CurrentEmblemHealthPolicy MG.MM.PH.139

Cytogam (cytomegalovirus immune globulin, human) Intravenous

Defines medical necessity, dosing, coding, and coverage criteria for Cytogam used for CMV prophylaxis in transplant recipients for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyCytogam (cytomegalovirus immune globulin, human) Intravenous

Policy CodePolicy MG.MM.PH.139

Change TypeNo material change

Effective Date

Next Review DateMar 26, 2025

Key ActionPrior authorization required; provider must document indication and submit clinical records demonstrating medical necessity for Cytogam prophylaxis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthslength of authorization

2procedure/billing codes listed

1listed NDC

5transplant types specified

provideddosing regimen

Coverage Criteria for Cytogam

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Initial Approval Criteria - CMV Prophylaxis for Transplantation

Covered when ALL of the following are met and use is consistent with medical necessity criteria.

Transplant indication: Patient is undergoing transplantation of kidney OR lung OR liver OR pancreas OR heart for which CMV prophylaxis with Cytogam is being requested.

Source lists those five organ types explicitly.

Use consistent with medical necessity criteria: Use must be consistent with the policy's medical necessity criteria for Cytogam prophylaxis (clinical documentation supporting indication must be submitted).

Treating physician must submit clinical evidence; prior authorization is required.

Renewal Criteria

Renewal approval requires continued fulfillment of initial criteria.

Continued eligibility: Patient continues to meet INITIAL APPROVAL CRITERIA.

Renewal explicitly references continued fulfillment of initial criteria.

Cytogam is covered for CMV prophylaxis in transplant recipients only when the member meets all applicable medical necessity criteria and the requested use matches one of the specified transplant indications (kidney, lung, liver, pancreas, or heart). Prior authorization is required and the treating physician must submit clinical documentation demonstrating that the member meets the policy’s initial approval criteria; lack of such documentation may result in denial of the request. Dosing and administration must follow the policy’s post‑transplant dosing schedule (for example, the initial dose given within 72 hours of transplant and subsequent doses per the organ‑specific regimen).

Cytogam is not considered medically necessary and will be excluded from coverage in members who meet any of the policy’s explicit exclusions, including: persons with selective IgA deficiency with anti‑IgA and a history of anaphylactic reactions to human immune globulin preparations, and members with a history of a prior severe reaction to Cytogam or any other human immunoglobulin preparation.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. The provider must obtain prior authorization and document that one of the transplant prophylaxis indications for Cytogam is met and provide supporting clinical evidence for the request.

Prior authorization required before administration
Provider must document indication and supply clinical evidence

Step Therapy

No step therapy requirements specified for Cytogam. Providers do not need to complete a trial of other therapies prior to requesting prior authorization for Cytogam.

Documentation Required

Clinical Evidence Submission

The treating physician or primary care provider must submit clinical evidence that the member meets the medical necessity criteria for Cytogam. Without submission of the required documentation, EmblemHealth will not be able to properly review the preauthorization request or perform post-payment review.

Submit complete clinical records and rationale supporting the indicated transplant prophylaxis use
Failure to provide documentation may result in denial or delayed review

Denial Risk

Explicit Exclusion Risks

Do not administer Cytogam to individuals with selective IgA deficiency who have anti-IgA antibodies and a history of anaphylaxis to human immune globulin preparations, or to individuals with a prior severe reaction to Cytogam or any human immunoglobulin preparation. These are explicit exclusions due to risk of severe hypersensitivity or anaphylactic reactions.

Selective IgA deficiency with anti-IgA and prior anaphylaxis — Contraindicated
Prior severe reaction to Cytogam or other human immunoglobulin — Contraindicated

Applicable Billing Codes and Diagnoses

Applicable Procedure/Billing CodesHCPCSCovered

J0850	Injection, cytomegalovirus immune globulin intravenous (human) 1 billable unit per vial
90291	Cytomegalovirus immune globulin (CMV-IgIV), human, for intravenous use

Applicable NDCsNDCCovered

44206-0532-XX

Cytogam 50 mg/mL single use vial

ICD-10 Diagnoses (selected CMV)ICD-10

B25.0	Cytomegaloviral pneumonitis
B25.1	Cytomegaloviral hepatitis
B25.2	Cytomegaloviral pancreatitis
P35.1	Congenital cytomegalovirus infection

ICD-10/Other Diagnoses Related to Transplant Status/ComplicationsICD-10

T86.1	Complications of kidney transplant
T86.2	Complications of heart transplant
T86.4	Complications of liver transplant
T86.81	Complications of lung transplant
294.0	Kidney transplant status

Dosing and Administration Timing

Cytogam IV infusion — Dosing schedule

Initial peri‑operative dose150 mg/kg IV administered within 72 hours of transplant

Early post‑transplant doses (weeks 2–8)100 mg/kg IV on weeks 2, 4, 6, and 8 post‑transplant (kidney uses 100 mg/kg on these weeks per schedule)

Late post‑transplant doses (weeks 12 and 16)50 mg/kg IV on weeks 12 and 16 for kidney; 100 mg/kg IV on weeks 12 and 16 for lung, liver, pancreas, and heart as specified

Organ‑specific regimen summaryAll listed organs receive a 150 mg/kg IV dose within 72 hours; subsequent week‑by‑week dosing varies by organ as detailed above

Contraindications

Cytogam must not be administered to individuals with selective IgA deficiency who have anti‑IgA antibodies and a history of anaphylaxis to human immune globulin preparations. Such a history places the member at high risk for severe hypersensitivity reactions and is an explicit contraindication to use.

Additionally, a documented prior severe reaction to Cytogam or any other human immunoglobulin preparation is a contraindication; requests for Cytogam in these circumstances are excluded and may be denied.

Evaluation and Review Requirements

Documentation Required

Submit clinical documentation demonstrating indication and necessity

For prior authorization, clinical documentation demonstrating the indication and medical necessity (consistent with the policy's initial approval criteria for transplant prophylaxis) must be submitted.

Documentation should confirm transplant type (kidney, lung, liver, pancreas, or heart) and that Cytogam is being requested for CMV prophylaxis.
Include any relevant operative or transplant records and clinical notes supporting prophylactic use.

Definitions and Background

Cytogam — Definition and properties

Product identityCytogam (cytomegalovirus immune globulin, human) — an intravenous human CMV immune globulin preparation

Composition/propertyInjectable product that contains antibodies directed specifically against cytomegalovirus (CMV)

Indicated use (context)Used to attenuate or prevent CMV disease in immunosuppressed transplant recipients; FDA‑approved for renal (kidney) transplant patients

Clinical rationaleCMV is a significant cause of morbidity and mortality in immunosuppressed transplant recipients; Cytogam provides passive CMV‑specific antibodies

Cytogam is an intravenous human cytomegalovirus immune globulin preparation that contains antibodies directed against CMV and is used to attenuate or prevent CMV disease in immunosuppressed transplant recipients. CMV is a major cause of morbidity in transplant patients and prophylaxis is targeted to high‑risk post‑transplant periods.

The policy’s indications and exclusions reflect the safety profile of human immunoglobulin products: because of the risk of anaphylaxis in patients with anti‑IgA antibodies and the possibility of severe reactions in those with prior hypersensitivity to immunoglobulin products, Cytogam is contraindicated in those groups and excluded from coverage.