The FDA ordered 4 companies to stop selling 44 of their flavored e-liquid and hookah tobacco products that lack the required approval for sale; CMS has yet to implement a 2014 law preventing unnecessary, expensive screening tests (magnetic resonance imaging, computed tomagraphy scans and other tests) that could harm patients and waste resources; Amarin, which is seeking FDA approval for an expansion of Vascepa labeling to include data that showed a 25% reduction in the risk of heart attacks and strokes, said the FDA has scheduled an advisory committee meeting for November 14.
The FDA ordered 4 companies to stop selling 44 of their flavored e-liquid and hookah tobacco products that lack the required approval for sale, the agency said. The FDA said the products were launched after the effective date of a rule that extended FDA's authority to all tobacco products. Reuters reported the move comes against the backdrop of the FDA's efforts to curb the usage of the addictive substances among young adults.
CMS has yet to implement a 2014 law preventing unnecessary, expensive screening tests (magnetic resonance imaging, computed tomagraphy scans and other tests) that could harm patients and waste resources, NPR reported. The law requires that doctors consult clinical guidelines before Medicare will pay for many common medical scans. Although the law is slated to begin in January 2020, it will be a "testing" period, which means that Medicare will still pay for the scan even if guidelines are not consulted.
Amarin, which is seeking FDA approval for an expansion of Vascepa labeling to include data that showed a 25% reduction in the risk of heart attacks and strokes, said the FDA has scheduled an advisory committee meeting for November 14, Stat News reported. Last week, the company said it was “unlikely” that the agency would want a formal meeting for its fish oil-derived drug. The agency’s deadline for making an approval decision will also likely be extended into late December from September 28, the company said.
Prices for care at hospital trauma centers vary across hospitals; drug shortages reached a record high during the first quarter of 2024; although 3 of the biggest makers of asthma inhalers pledged to cap out-of-pocket costs for some US patients at $35, these do not apply to daily inhalers used by the youngest kids with asthma.
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Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
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The Biden administration recently launched the Global Health Security Strategy, a new effort to combat the spread of infectious diseases; lawmakers zeroed in on the risks of massive consolidation in health care during the first congressional hearing on the Change Healthcare hack; the FDA recently announced the recall of a pair of heart devices linked to numerous deaths and injuries.
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March 26th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the March 2024 issue of The American Journal of Managed Care® about their findings on variations in prior authorization use across Medicare Advantage plans.
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