Immunizations

50.4.4.2 - Immunizations (Rev. 13295; Issued: 07-25-25; Effective: 01-01-25; Implementation: 10-06-25) Vaccinations or inoculations are excluded as immunizations unless they are directly related to the treatment of an injury or direct exposure to a disease or condition, such as anti-rabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin sera, or immune globulin. In the absence of injury or direct exposure, preventive immunization (vaccination or inoculation) against such diseases as smallpox, polio, diphtheria, etc., is not covered. However, pneumococcal, hepatitis B, influenza virus, and COVID-19 vaccines are exceptions to this rule. (See items A, B, C, and D below.) In cases where a vaccination or inoculation is excluded from coverage, related charges are also not covered. A. Pneumococcal Pneumonia Vaccinations 1. Background and History of Coverage: Section 1861(s)(10)(A) of the Social Security Act and regulations at 42 CFR 410.57 authorize Medicare coverage under Part B for pneumococcal vaccine and its administration. For services furnished on or after May 1, 1981 through September 18, 2014, the Medicare Part B program covered pneumococcal pneumonia vaccine and its administration when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. Coverage included an initial vaccine administered only to persons at high risk of serious pneumococcal disease (including all people 65 and older; immunocompetent adults at increased risk of pneumococcal disease or its complications because of chronic illness; and individuals with compromised immune systems), with revaccination administered only to persons at highest risk of serious pneumococcal infection and those likely to have a rapid decline in pneumococcal antibody levels, provided that at least 5 years had passed since the previous dose of pneumococcal vaccine. Those administering the vaccine did not require the patient to present an immunization record prior to administering the pneumococcal vaccine, nor were they compelled to review the patient’s complete medical record if it was not available, relying on the patient’s verbal history to determine prior vaccination status. Effective for claims with dates of service on and after September 19, 2014, an initial pneumococcal vaccine may be administered to all Medicare beneficiaries who have never received a pneumococcal vaccination under Medicare Part B. A different, second pneumococcal vaccine may be administered 1 year after the first vaccine was administered (i.e., 11 full months have passed following the month in which the last pneumococcal vaccine was administered). Effective July 1, 2000, Medicare no longer required for coverage purposes that a doctor of medicine or osteopathy order the vaccine. Therefore, a beneficiary could receive the vaccine upon request without a physician’s order and without physician supervision. 2. Coverage Requirements: Effective July 1, 2021, the Centers for Medicare & Medicaid Services (CMS) updated the Medicare coverage requirements to align with ACIP recommendations. Adults age ≥65 years who have not previously received pneumococcal conjugate vaccine (PCV) or whose previous vaccination history is unknown should receive 1 dose of PCV (either PCV20 or PCV15). When PCV15 is used, it should be followed by a dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23). For those adults age 19–64 years with certain underlying medical conditions or other risk factors who have not previously received PCV or whose previous vaccination history is unknown should receive 1 dose of PCV (either PCV20 or PCV15). When PCV15 is used, it should be followed by a dose of PPSV23. Underlying medical conditions or other risk factors include alcoholism, chronic heart disease, chronic liver disease, chronic lung disease, cigarette smoking, diabetes mellitus, cochlear implant, cerebrospinal fluid leak, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, chronic renal failure, congenital or acquired immunodeficiencies, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome and solid organ transplant. Clinical guidance shows that when PCV15 is used, the recommended interval between administration of PCV15 and PPSV23 is ≥1 year. A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, cochlear implant, or cerebrospinal fluid leak to minimize the risk for invasive pneumococcal disease caused by serotypes unique to PPSV23 in these vulnerable groups. Immunocompromising conditions include chronic renal failure, congenital or acquired immunodeficiencies, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplant, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies. For adults who only received PPSV23, they may receive a PCV (either PCV20 or PCV15) ≥1 year after their last PPSV23 dose. When PCV15 is used in those with history of PPSV23 receipt, it need