Does Medicare Advantage Cover AndroGel? Prior Authorization, Formulary Tiers, and Appeal Steps
At a glance
- Coverage / Set by the individual Medicare Advantage plan's drug list and coverage documents
- Approved use / Low testosterone plus an associated medical condition [1]
- Not an approved use / Low testosterone without an associated condition, including age-related low testosterone [1][2]
- Controlled substance / Schedule III under the Controlled Substances Act [2]
- Testing before treatment, 1% gel label / Two morning serum testosterone results below the normal range [2]
- Contraindications, 1% gel label / Breast cancer, known or suspected prostate cancer, pregnancy [2]
- Boxed warning, 1% gel label / Virilization reported in children secondarily exposed to the gel [2]
Does Medicare Advantage cover AndroGel?
Whether AndroGel is covered depends on your specific plan. The plan's current drug list and coverage documents give the tier and any prior authorization requirement, and those terms differ from plan to plan.
Who testosterone products are approved for
FDA-approved testosterone products are approved only for men who lack or have low testosterone levels in conjunction with an associated medical condition. FDA's examples are testicular failure from causes such as genetic problems or chemotherapy, and problems with the hypothalamus or pituitary, the brain structures that control testosterone production. FDA states that none of the approved products is approved for men with low testosterone who lack an associated medical condition [1].
The label details below come from the testosterone gel 1% prescribing information. That label says safety and efficacy in age-related hypogonadism have not been established [2]. In June 2026, FDA requested removal of that limitation of use from testosterone labels, along with revised prostate cancer and benign prostatic hyperplasia safety information [1].
What the diagnosis has to look like
The testosterone gel 1% label directs confirming hypogonadism before treatment: serum testosterone measured in the morning on at least two separate days, both results below the normal range [2]. The Endocrine Society's 2018 guideline takes the same position, recommending a diagnosis only in men with symptoms and signs of deficiency plus unequivocally and consistently low serum testosterone, measured fasting in the morning and confirmed by repeating the test [3].
TRAVERSE, the cardiovascular safety trial that used 1.62% testosterone gel, enrolled men with two fasting testosterone levels below 300 ng/dL [4].
The same 1% gel label lists breast cancer, known or suspected prostate cancer and pregnancy as contraindications [2]. Testosterone is a Schedule III controlled substance [2].
What the labels list as risks
The 1% gel label carries a boxed warning about secondary exposure: virilization has been reported in children exposed to testosterone gel, and children should avoid contact with unwashed or unclothed application sites [2]. That label also directs hematocrit before treatment, a recheck 3 to 6 months after starting and then annually, and says to stop if hematocrit becomes elevated until it falls to an acceptable level [2]. Separately, FDA reports that ambulatory blood pressure studies confirmed a rise in blood pressure with all testosterone products, class-wide [5].
Is another testosterone gel a like-for-like swap?
The 1% gel label warns that topical testosterone products may have different doses, strengths or application instructions, which can result in different systemic exposure, and says the application site and dose of testosterone gel 1% are not substitutable with other topical testosterone products [2].
Frequently asked questions
Does Medicare Advantage cover AndroGel?
What diagnosis does an AndroGel prescription need?
Does the label require two low testosterone tests first?
Is AndroGel a controlled substance?
Can a plan substitute another testosterone gel?
References
- Testosterone Information | FDA. Testosterone Information | FDA
- U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical, generic prescribing information. Testosterone gel 1% topical, generic label
- Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline
- Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. Cardiovascular Safety of Testosterone-Replacement Therapy
- FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA