Not Guilty on All Counts – Health Care Fraud (Pt. I)
In November of 2019, Odom, Davis & Hobson went to trial in federal court on a 25-count indictment alleging Medicare fraud, wire fraud and money laundering. The indictment can effectively be broken down into 4 categories: 1) billing for chelation therapy that was not medically necessary (count 1), 2) billing for services without the requisite supervision (counts 2-12), 3) billing for services that could not be performed in a 24-hour day (counts 13-18), and 4) transferring illegally obtained money to purchase assets (counts 19-25 – Money Laundering).
The prosecution’s main focus was the medical necessity allegation in count 1. Though evidence and argument were presented for counts 2-18, the crux of the case was the viability of using chelation therapy to treat elderly patients with chronic lead exposure.
This case involved complex scientific testimony and a large sum of money billed to Medicare. We were concerned a jury would get lost in the science, and ultimately struggle to follow the law. We did not believe they would be able to see past the amount billed. Based on these concerns, we advised our client to waive his right to a jury trial. The case was tried before a District Court Judge in the Southern District of Texas.
Medical Judgment Cases
Most health care fraud prosecutions fit neatly into a few large categories: 1) billing Medicare for services that were not performed, 2) billing Medicare for a different service than the one provided (upcoding), or 3) billing Medicare for services that were obtained after making a false statement to the patient (lying about heart blockage to justify stent procedures). These cases are generally straight forward, and the defendant will often lean on a lack of knowledge in his defense.
However, there are cases, though much fewer in number, where the government pursues criminal charges based on a disagreement with a treatment option. That smaller subsect is where the facts of this case fell. There was no allegation the defendant failed to perform a service or upcoded for the chelation therapy that was performed. There was no evidence the defendant lied to his patients. The prosecution pursued fraud because they believed the defendant’s use of chelation therapy had no acceptance in any medical community. When analyzing this case, it is helpful to understand the origin of chelation therapy and its evolution over the last 20 years.
History of Lead under OSHA
Many metals are xenobiotics. Their presence in the human blood has a negative impact on many bodily functions while serving no beneficial purpose. Lead is one of these xenobiotic metals found in human systems.
Prior to the 1980’s, lead was found in common products throughout the United States such as paint, gasoline, and residential pipes. People living and working in the United States prior the 1980’s were exposed to lead in varying degrees. The most heavily exposed persons were those that worked in select industries during this time period. These occupations included painters, refinery workers, plumbers and many others.
In the 1970’s, as organizations became cognizant of the harmful effects of lead, government agencies (OSHA) began publishing guidelines to handle acute lead poisoning in the workplace. These guidelines provided for worker removal based on the amount of lead (in micrograms per deciliter (µg/dl) of blood) present in the worker’s system. Further, they provided for the use of intravenous chelation treatment for those workers with very high blood lead levels (over 70 µ/dl). At these levels, a patient will exhibit cognitive impairment, and organ damage is possible. Patient’s with lead levels over 70 µg/dl need immediate emergency medical attention.
Chelation Therapy under OSHA
Chelation therapy is the only FDA approved procedure to remove lead from a patient. The process involves introducing Calcium EDTA through an intravenous infusion. The Calcium EDTA binds to the lead molecules in the blood and allows the patient to excrete the lead through urination. It has been proven effective in removing various metals from a person’s blood.
Chelation therapy has been sanctioned by OSHA for use in acute lead poisonings for over 50 years. The treatment involves pumping a high dose of calcium EDTA into the patient and following up intermittently to ensure the blood lead levels have dropped to an acceptable range. When the blood lead levels drop below 20 µ/dl, the patient was approved for return to work.
Starting in the 1980’s, and gaining steam in the last 20 years, epidemiologists researched the effects of lead in non-acute or chronic situations. Their initial studies noted that elderly patients with a history of lead exposure had low levels of lead present in their blood. This was true even if the patient was not currently exposed to any external lead source. Using highly advanced testing, only available in four labs in the country, scientists were able to determine the source of the blood lead level.
When a person is exposed to lead, some is excreted through urination and other molecules are stored in their bones. When young, the bones are somewhat effective at storing the lead and segregating the poisonous metal from other bodily functions. However, human bones begin to deteriorate through osteoporosis and bone turn over as a person ages. This accelerated bone deterioration leads to the release of lead back into the blood stream. This process often sustains blood lead levels between 2 and 15 µg/dl for many years.
Armed with this knowledge, scientists began studying the effects of low, chronic lead presence in the elderly population. These initial studies showed a statistically significant connection between low lead levels and various ailments, including cardiovascular disease, memory issues, and renal failure.
Studies began around the globe to determine if chelation therapy was effective in removing the low levels of lead, and ultimately, improving the underlying diseases. Scientists began these studies in a few phases: 1) determine the safety of Calcium EDTA, 2) formulate a protocol to mitigate any side effects of chelation therapy, and 3) use chelation therapy to treat patients with various cardiovascular, cognitive and renal impairments.
Chelation therapy has a few known side effects when used at the dosage for treating acute poisoning. Notably, impairments to renal function. Acknowledging this issue, the studies produced a protocol advising the use of Calcium EDTA in much smaller doses spread out over many treatments. One notable trial that is still ongoing (TACT II) uses chelation therapy in small doses over 15 treatments bi-monthly before retesting the patient’s blood lead levels.
The trials over the last 20 years have produced statistically significant results using chelation therapy to treat patients for various underlying disease. The research and findings do support its efficacy, though more studies are likely needed before chelation therapy will be considered the standard of care. As stated by the defense expert, the use of chelation therapy for low blood level disease is “cutting edge.”
Part II of this post will discuss the defendant’s use of chelation therapy and the mens rea inherent in health care fraud cases based on medical judgment.