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This commenter also noted that CMS does not provide a legal or policy rationale for how it believes the Part B inflation rebates regulations can operate independently from one another

This product is not a drug, food, or cosmetic and may not be misbranded, misused or mislabeled as a drug, food or cosmetic.

Authorization criteria typically include documented testosterone levels below 300 ng/dL on two separate morning tests, clinical symptoms of hypogonadism, and absence of contraindications such as prostate cancer or severe heart failure

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