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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.

The Department of Justice has given the green light to insurance giant Cigna Corp.'s planned $67 billion acquisition of pharmacy benefit manager Express Scripts...The move terminates the applicable waiting period..The transaction still remains subject to certain state regulatory approvals and filings, including clearances from certain departments of insurance...Cigna and Express Scripts have obtained clearances from departments of insurance in 16 states. The companies are working with regulators in the remaining jurisdictions to obtain clearance for the merger...

Almost half of all European-registered clinical trials - in which scientists test drug treatments, interventions or therapies in humans - have breached EU rules by failing to report results...The analysis also found that while most major pharmaceutical companies are coming close to complying with EU reporting rules for trials in people, most major academic institutes are not...European Union guidelines say that funders of clinical trials must ensure all studies entered on the EU Clinical Trials Register since 2004 have posted results there within a year of concluding...Advocates for transparency in science say enforcing the rule is necessary to ensure researchers do not bury results they consider unfavorable...We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported...

The FDA's latest round of testing has revealed an additional impurity, N-nitrosodiethylamine (NDEA) in three lots of Torrent Pharmaceuticals' recalled valsartan products. NDEA is a known animal carcinogen and a suspected human carcinogen...The source of the impurity was the valsartan active pharmaceutical ingredient from Zhejiang Huahai Pharmaceuticals. Not all products made from Zhejiang Huahai's valsartan contain the impurity, however...More than half of valsartan products are now under recall and FDA said last month more are likely...The story has now escalated. Once the FDA and EMA learned that Zhejiang Huahai discovered an additional impurity, NDEA, the authorities retested all valsartan API and products. Like NMDA, NDEA appears to be formed as a result of a specific sequence of steps in manufacturing.

The landmark legislation would disburse nearly $8 billion to HHS, CMS, CDC and state governments, with big goals for population health, care coordination and patient safety...The Opioid Crisis Response Act of 2018...It's a massive bill comprising a wide array of proposals drawn from five Senate committees, and has many implications for the use and funding of health IT...It contains funding for stopping the flow of illegal opioids from other countries, and for supporting local programs for prevention, treatment and recovery...spur research and development of new non-addictive painkillers and stem "doctor shopping" by boosting prescription drug monitoring programs...has funds to give behavioral and mental health providers the tools they need to offer treatment and recovery – including potential electronic health record incentives – and for hospitals to better care for infants with neonatal abstinence syndrome.

Are rural hospitals properly tracking and reporting healthcare-associated infections like clostridium difficile? What about screening their patients in ambulatory clinics for alcohol use and abuse?...Those quality measures are among a set of suggested measures the National Quality Forum released...in an effort to put rural providers “on a pathway” to improvement...The measures are part of the NQF’s Measure Applications Partnership, created under the Affordable Care Act to provide input to the U.S. Department of Health and Human Services on the best performance measures for public reporting and performance-based payments...MAP singled out 20 measures that to fit the unique needs of rural providers and address their key concerns, such as access to care...The forum has recommended that the Centers for Medicare & Medicaid Services adopt the measures in Medicare first, and then potentially expand them to Medicare Advantage...Ensuring that rural hospitals and providers can participate in quality improvement is crucial...

The Reno and Sparks Chamber of Commerce announced...will begin offering an association health plan to its small business members in partnership with Prominence Health Plan, following in the footsteps of four other chambers of commerce in Southern Nevada that unveiled similar plans with other insurance companies last month...Small businesses that are members of the chamber will be able to purchase medical coverage through Prominence and dental, vision and life insurance through Kansas City Life...The Las Vegas Metro Chamber of Commerce and the Clark County Health Plan Association, a partnership of three smaller Southern Nevada chambers, each announced plans last month to begin offering association health plans to their members in the wake of a rule released by the Department of Labor in June loosening the rules on such plans. The new rule exempts association health plans from providing the essential health benefits required under the Affordable Care Act, eliminates restrictions based on geography and allows companies in different industries in the same region to provide coverage together...

California’s insurance regulator is suing AbbVie Inc., alleging that the pharmaceutical giant gave illegal kickbacks to health-care providers in order to keep patients on its blockbuster rheumatoid arthritis drug Humira...The company “engaged in a far-reaching scheme including both classic kickbacks -- cash, meals, drinks, gifts, trips, and patient referrals -- and more sophisticated ones -- free and valuable professional goods and services to physicians to induce and reward Humira prescriptions...AbbVie paid for registered nurses that it called ambassadors to help doctors with patients who were taking Humira. While the nurses were represented to patients as an extension of the doctor’s office, they were trained to tout the drug while downplaying its risks...The allegations “are without merit,”...The company complies with state and federal laws governing interactions between health-care providers and patients...Its services help patients and “in no way replace or interfere with interactions between patients and their health-care providers...

The Nevada Supreme Court is considering whether to put the brakes on oral arguments slated later this week on a bid by the state to resume planning the twice-postponed lethal injection of an inmate who says he wants to die...The high court called for a written response by Tuesday from state attorneys after pharmaceutical firms said there's no need to rush...The state attorney general's office has argued that unless the Supreme Court rules by mid-October whether the execution can proceed, some drugs will expire.

Nevada's prisons pharmacy chief says she ordered and obtained lethal injection drugs this year despite knowing drug manufacturers didn't want their products used for executions...Linda Fox's drug purchases allowed Nevada to plan its first execution since 2006 using a never-before-tried three-drug combination...She testified...that she didn't specify the end use when she obtained medications from a third-party supplier, not the drug makers...Fox was pressed by lawyers representing drug companies a day after the state's prisons chief provided sworn testimony about having trouble obtaining drugs for executions...