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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-24

Original Effective Date: 06/15/10

Reviewed: 10/09/13

Revised: 11/01/15

Subject: Hormone Replacement

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates
           

DESCRIPTION:

Testosterone is an androgen hormone responsible for normal growth and development of male sex characteristics. In males with hypogonadism or delayed puberty, the endogenous level of testosterone may fall below normal levels and require treatment with exogenous testosterone. Additionally, women diagnosed with metastatic breast cancer may benefit from a palliative care regimen that includes testosterone. Testosterone hormone replacement can be delivered by mouth, topical application, or intramuscular or subcutaneous injection.

Estrogen pellets for subcutaneous implantation have not been approved by the Food and Drug Administration in the United States for use in humans. Although the limited clinical studies indicate estrogen pellet implants can provide a safe and effective method of delivering hormone replacement therapy, the cardiovascular risk and long-term effects when used as hormone replacement therapy for female menopause are not known.

POSITION STATEMENT:

NOTE: Testosterone undecanoate (Aveed) oil for injection may only be prescribed by healthcare providers enrolled into the Aveed REMS Program.

Initiation of testosterone meets the definition of medical necessity for any of the following indications when ALL of the associated criteria are met:

1. Primary or secondary hypogonadism

a. Member is male

b. Member has a laboratory documented testosterone deficiency (i.e., measured testosterone is below laboratory’s lower limit of normal)

2. Delayed puberty

a. Member is male

b. Member is 14 years of age or older

c. Member has either a laboratory documented testosterone deficiency (i.e., measured testosterone is below laboratory’s lower limit of normal) or physical evidence of hypogonadism

3. Metastatic breast cancer

a. Member is female

b. Testosterone is a component of palliative therapy

Duration of approval: 1 year

Continuation of testosterone meets the definition of medical necessity for members meeting initiation criteria OR if previously approved by Florida Blue.

Duration of approval: 1 year

Subcutaneous pellet implants of estrogen or estrogen combined with testosterone are considered experimental or investigational and do not meet the definition of medically necessary.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Dosing is highly variable and dependent upon dosage form. Please refer to product label.

PRECAUTIONS:

Contraindications

• 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 who may become pregnant

• Individuals with serious cardiac, hepatic or renal disease

Precautions/Warnings

• Acute intermittent porphyria

• Children – use drug with great caution; may affect bone maturation

• Gynecomastia

• Do not interchange products because of their differences in duration of action

• Virilization

BILLING/CODING INFORMATION:

Oral and topical products are billed pursuant to a prescription through the pharmacy claims system. The following codes may be used to describe parenteral products:

HCPCS Coding:

J1071

Injection, testosterone cypionate, 1 mg

J3121

Injection, testosterone enanthate, 1 mg

J3145

Injection, testosterone undecanoate, 1 mg

S0189

Testosterone Pellet, 75mg

J3490

Unclassified drug

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C50.011 – C50.019

Malignant neoplasm of female breast

C50.111 – C50.119

Malignant neoplasm of female breast

C50.211 – C50.219

Malignant neoplasm of female breast

C50.311 – C50.319

Malignant neoplasm of female breast

C50.411 – C50.419

Malignant neoplasm of female breast

C50.511 – C50.519

Malignant neoplasm of female breast

C50.611 – C50.619

Malignant neoplasm of female breast

C50.811 – C50.819

Malignant neoplasm of female breast

C50.911 – C50.919

Malignant neoplasm of female breast

E29.0

Testicular hyperfunction

E89.5

Postprocedural testicular hypofunction

E29.1

Testicular hypofunction

E30.0

Delayed puberty

E89.5

Postprocedural testicular hypofunction

R62.50

Unspecified lack of expected normal physiological development in childhood

R62.51

Failure to thrive (child)

R62.59

Other lack of expected normal physiological development in childhood

R62.0

Delayed milestone in childhood

Z00.3

Encounter for examination for adolescent development state

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: TESTOSTERONE pellets (Testopel), (L33412) located at fcso.com. No National Coverage Determination (NCD) was found at the time of the last guideline revised date.

DEFINITIONS:

Cryptorchidism: is the absence of one or both testes from the scrotum. This usually represents failure of the testes to move, or "descend," during fetal development from an abdominal position, through the inguinal canal, into the ipsilateral scrotum.

Hypogonadism: is a term for decreased functional activity of the gonads. The gonads (ovaries or testes) produce hormones (testosterone, estradiol, antimullerian hormone, progesterone, inhibin B, activin) and gametes (eggs or sperm).

Orchidectomy: is any action, surgical, chemical, or otherwise, by which a male loses the functions of the testicles or a female loses the functions of the ovaries.

Orchitis: is a condition of the testes involving inflammation. It can also involve swelling and frequent infection.

RELATED GUIDELINES:

Subcutaneous Hormone Pellet Implants, 02-10000-12
Gonadotropin Releasing Hormone Analogs and Antagonists, 09-J0000-48

OTHER:

None applicable.

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2013 [cited 2013 Aug 2]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2013 [cited 20013 Aug 2]. Available from: http://www.clinicalpharmacology.com/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2013 Aug 2]. Available from: http://www.thomsonhc.com/.
  4. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2013 [cited 2013 Aug 2]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  5. Styne DM, Grumbach MM. Puberty: ontogeny, neuroendocrinology, physiology, and disorders. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR, eds. Williams Textbook of Endocrinology. Philadelphia, PA: Saunders Elsevier; 2011:1054–1201.
  6. Dohle GR, Arver S, Bettocchi C, et al. Guidelines on male hypogonadism. European Association of Urology; 2012.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/09/13.

GUIDELINE UPDATE INFORMATION:

06/15/10

New Medical Coverage Guideline.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

10/15/11

Review and revision to guideline; consisting of updating references.

10/15/12

Review and revision to guideline; consisting of reformatting position statement and updating coding and references.

03/15/13

Revision to guideline; consisting of further defining testosterone deficiency.

11/15/13

Review and revision to guideline; consisting of changing name of MCG to Hormone Replacement, revision and reformatting of position statement, precautions/warnings, decision tree.

06/15/14

Revision to guideline; consisting of adding continuation criteria to position statement.

09/15/14

Revision to guideline; consisting of position statement, HCPCS coding

01/01/15

Revision to guideline; consisting of annual HCPCS coding update

10/01/15

Revision to guideline; consisting of updating Billing/Coding section and Program Exceptions Section.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: August 18, 2017: 07:56 PM