L28947-LCD

Automated World Health

Local Coverage Determination (LCD) for Pemetrexed (L28947)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number

09101

Contractor Type

MAC - Part A

LCD Information

Document Information

LCD ID Number L28947

LCD Title Pemetrexed

Contractor's Determination Number AJ9305

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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 02/16/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 11/30/2011 Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Pemetrexed is an antifolate containing the pyrrolopyrimidine-based nucleus that exert antineoplastic activity by disrupting folate-dependent metabolic processes essential for replications.

Pemetrexed is FDA approved for treatment of the following medical conditions:

- Adjuvant treatment of malignant pleural mesothelioma (MPM) in combination with cisplastin for the treatment of patients whose disease is unresectable or who are otherwise not candidates for curative surgery.

- Single agent for the treatment patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.

- Use in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastic non-squamous NSCLC.

- Maintenance treatment of advanced or metastatic nonsquamous NSCLC after first-line treatment with platinum- base chemotherapy (effective 07/09).

Pemetrexed is approved for the following off-label (non FDA-approved) medical condition:

- Thymic malignancies when used as a second line chemotherapy regimen.

-Second-line therapy as a single agent for local/regional recurrent or distant metastatic cervical cancer.

-Single-agent recurrence therapy, if platinum resistant, for ovarian cancer that is recurrent after prior chemotherapy; progressive, stable, or persistent on primary chemotherapy; relapse has occurred after complete remission following primary chemotherapy; or stage II-IV disease has shown partial response to primary treatment.

-Second-line therapy as a single agent for metastatic bladder cancer.

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) 022x Skilled Nursing - Inpatient (Medicare Part B only) 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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J9305 INJECTION, PEMETREXED, 10 MG

ICD-9 Codes that Support Medical Necessity

162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS

162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG

162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG

162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG

162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG

162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

163.0 - 163.9 opens in new window

MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED

164.0 MALIGNANT NEOPLASM OF THYMUS

180.0 - 180.9 opens in new window

183.0 - 183.9 opens in new window

188.0 - 188.9 opens in new window

MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

189.1 MALIGNANT NEOPLASM OF RENAL PELVIS

189.2 MALIGNANT NEOPLASM OF URETER

212.6 BENIGN NEOPLASM OF THYMUS

233.7 CARCINOMA IN SITU OF BLADDER

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used. This shall include the histologic type of cancer, stage, prior therapy and the patient’s response to that therapy.

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

If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Documentation in the medical record must support pemetrexed was given for an indication specified in this Local Coverage Determination (LCD). The amount of drug, route & timing of administration, and any reaction of the patient should be documented in the medical record. In general, a facility should bill what is administered to the patient with attention to the code descriptor and quantity billed (see coding guidelines if applicable). In the event that only one patient needs a portion of the contents in the single-use vial, then the remainder can be discarded. In such a situation, the entire contents of the vial can be billed. Under no circumstances can multiple patients be billed for the entire contents of a single vial when the each patient received a portion of the drug from the same vial. With appropriate procedures, it is safe to re-enter a medication vial labeled as single use. CMS issued a procedure, developed with the approval of the Centers for Disease Control, for safe re-entry into “single-use” vials. Medicare expects this procedure to be used whenever feasible for efficient use of medications and minimal drug wastage. The hospital pharmacy record should have documentation on drugs discarded from single-use vials that are subsequently billed to a Medicare patient.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Clinical Pharmacology (2009) retrieved from http://www.clinicalpharmacology.com

NCCN Clinical Practice Guidelines in Oncology™ V.2.2009. Thymic Malignancies retrieved from www.nccn.org on September 20, 2009.

The United States Pharmacopeia Drug Information (USP DI). 2006. Thomson Micromedex Health Care Series [on- line]. Available http://www.thomsonhc.com/

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, February 2007. Available http://www.fda.gov/CDER/drug/infopage/alimta/default.htm

Facts & Comparisons 4.0 (2007) retrieved 08/16/2007 from http://online.factsandcomparisons.com

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 representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 03/01/2010

Revision History Number 3

Revision History Explanation Revision Number:3 Start Date of Comment Period:N/A

Start Date of Notice Period:12/01/2011 Revised Effective Date:11/30/2011

LCR A2011-089

November 2011 Connection

Explanation of Revision: LCD revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to add the following off-label indications: 1) Second-line therapy as a single agent for local/regional recurrent or distant metastatic cervical cancer, 2) Single-agent recurrence therapy, if platinum resistant, for ovarian cancer that is recurrent after prior chemotherapy; progressive, stable, or persistent on primary chemotherapy; relapse has occurred after complete remission following primary chemotherapy; or stage II-IV disease has shown partial response to primary treatment, 3) Second-line therapy as a single agent for metastatic bladder cancer. The ‘ICD-9 Codes that Support Medical Necessity’ section of the LCD has also been revised to add the following ICD-9-CM codes: 180.0-180.9, 183.0-183.9, 188.0-188.9, 189.1, 189.2, and 233.7. The effective date of this revision is based on date of service.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:03/01/2010 Revised Effective Date: 02/18/2010

LCR A2010-019

February 2010 Bulletin

Explanation of Revision: Revised the “Indications and Limitations of Coverage and/or Medical Necessity” section to update FDA-approved indications. Additionally, added off label indications for thymic malignancies. Added ICD- 9-CM codes 164.0 and 212.6 for off-label indications. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:04/01/2009 Revised Effective Date: 04/02/2009

LCR A2009-044

April 2009 Bulletin

Explanation of Revision: The LCD was revised under the “Indications and Limitations of Coverage and/or Medical Necessity” section to update FDA approved indications. This revision is effective for claims processed on or after 04/02/2009 for dates of service on or after 09/26/08.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-034FL LCR A2009-036PR/VI

December 2008 Bulletin

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

For Florida (00090) this LCD (L28947) replaces LCD L26294 as the policy in notice. This document (L28947) is effective on 02/16/2009.

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 22 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 0636 was changed

Reason for Change