Contractor Information
Contractor Name:
Highmark Medicare Services
Contractor Number:
12102, 12202, 12302, 12501, 12301, 12201
Contractor Type:
MAC Part A & B
LCD Information
LCD Database ID Number
L27500
LCD Title
Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
Contractor’s Determination Number
L27500
AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2007 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.
CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
CMS On-line Manual Pub. 100-4, Chapter 12, Section 30.5. This section addresses coverage of chemotherapy administration.
CMS On-line Manual Pub. 100-2, Chapter 15, Section 50 and 60.
CMS On-Line Manual Pub. 100-4, Chapter 17, Section 10
CMS On-Line Manual Pub.100-8, Chapter 13, Section 5.4
Primary Geographic Jurisdiction
Pennsylvania, Maryland, District of Columbia, Delaware
Oversight Region
Central Office
Original Determination Effective Date
For services performed on or after 07/11/2008
Original Determination Ending Date
N/A
Revision Effective Date
For services performed on or after 08/01/2008
Revision Ending Date
08/31/2008
Indications and Limitations of Coverage and/or Medical Necessity
Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.
NOTE: This LCD does not address the use of Supprelin® LA, histrelin acetate, HCPCS code J9226.
Covered Indications
Goserelin acetate, leuprolide acetate, triptorelin pamoate and histrelin are synthetic luteinizing hormone-releasing hormone (LHRH) analogs indicated in the palliative treatment of advanced carcinoma of the prostate. They offer an alternative treatment for prostate cancer when other treatments are either not indicated or are unacceptable to the patient.
Goserelin acetate (Zoladex®) (HCPCS code J9202) is available as a monthly and a 3-month implant that is administered by subcutaneous injection into the anterior abdominal wall.
Triptorelin pamoate (Trelstar™ ) (HCPCS code J3315) is a long-acting formula administered every twelve weeks as a single intramuscular injection into a buttock.
Leuprolide acetate (HCPCS code J9217) is available as an injectable suspension (Eligard®) that may be given subcutaneously monthly, every three months, every four months or every six months, and as a long-acting depot formulation (Lupron® Depot) that is administered intramuscularly on a monthly, every three months, or every four months basis. The leuprolide acetate implant (Viadur™) (HCPCS code J9219) is a once-yearly implant for the palliative treatment of advanced prostate cancer. It is a drug-filled, miniature titanium implant that is placed under the skin in the inner aspect of the upper arm via an in-office surgical procedure. The implant is effective for 12 months, after which the implant may be removed or replaced.
The histrelin implant (Vantas™) (HCPCS code J9225) is hormone-suppression therapy for advanced prostate cancer. The hydrogel implant containing histrelin is subcutaneously inserted in the upper, inner arm and delivers the drug continuously for 12 months. The implant may be removed or replaced after the 12-month treatment.
Response to the implants, leuprolide acetate (Viadur™) and histrelin (Vantas™), should be monitored periodically throughout the 12-month period by measuring serum concentrations of prostate-specific antigen (PSA) and testosterone. Patients who receive a LHRH analog implant should continue to be seen by the managing physician in follow-up at least every 3 to 4 months.
Coverage Limitations
Contractors implement Local Coverage Determinations (LCD) to apply reasonable and necessary standards in situations not covered by specific national policy. The underlying issue in the application of SSA 1862(a)(1)(A) is that if two services are clinically comparable, then Medicare does not cover the additional expense of the more costly service, because this additional expense is not attributable to an item or service that is medically reasonable and necessary.
An extensive review of the literature has revealed no demonstrable difference in clinical efficacy between goserelin acetate, leuprolide acetate, triptorelin pamoate, and histrelin acetate for treating advance prostate cancer. Therefore, Medicare will make payment for the least costly of the agents.
However, the beneficiary may choose to receive a more costly agent for various reasons. In such cases the beneficiary will be required to reimburse the provider for the difference between the more costly agent and the less costly one. The beneficiary must indicate acceptance of their responsibility for the additional payment by signing an Advance Beneficiary Notice (ABN) for each treatment.
- Claims for HCPCS codes J9202, J9217, and J3315 billed with diagnosis codes 185 or V10.46 will have least costly alternative applied. Medicare will reimburse based on the least costly drug’s allowable for the date of service billed on the claim.
- Claims for the 12 month implant HCPCS codes J9219 and J9225 billed with diagnosis codes 185 or V10.46 will have least costly alternative applied. Medicare will reimburse based on the least costly drug’s allowable for the date of service billed on the claim.
Medicare will deny payment for the additional expense of the more costly agent as not medically reasonable and necessary. As with any submitted charge that is not considered medically reasonable and necessary, the beneficiary can be held liable for the denied charge if an Advanced Beneficiary Notice is signed. The beneficiary's liability, however, must not exceed the difference in Medicare allowance between the two medications.
