Goserelin acetate (J9202), leuprolide acetate (J9217 and J9219), triptorelin acetate (J3315) and histrelin acetate (J9225) are synthetic Luteinizing Hormone-Releasing Hormone (LHRH) analogs whose labeled indications include palliative treatment of advanced carcinoma of the prostate. All offer an alternative treatment of advanced prostate cancer when orchiectomy and/or estrogen administration are either not indicated or are unacceptable to the patient.
Goserelin acetate is also indicated for treatment of breast cancer, endometriosis and for endometrial thinning to treat dysfunctional uterine bleeding. Leuprolide acetate (J9217 and J9219) is also indicated for treatment of breast cancer and leuprolide acetate (J1950) is indicated for treatment of uterine leiomyomata and endometriosis. Histrelin acetate (J9226) was Food and Drug Administration (FDA) approved for treatment of Central Precocious Puberty (CPP) effective May 3, 2007.
To be covered under Medicare, use of a drug or biological must be safe and effective and otherwise reasonable and medically necessary. Drugs or biologicals approved for marketing by the FDA are considered safe and effective for purposes of this requirement when used for approved indications as specified on the labeling. Medical necessity is determined by the contractor at the local level.
Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug, and made good faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in the attached article. Reference to national policy:Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.
Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.
Note: This LCD and the related Article do NOT describe drug and biological coverage under the Medicare Part D benefit.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 18X, 21X, 22X, 23X, 73X, 75X, 77X, 83X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.
025X, 0636
CPT/HCPCS Codes
Note:
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
J1950
Injection, leuprolide acetate (for depot suspension), per 3.75 mg
J3315
Injection, triptorelin pamoate, 3.75 mg
J9202
Goserelin acetate implant, per 3.6 mg
J9217
Leuprolide acetate (for depot suspension), 7.5 mg
J9219
Leuprolide acetate implant, 65 mg
J9225
Histrelin implant (Vantas), 50 mg
J9226
Histrelin implant (Supprelin LA), 50 mg
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS code J1950:
Covered for:
218.0218.2
Uterine leiomyoma
218.9
Uterine leiomyoma, unspecified
617.0617.6
Endometriosis
617.8617.9
Endometriosis
Medicare is establishing the following limited coverage for CPT/HCPCS code J3315:
Covered for:
185
Malignant neoplasm of prostate
198.5
Malignant secondary neoplasm of bone and bone marrow
V10.46
History of malignancy of the prostate
Medicare is establishing the following limited coverage for CPT/HCPCS code J9202:
Covered for:
174.0174.6
Breast cancer
174.8174.9
Breast cancer
175.0
Breast cancer
175.9
Breast cancer
185
Malignant neoplasm of prostate
196.3
Secondary and unspecified malignant neoplasm of lymph nodes, axilla and upper limb
198.5
Malignant secondary neoplasm of bone and bone marrow
617.0617.6
Endometriosis
617.8617.9
Endometriosis
626.8
Dysfunctional uterine bleeding
V10.3
History of cancer of the breast
V10.46
History of malignancy of the prostate
Medicare is establishing the following limited coverage for CPT/HCPCS codes J9217 and J9219:
Covered for:
174.0174.6
Breast cancer
174.8174.9
Breast cancer
175.0
Breast cancer
175.9
Breast cancer
183.0
Malignant neoplasm of ovary
185
Malignant neoplasm of prostate
196.3
Secondary and unspecified malignant neoplasm of lymph nodes, axilla and upper limb
198.5
Malignant secondary neoplasm of bone and bone marrow
V10.3
History of cancer of the breast
V10.46
History of malignancy of the prostate
Medicare is establishing the following limited coverage for CPT/HCPCS code J9225:
Covered for:
185
Malignant neoplasm of prostate
198.5
Malignant secondary neoplasm of bone and bone marrow
V10.46
History of malignancy of the prostate
Medicare is establishing the following limited coverage for CPT/HCPCS code J9226:
Covered for:
259.1
Precocious sexual development and puberty, not elsewhere classified.
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.