• California: Amgen last week announced that Repatha, a cholesterol-lowering drug, was able to prevent a composite of heart disease mortality, heart attack, and the most common type of stroke in a new large-scale trial. Repatha has been available since 2015, and existing data shows that it can reduce the risk of heart disease and stroke among patients who have heart problems. The new trial had 12,000 patients, and Amgen said that it was able to meet its primary goals showing that Repatha prevents death from coronary heart disease, heart attacks, and strokes, and to show that the medication prevented those same problems with stent and bypass procedures. According to Amgen, the results of the new trial could help Repatha reach a broader market. "These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide. The benefit across endpoints and established safety profile underscore Repatha's role as a cornerstone therapy in comprehensive lipid management," said Jay Bradner, Amgen's EVP of research and development. (Herper, STAT+ [subscription required], 10/2)
• Georgia: According to new CDC data, cases of newborn syphilis in the United States have increased for the 12th consecutive year. However, the rate of growth is slowing. In 2024, there were 3,941 cases of newborn syphilis, a 1.6% increase from the 3,878 cases in 2023. Over the last decade, the number of newborn syphilis cases has grown by almost 700%. In 2015, there were only 495 reported cases. Because of this significant rise in cases, CDC has classified newborn syphilis as a rising epidemic. The overall burden of sexually transmitted infections (STIs) has decreased over the last two to three years. But in 2024, congenital syphilis — when syphilis passes to infants during pregnancy — was the only STI to record a year-over-year increase. (Twenter, Becker's Clinical Leadership, 9/29)
• Texas: Late last month, Judge Reed O'Connor of Texas' Northern District vacated a Biden-era rule that would have clawed back billions of dollars in overpayments from Medicare Advantage (MA) insurers. In January 2023, CMS finalized the Medicare Risk Adjustment Data Validation (RADV) rule, which included a new methodology for calculating payment recoveries from MA audits. The new methodology allowed regulators to sample a small number of MA plans to find unsupported diagnoses that suggest a payer inflated risk scores to get higher reimbursement. These results would then be extrapolated across an entire contract and used to create an estimate for repayments. Later that year, Humana sued to block the rule. In his ruling, O'Connor said that CMS did not properly notify the industry about changes made between the RADV's proposed and final versions, which violated the Administrative Procedures Act — giving MA insurers a major win. So far, CMS' next steps are unclear, but some options include appealing O'Connor's decision or reissuing the rule after following proper notice-and-comment procedures. (Pifer, Healthcare Dive, 9/26)

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