How to Report Fraud by Companies in the Pharmaceutical, Medical Equipment, Medical Device and other Medical Technology Industries
There is increasing awareness that numerous companies in FDA-regulated industries continue to engage in fraud. From pharmaceutical and biotech fraud, to medical device and medical equipment fraud, the landscape has broadened. One reason may be a lack of sufficient resources for the FDA to regulate and police these very important, often life-saving industries. When the fraud involves payment under Medicare and Medicaid, multiple federal agencies provide ways to report it. For example, the Department of Health and Human Services (HHS) Office of the Inspector General maintains a hotline at 1-(800) HHS-TIPS. The Department of Justice created the “Stop Medicare Fraud” website (www.stopmedicarefraud.gov) which provides postal and email addresses for reporting fraud.
While well-intentioned, these agency tip lines are not an effective way for sophisticated insiders to report pharmaceutical fraud. For example, the HHS hotline and the “Stop Medicare Fraud” website for the most part are directed to Medicare and Medicaid beneficiaries, not insiders with knowledge of complex fraud issues. Due to the volume of fraud reported, and the brevity of the intake, it is hard to fathom how an adequate amount of information is taken in order to start a proper investigation.
Nolan & Auerbach, P.A. will provide initial feedback to determine whether your healthcare fraud allegations are valid, provable, and fit under the False Claims Act. We will further provide a complete evaluation/investigation for cases we accept. Not every situation is necessarily fraud; some conduct involving off-label marketing, inducements to potential referral sources, or some types of pharmaceutical pricing fraud, may not be violative of the False Claims Act. Our clients’ cases typically involve intentional and widespread fraud, which has permeated at least a sector of a company’s business operations for years.
Should you choose to contact us, we suggest taking the following steps:
- Document. Gather all relevant documentation which you are otherwise entitled to receive as part of your job duties. This includes Marketing Plans, PowerPoint presentations or binders from Plans of Action or annual meetings, emails, memos, call notes, etc. (Do not photocopy, download, or take any documentation that you are not entitled to view, or is in violation of policy or procedure);
- Write a short summary of the fraud. This is important as the facts are fresh in your mind now, as opposed to years from now. You need to do this whether or not you file a whistleblower lawsuit. We suggest that you provide the following information in your summary:
A. Describe the organization of the company. Explain divisions, hierarchy, management names, etc. Which divisions were involved? What were their responsibilities?
B. List and describe the Management Players.
C. Summarize the fraud in detail (four common areas are listed below):
1) Off-Label Marketing
i. Describe sales training. Include the time period and all details about any off-label aspect of it, both initial and thereafter. Also include medical liaisons and reimbursement specialists, if applicable, and any others who were part of the sales force.
ii. Describe sales meeting details.
iii. Describe compensation details.
iv. Explain off-label uses targeted.
v. Explain the percentage of estimated off-label sales of each product and a breakdown of the off-label use percentage.
vi. Explain types of physicians targeted for off-label use; what reports and target lists reps were provided with, etc.
vii. Describe the techniques used to interact with physicians.
viii. Describe any misrepresentations made to physicians.
2) Kickbacks
i. Describe any speaker programs, clinical trials, registries, and other “clinical” programs handled by marketing or sales; and attendee benefits (include discussion of speaker training, of speaker presentations, and whether they kept to script, attendee selection, etc.).
ii. Describe any and all of the following payments made for or to physicians:
- Honorariums;
- Grants;
- Preceptorships;
- Advisory Board Meetings (“Round Tables”); and
- Other consultant positions.
iii. Describe any inappropriate payments made to specialty pharmacies or any Pharmacy Benefit Manager fraud.
iv. Make a list of all documents that are not in your possession but that you believe are relevant. Doing so now will also be helpful to you to crystallize the facts, whether or not you file a qui tam lawsuit.
3) Manufacturing Violations and Defects in Products
i. Describe any material unreliability issues, known quality control failures, finished product release specification issues (i.e. describe how the devices were manufactured with performance characteristics that were set below what was claimed as performance specifications in respective product inserts, PMA’s and 510(k) submissions, which has resulted or could result in substandard, defective products). Describe other problems that the manufacturer is or should be aware of but has not adequately fixed or warned the provider community.
ii. Make a list of all documents that may or may not be in your possession but that you believe are relevant.
4) Pharmaceutical Pricing Violations (Pharma Companies Only)
i. Describe misrepresentations of any price reporting to the Center for Medicare and Medicaid Services (CMS).
ii. Make a list of all documents that may or may not be in your possession but that you believe are relevant.
If we accept your case for investigation, Nolan & Auerbach, P.A., will engage in a thorough and confidential evaluation of the facts. We will assess whether the law and regulations, together with the evidence, support allegations of widespread healthcare fraud. We will then provide you with feedback on your potential case, and jointly discuss whether to proceed.