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The criminal trial of William Harwin, MD, founder and former president of Florida Cancer Specialists, a multisite practice headquartered in Fort Myers, is set for June, according to federal documents reviewed by Medscape Medical News.
Harwin is charged with one count of conspiracy to restrain trade, which refers to his alleged role in a 17-year anticompetitive “market allocation” scheme in southwest Florida that limited patient choice by dividing up medical and radiation oncology treatment between two practices in the region.
Harwin, who has pleaded not guilty, surrendered his passport to authorities and posted a $250,000 bond.
He has responded publicly to the indictment: “Let me be absolutely clear about this — I am innocent of the charges that have been brought against me…” he said in a statement reported by the Fort Myers News-Press.
Last year, Florida Cancer Specialists, as an organization, was charged with the felony of criminal antitrust conspiracy, which was related to the same scheme, and agreed to pay a penalty of $100 million.
Five months later, Harwin was indicted by a federal grand jury for his alleged role in this conspiracy, which involved “Oncology Company A” (identified elsewhere as 21st Century Oncology, a large practice also headquartered in Fort Myers).
Under the agreement, in three southwest Florida counties (Collier, Lee, and Charlotte), Florida Cancer Specialists only offered medical oncology care and 21st Century Oncology only offered radiation oncology. In other parts of Florida, they offered both services, according to the US Department of Justice (DoJ).
The conspiracy allowed the two oncology providers to operate with “minimal competition,” the DoJ stated last year.
In the indictment, Harwin is described as allegedly enforcing the conspiracy via conversations and communications.
For example, after learning that 21st Century Oncology was offering medical oncology care (by administering the immunotherapy Provenge to patients with prostate cancer), Harwin told the company’s founder and CEO: “We expect you will end this.”
Also, when 21st Century Oncology acquired another oncology group that employed medical oncologists, Harwin instructed the founder and CEO to “Make then [sic] disappear.”
Florida Cancer Specialists’ revenues totaled nearly $1 billion for treatments delivered by way of the illegal deal, which ran from as early as 1999 until at least 2016, the DoJ stated.
Motions to Dismiss Case
Harwin’s legal team has brought multiple motions to dismiss the Department of Justice’s case, including the indictment’s “failure to state an offense.”
“The indictment charges a per se violation of the antitrust laws,” reads that motion. “Such a violation is premised on an agreement between competitors. Yet, the indictment fails to allege (and could not allege) that medical oncologists and radiation oncologists are competitors.”
Judge John L. Badalamenti of the US District Court in Ft. Myers has yet to rule on any of the motions to dismiss.
The charge leveled at Harwin carries a maximum penalty of 10 years in prison and a $1Â million fine for individuals.Â
However, the DoJ says that the maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by victims if either amount is greater than $1 million. In other words, the fine potentially may be much higher.
The federal prosecution of Florida Cancer Specialists has been extraordinary, say commentators in legal news outlets.
The $100 million penalty awarded last year was the statutory maximum monetary criminal penalty and was the largest ever for a wholly-domestic criminal antitrust case, according to the legal site Mintz.
Additionally, “criminal antitrust prosecutions of health care providers are very rare,” according to the site JDSupra. “There were none for over 50 years, between 1940 and 1990. The Antitrust Division of the US Department of Justice brought two criminal cases in 1990 and 1995, charging dentists and optometrists with price-fixing. Then for 25 years, DOJ did not charge a provider with an antitrust crime.”
That changed in 2020 with the federal prosecution of Florida Cancer Specialists.
Last year, Lucio Gordan, MD, current president of Florida Cancer Specialists, told the Wall Street Journal that changes have been made at the organization: “Shortly after learning about this [conspiracy] issue, FCS brought on new leaders, materially enhanced its employee training, and bolstered its compliance program.”
The Harwin indictment is part of an ongoing DoJ and FBI antitrust investigation into market allocation and other anticompetitive conduct in the oncology industry.
Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay, MedPageToday and has had bylines on WashingtonPost.com, MSNBC, and Yahoo. Email: [email protected] and on Twitter: @MulcahyNick
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