Human Papillomavirus Vaccine Gardasil-9 - Policy Number: PG0092 Last Review: 11/25/2019
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Human Papillomavirus Vaccine Gardasil-9
Policy Number: PG0092 HMO & PPO
Last Review: 11/25/2019 MARKETPLACE
MEDICARE – ELITE,
MAP & PROMEDICA
IMPORTANT | For Paramount Advantage Only: Paramount medical policies only apply to Paramount
Advantage Medicaid claims with dates of service before Feb. 1, 2023. Please contact Anthem, for Medicaid
claims with dates of service on or after Feb. 1, 2023.
GUIDELINES
• This policy does not certify benefits or authorization of benefits, which is designated by each individual
policyholder terms, conditions, exclusions and limitations contract. It does not constitute a contract or
guarantee regarding coverage or reimbursement/payment. Self-Insured group specific policy will
supersede this general policy when group supplementary plan document or individual plan decision
directs otherwise.
• Paramount applies coding edits to all medical claims through coding logic software to evaluate the
accuracy and adherence to accepted national standards.
• This medical policy is solely for guiding medical necessity and explaining correct procedure reporting
used to assist in making coverage decisions and administering benefits.
SCOPE
X Professional
_ Facility
DESCRIPTION
Genital human papillomavirus (HPV) is the most common sexually transmitted infection (STI). HPV is a group of
more than 200 related viruses. There are more than 40 types of HPV that can infect the genital areas of males and
females. These HPV types can also infect the mouth and throat. HPV can cause serious health problems,
including genital warts and certain cancers of the anus, penis, cervix, vulva and vagina.
Three vaccines that prevent infection with disease-causing HPV types have been licensed for use in the United
States: Gardasil®, Gardasil® 9, and Cervarix®. All three vaccines prevent infection with HPV types 16 and 18.
HPV types 16 and 18 are believed responsible for about 70% of cervical cancers and an even higher percentage of
some of the other HPV-caused cancers. Gardasil also prevents infection with HPV types 6 and 11, which cause
90% of genital warts. Gardasil 9 prevents infection with the same four HPV types plus five additional cancer-
causing types that together account for 10 to 20% of cervical cancers. Gardasil nine-valent is effective against HPV
types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Gardasil 9 is now the only HPV vaccine available for use in the United States. Cervarix and Gardasil has been
removed from the U.S. market, however they are still used in other countries. In October 2018, the FDA approved
an age expansion for Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) vaccine to include
women and men 27 through 45 years of age. On June 2019 the CDC’s Advisory Committee for Immunization
Practices (ACIP) recommended that person 27 through 45 years of age to engage in shared decision-making when
considering the 9-valent HPV vaccine.
Gardasil 9 is indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
• Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV)
types 16, 18, 31, 33, 45, 52, and 58.
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
PG0092 – 02/06/2023In addition, the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52,
and 58:
• Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in
situ (AIS).
• Cervical intraepithelial neoplasia (CIN) grade 1.
• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
Gardasil nine‐valent is indicated in boys 9 through 45 years of age for the prevention of the following diseases:
• Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
In addition, the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45,
52, and 58:
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
POLICY
Paramount Commercial Plans, Medicare Advantage Plans, and Paramount Medicaid Advantage
Paramount Commercial Plans
HPV Vaccines Gardasil 9 (90651), ages 9-45, does not require prior authorization
Paramount Medicaid Advantage
HPV Vaccines Gardasil 9 (90651), ages 9-26, does not require prior authorization, effective
through 12/31/2019
HPV Vaccines Gardasil 9 (90651), ages 9-45, does not require prior authorization effective
1/1/2020
University of Toledo
HPV Vaccines Gardasil 9 (90651), ages 8-27, does not require prior authorization effective
through 12/31/2019
HPV Vaccines Gardasil 9 (90651), ages 9-45, does not require prior authorization effective
1/1/2020
Medicare Advantage Plans
HPV Vaccines Gardasil 9 (90651) is not covered for Medicare Advantage Plans
COVERAGE CRITERIA
Coverage as recommended by the Centers of Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP): Gardasil 9 (human papillomavirus vaccine)
• Children and adults aged 9 through 26 years: HPV vaccination is routinely recommended
at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch‐up HPV
Vaccination is recommended for all persons through age 26 years who are not
Adequately vaccinated.