NOTE: Patients receiving Lupron® or Zoladex® for the treatment of prostatic cancer prior to May 2, 1998 will not be subjected to the guidelines outlined in the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy. These patients may continue to receive their current treatment regime without reimbursement reduction.
Patients receiving TrelstarTM, Eligard®, ViadurTM or VantasTM for the treatment of prostate cancer prior to October 15, 2005 will not be subjected to the least costly alternative provision. These patients may continue to receive their current treatment regimen without reimbursement reduction.
The least costly alternative provisions of this LCD specifically addresses the reimbursement for the treatment of malignant neoplasm of the prostate only. Reimbursement under the LCA provisions will differ depending on the LHRH analog's duration of action (short acting vs. 12 month implant). Whereas, there are other labeled indications for LHRH analogs, such indications are not affected by the least costly alternative (LCA) provisions of this LCD; that is, the LCA pricing will only be applied if the covered diagnosis is related to prostate cancer.
If a claim for either of the once yearly implants (J9219 and J9225) is submitted more often than once in a 12-month period, it will be denied.
Refer to the Drug Fee Schedule on our website, www.highmarkmedicareservices.com to determine drug allowances.
Coverage Topic
Chemotherapy (Outpatient), Doctor Office Visits
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.
999x | Not Applicable |
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
Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) 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 |
J9219 | LEUPROLIDE ACETATE IMPLANT, 65 MG |
J9225 | HISTRELIN IMPLANT (VANTAS), 50 MG |
ICD-9 Codes that Support Medical Necessity
It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.
The CPT/HCPCS codes included in this policy 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
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Medicare is establishing the following limited coverage for CPT/HCPS code J3315:
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Medicare is establishing the following limited coverage for CPT/HCPCS code J9202:
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Medicare is establishing the following limited coverage for CPT/HCPCS code J9217 and J9219:
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Medicare is establishing the following limited coverage for CPT/HCPCS code J9225:
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Diagnoses that Support Medical Necessity
N/A
ICD-9 Codes that DO NOT Support Medical Necessity
All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.
General Information
Documentation Requirements
- All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
- The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
Documentation to support the medical necessity of the procedure as outlined in the 'Indications and Limitations of Coverage and/or Medical Necessity' section of this policy must be maintained in the patient's medical record. This documentation includes, but is not limited to, a relevant medical history, physical examination, and results of pertinent diagnostic tests (including PSA and testosterone levels) and any relevant procedures.
The medical record documentation for patients receiving a once-yearly implant must support ongoing follow-up visits at least every 3 to 4 months.
The documentation described above must be maintained in the patient's medical record and be available to Medicare upon request.
Utilization Guidelines
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.
The leuprolide acetate and histrelin implants are designed to deliver their respective agents for 12-months at a controlled rate. Therefore, payment for these agents is limited to once in a 12-month period.
Administration of the depot forms of goserelin acetate, leuprolide acetate, and triptorelin pamoate should be in keeping with the FDA approval and package insert for the drug.
Sources of Information and Basis for Decision
Blue Cross Blue Shield Association. Relative Effectiveness and Cost-Effectiveness of Methods of Androgen Suppression in the Treatment of Advanced Prostate Cancer. AHRQ Evidence Reports and Summaries. May 1999.
Cassileth BR, Soloway MS, Volgelzang NJ, et al: Patient's Choice of Treatment in Stage D Prostate Cancer. Supplement to Urology; May 1989, Volume XXXIII, Number 5, Pages 57-62.
Chandler C, Sales M, Ganz M, et al. Drug Class Review: Luteinizing Hormone Releasing-Hormone (LHRH) Agonists in Prostate Cancer. VHA Pharmacy Benefits Management Strategic Healthcare Group and Medical Advisory Panel. 2003 Jan.
Facts and Comparisons Staff; Facts And Comparisons; loose-leaf drug information service; April 1996, Leuprolide Acetate, pages 669e-670i; and May 1996, Goserelin Acetate, Pages 670e-670i.
Filicori M, Gonadotrophin-Releasing Hormone Agonists; A Guide to Use and Selection. Drugs Volume 48, Number 1, 41-58, 1994.
Fowler JE, Flanagan M, Gleason DM, et al: Evaluation Of An Implant That Delivers Leuprolide For 1 Year For The Palliative Treatment Of Prostate Cancer. Urology. 2000 May; 55(5): 639-42.
Fowler JE Jr., Gottesman JE, Reid CF, et al: Safety And Efficacy Of An Implantable Leuprolide Delivery System In Patients With Advanced Prostate Cancer. J Urol. 2000 Sep; 164(3 Pt 1): 730-4.
Goldspiel BR, Kohler DR. Goserelin Acetate Implant: A Depot Luteinizing Hormone-Releasing Hormone Analog For Advanced Prostate Cancer; DICP, The Annals of Pharmacotherapy; 1991 July/August, Volume 25; pages 796-803.
