GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58;

Reimbursement Information

Vaccines for Children Program

CDC’s Advisory Committee on Immunization Practices (ACIP) has approved funding under the Vaccines for Children (VFC) Program for males and females11

CDC=Centers for Disease Control and Prevention.

Merck Access Program

Learn more about the Merck Access Program by clicking here.

CPT® and ICD-10-CM® Codes

Below are lists of codes that may be relevant for GARDASIL 9 and its administration. The information provided here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. This information is subject to change. You are solely responsible for determining appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs. Diagnosis codes should be selected only by a health care professional.

Common billing codes for GARDASIL 9

The commonly used codes below may apply to private payer reimbursement claims for vaccinations with GARDASIL 9.

CPT Code for Product12
90651
Human Papillomavirus 9-valent Vaccine, 2 or 3 dose schedule, for IM use
CPT Codes for Vaccine Administration12
90460 +90461 90471 +90472
Immunization administration (IA) through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered

Each additional vaccine or toxoid component administered (List separately in addition to code for primary procedure.)

Report 90461 in conjunction with 90460.

IA (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); one vaccine (single or combination vaccine/toxoid)

Do not report 90471 in conjunction with 90473.

Each additional vaccine (single or combination vaccine/ toxoid) (List separately to code for primary procedure.)

Use 90472 in conjunction with 90460, 90471, or 90473.

There can be only 1 first administration during a given visit.
ICD-10-CM Code13,14
Z23
Effective for dates of service on or after October 1, 2019, encounter for immunization
CPT Code for Product12
90651
Human Papillomavirus 9-valent Vaccine, 2 or 3 dose schedule, for IM use
CPT Codes for Vaccine
Administration12
90460
Immunization administration (IA) through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered
+90461

Each additional vaccine or toxoid component administered (List separately in addition to code for primary procedure.)

Report 90461 in conjunction with 90460.

90471

IA (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); one vaccine (single or combination vaccine/toxoid)

Do not report 90471 in conjunction with 90473.

+90472

Each additional vaccine (single or combination vaccine/ toxoid) (List separately to code for primary procedure.)

Use 90472 in conjunction with 90460, 90471, or 90473.

There can be only 1 first administration during a given visit.
ICD-10-CM Code13,14
Z23
Effective for dates of service on or after October 1, 2019, encounter for immunization

Remember, plan coding requirements vary

Plan coding requirements may vary, so it is important to check with each plan as to plan-specific requirements. For claim submission procedures regarding government programs (eg, Medicaid), contact the appropriate program representative.

ICD-10-CM=International Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification.

CPT®=Current Procedural Terminology. Copyright © 2020. American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.

ref11

Reference

  1. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices Vaccines for Children Program Vaccines to Prevent Human Papillomavirus. https://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/2016-10-2-hpv.pdf. Adopted and Effective October 19, 2016. Accessed March 20, 2020.
ref12

Reference

  1. American Academy of Pediatrics (AAP). Coding for Pediatric Preventive Care 2020. https://www.aap.org/en-us/documents/coding_preventive_care.pdf. Accessed March 13, 2020.
ref13

Reference

  1. Centers for Medicare and Medicaid Services. 2020 ICD-10-CM tabular list of diseases and injuries. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html. Last modified January 27, 2020. Accessed March 16, 2020.
ref14

Reference

  1. Centers for Medicare and Medicaid Services (CMS). 2020 ICD-10-CM. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html. Last modified March 31, 2020. Accessed April 7, 2020.

Indication for GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

GARDASIL ®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.

The duration of immunity of GARDASIL 9 has not been established.

Dosage and Administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.


US-GSL-01920 06/20