• Adults aged greater than 26 years: Catch‐up HPV vaccination is not recommended for all
Adults aged greater than 26 years. Instead, shared clinical decision‐making regarding
HPV vaccination is recommended for some adults aged 27 through 45 years who are not
Adequately vaccinated. HPV vaccines are not licensed for use in adults aged greater than
45 years.
• Dosing and Administration:
Gardasil 9 should be administered intramuscularly as a 0.5mL dose at the following schedule:
o Age 9 through 14 years: 2-dose regimen at 0, 6 to 12 months
If the second dose is administered earlier than 5 months after the first dose, administer a
PG0092 – 02/06/2023third dose at least 4 months after the second dose.
o Age 9 through 14 years: 3-dose regime at 0, 2, 6 months
o Age 15 through 45 years: 3 dose regimen at 0, 2, 6 months
o Please note: if the vaccine schedule is interrupted, it does not need to be restarted. If a product
becomes unavailable, another product can be used to replace the original in order to complete the
series.
The efficacy and safety of the vaccine in members less than nine years or age and over 45 years of age has not
been established.
Gardasil 9 vaccination of persons who have been vaccinated with Gardasil or Cervarix is considered experimental
and investigational. For persons who have been adequately vaccinated with Cervarix or Gardasil, there is no ACIP
recommendation regarding additional vaccination with Gardasil 9.
Gardasil (human papillomavirus vaccine) has not been demonstrated to protect against diseases due to HPV types
not contained in the vaccine.
A severe allergic reaction (e.g., anaphylaxis) to a vaccine component or following a prior dose of HPV vaccine is a
contraindication to receipt of HPV vaccine.
• Anaphylactic allergy to latex is a contraindication to bivalent HPV vaccine in a prefilled syringe since the tip
cap might contain natural rubber latex.
• Quadrivalent and 9-valent HPV vaccines are produced in Saccharomyces cerevisiae (baker's yeast) and
are contraindicated for persons with a history of immediate hypersensitivity to yeast.
• A moderate or severe acute illness is a precaution to vaccination, and vaccination should be deferred until
symptoms of the acute illness improve.
• A minor acute illness (e.g., diarrhea or mild upper respiratory tract infection, with or without fever) is not a
reason to defer vaccination.
HPV should not be utilized in impaired immune responsiveness.
HPV vaccine is not recommended for use during pregnancy.
• The vaccine has not been causally associated with adverse pregnancy outcomes or with adverse effects on
the developing fetus, but data on vaccination during pregnancy are limited
• Women known to be pregnant should delay initiation of the vaccine series until after the pregnancy
• Pregnancy testing before vaccination is not needed. However, if a woman is found to be pregnant after
initiation of the vaccination series, the remainder of the series should be delayed until after she is no longer
pregnant. No intervention is indicated
Gardasil (human papillomavirus vaccine) is considered experimental and investigational for the following
indications (not an all-inclusive list) because their effectiveness for indications other than ones listed above have
been established:
• Active genital warts
• External genital lesions
• Benign squamous papilloma
• Head and neck cancer
• Recurrent respiratory papillomatosis (recurrent laryngeal papillomatosis
• Treatment of active genital warts, cervical, vulvar, vaginal and anal cancers
Medicare Advantage Plans
Gardasil (90649), Gardasil 9 (90651) and Cervarix (90650) vaccines are not covered.
CODING/BILLING INFORMATION
The inclusion or exclusion of a code in this section does not necessarily indicate coverage. Codes referenced in
PG0092 – 02/06/2023this clinical policy are for informational purposes only.
