DANIEL ISLAND - Last summer, Gerald Murphy slipped and severely flayed his left leg.
Murphy, a retired insurance executive, has discussed self-medication, but is still experiencing problems with his right leg, and makes an appointment at a local wound care center.
"I told them you should look at my left leg," Murphy said.
During five office visits over the next two months, doctors and center staff placed material made from a pig's placenta sac into the calf — a material the size of four or five postage stamps, Murphy said. Each visit took about 30 minutes and she was satisfied with the care. Then he got a Medicare statement.
The wound care center paid $101,750, which Medicare reduced to about $71,759, according to a statement Murphy shared with Post & Courier. Health and supplemental insurance covered the costs, so she paid nothing out of pocket.
"But I never thought it would be this big," he said.
Welcome to the increasingly exotic and expensive world of alternative learning.
Thanks to advances in bioengineering, wound care manufacturers are creating amazing new products made from everything from pig placenta to fish skin.
Manufacturers see these new skin substitutes as a huge step forward in the healing of burns and chronic wounds. But some health experts say it's not clear if it really helps. The stakes are as high as Murphy's oral statement to Medicare.
“Skin substitutes certainly have an important place not only in burn and wound care, but also in reconstructive surgery,” said Stephen Kahn, MD, director of the South Carolina Burn Center at the Medical University of South Carolina. However, there is little evidence and high-quality literature on the effectiveness of some of these products. Seems like a new one comes out every day.
There is no doubt about the need for prompt and effective treatment of burns and other hard-to-heal wounds.
If left untreated, small cuts can become infected and fester. People with diabetes are at particular risk because the disease can reduce blood flow to patients' feet. It slows down the healing process and causes wounds to fester. If left untreated, diabetic foot ulcers can lead to amputation and death. In total, chronic wounds affect more than 6.5 million people in the United States each year, a number that will increase as newborns age.
Enter the learning option.
Traditional dressings made of gauze, foam, or cloth help protect and dry wounds. However, some skin substitutes mimic the function of normal skin. Like a garden wheel, it forms structures over wounds for new skin cells to grow.
Although many skin substitutes are new, the concept dates back at least 3,500 years, when Egyptian healers used frog skin in hot oil. Doctors have been using skin grafts taken from cadavers for centuries. “In modern burn care, we still use cadaver skin in many cases,” said Kahn of MUSC.
But in recent years, dozens of new learning alternatives have appeared on the market.
In 2020, researchers at ECRI, a Pennsylvania-based nonprofit organization that researches health technologies, identified at least 76 skin substitutes sold in the United States. Manufacturers made it from human placenta, pig intestines, pig urine, cod skin from Iceland, and horse heart tissue.
Next, ECRI researchers reviewed studies measuring the effectiveness of these skin substitutes. Here, they found, the evidence was lacking: many of the studies involved relatively small groups of patients. And the manufacturers funded about 90% of the research.
"We found that studies didn't follow patients long enough to see if their wounds healed," said David Snyder, senior research analyst at ECRI and co-leader of the federally funded study. "We don't know anything about relapse and how long it takes to recover."
The panel recommended more research into the long-term effectiveness of skin substitutes, as well as more studies comparing their performance to conventional treatments.
Clinical trials may be lacking, but one aspect of skin substitutes is clear: Their costs can be astronomical.
pig placenta
In the case of Gerald Murphy, his physician at Charleston Wound Care Center in Mount Pleasant used a relatively new skin substitute called the InnovaMatrix. The Medicare approved rate is $1,030 per square inch.
To put this in perspective, a typical United States Postal Service "forever" stamp is about 1.5 inches square.
For Murphy, that means Medicare paid about $17,000 for each of his first four visits and $4,400 for his last visit.
“Nobody told me how much these materials cost. “Nobody said they came from a pig placenta.”
A company called Convetech Group manufactures InnovaMatrix products.
One of the company's founders began pondering how to transplant human placental tissue five years ago, said Chris Sabatino, vice president of medical affairs for Convatec. Human tissues function well, but they also carry the risks of infection and toxins that come with being a person's biological baggage.
They purified the pork placenta because our immune systems are more receptive to pork and collagen based tissues. "You're probably using ham without even knowing it," Sabatino said. For example, jelly bean capsules are often made from porcine collagen.
Sabatino said researchers have found that farmers routinely discard pig placenta. "We were finding a way to make money from the waste stream, so the farmers were happy about that." The farms themselves can be strictly regulated and monitored. In many ways, he said, pigs are healthier than what people eat.
The company is washed, sterilized, dried, and then sterilized again. The result, Sabatino said, is a scaffold for new skin cells.
price? As with a new drug product, the company's research and development costs affect price, Sabatino said, adding that he expects prices to drop as more doctors use the ingredients. It is usually only used if the patient's wound has not healed after four weeks.
He added that in 2020, the Food and Drug Administration approved the use of InnovaMatrix products. But Medicare didn't release a special payment code until early 2022. "We couldn't sell for 14 months and had to keep our heads above water. A dollar is too expensive to make a device."
His company is based in Memphis, which is also the center for FedEx. Sabatino said workers there package the product in special cartons and ship it overnight to healthcare facilities across the country, including the Charleston Wound Care Center in Mount Pleasant.
"Everything in your arsenal"
Christopher Michaelis, MD, a physician at the Charleston Wonder Care Center who has treated Gerald Murphy, admits that skin substitutes are expensive—"so expensive that you don't stock up on this stuff."
But he said he has met people who suffered from wounds that did not heal for years because doctors did not use skin substitutes.
“We had patients who cried when they left because they were told they were going to lose a leg or a toe. “And then they recovered because you used these advanced therapies — everything in your arsenal to treat that person as quickly as possible.”
He added that moving quickly is more appropriate. “I have found that it is better for my patients to spend money upfront so that the person does not lose a leg, lose a job, or end up in the hospital. It is cheaper to be aggressive and treat these patients before complications arise.
He said Murphy's wound is an excellent example of why they use skin substitutes. He had wounds that were difficult to heal. He said Murphy's wound healed about 70 percent in the first week thanks to the skin substitute.
He said his practice did not thrive using it. According to him, most of the money goes to medical device companies. And he and his staff work with patient insurers, including Medicare, to ensure patients aren't scammed out of a large out-of-pocket bill.
"I tell all my patients, 'This stuff is very expensive.'" Don't let it shake you. Simply put, how much does the product cost. I will buy and fix the insurance price.
"everyone just pays"
Gerald Murphy wanted to know more about the complaint after reading Medicare's statement. I called Medicare hotlines.
"They just kicked me out. They didn't explain anything. They just said it was expenses."
Dividing the basket of Medicare and Medicaid costs is no easy task.
Medicare and Medicaid distribute their claims to private insurance companies across the country. These regional companies set the prices.
In South Carolina, Medicare has a contract with Palmetto GBA, the Blue Cross and Blue Shield affiliate of South Carolina.
It's $1,030 an inch with a wholesale price of 3 percent, according to federal regulations, Palmetto GBA spokeswoman Rose Dangerfield said. He did not respond to requests for more details.
Meanwhile, Murphy, an 87-year-old former insurance executive, thought he could save the federal government money.
"If I had known the price," he said, "who knows, I might have refrained a little."
"Insurance has been my life for 39 years," he added. "This is why I'm overreacting to the bill. Something went wrong. My problem isn't with the treatment. It's with Medicare. They just paid, no questions asked. Everyone just paid."