WEST PALM BEACH, Fla. (CN) – A South Florida eye doctor, accused of bilking Medicare and bribing a U.S. senator to help him skirt liability, mounted an aggressive defense after prosecutors presented weeks of testimony that portrayed him as a rogue physician engaged in medical profiteering.
Rounding the corner in a long-running Medicare fraud trial, ophthalmologist Salomon Melgen’s defense team on Thursday afternoon called up its witness Maggie Bronson, an elderly former patient who told the jury that Melgen helped restore her vision, and that prosecutors tried “to put words in [her] mouth to hurt him.”
Bronson, one of thirty patients listed in the indictment, was treated by Melgen for roughly a decade, until 2015, when Melgen closed up shop, facing separate criminal cases on charges of healthcare fraud and bribery.
Bronson said she initially visited Melgen’s office because she was going blind and had no vision in her left eye. She was suffering from diabetic eye disease, she said.
“I had [given] up on life because I couldn’t see at all,” Bronson testified, confined to a wheelchair.
But she said her vision improved substantially under Melgen’s care.
“I was very very happy that I could see,” Bronson testified, calling Melgen a “patient” and “kind” doctor.
She claimed members of the prosecution team met with her prior to the trial and tried to get her to criticize Melgen and “say something that [she] didn’t wanna say.”
According to the indictment, Melgen and his medical practice Vitreo-Retinal Consultants of the Palm Beaches billed Medicare an exorbitant $411,000 for his treatment of Bronson between mid-2008 and Dec. 2013. During that time, Vitreo-Retinal Consultants billed for more than 260 imaging tests on her, prosecutors claim.
While the indictment alleges that Melgen frequently failed to inject dye needed for the tests, Bronson testified that her veins were small and that Melgen’s office therefore determined that the dye should instead be administered orally.
Bronson’s testimony comes after three weeks of less-than-flattering statements from a team of experts for the prosecution. The experts told the jury that Melgen falsely diagnosed patients (including Bronson), injected pricey Lucentis medication into patients’ eyes without justification and applied thermal laser therapy that was obsolete for the condition he purported to be treating.
Julia Haller, Ophthalmologist-in-Chief at Wills Eye Hospital in Philadelphia, went so far as to say that Melgen’s handling of one patient was tantamount to “elder abuse,” and that his use of thermal laser on another patient was “unconscionable.”
Melgen also faced testimony from retired retina specialist Robert Bergen, who claimed that the amount of diagnostic tests for which Melgen was billing was “beyond absurd” and “in the next galaxy, as far as I’m concerned.”
“[It’s] absolutely not within the realm of medical reasonableness, if that’s what you want to call it,” Bergen testified.
Prosecutors meanwhile have been hammering away at allegations that Melgen and Vitreo-Retinal Consultants billed Medicare for supposed diagnostic testing on the prosthetic eyes of three patients listed in the indictment. An FBI analyst told the jury that Melgen billed Medicare for nearly 100 diagnostic tests that correspond to the prosthetic eye of one of those patients.
Altogether, Melgen and Vitreo-Retinal Consultants allegedly billed Medicare more than $190 million between 2008 and the end of 2013. Of that sum, they received at least $105 million in payments, prosecutors allege.
DEFENSE SEEKS TO PLANT SEEDS OF DOUBT
After the prosecution rested its case Tuesday afternoon in West Palm Beach federal court, Melgen’s defense team called its first expert witness, Michael Tolentino, a Florida ophthalmologist who is credited with seminal research that led to the cancer drug Avastin being used off-label to treat diseases of the eye.
Tolentino testified that both he and Melgen trained at the Schepens Eye Research Institute, a Harvard-affiliated facility where doctors were encouraged to be mavericks and do whatever it took to heal patients, even if it meant circumventing conventional wisdom, Tolentino said.
Treating the jury to an allegory about how violin lessons made his son too focused on technique, rather than musical intuition, Tolentino said that physicians have to trust their instinct.
“Medicine is an art,” Tolentino testified.
He lamented that doctors are often “only allowed to do what the insurance company will pay for,” as he phrased it.
He claimed he took on the Melgen case and waived his $600 hourly fee for his appearance at trial because the idea of someone telling him not to treat a patient in a certain way — when his “gut” says it’s the best treatment — “offends his principles.”
With Tolentino on the stand, the defense team sought to cast doubt on prosecutors’ central allegation: that Melgen and Vitreo Retinal Consultants falsely diagnosed patients with wet macular degeneration so he could apply laser treatments and pricey injections of Lucentis, a pharmaceutical successor to Avastin that has putatively replaced laser as the standard of care in treating wet macular degeneration.
Tolentino claimed it is ordinary for diagnostic tests to be interpreted differently from doctor to doctor. In his past experience, when he had to send patients’ angiographies to a 3-physician panel for diagnostic confirmation before the patients were included in an ophthalmology study, it was common for there to be dissent among the trio, he said.
He testified that frequent administration of Lucentis is appropriate in some patients. He likened the drug, which treats leaking ocular blood vessels, to a mop that sweeps up water from a leaky faucet.
