Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (L30479)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L30479

LCD Title
Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

Contractor's Determination Number
INJ-039

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region



Original Determination Effective Date
For services performed on or after 03/18/2010

Original Determination Ending Date


Revision Effective Date
For services performed on or after 07/01/2011

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act section 1862(a) (1) (A). This section allows coverage and payment for those services that are considered medically reasonable and necessary.

Title XVIII of the Social Security Act section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Title XVIII of the Social Security Act section 1862(a) (1) (D). This section excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act section 1861(t). This section defines coverage of drugs and biologicals.

Title XVIII of the Social Security Act section 1888(e)(20(A)(iii)(11). This section includes chemotherapy and chemotherapy administration services on the list of items excluded from payment to skilled nursing facilities as routine service costs.

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 8: 50.5 Drugs and Biologicals [Coverage of SNF services] 70 Medical and Other Health Services Furnished to SNF Patients.

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 12:40.10 Drugs and Biologicals [Coverage of Comprehensive Outpatient Rehabilitation Facility services].

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15: 50-50.1 Drugs and Biologicals and 50.4.5 Unlabeled Use for Anti-Cancer Drugs.

CMS Publication 100-4; Medicare Claims Processing Manual, Chapter 12, 30.5 Medicare Coverage for Chemotherapy Administration.

CMS Publication 100-4; Medicare Claims Processing Manual, Chapter 17, 20 Payment Allowance Limits for Drugs and Biologicals.

CMS Publication 100-8, Chapter 13: 5.4 Medicare Program Integrity Manual LCD Requirements That Alternative Service Be Tried First
Indications and Limitations of Coverage and/or Medical Necessity
Goserelin acetate (J9202), leuprolide acetate (J9217, J9218, J9219, and J1950), triptorelin (J3315), histrelin implants (J9225, J9226), and histrelin acetate (J1675) are synthetic luteinizing hormone-releasing hormone (LHRH) agonists, analogs of the naturally occurring gonadotropin releasing hormone (GnRH) indicated in one or more of the following:
1. palliative treatment of advanced carcinoma of the prostate
2. carcinoma of the breast
3. certain gynecological conditions
4. precocious puberty

(Note that "advanced" does not necessarily entail either "symptomatic" or "metastatic.") Some of these offer an alternative treatment for prostatic cancer when neither orchiectomy nor estrogen administration is indicated or acceptable to the patient. Additional GnRH analogs are currently seeking approval, and this LCD will apply to those, once approved.

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.

Goserelin acetate is administered by a slightly different delivery system than triptorelin and leuprolide acetate. The former is given by injecting drug-containing beads below the abdominal skin and the latter two are given as an intramuscular injection. WPS acknowledges 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.

J1950 (Leuprolide acetate for depot suspension)
1. Is indicated for uterine leiomyomas only when it is given "concomitantly with iron therapy for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata." (Drug Facts and Comparisons, p 2077.)

J9202 (Goserelin acetate implant, per 3.6 mg)
1. For the indication of dysfunctional uterine bleeding is valid only when J9202 is used as a single injection prior to endometrial ablation.

2. According to the 2004 USP DI, "Goserelin as the 3.6 mg implant is indicated for the palliative treatment of advanced breast cancer in pre- and post menopausal females. The 10.8 mg implant should not be used for this indication because it has not been shown to suppress estradiol reliably."

3. The 2004 USP DL states further, "Goserelin , as the 3.6-mg implant, is indicated for the management of endometriosis, including treatment of pelvic pain and reduction in the size and number of lesions. The 10.8-mg implant should not be used for this indication because it has not been shown to suppress serum estradiol reliably."

J9217 (Leuprolide acetate injection, per 7.5 MG)
1. Indicated for palliative and adjuvant treatment of prostate cancer and is available as an injectable suspension that may be administered subcutaneously, or as a long-acting depot formulation, on a monthly, every three months or every four months basis. The usual dosage of the depot form of leuprolide acetate is 7.5 mg per month, 22.5 mg per three months, or 30 mg per four months, or 45 mg per 6 months.

J9219 (Leuprolide Acetate implant is a once-yearly implant, 65 mg per year)
1. Indicated for palliative and adjuvant treatment of prostate cancer. It is a drug-filled, miniature titanium implant that is placed under the skin, usually in the inner aspect of the upper arm via an in-office surgical procedure. The leuprolide acetate implant delivers approximately 120 micrograms of leuprolide acetate per day over 12 months. After 12 months the implant may be removed or replaced. The physician should reasonably expect the life expectancy of the patient to be longer than one year.

J3315 (Triptorelin pamoate, per 3.75 MG)
1. Indicated in the palliative and adjuvant treatment of prostate cancer. The recommended dose of treorelin pamoate depot is 3.75 mg incorporated in a depot formulation and administered monthly as a single intramuscular injection. The recommended dose of triptorelin pamoate LA is 11.25 mg incorporated in a long acting formulation administered every twelve weeks (approximately 84 days) as a single intramuscular injection.

Response to all forms of LHRH analogs should be monitored periodically throughout the 12-month period by measuring serum concentrations of prostate-specific antigen (PSA) and/or testosterone.

