In particular, the government stated that Good Days worked with Novartis, Dendreon, Astellas, Onyx and Questcor from 2010 to 2014 to create funds to pay Medicare patients who take their medications or pay for travel, but not to patients taking other medications and, in some cases, to provide data on the number of patients receiving money from the Fund. Similarly, the government claimed that PANF had worked with Bayer, Astellas, Dendreon and Amgen from 2011 to 2014 to create certain funds that primarily, if not exclusively, financed drug co-payments by the only company that financed each fund. PNET Co-Pay Fund of CDF for Novartis. In May 2011, Afinitor, a Novartis product, was approved for the treatment of progressive neurodocreas neurodepinekris tumors of the pancreas („PNET”). In 2012, Novartis asked CDF to open a co-paying fund to cover the Afinitor-Co-Country for patients with PNET. At that time, CDF knew that Sutent, a Pfizer drug, was also licensed for the treatment of PNET. In August 2012, at Novartis` request, CDF opened a so-called „PNET” fund. The fund that Novartis financed alone covered only the soitor; It did not cover Co-Country for Le Sutent, the other drug authorized PNET. PANF prostate cancer subfunds. In March 2010, PANF opened a fund that covered co-country for patients taking a drug that treats prostate cancer. In September 2012, PANF opened a fund that covered co-country patients taking mCRPC drugs. PANF`s MCRPC fund covered a number of drugs, including Xofigo (a Bayer drug), Xtandi (an Astellas drug) and Provenge (a Dendreon drug) as well as competing drugs from other companies. After PANF opened its mCRPC fund, Bayer, Astellas and Provenge collaborated with PANF to create smaller funds, each covering first, if not exclusively, the drug of the only company that financed each fund.
Along with the payment of the FCA fees, Novartis entered into an Enterprise Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). Among other things, the CIA requires Novartis to significantly reduce its paid speaker programs and the amount spent on programs. In addition, all remaining speaker programs may only occur in limited circumstances (which may only be available within 18 months of FDA approval of a new state reimbursement product or a new indication of a national reimbursement product previously authorized by the FDA) and in a virtual format (external speakers must be remote and not in the same location as a member of the public). In addition, there is a cap of $100,000 in total compensation for speech and spokesperson training and a total salary cap of $10,000 per spokesperson (without direct payment by Novartis for travel and travel expenses). Similarly, Novartis would have learned with Afinitor (a treatment for advanced renal carcinoma (RCC) and progressive neuroendocrine pancreatic tumours (PNET)) that Novartis would be the sole donor for the 2010 fundraising year for a Copay RCC fund created by a non-profit foundation (National Organization for Rare Disorders – NORD). Novartis reportedly informed NORD that it would only be willing to make a donation to the Fund if the foundation`s eligibility was limited, to ensure that more of the copay assistance would go to patients taking Afinitor. As a result, the government stated that in reviewing the fund`s definition, the Fund has helped patients who take Afinitor disproportionately relative to its overall rate of use of CCR drugs. Then, in 2012, Novartis reportedly asked another foundation (CDF) to open a copay fund to pay copays for patients with PNET – which Novartis knew would only be used to pay supplements for patients with Afinitor.