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2 Zenzmaier et al reported human chorionic gonadotropin (hCG) and its free subunits (hCGα and hCGβ) are produced in the male reproductive tract and found in high concentrations in seminal fluid, especially hCGα

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We note that, similar to our discussion in the FY 2023 IPPS/LTCH PPS proposed rule (87 FR 28312), with respect to the evidence provided by the applicant to support its assertion that XENOVIEW TM is able to diagnose a medical condition in a patient population where the medical condition is currently undetectable and diagnose a medical condition earlier than currently available methods, the studies do not appear to provide evidence showing that use of the technology to make a diagnosis affected the management of the patients, as under § 412.87(b)(1)(ii)(B)