LCD/NCD Portal

L28901

 

LUTEINIZING HORMONE-RELEASING HORMONE (LHRH) ANALOGS

 

 

05/07/2010

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• In order to be covered by Medicare, an injectable drug must be safe and effective and otherwise reasonable and necessary.

• Drugs that are used according to FDA approval are considered safe and effective.

• Medical necessity is, however, determined by the Carrier at the local level.

• Additional LHRH drugs will be automatically included in this LCD once released and approved by the FDA for the indications listed below.

Indications

• Leuprolide Acetate (J1950, J9217, J9218 and J9219) is FDA approved for the following indications:

o Anemia due to uterine leiomyomas (treatment): preoperative hematologic improvement of patients with anemia caused by uterine leiomyomas (fibroids), in conjunction with iron supplement therapy.

o Carcinoma, prostatic (treatment): palliative treatment of advanced prostatic cancer, especially as an alternative to orchiectomy or estrogen administration.

o Endometriosis (treatment): management of endometriosis, including pain relief and reduction of endometriotic lesions.

• In addition to the FDA approved indications, Medicare will cover Leuprolide Acetate for the following off-labeled indication:

o Carcinoma, breast (treatment): palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.

 

• Goserelin Acetate (J9202) is indicated for the following FDA approved indications:

o Carcinoma, breast (treatment): as the 3.6mg implant, for the palliative treatment of advanced breast carcinoma in pre- and perimenopausal females.

o Carcinoma, prostatic (treatment): palliative treatment of advanced prostatic carcinoma.

 Goserelin is indicated for use in combination with radiotherapy and flutamide for the treatment of locally confined Stage T2b-T4 (Stage B2-C) prostatic cancer.

o Endometrial thinning: as the 3.6 mg implant, endometrial thinning agent prior to endometrial ablation.

o Endometriosis (treatment): as the 3.6mg implant, management of endometriosis, including treatment of pelvic pain and reduction in the size and number of lesions.

 

• Triptorelin Pamoate (J3315) is indicated for the following FDA approved indication:

o Carcinoma, prostatic (treatment): palliative treatment of advanced prostatic carcinoma.

 

• Histrelin Acetate implant (J9225) is indicated for the following FDA approved indication:

o Palliative treatment of advanced prostate cancer.

Limitations

• Leuprolide Acetate (J1950, J9217, J9218 and J9219)

o For anemia due to uterine leiomyomas, some patients respond to iron supplementation alone.

 A 1-month trial period with iron should be considered prior to initiation of leuprolide therapy.

 Leuprolide may then be initiated if the response to iron is inadequate.

o Leuprolide Acetate implant (J9219) continually releases Leuprolide Acetate for 12 months.

 It would not be reasonable to use this drug formulation for a patient whose life expectancy is not at least 12 months.

o If a patient has had any of the other forms of GnRH, implantation of J9219 should be delayed until the therapeutic span of these forms of GnRH has ended.

 If the patient has had a bilateral orchiectomy, he does not need nor should he get any form of GnRH.

o Leuprolide Acetate, 1mg (J9218) is self-administered and therefore not covered.

 

• Goserelin Acetate (J9202)

o For treatment of breast cancer, the 10.8mg implant should not be used for this indication because it has not been shown to suppress serum estradiol reliably.

o For the treatment of endometriosis, the 10.8 mg implant should not be used for this indication because it has not been shown to suppress estradiol reliably.

 

• Histrelin Implant (J9225)

o The Histrelin Implant (J9225) is designed to release Histrelin continuously for 12 months.

 It would not be reasonable to use this drug formulation for a patient whose life expectancy is not at least 12 months.

o If a patient has had any of the other forms of GnRH, implantation of J9225 should be delayed until the therapeutic span of these forms of GnRH has ended.

 If the patient has had a bilateral orchiectomy, he does not need nor should he get any form of GnRH.

 

 

Coding Information

 

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.

 

13x Hospital Outpatient

85x Critical Access Hospital

 

 

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.

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

11981 INSERTION, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT

11982 REMOVAL, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT

11983 REMOVAL WITH REINSERTION, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT

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

J9218 LEUPROLIDE ACETATE, PER 1 MG

J9219 LEUPROLIDE ACETATE IMPLANT, 65 MG

J9225 HISTRELIN IMPLANT (VANTAS), 50 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

For J1950 the following ICD-9 CM codes are covered

 

218.0 SUBMUCOUS LEIOMYOMA OF UTERUS

218.1 INTRAMURAL LEIOMYOMA OF UTERUS

218.2 SUBSEROUS LEIOMYOMA OF UTERUS

218.9 LEIOMYOMA OF UTERUS UNSPECIFIED

280.0 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

285.1 ACUTE POSTHEMORRHAGIC ANEMIA

617.0 ENDOMETRIOSIS OF UTERUS

617.1 ENDOMETRIOSIS OF OVARY

617.2 ENDOMETRIOSIS OF FALLOPIAN TUBE

617.3 ENDOMETRIOSIS OF PELVIC PERITONEUM

617.4 ENDOMETRIOSIS OF RECTOVAGINAL SEPTUM AND VAGINA

617.5 ENDOMETRIOSIS OF INTESTINE

617.6 ENDOMETRIOSIS IN SCAR OF SKIN

617.8 ENDOMETRIOSIS OF OTHER SPECIFIED SITES

617.9 ENDOMETRIOSIS SITE UNSPECIFIED

 

 

For J9217 the following ICD-9 CM codes are covered

 

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

185 MALIGNANT NEOPLASM OF PROSTATE

218.0 SUBMUCOUS LEIOMYOMA OF UTERUS

218.1 INTRAMURAL LEIOMYOMA OF UTERUS

218.2 SUBSEROUS LEIOMYOMA OF UTERUS

218.9 LEIOMYOMA OF UTERUS UNSPECIFIED

233.0 CARCINOMA IN SITU OF BREAST

233.4 CARCINOMA IN SITU OF PROSTATE

280.0 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

285.1 ACUTE POSTHEMORRHAGIC ANEMIA

617.0 ENDOMETRIOSIS OF UTERUS

617.1 ENDOMETRIOSIS OF OVARY

617.2 ENDOMETRIOSIS OF FALLOPIAN TUBE

617.3 ENDOMETRIOSIS OF PELVIC PERITONEUM

617.4 ENDOMETRIOSIS OF RECTOVAGINAL SEPTUM AND VAGINA

617.5 ENDOMETRIOSIS OF INTESTINE

617.6 ENDOMETRIOSIS IN SCAR OF SKIN

617.8 ENDOMETRIOSIS OF OTHER SPECIFIED SITES

617.9 ENDOMETRIOSIS SITE UNSPECIFIED

V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

For J9219 the following ICD-9 CM codes are covered

 

185 MALIGNANT NEOPLASM OF PROSTATE

233.4 CARCINOMA IN SITU OF PROSTATE

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

For J9202 the following ICD-9 CM codes are covered

 

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

185 MALIGNANT NEOPLASM OF PROSTATE

218.0 SUBMUCOUS LEIOMYOMA OF UTERUS

218.1 INTRAMURAL LEIOMYOMA OF UTERUS

218.2 SUBSEROUS LEIOMYOMA OF UTERUS

218.9 LEIOMYOMA OF UTERUS UNSPECIFIED

233.0 CARCINOMA IN SITU OF BREAST

233.4 CARCINOMA IN SITU OF PROSTATE

280.0 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

285.1 ACUTE POSTHEMORRHAGIC ANEMIA

617.0 ENDOMETRIOSIS OF UTERUS

617.1 ENDOMETRIOSIS OF OVARY

617.2 ENDOMETRIOSIS OF FALLOPIAN TUBE

617.3 ENDOMETRIOSIS OF PELVIC PERITONEUM

617.4 ENDOMETRIOSIS OF RECTOVAGINAL SEPTUM AND VAGINA

617.5 ENDOMETRIOSIS OF INTESTINE

617.6 ENDOMETRIOSIS IN SCAR OF SKIN

617.8 ENDOMETRIOSIS OF OTHER SPECIFIED SITES

617.9 ENDOMETRIOSIS SITE UNSPECIFIED

V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

For J3315 the following ICD-9 CM codes are covered

 

185 MALIGNANT NEOPLASM OF PROSTATE

233.4 CARCINOMA IN SITU OF PROSTATE

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

For J9225 the following ICD-9 CM codes are covered

 

185 MALIGNANT NEOPLASM OF PROSTATE

233.4 CARCINOMA IN SITU OF PROSTATE

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

Diagnoses that Support Medical Necessity

 

See ICD-9 –CM codes that support medical necessity

 

 

ICD-9 Codes that DO NOT Support Medical Necessity

 

185 MALIGNANT NEOPLASM OF PROSTATE

233.4 CARCINOMA IN SITU OF PROSTATE

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

 

 

Documentation Requirements

 

• Medical record documentation maintained by the physician must indicate the medical necessity for using any of these drugs.

o Documentation of the symptoms, the administration and dosage of the drug should be found in the patient’s medical record.

o This information is usually found in the history and physical and/or office/progress notes.

o This documentation must be available upon request.

