(Medicare Benefit Policy Manual)

Payment may be made for a reasonable supply of antigens that have been prepared for a particular patient if: (1) the antigens are prepared by a physician who is a doctor of medicine or osteopathy, and (2) the physician who prepared the antigens has examine d the patient and has determined a plan of treatment and a dosage regimen.   Antigens must be administered in accordance with the plan of treatment and by a doctor of medicine or osteopathy or by a properly instructed person (who could be the patient) under the supervision of the doctor.  The associations of allergists that CMS con sulted advised that a reasonable supply of antigens is considered to be not more than a 12- month supply of antigens that has been prepared for a particular patient at any one time.  The purpose of the reasonable supply limitation is to assure that the anti gens retain their potency and effectiveness over the period in which they are to be administered to the patient.  (See 20.2 and 50.2.)   50.4.4.2 - Immunizations (Rev.  11905; Issued:03-  16-23; Effective:10 -19-22; Implementation: 04 -17-23)  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 dise ase 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 patients complete medical record if it was not available, relying on the patients 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 physicians 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 P PSV23 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 patients complete medical record if it is not available. Instead, provided that the patient  is competent, it is acceptable to rely on the patients  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 physicians order and without physician supervision.  B. Hepatitis  B Vaccine   Effective for services furnished on or after 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 the mentally retarded;   Persons who live in the same household as a Hepatitis B Virus (HBV) carrier;   Homosexual men;   Illicit injectable drug users; and    Persons diagnosed with diabetes mellitus              Intermediate  risk groups currently identified  include:    Staff  in institutions  for the mentally  retarded;  and   Workers  in health  care professions  who have  frequent  contact  with blood or blood- derived body fluids during routine work.   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.)   For Medicare program purposes, the vaccine may be administered upon the order of a doctor  of medicine  or osteopathy, by a doctor  of medicine  or osteopathy, or  by home  health agencies, skilled nursing facilities, ESRD facilities, hospital outpatient departments, and persons recognized under the incident to physicians services provision of law.  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 physicians 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 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.   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 physicians order and without physician supervision.  50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen  (Rev. 212, Issued: 11- 06-15, Effective: 08 -12-15, Implementation: 02- 10-16)  A. Overview   Effective January 1, 1994, off-label, medically accepted indications of Food and Drug Administration-(FDA) approved drugs and biologicals used in an anti -cancer chemotherapeutic regimen are identified under the conditions described below.  A regimen is a c ombination of anti-cancer agents clinically recognized for the treatment of a specific type of cancer.  Off-label, medically accepted indications are supported in either one or more of the compendia or in peer-reviewed medical literature.  The contractor may maintain its own subscriptions to the listed compendia or peer-reviewed publications to determine the medically accepted indication of drugs or biologicals used off- label in an anti -cancer chemotherapeutic regimen.  Compendia documentation or peer-reviewed literature supporting off-label use by the treating physician may also be requested of the physician by the contractor.