Reporting unapproved drugs or adulterated drugs billed to Medicare or Medicaid

This article shows you how to get a reward for reporting fraud against Medicare or Medicaid by reporting a drug company, pharmacist or healthcare provider billing for drugs that have not been FDA approved or drugs that have been adulterated.

Defining Unapproved Drugs (non-FDA approved drugs)

Medicare and Medicaid will only reimburse a healthcare provider that bills for drugs that have been FDA approved. It is Medicare fraud to bill for unapproved drugs.

Not every drug that a doctor or pharmacist prescribes is FDA approved. For instance, some vitamins or homeopathic drugs are not FDA approved. It can be Medicare fraud to bill Medicare (or Medicaid) for unapproved drugs.

In addition, drugs that were developed or entered the market prior to 1962 must undergo a review for effectiveness under the Drug Efficacy Study Implementation (DESI) program. However, hundreds of drugs marketed prior to 1962 have still not met the DESI program requirements or otherwise FDA approval, and it is Medicare and FDA fraud to sell these drugs or bill government programs for such unapproved drugs.

Adulterated drugs cannot be billed to Medicare or other government healthcare programs

It is also Medicare fraud to bill Medicare for a drug that has been adulterated. A drug that has not been manufactured in accordance with all manufacturing processes or quality control procedures is considered adulterated. This website has additional articles discusses in more detail Medicare fraud by pharmaceutical companies for adulterated drugs.

Tips for reporting unapproved drugs (non-FDA approved drugs)

To properly report fraudulent schemes of billing healthcare programs for unapproved drugs (non-FDA approved drugs) and be eligible for a whistleblower reward, you cannot simply call a Medicare fraud hotline. To apply for a reward for reporting unapproved drugs (non-FDA approved drugs) you must use an attorney (on a contingency basis) to file qui tam suit under the False Claims Act. Your attorney must follow the exact procedures of the whistleblower reward statute to get a reward for reporting unapproved drugs (non-FDA approved drugs).

In addition, you need to report in detail how the pharmacist, hospital, drug company, or other healthcare provider is engaged in a fraudulent scheme to cheat Medicare by using unapproved drugs (non-FDA approved drugs). The government needs your help in uncovering unapproved drugs (non-FDA approved drugs) billed to Medicare or other government programs. But, since most whistleblower reward applications lack specific proof or contain other defects, the government turns away 75% of reward claims. That’s why selecting an experienced attorney that has handled Medicare fraud cases is important.

How much reward for reporting unapproved drugs (non-FDA approved drugs)?

The amount of a whistleblower reward for reporting fraudulent billing of unapproved drugs (non-FDA approved drugs) is based upon the amount of money the government recovers back, and the reward is between 15% and 25% of what the government collects back from the drug company or healthcare provider that is cheating Medicare by billing for unapproved drugs (non-FDA approved drugs). The amount can be substantial, because Medicare can claim that the total sales for every drug billed to the government must be repaid.

How to report unapproved drugs (non-FDA approved drugs) billed to Medicare

This website (and the books authored by Mr. Hesch) walk you step-by-step through the entire process of reporting unapproved drugs (non-FDA approved drugs) and fraud against Medicare and shows you how to obtain a whistleblower reward.

Mr. Hesch has considerable experience with investigating Medicare fraud against the federal government while working for 15 years at the Civil Fraud Section of the U.S. Department of Justice in Washington, D.C., which is the office with nationwide authority over the whistleblower reward program. He is ready to confidentially review your information and show you whether and how to report fraud against Medicare by unapproved drugs (non-FDA approved drugs).

The link at the bottom of the page below “Do I have a case” shows you how to ask Mr. Hesch to review your allegations of unapproved drugs (non-FDA approved drugs) in confidence and how to get a reward for reporting healthcare fraud schemes by billing for unapproved drugs (non-FDA approved drugs).

Click on this link to read this article in pdf format: How to report non-FDA approved drug fraud or adulterated drugs and how to get a whistleblower reward PDF version