not be followed by another dose of PPSV23. Effective October 19, 2022, CMS adds the following coverage requirements to align with additional ACIP recommendations and further clarifies the 2021 update. For adults aged ≥65 years who completed their vaccine series with both PCV13 and PPSV23, but no PPSV23 was received at age ≥65, either one dose of PCV20 is recommended at least 5 years after the last pneumococcal vaccine dose, or complete the recommended PPSV23 series as previously recommended. Shared clinical decision-making is recommended regarding administration of PCV20 for adults age ≥65 years who completed their vaccine series with both PCV13 and PPSV23, and PPSV was received at age ≥65. If a decision to administer PCV20 is made, a dose of PCV20 is recommended at least 5 years after the last pneumococcal vaccine dose. In addition, adults age ≥65 years and adults age 19-64 years with certain underlying medical conditions or other risk factors who received PCV13 only are recommended to receive a dose of PCV20 at least 1 year after the PCV13 dose, or PPSV23 as previously recommended to complete their pneumococcal vaccine series. ACIP recommends that adults age 19-64 years with certain underlying medical conditions or other risk factors who have received both PCV13 and PPSV23 with incomplete vaccination status are recommended to complete their pneumococcal vaccine series by receiving either a dose of PCV20 at least 5 years after the last pneumococcal vaccine dose, or PPSV23 as previously recommended. Those administering the vaccine should not require the patient to present an immunization record prior to administering the pneumococcal vaccine, nor should they feel compelled to review the patient’s complete medical record if it is not available. Instead, provided that the patient is competent, it is acceptable to rely on the patient’s verbal history to determine prior vaccination status. Medicare does not require for coverage purposes that a doctor of medicine or osteopathy order the vaccine. Therefore, the beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision. B. Hepatitis B Vaccine Effective for services furnished on or after January 1, 2025, (originally September 1, 1984, P.L. 98-369) provides coverage under Part B for hepatitis B vaccine and its administration, furnished to a Medicare beneficiary who is at high or intermediate risk of contracting hepatitis B. High-risk groups currently identified include (see exception below): • ESRD patients; • Hemophiliacs who receive Factor VIII or IX concentrates; • Clients of institutions for individuals with intellectual disabilities; • Persons who live in the same household as a Hepatitis B Virus (HBV) carrier; • Homosexual men; • Illicit injectable drug abusers; • Pacific Islanders (that is, those Medicare beneficiaries who reside on Pacific islands under U.S. jurisdiction, other than residents of Hawaii); and, • Persons diagnosed with diabetes mellitus. Intermediate risk groups currently identified include: • Staff in institutions for individuals with intellectual disabilities and classroom employees who work with individuals with intellectual disabilities; • Workers in health care professions who have frequent contact with blood or blood-derived body fluids during routine work (including workers who work outside of a hospital and have frequent contact with blood or other infectious secretions); • Heterosexually active persons with multiple sexual partners (that is, those Medicare beneficiaries who have had at least two documented episodes of sexually transmitted diseases within the preceding 5 years); and, • Individuals who have not previously received a completed hepatitis B vaccination series or whose previous vaccination history is unknown. EXCEPTION: Persons in both of the above-listed groups in paragraph B, would not be considered at high or intermediate risk of contracting hepatitis B, however, if there were laboratory evidence positive for antibodies to hepatitis B. (ESRD patients are routinely tested for hepatitis B antibodies as part of their continuing monitoring and therapy.) A charge separate from the ESRD composite rate will be recognized and paid for administration of the vaccine to ESRD patients. C. Influenza Virus Vaccine Effective for services furnished on or after May 1, 1993, the Medicare Part B program covers influenza virus vaccine and its administration when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. Typically, these vaccines are administered once a flu season. Medicare does not require, for coverage purposes, that a doctor of medicine or osteopathy order the vaccine. Therefore, the beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision. D. COVID-19 Vaccine Effective for services furnished on or after November 2, 2020, under the authority of section 1861(s)(10)(A) of the Act as