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DESCRIPTIONGoserelin (Zoladex®) is a synthetic analog of luteinizing hormone-releasing hormone (LHRH or GnRH). It acts as a potent inhibitor of pituitary gonadotropin secretion. In males, goserelin (Zoladex®) causes an initial increase in serum LH and FSH values with subsequent increases in serum levels of testosterone. Chronic administration leads to sustained suppression of pituitary gonadotropins; testosterone serum levels consequently fall into the range normally seen in surgically castrated men. This leads to accessory sex organ regression. In females, a similar down-regulation of the pituitary gland by chronic exposure to goserelin (Zoladex®) leads to suppression of gonadotropin secretion, a decrease in serum estradiol to levels consistent with the postmenopausal state, and would be expected to lead to a reduction of ovarian size and function, reduction in the size of the uterus and mammary gland and a regression of sex hormone-responsive tumor, if present.
Goserelin (Zoladex®) is FDA approved for the following indications:
POLICYGoserelin (Zoladex®) is considered medically necessary for the following disease states:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
POLICY HISTORY5/1999: Approved by Pharmacy & Therapeutics (P & T) Committee
1/30/2002: Prior Authorization and Managed Care Requirements deleted
2/14/2002: Investigational definition added
3/26/2002: Endometrial thinning agent indication added
4/24/2002: Type of Service and Place of Service deleted. Code Reference section completed.
11/13/2002: Cancer endometrium added Policy section, Code Reference section updated
10/26/2005: Non-covered table deleted, CPT-4 codes 83727, 90782 deleted. ICD-9 diagnosis codes 189.3, 198.1 and 233.9 deleted. ICD-9 diagnosis codes 173.5, 232.5 and 233.2 added. Verbiage changed on ICD-9 codes 175.0, 182.0, 198.82 and 617.0. HCPCS codes J9202 and S9560 added
10/30/2006: Dosing, off-label, and investigational information removed
11/3/006: Code reference updated. Deleted ICD-9 code 182.0
08/25/2015: Code Reference section updated for ICD-10.
05/26/2016: Policy number added. Policy Guidelines updated to add medically necessary definition.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)American Hospital Formulary Services 1998
Fact and Comparisons, October, 1997
Micromedex, 1998, 2006
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.