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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsConnectiCare Cytogam Prior Auth Coverage | OpenPay…
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    CurrentConnectiCarePolicy C9970-A

    Cytomegalovirus Prophylaxis Post Solid Organ Transplant

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    This policy governs prior authorization and coverage of Cytogam (cytomegalovirus immune globulin intravenous [human]) for CMV prophylaxis after specified solid organ transplantation and for adjunctive treatment of CMV pneumonitis. It applies to members receiving the drug under the pharmacy or medical benefit, subject to benefit eligibility and the clinical criteria in the policy.

    Policy Summary
    PayerConnectiCare
    PolicyCytomegalovirus Prophylaxis Post Solid Organ Transplant
    Policy CodePolicy C9970-A
    Change TypeAdministrative and reference updates
    Effective DateMar 27, 2026
    Next Review DateJan 1, 2027
    Key ActionSubmit documentation showing the member meets the applicable CMV prophylaxis or CMV pneumonitis criteria, including required transplant or diagnostic information and concomitant antiviral therapy.
    SourceLink
    POLICY UPDATE CHANGES

    The annual review updated coding, billing information, and references without changing coverage criteria.

    16 weeksMaximum prophylaxis authorization
    1 monthMaximum pneumonitis authorization
    18+Minimum member age

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    6
    Eligible transplanted organs
    J0850Covered HCPCS code

    Coverage Criteria

    CMV prophylaxis after solid organ transplant

    Covered when all of the following are met:

    Post-solid-organ-transplant CMV prophylaxis

    • Qualifying transplant

      • Member has a history of a kidney transplant.
      • Member has a history of a lung transplant.
      • Member has a history of a liver transplant.
      • Member has a history of a pancreas transplant.
      • Member has a history of a heart transplant.
      • Member has a history of a kidney-pancreas transplant.

    • CMV serology

      • The organ donor is CMV seropositive.
      • The organ recipient is CMV seropositive.
    • Concomitant antiviral therapy: CMV immune globulin will be provided in addition to antiviral therapy.

      Antivirals listed include valganciclovir, ganciclovir, and foscarnet.

    CMV pneumonitis

    Covered when all of the following are met:

    • Documented diagnosis: Member has a documented diagnosis of cytomegalovirus pneumonitis.
    • Adjunctive therapy: Cytomegalovirus immune globulin will be provided in addition to antiviral therapy.

      Antivirals listed include valganciclovir and ganciclovir.

    General authorization requirements

    The following administrative and clinical requirements also apply:

    • Member is 18 years of age or older.18 years of age and older

    • Qualified prescriber

      • The drug is prescribed by an immunologist.
      • The drug is prescribed by a nephrologist.
      • The drug is prescribed by a pulmonologist.
      • The drug is prescribed by a hepatologist.

    CMV-IVIG prophylaxis is not supported by evidence for CMV-seronegative recipients of a bone marrow allograft from a CMV-seropositive donor. Other uses of Cytogam are considered experimental or investigational and follow the applicable off-label policy.

    Cytogam is excluded for individuals with a prior severe reaction to Cytogam or another human immunoglobulin preparation. It is also excluded for individuals with selective IgA deficiency, anti-IgA antibodies, and a history of anaphylactic reactions to human immune globulin preparations.

    Initial Therapy Criteria

    Initial CMV prophylaxis

    Initial authorization for post-solid-organ-transplant CMV prophylaxis requires all criteria below:

    Initial prophylaxis criteria

    • Qualifying transplant

      • Member has a history of a kidney transplant.
      • Member has a history of a lung transplant.
      • Member has a history of a liver transplant.
      • Member has a history of a pancreas transplant.

    Continuation and Reauthorization

    Continuation and reauthorization

    Continuation therapy is not available under this policy.

    No continuation authorization: Reauthorization beyond the initial authorization period is not permitted for either indication.

