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L29287
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 L29287 TESTOSTERONE CYPIONATE AND TESTOSTERONE ENANTHATE