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Analysis Finds Span of Years for New Technologies to Get Medicare Coverage in US

It takes more than five years for new medical technologies to garner Medicare coverage in the US, according to a new analysis appearing in JAMA Health Forum. Researchers from Stanford University examined 64 devices or diagnostics that received premarket approvals, de novo authorizations, or 510(k) clearance with breakthrough device designations from the US Food and Drug Administration between 2016 and 2019. Of these, 44 percent reached a Medicare coverage milestone during the study timeline — they found the median time to nominal coverage was 5.7 years. The researchers note, though, that there was variability in time to coverage by manufacturer size with larger manufacturers getting coverage faster and by product type with diagnostic assays getting coverage faster. "The time required to establish at least nominal coverage results in uneven beneficiary availability and stretches longer than the time to average FDA authorization," the researchers write in their paper. "These data highlight the need for establishment of a more efficient and timely reimbursement process for novel FDA-authorized medical devices and diagnostics."

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.