Cigna Drug and Biologic Coverage Policy

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1 Cigna Drug and Biologic Coverage Policy Subject Routine Immunizations Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 3 References... 7 Effective Date... 4/15/2018 Next Review Date... 4/15/2019 Coverage Policy Number Related Coverage Resources Human Papillomavirus Vaccine Preventive Care Services INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be d as treatment guidelines. In certain markets, delegated vendor guidelines may be d to support medical necessity and other coverage determinations. Coverage Policy The Affordable Care Act (ACA) requires individual and group health plans to cover in-network routine immunizations without cost sharing (e.g., deductibles, coinsurance, copayments) unless the plan qualifies under the grandfather provision or for an exemption. Coverage of routine immunizations is generally subject to the terms, conditions and limitations of a preventive services benefit as described in the applicable plan s schedule of copayments. Please refer to the applicable benefit plan document to determine benefit availability and the terms and conditions of coverage. Many benefit plans specifically exclude immunizations that are for the purpose of travel or to protect against occupational hazards and risks. For any benefit exclusion, coverage will not be provided even if the medical necessity criteria described below are met. Please refer to the applicable benefit plan document to determine benefit availability and the terms, and conditions of coverage. This Coverage Policy does not pertain to Therapeutic Vaccines (such as those d for treatment of infectious disease and oncology nor does it apply to immune globulins, serum or recombinant products [such as, but not limited to Rabies, Respiratory Syncytial Virus, or Rho(D) immune globulins]. If coverage is available for routine immunizations, the following conditions of coverage apply: Cigna covers routine immunizations with a U.S. Food and Drug Administration (FDA) licensed vaccine as medically necessary when d in accordance with a recommendation by the Centers for Disease Control and Prevention s (CDC) Advisory Committee on Immunization Practices (ACIP). Page 1 of 7

2 Cigna covers routine immunizations according to the provisional recommendations of the ACIP until the recommendations are officially published in the Morbidity and Mortality Weekly Report (MMWR). General Background Disease prevention vaccines are those products which are designed to trigger acquired immunity against certain infectious diseases. Disease prevention vaccines are administered to healthy individuals to prevent a disease. In most cases these vaccines are administered prior to exposure to the disease, but in some cases, the vaccine is administered after an exposure has occurred (i.e. Rabies vaccine). A therapeutic vaccine by definition is a vaccine which prevents or eases the severity of the problems from an infection that has already occurred. Therapeutic vaccines are also under development in oncology such as for prostate cancer. Vaccines must be licensed by the U.S. Food and Drug Administration s (FDA) Center for Biologics Evaluation and Research (CBER) prior to in the United States (U.S.). Before the FDA approves a license, vaccines are tested for safety and efficacy. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects. The Advisory Committee on Immunization Practices (ACIP) The ACIP is comprised of experts in fields associated with immunization, who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases. The ACIP is the only entity in the federal government that makes such recommendations. Subsequent to the licensing of a new vaccine by the FDA, the ACIP will review the vaccine and provide advice and guidance regarding the most appropriate selection of vaccines for administration to children and adults in the U.S. Recommendations include age for vaccine administration, number of doses and dosing interval, and precautions and contraindications. Additional guidance may be provided for catch up age ranges, periodic revaccination, guidance regarding high risk sub-groups who should receive the vaccine and guidance for individual decision making. The ACIP meets three times each year and submits their recommendations to the Director of the CDC and the Department of Health and Human Services (HHS) for approval. ACIP recommendations are considered provisional until published in the CDC s Morbidity and Mortality Weekly Report (MMWR). The MMWR represents the official CDC recommendations for immunization of the U.S. population. NOTE: On June 21, 2017, the ACIP voted that live attenuated influenza vaccine (LAIV) should not be d during the flu season. This recommendation was officially adopted by the CDC with the publication of the MMWR on August 25, The ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV), for everyone 6 months and older. On February 21, 2018, the ACIP voted that for the influenza season, immunization providers may choose to administer any licensed, age appropriate, influenza vaccine (including LAIV, IIV, and RIV). ACIP Recommendations The ACIP recommendations are developed using an evidence-based method based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Key factors considered in development of recommendations include balance of benefits and harms, type or quality of evidence, values and preferences of the people affected, and health economic analyses. Category A recommendations are made for all persons in an age- or risk-factor-based group. Category B recommendations are made for individual clinical decision making. Page 2 of 7