    The initial authorization period is 16 weeks for post-solid-organ-transplant CMV prophylaxis and 1 month for CMV pneumonitis. Any subsequent request must meet the applicable initial approval criteria.

    Authorization and Provider Requirements

    Prior Authorization

    Clinical Criteria Required

    Prior authorization requires documentation that the member meets the applicable Cytomegalovirus (CMV) prophylaxis post-solid-organ-transplant or CMV pneumonitis criteria.

    Prior Authorization

    Qualified Prescriber Required

    The drug must be prescribed by, or in consultation with, an appropriate specialist.

    • Eligible specialists include an immunologist, nephrologist, pulmonologist, hepatologist, gastroenterologist, cardiologist, infectious disease specialist, or transplant specialist.
    Prior Authorization

    Adult Age Requirement

    Coverage is limited to members who are 18 years of age or older.

    Billing and Coding

    Covered HCPCS CodesHCPCSCovered
    J0850Injection, cytomegalovirus immune globulin intravenous (human), per vial

    Quantity and Duration Limits

    Cytogam quantity requirements
    DosageMust be supported by FDA labeling or compendia-supported dosing for the prescribed indication.
    FrequencyMust be supported by FDA labeling or compendia-supported dosing for the prescribed indication.
    Total treatment durationMust be supported by FDA labeling or compendia-supported dosing for the prescribed indication.

    Site of Care Requirements

    Billing Rule

    Use the recommended hospital outpatient setting

    Infused medications are recommended for administration in a non-inpatient hospital facility-based location under the pharmacy or medical benefit.

    Clinical Background

    Cytomegalovirus immune globulin is used to reduce the risk of CMV disease after transplantation of specified solid organs, including the kidney, lung, liver, pancreas, and heart. It may also be used as adjunctive therapy with antiviral treatment for CMV pneumonitis in solid organ transplant recipients.

    Definitions

    CMV prophylaxis
    DefinitionPrevention of cytomegalovirus disease associated with transplantation.
    Eligible transplanted organsKidney, lung, liver, pancreas, or heart.
    Serologic contextFor transplants other than kidney, prophylactic CMV immune globulin may be considered with ganciclovir when the donor is CMV seropositive and the recipient is seronegative.
    CMV pneumonitis
    DefinitionCMV pneumonitis in a solid organ transplant recipient.
    Treatment roleAdjunctive therapy.
    Patient population
    Policy Summary
    PayerConnectiCare
    PolicyCytomegalovirus Prophylaxis Post Solid Organ Transplant
    Policy CodePolicy C9970-A
    Change TypeAdministrative and reference updates
    Effective DateMar 27, 2026
    Next Review DateJan 1, 2027
    Key ActionSubmit documentation showing the member meets the applicable CMV prophylaxis or CMV pneumonitis criteria, including required transplant or diagnostic information and concomitant antiviral therapy.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaContinuation and ReauthorizationAuthorization and Provider RequirementsBilling and CodingQuantity and Duration LimitsSite of Care RequirementsClinical BackgroundDefinitions
    The drug is prescribed by a gastroenterologist.
  1. The drug is prescribed by a cardiologist.
  2. The drug is prescribed by an infectious disease specialist.
  3. The drug is prescribed by a transplant specialist.
  4. The drug is prescribed in consultation with one of the listed specialists.

    When prescribed in consultation, submit consultation notes with the initial request.

  5. Dosage, frequency, and total treatment duration are supported by FDA labeling or compendia-supported dosing for the prescribed indication.
  6. The drug is administered intravenously in a non-inpatient, hospital facility-based location under the pharmacy or medical benefit.

    The policy recommends this site of care for infused medications.

    7. Member has a history of a heart transplant.
  7. Member has a history of a kidney-pancreas transplant.
  8. The organ donor or recipient is CMV seropositive.
  9. CMV immune globulin is provided in addition to antiviral therapy.

