LCD/NCD Portal

L28990

 

TESTOSTERONE CYPIONATE AND TESTOSTERONE ENANTHATE

 

 

03/22/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

 

FDA approved indications covered by Medicare:

• Testosterone cypionate and testosterone enanthate are indicated for replacement therapy in the male in conditions associated with symptoms or deficiency or absence of endogenous testosterone:

o Primary hypogonadism (congenital or acquired):

 Testicular failure due to:

• Cryptorchidism.

• Bilateral torsion.

• Orchitis.

• Vanishing testes syndrome.

• Orchidectomy.

o Hypogonadadotropic hypogonadism (congenital or acquired):

 Idiopathic gonadotropin or LHRH deficiency.

 Pituitary-hypothalamic injury from:

• Tumors.

• Trauma.

• Radiation.

• In addition to the FDA approved indications, Medicare will cover Testosterone cypionate and testosterone enanthate for the following off-label indication:

o Hypogonadism in patients who are infected with HIV, particularly those whose disease has progressed to AIDS and who have developed wasting syndrome.

 Wasting syndrome is an AIDS defining condition.

 Wasting is evidence of symptomatic HIV infection.

 Wasting syndrome is defined as unintentional weight loss > 10% and the presence of chronic weakness and documented fever lasting at least 30 days.

 Wasting is defined as unintentional weight loss >10 %.

 Wasting syndrome and wasting must be differentiated from lipoatrophy, which is isolated fat loss and is seen in patients who are on a successful course of antiretroviral therapy.

o The literature supports that the preferred route of administration of testosterone for this indication is topical or transcutaneous.

 This route provides a steady dose of the drug versus weekly or bi-weekly injectables that can cause increases and decreases in testosterone levels.

Limitations

o The CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) outlines that "reasonable and necessary" services are "ordered and/or furnished by qualified personnel."

 Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

o A qualified physician for this service/procedure is defined as follows:

 Physician is properly enrolled in Medicare.

 Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

o "Drugs or biologicals approved for marketing by the FDA are considered safe and effective when used for indications specified on the labeling.

o The labeling lists the safe and effective, i.e. medically reasonable and necessary dosage and frequency. Therefore, doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered not medically reasonable and necessary and, therefore, not reimbursable."

o Testosterone cypionate and testosterone enanthate are contraindicated for the following:

 Known hypersensitivity to the drug.

 Males with carcinoma of the breast.

 Males with known or suspected carcinoma of the prostate gland.

 Women who are or may become pregnant.

 Patients with serious cardiac, hepatic or renal disease.

o For patients with AIDS

 The patient must have documented hypogonadism and must meet the definition of wasting syndrome.

 If the AM free testosterone level is > 400 ng/dl, the patient is not considered hypogonadal and should not receive injections of testosterone cypionate.

 

 

CPT/HCPCS Codes

 

J1070 INJECTION, TESTOSTERONE CYPIONATE, UP TO 100 MG

J1080 INJECTION, TESTOSTERONE CYPIONATE, 1 CC, 200 MG

J3120 INJECTION, TESTOSTERONE ENANTHATE, UP TO 100 MG

J3130 INJECTION, TESTOSTERONE ENANTHATE, UP TO 200 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

042* HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

257.2 OTHER TESTICULAR HYPOFUNCTION

799.4* CACHEXIA

*please note that for patients with AIDS wasting syndrome, ICD-9 codes 042 and 799.4 must be billed together.

 

 

Diagnoses that Support Medical Necessity

 

Documentation Requirements

 

• Medical record documentation maintained by the ordering/referring physician/qualified nonphysician practitioner must indicate the medical necessity for administering this drug.

• Documentation should support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy and should reflect how the administration of this drug will be used in the patient’s plan of care.

• For FDA approved indications:

o In addition to the above, the medical record should reflect an AM free testosterone level along with a TSH level

• For AIDS wasting/hypogonadism:

o Document weight with each injection, document AM free testosterone to support that the administration of testosterone is medically necessary.

o Initiation of therapy:

 The medical record should document that the patient meets the definition of wasting syndrome as defined in the indications and limitations section of the LCD.

 A TSH level should also be documented.

 If the parenteral form of testosterone is chosen over topical or transcutaneous form, the rationale must be documented in the medical record.

Utilization Guidelines

• In the parental form testosterone cypionate and testosterone enanthate should be given as a deep IM injection into the gluteal muscle.

o If the method of delivery is the parental form of testosterone, the medical record should reflect the justification of this decision.

• The suggested dosage for DEPO- testosterone injection varies depending on the age, sex and diagnosis of the individual patient.

o Dosage is adjusted according to the patient’s response and adverse reactions.

o Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels.

o Other experts emphasize that higher dosages can be used for maintenance after puberty.

o The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

• For standard testosterone replacement in the hypogonadal males, 50-400 mg should be administered every 2-4 weeks.

o The dose should be titrated until there is amelioration of symptoms and an AM testosterone level > 400mg/dL.

• For patients with wasting syndrome: may start with 400mg IM every two weeks until weight is restored.

o Then the dose should be reduced to 200mg IM every two weeks.

Treatment Logic

• Testosterone cypionate and Testosterone enanthate, for IM injection, are oil-soluble 17 (beta)-cyclopentylpropionate esters of the androgenic hormone testosterone.

• Testosterone esters are less polar than free testosterone.

• Testosterone esters, in oil, injected intramuscularly are absorbed slowly from the lipid phase;

o Thus, they can be given at intervals of 2 to 4 weeks.

 

 

Sources of Information and Basis for Decision

 

Basaria, S., Wahlstrom, J., and Dobs, A. (2001). Anabolic-Androgenic steroid therapy in the treatment of chronic diseases. The Journal of Clinical Endocrinology and Metabolism, 86 (11). Retrieved from http://jcem.endojournals.org on 1/12/06.

 

Cofrancesco, Jr., J (2004). Wasting. Johns Hopkins poc-it HIV Guide. Retrieved from http://www.hopkins-hivguide.org on 3/20/06.

 

Depo®-Testosterone, testosterone cypionate injection, USP. Pharmacia & Upjohn Co. Package insert 2002.

 

FCSO LCD 29287, Testosterone Cypionate and Testosterone Enanthate, 03/22/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Grinspoon, S., Corcoran, C. (1999). The use of testosterone in the AIDS wasting syndrome. AIDS Clinical Care. Retrieved form http://aids-clinical-care.jwatch.org.cgi.content/full/1999/401/1 on 1/23/06.

 

Grinspoon, S., Corcoran, C., et al (1996). Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting*. Journal of Clinical Endocrinology and Metabolism, 81 (11). Retrieved from www.jcem.endojournals.org on 3/16/2006.

 

Medline Plus Medical Encyclopedia: Hypogonadism. Retrieved from http://www.nlm.nih.gov/medlineplus/ency/article/001195.htm on 3/16/2006.

 

Pham, P. and Bartlett, J. (2004). Testosterone. Johns Hopkins poc-it HIV Guide. Retrieved from http://www.hopkins-hivguide.org on 3/20/06.

 

Testosterone. AIDSinfo (2004). Retrieved from http://aidsinfo.nih.gov on 3/16/06.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L28990 TESTOSTERONE CYPIONATE AND TESTOSTERONE ENANTHATE_AJ9