• For the two drugs that are delivered over a 12-month period (J9219 and J9225), the medical record must document and justify the physician’s belief that the patient’s life expectancy is at least 12 months.

• For patients being treated for pre-operative hematologic improvement of anemia caused by uterine leiomyomas (fibroids) in conjunction with oral iron supplement therapy:

o The FDA label states that a one-month trial of oral iron should be considered prior to initiation of leuprolide therapy.

o For this LCD, Medicare would expect the provider to take into consideration the condition of the patient (e.g., degree of anemia, size of the fibroid etc.) and clearly document in the medical record the rationale for why the one month trial of oral iron would or would not be medically reasonable.

Utilization Guidelines

Frequency and Dosing:

• Leuprolide Acetate (for depot suspension) (J1950), for the treatment of endometriosis and uterine leiomyomas. 3.75mg monthly or 11.25mg once every 3 months.

o Treatment should not exceed three months for anemia due to uterine leiomyomas and six months for endometriosis.

o Retreatment is not recommended.

• Leuprolide Acetate Implant (J9219) for the treatment of carcinoma of the prostate.

o Subcutaneous implant, one implant per 12 months (120mcg/day).

o When one implant is removed another may be inserted.

• Leuprolide Acetate (for depot suspension) (J9217) for the treatment of prostate cancer.

o Intramuscular 7.5mg once a month.

o 22.5mg once every three months (eighty four days).

o 30 mg every four months.

o 45mg once every 6 months.

 Leuprolide acetate (J9218) 1mg/day for the treatment of prostate cancer is non-covered as this drug is self-administered.

• Triptorelin pamoate (J3315) for the treatment of prostate cancer.

o 3.75mg monthly or 11.25 mg once every three months (12 weeks).

• Goserelin acetate implant (J9202) for the treatment of prostate cancer, breast cancer and endometriosis:

o 3.6 mg once every 28 days.

• Goserelin acetate implant (J9202) for the treatment of prostate cancer.

o 10.8mg once every 3 months (12 weeks).

• Histrelin implant (J9225) for the treatment of prostate cancer.

o 50mg once a year.

o When one implant is removed another implant may be inserted.

Treatment Logic

• Leuprolide Acetate (J1950, J9217, J9218 and J9219), goserelin acetate (J9202), triptorelin (J3315) and histrelin acetate implant (J9225) are synthetic luteinizing hormone-releasing hormone (LHRH) agonists, analogs of the naturally occurring gonadotropin-releasing hormone (GnRH).

 

 

Sources of Information and Basis for Decision

 

FCSO LCD 29215, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs, 05/07/2010. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Mahutte, N., Aydin, A. (2003). Medical management of endometriosis-associated pain. Obstetrics and Gynecology Clinics, 30(1), W.B. Saunders Company. Retrieved from http://home.mdconsult.com on 12/16/2005.

 

Other Intermediaries Local Coverage Determinations.

 

Package insert for ViadurÒ (leuprolide acetate implant). Retrieved from www.drugs@FDA.gov

 

Package insert for VantasÒ (histrelin acetate implant). Retrieved from http://www.vantasimplant.com and http://www.drugs.com on 12/12/2005.

 

The Association of Community Cancer Centers (2005). Leuprolide (systemic); Goserelin (systemic); Triptorelin (systemic). Retrieved from http://www.acc-cancer.org on 10/27/2005.

 

Rivera, J.A., Christopoulos, S., Small, D. and Trifiro, M. (2004). Clinical Case Seminar. Hormonal manipulation of benign metastasizing leiomyomas: report of two cases and review of literature. Journal of Clinical Endocrinology and Metabolism, 89 (7). The Endocrine Society. Retrieved from http://home.mdconsult.com on 12/16/2005.

 

Zelnak, A., O’Regan, R. (2004). Goserelin was as effective as chemotherapy±goserelin for treatment of ER-positve, but not ER-negative, breast cancer. Evidence-based Obstetrics & Gynecology,

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

 

CMS LCD L28901 LUTEINIZING HORMONE-RELEASING HORMONE (LHRH) ANALOGS