Implantable Hormone Replacement Pellets

Policy ID: S-32-014

Section: Surgery

Effective Date: February 01, 2020

Revised Date: March 07, 2025

Revision Effective Date: May 01, 2025

Last Reviewed: March 11, 2025

Applies To: Commercial and Medicaid Expansion

Description

Hormone replacement therapy (HRT) using formulas in subcutaneously implantable pellet form is an alternative to hormone therapy by injection or oral ingestion. Pellets are implanted in the physician's office and release their contents over a period of months.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Subcutaneous testosterone pellets may be considered medically necessary when there is documented failure or contraindication to other topical, oral, and injectable HRT and ONE of the following conditions:

Treatment of primary hypogonadism (congenital or acquired) due to testicular failure from conditions such as cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals and who have documented testosterone deficiency as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performing the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range; or
Treatment of hypogonadotropic hypogonadism (congenital or acquired) due to idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, pituitary-hypothalamic injury from tumors, trauma, radiation and who have documented testosterone deficiency as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performing the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range; or
Delayed puberty in males greater than 14 years of age with either physical or laboratory evidence of hypogonadism as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performi ng the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range.

Subcutaneous testosterone pellets not meeting the criteria as indicated in this policy are considered experimental/investigational.

Procedure Codes

11980

S0189

Subcutaneous testosterone pellets as a treatment for menopausal symptoms and/or reduced libido are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Subcutaneous pellets composed of estradiol, estrogen, or estrogen in combination with testosterone are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

11980

S0189

Diagnosis Codes

Covered diagnosis codes for 11980 and S0189

E23.0

E23.6

E29.1

E30.0

E89.5

G11.5

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Adopted policy

Internal Medical Policy Committee 7-22-2020 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 1-20-2022 Updated experimental/investigational statements

Internal Medical Policy Committee 1-26-2023 Annual review, no clinical content change

Internal Medical Policy Committee 1-16-2024 Effective March 04, 2024

Added diagnosis code G11.5

Internal Medical Policy Committee 03-11-2025 Effective May 01, 2025

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-32-013

Section: Surgery

Effective Date: February 01, 2020

Revised Date: January 11, 2024

Revision Effective Date: March 04, 2024

Last Reviewed: January 16, 2024

Archived Date: April 30, 2025

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Treatment of primary hypogonadism (congenital or acquired) due to testicular failure from conditions such as cryptorchidism, bilateral torsions, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals and who have documented testosterone deficiency as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performing the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range; or
Treatment of hypogonadotropic hypogonadism (congenital or acquired) due to idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, pituitary-hypothalamic injury from tumors, trauma, radiation and who have documented testosterone deficiency as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performing the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range; or
Delayed puberty in males greater than 14 years of age with either physical or laboratory evidence of hypogonadism as defined by ONE of the following:
- A low total testosterone level, below the normal range as defined by the laboratory performi ng the test; or
- A total testosterone level near the lower limit of the normal range and a low free testosterone level which is less than normal based upon the laboratory reference range.

Subcutaneous testosterone pellets not meeting the criteria as indicated in this policy are considered experimental/investigational.

Procedure Codes

11980

S0189

Procedure Codes

11980

S0189

Diagnosis Codes

Covered diagnosis codes for 11980 and S0189

E23.0

E23.6

E29.1

E30.0

E89.5

G11.5

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Adopted policy

Internal Medical Policy Committee 7-22-2020 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 1-20-2022 Updated experimental/investigational statements

Internal Medical Policy Committee 1-26-2023 Annual review, no clinical content change

Internal Medical Policy Committee 1-16-2024 Effective March 04, 2024

Added diagnosis code G11.5

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