Varicella and Herpes Zoster Vaccines (Clinical Policy Bulletin)
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Clinical policy bulletin describing medical necessity, experimental/investigational determinations, and coding related to varicella (including MMRV) and herpes zoster (Shingrix, Zostavax) vaccines for Aetna members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Varicella and Herpes Zoster Vaccines
Covered Indications
Aetna considers varicella and herpes zoster vaccines medically necessary for the following indications:
Repeat (booster) beyond the primary two‑dose Shingrix series is considered experimental/investigational.
Coverage-related clinical recommendations
Guidance and criteria referenced from ACIP/CDC and FDA approvals:
ACIP preference and FDA approval noted.
Second dose interval may be shortened to 1–2 months for immunocompromised adults.
CDC guidance referenced.
Clinical evidence and timing considerations
Summarized findings and recommended timing/considerations for vaccination in special populations:
Systematic review/meta‑analysis of 8 studies including 404,561 individuals.
Phase II/III trial evidence summarized.
Trial efficacy and safety data cited.
Phase III and other trials summarized.
Trial subgroup results.
Guideline and review sources summarized.
Coverage-relevant clinical criteria
Key coverage-related clinical points supported by the evidence presented:
Based on ACIP and guideline reviews.
Systematic reviews and meta‑analyses reported.
Trial and systematic review data cited.
Aetna considers recombinant herpes zoster vaccine (Shingrix) experimental and investigational for the treatment of zoster or postherpetic neuralgia (PHN), for the prevention of primary varicella infection (chickenpox), and for all other indications not established, because effectiveness for these indications has not been demonstrated.
The live-attenuated zoster vaccine (Zostavax) is not indicated for prevention of primary varicella infection (chickenpox) and is not indicated for treatment of zoster or postherpetic neuralgia (PHN) per the FDA package insert. Note that Zostavax is no longer available for use in the United States as of November 18, 2020.
ACIP guidance indicates that the live zoster vaccine is contraindicated in immunosuppressed patients, but notes exceptions where certain patients are not considered sufficiently immunosuppressed to preclude vaccination — for example, those receiving short-term corticosteroid therapy (<14 days) or low-to-moderate dose corticosteroids (<20 mg/day), and patients on certain low-dose immunomodulators (e.g., methotrexate ≤0.4 mg/kg/week, azathioprine ≤3.0 mg/kg/day, or 6-mercaptopurine ≤1.5 mg/kg/day).
Live zoster vaccine (Zostavax) is contraindicated in immunosuppressed patients. Live zoster vaccine should generally be avoided in persons with immunodeficiency or receiving immunosuppressive therapies.
Clinical Policy Bulletins are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. They provide only a partial description of plan or program benefits and do not constitute a contract; coverage determinations may differ by plan and treating providers are responsible for medical decisions.
Aetna considers repeat (booster) administration of recombinant herpes zoster vaccine (Shingrix) beyond the primary two-dose series to be experimental and investigational. Re-vaccination is addressed specifically for HSCT recipients under defined conditions, but routine additional booster doses beyond the two-dose primary series are not considered established.
Coding and Diagnostic Requirements
| 90750 | Zoster (shingles) vaccine (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection [Shingrix]. |
| B20 | Human immunodeficiency virus [HIV] disease. |
| Z21 | Asymptomatic human immunodeficiency virus [HIV] infection status. |
| Z23 | Encounter for immunization. |
| B01.9 | Varicella without complication [prevention of chickenpox]. |
| B02.0 - B02.9 | Zoster (herpes zoster). |
| D89.810 - D89.813 | Graft-versus-host disease. |
Provider Actions, Documentation, and Billing Guidance
Potential Denial Triggers
Claims may be denied if billed with ICD-10 diagnosis codes that are listed as not covered for the indications in this Clinical Policy Bulletin. Providers should verify that the diagnosis supports the vaccine indication before submission.
- Potential denial triggers: submission of vaccines with ICD-10 codes specifically listed as not covered for the CPB indications.
- Verify member eligibility and indication against the CPB before billing.
