· Incomplete or delayed sexual development
· Reduced sexual desire (libido) and activity
· Decreased spontaneous erections, erectile dysfunction
· Breast discomfort, gynecomastia
· Loss of axillary and/or pubic hair
· Very small (<6 mL) or shrinking testes
· Infertility due to low sperm count
· Height loss due to vertebral fractures, low trauma fractures, low bone density
· Hot flushes, sweats
· Eunuchoidal body proportions
· Decreased energy, motivation, initiative, and self-confidence
· Feeling sad or blue, depressed mood, persistent low-grade depressive disorder
· Poor concentration and memory
· Sleep disturbance, increased sleepiness
· Mild unexplained anemia (normochromic, normocytic)
· Reduced muscle bulk and strength
· Increased body fat, body mass index

(Note: For Testosterone use in Gender Dysphoria, please refer to policy 141 Drug Therapy for Transgender Policy.)

Implantable testosterone pellets (Testopel pellets)

I. Implantable testosterone pellets (Testopel pellets) are considered medically necessary as testosterone replacement therapy in men for the following indications when all of the numbered criteria in the applicable diagnosis category are met:

A. Primary hypogonadism
1. Documentation in the member’s medical records that the drug is used for primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy, and

2. Member has 2 or more symptoms of hypogonadism, and

3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and
4. Documentation in the member’s medical records that prior use of transdermal/topical, oral, or intra-muscular testosterone replacement therapy is ineffective or inappropriate AND member will not be using another form of testosterone concurrently with the requested agent; and

5. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

B. Hypogonadotropic hypogonadism
1. Documentation in the member’s medical records that the drug is used for hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation, and

2. Member has 2 or more symptoms of hypogonadism, and

3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and
4. Documentation in the member’s medical records that prior use of transdermal/topical, oral, or intra-muscular testosterone replacement therapy is ineffective or inappropriate AND member will not be using another form of testosterone concurrently with the requested agent; and

5. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.
C. Delayed male puberty
1. Documentation in the member’s medical records of limited or no signs of puberty
2. Testosterone is being used short term (4 to 6 months) to stimulate puberty

[INFORMATIONAL NOTE: Signs of puberty in males include: Growth of pubic hair, other body hair, and facial hair; enlargement of testicles and penis; muscle growth; growth spurt; acne; deepening of the voice.]

II. A. When medical necessity criteria are met, initial use of implantable testosterone pellets will be approved for 12 months at the following FDA approved dosing:
1. 2-6 pellets (150 mg - 450 mg) subcutaneously every 3 to 6 months
2. Dosage may be adjusted according to the patient’s response and the appearance of adverse reactions
3. For the indication of delayed male puberty, approval will be for 6 months only

B. Subsequent use of implantable testosterone pellets will be approved for an additional 12 months when documentation is provided demonstrating that the following examination/tests have been performed:
1. hemoglobin and hematocrit; and
2. digital rectal examination and PSA levels for men >40 years old with baseline PSA >0.6 ng/ml; and
3. current total testosterone level is NOT greater than the testing laboratory’s upper limit of normal range; and
4. member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin)
b. HCG (Novarel/Pregnyl)
5. Member is not using for the indication of delayed male puberty as testosterone therapy should be used for short term (4-6 months)

[INFORMATIONAL NOTE:
As per Testopel® package insert, hemoglobin and hematocrit should be checked at baseline, 3 months, 6 months and annually for polycythemia in patients who are receiving high doses of androgens.
As per the Testopel® package insert, 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 75mg pellets for each 25mg testosterone propionate required weekly. Thus when a patient requires injections of 75mg per week, it is usually necessary to implant 450mg (6 pellets). With injections of 50mg per week, implantation of 300mg (4 pellets) may suffice for approximately three months. With lower requirements by injection, correspondingly lower amounts may be implanted. 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. Adequate effect of the pellets ordinarily continues for three to four months, sometimes as long as six months.]

III. All other uses of implantable testosterone pellets are considered investigational including, but not limited to, their use in the treatment of sexual dysfunction in both men (e.g., erectile dysfunction) and women (e.g., decreased libido), post-menopausal symptoms, depression, and for the enhancement of athletic performance.

