NCD 230.19

Item/Service Description

CIM 45-32

Carnitine is a naturally occurring substance that functions in the transport of long-chain fatty acids for energy production by the body. 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.

Indications and Limitations of Coverage

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

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.

Continued use of levocarnitine will not be covered if improvement has not been demonstrated within 6 months of initiation of treatment. All other indications for levocarnitine are non-covered in the ESRD population.

For a patient 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.

Revision History

03/2006 - Correct typegraphical errors from conversion of CIM to NCD. Effective and implementation dates 06/19/2006. (TN 48) (CR4278)

11/2002 - Implemented National Coverage Determination for Levocarnitine for End Stage Renal Disease under §1862(a)(1)(A) of the Social Security Act. Effective and implementation dates 01/01/2003. (TN 162) (CR 2438)