Three senior executives at scope manufacturer Olympus Corp., which is under federal investigation for its role in “superbug” outbreaks, repeatedly invoked their Fifth Amendment right against self-incrimination when questioned recently about internal company emails, according to a report from Kaiser Health News (KHN).

The FDA has approved updates to the labeling for varenicline (Chantix, Pfizer), including removal of the boxed warning regarding serious neuropsychiatric events.

A study led by investigators at the University of California, Los Angeles, has found that Zika-linked abnormalities that occur in human fetuses are more extensive—and more severe—than previously thought, with 46% of 125 pregnancies among Zika-infected women resulting in birth defects in newborns or ending in fetal death.

The FDA has given the green light to Xpert MRSA NxG (Cepheid International), a new infection-control test for methicillin-resistant Staphylococcus aureus (MRSA). The molecular assay provides actionable results in approximately one hour.

The CMS released final regulations for ACA marketplaces in 2018.

What if you gave a condition and everybody came? The New York Times takes a skeptical view of the fuss being made over prediabetes.

Psychological health, access to care, expanded and personalized treatment options, and the tracking of hypoglycemia in people with diabetes are key areas emphasized in the American Diabetes Association (ADA) 2017 Standards of Medical Care in Diabetes.

A supplemental biologics license application has been submitted to the FDA seeking approval of ustekinumab (Stelara, Janssen Biotech, Inc.) for the treatment of adolescents (12–17 years of age) with moderate-to-severe plaque psoriasis.

In chronic obstructive pulmonary disease (COPD), the patients’ lungs lose their ability to repair damage on their own. Scientists at the Helmholtz Zentrum München, partner in the German Center for Lung Research, now have a new idea about why this may occur.

Considerable evidence has indicated that the drug metformin, used for more than 50 years to treat type-2 diabetes, also can prevent or slow the growth of certain cancers, but the mechanism behind its anticancer effects has been unknown.

The EpiPen generic Mylan promised in August amid a pricing firestorm is officially on its way to market. The product—priced at $300 per two-pack, less than half the branded drug’s list price—will hit pharmacy shelves next week, Mylan announced.

The outcome of the Anthem-Cigna and Aetna-Humana merger cases would change the health insurance landscape by making the “big five” insurers into the “big three.” The U.S. Justice Department doesn’t like the idea, and filed antitrust suits against both back in July.

The U.S. Department of Justice (DOJ) has charged two former senior generic pharmaceutical executives for their roles in conspiracies to fix prices, rig bids, and allocate customers for certain generic drugs—the first criminal charges stemming from a two-year investigation. The men are reportedly in talks with the government about a plea agreement.

The FDA has approved crisaborole ointment (Eucrisa, Anacor Pharmaceuticals) for the treatment of mild-to-moderate eczema (atopic dermatitis) in patients 2 years of age and older. 

According to PwC’s Health Research Institute (HRI), 2017 will be a year dominated by the continued shift toward value within health care as the industry adapts to a new era under the administration of President-elect Donald J. Trump.


Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.