I. Testosterone undecanoate, injection is considered medically necessary as androgen replacement therapy in men greater than or equal to 18 years old for the following indications:
A. Primary hypogonadism
1. Documentation in the member’s medical records that the drug is used for primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy, and

2. Member has 2 or more symptoms of hypogonadism, and
3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and
4. Documentation in the member’s medical records that prior use of transdermal/topical, oral, or intra-muscular testosterone replacement therapy is ineffective or inappropriate AND member will not be using another form of testosterone concurrently with the requested agent; and

5. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.
B. Hypogonadotropic hypogonadism (congenital or acquired)
1. Documentation in the member’s medical records that the drug is used for hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation, and

2. Member has 2 or more symptoms of hypogonadism, and
3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and

4. Documentation in the member’s medical records that prior use of transdermal/topical, oral, or intra-muscular testosterone replacement therapy is ineffective or inappropriate AND member will not be using another form of testosterone concurrently with the requested agent; and

5. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

[INFORMATIONAL NOTE: Safety and efficacy of Aveed in males less than 18 years old have not been established. Based on clinical literature improper use may result in acceleration of bone age and premature closure of epiphyses.]
II. A. When medical necessity criteria are met, initial use of testosterone undecanoate will be approved for 12 months at the following FDA approved dosing:
1. 3 ml (750 mg) injected intramuscularly, followed by 3 ml (750 mg) injected after 4 weeks, then 3 ml (750 mg) injected every 10 weeks thereafter

B. Subsequent use of testosterone undecanoate, depo-testosterone, testosterone cypionate, and testosterone ethanthate will be approved for an additional 12 months in patients with primary or hypogonadotropic hypogonadism when documentation is provided demonstrating that the following examination/tests have been performed:
1. hemoglobin and hematocrit; and
2. digital rectal examination and PSA levels for men >40 years old with baseline PSA >0.6 ng/ml; and
3. current total testosterone level is NOT greater than the testing laboratory’s upper limit of normal range; and
4. member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin)
b. HCG (Novarel/Pregnyl)

[INFORMATIONAL NOTE:
As per Aveed® package insert, hematocrit should be checked at baseline,3 months, 6 months and annually for polycythemia.]

III. All other uses of testosterone undecanoate, depo-testosterone, testosterone cypionate, and testosterone ethanthate are considered investigational including, but not limited to, their use in the treatment of pediatric patients, sexual dysfunction in both men (e.g., erectile dysfunction) and women (e.g., decreased libido), post-menopausal symptoms, depression, and for the enhancement of athletic performance.

I. Testosterone cypionate injection is considered medically necessary as testosterone replacement therapy in men for the following indications when all of the numbered criteria in the applicable diagnosis category are met:

A. Primary hypogonadism
1. Documentation in the member’s medical records that the drug is used for primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy, and
2. Member has 2 or more symptoms of hypogonadism, and
3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and

4. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

B. Hypogonadotropic hypogonadism
1. Documentation in the member’s medical records that the drug is used for hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation, and

2. Member has 2 or more symptoms of hypogonadism, and

3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and

4. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

II. Use of testosterone therapy is considered medically necessary as off-label use for the treatment of the following conditions:
A. Breast cancer
1. Palliative treatment of breast cancer that is inoperable in women

B. For the treatment of delayed puberty in males

C. Female-to-male transsexual - Gender identity disorder

III. A. When medical necessity criteria are met, initial use of testosterone cypionate will be approved for
12 months at the following FDA approved dosing:

1. Primary hypogonadism and hypogonadotropic hypogonadism: 50 to 400 mg IM every 2 to 4 weeks based on patient response and presence of adverse effects
2. Treatment of delayed puberty: 50-200 mg IM once every 2-4 weeks for a limited period. Or, 40-50 mg/m²/dose IM monthly for 6 months.
3. Treatment of breast cancer: 200-400 mg IM once every 2-4 weeks

B. Subsequent use of testosterone cypionate will be approved for an additional 12 months when documentation is provided demonstrating that the following examination/tests have been performed:
1. hemoglobin and hematocrit; and
2. digital rectal examination and PSA levels for men >40 years old with baseline PSA >0.6 ng/ml; and
3. current total testosterone level is NOT greater than the testing laboratory’s upper limit of normal range; and
4. member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin)
b. HCG (Novarel/Pregnyl)

IV. All other uses of testosterone cypionate are considered investigational including, but not limited to, their use in the treatment of pediatric patients, sexual dysfunction in both men (e.g., erectile dysfunction) and women (e.g., decreased libido), post-menopausal symptoms, depression, and for the enhancement of athletic performance.