Required Coding & Diagnosis Documentation
Use appropriate CPT/HCPCS codes and supporting ICD-10 diagnosis codes on claims to reflect the immunization encounter and clinical indication. Common documentation codes include Z23 (encounter for immunization). For Shingrix use CPT 90750; for varicella/MMRV use 90716 and 90710 as applicable. Do not bill live zoster vaccine codes for indications excluded by this CPB.
- Submit vaccine CPT (e.g., 90750 for Shingrix) with a supporting ICD-10 diagnosis that documents the indication.
- Include Z23 for routine immunization encounters when appropriate.
Herpes Zoster Live Vaccine Contraindication
The live zoster vaccine (Zostavax; CPT 90736) is contraindicated for use in immunosuppressed patients and is not indicated for primary varicella prevention or treatment of zoster/PHN. Zostavax supply was discontinued in the U.S.; remaining stock may be used until it expires but is not covered for CPB-listed indications where live vaccine is contraindicated.
- Do NOT administer or bill live zoster vaccine for immunosuppressed members or for indications excluded by this policy.
- If live vaccine is used from existing stock, ensure indication and member immune status meet any applicable plan rules.
Documentation for Hematopoietic Cell Transplant (HCT) Recipients
Document clinical evidence when vaccinating transplant recipients or immunocompromised patients. For hematopoietic cell transplant (HCT) recipients, document that at least 24 months have passed since HCT, absence of graft-versus-host disease (GVHD), and that the patient is considered immunocompetent prior to administration of varicella/zoster/MMRV vaccines per CPB guidance.
- Document date of HCT and that ≥24 months have elapsed.
- Document absence of graft-versus-host disease and clinical assessment of immunocompetence.
Document Timing Relative to Transplant or Immunosuppression
Document timing of vaccination relative to planned immunosuppression or transplant. Whenever possible, administer live vaccines ≥4 weeks before initiating immunosuppressive therapy. For Shingrix in immunocompromised persons, follow ACIP and FDA guidance on dosing intervals (2–6 months for immunocompetent; 1–2 months may be used for certain immunocompromised schedules).
- Document planned or current immunosuppressive therapies and vaccination dates relative to therapy/transplant.
- If vaccinating prior to immunosuppression, note the timing (e.g., ≥4 weeks before therapy).
Preferred Vaccine Sequencing and Step Therapy
ACIP recommends recombinant zoster vaccine (Shingrix) over zoster live vaccine (Zostavax). For patients previously vaccinated with Zostavax, Shingrix is preferred and may be administered according to ACIP guidance. There are no step therapy requirements in this CPB — RZV superiority to ZVL is described but no step edits or step therapy rules are specified.
- Preferred sequencing: RZV (Shingrix) preferred over ZVL; previously vaccinated persons with Zostavax may receive Shingrix.
- No step therapy rules or requirements are specified in this Clinical Policy Bulletin.
Provider Responsibility and Plan Provisions
Providers are responsible for making treatment decisions and must follow plan benefit provisions. This CPB is informational and does not guarantee coverage; verify specific member benefits and prior authorization requirements with the payer.
- Confirm member coverage, benefit limits, and any plan-specific prior authorization requirements before administering vaccines.
- Document clinical rationale for vaccination in the medical record.
Additional Provider Actions / When CPB Is Silent
General provider action reminders and placeholders: when requirements are not explicitly stated in the CPB (e.g., prior authorization rules), refer to plan-specific provisions and payer portals or contact the payer directly for clarification.
- If prior authorization is required by the specific member plan, follow plan portals/processes even if CPB does not list PA rules.
- Maintain immunization record, informed consent, and screening for contraindications/allergies prior to administration.
Background and Clinical Context
ACIP recommends varicella vaccination as a 2-dose series beginning at 12 months of age for children, and varicella vaccination for susceptible adolescents and adults per ACIP guidance. Herpes zoster results from reactivation of varicella-zoster virus, and risk of herpes zoster and postherpetic neuralgia increases with age and immunosuppression.
Definitions
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