LCD/NCD Portal

L28812

 

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).

 

 

Coding Information

 

Bill Type Codes

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

71x Clinic - Rural Health

72x Clinic - Hospital Based or Independent Renal Dialysis Center

 

 

Revenue Codes

 

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

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.

 

 

CMS LCD L28812 CYTOMEGALOVIRUS IMMUNE GLOBULIN (HUMAN), INTRAVENOUS (CMV-IGIV)_AJ9