This bulletin explains the medical policy relating to hormone implants. The policy addresses the use of subcutaneous hormone implants to replace hormones and treat conditions resulting from a decrease in naturally occurring hormones. The policy does not address the use of hormone implants for other conditions, such as contraception, treatment of cancer or precocious puberty. CPT code 11980 identifies the hormone pellet implantation. HCPCS code S0189 is recognized as the testosterone pellet. Code J3490 filed in conjunction with the appropriate NDC code is used for the estradiol pellet.
Implanted estrogen pellets (including estradiol pellets) are considered INVESTIGATIONAL because they have been shown to produce unpredictable and fluctuating serum concentrations of estrogen. Currently there are no FDA-approved, commercially available formulations of implantable estrogen pellets. The FDA warns that these products are "potentially" dangerous.
Implantable testosterone pellets (Testopel pellets) are considered MEDICALLY NECESSARY for either of the following indications:
Implantable testosterone pellets are considered INVESTIGATIONAL for the treatment of symptoms associated with menopause as this use remains unlabeled and unsubstantiated. Implantable testosterone pellets are considered INVESTIGATIONAL for all other indications.
**Failed first line treatment must be documented in the patient's medical records when neither oral nor intra-muscular testosterone replacement therapy is effective.
BIOIDENTICAL HORMONE REPLACEMENT
Bioidentical Hormone Replacement Implants are considered to be INVESTIGATIONAL as they are not FDA approved, and therefore not a covered benefit.
The above policies are effective 90 days from the date of this notice.