Dr. Julia Haller, one of the top opthalmologists in the country, testified at the Medicare fraud trial of Dr. Salomon Melgen in a Florida federal court last week that his medical practices were “abusive.” In subsequent testimony, she said they were “unconscionable” and “horrifying.”
Haller, opthalmologist-in-chief at Philadelphia’s Wills Eye Hospital and a professor of medicine at Jefferson Medical College of Thomas Jefferson University, is president of the Retina Society and a graduate of Harvard Medical School and Princeton University.
Melgen’s Medicare fraud trial began in Florida earlier this month. When that trial is over, he and Sen. Menendez will stand trial on those public corruption charges in a New Jersey federal court some time in the fall.
Menendez asked the Supreme Court to throw out the public corruption charges against him, but on March 20 the nation’s highest court said, “It will not hear Sen. Bob Menendez’s (D-NJ) appeal asking that his public corruption indictment be thrown out,” Breitbart News reported.
Haller’s testimony in the Florida federal courtroom last week was a serious blow to Melgen’s defense, which tried to minimize the damage.
“It’s terrible and disgraceful and I’m embarrassed for our entire profession,” Haller said in her trial testimony, the Palm Beach Post reported.
“Testifying for three days before a federal jury that will decide whether Melgen is guilty of 76 charges of health-care fraud, Haller said Melgen’s methods were obsolete, his treatment often barbaric and his diagnoses wrong,” according to the Post:
Occasionally gasping, she declared his treatment of a 73-year-old patient was “elder abuse.” At another point, she characterized notes he made in a patient’s chart to back up yet another diagnosis of wet age-related macular degeneration as “fraud.”
At the request of Melgen attorney Matthew Menchel, U.S. District Judge Kenneth Marra asked Haller not to use terms like “fraud” or “miscarriage of justice” to describe Melgen’s methods. But her obvious disdain for his work continued.
“If one is on Pluto, the other is in another galaxy far, far away,” she testified, describing “how wildly out of bounds she claimed both his diagnoses and his treatment plans were.”
Melgen, 62, who also faces trial on corruption charges in New Jersey with his longtime friend, U.S. Sen. Bob Menendez, showed no emotion during Haller’s testimony. As she offered scathing comments about his treatment of 30 patients while methodically reviewing their charts for the jury, Melgen kept his head down, writing notes on a legal pad.
Haller’s assessments of Melgen’s practices weren’t that different from ones offered by another prosecution expert, Dr. Stuart Fine, who testified this past week that he found little evidence to back up Melgen’s claims that more than two dozen patients had wet macular degeneration, a disease that causes blindness in the elderly. But her language, under questioning by Assistant U.S. Attorney Alexandra Chase, was much more inflammatory.
Striving to dull Haller’s impact, Menchel on Wednesday pointed out that she had reviewed only a fraction of the 3,000 patients Melgen treated at his clinics in West Palm Beach, Wellington, Delray and Port St. Lucie. Of those, he said, roughly 2,300 were on Medicare.
“One of Haller’s repeated criticisms of Melgen was his use of lasers to treat macular degeneration and his use of flouriscene angiograms to figure out what was causing patients to lose their vision. Both are obsolete, she said,” the Post reported:
Since about 2006, retinal specialists have used drugs, not damaging laser treatments, to slow the progression of wet macular degeneration, she said. Since 2000, most retinal specialists have abandoned flouriscene angiograms, in favor of a machine that allows them to pinpoint eye problems in seconds without having to inject patients with dye that lights up microscopic eye problems.
“You’re subjecting a patient to a test that has potential risks and no benefit,” she said of Melgen’s continued use of the flouriscene angiograms. “That’s malpractice.”
This past week, a former technician testified that Melgen had tested out the machine Haller described as essential for retina specialists. Melgen decided the information it provided was inferior to what he received from the angiograms, he testified.
“According to Haller’s testimony, Melgen’s medical records suggest that he improperly administered laser treatment to an elderly patient in her late 90s. Haller said the records also indicate Melgen employed a focal laser regimen on a patient who had only one working eye, a decision which Haller described as “unconscionable” in light of a lack of evidence to support the underlying diagnosis,” Courthouse News reported.
“It’s contraindicated. It’s damaging. It’s his only eye,” said Haller . . .
