SUPERSEDED Local Coverage Determination (LCD)

Treatment of Males with Low Testosterone

L36569

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Superseded
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36569
Original ICD-9 LCD ID
Not Applicable
LCD Title
Treatment of Males with Low Testosterone
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36569
Original Effective Date
For services performed on or after 07/12/2016
Revision Effective Date
For services performed on or after 11/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
05/27/2016
Notice Period End Date
07/11/2016
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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Title XVIII of the Social Security Act, §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

42 Code of Federal Regulations (CFR) §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

CMS Internet Online Manual Pub. 100-02 (Medicare Benefit Policy Manual), Chapter 15, Section 80, “Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests”

CMS Internet-Only Manuals, Publication 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, 60.12 Independent Laboratory Specimen Drawing, 60.2. Travel Allowance.

CMS Internet Online Manual Pub. 100-04 (Medicare Claims Processing Manual), Chapter 23 (Section 10) “Reporting ICD Diagnosis and Procedure Codes”.

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 12, §30-Correct Coding Policy

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Noridian has noted a rapid increase in the use of testosterone supplements that exceed the expected use in the Medicare population based on current published data. According to a Health Technology Assessment on Testosterone Testing from the Washington State Health Care Authority, the presence of low serum testosterone is 9.0% in men aged 45 to 54 years, 16.5% in men aged 55 to 64 years, and 18.3% in men aged 65 to 74 years. These estimates were derived from the National Health and Nutrition Examination Survey III (NHANESIII), which defined low testosterone levels as < 300 nanogram per deciliter (ng/dL) (10.4 nanomoles per liter [nmol/L]). The diagnosis of hypogonadism depends on measuring the total, free and/or biologically active testosterone; sex hormone binding globulin (SHBG) and the pituitary axis. Male hormone is bound to SHBG, and SHBG tends to rise with age, lowering the free testosterone level. Testosterone level accuracy varies among labs with different assays, and can be affected by chronic diseases, age, levels of binding, measurement variables, testing accuracy, etc. Estimates of the low end of testosterone depend on the method and accuracy of testing and can be as low as 160 ng/dl. Decisions on hypogonadism depend on both repeated hormone testing and a group of clinical symptoms. Neither alone is adequate for defining hypogonadism.

Testosterone levels are controlled by interaction of the testicular-pituitary-hypothalamic axis. Primary hypogonadism is failure of the testes to produce testosterone (for a number of reasons) and is usually accompanied by elevated LH and/or FSH. Secondary hypogonadism is disruption of the testicular-pituitary-hypothalamic pathway and may be due to pituitary or hypothalamic axis damage including systemic illness and genetic aberration. Age related hypogonadism (e.g. lower testosterone in the older male population) is not necessarily a disease and may be asymptomatic and / or may be related or associated with many chronic illnesses. “Low T Syndrome” or “Low T” is not a syndrome and may be an incidental finding or lab error. Low serum testosterone alone does not constitute a diagnosis of androgen deficiency or clinical hypogonadism. Diagnosis of a clinical condition requires the presence of certain characteristic symptoms as well as an abnormally low serum testosterone.

Many of the symptoms are not specific to, and not directly correlated to specific levels of testosterone. Guidelines from the Endocrine Society suggest some of the following symptoms may be related to low serum testosterone but may also have many other causes in the elderly population:

More Specific Signs / Symptoms

    • Incomplete or delayed sexual development; eunuchoidism

 

    • Reduced sexual desire (libido) and activity

 

    • Breast discomfort, gynecomastia

 

    • Loss of body (axillary and pubic) hair, reduced shaving

 

    • Very small (Especially < mL) or shrinking testes

 

    • Inability to father children

 

    • Low or zero sperm count

 

    • Height loss, low-trauma fracture, low bone mineral density

 

    • Hot flushes, sweats


Less Specific Signs/Symptoms

    • Decreased energy, motivation, initiative and self confidence

 

    • Feeling sad or blue, depressed mood, dysthymia

 

    • Poor concentration and memory

 

    • Sleep disturbance, increased sleepiness

 

    • Mild anemia

 

    • Reduced muscle bulk and strength

 

    • Increased fat or increased body mass index

 

    • Diminished physical or work performance


Noridian expects that the evaluation of primary hypogonadism be undertaken with at least 2 separate serum testosterone levels taken on two different days in the morning (when testosterone secretion is highest) , and / or two morning levels of “free” or bioavailable testosterone) and LH or FSH levels. Elevated LH /FSH confirms primary hypogonadism and the potential need for replacement hormone. If the two testosterone determinations are low AND the LH/FSH levels are also low, pituitary disease (including a serum prolactin) or chronic diseases should be assessed before making a diagnosis of age related low testosterone. Only patients with low testosterone associated significant symptoms should be considered for treatment. A comprehensive examination is required to evaluate for medications or chronic diseases known to cause decreased energy, memory problems, impotence and mental health problems.

