LCD/NCD MedicationsL29215-LCD

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Local Coverage Determination (LCD) for Luteinizing Hormone- Releasing

Hormone (LHRH) Analogs (L29215)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29215

LCD Title Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

Contractor's Determination Number J1950

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 05/07/2010

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50

Indications and Limitations of Coverage and/or Medical Necessity

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).

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:

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

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

• 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:

• 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:

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

• 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.

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

• 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:

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

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

• Palliative treatment of advanced prostate cancer

Limitations

Leuprolide Acetate (J1950, J9217, J9218 and J9219)

• 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.

• 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.

• 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.

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

Goserelin Acetate (J9202)

• 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.

• 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)

• 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.

• 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.

Coverage Topic

Prescription Drugs

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.

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.

99999 Not Applicable

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 - 218.9 SUBMUCOUS LEIOMYOMA OF UTERUS - LEIOMYOMA OF UTERUS UNSPECIFIED

280.0 IRON DEFICIENCY ANEMIA SECONDARY TO BLOOD LOSS (CHRONIC)

285.1 ACUTE POSTHEMORRHAGIC ANEMIA

617.0 - 617.9 ENDOMETRIOSIS OF UTERUS - ENDOMETRIOSIS SITE UNSPECIFIED

For J9217 the following ICD-9 CM codes are covered

174.0 - 174.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 - 175.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

185 MALIGNANT NEOPLASM OF PROSTATE

218.0 - 218.9 SUBMUCOUS LEIOMYOMA OF UTERUS - 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 - 617.9 ENDOMETRIOSIS OF UTERUS - 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 - 174.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 - 175.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

185 MALIGNANT NEOPLASM OF PROSTATE

218.0 - 218.9 SUBMUCOUS LEIOMYOMA OF UTERUS - 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 - 617.9 ENDOMETRIOSIS OF UTERUS - 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

Any diagnosis that does not appear in the ICD-9 codes that support medical necessity section of this LCD and specifically for the following:

J9218 (this HCPCS is non-covered as it is self administered)

185 MALIGNANT NEOPLASM OF PROSTATE

233.4 CARCINOMA IN SITU OF PROSTATE

V10.46 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

See ICD-9 codes that do not support medical necessity

General Information

Documentations Requirements

Medical record documentation maintained by the physician must indicate the medical necessity for using any of these drugs. Documentation of the symptoms, the administration and dosage of the drug should be found in the patient’s medical record. This information is usually found in the history and physical and/or office/progress notes. 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: The FDA label states that a one-month trial of oral iron should be considered prior to initiation of leuprolide therapy. 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.

Appendices

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

Leuprolide Acetate Implant (J9219) for the treatment of carcinoma of the prostate. Subcutaneous implant, one implant per 12 months (120mcg/day). When one implant is removed another may be inserted.

Leuprolide Acetate (for depot suspension) (J9217) for the treatment of prostate cancer, intramuscular 7.5mg once a month, 22.5mg once every three months (eighty four days), or 30 mg every four months or 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. Give 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, 3.6 mg once every 28 days.

Goserelin acetate implant (J9202) for the treatment of prostate cancer, 10.8mg once every 3 months (12 weeks). Histrelin implant (J9225) for the treatment of prostate cancer. 50mg once a year. When one implant is removed another implant may be inserted.

Sources of Information and Basis for Decision

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,

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 08/01/2010

Revision History Number 1

Revision History Explanation Revision Number 1 Start Date of Comment Period:N/A

Start Date of Notice Period:06/01/2010 and 08/01/2010 Revision Effective Date 05/07/2010

LCR B2010-044 LCR B2010-057

May 2010 Update

July 2010 Update

Explanation of Revision: This LCD is being revised to remove all language pertaining to the least costly alternative (LCA) provision discussed in the LCD. This revision is done per guidance from CMS. The effective date of this revision is based on process date. (Although the effective date of the LCD revision is 5/7/10; the effective date of the CMS instruction to contractors for removal of the LCA provision was 4/19/10.)

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29215) replaces LCD L5769 as the policy in notice. This document (L29215) is effective on 02/02/2009.

Reason for Change