BOSTON- Due to the Indictment of violating The False Claims Act by illicitly paying the Medicare to shell out from its own pockets for its own medicine, Novartis Pharmaceutical Corporation has surrendered by paying an amount of $51.25 million to settle upon conflict and has to face other major sanctions according to the law.
The Medicare grantee may be obligated to give out an advance payment serving as their co-insurance after they had obtained a prescribed medicine insured by Medicare Part B or D. To motivate demand forces, the council involved co-pay conditions to keep track of healthcare expenses. As part of the inclusion, Pharmaceutical Companies may demand a higher price for their products. Persuading Medicare patients to buy the companies drugs by offering them money directly or indirectly or anything of value is no doubt an act of abusing economic rights that the Anti-Kickback Statute highly prohibits.
This has led to the U.S Attorney Andrew E. Lelling statement, “Novartis Corporation was found guilty of illegal activities such as channeling money through the three co-pay foundations to victims obtaining Novartis own drugs,” Lelling also added, “the results of Novartis actions were found non-charitable but somewhat served as a kickback strategy which resulted to sabotaging the Medicare systems program and illegally funded their high costs drugs using the taxpayers’ money. At the same time, we acknowledge Novartis’ current administration’s formative efforts when they addressed the nation’s concerns with the company’s previous connections with the co-pay foundations.”
According to Assistant Attorney General Jody Hunt from the Department of Justice’s Civil Division, “the administration has verified its accountability to assuring that the medicine firms do not use co-pay kickbacks to be bought by clients after the doctor’s given procedures, as compromised” In addition to Hunt’s statement, “To avoid a chance of conflict that may bring danger to the client, we will do our utmost in defending the Medicare program from co-pay kickbacks and their destructive effects, including the weakening of significant cost-control instruments formed by the senate.”
The Chief Counsel to the Inspector General, Gregory E. Demske also pointed, “the alliance between the Pharmaceutical Manufacturers and 3 co-pay foundations really do exists. Not only it brings harm to patient buying medicines but also to the Medicare program as well.” In addition to Demske’s statement, “Due to the illegal actions of the Board of Directors and Management of Novartis Pharmaceutical Corporation, they will be held accountable and face major sanctions in accordance with the CIA.”
According to Joseph R. Bonavolonta’s statement, a Special Agent from the FBI Boston Division, “To my knowledge, Novartis would not attempt to commit mistakes such as taking advantage of the expense of the clients and used their gains to upgrade their systems if they had not struck the bottom,” An extension to Bonavolonta’s statement, “Announcements made today serves as a warning to every pharmaceutical company that if they make a move, just like what Novartis did, our healthcare fraud group will make sure that they will face the same sanctions in accordance with the law.”
The government’s testimonies in today’s settlement are as follows:
Novartis had begun their operations since the year 2010, 1st of January until December 31st, the year 2014. First, the Assistance Fund (TAF) funnel kickback pays to Medicare clients taking Gilenya, a Novartis drug for multiple sclerosis (MS). Lastly, the other 2 foundations namely the National Organization for Rare Disorders (NORD) and Chronic Diseases Fund (CDF) acted as a funnel as well to compensate kickbacks to patients receiving Afinitor, a drug for Renal Cell Carcinoma (RCC) and Progressive Neuroendocrine Tumors of Pancreatic Origin (PNET)
With regards to TAF, Novartis learned from Express Scripts that there were a total of 364 MS patients who have been provided a free drug program through The Assistance Fund in October 2012. This also includes the eligibility of these patients to Medicare the next year. These 364 patients had been moved to Medicare Part D through Novartis and Express Scripts. When patients had finished asking for their drug prescriptions, Novartis would obtain gains from Medicare. Unfortunately, these patients don’t have the money to pay for the drug so Novartis came up with a plan in covering them up through The Assistance Fund (TAF), which regulated a fund that is only offered to patients with MS who met the requirements for TAF financial eligibility. Regardless of whichever drug the MS patient was taking. Novartis arranged a schedule for TAF to open it’s MS fund at 6 in the evening on Friday the 14th of December 2012 after making payment given to TAF. It had the Express Scripts employees working overnight until the next morning submitting petitions to TAF on behalf of patients who had been receiving free Gilenya drug from Novartis. All Novartis and Express Scripts combined efforts for the program, at that time, were all wasted when Novartis found out the patients got an unequal share of grants from TAF while it was open.
