common kickbacks in the pharmaceutical industry has involved sham speaker programs. Manufacturers with largely bogus speaker programs have filled their speakers’ bureau with “thought leaders” based on the physicians’ prescription potential, rather than their true credentials. Oftentimes, the speaker recruitment efforts have focused on those providers who are prescribing competitor products. For high decile prescribers, senior managers have flown across the country to wine and dine the physicians and to pitch the monetary benefits of joining the speaker program. Too, the recruited physicians have been paid thousands of dollars to attend training sessions held at luxurious resorts and venues. Typically, while the trainings have lasted half a day, the attendees have been flown in for an all-expense-paid extended weekend getaway.
Once the physicians have survived this “training” weekend, they are then inserted into a full calendar of paid speaker events, including roundtable discussions, advisory boards, and even patient outreach programs. In sham speaker programs, the speakers’ honoraria sometimes vary based on the speakers’ prescription volume, and speakers have been paid for events even when no attendees show up.
Pharmaceutical Speaker Programs: Legit or a Sham?
The line between bona fide and sham speaker programs is not always clear. Here are 18 questions to consider about physician speaking programs:
- Do the programs truly have educational value to the attendees?
- Are standard, compliance-vetted PowerPoint slides presented at the events?
- Are the events held at venues that are not conducive to an educational program (e.g., in sports bars, on fishing trips, at restaurants without private meeting areas)?
- Does the manufacturer conduct internal ROI analyses of payments to speaker program leaders?
- Does ROI analyses show a significant increase in prescription writing for each prescriber after they begin receiving honoraria payments in connection with the drugs?
- Are the speakers nominated by sales reps, who pick doctors from among those they call on?
- Are speakers selected and approved based upon any type of objective, bona fide criteria?
- Do sales reps have a budget for speaker programs, which they are pressured to spend?
- Does the manufacturer place no limit on the number of programs a doctor can attend or how often a doctor can attend the same program?
- Is there a system to prevent a sales rep from repeatedly selecting the same doctors on his call list as attendees or speakers, on exactly the same topics?
- Are there system controls to prevent a sales rep from arranging for the same doctors to take turns speaking and attending each other’s programs repeatedly?
- Are sales reps able to sidestep per-attendee spending limits placed on events held at restaurants?
- Do the sales reps spend lavishly on food and alcohol for attendees and speakers?
- Are processes in place to ensure that sales reps are reporting truthfully on who attends speaker programs?
- Does the manufacturer require signatures on attendance sheets at speaker events?
- Do doctors repeatedly speak to the same attendees on exactly the same topics?
- Does the manufacturer threaten to remove physician speakers from the speaker’s bureau when their prescription volumes decrease?
- Are high-prescribing physician speakers paid to speak at events even when they lack basic communication skills and knowledge of the drugs?
Additional Pharmaceutical Payments That Could Violate the AKS
Other payments of value from pharmaceutical manufacturers to healthcare providers that tend to violate the Anti-kickback Laws include, but are not limited to:
- Offering Pharmaceutical Kickbacks to Physicians in the Form of Phony Drug Studies – Some pharmaceutical companies have provided remuneration for post-marketing clinical studies or data collection as a means to induce physicians to prescribe their products. The “research” performed has little clinical value and is merely a pretext for payments for referrals.
- Phony Grants – Approved by management, pharmaceutical sales representatives have been allowed by certain companies to give “grants” (or consulting fees) to physicians, physician groups and other healthcare providers, ostensibly for an educational program or research program.
- Phony Investigator Meetings – “Investigator” meetings are used as an opportunity for pharmaceutical companies to disseminate off-label and other forms of illegal marketing under the guise of science. Sales representatives are allowed and instructed to spend lavishly on all physicians, both the speakers and invitees. It has been typical for investigator meetings to last a few hours, yet pharmaceutical companies pay for weekend costs such as airfare, hotel, golf, spa treatments, etc. at luxury hotels at choice locations around the country.
- Advisory Board and other Meetings – These meetings are typically for the ostensible purpose of getting input/feedback from physicians on drug performance, how they treat disease states, etc. During Advisory Board meetings, honoraria, lavish entertainment and expenses for physicians are paid for by the pharmaceutical companies.
Common Types of Pharmaceutical Kickbacks
The Federal Anti-Kickback Statute and the qui tam provisions of the False Claims Act make it possible for whistleblowers to collect a percentage of what has been recovered as an award for their important service. Our pharmaceutical anti-kickback whistleblower attorneys file lawsuits under the qui tam provisions, which is designed to encourage private individuals who are aware of Pharmaceutical Fraud to bring such information forward by providing financial incentives for recovery against the pharmaceutical company in the lawsuit.
If you are aware of illegal pharmaceutical kickbacks or other fraud within the pharmaceutical industry, the law protects you as a whistleblower. Scheduling a free evaluation of your case is a confidential way to get started.
Contact us online or call us at 800.372.8304 to speak with our qui tam attorneys.
Learn More: Whistleblower Protection
Additional Types of Healthcare Fraud
Our Healthcare Fraud attorneys have the knowledge and experience to discuss in-depth areas of fraud within the healthcare industry. Other common types of fraudulent activity we encounter and encourage individuals to bring forward as whistleblowers include:
Frequently Asked Questions About Pharmaceutical Kickbacks
✅ Who Does The Anti-Kickback Statute Apply To?
The federal AKS applies to provider or receiver of healthcare or pharmaceutical referral. This includes pharmaceutical companies (as well as medical equipment providers, hospital systems, etc.) that receive payments from federally-funded healthcare programs including Medicare, Medicaid, and Tricare.
✅ Are Pharmaceutical Kickbacks Legal?
Pharmaceutical Kickbacks are prohibited by the AKS and are therefore a violation of federal law. Civil and criminal penalties may be enforced upon both the recipients and payers of kickbacks.
✅ How Many Doctors Get Kickbacks From Drug Companies?
ProPublica reports that between the years 2014 and 2018, “more than 2,500 physicians have received at least half a million dollars apiece from drugmakers and medical device companies.”