HYPERBARIC
related to reimbursement,” said Andrew Boulton, an internationally recognized expert on hyperbaric therapy and a professor of medicine at the University of Manchester medical school in Britain.
“Some folks are chasing the money. It’s seen as a money grab because reimbursement has been favorable,” said John Peters, executive director of the Undersea and Hyperbaric Medical Society, which accredits 200 hyperbaric oxygen facilities nationally and has inspected 500 for accreditation in the past 15 years.
In 2002 — after industry lobbying and some encouraging research — Medicare approved hyperbaric therapy for certain diabetic wounds that did not respond to conventional treatments.
Medicare covers the treatment for more than a dozen conditions in which skin fails to heal, such as failing grafts and tissue damage from anti-cancer radiation, but the rising diabetic population supplies much of the demand.
It costs about $500,000 to install a hyperbaric unit with two chambers. With Medicare’s reimbursement policies, “Hospitals can generate cash almost immediately,” Peters said.
The business model is so compelling that management companies typically pay for the equipment and staff. Hospitals provide space for the chamber, make patient referrals and handle billing. The companies and the hospitals split revenue from insurers.
Because of poor blood circulation, diabetics are susceptible to developing ulcers in their lower legs and feet that heal poorly and can sometimes lead to amputations. Hyperbaric oxygen therapy, in theory, works by stimulating the body’s creation of new blood vessels and aiding the formation of new skin around the wound.
In 2015, Medicare imposed stricter billing procedures in three states where its payments for hyperbaric services were 21 percent above the national average — possible evidence of overuse or overbilling. As a result, providers in Illinois, Michigan and New Jersey must get regulators’ preauthorization before treating Medicare patients for the most commonly approved conditions in non-emergency cases.
Elsewhere, Medicare requires documentation supporting the therapy’s need only after services begin.
Signs of abusive industry practices predate the 2015 action. A critical report in 2000 by the inspector general of the Health and Human Services Department disclosed that Medicare was billed millions of dollars for non-diabetic woundcare treatments that were inappropriate or excessive. The office has said it plans to issue a follow-up report before Oct. 1 — its first since 2000.
The Justice Department alleged fraud or other wrongdoing involving hyperbaric therapy in at least five cases between 2008 and 2014. It has won more than $11 million in penalties and restitution, along with some jail sentences.
Medicare’s crackdown on billing in three states saved $5.3 million in its first 13 months, the government said in November. Medicare’s total spending on hyperbaric therapy fell about 10 percent in 2015 to $230 million. That was the first annual decline in a decade.
Debates about the utility of the treatment continue despite decades of use. Few large, controlled studies have explored hyperbaric oxygen therapy for diabetic wounds.
Some studies have found the treatment benefits certain patients, while others have concluded it neither increases a wound’s chances of healing nor prevents amputations. The problem is not knowing which wounds would have healed over time on their own.
But Randall Slaybaugh, medical director of the hyperbaric program at OhioHealth — OhioHealth has eight hyperbaric chambers in its system of hospitals — said he’s seen positive responses to treatment. But he said the treatment is not a cure-all for everyone.
“There are a multitude of factors that can inhibit healing,” he said, such as unknown medical problems. It’s also difficult to do research on these patients because each case is different.
Still, Slaybaugh said the treatment, while not to be viewed as a substitute for standard treatment, can provide “enriching therapy” for people who have exhausted other options.
“The vast majority of providers are looking to multidisciplinary treatments,” he said.
Businesses and individuals invested in the facilities remain loyal boosters. The treatment “used to be considered voodoo medicine. But today, more doctors have been swayed, and it’s now seen as mainstream therapy,” said Marc Kaiser, owner of Precision Health Care, which manages hyperbaric centers at five hospitals in New York and Connecticut.
Based on studies and anecdotal experience, Geoffrey Gurtner, who helped establish the Stanford University Wound Care Center in 2014, believes the therapy has some merit. But Gurtner, a plastic surgeon, said research is needed to understand how the treatment works, which patients need it and the right number of sessions for each wound.
Medicare pays for hyperbaric therapy for diabetic wounds that have not healed after 30 days of standard treatment. If hospitals provide more than 30 treatments, they must document that patients’ wounds are improving.
Twenty to 30 sessions of hyperbaric therapy should heal diabetic wounds, but radiation-damaged skin might require 40 treatments, said Phi-Nga Jeannie Le, a Houston physician.
“The problem is, we see these financially motivated centers keep doing the treatment into the hundreds of visits,” she said.
Also, Medicare pays nearly double the standard rate when the treatment is performed at hospital-affiliated facilities, which can add on a “facility fee.” Because of this quirk in the rules, hyperbaric management companies tend to court hospitals to install their devices.
Sometimes even dozens of treatments do not avert amputations, as diabetic William Padgett Jr., 65, of Culpeper, Virginia, can attest. He lost his right leg in 2013 after nearly 90 hyperbaric sessions.
Last year, he tried hyperbaric oxygen again to close a wound on his left leg, taking about 80 sessions over four months at a hospital in Arlington, Virginia. The wound healed. “It has been a slow process ... but well worth the time,” he said.