L28899-LCD

Automated World Health

Local Coverage Determination (LCD) for Levocarnitine (Carnitor®, L

-carnitine®) (L28899)

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 L28899

LCD Title

Levocarnitine (Carnitor®, L-carnitine®)

Contractor's Determination Number AJ1955

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

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. 100-3, Medicare National Coverage Determinations, Chapter 1, Section 230.19

Indications and Limitations of Coverage and/or Medical Necessity

Levocarnitine is a naturally occurring amino acid required in energy metabolism. This carrier molecule transports fatty acids into cellular mitochondria and transports potentially toxic metabolic waste products, acyl groups, out of the mitochondria. Carnitine is derived from dietary red meat and dairy products with biosynthesis primarily occurring in the liver and kidneys. Deficiency can occur due to a congenital defect in synthesis or utilization, or from dialysis. The causes of carnitine deficiency in hemodialysis patients include dialytic loss, reduced renal synthesis, and reduced dietary intake.

Select patients with carnitine deficiency require supplemental levocarnitine. Levocarnitine is available in tablets, capsules, oral solution and parenteral forms.

Medicare will consider intravenous levocaritine medically reasonable and necessary when provided for the following indications:

Non-ESRD Patients:

Intravenous levocarnitine is only indicated for the acute (e.g. metabolic crisis) treatment of non-ESRD patients with an inborn error of metabolism that results in carnitine deficiency.

ESRD Patients:

Intravenous levocarnitine will only be covered for those ESRD patients who have been on dialysis for a minimum of three months for one of the following indications:

Patients must have documented carnitine deficiency, defined as a plasma free carnitine level < 40 micromol/L (determined by a professionally accepted method as recognized in current literature), along with signs and symptoms of:

Erythropoietin-resistant anemia (persistent hematocrit < 30% with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or

Hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management). Such episodes of hypotension must have occurred during at least 2 dialysis treatments in a 30-day period.

*For ESRD patients currently receiving intravenous levocarnitine, Medicare will cover continued treatment if:

Levocarnitine has been administered to treat erythropoietin-resistent anemia (persistent hematocrit < 30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management) and such episodes of hypotension occur during at least 2 dialysis treatments in a 30-day period; and

The patient's medical record documents a pre-dialysis plasma free carnitine level < 40 micromol/L prior to the initiation of treatment; or the treating physician certifies (documents in the medical record) that in his/her judgment, if treatment with levocarnitine is discontinued, the patient's pre-dialysis carnitine level would fall below 40 micromol/L and the patient would have recurrent erythropoietin-resistant-anemia or intradialytic hypotension.

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

072x Clinic - Hospital Based or Independent Renal Dialysis Center 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

J1955 INJECTION, LEVOCARNITINE, PER 1 GM

ICD-9 Codes that Support Medical Necessity Non-ESRD Patients:

791.3 MYOGLOBINURIA ESRD Patients:

Note: Renal dialysis facilities (72x) should report a diagnosis code of 585.6 for submission of claims

585.4 CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)

585.5 CHRONIC KIDNEY DISEASE, STAGE V

585.6 END STAGE RENAL DISEASE

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity 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 performing provider must substantiate the medical necessity for the use of parenteral levocarnitine by clearly indicating the condition for which this drug is being used. This documentation includes, but is not limited to, relevant medical history, physical exam including current weight,

and results of pertinent diagnostic tests or procedures.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Evans, A. (2003). Dialysis-related carnitine disorder and levocarnitine pharmacology [Electronic version]. American Journal of Kidney Disease 41(4 Suppl 4): S13-26.

Facts and Comparisons. (2000). Levocarnitine (L-carnitine). Drug Facts and Comparisons®. St. Louis, MO: Author.

Katz, D.L. (2001). Diet and renal disease. In Nutrition in clinical practice (p. 110). Philadelphia, PA: Lippincott Williams & Willkins.

Kidney Disease Outcomes Quality Initiative (2000). Clinical practice guidelines for nutrition in chronic renal failure: L-carnitine for maintenance dialysis patients. American Journal of Kidney Diseases, 6 (Suppl. 2), S54- S55.

Sigma Tau Pharmaceuticals, Inc. (2000). Package insert for Carnitor®. [On-line]. Available: http://www.carnitor.com

United States Pharmacopeial Convention, Inc. (2000). USPDI Drug information for the health care professional (20th ed., Vol. 1). Engelwood, CO: Micromedex, Inc.

Wasserstein, A. (2000). Carnitine metabolism in renal disease and dialysis. [On-line]. Available: http://www.uptodate.com

Advisory Committee Meeting Notes 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 includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation 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-

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 (L28899) replaces LCD L13789 as the policy in notice. This document (L28899) 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 72 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