Noridian would consider the low testosterone related symptoms from the nonspecific and specific groups described above to be documented in the chart along with two low testosterone levels drawn on two mornings and a single LH or FSH to demonstrate the need for testosterone therapy in the age related group of symptomatic androgen deficiency. Documentation of the symptoms, signs, physical examination and lab tests must be available in the chart if requested.

Treatment of symptoms associated with low testosterone is controversial. It is not certain if low testosterone is the cause of the symptoms, a marker for underlying chronic diseases, or the effect of the symptoms-and there is a considerable placebo effect. Long term effects of testosterone on the geriatric population are mixed but are being studied by the NIH. Long term use of testosterone can damage the hypothalamic-pituitary-testicular axis and lead to permanent testicular failure.

Testosterone replacement therapy is contraindicated in patients with breast cancer and untreated prostate cancer. There are recent FDA listed warnings about thromboembolic disease, increase in erythrocythemia, and hypertension. The clinical records shall reflect that these issues were discussed with the patient before initiating therapy. Some physicians recommend obtaining baseline PSA testing and ongoing monitoring to test for prostate cancer.

Long term testosterone therapy will shrink testicular tissue and can lead to infertility, and therefore would be contraindicated in those interested in reproduction.

Where replacement is indicated, the dose of replacement therapy should be the least amount necessary to obtain a serum testosterone in the low normal range. Testosterone replacement can be administered by many routes. The current preferred routes are by transdermal preparations. Since topical or transdermal agents are administered daily in low dose, the risk of supraphysiological or subtherapeutic levels is minimized. The use of topical agents is thought to minimize adverse events. Indeed, in series examining the toxicity of topical agents, adverse events are nearly nonexistent when administered by these routes (Steidle et al., 2003). The main disadvantage of the topical agents are their high cost ($100 to $150 per month), substantially higher than self-administered injection therapy, and the potential risk of inadvertent transfer of hormone to women or children through skin contact. There is no evidence that unusually high doses-or higher than published frequencies of administration-are any more effective than doses established by the FDA and could lead to increased side effects. Ongoing monitoring of hormone levels and side effects are necessary.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information

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Sources of Information

1. Bhasin, MD, S., Travison, PHD, T., & Jasuja, PhD, R. Testosterone and Aging. Translational Endocrinology & Metabolism, 2 (2), 39-72. 2011.

2. Bhasin, MD, S., Cunningham, G., & Hayes, F. (2013). Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline. JCEM

3. Brannigan, MD, R., Paduch, MD, PHD, D., & Fuchs, E., et al; The Laboratory Diagnosis of Testosterone Deficiency, 2013 AUA White Paper., (American Urological Association Education and Research, Inc.).

4. FDA Safety Alert: Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack and Stroke; UPDATE 04/15/2015.

5. Handelsman, MBBS, PHD, D., & Perls MD, MPH, T. (n.d.). , Disease Mongering of Age-Associated Declines in Testosterone and Growth Hormone Levels. Journal of the American Geriatrics Society, 63(4), 809-811. April 2015.

6. Huhtaniemi, I. (2014). Late-onset hypogonadism: Current concepts and controversies of pathogenesis, diagnosis and treatment. Asian Journal of Andrology, 16(2), 192-202.

7. Paduch, D. et al "Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial" J Clin Endicrinol Metab. 2014-4434. 2015.

8. Rishi Sharma, Olurinde A. Oni, Kamal Gupta, et.al. European Heart Journal, published online: 6 August 2015.

9. Steidle, C.P. MD, New Advances in the Treatment of Hypogonadism in the Aging Male, Rev Urol. 2003; 5 (Suppl 1): S34–S40.

10. Testosterone Testing, Health Technology Assessment Program (HTA) Washington State Health Care Authority (Draft Report) February 6, 2015.

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/01/2019 R4

11/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage.

As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.

  • Provider Education/Guidance
  • Revisions Due To Code Removal
10/01/2017 R3

08/21/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice.  This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

LCD is revised to add the following diagnoses effective 10/01/2017:

D44.3: Neoplasm of uncertain behavior of pituitary gland

  • Revisions Due To ICD-10-CM Code Changes
01/01/2017 R2 2017 CPT Coding update to include 84410
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2016 R1 Added ICD-10 CM Code N50.89 per ICD-10 CM 2016-2017 Coding Updates.
  • Revisions Due To ICD-10-CM Code Changes
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
01/29/2020 11/01/2019 - N/A Currently in Effect View
10/24/2019 11/01/2019 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • 11980
  • 96372
  • 84410
  • J1071
  • J3121
  • J3145
  • J3490

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