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Human papillomavirus (HPV) vaccine (Gardasil 9)
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Defines Aetna's coverage stance on the 9‑valent HPV vaccine (Gardasil 9), including medical necessity, investigational indications, coding guidance, limitations, and background; applies to Aetna members and providers submitting claims.
No material clinical or coverage changes in this revision.
Coverage Criteria for Gardasil 9 (9vHPV)
Medical Necessity (Gardasil 9)
Covered when ALL of the following are met
If prior vaccine product is unknown or transitioning to Gardasil 9, Gardasil 9 may be used to continue or complete a 3‑dose series.
Indications by age and dosing
Coverage and recommended use described by age and indication
ACIP routine recommendation for 11–12 year olds
ACIP catch-up guidance
ACIP dosing guidance
FDA expanded age; ACIP recommends shared decision-making
Prevention of recurrence of ano-genital warts
Evidence summary regarding secondary prevention of ano-genital warts (AGWs):
Authors concluded vaccination did not provide secondary benefit for recurrence of AGWs but evidence is limited and not generalizable
Vaccine effectiveness by number of doses
Effectiveness by number of doses (post-licensure observational studies):
Future studies should vaccinate prior to sexual initiation and reduce bias
HPV vaccine in head and neck cancer
Therapeutic vaccine research for HPV+ head and neck cancer and regulatory status:
Therapeutic vaccines are promising but insufficient data for conclusions
Accelerated approval per FDA
Post-treatment vaccination and CIN recurrence
Post-treatment HPV vaccination for women undergoing excisional treatment for CIN:
Serious risk of bias and heterogeneity limit confidence; large RCTs needed
Adjuvant use in JoRRP
HPV vaccine as adjuvant therapy for juvenile-onset RRP:
Prospective multi-center studies with larger sample sizes needed
Guideline updates (ACS, ACOG)
Guideline positions on vaccination timing and age limits:
Providers should inform individuals aged 22–26 that vaccination at older ages is less effective
Encourages stocking/administering vaccine in offices when feasible
Aetna considers administration of Gardasil 9 (9‑valent HPV vaccine) not medically necessary when the member has already completed a documented three‑dose series with Gardasil (quadrivalent) or Cervarix (bivalent). An exception applies when the prior vaccine product is unknown or unavailable — in those situations, use of Gardasil 9 to continue or complete the three‑dose series is considered medically necessary.
Not all benefit plans provide coverage for preventive services. Providers should verify member benefit plan descriptions and prior authorization requirements before administering Gardasil 9, since coverage for preventive vaccination is plan‑dependent and may vary by contract.
Gardasil 9 will not prevent disease caused by HPV types not contained in the vaccine and is not therapeutic for established HPV infections or lesions. Vaccination does not accelerate clearance of pre‑existing HPV infection and should not be used to treat active genital warts or established cervical, vulvar, or vaginal disease.
The American Cancer Society recommends routine HPV vaccination beginning between ages 9 and 12 years and supports catch‑up vaccination through age 26 years for persons not adequately vaccinated. The ACS does not endorse routine catch‑up vaccination for adults older than 26 years and advises that vaccination after young adulthood is less effective in lowering cancer risk.
This Clinical Policy Bulletin provides a general, partial description of plan or program benefits and is intended to assist in administering benefits. It does not constitute a contract; coverage and any prior authorization requirements are subject to the member's specific plan terms.
Gardasil 9 is considered not medically necessary for indications listed in this policy as experimental or investigational, including uses for which effectiveness has not been established (see policy list). Services inconsistent with plan benefits or policy criteria may be denied under the member's plan terms.
Use of HPV vaccine as a therapeutic intervention for persons already infected — for example, to accelerate viral clearance or to treat active genital warts — is not supported by available evidence and is considered not medically necessary. Randomized trial data do not show increased viral clearance in persons vaccinated while infected.
Available randomized controlled trial evidence on vaccination to prevent recurrence of ano‑genital warts is limited. A systematic search identified 824 potentially relevant studies but only 2 RCTs (656 subjects) met eligibility; the pooled estimate showed no secondary preventive benefit (overall effect 1.02; 95% CI 0.75–1.38). These findings do not support HPV vaccination as effective for preventing AGW recurrence after treatment.
Coding Guidance
| 90651 | Human Papillomavirus vaccine types 6, 11, 16, 18, 31, 33, 45, 52, 58, nonavalent (9vHPV), 3 dose schedule, for intramuscular use. |
| 90649 | Human Papillomavirus vaccine, types 6, 11, 16, 18, quadrivalent (4vHPV), 3 dose schedule, for intramuscular use. |
| 90650 | Human papillomavirus vaccine, types 16, 18, bivalent (2vHPV), 3 dose schedule, for intramuscular use. |
| 90471 | Immunization administration; one vaccine (single or combination vaccine/toxoid). |
| 90472 | Each additional vaccine (single or combination vaccine/toxoid). |
| D1781 | Vaccine administration – human papillomavirus – Dose 1. |
| D1782 | Vaccine administration – human papillomavirus – Dose 2. |
| D1783 | Vaccine administration – human papillomavirus – Dose 3. |
| A63.0 | Anogenital (venereal) warts. |
| C44.520 | Squamous cell carcinoma of anal skin. |
| C51.0 - C53.9 | Malignant neoplasm of vulva, vagina and cervix uteri. |
| D06.0 - D07.2 | Carcinoma in situ of cervix uteri, vulva and vagina. |
| D10.0 - D10.9 | Benign neoplasm of mouth and pharynx [benign squamous papilloma]. |
| D14.1 | Benign neoplasm of larynx [benign squamous papilloma][Juvenile-onset recurrent respiratory papillomatosis]. |
| K62.82 | Dysplasia of anus. |
| N87.0 - N87.9 | Dysplasia of cervix uteri. |
Provider Responsibilities, Prior Authorization, and Documentation
Prior authorization / coverage headline
Gardasil 9 (CPT 90651) is considered medically necessary for persons age 9 to 45 years when selection criteria are met; verify member benefits and plan coverage prior to vaccine administration.
