LCD/NCD Portal

L29127

 

CYTOMEGALOVIRUS IMMUNE GLOBULIN (HUMAN), INTRAVENOUS (CMV-IGIV)

 

 

03/22/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Medicare will consider the use of CMV-IGIV medically reasonable and necessary for the following indications:

• Prophylaxis against CMV disease associated with transplantation of lung, liver, pancreas, and heart.

• In transplants of these organs, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

• To attenuate primary CMV disease in seronegative kidney transplant recipients who receive a kidney from a CMV seropositive donor.

• CMV seropositive recipients who receive organs (lung, liver, pancreas, heart, or kidney) from seropositive donors may experience reactivation or reinfection, but the clinical manifestations are often milder than primary disease.

o Therefore, CMV-IGIV is not considered medically reasonable and necessary when the recipient and the donor are CMV seropositive.

• CMV-IGIV is supplied as an injectable drug (2.5g/50ml vial). Its I.V. administration is prescribed in accordance with the post-transplant period.

• The maximum recommended total dosage per infusion is 150 mg/kg, administered according to the following schedule:

o Within 72 hours of transplant (150 mg/kg).

o 2 weeks post-transplant (100 mg/kg).

o 4 weeks post-transplant (100 mg/kg).

o 6 weeks post-transplant (100 mg/kg).

o 8 weeks post-transplant (100 mg/kg).

o 12 weeks post-transplant (50 mg /kg).

o 16 weeks post-transplant (50 mg/kg).

• CMV-IGIV is not considered to be reasonable and necessary when given in excess of this administration/dosage schedule.

• CMV-IGIV may not be used as a substitute for intravenous immunoglobulin (IGIV).

 

 

CPT/HCPCS Codes

 

J0850 INJECTION, CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN), PER VIAL

 

 

ICD-9 Codes that Support Medical Necessity

 

V07.2* NEED FOR PROPHYLACTIC IMMUNOTHERAPY

V42.0 KIDNEY REPLACED BY TRANSPLANT

V42.1 HEART REPLACED BY TRANSPLANT

V42.6 LUNG REPLACED BY TRANSPLANT

V42.7 LIVER REPLACED BY TRANSPLANT

V42.83 PANCREAS REPLACED BY TRANSPLANT

 

* The billing of Cytomegalovirus Immune Globulin (Human), Intravenous (CMV-IGIV) requires dual diagnoses. To ensure reimbursement for this service, dual diagnoses must be submitted. An ICD-9-CM code of V07.2 must be billed with one of the following ICD-9-CM codes: V42.0, V42.1, V42.6, V42.7 and V42.83.

 

 

Documentation Requirements

 

• Medical documentation maintained by the ordering/referring physician must clearly indicate:

o That the organ recipient was CMV seronegative prior to the lung, liver, pancreas heart or kidney transplant and has received an organ from a CMV seropositive donor.

o The date of the organ transplantation.

o The administration and dosage of the CMV-IGIV.

Utilization Guidelines

• It is not expected that dosages will exceed those recommended in schedule in the indications and limitations section of this policy.

Treatment Logic

• CMV-IGIV (CMV-IGIV) is an intravenous immunoglobulin (Ig) that provides passive immunity by supplying a relatively high concentration of Ig-G antibodies against CMV.

• CMV infection continues to be the most important disease encountered in organ transplantation.

• Patients who are at the greatest risk for morbidity are those who experience primary disease, (i.e., those individuals who have never been exposed to the virus [CMV seronegative] and receive an organ transplant from a CMV seropositive donor).

 

 

Sources of Information and Basis for Decision

 

Mosby’s Drug Consult (2006) Mosby, Inc.

 

Cytomegalovirus infection. Atlanta, GA: National Center for infectious diseases. Retrieved from the internet January 6, 2005. Available at URL address: http://www.cdc.gov/ncidod/diseases/cmv.htm

 

FCSO LCD 29127, Cytomegalovirus Immune Globulin (Human), Intravenous (CMV-IGIV), 03/22/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Zemora MR (2004) Following universal prophylaxis with intravenous ganciclovir and cytomegalovirus immune globulin, valganciclovir is safe and effective for prevention of CMV infection following lung transplantation. Abstract Retrieved from NIH/NLM Medline.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L29127 CYTOMEGALOVIRUS IMMUNE GLOBULIN (HUMAN), INTRAVENOUS  (CMV-IGIV)