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Testopel® (testosterone pellets)

Policy Number: PH-0282

Subcutaneous implant


Last Review Date: 09/05/2023

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,


FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  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
  1. 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   

Compounded testosterone products containing ingredients that are not FDA approved, including but not limited to bulk powders/chemicals/products and compound kits, do not meet medical criteria for coverage and are considered investigational. These compounded products are not included in this policy and are not covered.

  1. 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

Primary hypogonadism

Secondary (hypogonadotropic) hypogonadism

  • Testicular failure due to cryptorchidism
  • Bilateral torsion
  • Orchitis
  • Vanishing testes syndrome
  • Orchiectomy
  • Klinefelter’s Syndrome
  • Chemotherapy
  • Toxic damage from alcohol or heavy metals
  • Gonadotropic LHRH deficiency
  • Pituitary hypothalamic injury due to trauma, radiation, or tumor

Delayed Puberty in males † 1,4,6

  • Patient is at least 14 years of age; 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. The patient is an adult (18 years of age or older)


      1. 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


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


        1. 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


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


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


      1. 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 Recommended Indication(s); Ф Orphan Drug

  1. 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


  • Compounded testosterone products are not covered by this policy.
  • Use as a transmasculine regimen for female-to-male transgender transition will be reviewed on a case-by-case basis.
  1. Dosage/Administration 1



Replacement therapy in androgen-deficient males

150 mg to 450 mg implanted subcutaneously by a healthcare provider every 3 to 6 months

Delayed Puberty

Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months.


  • Schedule III (CIII) controlled substance
  • Each pellet contains 75 mg of testosterone
  • Adequate effect of the pellets ordinarily continues for three to four months, sometimes as long as six months.
    • It has been found that approximately one-third of the material is absorbed in the first month, one-fourth in the second month and one-sixth in the third month.
  • The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally.
    • The usual dosage is as follows: implant two 75 mg pellets for each 25 mg testosterone propionate required weekly. (Thus when a patient requires injections of 75 mg per week, it is usually necessary to implant 450 mg (6 pellets). With injections of 50 mg per week, implantation of 300 mg (4 pellets) may suffice for approximately three months.)

  1. Billing Code/Availability Information


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


  • Testopel 75 mg pellets: 66887-0004-xx
  1. References
  1. Testopel [package insert]. Malvern, PA; Endo Pharmaceuticals Inc.; August 2018. Accessed August 2023.
  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:
  7. Palmetto GBA, LLC. Local Coverage Article (LCA): Billing and Coding: Treatment of Males with Low Testosterone . Centers for Medicare & Medicaid Services, Inc. Updated on 01/20/2022 with effective date 02/13/2022. Accessed August 2023.

Appendix 1 – Covered Diagnosis Codes


ICD-10 Description




Testicular hypofunction


Delayed puberty


Postprocedural hypopituitarism


Postprocedural testicular hypofunction

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: Additional indications may be covered at the discretion of the health plan.

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

Jurisdiction(s): J, M

NCD/LCD Document (s): A58828,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1  

Medicare Part B Administrative Contractor (MAC) Jurisdictions


Applicable State/US Territory


E (1)


Noridian Healthcare Solutions, LLC

F (2 & 3)


Noridian Healthcare Solutions, LLC



Wisconsin Physicians Service Insurance Corp (WPS)



National Government Services, Inc. (NGS)

H (4 & 7)


Novitas Solutions, Inc.



Wisconsin Physicians Service Insurance Corp (WPS)

N (9)


First Coast Service Options, Inc.

J (10)


Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)


National Government Services, Inc. (NGS)



CGS Administrators, LLC

TESTOPEL® (testosterone pellets) Prior Auth Criteria
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