Human Papillomavirus (HPV) Vaccine Gardasil® and ... - MCS a

Clinical Medical Policy DepartmentClinical Affairs Division054.19 Other genital herpes054.2 Herpetic gingivostomatitis054.3 Herpetic meningoencephalitis054.40 Herpes simplex with unspecified ophthalmic complication054.41 Herpes simplex dermatitis of eyelid054.42 Dendritic keratitis054.43 Herpes simplex disciform keratitis054.44 Herpes simplex iridocyclitis054.49 Herpes simplex with other ophthalmic complications054.5 Herpetic septicemia054.6 Herpetic whitlow054.71 Visceral herpes simplex054.72 Herpes simplex meningitis054.73 Herpes simplex otitis externa054.74 Herpes simplex myelitis054.79 Herpes simplex with other specified complications054.8 Herpes simplex, with unspecified complication054.9 Herpes simplex, without mention of complication079.4 Human Papillomavirus180.0 Malignant neoplasm of endocervix180.1 Malignant neoplasm of exocervix180.8 Malignant neoplasm of other specified sites of cervix180.9 Malignant neoplasm of cervix uteri, unspecified site184.0 Malignant neoplasm of vagina184.1 Malignant neoplasm of labia majora184.2 Malignant neoplasm of labia minora184.3 Malignant neoplasm of clitoris184.4 Malignant neoplasm of vulva, unspecified site233.1 Carcinoma In Situ Of Cervix Uteri233.31 Carcinoma In Situ Of Vagina233.32 Carcinoma In Situ Of Vulva622.10 Dysplasia of cervix , unspecified622.11 Mild dysplasia of cervix622.12 Moderate dysplasia of cervix624.01 Dystrophy of vulva, Vulvar intraepithelial neoplasia I (VIN I) (mild dysplasia of vulva)624.02 Dystrophy of vulva, Vulvar intraepithelial neoplasia II (VIN II) (moderate dysplasia ofvulva)This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®6

Clinical Medical Policy DepartmentClinical Affairs Division795.05 Cervical High-Risk Human Papillomavirus (HPV) DNA Test Positive795.09 Other Abnormal Papanicolaou Smear Of Cervix And Cervical HPVV01.6 Contact With Or Exposure To Venereal DiseasesV02.8 Carrier or Suspected Carrier Of Other Venereal DiseasesV04.89 Need For Prophylactic Vaccination And Inoculation Against Other Viral DiseasesV05.8 Need For Prophylactic Vaccination And Inoculation Against Other Specified DiseaseV69.2 High-Risk Sexual Behavior2014 HCPCS LEVEL II Professional Edition® (American Medical Association).ICD-10 Codes (Preview Draft)In preparation for changes in the coding systems form ICD- 9 to ICD -10, this policy includes a sample listof ICD-10 codes for your reference. These codes may become subject to changes or modifications sincethey will be in effect on October 1, 2015.ICD-10-CodesB00.0 Eczema herpeticumDESCRIPTIONA60.00 Herpesviral infection of urogenital system, unspecifiedA60.9 Anogenital herpesviral infection, unspecifiedA60.04 Herpesviral vulvovaginitisA60.01 Herpesviral infection of penisA60.02 Herpesviral infection of other male genital organsA60.03 Herpesviral cervicitisA60.09 Herpesviral infection of other urogenital tractA60.1 Herpesviral infection of perianal skin and rectumB00.2 Herpesviral gingivostomatitis and pharyngotonsillitisB00.4 Herpesviral encephalitisB00.50 Herpesviral ocular disease, unspecifiedB00.59 Other herpesviral disease of eyeB00.52 Herpesviral keratitisB00.51 Herpesviral iridocyclitisB00.53 Herpesviral conjunctivitisB00.59 Other herpesviral disease of eyeB00.7 Disseminated herpesviral diseaseB00.89 Other herpesviral infectionB00.81 Herpesviral hepatitisB00.3 Herpesviral meningitisB00.1 Herpesviral vesicular dermatitisB00.82 Herpes simplex myelitisB00.9 Herpesviral infection, unspecifiedThis document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®7

