- Drug Maker Pays $360 Million to Settle Investigation Into Charity Kickbacks (nytimes.com)
The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity...Actelion...makes expensive drugs to treat a rare lung condition, is the latest pharmaceutical company to settle federal inquiries into their ties to patient-assistance groups, including whether companies have used the patient programs to increase the price of their drugs...But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization...Federal prosecutors said Actelion violated the law by collecting detailed data in 2014 and 2015 about the patients receiving help from a nonprofit, the Caring Voice Coalition, and using the data to budget for future donations. As a result, Actelion ensured that the money it donated would be used only to assist patients who used its drugs, and not competing companies’ treatments for the pulmonary condition.
- Florida’s opioid lawsuit against CVS and Walgreens takes aim at distributors with deep pockets (cnbc.com)
Florida Attorney General Pam Bondi has added Walgreens and CVS Health as defendants in the state's massive lawsuit against the opioid industry...Legal analysts say Florida and other plaintiffs are targeting the distributors and pharmacies, in part, because they have deep pockets...The...lawsuit accuses the drug stores and pharmaceutical distributors like Cardinal Health, Amerisource Bergen and McKesson of playing as big a role in the proliferation of opioid addiction as drug manufacturers like...Purdue Pharmaceuticals and Johnson & Johnson's Janssen Pharmaceuticals...
- How Nevada Medicaid struggles with mental health care fraud (reviewjournal.com)
The expansion of Medicaid in Nevada in 2014 made mental health care much more widely available in a state ranked last in the nation for access to such services. It also provided a great opportunity for bad actors...catching those who abuse the Medicaid system is a tortuous process that can either come too late or result in relatively minor penalties...fraudsters are undoubtedly adding to the $56 million deficit Nevada Medicaid predicts it will face in the 2019 fiscal year, up from last year’s $30 million forecast at this time...The Medicaid expansion has certainly “exacerbated” the problem of fraudulent or improper claims in the field of behavioral health...Suspicious claims from mental health providers led Nevada Medicaid to investigate $73 million paid out in the 2018 fiscal year...So far, about $10 million — or 13 percent — has been recovered...
- UK doctors win battle with drug giants over cheaper eye medicine (reuters.com)
Drug giants Novartis, Bayer and Roche on Friday lost a bid to stop British doctors from recommending a cheaper drug option for people with an eye disease that causes blindness, the High Court in London ruled...A drug industry group said the decision was “extraordinary” and was bad news for future regulatory cooperation between Britain and the European Union after Britain’s exit from the bloc...The companies had sought to block doctors from 12 health groups in the north of England from making Roche’s cancer therapy Avastin the preferred option for wet age-related macular degeneration, even though it is not licensed for this use...Avastin works similarly to Bayer’s Eylea and Roche’s and Novartis’s Lucentis, but those drugs were made specifically for the eye...“Treating clinicians can lawfully choose Avastin for opthalmic use on grounds of cost,” according to the ruling. It added that NICE, the UK’s drug cost effectiveness agency, had concluded that using Avastin for AMD was safe...
- Bristol-Myers Squibb must face whistleblower suit claiming underpaid Medicaid rebates (fiercepharma.com)
Years after a former pharmacist sued Bristol-Myers Squibb and other companies for allegedly underpaying Medicaid rebates, a federal court rejected Bristol's attempt to escape the case...Pharmacist and lawyer Ronald Streck filed a False Claims Act whistleblower lawsuit against Bristol-Myers and other companies back in 2013, but later withdrew his claims against the other defendants. Now, his lawsuit alleges that BMS fraudulently manipulated its average manufacturer prices to underpay Medicaid rebates from 2007 to 2016...Pennsylvania federal judge Timothy Savage ruled last week that Streck "has alleged sufficient facts to state a false claims cause of action."...
- US court says Vegas hospital must pay $820K in wages case (apnews.com)
Nevada’s public hospital in Las Vegas has been ordered to pay nearly $820,000 in sanctions and attorney fees for failing to produce required emails, text messages and computer records in an ongoing federal employee wages lawsuit...University Medical Center has until Dec. 5 to pay the penalty in the civil case alleging that thousands of nurses and other employees routinely worked through 30-minute meal periods for no pay...The court found that UMC had repeatedly violated its discovery obligations and its duty to preserve...noting that some electronically stored information that was turned over included “indecipherable codes complete with Japanese and Korean characters.”
- AmerisourceBergen to pay $625 million in U.S. civil fraud settlement (reuters.com)
AmerisourceBergen Corp...will pay $625 million to resolve civil fraud charges over the sale of syringes containing drugs for cancer patients, double billing, and providing kickbacks to doctors...The settlement...boosts AmerisourceBergen’s total payout to $885 million over its repackaging and distribution of pre-filled syringes that were not approved by the Food and Drug Administration...AmerisourceBergen admitted that from January 2001 to January 2014, its Medical Initiatives Inc pharmacy unit in Alabama shipped millions of syringes for patients undergoing chemotherapy that contained drugs prepared in an unsterile environment...Authorities said AmerisourceBergen would harvest “overfill” from the original vials of such drugs as Aloxi, Anzemet, Kytril and generic Kytril, Neupogen and Procrit...That enabled the company to create more doses than it bought, and generate at least $99.6 million of extra profit...
- Elko cardiologist pleads guilty to opioid charges (kolotv.com)
An Elko cardiologist has pleaded guilty to distributing highly-addictive prescription drugs...to patients without a medical purpose...59-year-old Dr. Devendra I. Patel...who owns and operates Northeastern Nevada Cardiology, was indicted by a grand jury in December 2017...The investigation showed Patel illegally prescribed opioids and other prescription narcotics to patients for financial gain. As part of his plea, Patel admitted that, between September 2015 and February 2016, he prescribed Oxycodone and Hydrocodone to patients without a legitimate medical purpose and outside the usual course of professional practice...The statutory maximum penalty is 20 years in prison and a $1,000,000 fine.
- Mavyret maker AbbVie slaps NHS England with lawsuit over hepatitis C drug procurement: report (fiercepharma.com)
In an aggressive push to end hepatitis C in England, health authorities there are in the process of weighing bids in NHS England's “largest ever” drug procurement process. But AbbVie isn’t happy with the negotiations, and it’s suing the health service for treating bidders unfairly...AbbVie, which makes the fast-growing Mavyret, claimed the National Health Service broke procurement rules in its effort to buy hundreds of millions of pounds worth of hepatitis C drugs...The NHS wants to buy the drugs in bulk to keep costs down as it works to eliminate hep C in England by 2025...
- Brazilian court strips Gilead of its patent for Hepatitis C drug Sovaldi (pharmaceutical-technology.com)
A judge from the 21st Federalist Court of Brasilia has ruled to invalidate US biopharma company Gilead’s exclusivity patent for Sovaldi (sofosbuvir)...Hepatitis C is a major public health issue in Brazil; it has been estimated by Brazilian academics that 1.5 million people in the country were chronically infected with the virus in 2014...A centre-left, environmentalist presidential candidate for the upcoming election, Marina Silva, filed a popular action analysis complaint to the court arguing that Gilead’s patent for Sovaldi should be overturned in order to reduce costs for patients...The patent was granted in 2015 by the National Institute of Industrial Property...Silva and her running mate Eduardo Jorge claim the INPI made the decision without the consent of the National Agency of Sanitary Surveillance, meaning Brazil’s national interest was not adequately recognised in the decision...