- Covered code: CPT 90651 (9‑valent HPV vaccine, 3‑dose schedule)
- Not all plans cover preventive services; check benefit plan descriptions for specifics
Shared decision‑making for ages 27–45
For persons aged 27–45, vaccination should be based on shared clinical decision‑making because public health benefit is minimal but some individuals who are not adequately vaccinated may benefit.
- ACIP recommends shared clinical decision‑making for persons 27–45 years
- FDA expanded age indication for Gardasil 9 supports individualized decision making
Verify coverage and prior authorization for >26 years
Verify member benefits and any prior authorization requirements before administering HPV vaccine to adults older than 26 years, since vaccination after age 26 may not be covered by payers.
- Clinicians and patients should be aware vaccination after age 26 may not be covered by insurance providers
- Check benefit plan descriptions for coverage details
Prior authorization determined by member's plan
This Clinical Policy Bulletin is intended to assist in administering plan benefits; prior authorization requirements are determined by the member's plan and are not specified in this bulletin—confirm plan‑specific rules.
- Prior authorization determination rests with the member’s plan
- Bulletin does not constitute a contract or complete benefit description
No step therapy specified
No step therapy requirements for Gardasil 9 are specified in this Clinical Policy Bulletin.
- Documented policy sections list no step therapy requirements
Step therapy not specified in excerpt
Affirmation: the provided policy sections do not specify step therapy requirements for HPV vaccination in this bulletin.
Document vaccine product and dosing
When administering Gardasil 9, document the vaccine product and dosing—include whether the dose completes or continues a series and the dosing schedule used.
- Record vaccine product (Gardasil 9) and CPT code (90651)
- Indicate whether dose completes a 3‑dose series or continues a series
Document vaccination dates and dosing schedule
Record vaccination dates and the dosing schedule administered: for the 3‑dose series note doses at 0, 2, and 6 months; for the 2‑dose schedule (ages 9–14) document the 6–12 month interval and patient age at initiation.
- 3‑dose schedule: 0, 2, and 6 months
- 2‑dose schedule (start ages 9–14): 6–12 months apart; document dates for each dose
Document indication/rationale for patients >26 years
When vaccinating patients aged 27–45, document the clinical rationale (for example: low likelihood of prior HPV exposure, planned future risk, or occupational exposure) because coverage and benefits may vary in this age group.
- Record indication/rationale for vaccination in 27–45 age group
- Verify and note benefit coverage if insurance may not cover vaccination after age 26
Provider responsibility for medical advice and benefits verification
Treating providers are responsible for medical advice and treatment of members; this bulletin is a partial description of plan benefits and does not replace clinical judgment or plan‑specific rules.
- Providers are independent contractors and responsible for medical care
- Bulletin is not a contract and may be updated
Non‑covered CPT codes (90649, 90650) — denial risk
Claims billed with CPT codes 90649 (quadrivalent) or 90650 (bivalent) are not covered for the indications listed in this Clinical Policy Bulletin and may be denied if used for those indications.
- Do not bill 90649 or 90650 for indications covered by this CPB
- Use CPT 90651 for Gardasil 9 when selection criteria are met
Contraindications — anaphylaxis and pregnancy
Do not administer HPV vaccine to individuals with a history of anaphylactic reaction to any component (including excipients) of the vaccine or to persons who are pregnant; these are contraindications that may trigger denial or adverse events.
- History of anaphylaxis to any vaccine component is a contraindication
- Pregnancy is a contraindication to vaccination
Coverage risk for adults >26 years
Inform clinicians and patients that insurers may not cover HPV vaccination after age 26; this coverage risk should be considered when deciding to vaccinate adults older than 26.
- Vaccination after age 26 may not be covered by insurance providers or payers
- Verify benefits and prior authorization before administration
Denial risk for services not consistent with plan or policy
Services that are inconsistent with plan benefits or with the criteria in this policy may be denied; the Clinical Policy Bulletin is intended to assist administering plan benefits but does not guarantee coverage.
- Services not meeting policy criteria may be denied per plan terms
- Bulletin provides only a partial, general description of benefits
Background and Rationale
Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States and can cause several cancers and ano‑genital warts. Gardasil 9 is the only HPV vaccine currently distributed in the U.S. and protects against nine HPV types — seven oncogenic types (16, 18, 31, 33, 45, 52, 58) and two low‑risk types (6, 11). Vaccination is most effective when given before exposure and routine immunization is recommended to begin at age 9, with the routine target ages of 11–12 years.
Key Definitions
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