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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 08/02/2011 Title: Testosterone Replacement Therapy
Revision Date: 10/01/2020 Document: BI305:00
CPT Code(s): C9023; J1070-J1071; J1080; J3120-J3121; J3130; J3145; S0189
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Testosterone replacement products require prior authorization.

2)    Testim, Fortesta, Androderm, Androgel, testosterone gel 1%, and Axiron are not covered.

3)    Testosterone gel 1.62% is covered under the pharmacy benefit when criteria are met.

4)    Aveed is not covered.

5)    Other injectable testosterone products are covered under the medical benefit when criteria are met.


Medical Statement

1)    The following Testosterone replacement products require prior authorization:

a.    Testosterone gel  1.62%

b.    Testosterone cypionate injections.

c.    Testosterone enanthate

d.    Testosterone pellets(Testopel)

2)    The role of testosterone replacement to treat the decline in serum testosterone concentration that occurs with increasing age in men in the absence of identifiable pituitary, hypothalamic, or testicular disease is uncertain.

Testosterone replacement for members with complex or multiple endocrine diagnosis require management by endocrinologist.3) Testosterone replacement products are considered medically necessary for members who meet all of the following criteria for the initial request.  Initial approval for 3 months.

a.    Member does not have any of the following:

                                          i.     diagnosis of prostate cancer or breast cancer;

                                        ii.    Hematocrit > 50%

                                       iii.    Palpable prostate nodule or induration on digital rectal exam within the last 6 months

                                       iv.    PSA > 4ng/ml or 3ng/ml in African-American men or men with first-degree relative with prostate cancer or an increase in PSA without further urologic evaluation.

                                        v.    Untreated severe obstructive sleep apnea

                                       vi.    Severe lower urinary tract symptoms

                                      vii.    Poorly controlled  heart failure,

                                     viii.    Myocardial infarction or stroke within the last 6 months,

b.    Member has subnormal (less than 280mg/dl) morning (fasting and drawn between 8 to 10 AM) serum total testosterone concentration on three (3) separate occasions (copies of lab reports with time/date stamp and with normal range indicated from lab must be provided). Serum free testosterone levels may only be considered if total testosterone levels remain borderline. Testing must be performed at an independent lab with recording of the time of the day and fasting status.

c.    Appropriate diagnostic evaluation has been done to determine the cause of androgen deficiency. For secondary hypogonadism evaluation and recommendations from an endocrine specialist is required.

d.    Member must have at least 3 symptoms/signs of androgen deficiency from listing below:

                                          i.    Eunuchoidism, aspermia

                                        ii.    Loss of body hair (axillary and pubic)

                                       iii.    Hot flashes, sweats

                                       iv.    Breast discomfort and gynecomastia

                                        v.    Height loss, bone loss

                                       vi.    Low trauma fracture

                                      vii.    Decreased sex drive

                                     viii.    Decreased morning erections

                                       ix.    Needing to shave less often

e.    Other causes of above symptoms have been ruled out. Symptoms and signs such as fatigue, depression, anemia reduced muscle strength and increased fat mass are not specific for hypogonadism.

f.     Testosterone therapy is not indicated for decreased sperm counts. Testosterone therapy decreases sperm production further by suppressing pituitary gonadotropin secretion.

g.    There is documentation of discussion with the member about potential benefits and risks of testosterone replacement therapy and member’s involvement in decision making.

h.    Per Endocrine Society Guidelines when testosterone therapy is instituted, the clinicians should aim at achieving T concentrations in the mid-normal range (500-600 ng/dL) during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Dosage should be reduced if levels are higher than the mid-normal range.

i.      Monitoring should be done 2 to 3 months after initiation of testosterone therapy and after changing a dose. When the dose appears to be stable, monitoring every 6 to 12 months should suffice. They should also be monitored for undesirable effects.

j.      Serum testosterone should be measured midway between injections in men who are receiving testosterone enanthate or cypionate, and the value should be mid normal, eg, 500 to 600 ng/dL. The dose should be reduced if higher values are obtained.

