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Office of the Inspector General

HHS OIG Finds CMS Oversight Failed to Reduce Risk of Improper Genetic Testing Payments

The agency's audit was intended to determine whether CMS oversight of payments for rare disease testing code 81408 was adequate in reducing the risk of inappropriate payments.

FDA Allowed Problematic COVID-19 Tests on the Market Due to Agency's EUA Approach, HHS OIG Finds

In a report released on Wednesday, the office critiqued the FDA's pandemic performance and recommended new approaches.

How Will OIG's Findings on Widely Divergent Gene Test Reimbursement Rates Influence CMS Payment?
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A new report from the Office of the Inspector General that found wide variance in reimbursement rates for laboratory-developed genetic tests has industry players concerned that the Centers for Medicare and Medicaid Services may reduce payment levels for some of these diagnostics.
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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.