amended by section 3713 of the CARES Act (P.L. 116-136), the Medicare Part B program covers COVID-19 vaccines and their administration when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. Effective for services furnished on or after December 11, 2020, the COVID-19 vaccine and its administration are covered when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. Effective dates for coverage and payment of COVID-19 vaccines and their administration can be found on the CMS COVID-19 Vaccine Pricing website, https://www.cms.gov/medicare/payment/fee-for-service- providers/part-b-drugs/average-drug-sales-price/vaccine-pricing, under “COVID-19 Vaccines & Monoclonal Antibodies.” Payment rates can also be found in the Outpatient Prospective Payment System (OPPS) Addendum B available at, https://www.cms.gov/medicare/payment/prospective-payment- systems/hospital-outpatient/addendum-a-b-updates. Medicare does not require, for coverage purposes, that a doctor of medicine or osteopathy order the vaccine. Therefore, the beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision. E. In-Home Administration of Part B Preventive Vaccines 1. Background Effective June 8, 2021, CMS announced an additional payment for the administration of a COVID-19 vaccine in the home. This payment was established on a preliminary basis to ensure access to COVID-19 vaccines during the public health emergency, and it was extended for CY2022 and CY2023. Effective January 1, 2024, CMS established an additional Part B payment for the administration of a pneumococcal, influenza, hepatitis B, or COVID-19 vaccine in the home, under certain circumstances. 2. Required Circumstances An additional payment for preventive vaccine administration in the home can be made if one of the following circumstances are met: • The patient has difficulty leaving the home, or faces barriers to getting a vaccine in settings other than their home. For example: o They have a condition, due to an illness or injury, that restricts their ability to leave home without a supportive device or help from a paid or unpaid caregiver; o They have a condition that makes them more susceptible to contracting a disease; o They are generally unable to leave the home, and if they do leave home, it requires a considerable and taxing effort. o The patient is hard-to-reach because they have a disability or face clinical, socioeconomic, or geographical barriers to getting a vaccine in settings other than their home. These patients face challenges that significantly reduce their ability to get vaccinated outside the home, such as challenges with transportation, communication, or caregiving. • The sole purpose of the visit is to administer one or more preventive vaccines. o Medicare will not pay the additional amount if the provider or supplier furnished another Medicare covered service in the same home on the same date. • The home is not an institution that meets the requirements of sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, or §§ 409.42(a). o This includes hospitals and skilled nursing facilities (SNFs), as well as most nursing facilities under Medicaid. o A home can be:  A private residence, temporary lodging (for example, a hotel or motel, campground, hostel, or homeless shelter);  An apartment in an apartment complex or a unit in an assisted living facility or group home (including assisted living facilities participating in the CDC's Pharmacy Partnership for Long-Term Care Program when their residents are vaccinated through this program);  A patient's home that is made provider-based to a hospital during the PHE for COVID–19; or  Communal spaces of a multi-unit or communal living arrangement. Unlike the requirements under the Medicare home health benefit, the furnisher of the vaccines does not need to certify that the Medicare patient is homebound. However, the furnisher must document in the patient’s medical record their clinical status or the barriers they face to getting the vaccine outside the home. 3. Additional Limitations In addition, the in-home additional payment has the following limitations: • The additional in-home payment amount is only made if the sole purpose of the visit to the home is to administer one or more Part B preventive vaccines. • Only one additional payment is made per patient per home visit, even if multiple vaccines are administered during the same home visit. Every vaccine dose that is furnished still receives its own unique vaccine administration payment. • When multiple patients reside in the same home unit or communal space within a single group living location and those patients are administered one or more Part B preventive vaccines, the in-home additional payment has additional limitations. Please see Chapter 18, Section 10.1.5 of the Medicare Claims Processing Manual for more information.