I. Testosterone enanthate injection is considered medically necessary as testosterone replacement therapy in men for the following indications when all of the numbered criteria in the applicable diagnosis category are met:

A. Primary hypogonadism
1. Documentation in the member’s medical records that the drug is used for primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy, and

2. Member has 2 or more symptoms of hypogonadism, and

3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and

4. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

B. Hypogonadotropic hypogonadism
1. Documentation in the member’s medical records that the drug is used for hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation, and

2. Member has 2 or more symptoms of hypogonadism, and

3. Diagnosis of primary hypogonadism is confirmed with all of the following:
a. Copies of actual laboratory results that include the reference laboratory range, the date, and time the specimen was taken for the following levels:
i. one of the following testosterone levels:
a. At least 2 early (8AM – 10 AM) morning total testosterone levels that are below the lower limit of the reference range; or
b. At least 1 early (8AM – 10AM) morning total testosterone levels that is below the lower limit of the reference range with 1 early (8AM – 10AM) morning free testosterone levels below the lower limit of the reference range; AND
ii. Luteinizing Hormone (LH) prior to initiation of testosterone replacement therapy; AND
iii. Prolactin levels prior to initiation of testosterone replacement therapy; AND
iv. Hemoglobin and hematocrit prior to initiation of testosterone replacement therapy; AND
v. Prostate specific antigen (PSA) that is below 4 ng/mL; and

4. Member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin);
b. HCG (Novarel/Pregnyl) or HCG therapy will be discontinued before starting therapy with testosterone.

C. Treatment of delayed puberty
1. Documentation in the member’s medical records of limited or no signs of puberty
2. Testosterone is being used short term (4 to 6 months) to stimulate puberty

[INFORMATIONAL NOTE: Signs of puberty in males include: Growth of pubic hair, other body hair, and facial hair; enlargement of testicles and penis; muscle growth; growth spurt; acne; deepening of the voice.]

D. Metastatic mammary cancer
1. Secondarily in women with advancing inoperable metastatic (skeletal) breast cancer who are 1 to 5 years postmenopausal
2. Premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor
II. A. When medical necessity criteria are met, initial use of testosterone enanthate will be approved for 12 months at the following FDA approved dosing:
1. Primary hypogonadism and hypogonadotropic hypogonadism: 50 to 400 mg IM every 2 to 4 weeks based on patient response and presence of adverse effects
2. Treatment of delayed puberty:
a. 50—200 mg IM once every 2—4 weeks
b. Or, 40—50 mg/m²/dose IM monthly
c. Approval will be for 6 months only
3. For palliative treatment of breast cancer that is inoperable in women: 200-400 mg IM once every 2-4 weeks.

B. Subsequent use of testosterone enanthate will be approved for an additional 12 months when documentation is provided demonstrating that the following examination/tests have been performed:
1. hemoglobin and hematocrit; and
2. digital rectal examination and PSA levels for men >40 years old with baseline PSA >0.6 ng/ml; and
3. current total testosterone level is NOT greater than the testing laboratory’s upper limit of normal range; and
4. member is NOT treated with any of the following medications:
a. aromatase inhibitor (i.e., Femara, Arimidex, or Aromasin)
b. HCG (Novarel/Pregnyl)
5. Member is not using for the indication of delayed male puberty as testosterone therapy should be used for short term (4-6 months).

III. All other uses of testosterone enanthate are considered investigational including, but not limited to, their use in the treatment of pediatric patients, sexual dysfunction in both men (e.g., erectile dysfunction) and women (e.g., decreased libido), post-menopausal symptoms, depression, and for the enhancement of athletic performance.


Medicare Coverage

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.

Medicaid Coverage

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Testosterone [Implantable Testosterone Pellets (Testopel Pellets), Testosterone Undecanoate (Aveed)], Testosterone Cypionate (Depo-Testosterone), or Testosterone Enanthate (Delatestryl)]
Implantable Testosterone Pellets (Testopel Pellets)
Testosterone Pellet
Testopel Pellets
Testosterone Undecanoate
Aveed
Depo-Testosterone
Testosterone Cypionate
Testosterone Ethanthate
Delatestryl
Xyosted

References:
1. Testopel (testosterone pellets). Prescribing Information. Bartar Pharmacal. Rye, NY. October 2016.

2. Petak SM, Nankin HR, Spark RF et al. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients---2002 Update. Endroc Pract. 2002 Nov-Dec;8(6):440-56. Available at: http://alt.aace.com/pub/pdf/guidelines/hypogonadism.pdf (last accessed 05/03/2011).

3. Cobin RH, Futterweit W, Ginzburg SB et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocr Pract. 2006 May-Jun;12(3):315-37. Available at: http://aace.metapress.com/content/1bvpkkjbtwh72cqk/fulltext.pdf (last accessed 05/03/11)

4. 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 Jun;91(6):1995-2010.

