Preventive Vaccines

70.3 - Preventive Vaccines (Rev. 13547; Issued: 12-18-25; Effective: 01-20-26; Implementation: 01-20-26) Prior to July 1, 2025, influenza virus, pneumococcal, and COVID-19 vaccines and their administration did not count as RHC/FQHC visits. The cost for these vaccines and their administration was included in the cost report and a visit was not billed for these services. RHCs did not report vaccines on the claim, TOB 71X. However, for FQHCs, if there was another reason for the visit, the vaccine and the administration code would be reported on the claim, TOB 77X, for informational and data collection purposes only. Coinsurance and deductible did not apply to these vaccines. Prior to January 1, 2025, payment for the hepatitis B vaccine and its administration was included in the RHC all-inclusive and the FQHC PPS rate. The charges of the vaccine and its administration were included in the line item for the otherwise qualifying visit. A visit could not be billed if the vaccine and its administration was the only service the RHC/FQHC provides. Effective January 1, 2025 through June 30, 2025, payment for the hepatitis B vaccine and its administration is through the cost report and no longer included in the RHC all- inclusive and FQHC PPS rate. The cost for these vaccines and their administration is included in the cost report and a visit is not billed for these services. RHCs do not report vaccines on the claim, TOB 71x. However, for FQHCs, if there was another reason for the visit, the vaccine and the administration code should be reported on the claim, TOB 77x, for informational and data collection purposes only. Coinsurance and deductible do not apply to these vaccines. Effective for dates of service on or after July 1, 2025, RHCs (bill type 71x) and FQHCs (bill type 77x), shall report all Part B preventive vaccines and their administration – pneumococcal, influenza, hepatitis B and COVID-19 -- on the claim. A visit/encounter is not required for these services; however, if reported on the same day, the vaccines and administrations shall receive a separate payment. Coinsurance and deductible do not apply to these vaccines. Although paid at the time of service, payments for these services must be annually reconciled with the RHC or FQHC’s actual vaccine and vaccine administration costs, to ensure these services are ultimately reimbursed at 100% of reasonable costs through the cost report. • Each year, CMS updates the Seasonal Influenza Vaccines Pricing webpage to reflect the seasonal influenza virus vaccines and their applicable payment allowances that are effective August 1 through July 31 of the following year. RHCs and FQHCs must refer to this webpage to ensure they are billing the appropriate HCPCS codes for the applicable influenza season. See the CMS Seasonal Influenza Vaccines Pricing webpage: https://www.cms.gov/medicare/medicare-part-b-drug-average-sales- price/vaccine-pricing • Payment for the vaccine products is based on 95% of the Average Wholesale Price. See the CMS webpage with the ASP pricing files: https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files • Payment for the vaccine administration is based on the National Vaccine Administration Fee Schedule. See the CMS webpage for the geographically adjusted payment rates for preventive vaccine administration: https://www.cms.gov/medicare/payment/part-b-drugs/vaccine-pricing Note: RHCs and FQHCs can bill HCPCS code M0201 for an in-home additional payment for influenza, pneumococcal, hepatitis B, COVID-19 vaccine administration, provided that a home visit meets all the requirements of both part 405, subpart X, for FQHC services provided in the home, and § 410.152(h)(3)(iii) for the in-home additional payment for Part B preventive vaccine administration. See Pub. 100-02, Chapter 15, Section 50.4.4.2.E for more information. Additional information on vaccines can be found in Chapter 18, section 10 of this manual. Additional coverage requirements for pneumococcal vaccine, hepatitis B vaccine, COVID-19, influenza virus vaccine can be found in Publication 100-02, the Medicare Benefit Policy Manual, Chapter 13. Covered monoclonal antibody products used as pre-exposure prophylaxis prevention of COVID-19 and their administration are paid at 100 percent of reasonable cost through the cost report. Monoclonal antibody products used for the treatment or for post- exposure prophylaxis of COVID-19 (when they are not purchased by the government) and their administration are paid through the cost report until the end of the calendar year in which the Emergency Use Authorization declaration for drugs and biological products with respect to COVID-19 ends.