Retina surgeon’s AMD regimen at center of Medicare fraud case

Editor’s Note: Welcome to “Eye Catching: Let's Chat,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by Adam Berger, MD. The views expressed in these blogs are those of their respective contributors and do not represent the views of Ophthalmology Times or UBM Medica.

Earlier this month, a jury convicted West Palm Beach retina surgeon Solomon Melgen, MD, on 67 counts of Medicare fraud. This high-profile case hit very close to home, as myself and another retina specialist from my own community were on opposing sides of the case.

Michael J. Tolentino, MD, testified for the defense team. Meanwhile, I was asked to testify as an expert witness for the prosecution. Until recently, we were in practice together at The Center for Retina & Macular Disease, Winter Haven, FL. Dr. Tolentino is no longer with the practice. Neither of us accepted a fee for our testimony. (Editor's Note: Dr. Tolentino was not paid for his testimony, but was paid a "retainer fee" pre-trial.)   

According to Dr. Tolentino, there was a principle at stake.

Related: Ophthalmologist pleads guilty to fraud charges

In his sworn testimony, he said, “Nobody can tell you what to do as a doctor. A lot of medicine is in your gut. And if somebody tells me that I can't do this and I can't do that . . . , and I know in my gut that this is the best thing for the patient, well, guess what? That offends my principle; and that's why I'm not taking a fee.”

I saw it much differently.

It’s one thing to study innovative treatments in a controlled clinical trial with institutional review board (IRB) oversight, informed consent, a proper control group, and safety monitoring.

It’s quite another to treat patients with unproven, experimental procedures without their knowledge or consent, and then try to trick Medicare into paying for it by billing for it under a different code. That is exactly what Dr. Melgen was doing.

Unfortunately, this scam is not unique. Last year, I testified against David M. Pon, MD, who earlier this year was sentenced to 10 years in federal prison in a similar fraud case.

Charging for multi-dosing

In a separate civil proceeding, Dr. Melgen has already had to repay Medicare $8.9 million and has been asked to return another $32 million. National health regulators and federal judges agreed he wasn’t entitled to the $57.3 million he made by using a single vial of ranibizumab injection (Lucentis, Genentech) for treatment of wet age-related macular degeneration (AMD) on multiple patients. The practice is known as multi-dosing.

Dr. Tolentino not only defended Dr. Melgen’s practice of multi-dosing, but claimed to have engaged in it himself in the past. However, he admitted that he had never billed Medicare for the additional doses as Dr. Melgen did. 

According to prosecutors, Dr. Melgen used fluorescein angiography and indocyanine green (ICG) (using orally administered fluorescein AND ICG) to make the diagnosis of wet AMD on almost every patient he saw. But in the courtroom, experts called by federal prosecutors saw no signs in the scans to confirm Dr. Melgen’s diagnoses of wet AMD, and even the defense’s own witnesses who looked at the same images struggled to find evidence of the disease.

Meanwhile, OCT, which could have easily confirmed or ruled out the disease, was curiously never utilized by Dr. Melgen, and in fact he did not even own a machine to perform the simple and reliable scan, despite the fact that virtually every retina specialist in the country uses this technology to diagnose their patients and make sure they are responding to treatment.

Dr. Tolentino testified that it was analogous to using an x-ray to diagnose a broken bone instead of an MRI or CAT scan. I disagreed. It’s more like a patient with chest pain going to a cardiologist who has a stethoscope but not an EKG machine. And then, based on what he hears, he puts a stent in your heart. . .every three months.

Additional charges centered on Dr. Melgen’s use of a highly controversial and unapproved laser procedure. Dr. Melgen’s defense witnesses claimed that his use of a low-power laser (called sub-threshold laser) to treat wet AMD was justified and actually helped patients.

Dr. Tolentino argued that sub-threshold laser was a viable procedure because of the theory behind it. He defended Dr. Melgen’s practice of scheduling patients 3 months in advance for another laser treatment, before he had determined that the patient had benefited from the treatment or whether the patient had continued leakage to justify the treatment.

I strongly disagreed, arguing that subthreshold laser has never been shown in the literature to be beneficial for wet AMD, and had actually been proven to make patients with dry AMD worse. If his results with subthreshold laser were so impressive, why did he not feel compelled to share his results with the rest of the retina community? Why has the procedure still not become a standard part of the retina specialist’s armamentarium, even a decade later?

In addition, since the treatment is not approved and there was no billing code for it, Dr. Melgen was billing Medicare using the 67220 code which is reserved for laser photocoagulation of a choroidal lesion. This code is rarely used since the advent of intraocular injections.  Between 2008 and 2013, Dr. Melgen billed Medicare for this code more than 15,000 times. That explains the private jet.

Why I testified

When I was asked under oath why I had agreed to testify in the case, I responded this way: I have been given a gift, and it is a great privilege to use that gift every day in the service of my community and the patients entrusted to my care. But with that privilege comes responsibility, and one of those responsibilities is to defend the integrity of my profession and speak out when I see patients being defrauded and the standard of care being violated.

To me, this case was cut and dry: A highly intelligent, well-trained retina specialist made a diagnosis of wet AMD on almost every patient he saw, and made that diagnosis and all of his treatment decisions relying on antiquated technology with images of such poor quality that his own expert witness couldn’t even read them.

Meanwhile, the standard of care to make that diagnosis-and the definitive way to confirm the existence (or absence) of this disease-is a fast, cheap, non-invasive test that he conveniently happens to be the only retina specialist in the country who chooses not to own one!

He is allegedly using a treatment that has never been described or studied in the literature and miraculously leaves no traces that it has ever been done. He did not have approval from the patient or any IRB to use this experimental technique instead of the standard of care, and he billed the government for a completely different kind of laser treatment, which, had he actually done, would have left unequivocal clinical and angiographic evidence that it had been done. Finally, he also knowingly and wittingly attempted to circumvent the labeling for a very expensive drug in order to get reimbursed by the government multiple times for the same individual-use vial.

The jury apparently agreed.  Sentencing is scheduled for later this year.