Xenaderm has been around since the 70s and the problem here with the billing is that prescriptions were written for the product so Medicare and Medicaid would cover. If you are not aware, many over the counter drugs are given prescription forms for those covered by Medicaid especially. If a prescription is written, then the drug or treatment is free versus paying the over the counter cost for the drug.
Why did it take since the 1970s for all of this to come to light when the drug has been used pretty heavily for years for wound treatment? The company, Healthpoint is accused of submitting false statements about what it could do in the way of treating wounds. If we really want to go there, let’s pick on aspirin next as it gets compensated by Medicaid? Does the FDA give approval for every problem that aspirin could potentially solve? If nobody was using the ointment, it would seem to me that it was not working, but that’s the not the case here.
Now we have the Department of Justice joining the lawsuit? This lawsuit deserves a thumbs down for all of this and if the FDA doesn’t feel it’s appropriate to be used, then ban it. It’s not the type of drug that’s going to kill anyone as it’s a topical solution for helping heal. I looked up the drug along with the generic equivalent and not much price difference from what I saw and looked up a competitor that was a little more expensive, so what’s the real deal here? How many patients used it to remove dead skin if this is the case and how many really needed it for wound care? I bet the wound care bunch will win out here and this sounds like a technicality to find some money. If I missed something, please let me know but this looks like a big waste of time. BD
The U.S. government said Friday it filed a complaint against Healthpoint Ltd., saying the company sold an unapproved wound care drug and caused Medicare and Medicaid to be fraudulently billed tens of millions of dollars for coverage.
According to the complaint filed in the District of Massachusetts, Healthpoint has been marketing the drug Xenaderm as an ointment for the treatment of bedsores and pressure sores since 2002 even though the drug is not approved by the Food and Drug Administration. The U.S. Department of Justice said Healthpoint submitted false statements about Xenaderm so that prescriptions would be eligible for reimbursement by Medicare and Medicaid.
The main ingredient in Xenaderm is trypsin, which is intended to clear dead tissue from around a wound. But the government said the FDA determined in the 1970s that trypsin was not effective for that purpose and the agency rescinded approval for products containing the drug. The government says the company knew Xenaderm was not approved and "knew of or recklessly disregarded the FDA notices concerning trypsin's lack of effectiveness" as a way to remove dead tissue.
"This action reflects our continued efforts to ensure that drug manufacturers do not evade the drug approval process or cause the government to pay for less than effective drugs," said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.
Healthpoint, which is based in Fort Worth, Texas, said Xenaderm is an important option for patients.
The government joined a whistleblower lawsuit against Healthpoint, a unit of Fort Worth, Texas-based DFB Pharmaceuticals Inc. The Justice Department said that if the lawsuit succeeds, it can recover $5,500 to $11,000 from Healthpoint for each fraudulent Medicare or Medicaid claim, plus as much as triple damages. Healthpoint was investigated by the Justice Department's Civil Division, the U.S. Attorney's Office for the District of Massachusetts, the Office of Inspector General of the Department of Health and Human Services, and the FDA.