Sometimes the waiting game isn’t just a bureaucratic hurdle—it’s a matter of life and death.

Patients and device manufacturers are tired of counting down the days for Medicare to cover treatments designated as breakthrough devices, a label given to inventions the FDA thinks could significantly improve serious or life-threatening conditions. Breakthrough devices receive speedier development, review, and FDA approval—but sometimes they get stuck in CMS limbo.

After years of pressure, however, the Centers for Medicare and Medicaid Services (CMS) unveiled a final notice on August 7 to reduce wait times for Medicare coverage of these inventions.

Still, not everyone thinks these changes are for the better. Some researchers have raised safety concerns, and some manufacturers and lobbyists want CMS to do even more to eliminate hurdles to patient access.

Keep reading here.—CC

Our mental and physical health are intertwined, yet it can feel like mental and physical health are treated as two very separate things.

In fact, two-thirds of primary care physicians in the US are *unable* to refer patients to mental health services that are related to a physical health condition. So how can we bridge this gap? With a unique digital solution, like Calm Health.

Watch this on-demand webinar to learn how Calm Health:

• provides personalized recommendations based on mental health screenings
• uses evidence-based programs to support specific health conditions, life experiences, and occupations
• is based on the science behind the mind-body connection

Hear directly from Calm’s Chief Clinical Officer and SVP of Product in their on-demand webinar.

GE HealthCare is setting its sights on women’s health. Literally.

The Chicago-based medical device company is teaming up with the University of California, San Diego School of Medicine to study MRI protocols for pelvic conditions commonly experienced by women, like endometriosis and ovarian cancer, and developing educational resources to support clinicians.

The goal is to improve women’s pelvic health and address gaps in medical research and healthcare by giving providers more resources to make informed decisions, diagnose diseases faster, and provide women more access to quality care, according to the company.

One 2023 Columbia University study found that 4% to 16% of women experience chronic pelvic pain (CPP), and that about half of cases remain undiagnosed.

“Diseases and conditions impacting female patients below the belly button are often misdiagnosed, misunderstood, and understudied in our industry,” Erin Angel, GE HealthCare’s global VP of research and scientific affairs, said in a press release.

Keep reading here.—CM

In recent months, the financial downfall and bankruptcy of Steward Health Care has dominated the news. But aside from Steward, Chapter 11 filings are less prominent, though the industry is still facing financial headwinds.

An August 14 report by Gibbins Advisors, a healthcare restructuring advisory firm, analyzed Chapter 11 bankruptcy cases among medical industry companies with more than $10 million in liabilities from the beginning of January 2019 to the end of June 2024.

Researchers found that while there was a sharp rise in bankruptcies in Q3 2023, the number of filings has decreased in the following three quarters through Q2 2024.

So far, there have been 58 cases filed in 2024. Compared to the 79 cases filed in 2023, 2024 is on track to see a 27% overall decline in bankruptcy filings, according to the report.

Size matters. The decline in filings, researchers reported, is due to the bankruptcy filing activity among middle-market companies—companies with liabilities ranging from $10 million to $100 million—which is currently 33% lower in 2024 than last year. However, bankruptcy filings from large healthcare companies, with liabilities over $500 million, remain as high as 2023 and are on track to report 12 bankruptcies, the report found.

Keep reading here.—CM

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