Patients who receive an LHRH analog implant should continue to be seen by the managing physician in follow-up at least every three (3) to four (4) months.

J9225 (Histrelin acetate implant, per 50 MG)
1. Indicated for the palliative and adjuvant treatment of prostate cancer. A hydrogel implant containing histrelin is subcutaneously inserted usually in the upper, inner arm and delivers the drug continuously for 12 months. The usual dosage of histrelin acetate in men is 50 mg (implanted subcutaneously) every 12 months. The implant must be removed or replaced after the 12-month treatment. The physician should reasonably expect the life expectancy of the patient to be longer than one year.

Histrelin acetate may also be used of the diagnosis of precocious puberty for children with disability who are covered under Medicare.


 

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.

013x Hospital Outpatient
021x Skilled Nursing - Inpatient (Including Medicare Part A)
023x Skilled Nursing - Outpatient
085x 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.

Revenue codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes.

0250 Pharmacy - General Classification
0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

11981INSERTION, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT
11982REMOVAL, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT
11983REMOVAL WITH REINSERTION, NON-BIODEGRADABLE DRUG DELIVERY IMPLANT
96402CHEMOTHERAPY ADMINISTRATION, SUBCUTANEOUS OR INTRAMUSCULAR; HORMONAL ANTI-NEOPLASTIC
J1675INJECTION, HISTRELIN ACETATE, 10 MICROGRAMS
J1950INJECTION, LEUPROLIDE ACETATE (FOR DEPOT SUSPENSION), PER 3.75 MG
J3315INJECTION, TRIPTORELIN PAMOATE, 3.75 MG
J9202GOSERELIN ACETATE IMPLANT, PER 3.6 MG
J9217LEUPROLIDE ACETATE (FOR DEPOT SUSPENSION), 7.5 MG
J9218LEUPROLIDE ACETATE, PER 1 MG
J9219LEUPROLIDE ACETATE IMPLANT, 65 MG
J9225HISTRELIN IMPLANT (VANTAS), 50 MG
J9226HISTRELIN IMPLANT (SUPPRELIN LA), 50 MG

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.
J1950 (Injection, leuprolide acetate (for depot suspension), per 3.75 mg)

174.0 - 174.6MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST
174.8 - 174.9MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST
175.9MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
218.0 - 218.2SUBMUCOUS LEIOMYOMA OF UTERUS - SUBSEROUS LEIOMYOMA OF UTERUS
218.9LEIOMYOMA OF UTERUS UNSPECIFIED
617.0 - 617.6ENDOMETRIOSIS OF UTERUS - ENDOMETRIOSIS IN SCAR OF SKIN
617.8 - 617.9ENDOMETRIOSIS OF OTHER SPECIFIED SITES - ENDOMETRIOSIS SITE UNSPECIFIED
V10.3PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST
J3315 (Injection, triptorelin pamoate, 3.75 mg)
185MALIGNANT NEOPLASM OF PROSTATE
V10.46PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE
J9202 (Goserelin acetate implant, per 3.6 mg)
174.0 - 174.6MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST
174.8 - 174.9MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST
175.9MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
185MALIGNANT NEOPLASM OF PROSTATE
218.0 - 218.2SUBMUCOUS LEIOMYOMA OF UTERUS - SUBSEROUS LEIOMYOMA OF UTERUS
218.9LEIOMYOMA OF UTERUS UNSPECIFIED
617.0 - 617.6ENDOMETRIOSIS OF UTERUS - ENDOMETRIOSIS IN SCAR OF SKIN
617.8 - 617.9ENDOMETRIOSIS OF OTHER SPECIFIED SITES - ENDOMETRIOSIS SITE UNSPECIFIED
626.8OTHER DISORDERS OF MENSTRUATION AND OTHER ABNORMAL BLEEDING FROM FEMALE GENITAL TRACT
V10.3PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST
V10.46PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE
J9217 (Leuprolide acetate (for depot suspension), 7.5 mg)
174.0 - 174.6MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST
174.8 - 174.9MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST
175.9MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
185MALIGNANT NEOPLASM OF PROSTATE
218.0 - 218.2SUBMUCOUS LEIOMYOMA OF UTERUS - SUBSEROUS LEIOMYOMA OF UTERUS
218.9LEIOMYOMA OF UTERUS UNSPECIFIED
617.0 - 617.6ENDOMETRIOSIS OF UTERUS - ENDOMETRIOSIS IN SCAR OF SKIN
617.8 - 617.9ENDOMETRIOSIS OF OTHER SPECIFIED SITES - ENDOMETRIOSIS SITE UNSPECIFIED
V10.3PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST
V10.46PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE
J9219 (Leuprolide acetate implant, 65 mg) Surgical Implant
185MALIGNANT NEOPLASM OF PROSTATE
V10.46PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE
J9225 (Histrelin implant, Vantas, 50mg) J9226 (Histrelin implant, Supprelin LA, 50 mg) Surgical Implants
185MALIGNANT NEOPLASM OF PROSTATE
V10.46PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE

Diagnoses that Support Medical Necessity
Diagnoses listed above.

ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 codes not listed above

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

Diagnoses that DO NOT Support Medical Necessity
Diagnoses not listed above

General Information

Documentations Requirements
1. Any administration of the drugs addressed in this policy, in the absence of an acceptable clinical diagnosis, will be denied as not reasonable and necessary.
2. Documentation must be available to Medicare upon request.
Appendices
Utilization Guidelines
1. Coverage of leuprolide acetate and histrelin acetate, administered every 12 months in the surgical implant form for treatment of prostate cancer, is considered medically appropriate only for patients having a reasonable expectation of surviving at least 12 months.

2. Surgical implant forms of leuprolide acetate and histrelin acetate hormonal therapy must be removed after twelve months. When a surgical implant is removed, another surgical implant may be inserted to continue therapy.

3. GnRH analogs are covered for the indicated diagnosis, with frequency of administration governed by the duration of action of the previously administered GnRH analog.

4. Diagnostic restrictions do not apply to the following CPT/HCPCS codes;

11982 Removal, non-biodegradable drug delivery implant
11983 Removal, with reinsertion, non-biodegradable drug delivery implant
96402 Chemotherapy administration, subcutaneous or intra-muscular; Hormonal anti-neoplastic

5. If a patient has previously received a GnRH analog, a subsequent injection or implantation should be delayed until the therapeutic span of the earlier GnRH analog has ended. If the patient has had a bilateral orchiectomy, he does not need and should not receive, any form of GnRH.

6. If a patient has had a bilateral orchiectomy, he does not need and should not receive any form of GnRH.

Other Comments: Medicare Contractors implement LCDs to apply the standard of reasonable and necessary in situations not covered by specific national policy.

Abarelix for the treatment of prostate cancer is not addressed in this LCD. Abarelix is not a gonadotropin releasing hormone analog, but rather is considered a GnRH receptor antagonist. There is a National Coverage Determination (NCD) for the use of Abarelix. To review this NCD go to CMS manual 100-3, section 110.19.

Degarelix, for the treatment of prostate cancer, antagonizes the gonadotropin-releasing hormone (GnRH) receptors and thus is not addressed in this LCD.

For claims submitted to the fiscal intermediary or MAC Part A: This local coverage determination also applies to facilities that have nominated Wisconsin Physician Services to process their claims.

A prior version of Luteinizing Hormone-Releasing Hormone (LHRH) Analogs entitled Gonadotropin-Releasing Hormone Analogs was previously in effect for WPS Part B.

See companion document entitled Billing and Coding Guidelines for INJ-039, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

* - Unless otherwise indicated, an asterisk indicates a revision to that section of the policy.

Unless otherwise specified, italicized text represents quotation from one or more of CMS sources

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups which include representatives from urology, endocrinology, oncology, gynecology and other specialties.

Sources of Information and Basis for Decision
1. Adaptation of WPS Carrier LCD
2. Other Medicare LCDs
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin: 09/25/2009
Illinois: 09/16/2009
Michigan: 09/09/2009
Minnesota: 09/24/2009
Iowa, Kansas, Missouri, Nebraska 10/08/2009
Open Meeting: 08/19/2009
Start Date of Comment Period
10/08/2009
End Date of Comment Period
11/23/2009
Start Date of Notice Period
02/01/2010
Revision History Number
2
Revision History Explanation
04/19/2010: Criteria for least costly alternatives removed per directives from CMS (one).
The following message has been deleted from this LCD. Based on the following directive from CMS this LCD is revised effective 04/19/2010.
contractors shall not implement the LCA policy for any Part B drugs in new Local Coverage Determinations (LCDs). Contractors shall suspend and remove all LCA provisions in current LCDs and adjudicate claims without using LCA for all Part B drugs. Contractors shall no longer apply Chapter 15, Section 110.1.C.3 of the Benefit Policy Manual and Chapter 13, Sections 13.4(A) and the last sentence of 13.7.1 of the Program Integrity Manual in establishing LCDs for Part B drugs.

04/19/2010: Based on the following directive from CMS this LCD is revised effective 04/19/2010. contractors shall not implement the LCA policy for any Part B drugs in new Local Coverage Determinations (LCDs). Contractors shall suspend and remove all LCA provisions in current LCDs and adjudicate claims without using LCA for all Part B drugs. Contractors shall no longer apply Chapter 15, Section 110.1.C.3 of the Benefit Policy Manual and Chapter 13, Sections 13.4(A) and the last sentence of 13.7.1 of the Program Integrity Manual in establishing LCDs for Part B drugs. (one)

04/19/2010€”In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor  Palmetto.

8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 21 was changed
8/1/2010 - The description for Bill Type Code 23 was changed
8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0250 was changed
8/1/2010 - The description for Revenue code 0636 was changed

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

02/21/2011 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

07/01/2011: Annual review. Formatting changes only (two).
Reason for Change
Last Reviewed On Date
06/10/2011
Related Documents
This LCD has no Related Documents.

LCD Attachments

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Page Last Updated: Thursday, 15-Dec-2011 12:29:39 CST