A study by Memorial Sloan Kettering Cancer Center in New York has estimated that nearly $3 billion in cancer medicine is wasted every year in the United States. This happens because infused cancer drugs are distributed in vials that contain excess medicine which is usually thrown out.

The cost of cancer treatment has been a hot issue in health care recently. Over the past 15 years, the average price of a cancer drug has increased 5 to 10-fold. Many of the leading cancer drugs now cost more than $100,000 per year. In protest of the price inflation and unaffordable costs, more than 100 oncologists signed a letter objecting last summer.

As it turns out, much of the high priced pharmaceuticals paid for by patients, insurance companies and the United States is discarded. Up to 1/3 of the single-dose vials of the top cancer drugs administered based on the patient’s weight remains in the vial following patient treatment, according to the study by Memorial Sloan Kettering. The result is that a significant portion of the pharmaceutical companies potentially get tens of thousands from

It doesn’t mean there is health care fraud simply because some amount is wasted. Hospitals and doctors are allowed to discard and bill the U.S. Government for the discarded, unused amount if it is a single-use vial, they chose the smallest vial available from the manufacturer which would be appropriate for the patient, and the left-over amount was actually discarded.

However, there have been a few different lawsuits over the False Claims Act involving the quantity of medicine distributed in vials. One involved filling vials with excess overfill as a kickback which it encouraged the doctor to use and bill to the government. Another involved the selection of larger single use vials in order to bill the entire vial when there was significant discarded as excess. A third involved double billing for single-dose vials by pooling excess portions and using them in treatment which it billed to the United States. Another lawsuit involved the reuse of medicine from single use vials in disregard of regulations designed to protect patient safety.

The question now is whether the federal government takes additional steps to ensure pharmaceutical companies are minimizing the amount of discarded drugs by requiring single dose vials to be available in more sizes. It would be a prudent step that has been taken in Europe to combat the problem. If those regulations are developed, then the False Claims Act would become a viable tool for whistleblowers to report drug companies making money off the discarded drugs. In the meantime, we’ll just keep our eyes open for doctors and hospitals fraudulently billing for the use of single and multiple use vials.

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