National Coverage Analysis (NCA) Tracking Sheet

Levocarnitine for End Stage Renal Disease

CAG-00077N

Issue

Carnitine is an endogenous molecule that serves as a carrier in the transport of long-chain fatty acids across the inner mitochrondrial membrane, facilitating oxidation and energy production. Dialytic losses, combined with reduced renal synthesis and reduced intake of meat and dairy products, can cause carnitine deficiency in end stage renal disease (ESRD) patients. Levocarnitine injection has been approved by the Food and Drug Administration (FDA) for the "prevention and treatment of carnitine deficiency in ESRD patients who are undergoing dialysis. Levocarnitine injection was first approved by the in FDA 1992. The FDA approved the drug's indication for ESRD patients on December 15, 1999. Given inconsistencies among the fiscal intermediaries' local coverage policies for this drug, the Centers for Medicare and Medicaid Services (CMS) believes a national review is appropriate. Among other issues, CMS plans to examine, in this review, the clinical significance of carnitine deficiency and the issue of intravenous administration of carnitine supplementation versus oral administration.

Benefit Category

Drugs and Biologicals

Requestor Information

Requestor Name Requestor Letter
HCFA internally generated request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/18/2001
Expected NCA Completion Date
07/19/2002
Public Comment Period
05/18/2001 - 06/18/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
07/22/2002

Contacts

Lead Analysts
Sharon Hippler
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

April 18, 2001

Request for reconsideration was internally generated.

April 18, 2001

Referred to Center for Health Plans and Providers (CHPP) for final benefit category determination.

May 18, 2001

Referred to the MCAC Drugs, Biologics, Therapeutics Panel - Meeting June 20, 2001  at the Baltimore Convention Center.

June 20, 2001

MCAC Panel Meeting. Recommendation to be ratified at October 17 Executive Committee meeting.

November 30, 2001

Minutes from October 17, 2001 MCAC Executive Committee  meeting received.

February 4, 2002

Additional time needed to complete the review. Due date will be extended to March 8, 2002.

March 19, 2002

Additional time needed to complete the review. Due date will be extended to April 19, 2002.

April 19, 2002

Additional time is needed to complete the review. Due date will be extended to June 19, 2002.

June 21, 2002

Additional time is needed to review new material submitted to the agency. Due date will be extended to July 19, 2002.

July 22, 2002

CMS posts the decision memorandum announcing its intent to issue a limited positive national coverage determination.

November 2002

Claims Processing Instructions issued and NCD updated