Tuesday, October 10, 2017

cpt code for testosterone - j3490, 11980, 84403

CPT/HCPCS Codes

J3490* Testosterone pellets (Testopel®)

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

* 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.

TESTOSTERONE CPT CODE: 84403

Covered ICD code for 84403

E89.5 Post procedural testicular hypofunction L63.8 Other alopecia areata
E29.1 Other testicular hypofunction N40.0 Enlarged prostate without LUT symptoms (BPH)
E29.8 Other testicular dysfunction N40.1 Enlarged prostate with LUTS
E34.9 Hormonal imbalance (elevated testosterone)
ICD-10 description: Endocrine disorder unspecified N41.0 Acute prostatitis
F52.22 Female sexual arousal disorder N42.89 Other specified disorders of prostate (Atrophy of prostate)
F52.0 Sexual dysfunctin not due to a substance or known physiological condition (may not be a covered indication for all payers) N46.01 Organic azoospermia
R68.82 Decreased libido N46.11 Organic oligospermia
F52.0 Hypoactive sexual desire disorder N46.029 Infertility due to extratesticular causes
F52.21 Male erectile disorder N52.9 Azoospermia due to other extratesticular causes
F52.31 Female orgasmic disorder L65.9 Alopecia, unspecified
F52.32 Male orgasmic disorder L63.2 Ophiasis
F52.4 Premature ejaculation

Indications and Limitations of Coverage and/or Medical Necessity

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.

Testosterone pellets (Testopel®) have been approved by the Food and Drug Administration (FDA) for the treatment of primary hypogonadism (congenital or acquired) and hypogonadotrophic hypogonadism (congenital or acquired). Primary hypogonadism includes such conditions as testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchidectomy. Hypogonadotrophic hypogonadism (secondary hypogonadism) includes conditions such as idiopathic or gonadotropic luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation.

Indications:

Testosterone pellets (Testopel®) will be considered medically reasonable and necessary for the following indications:

• Second line testosterone replacement therapy in males with congenital 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,
• For treatment of delayed male puberty

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 testosterone) is not a covered indication. 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.



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 testosterone 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. The results of both tests must fall below the normal laboratory reference range. 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 upon request. 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.



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. In certain medical conditions such as hypogonadism, the endogenous 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.

Testosterone pellets (Testopel®) have been approved by the Food and Drug Administration (FDA) in adult males for the treatment of primary hypogonadism (congenital or acquired) and hypogonadotrophic hypogonadism (congenital or acquired). Primary hypogonadism includes such conditions as testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchidectomy. Hypogonadotrophic hypogonadism (secondary hypogonadism) includes conditions such as idiopathic or gonadotropic luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation. Testopel Pellets are not FDA-approved for administration to females.

Guidelines

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

* Second line testosterone replacement therapy in males with congenital 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,
* 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 testosterone) is not a covered indication. 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 Code Description

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


HCPCS Code Description

J3490 Unclassified drugs (Testopel)
S0189 Testosterone pellet, 75 mg (Not recognized by Medicare)


ICD-10 Diagnosis Code Description

C75.1 Malignant neoplasm of pituitary gland
C75.2 Malignant neoplasm of craniopharyngeal duct
D35.2 Benign neoplasm of pituitary gland
D35.3 Benign neoplasm of craniopharyngeal duct
E23.6 Other disorders of pituitary gland
E29.1 Testicular hypofunction
E30.0 Delayed puberty
N44.00 Torsion of testis, unspecified
N44.01 Extravaginal torsion of spermatic cord
N44.02 Intravaginal torsion of spermatic cord


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