    Antivirals listed include valganciclovir, ganciclovir, and foscarnet.

    10. Initial CMV pneumonitis treatment

    Initial authorization for CMV pneumonitis requires all criteria below:

    Initial CMV pneumonitis criteria

    • Member has a documented diagnosis of cytomegalovirus pneumonitis.
    • Cytomegalovirus immune globulin is provided in addition to antiviral therapy.

      Antivirals listed include valganciclovir and ganciclovir.

    Documentation Required

    Label- or Compendia-Supported Dosing

    Dosage, frequency, and total treatment duration must be supported by FDA-labeled or compendia-supported dosing for the prescribed indication.

    Billing Rule

    Administration Requirements

    Cytogam must be administered intravenously and may be covered under the pharmacy or medical benefit when administered in an appropriate site of care.

    • The recommended site of service is a non-inpatient hospital facility-based location.
    Documentation Required

    Required Clinical Documentation

    Submit records supporting the qualifying transplant or CMV pneumonitis diagnosis and relevant CMV status.

    • For post-transplant prophylaxis, document a history of kidney, lung, liver, pancreas, heart, or kidney-pancreas transplant.
    • Document that the organ donor or recipient is CMV seropositive.
    • For CMV pneumonitis, document the diagnosis.
    • Document that CMV immune globulin will be provided in addition to antiviral therapy, such as valganciclovir or ganciclovir.
    Documentation Required

    Consultation Documentation

    When Cytogam is prescribed in consultation with a specialist, consultation notes must be submitted with the initial request.

    Documentation Required

    Additional Medical Necessity Support

    The plan may request additional documentation to support medical necessity, coverage eligibility, and appropriate use.

    • Requested records may include patient records, test results, provider credentials, dosing measurements, and other clinical rationale.
    • Documentation must support that the treatment is medically necessary, not investigational or experimental, and within the member's benefits.
    Denial Risk

    Post-Transplant Prophylaxis Criteria Not Met

    Coverage may be denied when post-transplant prophylaxis criteria are not met or are not adequately documented.

    • No documented eligible kidney, lung, liver, pancreas, heart, or kidney-pancreas transplant.
    • No documentation that the organ donor or recipient is CMV seropositive.
    • CMV immune globulin is not being provided in addition to antiviral therapy.
    Denial Risk

    CMV Pneumonitis Criteria Not Met

    Coverage may be denied when CMV pneumonitis criteria are not met or the requested treatment purpose is not supported.

    • No documented diagnosis of CMV pneumonitis.
    • CMV immune globulin is not being provided in addition to antiviral therapy.
    • The request does not identify CMV pneumonitis as the proposed treatment purpose.
    Denial Risk

    Unsupported or Investigational Use

    Use that is unsupported by evidence or otherwise outside the covered indications is considered experimental or investigational and is not covered under this policy.

    • Use for primary CMV prophylaxis after hematopoietic stem cell or bone marrow transplantation is not supported by evidence.
    • All other uses of Cytogam are considered experimental or investigational and are subject to the applicable off-label policy.
    Denial Risk

    Contraindication or Severe Hypersensitivity

    Coverage is excluded for members with a prior severe reaction to Cytogam or another human immunoglobulin preparation.

    • Also contraindicated in persons with selective IgA deficiency who have antibodies to IgA and a history of anaphylactic reactions to human immune globulin preparations.
    Denial Risk

    Authorization Duration Exceeded

    Reauthorization beyond the initial authorization period is not permitted; the member must meet the initial approval criteria for the applicable indication.

    • CMV prophylaxis post solid organ transplant: initial authorization is limited to 16 weeks.
    • CMV pneumonitis: initial authorization is limited to 1 month.
    • Continuation of therapy is not applicable.
    Solid organ transplant recipients.
    Immune serums
    Therapeutic categoryImmune Serums.
    ProductCytogam.
    Therapy typeCytomegalovirus immune globulin intravenous (human).