Last Review Date: 12/01/2022

Date of Origin: 07/26/2016

Dates Reviewed: 07/2016, 10/2016, 01/2017, 01/2018, 08/2018, 08/2019, 08/2020, 10/2021, 12/2022

1. Length of Authorization

Coverage will be provided for:

• Primary or secondary hypogonadism in males: 6 months initially and may be renewed annually thereafter
• Delayed puberty: 6 months and may be renewed once

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Testopel 75 mg implantable pellet: 6 pellets per 90-day supply

B. Max Units (per dose and over time) [HCPCS Unit]:

• 6 billable units every 90 days   

3. Initial Approval Criteria* ¹

Coverage is provided in the following conditions:

• Patient does not have carcinoma of the breast or known or suspected carcinoma of the prostate; AND

Universal Criteria ¹

• Prescribed by, or in consultation with, an endocrinologist or urologist; AND
• The patient will be receiving only one androgen or anabolic agent; AND
• Patient hemoglobin, hematocrit, and lipid concentrations are measured at baseline and monitored periodically, during treatment; AND

Primary or Secondary (hypogonadotropic) hypogonadism in males † ^1-3,5

• Patient does not have ‘age-related’ hypogonadism; AND
• Patient does not have a prostate specific antigen (PSA) level of > 4.0 ng/mL, at baseline; AND
• Patient has signs and symptoms consistent with hypogonadism (e.g., low libido, decreased morning erections, loss of body hair, low bone mineral density, gynecomastia, small testes, etc.); AND
• Diagnosis is confirmed by one of the following:
  • Pre-treatment morning total testosterone of less than 300 ng/dL (or below lower limit of normal by the testing laboratory); OR
  • Pre-treatment free testosterone of less than 50 pg/mL (or below lower limit of normal by the testing laboratory); AND
• Patient has had an inadequate response (or contraindication or intolerance) to a 3 or more-month trial with intramuscular testosterone such as testosterone cypionate or testosterone enanthate

Delayed Puberty in males † ^1,4,6

• Patient is at least 14 years of age; AND
• Patient did not respond to psychological support for delayed puberty; AND
• Effect on bone maturation has been discussed with the patient and parent(s); AND
• Secondary causes of delayed puberty (e.g., hypothyroidism, hyperprolactinemia, etc.) have been addressed or ruled out; AND
• Bone maturation must be monitored by assessing bone age of the wrist and hand via x-ray examinations every 6 months to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers; AND
• Patient has had an inadequate response (or contraindication or intolerance) to a 3 or more-month trial with intramuscular testosterone such as testosterone cypionate, testosterone enanthate, etc.

The patient has a diagnosis of gender identity disorder (GID) and ALL of the following:

1. 1. 1. The patient is an adult (18 years of age or older)

AND

1. 1. 2. The patient has received evaluation from TWO qualified mental health professionals who have independently assessed the patient and ALL of the following:
         1. At least one of the evaluating professionals must have a doctoral degree (PhD, MD, Ed.B, D.Sc, D.S.W. or Psy.D) and be capable of adequately evaluating co-morbid psychiatric conditions

AND

1. 1. 1. 2. One evaluation should be from a person who has only had an evaluative role with the patient

AND

1. 1. 1. 3. The evaluations document that the patient has demonstrated a knowledge and understanding of the expected outcomes of cross-sex hormone treatment, as well as the medical and social risks and benefits

AND

1. 1. 3. ONE of the following:
         1. The patient does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment

OR

1. 1. 1. 2. If the patient has significant medical or mental health issues present, they must be reasonably well controlled and noted in the medical documentation submitted

AND

1. 1. 4. For patients new to therapy, the patient has completed at least 12 continuous months of living in a congruent gender role with his/her gender identity (real life experience) prior to cross-sex hormone treatment (this should be noted in medical documentation submitted including start/end dates)

† FDA Approved Indication(s); ‡ Compendia/Literature Supported Indication(s); Ф Orphan Drug

4. Renewal Criteria* ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hepatotoxicity, hepatitis, hepatic neoplasms (including hepatocellular carcinoma), stroke, myocardial infarction, fluid/electrolyte disturbances, prostatic hypertrophy/carcinoma, polycythemia, venous thromboembolic events (including deep vein thrombosis and pulmonary embolism), edema with or without congestive heart failure, gynecomastia, implant site infection and/or pellet extrusion, etc.; AND
• Patient’s testosterone levels (within the preceding 28 days) do not exceed the upper limit of the normal range for the testing laboratory (generally mid-range is targeted); AND

Primary or secondary hypogonadism ^1-3,5

• Patient has an improvement in signs and symptoms; AND
• Patient has not had a PSA increase of > 1.4 ng/mL above baseline or an absolute level > 4.0 ng/mL

Delayed puberty ^1,4,6

• Patient is continuing to be monitored for bone maturation (refer to initial criteria); AND
• Patient continues to require testosterone supplementation in order to complete development of secondary sexual characteristics (i.e. patient has not progressed spontaneously through puberty which may occur in patients with constitutional delay of puberty); AND
• Testopel therapy has not exceeded a total of 12 months in duration

*Note: compounded testosterone products are not covered by this policy

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• S0189 – testosterone pellet, 75 mg injection; 1 billable unit = 75 mg (Not payable by Medicare)
• J3490 – Unclassified drugs

NDC:

• Testopel 75 mg: 66887-0004-xx

7. References

1. Testopel [package insert]. Malvern, PA; Endo Pharmaceuticals Inc.; August 2018. Accessed October 2022.
2. Bhasin S, Cunningham GR, Hayes FJ et al. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2006; 91: 1995–2010.
3. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab May 2018; vol 103; 5: 1715-1744.
4. Richman RA, Kirsch LR. Testosterone treatment in adolescent boys with constitutional delay in growth and development. N Engl J Med. 1988;319(24):1563.
5. Qaseem A, Horwitch CA, Vijan S, et al for the Clinical Guidelines Committee of the American College of Physicians.  Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians. Ann Int Med. 2020;172;2. 126-134.
6. Emmanuel M, Bokor BR. Tanner Stages. [Updated 2021 Dec 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470280/
7. Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA): Billing and Coding: TESTOPEL Coverage (A55056). Centers for Medicare & Medicaid Services, Inc. Updated on 05/08/2020 with effective date 07/12/2016. Accessed October 2022.
8. Noridian Healthcare Solutions, LLC. Local Coverage Article (LCA): Billing and Coding: TESTOPEL Coverage (A55057). Centers for Medicare & Medicaid Services, Inc. Updated on 05/08/2020 with effective date 07/12/2016. Accessed October 2022.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Article (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD):