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Helen Bernie, associate professor of urology and director of the Male Sexual and Reproductive Medicine Program at Indiana University School of Medicine recently testified at the FDA's Expert Panel on Testosterone Replacement Therapy for Men and stated that serum testosterone is one of the most powerful yet underutilized biomarkers in men's health

Similarly, several commenters indicated that CMS' one-time burden estimate to encode the new data elements in the MRF as proposed in the CY 2026 OPPS/ASC proposed rule was underestimated

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