HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-32-009
Topic:
Implantable Hormone Replacement Pellets
Section:
Surgery
Effective Date:
October 9, 2017
Issued Date:
February 4, 2019
Last Revision Date:
January 2019
Annual Review:
January 2019
 
 

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.

Policy Position

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 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.

11980

S0189

 

 

 

 

 

 



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.

11980

 

 

 

 

 

 


Related Policies

NOTE:  Dosage recommendations per the FDA label. 

Refer to medical policy I-145 Testosterone Androgens for additional information


Covered diagnosis codes for 11980 and S0189

E23.0

E23.6

E29.1

E30.0

E89.5

 

 


Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Implantation of Hormone Replacement Pellets is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.