Novartis confirmed on Saturday, December 15, 2012, that TAF used Novartis funds to provide Gilenya drug for MS patients with guaranteed shares to cover their Medicare co-insurance in 2013. While Novartis thereafter made additional payments to TAF. On the other hand, TAF contributed the need for the same MS patients with donations to cover their medicare co-insurance in 2014.
With regards to NORD, Novartis found out that no other producers of RCC medications would be contributing to a pre-existing NORD RCC co-insurance assistance fund, as of the 2010 donation year. Novartis had known that Afinitor drug was confirmed to function as a second-line RCC treatment only, and only when specific first-line products had not taken effect. Novartis also recognized, thus, that any co-insurance NORD covered for prior RCC treatments would not be used to cover co-insurance for Afinitor. NORD had been notified by Novartis that it would be inclined to give out its RCC fund if NORD shortened the funds’ eligibility intention so as not to wrap co-insurance for first-lines. To make sure that a bigger amount of its contributions would finance its product, Novartis wanted the funds to be limited, as disagreed with others. NORD then published a current fund with the title Enhanced Renal Cell Carcinoma Second Line Co-Insurance Assistance Program. This fund did not include patients asking for co-pay coverage for first-line RCC treatments and unequally funded patients taking Afinitor in contrast to its total usage ratio among all RCC drugs. Novartis subsidized this NORD fund through 2014.
In 2012, with regards to CDF, after Afinitor was confirmed to deal with PNET, Novartis suggested CDF open a fund, just like what it did to TAF, to coat Afinitor drug co-insurance for PNET patients. During this period, Novartis had come to know that the FDA had authorized a contending drug to treat PNET. As a result, with Novartis’ wisdom, CDF published a fund with a title PNET that permitted co-insurance only for Afinitor and excluded co-insurance for the other PNET drug. Through 2014, Novartis proceeded as the exclusive financial donor of this supposed PNET fund with this understanding.
As announced today by the United States Attorneys Office for the Southern District of New York, Novartis signed into a five-year agreement called Corporate Integrity Agreement (CIA) with OIG as part of this accord and a simultaneous settlement. Novartis had been given an obligation from the CIA to execute standards, commands, and formulations to encourage freedom from any patient assistance programs that furnish income. In extension, Novartis decided to execute programs with an examination of risk to achieve abidance-related certifications from Board members and company leaders.
As of the moment, the Department of Justice has gathered over $900 million from ten Pharmaceutical Corporations namely (Alexion, Pfizer, Actelion, Jazz, Lundbeck, Astellas, Amgen, United Therapeutics, Sanofi, and Novartis) that asserted to be true that they had used third-party foundations as kickback carriers. The Department also has found compensation with four foundations namely (Chronic Disease Fund, The Assistance Fund, and Patient Services Inc, and Patient Access Network Foundation) that they happened to have conspired with these Pharmaceutical Companies.
The announcement made today came from the Assistant U.S. Attorneys Gregg Shapiro and Abraham George U.S. Attorney Lelling, Assistant Attorney General Hunt, HHS Chief Counsel to the Inspector General Demske, and FBI Boston SAC Bonavolonta.
The trial was handed over to the Attorneys Sarah Arni and Augustine Ripa of the Justice Department Civil Division. While the U.S. Postal Inspection Service also reached out in the investigation period. Any act that abuses Human Economic Rights is considered a fraud. The accused who violates these rights and found guilty in court will spend a lifetime in jail. The side effects of bad works have a greater impact which can result in ruining a person’s reputation. If you are a concerned citizen, take immediate response against the crime as soon as it is recognized. Also, our Healthcare Fraud Specialists will take care of the matter as soon as we get notified through our hotline number at 888-402-4054