CMS Pub. 100-03, ch. 1, § 230.19

Patients

(Rev. 48, Issued: 03-17-06; Effective/Implementation Dates: 06-19-06)

CIM 45-32

Carnitine is a naturally occurring substance that functions in the transport of the 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.

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 percent with treatment) that has not

responded to standard erthropoietin 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 noncovered in the ESRD

population.

For a patient currently receiving intravenous levocarnitine, Medicare will cover continued treatment if:

• Levocarnitine has been administered to treat erythropoietin-resistant 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 the 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.