Opioid makers have been accused—and in many cases convicted—of doing all kinds of shady things to get people addicted to the highly addictive, often deadly opioid pain medications and cause the nation’s worst epidemic. is facing now. They have allegedly greased doctors into writing unnecessary prescriptions, concealed and misled the public on the drug addiction, and looked the other way as large orders of opioids made their way to the black market.
But an investigation led by Sen. Claire McCaskill (D-Mo.), the top Democrat on the Homeland Security and Governmental Affairs Committee, added a seedy new tidbit to the list: posing as doctor’s offices and lying directly to the insurance to get dangerous, powerful opioids covered for patients who don’t need them. In an audio file and report (PDF) released Wednesday by McCaskill, that’s exactly what you can hear a representative of Insys Therapeutics doing.
In the filing, the Insys representative is working to circumvent the so-called “prior consent process” used by professionals to eliminate unnecessary or abusive procedures. In this case, an Insys representative wanted to get Insys’ drug, Subsys, approved and covered for a patient in New Jersey named Sarah Fuller.
The problem is that Subsys is an incredibly powerful and dangerous opioid fentanyl, approved only by the Food and Drug Administration for use by cancer patients with “progressive” pain. That’s pain that doesn’t respond to other powerful opioids. Fuller has back and neck pain and fibromyalgia—not cancer or intractable pain from it. He also has a history of addiction to narcotic drugs.
Despite knowing this, Fuller’s doctor, Dr. Vivienne Matalon of Cherry Hill, New Jersey, has been prescribing her opioid medications for pain management—namely OxyContin and Percocet—since 2014. But, in January 2015, Matalon and Fuller had a meeting with the tribe. An Insys representative to discuss your switch to Subsys, which costs more than $20,000 per month.
It was that month that an Insys representative called his pharmacy benefit manager to try to get Fuller’s Subsys prescription covered. Initially, your prescriber denied the coverage of the “off-label” prescription.
In the call, Insys repeated and suggested that Matalon take his job and that he was calling from his doctor’s office. He then equivocated and omitted the answers to get the chance manager to think that Fuller had successful cancer.
Here is the audio file (mp4) and transcript of the important bit (~4:45):
PBM: Hello, Gina? Hi, Gina, thanks for waiting, I appreciate your patience. So treat the beginning or continue?
Insys repair: This is the beginning.
PBM: Okay, and what is the diagnosis for the patient?
Insys representative: Yes, let me see here…(mumbling)… medication is the only solution for successful cancer pain management. The doctor is treating the patient for chronic pain with a diagnosis code of 338.29 (chronic pain)…
Insys correction: 338.29, yes and 338.4 (chronic pain syndrome)
PBM: And you still say 338.4?
Insys repair: Yes
PBM: Thank you. (pause) Do you still give cancer pain relief or not?
Insys correction: Well, there is no code for successful cancer pain.
PBM: Yes, and it’s good. I printed out the description. I just want to make sure I heard you correctly.
Insys repair: It’s for back pain, yes.
PBM: Good. It’s good.
According to court documents filed by Fuller’s family, Fuller died on March 25, 2016, “due to an adverse reaction to prescription drugs.”
In one wordMcCaskill explained that this is unlikely to be a unique situation, saying:
“There is overwhelming evidence that Insys aggressively forced its employees and the entire medical system to increase the use of the fentanyl product during a national epidemic that claims the lives of thousands of Americans a year in order to make more money. more — it’s difficult. to imagine anything more ridiculous. Their efforts to manipulate the drug approval process for this drug appear to have been systematic, and whoever is responsible for this manipulation should be prosecuted.”
McCaskill also released a letter from Insys’ new president and CEO, Saeed Motahari, in which he emphasized that the company had gone through a major restructuring, reshuffled executives and rotated more than 90 percent of its workforce. He joined Insys in mid-2017 and is the former CEO of Purdue Pharma.
“Like you and your staff,” he wrote, “I am concerned about certain wrongdoings and unacceptable practices by former Insys employees.” He said the company has put new systems and procedures in place to fix the problems. “We strongly believe that the company has taken steps to ensure that we do not repeat the mistakes of the past.”
Insys and its former executives face numerous federal, state, and municipal lawsuits related to its opioid drugs and their distribution.
The Senate investigation continues. McCaskill expanded to include “documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while a request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on the distribution of opioid products they.”