Today's News

About public health:

H.R.1318 - Preventing Maternal Deaths Act of 2018: Finally, Congress agrees about one issue. Today it passed this law, which amends the Public Health Service Act. Its purpose is “to develop surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among population at risk of death and complications from pregnancy.” The bill goes to the president for signature.

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About insurance:

Federal court blocks Trump administration's exceptions to birth control rule in five states: California, Delaware, Virginia, Maryland and New York sued the federal government to stop implementation of a religious conscience exemption for providing coverage of birth control. The US Court of Appeals for the Ninth Circuit found in the states’ favor to block the rule.

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Average outpatient visit in US approaching $500: For once, we are not first in healthcare costs. The US ranked second between #! Switzerland and #3 Norway for the world’ highest average outpatient costs. But inpatient care is by far the highest here. At $22,500 it is about $7000 higher than #2 Switzerland. Why are our insurance costs so high? As many economists have said before: “It’s the process, stupid.”

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Appeals court rules BCBS must face antitrust claims: Is the Blue Cross/Blue Shield Association guilty of anticompetitive behavior based on actions by member organizations in overlapping territories and excluding non-Blues plans? Not yet…but the “11th Circuit United States Court of Appeals denied an appeal from the insurance giant after a lower court ruled in April that BCBS must defend itself against allegations it engaged in anticompetitive behavior that violates the Sherman Antitrust Act of 1890.” Stay tuned.

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About pharma:

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development: In the past, generic drug manufacturers could rely on the accuracy of the approved labeling (the “package insert” explaining uses and potential harms) of comparable branded drugs. However, due to successful litigation five years ago, these companies were held to be independently liable if the brand drug labeling was not sufficient to prevent adverse outcomes. The problem was that generic companies were not allowed to change the labeling- a “Catch-22.” So the FDA proposed a rule to allow them to do so. The FDA just withdrew the rule- citing potential increased costs that would be passed on to consumers and confusion if different generic versions of the same chemical entity had different labeling. The FDA claims that this change will allow generic companies to retain their legal shield against patient lawsuits.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics: The FDA has been moving to include “real world” data in decisions on both new drug approvals and modification of indications. This statement explains the latest program update.

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Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder: Starting about twenty years ago, lawsuits started appearing that claimed J&J’s Baby Powder cause mesothelioma- a rare cancer most often associated with asbestos. But the company denied that the talc-based product had any such toxic ingredients. Today, Reuter’s investigative reporting revealed that the powder did, indeed, contain asbestos and J&J covered up its knowledge of this contamination.. The stock price dropped about 10% at the close of trading.

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5 convicted in meningitis outbreak case; 1 acquitted:
Most medications come from highly regulated pharmaceutical facilities which must adhere to rules termed “Good Manufacturing Practices” or GMPs. Sometimes, however, physicians need specially formulated drugs. These products are created in what are called “compounding pharmacies.” Unfortunately, these pharmacies were not subject to GMP.
In 2014, a Massachusetts compounder sent steroid solutions to physician customers that was contaminated with fungus. These solutions were used to inject patients with back pain. The result was 76 patients died from meningitis and many hundreds were sickened. As a result of this case, regulations on compounding pharmacies were implemented. It was only yesterday, however that these convictions were handed down.

The story doesn’t end there, however. The real problem is that steroid injections for back pain do not meet criteria for evidence-based care. In other words, a contaminated drug was injected into patients for whom the treatment was not proven effective.

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About healthcare IT:

The 15 largest health data breaches of 2018: Breaches continue to plague healthcare companies as they strive for more interoperability, Here is the top 15 list for this year. The #1 spot goes to Charlotte, NC- based Atrium Health, affecting 2.6 million patients.

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Eli Lilly and Evidation expand digital biomarker collaboration to data from smartphones and wearables: Data gathered from smartphones, wearable devices and voice data are to be used (with patient consent) to gather biodata that the drug company can use to modify and extend it products. For example, “Evidation's platform is being used by Lilly to analyze data from continuous glucose monitors, insulin pumps and real-world information to improve its diabetes offerings, toward the Big Pharma’s goal of building a connected ecosystem that includes an automated insulin delivery device and connected insulin pen.”

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Report on Non-Device Software Functions: Impact to Health and Best Practices-December 2018; Submitted Pursuant to Section 3060(b) of the 21st Century Cures Act: When is software a device that the FDA regulates and when is it exempt? This issue was addressed by Section 3060(a) of the 21st Century Cures Act of December 13, 2016 (Pub. L. 114-255). This section specified that certain software functions were to be excluded from FDA review, but also mandated reporting about this issue every two years. This report is the first update. In general, such software falls into five categories: “(1) administrative support of a health care facility; (2) maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; (3) serving as electronic patient records when not intended to interpret or analyze patient records; (4) transferring, storing, converting formats, or displaying data; or (5) providing certain types of clinical decision support to a health care provider unless interpreting or analyzing a clinical test or other device data.”

The “bottom line” on this report is that:  “In general, the analysis found more benefits than risks to patient safety and health related to these software functions.”

Read the full report