HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-145-008
Topic:
Testosterone Androgens
Section:
Injections
Effective Date:
January 3, 2022
Issued Date:
January 3, 2022
Last Revision Date:
October 2021
Annual Review:
October 2021
 
 

Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.

Policy Position

Drugs addressed in this policy include injectable testosterone products categorized as androgens, which include:

  • Testosterone enanthate (e.g Xyosted®)
  • Testosterone cypionate (Depo-Testosterone®, Testone CIKTM)
  • Testosterone undecanoate (AVEED®)

Testosterone injections may be considered medically necessary in males when the following criteria are met:

  • Diagnosis of hypogonadism AND ANY ONE of the following specific criteria:
    •  Primary or secondary hypogonadism with testicular failure due to ONE of the following:
      • Bilateral torsions; or
      • Chemotherapy; or  
      • Cryptorchidism; or
      • Gonadal failure syndrome ( e.g., Klinefelter's syndrome); or
      • Orchitisor
      • Orchiectomy; or
      • Radiation or toxic damage from alcohol or heavy metals; or
      • Vanishing testis syndrome; or
    • Primary or secondary hypogonadism in males with at least ONE of the following symptoms or signs as:
      • Breast discomfort or enlargement (gynecomastia); or
      • Height loss due to vertebral fractures; or
      • Incomplete or delayed sexual development; or
      • Loss of axillar and/or pubic body hair; or
      • Low impact fractures; or
      • Low bone density; or
      • Hot flushes; or
      • Very small testes (< six (6) ml); or
    • Diagnosis of secondary hypogonadism due to hypopituitarism (pituitary hormone deficiencies); or
    • HIV-infected men with weight loss; or
    • Men on chronic steroid treatment;

AND

  • The individual has documented low testosterone levels as defined by:
    • Low total testosterone level, below the normal range for the laboratory; or
    • Total testosterone level near the lower limit of the normal range; or
    • Low free testosterone level, below the normal range for the laboratory; or
    • Provider attests that the individual is not producing any testosterone.

J1071

J3121

J3145

 

 

 

 




Testosterone injections may be considered medically necessary for palliative treatment in females with metastatic breast cancer (testosterone enanthate or testosterone cypionate).

J1071

J3121

 

 

 

 

 




Testosterone injections may be considered medically necessary for transgender individuals who meet ALL the following:

  • Individual is 14 years of age or older; and
  • Individual has a diagnosis of gender dysphoria or gender identity disorder; and
  • The goal of treatment is masculinization.

J1071

J3121

 

 

 

 

 




Testosterone injections not meeting the above criteria, or for any other indications are considered not medically necessary.

J1071

J3121

J3145

 

 

 

 




NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.  


Related Policies

Refer to pharmacy policy J-197, Testosterone Androgens, for additional information.

Refer to Medical Policy S-32, Implantable Hormone Replacement Pellets, for additional information.


Covered Diagnosis Codes for Procedure Codes J1071, J3121, and J3145

B20

C50.011

C50.012

C50.019

C50.111

C50.112

C50.119

C50.211

C50.212

C50.219

C50.311

C50.312

C50.319

C50.411

C50.412

C50.419

C50.511

C50.512

C50.519

C50.611

C50.612

C50.619

C50.811

C50.812

C50.819

C50.911

C50.912

C50.919

E23.0

E23.6

E29.1

E30.0

E89.5

F64.0

F64.2

M85.9

N44.00

N44.8

N45.2

N62

N52.9

N64.4

Q53.10

Q53.20

Q53.9

Q53.111

Q53.112

Q53.13

Q53.211

Q53.212

Q53.23

Q55.0

Q55.1

Q98.0

Q98.1

Q98.3

Q98.4

R23.2

R29.890

R39.83

R39.84

R62.0

R62.50

R62.59

R63.4

R68.82

Z79.52

Z87.311

Z87.312

Z87.81



Place of Service: Inpatient/Outpatient

The administration of testosterone androgens 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, and subject to the applicable laws of your state.


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.