Hormone Pellet Implantation for Hormone Replacement Therapy (HRT) in Women

POLICY NUMBER

L.5.01.500

DESCRIPTION

Menopause is a normal event that occurs as a woman ages and marks the permanent end of fertility. The ovaries progressively fail to produce estrogen and other hormones.

For many women, menopause is asymptomatic and associated with little disruption of normal life. However, some women experience symptoms that adversely affect their quality of life. Some of these are changes in menstrual periods, hot flashes, sleep disturbances, night sweats, vaginal dryness, and decreased sex drive.

Several prescription medications are available to help relieve menopause related symptoms. Hormone replacement therapy (HRT) is the most effective method to manage the symptoms associated with menopause. HRT may be estrogen therapy alone or a combination of estrogen and progestin.

This policy is related to subcutaneously implanted hormone pellets for HRT. 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 for 3 to 6 months.

Estrogen compounded with testosterone for subcutaneous HRT is not FDA approved.

POLICY

Subcutaneous hormone pellet implantation (testosterone, estrogen, bioidentical hormone formulations, or a combination of hormones) is considered investigational for hormone replacement therapy in women, including postmenopausal women.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/25/2016: New policy L.5.01.500 added. Approved by Medical Policy Advisory Committee. Effective 08/15/2016.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description revised. Policy statement updated to state that subcutaneous hormone pellet implantation (testosterone, estrogen, bioidentical hormone formulations, or a combination of hormones) is considered investigational for hormone replacement therapy in women, including postmenopausal women. It previously stated: Hormone pellet implantation is considered investigational for hormone replacement therapy in women. Code Reference section updated to change the coding table from "Investigational" to "Non Covered."

02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding hormone replacement therapy as a method to manage symptoms associated with menopause. Added policy statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Exceptions updated regarding State Health Plan members. Policy Guidelines updated to define medically necessary and regarding BCBSMS request for medical records. Sources updated.

11/07/2022: Policy reviewed; no changes.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

10/27/2023: Policy reviewed; no changes.

12/05/2024: Policy reviewed. Policy statements unchanged. Sources updated.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statements unchanged. Sources updated.

01/01/2026: Code Reference section updated to add new HCPCS code J1073.

SOURCE(S)

1. American Association of Clinical Endocrinologists. AACE Medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients, 2002 update. Endocr Pract. 2002; 8:439-456.

2. American Association of Clinical Endocrinologists (AACE). AACE medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocrine Practice. 2011; 1(6): 11-25.

3. American College of Obstetricians and Gynecologists. ACOG Committee Clinical Consensus No. 6, November 2023: Compounded Bioidentical Menopausal Hormone Therapy. Available at: https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/2023/11/compounded-bioidentical-menopausal-hormone-therapy . Accessed February 2025.

4. Cobin RH, Goodman NF; AACE Reproductive Endocrinology Scientific Committee. AACE and American College of Endocrinology Position Statement on Menopause-2017 UPDATE. Endocr Pract. 2017 Jul;23(7):869-880. doi: 10.4158/EP171828.PS. Erratum in: Endocr Pract. 2017 Dec;23 (12 ):1488. PMID: 28703650.

5. Howell S, Shalet S. Testosterone deficiency and replacement. Horm Res. 2001; 56 Suppl 1:86-92.

6. Suhonen SP, Allonen HO, Lähteenmäki P. Sustained-release estradiol implants and a levonorgestrel-releasing intrauterine device in hormone replacement therapy. Am J Obstet Gynecol. 1995; 172:562-567.

7. Templeman C, Quinn D, Hansen R, et al. An audit of oestrogen implant hormone replacement therapy. Aust NZ J Obstet Gynaecol. 1998; 38:455-460. 

8. Wahab M, Ballard P, Purdie DW, Cooper A, Willson JC. The effect of long-term oestradiol implantation on bone mineral density in postmenopausal women who have undergone hysterectomy and bilateral oophorectomy. Br J Obstet Gynaecol. 1997; 104(6):728-731.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Non Covered Codes

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