Bergen had testified last week that out of a sample group he analyzed, comprised of roughly 300 of Melgen’s patients, an inordinately high percentage were diagnosed with wet age-related macular degeneration. Only 16 percent of those diagnoses were actually supported by the imaging tests in the patients’ charts, he testified.
Calling Melgen’s methods “medically horrible,” Bergen said that in patient files he reviewed, the diagnoses listed in Melgen’s medical charts frequently did not match the true condition of the patients’ eyes as they appeared on the imaging tests.
The defense argued that Bergen could not know whether Melgen had seen something in a live exam that did not appear on the imaging tests. Bergen’s tally of allegedly unsupported diagnoses moreover included instances where imaging tests were blurry or otherwise inconclusive, the defense added.
Bergen’s apparently fervent disdain during his testimony at one point prompted Melgen’s defense attorney Matthew Menchel to implore the court to clamp down on medical experts’ emotional speech.
“[These] are expert witnesses. They’re not victims of robberies,” Menchel argued.
Menchel further contended that the patient sample analyzed by Bergen was not truly random, and was unfairly picked out by prosecutors.
INNOVATION OR OBSOLESCENCE?
Aiming to dispel the notion that Melgen was a reckless doctor blasting his patients with obsolete harmful lasers, Tolentino testified that a “subthreshold” or low-power laser therapy (the kind Melgen supposedly employed in his practice) is medically justifiable in the treatment of certain eye conditions including wet macular degeneration.
Tolentino told the jury that while a traditional past use of focal laser has been to torch problematic leaking vessels, the laser can also be applied at lower settings, with medical benefits and less side effects.
The issue momentarily popped up in the defense’s cross examination of Bergen, who testified that in patient files he reviewed, Melgen applied lasers at very low power settings. Bergen interpreted the low-power laser treatments as therapeutically ineffective, while the defense team represented that the treatments were an innovative, non-destructive use of laser that is now being explored by ophthalmologists as a therapy complementary to Lucentis.
Both Bergen and Haller had contested that with the advent of Lucentis, the traditional application of thermal laser therapy has become largely obsolete in the treatment of wet macular degeneration, because it can permanently scar structures in the eye.
Menchel on the other hand presented doctor survey data indicating that thermal lasers were still widely used by physicians around the timeframe cited in the healthcare fraud indictment.
EYE INJECTIONS IN FOCUS
In addition to being accused of administering Lucentis injections to patients who did not need them, Melgen faces allegations that he profited by improperly splitting “single-use” vials of the drug into multiple doses, in violation of Medicare reimbursement guidelines.
Melgen’s attorneys argue that the guidelines forced doctors to throw out good medicine, i.e. the contents left over in Lucentis vials after a single dose is removed.
Melgen’s practice of multidosing from Lucentis vials prompted Medicare to issue an $8.9 million clawback order against him in 2009, triggering a hard-fought dispute in administrative venues and later in federal civil court.
Prosecutors and the defense team in the ongoing criminal trial have fought for the last say with respect to exactly how much Melgen has paid back to Medicare. Though attorneys from both sides are indicating Melgen executed a repayment of the $8.9 million, prosecutors claim that subsequent Medicare clawbacks against Melgen, to the tune of $32 million, remain unpaid.
In a second, not-yet tried criminal case, Melgen is charged with showering New Jersey Senator Robert Menendez with gifts and campaign contributions in exchange for political favors, including lobbying for Melgen in his dispute with Medicare over his use of Lucentis.
Sen. Menendez, who is charged alongside Melgen in the bribery case, allegedly met with top officials from the Centers for Medicare and Medicaid Services and advocated for Melgen between 2009 and 2013. In the meanwhile, the senator was taking trips on Melgen’s private jet and vacationing at the doctor’s villa in the Dominican Republic, prosecutors say.
In the summer of 2012, shortly after Melgen issued a $300,000 check to a political action committee tied to Sen. Menendez, the senator spoke to the Acting Administrator of CMS and suggested Melgen should not have been hit with clawback attempts for his Lucentis multi-dosing, according to the bribery indictment. In concert with Melgen’s lobbyist, prosecutors say, the senator’s staff had prepared a talking-points memo for the conversation, which reads in part: “The [Centers for Disease Control] guidelines, while necessary to ensure patient safety and reduce the number of healthcare-associated infections, has no bearing on Medicare reimbursement policy.”
Adding to Melgen’s legal woes, several former patients have sued him in Palm Beach County state court, alleging that they suffered severe infections in their eyes after receiving contaminated injections of Lucentis at Melgen’s medical practice.
The plaintiffs claim Melgen ordered his Lucentis vials to be compounded in spite of the known risk of infection associated with multi-dosing. The Centers for Disease Control and Lucentis’ manufacturer Genentech have warned that multi-dosing from single-use vials puts patients at risk of infection, the lawsuits note.
Melgen has maintained that multidosing from Lucentis vials was common practice among physicians, and that if the plaintiffs suffered an infection, it stemmed from lax sterility controls at the compounding pharmacy facilities that had recombined vial contents for him.