August 28, 2003 - The Centers for Medicare and Medicaid Services (CMS) has issued a Change Request in a Program Memorandum to Carriers and Intermediaries on payment instructions for intravenous levocarnitine for End Stage Renal Disease (ESRD) patients. This Program Memorandum corrects Program Memorandum AB-02-0165, Change Request 2438 dated November 8, 2002. All information is the same except for the deletion of bill types 13x and 85x; and the addition of payment methodology for hospital-based ESRD facilities.

Transmittal AB-03-130 (pdf) - "Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients"

November 9, 2002 - The Centers for Medicare and Medicaid Services (CMS) has issued a Change Request in a Program Memorandum to Carriers and Intermediaries on payment instructions for intravenous levocarnitine for End Stage Renal Disease (ESRD) patients received on or after January 1, 2003.

Transmittal AB-02-165 (pdf) - "Levocarnitine for use in the treatment of Carnitine Deficiency in ESRD Patients"

July 27, 2002 - The Centers for Medicare and Medicaid Services (CMS) has issued a National Coverage Determination for Levocarnitine for end-stage renal disease (ESRD) patients. The Decision Memorandum and the Tracking Sheet are on-line at www.cms.hhs.gov/coverage/8b3-uu.asp

Decision:

"This decision memorandum announces our intention to issue a national coverage determination for the use of levocarnitine in ESRD patients. Intravenous levocarnitine will only be covered in 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, as noted by a pre-dialysis (trough) plasma free carnitine level < 40 micromol/L, along with signs and symptoms of:

1. Erythropoietin-resistant anemia (persistent hematocrit < 30% with treatment) that has not responded to standard eythropoietin dosage with iron replacement, and for which other causes have been investigated and adequately treated; or
   
   
2. Hypotension on hemodialysis that requires intervention and is unresponsive to all usual management measures (e.g., fluid management) and interferes with dialysis. 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. Most of the studies reviewed that reported a positive result found a benefit with levocarnitine within six months or less 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:

1. Levocarnitine has been administered to treat an indication covered under the national policy described above; and
   
   
2. The patient's medical record documents a pre-dialysis (trough) plasma free carnitine level < 40 micromol/L prior to the initiation of therapy; or
   
   
3. The treating physician certifies 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 become symptomatic from erythropoietin-resistant anemia or intradialytic hypotension."
   

[This message has been edited by Gary Peterson (edited 10-19-2003).]