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However, this therapy is not indicated for men with age-related declines in testosterone alone, and its safety and efficacy have not been established for so-called late-onset hypogonadism in older males

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As discussed in the CY 2026 PFS proposed rule (90 FR 32593 through 32594), we believe maintaining the ONC direct review process (45 CFR part 170, subpart E) in ASM increases accountability among certified health IT developers and vendors by ensuring ASM participants' Health IT Module [277] conforms to ONC Health IT Certification Program's requirements not only during implementation of CEHRT, but also while CEHRT is being used during patient care and in care delivery