Medical Policy: 02.01.49
Original Effective Date: June 2012
Reviewed: February 2016
Revised: February 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Menopause is a normal, natural sign of aging. There is a long list of physical changes that women may experience around menopause, which may be related to menopause or aging- or both. Some of these symptoms include hot flashes, sleep disturbances, night sweats and vaginal dryness and decreased sex drive.
Several prescription drugs are available to help relieve menopause-related symptoms. Hormone therapy has been shown to be the most effective intervention for management of these symptoms.
This policy is specifically related to subcutaneously implanted hormone pellets. The individual pellets are smaller than a grain of rice and are implanted into the subcutaneous tissue, where they provide a slow continuous release of hormone into the bloodstream. The pellets are implanted in the lower abdomen or buttocks. The procedure is done in a physician's office with the use of a local anesthetic and a small incision for insertion. The release of the drug continues over a 3-6 month period.
Subcutaneous implantable pellets made up of estradiol, estrogen, or testosterone in combination with estrogen or estradiol has been custom compounded by pharmacists according to physician specifications. However, none of these are FDA approved for U.S. distribution and their safety and efficacy has not been adequately demonstrated in well-designed clinical trials.
The American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice and the Practice Committee of the American Society for Reproductive Medicine make the following conclusions and recommendations:
- Evidence is lacking to support superiority claims of compounded bioidentical hormones over conventional menopausal hormone therapy.
- Customized compounded hormones pose additional risks. These preparations have variable purity and potency and lack efficacy and safety data.
US Food and Drug Administration
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.
Subcutaneous hormone pellets containing estrogen alone or estrogen combinations (including bioidentical hormone formulations) are considered INVESTIGATIVE for all indications including, but not limited to, symptoms associated with female menopause because there are no FDA-approved formulations of these products.
The use of testosterone pellets specifically Testopel, in women is considered investigational as the FDA indications are only for the use in males. The literature does not support off-label use for menopausal symptoms or decreased libido.
Testopel use in males is considered medically necessary for the following conditions:
- Delayed puberty in males greater than 14 years old with laboratory evidence of hypogonadism or
- Treatment of primary or secondary hypogonadism due to disorders of the testicles, pituitary gland, or brain.
The use of subcutaneous hormone pellets in men, outside of the use of Testopel, is considered investigational. Testopel is the only FDA approved subcutaneous pellet approved at this time.
The use of Testopel is considered investigational for male menopause, hypogonadism due to aging, erectile dysfunction, and for all other conditions not listed above.
The use of Testopel dosage is limited to a maximum number of pellets per injection, based on labeling indications.
At the current time, there is lack of medical and scientific evidence to support the efficacy and safety of customized subcutaneous hormone replacement regimes utilizing bioidentical hormones. Well-designed and controlled clinical trials are needed to provide evidence of improved net health outcomes with compounded bioidentical hormone replacement, subcutaneously inserted over conventional hormone therapies. The FDA issed a safety communication in 2015, warning against the use of testosterone products for low testosterone due to aging.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 11980 Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)
- J3490 Unclassified drugs
- S0189 Testosterone pellet, 75 mg
- North American Menopause Society. Bioidentical Hormone TherapyExternal Site.
- American College of Obstetricians and Gynecologists. ACOG Committee Opinion #532, November 2005 (Reaffirmed 2012): Compounded Bioidentical Menopausal Hormone TherapyExternal Site.
- The Endocrine Society. Position Statement: Bioidentical HormonesExternal Site. October 2006.
- Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Menopause and Hormone Therapy (HT): Collaborative Decision-Making and ManagementExternal Site. Ninth Edition, October 2008.
- Gallenberg, Mary. Mayo Foundation for Medical Education and Research (MFMER). Bioidentical hormones: Are they safer?External Site December 15, 2011.
- Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Menopause. Endocr Pract. November/December 2011; 17(Suppl 6).
- Position Statement: The 2012 Hormone Therapy Position Statement of the North American Menopause Society. Menopause. January 17, 2012; 19(3): pp. 257-271.
- FDA Consumer Health Information. Bio-Identicals: Sorting Myths from FactsExternal Site. April 8, 2008. Accessed 3/25/2014.
- National Institutes of Health (NIH). Menopausal Hormone Therapy InformationExternal Site. Last reviewed September 15, 2011. Accessed 3/25/2014.
- Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8; 11: 27.
- Conaway E. Bioidentical hormones: an evidence-based review for primary care providers. J Am Osteopath Assoc. 2011 Mar;111(3):153-64.
- Sood R, Shuster L, Smith R, Vincent A, Jatoi A. Counseling postmenopausal women about bioidentical hormones: ten discussion points for practicing physicians. J Am Board Fam Med. 2011 Mar-Apr; 42(2):202-10.
- U.S. Food and Drug Administration. Compounded menopausal hormone therapy questions and answers.
- Wierman ME, Wiebke A, Basson R, et al. Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2014:99;3489-3510.
- Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause 2004; 11:356.
- Takahashi K, Manabe A, Okada M, et al. Efficacy and safety of oral estriol for managing postmenopausal symptoms. Maturitas 2000; 34:169.
- Xu L, Freeman G, Cowling BJ, Schooling CM (2013).Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trialsExternal Site. BMC Med, 11, 108.
- Fda.gov,. "FDA Drug Safety Communication: FDA Cautions About Using Testosterone Products For Low Testosterone Due To Aging; Requires Labeling Change To Inform Of Possible Increased Risk Of Heart Attack And Stroke With Use". N.p., 2015. Web. 8 May 2015.
February 2016 - Annual Review
March 2015 - Annual Review, Policy Revised
April 2014 - Annual Review, Policy Revised
May 2013 - Annual Review, Policy Revised
June 2012 - New Policy
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.