Subject Luteinizing Hormone Releasing Hormone

Policy Number 98 8.8

Description Goselerin Acetate (J9202) and Leuproide Acetate (J9217) are synthetic luteinizing hormone-re1easing hormone (LHRH) analogs indicated in the palliative treatment of advanced carcinoma of the prostate. Both offer an alternative treatment of prostatic cancer when orchiectomy or estrogen administration are either not indicated or are unacceptable to the patient.

Policy Type Local Medical Review Policy

HCPCS Section Chemotherapy Drugs

HCPCS Codes J9217 Leuprolide Acetate

J9202 Gloserelin Acetate

HCFA's

National Poilcy §1862 (a)(1)(A) of the Social Security Act specifies that Medicare will not pay for items or services which are not reasonable and necessary for the treatment or diagnosis of illness or injury or to improve the functioning of a malformed body member.
 

§1879 of the Act describes the conditions under which a Medicare supplier and/or a Medicare beneficiary may be relieved of 1iability on assigned claims for changes denied under §1862(a)(I )(A)
 

Indications & Limitations of Coverage

In order to be covered by Medicare, an injectible drug must be safe and effective, and otherwise reasonable and necessary. Drugs which are used according to FDA approval are considered safe and effective. Goserelin acetate and leuprolide acetate are administered by slightly different delivery systems. The former is given by injecting drug-containing beads below the abdominal skin and the latter is given as an intramuscular injection. Although we acknowledge that the differences in administration methods may cause a preference or even, in some isolated cases a specific need to use one drug rather than the other, clinical evidence and FDA indications do not support differential effectiveness of one over the other for prostate cancer treatment. Therefore, for approved clinical indications, Medicare will only pay for the dosage administered for either of these drugs at the rate approved for the lower priced of the two. It is acknowledged that there may be true medical indications (such as drug tolerance) requiring the use of one drug over the other. However, if  there are such indications for an individual patient, they must be documented with each claim for the more expensive drug. Such  documentation must include an invoice for the more expensive drug, as well as a statement of the reason for the use of this drug over the other.

It is also understood that patients may have preferences for one form of administration (delivery system) over the' other. Since there is no medical  reason for the delivery system per se, if the patient desires the form of medication with the more expensive delivery' system, and if the patient  signs an appropriate advanced beneficiary notice explaining that the  likelihood of denial; the patient may he charged for the difference between the Medicare allowance of the medication with the more expensive delivery system and the Medicare allowance of the medicine with the lower priced delivery system.

Covered

ICD-9 CM Codes

185.0 Malignant neoplasm of prostate
198~82 Secondary malignancies of^. genital organs
233.4 Carcinoma in situ of prostate

Reasons for  Noncoverage

Medicare will not cover the excess expense for the more expensive of  these two medications which have two delivery systems but the same overall clinical response. Any charge for the more expensive delivery system which does not demonstrate reasonableness and necessity as described above will be paid as the lower-priced drug. The patient will not be responsible for the difference in price between the two drugs without an acceptable advanced beneficiary notification. Any administration made of either of these drugs in the absence of an acceptable clinical diagnosis (see above section) will be denied as not reasonable and necessary.

Any claim submitted with an incorrect ICD-9 CM code, or with an  abridged code (according to the latest. edition) will be denied as incomplete.
 

Noncovered

ICD-9 CM Code(s)

Any diagnosis not listed in the "Covered ICD-9CM Codes" section Above.

Sources of Filicor Marco in Practical Theraputics: "Gonadotrophin-Releasing Hormone Agonists--A guide to Use and Selection "; Adis International United, 1994.

Ellis, William; Higano, Celestia S.;Lange, Paul H; RusseI1, Kenneth

Preliminary Communication; "Intermittent Androgen Suppression withLeuprolide and Flutamide for Prostate Cancer: A Pilot Study", Division of Oncology, Department of Medicine Department of Urology and
Department of Radiation Oncology, University of' Washington Seattle;  July 29, 1996. Cassileth BR, Sologway MS, Vogelzang,NJ,Schellhammer,PS, Seidmon, EJ, Hait, HI, Kennealey GT;

Urology 33 (SUPPL); "Patients' Choice of Treatment in Stage D Prostate Cancer";  1989. Cassileth BR, SoIoway,MS, Vogelzang NJ, Chou JM, Schelhammer PF, Seidmon EJ, and Kennealey GT;

Qual Life Res; "Quality of Life and Psychosocial Status in Stage D Prostate Cancer", Zoladex Prostate Cancer Study Group"; 1992.

Technology Advisory Committee, February 4-5, 1997

Other Carriers' Local Medical Review Policies

Information

Coding Guidelines

Use J9202 to indicate goserelin acetate and J9217 to indicate leupro1ide  acetate. Medicare wi1l pay for 95% of the AWP of the lesser-priced medication.
 
 

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