Industry News: Volume 3, Issue 5

Advocates ask U.S. trade rep to allow countries to sidestep Trikafta patents – Cystic fibrosis patients around the globe are clamoring for access to Trikafta, a potent drug from Vertex Pharmaceuticals that can treat 90% of patients with the inherited respiratory disorder. But it’s very expensive: The U.S. list price is nearly $322,000 — which is likely why only 12% of CF patients in nearly 100 countries are receiving the treatment.  

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US spends most on health care but has worst health outcomes among high-income countries, new report finds

By Jacqueline Howard, CNN – The United States spends more on health care than any other high-income country but still has the lowest life expectancy at birth and the highest rate of people with multiple chronic diseases, according to a new report from The Commonwealth Fund, an independent research group.

The report, released Tuesday, also says that compared with peer nations, the US has the highest rates of deaths from avoidable or treatable causes and the highest maternal and infant death rates.

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Mental health shame and presenteeism: Results from a German online survey

By Christian Sander a, Ezgi Dogan-Sander a, Joachim E. Fischer b, Georg Schomerus a – We conducted a survey amongst 5177 German employees asking about current mental well-being, mental health shame, help-seeking and presenteeism likelihood. Low mental well-being was reported in 22.9% of respondent; 65.5% stated that they would feel ashamed for own mental health problems. 54.1% said they were likely to go to work without talking to colleagues and supervisors despite mental health problems.

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Commonwealth Fund: US has lower life expectancy but spends most on health compared to other countries

By Robert King – The U.S. has both the lowest life expectancy compared to other wealthy nations and the highest rate for avoidable deaths, a new study finds.

The study, released Tuesday by the Commonwealth Fund, also found that the U.S. has the highest infant and maternal mortality rates as well as deaths by assault. The findings come as the Biden administration is hoping to improve maternal mortality.

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CMS: Tighter price transparency enforcement, standardized requirements for hospitals are on the horizon

By Dave Muoio – Centers for Medicare & Medicaid Services (CMS) leaders say the agency has handed out nearly 500 warnings to hospitals falling short on price transparency as of January and plans to streamline enforcement and standardize hospital reporting requirements.

Enforcement of the transparency requirements has also included more than 230 requests for corrective action plans, CMS’ Deputy Administrator and Director Meena Seshamani, M.D., and Center for Medicare Chief Transformation Officer Douglas Jacobs, M.D., wrote last week in an article for Health Affairs.

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Why Disney shifted to a value-based care model for its 77,000 Florida employees

By Deanna Cuadra – Healthcare prices are on the rise, and in a system already notorious for its lack of affordability, many employers are nervous about what this means for their employees’ health. But instead of taking a wait-and-see approach, some employers have decided to change the way they provide healthcare altogether.

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The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

By Lizzy Lawrence – Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance.

In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. In a fierce rebuttal, the Clinical Decision Support Coalition filed a petition earlier this month asking the FDA to withdraw the final CDS guidance, arguing regulators are overstepping their bounds by trying to police medical practice. They also claim the FDA’s move violates the 21st Century Cures Act, a 2016 law that says tools that “provide limited clinical decision support” don’t count as medical devices.

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