Legal and Regulatory Issues

VittiLabs, the Sopranos, and an FDA Warning Letter

I’ve blogged quite a bit on the crumbling amniotic and umbilical cord fake stem cell market. Despite peer-reviewed research demonstrating that these products clearly have no stem cells, throughout social media, we still see patients who are getting bombarded by influencers who claim they are loaded with young and vital stem cells. One of the…read more

Why Language from a New FDA Amniotic and Umbilical Cord Warning Letter Is a Big Deal

I’ve covered the stem cell wild west for years. One of the crazier things out was amniotic and umbilical cord tissue vendors claiming to sell “stem cell” products that don’t actually contain any live and functional stem cells. In addition, despite an FDA crackdown on these companies, there are still vendors selling this stuff with…read more

US Stem Cell Loses Appeal

US Stem Cell has been featured many times on this blog. In an unsurprising move, an appeals court just upheld a lower court decision on the concept that adipose stromal vascular fraction prepared in a doctor’s office is a drug that can be regulated by the FDA. This ruling also contains an interesting easter egg…read more

Medicare Umbilical Cord and Amniotic “Stem Cell” Scam Is Crashing

I’ve blogged a number of times on manufacturers who found a creative way to make it appear that their umbilical cord and amniotic “stem cell” products were covered by Medicare to treat orthopedic and spinal problems. This scam is now ending and recent information from CMS provides hard evidence of that change. Let’s dig in.…read more

Why Did a Major University Sell Amniotic Fluid to a Fraudster?

This week’s blog on the Missouri woman who is being charged for fraud by selling Amniotic fluid brought up an interesting question. She bought this fluid from the University of Utah. Huh? Let’s dig in. The Missouri Case The feds this week brought criminal charges through a grand jury against a Missouri woman who was…read more

Medicare Begins Cracking Down on Amniotic Tissue Billing

Can you get a “stem cell” treatment covered by Medicare? For the past 1-2 years, a handful of amniotic tissue companies have been trying to convince physicians to bill Medicare for their products. The problem? This is illegal. Now a new statement by one Medicare region lays a stick of dynamite at the feet of…read more

He Blinded Me with Science! David Singer Strikes Again

I wrote about David Singer a while back. He’s a chiropractic practice consultant who has now reinvented himself as a stem cell expert. IMHO, he and others like him are helping to perpetuate stem cell fraud in hundreds of chiropractic clinics all over the country. Today we’ll dig into the fraudulent use of research to…read more

How Are Companies Getting Paid for Amnion? The Magic Trick Explained

If you’re following the Medicare reimbursement scam for amnion and umbilical cord products I’ve been covering, you may wonder how that scam began. While I knew some of this story prior to yesterday, I still hadn’t put all of the pieces of the fraud together to show a clear picture from start to finish. Now…read more