Federal prosecutors claim Melgen falsely diagnosed patients with wet macular degeneration so he could administer focal laser treatment as well as pricey Lucentis drug injections. Lucentis is the pharmacological remedy which has essentially replaced lasers in the treatment of wet macular degeneration, Haller said.
Haller testified that while Melgen’s allegedly unnecessary Lucentis injections were outside the standard of care, the laser regimens listed in his medical charts were particularly egregious given that they would scar ocular tissue.
“Haller also said that many of the angiograms done by Melgen’s staff were unreadable. She said they were blurry and off-center and many were taken too quickly, before the dye had been allowed to do its work,” the Post noted:
She said she was stunned Melgen billed Medicare for another type of scan when it produced unreadable images. The type of dye it requires has to be injected for it to get in the bloodstream. Instead, when Melgen’s technicians couldn’t find good veins in elderly patients or they simply objected, Melgen allowed them to take the dye orally.
However, Haller said, if the dye is taken orally, it never makes it into the eyes, so the images are useless.
“It’s shocking,” she said when told that Melgen billed Medicare for such images. “It’s beyond comprehension.”
“Haller and retinal expert Stuart Fine, a fellow witness for the prosecution, have testified that medical notes in Melgen’s charts were concocted, often bearing no relation to the actual condition of his patients’ eyes,” Courthouse News continued, adding:
Throughout the trial, Melgen’s defense team countered that Melgen’s diagnoses may not be line with academic experts like Fine and Haller, but that he did not intentionally mislead Medicare. Courthouse News previously reported that Melgen’s defense team characterized Fine as an ivory-tower professor whose interpretation of the patients’ past angiographies would naturally be different than that of a typical clinician such as Melgen.
The defense has also challenged prosecutors’ focus on a small patient group plucked from a massive number of Medicare patients treated by Melgen.
Melgen’s legal troubles are not limited to the current Medicare fraud trial in Florida or the pending public corruption charges in New Jersey.
“In addition to the healthcare fraud and bribery cases, Melgen faces a barrage of lawsuits in Palm Beach County state court, filed by patients claiming his medical practice administered contaminated Lucentis and Avastin injections into their eyes in 2013 and 2014, causing them to develop eye infections that blinded them or impaired their vision,” Courthouse News reported:
The lawsuits allege Melgen arranged for single-use Lucentis vials to be recombined, so he could milk multiple doses from them. He did so in defiance of manufacturer guidelines and the Centers for Disease Control’s warnings to the medical community that compounding the drug could cause it to become tainted with microbes prior to injection, the lawsuits claim.
Those allegations are echoed in the yet-to-be-tried bribery case against Melgen and Sen. Menendez.
Melgen and his medical malpractice insurer have blamed the purported bacterial contamination on a compounding pharmacy that recombined the Lucentis vial contents for him. The pharmacy, a co-defendant in several patients’ lawsuits against Melgen, shut down its sterile drug production per a 2014 agreement with the Florida Department of Health, after tainted batches of the eye medication were traced back to its facilities.
Melgen received bad news earlier in the week on another front.
“The U.S. Supreme Court declined on Monday to review a determination that a Florida ophthalmology clinic connected to criminal charges against U.S. Sen. Robert Menendez, D-N.J., overbilled Medicare by nearly $9 million by extracting multiple doses of a macular degeneration drug from a single-dose vial,” Law360.com reported.
The nation’s highest court rejected the challenge of Dr. Salomon Melgen, who owns Vitreo Retinal Consultants of the Palm Beaches PA, to a Medicare Appeals Council decision that his clinic was overpaid for the use of Lucentis.
U.S. District Judge Marcia G. Cooke upheld the council’s determination in September 2014 and a three-judge panel of the Eleventh Circuit affirmed in April. The panel rejected Melgen’s arguments that the lower court’s determination had to be overturned because Medicare has for years reimbursed for double-dosing other drugs, like Botox and Avastin, even though those also carry the “single-use” instruction.
“Melgen maintains that the U.S. Department of Health and Human Services overstepped its authority, saying the Medicare Act makes it clear that when a physician administers a drug covered under Part B of the act, the HHS must pay the doctor back at the rate dictated by the framework and formulas Congress specified,” Law360.com noted.