Drug and Biologic Coverage Policy Effective Date ............................................... 7/1/2021 Next Review Date ......................................... 4/1/2022 Coverage Policy Number .................................. 9001 Routine Immunizations Table of Contents Related Coverage Resources Coverage Policy ................................................... 1 Preventive Care Services General Background ............................................ 2 Covid-19 Vaccine Coding/Billing Information .................................... 3 References .......................................................... 7 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 used as treatment guidelines. In certain markets, delegated vendor guidelines may be used 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 used for treatment of infectious disease and oncology) nor does it apply to Respiratory Syncytial Virus, non-routine vaccines and immune globulins [such as, but not limited to Rabies or Rho(D) immune globulins]. If coverage is available for routine immunizations, the following conditions of coverage apply: Page 1 of 8 Drug and Biologic Coverage Policy: 9001 Routine immunizations with a U.S. Food and Drug Administration (FDA) licensed vaccine are covered as medically necessary when used in accordance with a recommendation by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Routine immunizations are covered 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. Routine vaccines are those recommended for everyone in the United States, depending on age and vaccine history and are available for the prevention of 18 diseases: Chickenpox (Varicella) Mumps Diphtheria Pneumococcal Flu (Influenza) Polio (Poliomyelitis) Hepatitis A Rotavirus Hepatitis B Rubella (German Measles) Hib (Haemophilus influenzae type b) Shingles (Herpes Zoster) HPV (Human Papillomavirus) Tetanus (Lockjaw) Measles Whooping cough (Pertussis) Meningococcal A therapeutic vaccine by definition is a vaccine which prevents or eases the severity of the problems from an infection or disease 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 use 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 re- vaccination, 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. Page 2 of 8 Drug and Biologic Coverage Policy: 9001 NOTE: On February 21, 2018, the ACIP voted that for the 2018-19 influenza season, immunization providers may choose to administer any licensed, age appropriate, influenza vaccine (including LAIV, IIV, and RIV). This is a change from when LAIV was not recommended by the ACIP for the 2017-2018 influenza season. 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. 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