5. FDA warning letter on the promotion of unapproved uses of Testopel. March 24, 2010. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm208007.htm

6. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab.2010 Jun:95(6):2536-59.

7. Petak SM, Nankin HR, Spark RF, et al. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients – 2002 update. Endocr Pract. 2002 Nov-Dec;8(6):440-56.

8. Carter HB, Albertsen PC, Barry MJ et al. Early Detection of Prostate Cancer: AUA Guideline. American Urological Association 2013. Accessed November 1, 2013.

9. Wang C, Nieschlag E, Swerdloff R et al. ISA, ISSAM, EAU, EAA and ASA Recommendations: Investigation, Treatment and Monitoring of Late-Onset Hypogonadism in Males. Int J Impot Res 2009;21(1):1-8. Available at http://www.medscape.com/viewarticle/586871_2

10. UpToDate. Clinical features and diagnosis of male hypogonadism. Literature current through February 2014.

11. Aveed® (testosterone undecanoate injection). Prescribing Information. Endo Pharmaceuticals. Malvern, PA. October 2019.
12. Tamoxifen Product information. Mylan Pharmaceuticals Inc. April 2014.

13. Femara. Product information. Novartis Inc. January 2014.

14. Arimidex. Product information. AstraZeneca Inc. March 2016.

15. Aromasin. Product information. Pfizer Inc. May 2014.

16. Depo®-Testosterone. Prescribing Information. Pfizer Inc. August 2018.

17. Delatestryl (testosterone enanthate). Prescribing Information. Endo Pharmaceuticals. Malvern, PA. October 2016.

18. Testosterone Replacement Therapies. Medical Policy Reference Manual MPRM 5.01.23. Blue Cross Blue Shield Association. Accessed May 8, 2015.

19. Bhasin S, Calof OM, Storer TW, et al. Drug insight: Testosterone and selective androgen receptor modulators as anabolic therapies for chronic illness and aging. Nat Clin Pract Endocrinol Metab. Mar 2006;2(3):146-159. PMID 16932274

20. Baillargeon J, Urban RJ, Morgentaler A, et al. Risk of venous thromboembolism in men receiving testosterone therapy. Mayo Clin Proc. Aug 2015;90(8):1038-1045. PMID 26205547

21. Seftel AD, Kathrins M, Niederberger C. Critical update of the 2010 Endocrine Society clinical practice guidelines for male hypogonadism: a systematic analysis. Mayo Clin Proc. Aug 2015;90(8):1104-1115. PMID 26205546

22. Testosterone. Micromedex 2.0. Truven Health Analytics, Inc. Greenwood Village, CO. Available at: http://www.micromedexsolutions.com. Accessed March 2017.

23. Meyer WJ, Webb A, Stuart CA, et al: Physical and hormonal evaluation of transsexual patients: a longitudinal study. Arch Sex Behav 1986; 15(2):121-138.

24. Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: American Urological Association (AUA) Guideline. J Urol. 2018

25. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab.2018 May:103(5):1715-1744.

26. Antares receive FDA approval of Xyosted (testosterone enanthate) injection for testosterone replacement therapy in adult males. October 1, 2018. https://www.antarespharma.com/application/files/2715/3835/7488/XYOSTED_FDA_Approval_Final.pdf

27. Testosterone [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp (accessed 2020 Apr 1).

28. American Urology Association. Evaluation And Management Of Testosterone Deficiency: Treatment Algorithm. 2018.

29. Park HJ, Ahn ST, Moon DG. Evolution of Guidelines for Testosterone Replacement Therapy. J. Clin. Med. 2019;8.

30. de Ronde W, de Jong FH. Aromatase inhibitors in men: effects and therapeutic options. Reproductive Biology and Endocrinology. 2019;9(93).

31. Coviello AD, Matsumoto AM, Bremner WJ, et al. Low-Dose Human Chorionic Gonadotropin Maintains Intratesticular Testosterone in Normal Men with Testosterone-Induced Gonadotropin Suppression. J Clin Endocrinol Metab. 2005;90(5):2595–2602.

32. Hsieh TC, Pastuszak AW, Hwang K, et al. Concomitant Intramuscular Human Chorionic Gonadotropin Preserves Spermatogenesis in Men Undergoing Testosterone Replacement Therapy. Journal of Urology. 2013;189:647-650.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

11980

J1071
J3121
J3145
S0189