Hellerstedt BA, Pienta KJ. The Current State of Hormonal Therapy for Prostate Cancer. CA Cancer J Clin 2002; 52(3): 154-179.
Higano CS, Ellis W, Russell K, Lange PH. Intermittent Androgen Suppression With Leuprolide And Flutamide For Prostate Cancer: A Pilot Study. Urology. 1996 Nov; 48(5): 800-4.
Marks LS. Luteinizing Hormone-Releasing Hormone Agonists in the Treatment of Men with Prostate Cancer: Timing, Alternatives, and the 1-Year Implant. Urology. 2003 Dec 22; 62(6A): 36-42.
McConnell JD, Physiologic Basis Of Endocrine Therapy For Prostatic Cancer. Urologic Clinics of North America -Vol. 18, No. 1, February 1991.
Medical Advisory Panel and Pharmacy Benefits Management Strategic Health Group; Final Draft 12/96.
Moul JW, Fowler JE Jr. Evolution of Therapeutic Approaches with Luteinizing Hormone-Releasing Hormone Agonists in 2003. Urology. 2003 Dec; 22(62): 20-28.
Peeling WB, Phase III Studies To Compare Goserelin (Zoladex) With Orchiectomy And With Diethylstilestrol In Treatment Of Prostatic Carcinoma. Supplement to Urology, May 1989, Volume XXXIII, Number 5, Pages 45-52.
Sarosdy MF, Schellhammer PF, Sharifi R, et al: Comparison Of Goserelin And Leuprolide In Combined Androgen Blockade Therapy. Urology. 1998 Jul; 52(1): 82-8.
Schellhammer PF, Sharifi R, Block NL, et al: A Controlled Trial Of Bicalutamide Versus Flutamide, Each In Combination With Luteinizing Hormone-Releasing Hormone Analogue Therapy, In Patients With Advanced Prostate Carcinoma. Analysis Of Time To Progression CASODEX Combination Study Group. Cancer 1996 Nov 15; 78(10): 2164-2169.
Schlegel PN, Kuzma P, Frick J, et al. Effective Long-Term Androgen Suppression in Men with Prostate Cancer Using a Hydrogel Implant with the GnRH Agonist Histrelin. Urology. 2001 Oct; 58(4): 578-82.
Sharifi R, Soloway M, Clinical Study Of Leuprolide Depot Formulation In The Treatment Of Advanced Prostate Cancer; and The leuprolide Study Group. The Journal of Urology, Volume 143, Copyright 1990 by American Urological Association, Inc.
Technology Advisory Committee of August 6 and 7, 1996 Minutes.
Tomera K, Gleason D, Gittelman M, et al: The Gonadotropin-Releasing Hormone Antagonist Abarelix Depot Versus Luteinizing Hormone Releasing Hormone Agonists Leuprolide Or Goserelin: Initial Results Of Endocrinological And Biochemical Efficacies In Patients With Prostate Cancer. J Urol. 2001 May; 165(5): 1585-9.
Vogelzang NJ, Soloway MS, Block NL, et al: Goserelin Versus Orchiectomy In The Treatment Of Advanced Prostate Cancer: Final Results Of A Randomized Trial. Adult Urology 46 (2), 1995.
1997 Physicians' Desk Reference; pages 2741-2744, (Lupron Depot 7.5 mg) and pages 2976-2980 (Zoladex 3.6mg)
FDA approval letters for Lupron®, Zoladex®, Viadur™, Vantas™, and Eligard
Manufacturer's drug package inserts
Other Contractor's Policies: Empire Medicare Services; Palmetto GBA; TrailBlazer Health Enterprises, LLC; AdminiStar Federal, Inc.; Noridian Administrative Services, LLC; National Heritage Insurance Company; The Regence Group; Aetna
Carrier Advisory Committee
Highmark Medicare Services Contractor Medical Directors
Advisory Committee Meeting Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups that include representatives from various specialties.
CAC/IAC Distribution: 04/01/2008
Start Date of Comment Period
End Date of Comment Period:
05/15/2008
Start Date of Notice Period
05/23/2008
Revision History
Revision History Number
L27500
Revision History Explanation
| Date | Policy # | Description |
|---|---|---|
08/01/2008 |
L27500 |
LCD effective 08/01/2008 for DC Part A, Maryland Part A, and Pennsylvania Part A. LCD is now effective for DC Part A and DCMA Part B; Maryland Part A and Maryland Part B; Pennsylvania Part A; and Delaware Part B. |
05/23/2008 |
L27500 |
Original LCD posted for notice. LCD to become effective 07/11/2008 for Maryland Part B, DCMA Part B and Delaware Part B. |
04/01/2008 |
Draft J12-D25 |
Original LCD posted for comment. |
Last Reviewed On
07/31/2008
Related Documents
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LCD Attachments
There are no attachments for this LCD.