The drug maker used a combination of tactics, such as falsifying medical records and misleading insurance companies, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.
The new report by McCaskill's office released Wednesday includes allegations about just how far the company went to push prescriptions of its sprayable form of fentanyl. Because of the high cost associated with Subsys, most insurers wouldn't pay for it unless it was approved in advance. That process, likely familiar to anyone who's taken an expensive medication, is called "prior-authorization." So Insys set up an elaborate charade -- with employees that pretended to be doctors' offices -- to fool insurance companies into approving the drug, according to the Senate report. The Senate report documented how beginning in 2014, when someone needed to obtain prior approval for a Subsys prescription, it was actually an Insys employee who called the insurer and its affiliates to persuade them. The insurers thought they were talking to someone who worked for the actual patient's doctor, and the Insys employees had a carefully crafted script designed to intentionally leave that impression, according to the report. Insys even went so far as to obscure its outgoing phone number on caller IDs, so that calls wouldn't be traced back to the company, the report said. And if an insurer needed a phone number for a return call, company employees "reportedly provided a 1-800 number manned by another Insys representative -- instead of contact information for the prescribing physician," according to McCaskill's report. During such calls, there was usually a key question: did the patient have acute pain caused by cancer, known as "breakthrough" pain? Cancer was a requirement for prior clearance to prescribe Subsys. Insys got around this by finding various ways for its employees to create the impression on the phone calls that the answer was yes, they did have cancer, without explicitly saying so, according to the report. A recording of a such a call, obtained by McCaskill's investigators and provided below, shows the wordplay Insys employees engaged in.
On the call, the Insys employee began by saying she was "with" the office of Fuller's doctor, and subsequently claimed she was "calling from the doctor's office."
The Insys employee is then heard suggesting she's thumbing through Fuller's paperwork, trying to find the diagnosis in the medical records. She casually drops the line -- sounding as if she's reading from the patient's records -- that Subsys is "intended for the management of breakthrough cancer pain," without explicitly saying Fuller herself has cancer. The Insys employee then tells the insurance representative that Fuller suffers from "breakthrough pain" -- leaving out the word "cancer." Later in the call, a different insurance representative asks flatly if the Subsys will be used to treat "breakthrough cancer pain or not," and the Insys employee first responds that there's "no code for breakthrough cancer pain." When the representative for the insurance affiliate reiterates that he wanted to "make sure that I heard you correctly," the Insys employee tells him: "It's for breakthrough pain, yeah," again leaving out the word cancer. The company's president and CEO Saeed Motahari submitted a letter to congressional investigators dated September 1 to respond to McCaskill's probe. "These mistakes and actions are not indicative of the people that are currently employed at Insys," Motahari wrote, according to a copy of the letter obtained by CNN. He wrote that Insys had "completely transformed its employee base over the last several years," and has "actively taken the appropriate steps to place ethical standards of conduct and patient interests at the heart of our business decisions." Insys is currently in the midst of an avalanche of criminal and civil legal trouble. In December, federal prosecutors in Boston criminally charged six former Insys executives, including its former CEO, with fraud and racketeering charges related to Subsys. Prosecutors described a "nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud health care insurers." The Opioid Epidemic
The opioid epidemic has resulted in a staggering human and financial cost in the United States over the past 20 years. Approximately 183,000 Americans died from prescription opioid overdoses between 1999 and 2015, with more than 15,000 Americans dying in 2015 alone. According to the Centers for Disease Control and Prevention (CDC), in 2015 “[t]he age-adjusted rate of drug overdose deaths in the United States in 2015...was more than 2.5 times the rate in 1999.” Provisional 2016 statistics from the CDC also show that “[d]rug deaths involving fentanyl more than doubled from 2015 to 2016,” and “deaths involving synthetic opioids, mostly fentanyls, have risen to more than 20,000 from 3,000 in just three years.” In Missouri, the rate of prescription opioid-related inpatient hospitalizations and emergency room visits more than doubled from 187 per 100,000 to 424 per 100,000 between 2005 and 2014.
References
Department of Justice. (2017). Pharmaceutical Executives Charged in Racketeering Scheme. [online] Available at: https://www.justice.gov/usao-ma/pr/pharmaceutical-executives-charged-racketeering-scheme [Accessed 14 Sep. 2017].
Kessler, A. (2017). Report: Drug company faked cancer patients to sell drug. [online] CNN. Available at: http://www.cnn.com/2017/09/06/politics/insys-cancer-drug-company-faked-cancer-patients-to-sell-drug/index.html [Accessed 14 Sep. 2017].
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