Michigan Attorney General Dana Nessel last Friday announced that Michigan and 32 other states have reached an agreement in principle to settle allegations that pharmaceutical manufacturer Reckitt Benckiser Group (Reckitt) improperly marketed and promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds. Suboxone contains a combination of buprenorphine (an opioid) and naloxone (blocks the effects of opioid medication, including pain relief and feelings of well-being that can lead to opioid abuse). The drug was approved to suppress opioid withdrawal symptoms as part of a complete withdrawal treatment plan that would include counseling and psychosocial support.
Reckitt will pay a total of $700 million dollars in resolution of various civil fraud allegations impacting Medicaid and other government health care programs, of which over $400 million will go to the Medicaid program. Reckitt will also enter into a separate non-prosecution agreement with the United States Attorney’s Office for the Western District of Virginia and the United States Department of Justice’s Consumer Protection Branch.
The federal and state civil settlements will resolve the following allegations:
• That Reckitt directly or through its subsidiaries knowingly promoted the sale and use of Suboxone to physicians who were writing prescriptions (1) to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted indication; and (2) for uses that were unsafe, ineffective and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose. Such prescriptions lacking a legitimate medical purpose are also not for a medically accepted indication.
• That Reckitt directly or through its subsidiaries knowingly promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that Suboxone Sublingual Film was less subject to diversion and abuse than other buprenorphine products and that Suboxone Sublingual Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets. Physicians relied on these false and misleading claims in prescribing Suboxone Sublingual Film, and state Medicaid agencies relied on these false and misleading claims to their detriment in making formulary and prior authorization decisions.
• That Reckitt directly or through its subsidiaries knowingly submitted a petition to the Food and Drug Administration on September 25, 2012, fraudulently claiming that Suboxone Sublingual Tablets had been discontinued “due to safety concerns” about the tablet formulation of the drug and took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone, including pricing to federal health care programs.
The investigation resulted from a number of Medicare and Medicaid fraud actions, three of which were originally filed in the United States District Court for the Western District of Virginia.
“My office has continued to prioritize combatting the opioid crises and stopping its devastating impact in our communities,” said Nessel. “That work includes teaming with the United States and other state Attorneys General in cases like this to hold drug manufacturers responsible for their role in the crisis.”
The proposed settlement has not yet been approved by any of the states and Michigan’s specific recovery amount under the proposed settlement has not yet been determined.
A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and is working with Reckitt on behalf of the states regarding the settlement in principle.
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