Codes that are covered may have selection criteria that must be met.
Payment for supplies may be included in payment for other services rendered.
CPT CODES
90649 HPV vaccine, types 6, 11, 16, 18 (quadrivalent), 3-dose schedule, for intramuscular use.
90650 HPV vaccine, types 16, 18, bivalent, 3 dose schedule, for intramuscular use.
90651 Human Papillomavirus vaccine types 6, 11, 16, 18, 31, 33, 45, 52, 58, nonavalent (HPV), 2 or
3 dose schedule, for intramuscular use
Paramount reserves the right to review and revise our policies periodically when necessary. When
there is an update, we will publish the most current policy to
https://www.paramounthealthcare.com/services/providers/medical-policies/ .
REVISION HISTORY EXPLANATION
ORIGINAL EFFECTIVE DATE: 08/01/2006
Date Explanation & Changes
12/01/2006 • Advantage coverage
04/15/2007 • Advantage age limit changes
11/15/2008 • New code
10/15/2009 • Updated verbiage
01/15/2010 • Added coverage for Advantage males
07/01/2011 • No changes
11/04/2011 • Added coverage for males, HMO, PPO, OBA product lines
• Rewrite of policy
02/06/2012
• Present to MAC
• Policy reviewed and updated to reflect most current clinical evidence
04/08/2014
• Approved by Medical Policy Steering Committee as revised
• Added new Gardasil 9 (90651) as preventive coverage
05/12/2015 • Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
• Gender verbiage changes completed per Meaningful Access Section 1557 of the
11/23/2016
Affordable Care Act
• If the HMO, PPO, Individual Marketplace, or Advantage member began the vaccine
series before age 27, but the three part vaccine series is not completed by the time they
02/14/2017 reach age 27, the additional doses will now be covered with prior authorization
• Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
• Revised effective 01/01/18 code 90651
01/09/2018 • Policy reviewed and updated to reflect most current clinical evidence per Medical Policy
Steering Committee
• Changed title from HPV Vaccine Gardasil and Cervarix to Human Papillomavirus
Vaccine Gardasil-9
• Revised coverage to the up-to-date industry standards, following the Centers of Disease
11/14/2019 Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP):
Gardasil 9 (human papillomavirus vaccine) coverage and criteria
• Policy reviewed and updated to reflect the current clinical evidence per Medical Policy
Steering Clinical Work Group, 111419
• Received a response from ODM, on 11/18/2019, “Yes, beginning 1/1/20, ODM will cover
11/25/2019 the FDA indicated expanded age range.”
• Policy updated with the appropriate age limits for the Advantage product line
12/14/2020 • Medical policy placed on the new Paramount Medical policy format
02/06/2023 • Medical Policy updated to reflect Medicaid coverage to Anthem as of 02/01/2023
PG0092 – 02/06/2023REFERENCES/RESOURCES
Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and
services
Ohio Department of Medicaid
American Medical Association, Current Procedural Terminology (CPT®) and associated publications and
services
Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS
Release and Code Sets
U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/
Industry Standard Review
Hayes, Inc.
Industry Standard Review
Centers for Disease Control and Prevention (CDC). Human Papillomavirus (HPV) ACIP Vaccine
Recommendations. https://www.cdc.gov/vaccines/hsp/acip-recs/vacc-specific/phv.html
Centers for Disease Control and Prevention (CDC) Supplemental information and guidance for vaccination
providers regarding use of 9-valent HPV. https://www.cdc.gov/hpv.downloads/9vhpv-guidance.pdf.
Centers for Disease Control and Prevention. Recommended Immunization Schedules For Persons Aged
zero Through 18 Years ‐ United States, 2019. Available at https://www.cdc.gov/vaccines/schedules/hcp/imz/child‐
adolescent.html
Centers for Disease Control and Prevention (CDC). Recommended Adult Immunization Schedule – United
States, 2019. Available at https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
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