This policy does not address the use of a non-biodegradable drug delivery implant when utilized for purposes of contraception.
Blue Cross and Blue Shield of Montana (BCBSMT) may consider subcutaneous testosterone pellets (Testopel™) medically necessary for the following Food and Drug Administration (FDA) approved indications in males:
- Primary Hypogonadism (congenital or acquired);
- Hypogonadotrophic hypogonadism (congenital or acquired);
BCBSMT considers subcutaneous testosterone pellets (Testopel™) not medically necessary for treatment of delayed puberty not resulting from hypogonadism.
When the criteria for coverage is not met, BCBSMT encourages all participating providers to have a member complete and sign an Advanced Member Notification (AMN) form, stating that BCBSMT will not cover this service, supply, device, or drug. If an AMN is signed prior to delivery of the service, participating providers can balance bill the member. If an AMN is not signed, participating providers are financially liable for the service and cannot balance bill the BCBSMT member for denied services. Services deemed Not Medically Necessary, or Investigational that are provided by an out-of-state (Montana) or Out-of-Network provider are the financial responsibility of the member regardless of a completed AMN.
Refer to the Advanced Member Notification medical policy for more information. The AMN form is available at www.bcbsmt.com (Click on Providers and then Forms).
BCBSMT considers subcutaneous testosterone pellets experimental, investigational and unproven for all non-FDA approved indications including, but not limited to, symptoms associated with menopause.
Subcutaneous estradiol hormone pellet implants are considered experimental, investigational and unproven including but not limited to use as hormone replacement therapy (HRT) for female menopause.
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
According to the American Association of Clinical Endocrinologists (AACE), men with decreased testosterone levels may experience a higher incidence of osteoporosis, sexual dysfunction, fatigue, cardiovascular disease and disturbances in mood.
Testosterone hormone replacement can be delivered by mouth, intramuscular injection, topically or subcutaneously by testosterone pellets. Testosterone pellets have been approved by the FDA for the treatment of congenital or acquired androgen deficiency as a result of primary or secondary hypogonadism.
In a discussion on delayed puberty, the American Academy of Pediatrics (AAP) stated that most cases of delayed puberty are simply variants of normal development and not cause for alarm. Generally speaking, the “late bloomers” usually catch up to their peers, and sometimes surpass them.
Although secondary or tertiary hormonal treatments with androgens are indicated for palliation therapy in post-menopausal women with metastatic breast cancer, subcutaneous testosterone implants are not indicated for these uses and should not be used by females due to lack of controlled evaluations.
The use of implantable estradiol pellets when used as hormone replacement therapy (HRT) for treatment for symptoms of menopause is not approved by the U.S. Food and Drug Administration (FDA). The published peer reviewed literature does not demonstrate safety and utility in short- or long-term therapy.
There have been several randomized controlled studies and uncontrolled clinical trials evaluating implantable estradiol pellets. These implants have been shown to produce unpredictable and fluctuating serum concentrations of estrogen. The FDA’s Fertility and Maternal Health Drugs Advisory Committee (January 1988) unanimously agreed to terminate compassionate investigative new drug (IND) programs for estrogen pellets as a last-resort treatment of menopausal disorder. The committee noted “the risk of bleeding and infection, the lack of information on release dates rates, difficulty in reversibility of the drug, increased feasibility of over-dosage of the drug, and increased risk of non-compliance with safety measures [such as] the addition of progestin.”
Estradiol therapy was compared with placebo and with oral and transdermal therapy. The studies had relatively few subjects considering the large number of women candidates for HRT. None of the studies were completely blinded. Symptom relief was largely based on subjective and patient-reported results. These studies could be subject to bias based on placebo effect. Only three studies that measured the effect of estrogen implant on bone density directly compared estrogen replacement therapy implants with other methods of estrogen administration.
The North American Menopause Society (NAMS) has recently updated its 2010 recommendations regarding the use of postmenopausal hormone therapy (HT) based on evidence accumulated subsequent to the previous report. In the decade since the first publication of the results from the Women’s Health Initiative, the society has accumulated evidence to indicate that multiple factors influence the effects of hormone therapy, including the type of estrogen used, the way the hormones are given, the age and recency of menopause of the woman taking the medication. These factors also determine the risks associated with hormone therapy.
The North American Menopause Society (NAMS) Position Statement published in 2012 highlighted the following findings:
- For relief of hot flashes, combined estrogen-progestogen therapy (EPT) should be used in women with a uterus as progestogen protects the uterine lining from the cancer-promoting effects of estrogen alone.
- The duration of treatment differs for estrogen therapy (ET) and combined EPT. For EPT, duration is limited by the increased risk of breast cancer and breast cancer mortality associated with three to five years of use. A more favorable risk-benefit profile was observed for ET used for a mean duration of seven years of use; thus, estrogen therapy may provide more flexibility in terms of duration of use.
- Women with premature menopause who are otherwise appropriate candidates for hormone therapy (HT) can use HT at least until the median age of natural menopause (age 51 years). Longer duration of treatment can be considered if needed for symptom management.
- Although ET did not increase breast cancer risk in the Women’s Health Initiative (WHI), there is a lack of safety data supporting the use of ET in breast cancer survivors, and one randomized controlled trial reported an increased likelihood of recurrence of breast cancer among ET users.
- Both transdermal and low-dose oral estrogen have been associated with lower risks of venous thrombosis and stroke than standard doses of oral estrogen, but evidence from randomized controlled trials is not yet available.
- ET is the most effective treatment of vaginal atrophy; low-dose, local vaginal ET is advised when only vaginal symptoms are present.
This statement acknowledges that it is impossible to generate guidelines that can be used for all women. The decision to use hormone therapy must be made on a case-by-case basis, where the clinician takes into consideration the severity of the woman’s symptoms and their effect on her quality of life, as well as her personal risk factors for complications associated with hormone therapy (i.e., venous thrombosis, cardiovascular disease, stroke, and breast cancer). Overall, these findings are reassuring. While some women, specifically older postmenopausal women and those with certain risk factors, may not be good candidates for hormone therapy, estrogen remains a viable treatment option for many women with bothersome menopausal symptoms.
The U.S. Food and Drug Administration has ruled that some compounding pharmacies have made claims about the safety and effectiveness of bioidentical hormone therapy (BHT) unsupported by clinical trial data and considered to be false and misleading. Pharmacies have been instructed not to use estriol without an investigational new drug authorization. The Food and Drug Administration also states that there is no scientific basis for using saliva testing to adjust hormone levels.
NAMS recommends that BHT products include a patient package insert identical to that required for products that have government approval. In the absence of efficacy and safety data for BHT, the generalized benefit-risk ratio data of commercially available HT products should apply equally to BHT. For most women, government-approved HT will provide appropriate therapy without the risks of custom preparations. Therefore, NAMS does not generally recommend compounded EPT or ET unless necessary because of allergies to ingredients contained in government-approved products.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.