Policy ID: S-32-011
Section: Surgery
Effective Date: February 01, 2020
Revised Date: January 12, 2022
Revision Effective Date: March 01, 2022
Last Reviewed: January 20, 2022
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 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.
Subcutaneous testosterone pellets not meeting the criteria as indicated in this policy are considered experimental/investigational.
Procedure Codes
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
Diagnosis Codes
Covered diagnosis codes for 11980 and S0189
E23.0 | E23.6 | E29.1 | E30.0 | E89.5 |
Professional Statements and Societal Positions Guidelines
Not Applicable
ND Committee Review
Internal Medical Policy Committee 1-22-2020 adopting policy for diagnosis coding
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
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-32-010
Section: Surgery
Effective Date: February 01, 2020
Revised Date: July 07, 2021
Revision Effective Date: September 01, 2021
Last Reviewed: July 22, 2021
Archived Date: February 28, 2022
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 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.
Procedure Codes
Subcutaneous testosterone pellets as a treatment for menopausal symptoms and/or reduced libido or any other indications not listed above are considered experimental/investigational and therefore non-covered. Scientific evidence of safety and efficacy has not been proven.
Subcutaneous pellets composed of estradiol, estrogen, or estrogen in combination with testosterone are considered experimental/investigational and, therefore, non-covered. Scientific evidence of safety and efficacy has not been proven.
Procedure Codes
Diagnosis Codes
Covered diagnosis codes for 11980 and S0189
E23.0 | E23.6 | E29.1 | E30.0 | E89.5 |
Professional Statements and Societal Positions Guidelines
Not Applicable
ND Committee Review
Internal Medical Policy Committee 1-22-2020 adopting policy for diagnosis coding
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
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.