3 The Affordable Care Act (ACA) designates the ACIP as the source for recommended routine immunizations for children, adolescents, and adults. A recommendation from the ACIP is considered in effect when it has been adopted by the Director of the CDC and published in the MMWR or when it is listed on the Immunization Schedules of the CDC. ACA requires coverage of routine immunizations when prescribed by a health care professional consistent with the ACIP recommendation. Other Vaccination Recommendations The United States Preventive Services Task Force (USPSTF) recognizes the importance of immunizations in primary disease prevention. However, the USPSTF does not wish to duplicate the significant investment of resources made by others to review new evidence on immunizations in a timely fashion and make recommendations. The USPSTF therefore will not update its 1996 recommendations. The American Academy of Pediatrics (AAP) contributes collaboratively to the literature review, analyses of data, and deliberations as a liaison to several of the disease specific working groups for the ACIP. Combination Vaccines Several of the routinely administered childhood vaccines have been combined into single products. These are called combination vaccines. Some combination vaccines are routinely d in the United States (e.g. DTaP- Diphtheria, Tetanus, acellular Pertussis and MMR Measles, Mumps and Rubella). The advantage of combination vaccines is that children get the protection of all the component vaccines while getting fewer injections. ACIP includes the combined vaccine in recommendations for when any component of the combination is indicated, and if the other components are not contraindicated. They further note that the combined vaccine is to be d in its FDA indicated population and age range. Coding/Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement. Routine Disease Prevention Vaccines Covered when medically necessary: Meningococcal recombinant protein and outer membrane vesicle vaccine, serogroup B (MenB-4C), 2 dose schedule, for Meningococcal recombinant lipoprotein vaccine, Serogroup B (MenB-FHbp), 2 or 3 dose schedule, for Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, for intradermal Hepatitis A vaccine (HepA), adult dosage, for Hepatitis A vaccine (HepA), pediatric/adolescent dosage-2 dose schedule, for Hepatitis A vaccine (HepA), pediatric/adolescent dosage-3 dose schedule, for Hepatitis A and hepatitis B vaccine (HepA-HepB), adult dosage, for Meningococcal conjugate vaccine, serogroups C & Y and Haemophilus influenzae type B vaccine (Hib-MenCY), 4 dose schedule, when administered to children 6 weeks 2-18 months of age, for Haemophilus influenzae type b vaccine (Hib), PRP-OMP conjugate 3 dose schedule, for Page 3 of 7

4 90648 Haemophilus influenzae b vaccine (Hib), PRP-T conjugate, 4 dose schedule, for Human Papillomavirus vaccine, types 6, 11, 16, 18, quadrivalent (4vHPV), 3 dose schedule, for Human Papillomavirus vaccine, types 16, 18, bivalent (2vHPV), 3 dose schedule, for Human Papillomavirus vaccine types 6, 11, 16, 18, 31, 33, 45, 52, 58, nonavalent (9vHPV), 2 or 3 dose schedule, for Influenza vaccine, inactivated (IIV), subunit, adjuvanted, for Influenza virus vaccine, trivalent (IIV3), split virus, preservative-free, for intradermal Influenza virus vaccine, trivalent (IIV3), split virus, preservative free, 0.25 ml dosage, for Influenza virus vaccine, trivalent (IIV3), split virus, preservative free, 0.5 ml dosage, for Influenza virus vaccine, trivalent (IIV3), split virus, 0.25 ml dosage, for Influenza virus vaccine, trivalent (IIV3), split virus,0.5 ml dosage, for Influenza virus vaccine, trivalent, live (LAIV3), for intranasal (Effective for Dates of Service on or after 07/01/2018) Influenza virus vaccine, trivalent (cciiv3), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 ml dosage, for Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for Pneumococcal conjugate vaccine, 13 valent (PCV13), for Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal (Effective for Dates of Service on or after 07/01/2018) Influenza virus vaccine, trivalent (RIV3), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for Influenza virus vaccine, quadrivalent (cciiv4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 ml dosage, for Rotavirus vaccine, pentavalent (RV5), 3 dose schedule, live, for oral Rotavirus vaccine, human, attenuated (RV1), 2 dose schedule, live, for oral Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.25 ml dosage, for Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 ml dosage, for Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 ml dosage, for Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 ml dosage, for Diphtheria, tetanus toxoids, acellular pertussis vaccine and inactivated poliovirus vaccine (DTaP-IPV), when administered to children 4 through 6 years of age, for Diphtheria, tetanus toxoids, acellular pertussis vaccine, Haemophilus influenzae type B, and inactivated poliovirus vaccine (DTap-IPV/Hib), for Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP) when administered to individuals younger than 7 years, for Diphtheria and tetanus toxoids adsorbed (DT) when administered to individuals younger than 7 years, for Measles, mumps and rubella virus vaccine (MMR), live, for subcutaneous Page 4 of 7

