LCD/NCD Portal

L33002

 

TESTOSTERONE PELLETS (TESTOPEL®)

 

 

01/29/2013

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• Testosterone pellets (Testopel®) have been approved by the Food and Drug Administration (FDA) for the treatment of

o Primary hypogonadism (congential or acquired).

o Hypogonadotrophic hypogonadism (congential or acquired).

• Primary hypogonadism includes such conditions as testicular failure due to

o cryptorchidism,

o bilateral torsion,

o orchitis,

o vanishing testes syndrome; or

o Orchidectomy.

• Hypogonadotrophic hypogonadism (secondary hypogonadism) includes conditions such as

o idiopathic or gonadotropic luteinizing hormone releasing hormone (LHRH) deficiency or

o Pituitary-hypothalamic injury from tumors, trauma or radiation.

Indications:

 

 

• Medicare will consider testosterone pellets (Testopel®) medically reasonable and necessary for the following indications:

o Second line testosterone replacement therapy in males with congential or acquired endogenous androgen absence or deficiency associated with primary or secondary hypogonadism when other standard replacement [intramuscular (IM), buccal, transdermal] is not clinically effective;

OR

o For treatment of delayed male puberty

• Testosterone pellets (Testopel®) method of administration is subcutaneously by a health care professional.

Limitations:

• Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate.

• For patients that clearly meet the indication for testosterone replacement, the reason(s) for a transition to pellets from other effective replacement (IM, buccal, transdermal) must be specifically addressed in the medical record.

• Clinical diagnosis of androgen deficiency (non-specific symptoms, low normal testosterone levels, and normal free testerone) is not a covered indication.

o Office practices with high utilization of testosterone pellet implantations can be subject to pre- or post-payment review.

• Implantable testosterone pellets for the treatment of symptoms associated with menopause is considered not reasonable and necessary as there is insufficient clinical evidence to support this use and is therefore non-covered.

 

 

CPT/HCPCS Codes

 

* Providers must bill HCPCS code J3490 and CPT code 11980 on the same claim. If HCPCS code J3490 and CPT code 11980 are not billed on the same claim, the claim will be subject to prepayment review.

 

J3490* Testosterone pellets (Testopel®)

 

11980* Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin)

XX000 Not Applicable

 

 

ICD-9 Codes that Support Medical Necessity

 

257.2 OTHER TESTICULAR HYPOFUNCTION

259.0 DELAY IN SEXUAL DEVELOPMENT AND PUBERTY NOT ELSEWHERE CLASSIFIED

 

 

Documentation Requirements

 

• The medical record must substantiate the medical need for testosterone pellets (Testopel®) with documentation of unsuccessful treatments of standard replacement (IM, buccal, transdermal) on more than one occasion, in men with clinically significant symptoms of androgen deficiency.

 

• The reason(s) for a transition to pellets from other effective replacement (IM, buccal, transdermal) must be specifically addressed in the medical record.

• The medical record should reflect two total testosterone levels and free testerone levels when indicated to determine the medical necessity of testosterone replacement. It is suggested to measure morning testosterone level by a reliable assay on two different days.

o The results of both tests must fall below the normal laboratory reference range.

o The medical record should include the Clinical Laboratory Improvement Amendments (CLIA) approved reference normal range for the testosterone assay used.

• Medical record documentation must be made available to Medicare upon request.

o When the documentation does not meet the criteria for the services rendered, or the documentation does not establish the medical necessity for the service(s), such services will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.

Treatment Logic

• Testosterone is an endogenous androgen. Endogenous androgens are responsible for the normal growth and development of the male sex characteristics.

• Testosterone levels vary from hour to hour; periodic declines below the normal range can occur in some otherwise normal men.

• An overall diurnal rhythm is also present, the highest levels of circulating testosterone occurring during the early morning hours. In certain medical conditions such as hypogonadism, the endogeonous level of testosterone falls below normal levels.

• The diagnosis of androgen deficiency is made in men with consistent signs and symptoms and unequivocally low serum testosterone levels.

• Testosterone levels should be determined in the morning, and studies should be repeated in patients with subnormal levels.

 

 

Sources of Information and Basis for Decision

 

Bhasin, S., Cunningham, G., Hayes, F., Matsumoto, A., Snyder, P., Swerdloff, R., Montori, V. (2010). Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology & Metabolism. 95(6), 2536-59.

 

Clinical Pharmacology. (2012). Testosterone (Testopel). Retrieved from http://www.clinicalpharmacology.com

 

Goodman, N., Cobin, R., Ginzburg, S., Katz, I., Woode, D., (2011). American association of clinical endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. AACE Guidelines. Retrieved from https://www.aace.com/files/menopause.pdf

 

U.S. Food and Drug Administration. Department of Health and Human Services. (2012). FDA approved drug products. Retrieved from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist

 

U.S. National Library of Medicine (NLM). (2011). Testopel® (testosterone) pellet label. Slate Pharma. Retrieved from http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a1741a0b-3d4c-42dc-880d-a06e96cce9ef

 

01/29/2013

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

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 L33002 TESTOSTERONE PELLETS (TESTOPEL®)