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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.

A no-deal Brexit could cause up to six months of disruption at some ports, a British minister warned...vowing to prioritise pharmaceuticals as the UK develops contingency plans less than four months before it is due to leave the EU...Health minister Matt Hancock wrote to drugs companies in August to ensure they had at least six weeks’ worth of medicines in Britain but on Friday he suggested any potential disruption could last longer...Britain is planning to use aeroplanes and fast-track trucks to ensure the continued supply of medicines if it leaves the European Union without a deal, Hancock said, and will give preference to medicines in the face of competing pressures.

As pharmacists continually build their scope of expertise, hospital anti-microbial stewardship programs are just one more avenue for putting their experience and knowledge to work...Anna Legreid Dopp, PharmD, director of clinical guidelines and quality improvement at ASHP, says pharmacists have a responsibility to take a prominent role in antimicrobial stewardship programs by

• Promoting the opial use of antimicrobial agents;
• Reducing the transmission of infections;
• Decreasing adverse events associated with antibiotic use; and
• Participating in formulary management and educating health professionals, patients, and the public.

Litigation is growing over tainted blood pressure medications with a class-action lawsuit now filed in Florida against Walmart and three drug companies that span the supply chain...In addition to the retailer, the lawsuit names Indian drugmaker Aurobindo, U.S. drugmaker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals. It was filed in federal court in Florida against the four over the sale of irbesartan because the drug contained the impurity, N-nitrosodiethylamine...Hauppauge...and its distributor Westminster initiated a nationwide voluntary recall to the consumer level of all lots of unexpired irbesartan tablets because they had been made with the Aurobindo API and then shipped to Walmart. The FDA learned this summer that the suspected carcinogen...can show up in “sartan”-based drugs as a result of certain manufacturing processes...

Six Michigan doctors have been charged with insurance fraud and unnecessarily prescribing opioids to patients in a $464 million scheme, according to court documents...The 56-count indictment...named Dr. Rajendra Bothra...who owned and operated the Pain Center USA in Warren and Eastpointe, Mich., and the Interventional Pain Center in Warren. The other five doctors were employed by the clinics, which catered to patients with joint and spinal injuries...The doctors have been charged with submitting false claims...and diverting the proceeds to themselves...Prosecutors said the doctors submitted claims of $182.5 million to Medicare, $272.6 million to Medicaid and $9.2 million to Blue Cross Blue Shield of Michigan...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

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."...

Walgreens and FedEx are teaming up...The companies have launched Walgreens Express, a service that will provide next-day delivery nationwide, as well as same-day delivery in select markets...Patients who are enrolled in Walgreens text alerts will get a text message notification when their qualifying prescriptions are ready. They can then follow a process to choose to have their prescription delivered the next day for a $4.99 fee...Walgreens said most prescription orders are available to be delivered by the next business day, it said some prescription benefit plans and insurance plans do not allow home delivery, encouraging patients to talk to a pharmacist with any questions.

Pharmacy chain and benefits manager CVS Health Corp...said...it will offer a new prescription benefit option guaranteeing its health plan clients 100 percent of any rebates, discounts or other fees paid by drugmakers...The new plan model is aimed at providing greater drug cost simplicity, predictability and transparency...Under its new option, CVS takes on the risk of drug price inflation and shifts in drug use - at least for the term of each contract...The new model guarantees average spending per prescription across each distribution channel – retail, mail order and specialty pharmacy...

...the U.S. Food & Drug Administration will run out of 5-digit National Drug Code codes within the next ten to fifteen years…The problem now facing U.S. healthcare is that, due to an explosion of new labelers entering the market, the FDA is running out of 5-digit labeler codes. The 5-digit format provides 90,000 potential combinations, and although that seems like a lot, the FDA anticipates running out of labeler codes within the next 10-15 years...the disruption and impact to the healthcare industry will be widespread and of a large magnitude, and will require retooling of major industry systems...