As part of this comparison, the ETCM also agreed to a five-year enterprise integrity agreement (“CIA”), in which USWM must implement compliance measures to ensure that their promotional activities and interactions with PPPs are in compliance with the law. The CIA also requires the establishment of an independent compliance monitoring organization, company directors and board members to provide compliance certifications and implement risk assessment and mitigation processes. The USWM did not admit any wrongdoing. This is the sixth case of PAP in three weeks, a clear signal that doJ is strengthening enforcement measures for PAPS. The multi-million euro transaction resolves a whistleblower complaint filed by two former US WorldMeds employees, Dr. Bennett and Dr. Chinnapongse. Under the False Claims Act, the two Relators receive a common premium of 15 to 25 per cent of total recoveries. At the same time as the False Claims Act, the ETCM entered into a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General. Among other things, the five-year CIA requires the ETC to implement measures to ensure that their advertising activities and all agreements and interactions with third-party patient assistance programs comply with the law.
In addition, the CIA requires audits through an independent monitoring organization, compliance certifications of executives and board members, and the implementation of a risk assessment and mitigation process. The cases are under the title United States ex rel. Bennett v.US WorldMeds, LLC, The Assistance Fund, Inc. et al., No. 3:13-CV-363 (D. Conn.) and United States ex rel. Chinnapongse v.US WorldMeds, LLC, NO. 3:16-cv-0080 (D. Conn.). The claims that were settled by the transaction are only allegations and no liability has been found. The false claims of the False Claims Act, resolved by the transaction, were originally filed in whistleblower actions, pursuant to the provisions of the False Claims Act, which allow private parties to sue on behalf of the government and participate in any recovery. Whistleblowers receive $3,150,000.00 as part of the takeover.
“The integrity guarantee of TRICARE, the U.S. Department of Defense`s health program for military personnel and their loved ones, is a top priority for the Defense Criminal Investigative Service (DCIS),” said Leigh-Alistair Barzey, Special Agent in Charge, DCIS Northeast Field Office. The settlement agreement announced today is the direct result of a joint investigation and demonstrates DCIS` commitment to working with its law enforcement partners to review bribery programs that divert TRICARE funds and ensure that patients with TRICARE receive the treatment and treatment they deserve. When the transaction was announced, a Department of Justice spokesperson said that “drug selection by physicians and patients” should not be “influenced by inappropriate financial considerations.” As part of the agreement, US WorldMeds entered into a business integrity agreement with the Department of Health and Human Services.