5 90710 Measles, mumps, rubella and varicella vaccine (MMRV), live, for subcutaneous Poliovirus vaccine, inactivated (IPV), for subcutaneous or Tetanus and diphtheria toxoids adsorbed (Td), preservative free, when administered to individuals 7 years or older, for Tetanus, diphtheria toxoids and acellular pertussis vaccine (Tdap), when administered to individuals 7 years or older, for Varicella virus vaccine (VAR), live, for subcutaneous Diphtheria, tetanus toxoids, acellular pertussis vaccine, hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV), for Pneumococcal polysaccharide vaccine, 23-valent (PPSV23), adult or immunosuppressed patient dosage, when administered to individuals 2 years or older, for subcutaneous or Meningococcal polysaccharide vaccine, serogroups A, C, Y, W-135,quadrivalent (MPSV4), for subcutaneous Meningococcal conjugate vaccine, serogroups A, C, Y and W-135, quadrivalent (MCV4 or MenACWY), for Zoster (shingles) vaccine (HZV), live, for subcutaneous injection Hepatitis B vaccine (HepB), adult dosage, 2 dose schedule, for intramuscular Hepatitis B vaccine (HepB), dialysis or immunosuppressed patient dosage, 3 dose schedule, for Hepatitis B vaccine (HepB), adolescent, 2 dose schedule, for Hepatitis B vaccine (HepB), pediatric/adolescent dosage, 3 dose schedule, for Hepatitis B vaccine (HepB), adult dosage, 3 dose schedule, for intramuscular Hepatitis B vaccine (HepB), dialysis or immunosuppressed patient dosage, 4 dose schedule, for Hepatitis B and Haemophilus influenzae type b vaccine (Hib-HepB), for Zoster (shingles) vaccine (HZV), recombinant, subunit, adjuvanted, for intramuscular injection Influenza virus vaccine, quadrivalent (cciiv4), derived from cell cultures, subunit, antibiotic free, 0.5mL dosage, for Note: Age criteria apply HCPCS Q2034 Q2035 Q2036 Q2037 Q2038 Q2039 Description Influenza virus vaccine, split virus, for (Agriflu) age and older, for (Afluria) age and older, for (Flulaval) age and older, for (Fluvirin) age and older, for (Fluzone) Influenza virus vaccine not otherwise specified Vaccine administration codes: Immunization administration through 18 years of age via any route of Page 5 of 7

6 administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; each additional vaccine or toxoid component administered (List separately in addition to code for primary procedure) Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid) Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure) Immunization administration by intranasal or oral route; 1 vaccine (single or combination vaccine/toxoid) Immunization administration by intranasal or oral route; each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure) HCPCS G0008 G0009 G0010 J3530 Description Administration of influenza virus vaccine Administration of pneumococcal vaccine Administration of hepatitis B vaccine Nasal vaccine inhalation Not Covered-pending FDA approval, pending ACIP recommendation or not recommended by ACIP: Influenza virus vaccine, trivalent, live (LAIV3), for intranasal (Effective for Dates of Service 09/15/2016 through 06/30/2018) Influenza virus vaccine live (LAIV), pandemic formulation, for intranasal Influenza virus vaccine (IIV), pandemic formulation, split virus, preservative free, for Influenza virus vaccine (IIV), pandemic formulation, split virus, adjuvanted, for Influenza virus vaccine (IIV), pandemic formulation, split virus, for intramuscular Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal (Effective for Dates of Service 09/15/2016 through 06/30/2018) Diphtheria, tetanus toxoids, acellular pertussis vaccine, inactivated poliovirus vaccine, Haemophilus influenzae type b PRP-OMP conjugate vaccine, and hepatitis B vaccine (DTaP-IPV-Hib-HepB), for Not Covered- Immunizations for the purpose of travel are excluded under most benefit plans: Cholera vaccine, live, adult dosage, 1 dose schedule, for oral Typhoid vaccine, live, oral Typhoid vaccine, Vi capsular polysaccharide (ViCPs), for Yellow fever vaccine, live, for subcutaneous Japanese encephalitis virus vaccine, inactivated, for *Current Procedural Terminology (CPT ) 2017 American Medical Association: Chicago, IL. Page 6 of 7

7 References 1. Centers for Disease Control and Prevention (CDC). ACIP Vaccine Recommendations. Accessed on March 6, Available at: 2. Centers for Disease Control and Prevention (CDC). ACIP Recommendations. GRADE Evidence Tables. Accessed February 2, Available at: 3. Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger United States, February 6, Accessed on February 6, Available at: 4. Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older United States, February 6, Accessed on February 6, Available at: 5. Centers for Disease Control and Prevention (CDC). Immunization Schedules. Accessed on February 6, Available at: 6. Centers for Disease Control and Prevention (CDC). Media Statement. Accessed on February 2, Available at: 7. Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report. Prevention and Control of Seasonal Influenza with Vaccines Recommendations of the Advisory Committee on Immunization Practices United States, Influenza Season. Accessed on February 2, Health and Human Services. Center for Consumer Information and Insurance Oversight. Affordable Care Act Implementation. FAQs-Set 12. Accessed February 2, Available at: 9. U. S. Food and Drug Administration (FDA). Vaccines, Blood and Biologics. Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents. Accessed February 2, 2018 Available at: U.S. Preventive Services Task Force. Recommendations for Primary Care Practice. Published Recommendations. Immunizations for adults. Accessed on February 2, Available at: U.S. Preventive Services Task Force. Recommendations for Primary Care Practice. Published Recommendations. Immunizations for children. Accessed on February 2, Available at: Cigna Companies refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc Cigna. Page 7 of 7