This policy version was replaced on February 28, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).
Hormone therapy can be delivered by several routes of administration: oral, transdermal, vaginal, injection, or subcutaneous implantation of pellets. When implanted in pellet form, the pellet is placed in the lower abdomen or buttocks. The procedure is performed in the physician’s office with the use of a local anesthetic and a small incision for insertion. Release of the drug continues over a 3-6 month time period.
The testosterone pellet, Testopel®, has received approval from the U.S. Food and Drug Administration (FDA) as replacement therapy for the following conditions associated with a deficiency or absence of endogenous testosterone:
The prescribing information also states, if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
In 2015, the FDA issued a drug safety communication stating that prescription testosterone products are approved only for males with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. They cautioned that the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging. The FDA also concluded that there is a possible increased risk of heart attacks and strokes associated with testosterone use.
Implantation of pellets containing estrogen or estrogen combined with testosterone has also been proposed as treatment for symptoms associated with a decrease in naturally occurring hormones, such as female menopause. To date, no formulations of either of these types of pellets have received FDA approval. In addition, the use of these pellets has been shown to produce unpredictable and fluctuating serum concentrations of estrogens.
NOTE: This policy does not address the use of implanted progesterone products.
I. Subcutaneous Administration of Testosterone
II. Subcutaneous Administration of Estrogen or Estrogen Combined with Testosterone
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.