Clinical Medical Policy DepartmentClinical Affairs DivisionB97.7 Papillomavirus as the cause of diseases classified elsewhereC53.0 Malignant neoplasm of endocervixC53.1 Malignant neoplasm of exocervixC53.8 Malignant neoplasm of overlapping sites of cervix uteriC53.9 Malignant neoplasm of cervix uteri, unspecifiedC52Malignant neoplasm of vaginaC51.0 Malignant neoplasm of labium majusC51.1 Malignant neoplasm of labium minusC51.2 Malignant neoplasm of clitorisC51.9 Malignant neoplasm of vulva, unspecifiedD06.0 Carcinoma in situ of endocervixD06.1 Carcinoma in situ of exocervixD06.7 Carcinoma in situ of other parts of cervixD06.9 Carcinoma in situ of cervix, unspecifiedD07.2 Carcinoma in situ of vaginaD07.1 Carcinoma in situ of vulvaN87.9 Dysplasia of cervix uteri, unspecifiedN87.0 Mild cervical dysplasiaN87.1 Moderate cervical dysplasiaN90.0 Mild vulvar dysplasiaN90.1 Moderate vulvar dysplasiaR87.810 Cervical high risk human papillomavirus (HPV) DNA test positiveR87.820 Cervical low risk human papillomavirus (HPV) DNA test positiveZ20.2 Contact with and (suspected) exposure to infections with a predominantly sexualmode of transmissionZ22.4 Carrier of infections with a predominantly sexual mode of transmissionZ23Encounter for immunizationZ72.51 High risk heterosexual behaviorZ72.52 High risk homosexual behaviorZ72.53 High risk bisexual behaviorREFERENCES1. American Hospital Formulary Service (AHFS) Drug Information (2013). Human PapilomavirusVaccine (Gardasil® & Cervarix®). Pages 3408 – 3412. American Society of Health-SystemPharmacists: Bethesda, MD. Accessed May 07, 2014.This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®8

Clinical Medical Policy DepartmentClinical Affairs Division2. Carusi, D. Patient information: Genital warts in women (Beyond the Basics) – Overview &Prevention. Literature review current through: April 2013. Literature review current through:April 2014. This topic last updated: Jul 30, 2013. Accessed May 07, 2014. Available at URLaddress: http://www.uptodate.com/contents/genital-warts-in-women-beyond-the-basics3. Centers for Disease and Prevention (CDC). Advisory Committee on immunization PracticesVaccines for Children Program Vaccines to Prevent Human Papillomavirus. Adopted effectivedate: October 25, 2011. Accessed May 07, 2014. Available at URL address:http://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/1011-1-hpv.pdf4. Centers for Disease and Prevention (CDC) (n.d.). Centers for Disease Control and PreventionAdvisory Committee Recommends Human Papillomavirus Virus Vaccination. Dated: June 29,2006. Accessed May 07, 2014. Available at the URL address:http://www.thecmafoundation.org/projects/HPV/docs/CDC%20Press%20Release%20on%20Vaccine%20Approval.pdf?prod=WisBar+Advance+Desktop5. Centers for Disease and Prevention (CDC). (n.d). Centers for Disease Control and Prevention.Human Papillomavirus (HPV) Vaccine. Accessed May 7, 2014. Available at URL address:http://www.cdc.gov/vaccinesafety/Vaccines/HPV/Index.html6. Centers for Disease Control and Prevention (CDC). HPV (Human Papillomavirus) Cervarix® VIS.Current Edition Date: 5/3/2011. Accessed May 14, 2014. Available at URL address:http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-cervarix.html7. Centers for Disease Control and Prevention (CDC). HPV (Human Papillomavirus) Gardasil® VIS.Current Edition Date: 5/17/2013. Accessed May 14, 2014. Available at URL address:http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil.html8. Centers for Disease Control and Prevention (CDC). Recommendations on the Use ofQuadrivalent Human Papillomavirus Vaccine in Males — Advisory Committee on ImmunizationPractices (ACIP), 2011. Published: December 23, 2011. Accessed May 07, 2014. Available atURL address: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm9. Centers for Disease Control and Prevention (CDC). Recommended Adult Immunization Schedule(United States) for 2013 from 19 years of age henceforth. Accessed May 07, 2014. Available atURL address: http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule.pdf10. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule forpersons aged 0 through 18 years for 2013. Accessed May 07, 2014. Available at URL address:http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-schedule.pdfThis document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®9

