Updated Booster; Poor Healthcare Economy; and Skin Cancer Devices
United States to Offer Updated COVID Booster Shots in September
The Biden administration plans on supplying reformulated vaccines starting in September to provide better protection against Omicron subvariants, including BA.5.
Eligibility not expanded yet: Amidst the new shots, US Food and Drug Administration (FDA) officials decided to not expand eligibility this summer for second boosters for those younger than 50 years but rather wait until September to better protect against a potential winter surge.
Older than 50 years can currently get second booster: Adults older than 50 years and those older than 12 years with immune deficiencies are currently eligible for second booster doses.
Hundreds of millions anticipated doses: Both Moderna and Pfizer-BioNTech have agreements with the United States for “bivalent” vaccines, which contain the original coronavirus strain and mRNA from the BA.4 and BA.5 subvariants.
Physician Groups Face Worsening Economic Conditions
US medical groups face uneven recovery from the COVID-19 pandemic, rising costs, and cratering margins, according to a new report using survey data from the Medical Group Management Association.
Inflation and increasing labor costs: Ninety percent of practices are reporting that costs are rising faster than revenues are so far in 2022.
Unmet goals: In 2021, only 60% of practices hit their revenue goals, with profit margins for medical groups ranging from 3% to 7%.
Rebound for hospital-owned practices: Hospital-owned groups did better than physician-owned practices in 2021, but some of that was reflected in their poor 2020 performance.
Mixed Views on Devices to Detect Skin Cancer
New artificial intelligence–based devices are becoming increasingly popular to diagnose skin cancer, but accuracy concerns remain.
Two on the market: There are currently two FDA-cleared computer-aided skin-lesion classification devices, which are both meant to help clinicians assess suspected melanoma cases.
High risk for harm: Both devices were given a Class III designation, which is intended for products with a high risk for harm because of flawed design or implementation.
Limiting risk: At an FDA panel on July 29, issues including clinical performance testing in regard to sensitivity and specificity rates, software validation and verification, cybersecurity testing, and direction labeling were all discussed to help mitigate risk.
There was no formal voting at the meeting; rather, members engaged in broad discussions about risks and potential benefits of the new skin-cancer detecting tools.
Kaitlin Edwards is a staff medical editor based in New York City. You can follow her on Twitter @kaitmedwards. For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.
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