k.    Recommended dose is 100 to 200 mg every two weeks. It can be administered either by the patient himself or by someone in the patient`s household. The patient should be seen approximately two to three months later, and if he is bothered by fluctuations in energy, mood, or libido, the regimen can be changed to 50 to 100 mg once a week or transdermal testosterone can be offered again.

l.      Testosterone dosing or frequency which is not based on standard clinical guidelines as well as frequent monitoring for it are not covered. 

m.  Use of Aromatase inhibitors in combination with testosterone therapy has not been clinically proven and therefore is not covered.

n.    Initial approval for therapy is for 3 months.

 

3)    For renewal requests, approval based on meeting all of the following criteria.  Renewal is generally approved for 6 months.

a.    Member does not have breast cancer or prostate cancer.

b.    Member does not have hematocrit > 54%

c.    Member does not have palpable prostate nodule or induration on digital rectal exam within the past six months.

d.    Member does not have PSA > 4ng/ml or 3ng/ml in African-American men or men with first-degree relatives with prostate cancer, or increase in PSA level of by more than 1.4 ng/mL in any one-year period.

e.    Members does not have untreated severe obstructive sleep apnea

f.     Member does not have severe lower urinary tract symptoms

g.    Member does not have poorly controlled heart failure

h.    Member is not planning conception in next 6 months.

i.      Member has had fasting morning (8 to 10am) total testosterone levels within last 3 months.

j.      Member has had provider evaluation for potential adverse effects from testosterone replacement within past three months.

4)    Members who are transitioning to QualChoice and are currently on testosterone therapy, are allowed a 90 days transition period for continuity of care. Any additional requests for testosterone require documentation of above renewal criteria.

5)    For Testopel, the quantity of pellets is limited to 6 pellets every three months.


Reference
  1. Androderm Product Information
  2. Androgel Product Information
  3. Axiron Product Information
  4. Fortesta Product Information
  5. Testim Product Information
  6. The Use of Testosterone in the Aging Male.  Pharmacist’s Letter.  Detail Document #260713.  July 2010 (updated February 2011). 
  7. Testosterone Therapy in Adult men with Androgen Deficiency Syndromes:  An Endocrine Society Clinical Practice Guidelines.  J Clin Endocrinol Metab, June 2010, 95(6):2536-2559.
  8. Treatment for erection problems.  American Urological Association handout.  Accessed on Choosing Wisely website 6 June 2014.
  9. Snyder PJ, Peachey H, Berlin JA, et al. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab 2000; 85:2670.
  10. Caronia LM, Dwyer AA, Hayden D, et al. Abrupt decrease in serum testosterone levels after an oral glucose load in men: implications for screening for hypogonadism. Clin Endocrinol (Oxf) 2013; 78:291.
  11. Snyder PJ, Bhasin S, Cunningham GR, et al. Effects of Testosterone Treatment in Older Men. N Engl J Med 2016; 374:611.
  12. Snyder PJ, Matsumoto AM and Martin KA. Testosterone Treatment of Male Hypogonadism. UpToDate:
    https://www.uptodate.com/contents/testosterone-treatment-of-male-hypogonadism
    (Accessed 4/20/2018)
  13. Snyder PJ, Matsumoto AM and Martin KA. Clinical Features and Diagnosis of Male Hypogonadism. UpToDate:
    https://www.uptodate.com/contents/clinical-features-and-diagnosis-of-male-hypogonadism
    (Accessed 4/20/2018)
  14. Robert M. Sargis, Andrew M. Davis, Evaluation and Treatment of Male Hypogonadism. JAMA. April 2018;319(13):1375-1376.

15. Willem de Ronde and Frank H de Jong, Aromatase inhibitors in men: effects and therapeutic options, Reprod Biol Endocrinol. 2011; 9: 93.; retrieved from ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3143915/


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.