Clinical Medical Policy DepartmentClinical Affairs Division11. Centers for Disease Control and Prevention (CDC). (2004). Sexually Transmitted Diseases HumanPapillomavirus (HPV) Infection. Page last updated: April 14, 2014. Accessed May 07, 2014.Available at URL address: http://www.cdc.gov/std/hpv/default.htm12. Centers for Medicare & Medicaid Services (CMS). First Coast Service Options, Inc. LocalCoverage Determination (LCD) for Non-Covered Services (L29398). Original DeterminationEffective Date: For services performed on or after 03/02/2009. Revision Effective Date: Forservices performed on or after 07/01/2013. Accessed May 07, 2014. Available at URL address:http://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?LCDId=29398&ContrId=198&ver=61&ContrVer=1&CntrctrSelected=198*1&Cntrctr=198&name=First+Coast+Service+Options%2c+Inc.+(09202%2c+MAC+-+Part+B)&s=46&DocType=Active&bc=AggAAAIAAAAAAA%3d%3d&13. Gold Standard Elsevier / Clinical Pharmacology. Human Papillomavirus Vaccine: Gardasil® &Cervarix®. Last Revision: Feb 13, 2014. Accessed May 7, 2014. Available at URL address:https://www.clinicalpharmacology.com/Forms/Monograph/monograph.aspx?cpnum=3510&sec=monindi&t=014. Highlights of Prescribing Information (Package Insert) for Cervarix® (Human PapillomavirusBivalent, types 16 & 18, Vaccine, Recombinant). Initial U.S. Approval: 2009. Revised: 11/2013.Accessed May 7, 2014. Available at URL address:https://www.gsksource.com/gskprm/htdocs/documents/CERVARIX-PI-PIL.PDF15. Lex Juris of Puerto Rico. “Ley número 9 del 2010”. Law for the inclusion of the HPV vaccine forfemales between the aged of 11 – 18 years of age for all Health Insurance Companies (“Ley querequiere a toda aseguradora, organización de servicios de salud, plan de seguro, que suscribenseguros de servicio de salud en Puerto Rico”). Published: January 20, 2010. Accessed May 7,2014. Available at URL address: http://www.lexjuris.com/lexlex/Leyes2010/lexl2010009.htm16. Merck & Co., Inc. (n.d.). FDA approves Merck’s Gardasil®, the world’s first and only cervicalcancer vaccine. News Release. White House Station, NJ: Merck. Searched May 7, 2014. Nolonger available at URL address: www.merck.com17. Merck & Co., Inc. (2009). Publication Title: Gardasil® Package Insert. Publication Date: 2009.Accessed May 07, 2014. Available at URL address:http://www.rho.org/files/rb3/Gardasil_Package_Insert_Merck_2009.pdfThis document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®10

Clinical Medical Policy DepartmentClinical Affairs Division18. Merck & Co., Inc. Highlights of prescribing information (package insert) for Gardasil®. InitialU.S. Approval: 2006. Revised: 03/2014. Accessed May 07, 2014. Available at URL address:http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf19. Puerto Rico Chaimber of Representatives (“P. de la C. 2583”). Amendment to Law Number 9 ofthe year 2010 in order to include males between the ages of 11 – 18 years of age under the HPVVaccine Administration. Published: March 25, 2010. Accessed May 07, 2014. Available at URLaddress: www.oslpr.org , or at URL address:http://www.google.com.pr/url?sa=t&rct=j&q=enmiendas%20ley%20numero%209%20puerto%20rico%2020%20de%20enero%20de%202010&source=web&cd=4&cad=rja&ved=0CDoQFjAD&url=http%3A%2F%2Fwww.oslpr.org%2Ffiles%2Fdocs%2F%257B3883B188-8F87-4E09-BBC1-D26F30DB6741%257D.doc&ei=tk6SUc-lK8yC0QGzqoCgCw&usg=AFQjCNFZIDRp3xcuASWLU7uY-8ItuPWz7w&bvm=bv.46471029,d.dmQ20. Puerto Rico Department of Health. Vaccination Schedule for Children & Adolescents.Publication date: February 4, 2010. Searched May 07, 2014. Currently unavailable at URLaddress: www.salud.gov.pr21. Puerto Rico Department of Health. Vaccination Schedule for Children & Adolescents.Publication date: April 1, 2013. Accessed May 07, 2014. Available at URL address:http://www.salud.gov.pr/Programas/ProgramaVacunacion/Documents/20130411140501638.pdf22. U.S. Food and Drug Administration (FDA). FDA approves expanded uses for Gardasil® to includepreventing certain vulvar and vaginal cancers. FDA News. Rockville, MD. Published: September12, 2008. Page Last Updated: April 15, 2013. Accessed May 07, 2014. Available at URL address:http://www.fda.gov/newsevents/newsroom/pressannouncements/2008/ucm116945.htm23. U.S. Food and Drug Administration (FDA). FDA approves new indication for Gardasil® to preventgenital warts in men and boys. FDA News Release. Rockville, MD: FDA. Published: October 16,2009. Page Last Updated: April 17, 2013 Accessed May 7, 2014. Available at URL address:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm24. U.S. Food and Drug Administration (FDA). FDA approves new vaccine for prevention of cervicalcancer. FDA News Release. Rockville, MD: FDA. Published October 16, 2009. Page LastUpdated: April 17, 2013. Accessed May 7, 2014. Available at URL address:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm25. U.S. Food and Drug Administration (FDA). FDA licenses new vaccine for prevention of cervicalcancer and other diseases in females caused by human papillomavirus. Rapid approval marksThis document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®11

