Healthcare Inspection - Testosterone Replacement Therapy Initiation and Follow-Up Evaluation in VA Male Patients

The VA Office of Inspector General (OIG) initiated and conducted a study to assess whether VA providers established androgen deficiency (lower levels of male sex hormones, particularly testosterone, than is needed for health) prior to initiating testosterone therapy and the extent VA providers performed follow-up evaluation after initiating the therapy, in accordance with the 2010 Endocrine Society Clinical Practice Guidelines and current VA criteria for use. The OIG found that VA providers generally did not follow Endocrine Society Clinical Practice Guidelines and current VA criteria for use when initiating patients with testosterone replacement therapy or following up with patients within 3–6 months after therapy initiation. VA providers largely did not document clinically significant signs and symptoms consistent with androgen deficiency before initiating therapy or before performing biochemical confirmatory testosterone level tests. This suggests VA providers might have used testosterone tests to screen for, rather than to confirm, androgen deficiency. In addition, VA providers generally did not perform both follicle-stimulating hormone and luteinizing hormone tests to distinguish between primary and secondary androgen deficiency before initiating testosterone replacement therapy. VA providers did not document a discussion of the risks and benefits of testosterone replacement therapy with approximately two out of three patients before therapy initiation. After testosterone replacement therapy initiation, VA providers did not conduct follow-up evaluation within 3–6 months for about two out of three patients before continuing the therapy. The OIG made seven recommendations to the Under Secretary for Health to ensure that providers are in alignment with Veterans Health Administration current guidance related to the initiation and maintenance of testosterone replacement therapy.