Overview of CMS Policy on the Use of Intravenous Levocarnitine in End Stage Renal Disease (ESRD) Patients

On November 8, 2002, CMS issued a National Coverage Determination on the use of intravenous levocarnitine in End Stage Renal Disease (ESRD) patients with Medicare coverage.

The policy was effective on January 1, 2003. The policy replaces local medical review policies (LMRP) in effect at fiscal intermediaries (FI) prior to January 1, 2003.

A summary of the policy is as follows:

• Intravenous levocarnitine will only be covered for patients who have been on dialysis for at least three months.
• Prior to starting a patient on intravenous levocarnitine, a pre-dialysis plasma free carnitine level is required. The plasma free carnitine test results must be < 40µmol/L determined by a professionally accepted method as recognized in current literature. This is the only time that a carnitine test will need to be done.
• Along with a carnitine level < 40µmol/L, the patient needs to have signs and symptoms of erythropoietin-resistant anemia OR intradialytic hypotension.

Erythropoietin-resistant anemia is defined as 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.

Intradialytic hypotension is defined as 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

• After the patient has been on levocarnitine treatment for 6 months, an assessment of the condition (erythropoietin-resistant anemia or intradialytic hypotension) is required. If no demonstrable improvement has occurred within 6 months, continued use of intravenous levocarnitine will not be covered.
• All other indications (e.g. muscle weakness and cardiomyopathy) for levocarnitine are not covered for ESRD patients under this policy.