Clinical Medical Policy DepartmentClinical Affairs Divisionmajor advancement in public health. FDA News. P06-77. Published June 8, 2006. Page LastUpdated: April 08, 2013. Accessed May 07, 2014. Available at URL address:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm26. Thomson Micromedex® DrugDex. Cervarix® and Gardasil® - Indications & Contraindications.Retrieved May 07 , 2014 from https://www.thomsonhc.com/micromedex2POLICY HISTORYDATE ACTION COMMENTApril 22, 2010Origination of PolicyApril 1, 2011 Revised Policy revised to increase the vaccination age from 11-18 years of age tonow from 11-26 years of age.December 15, 2011 Revised Policy revised to add coverage for males to the policy; this coverage iseffective as of October 25, 2011.June 19, 2012 Revised Policy revised to reflect recommendations made by the InsuranceCommissioner of PR to increase the vaccination age for males from 9-21years of age to 9-26 years of age.May 8, 2013 Revised References updated. Added new references: numbers 1, 2, 6-9, 12, 13,16, 17, 19, & 24.To the Limitations Section:August 1, 2013 Reviewed References updated. Modified Limitation 1 to read: The HPV vaccines (i.e. Gardasil® &Cervarix®) are NOT COVERED under Medicare Contractor FirstCoast Service Options, Inc. under the LCD for Non-Covered Services(L29398). Therefore, the HPV Vaccines (CPT Codes 90649 & 90650)remain NOT COVERED for the MCS Classicare line of business. Added new limitations: numbers 8-12.To the Contraindications Section: Moved the following previous contraindication to the LimitationsSection: HPV is not a live virus vaccine and may be administered topersons with immune-compromising conditions who meet thevaccine age requirements and who lack evidence of immunity. Added new Contraindications: numbers 10-13.February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section wasadded to the policy.May 15, 2014 Revised References updated.To the Description Section: The entire section was res-structured. The Information for Cervarix vaccine was added to this section(Cervarix® is a vaccine indicated for the prevention of the diseasescaused by oncogenic human papillomavirus (HPV) types 16 and 18like cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2or worse and adenocarcinoma in situ, and cervical intraepithelialneoplasia (CIN) grade.To the Limitations Section:This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®12

Clinical Medical Policy DepartmentClinical Affairs Division Series of words were added to the limitation #10 (severe combinedimmunodeficiency (SCID), hypogammaglobulinemia, alteredimmune states due to generalized neoplastic disease; or animmune system compromised by radiation therapy or drugtherapy(e.g., chemotherapy or corticosteroid therapy with greaterthan physiologic doses).To the Contraindication Section: New contraindication #14 was added tothe Policy.To the References Section: New References #6, 7 were added to thePolicy.This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt ofbenefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance withthe terms of the member’s plan in effect as of the date services are rendered. Medical Card System, Inc., (MCS) medical policies aredeveloped with the assistance of medical professionals and are based upon a review of published and unpublished information including, butnot limited to, current medical literature, guidelines published by public health and health research agencies, and community medicalpractices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, MedicalCard System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. Medical Card System, Inc., (MCS)medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan’s ability to interpret plan language asdeemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type,quality, and levels of care and treatment they choose to provide.This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract.Medical technology is constantly changing and we reserves the right to review and update our policies periodically.Medical Card System, Inc.All Rights Reserved®13