Purpose
This communication provides notice regarding information and procedure codes related to the coverage of SARS-CoV-2 (Coronavirus Disease 2019 [COVID-19]) vaccines and administration of the vaccines that have been granted US Food and Drug Administration (FDA) approval and/or have received an Emergency Use Authorization (EUA). Coverage of SARS-CoV-2 vaccines granted an EUA shall remain in effect during the applicable EUA declaration, unless the specific EUA for a SARS-CoV-2 vaccine has been terminated and/or revoked.
Background
COVID-19 vaccine provides protection against COVID-19 viruses that infect the nose, throat, and lungs, and cause contagious respiratory illness. COVID-19 viruses can cause mild to severe illness, and at times can lead to death. COVID-19 viruses are always changing, so vaccination may be recommended by the Centers for Disease Control and Prevention (CDC). Scientists try to match the viruses in the vaccine to those most likely to cause COVID-19 in a specific year.
Coverage of vaccines are based on approval by the US Food and Drug Administration (FDA) and recommendations from the Centers for Medicare & Medicaid Services (CMS).
Coverage Statement
MEDICALLY NECESSARY
The monovalent COVID-19 vaccine is considered medically necessary and, therefore, covered as a preventive service when there is US Food and Drug Administration (FDA) approval or FDA Emergency Use Authorization (EUA) and the vaccine is in accordance with the Advisory Committee on Immunization Practices (ACIP) guidance for the following indications:
- Routine one- to three-dose vaccination against COVID-19 for individuals ages 6 months and older
- An additional COVID-19 vaccination for individuals ages 65 years of age and older
- An additional COVID-19 vaccination for individuals who are moderately or severely immunocompromised
A home visit for the sole purpose of administration of COVID-19 vaccine may be appropriate for individuals who meet either of the following criteria:
The individual has difficulty leaving the home to get the vaccine, which could mean any of these:
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
A condition that makes them more susceptible to contracting a pandemic disease like COVID-19
Generally unable to leave the home, and if they do leave home, it requires a considerable and taxing effort
The individual is hard to reach because they have a disability or face clinical, socioeconomic, or geographical barriers to getting a COVID-19 vaccine in settings other than their home. These individuals face challenges that significantly reduce their ability to get vaccinated outside the home, such as challenges with transportation, communication, or caregiving.
NOT MEDICALLY NECESSARY
As of April 18, 2023, the FDA revoked the EUA for the SARS-CoV-2 Wuhan-hu-1 strain (ancestral) monovalent COVID-19 vaccines. Due to this regulatory revocation, the SARS-CoV-2 Wuhan-hu-1 strain (ancestral) monovalent COVID-19 vaccines and their administration are no longer authorized for use in the United States. Therefore, the SARS-CoV-2 Wuhan-hu-1 strain (ancestral) monovalent COVID-19 vaccines and their administration are considered not medically necessary and, therefore, not covered by the Company.
As of September 12, 2023, the FDA revoked the EUA for bivalent COVID-19 vaccines. Due to this regulatory revocation, bivalent COVID-19 vaccines and their administration are no longer authorized for use in the United States. Therefore, bivalent COVID-19 vaccines and their administration are considered not medically necessary and, therefore, not covered by the Company.
NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT
For individuals currently receiving home care services, administration of COVID-19 vaccine is not eligible for separate reimbursement consideration from the home care visit.
NOT ELIGIBLE FOR REIMBURSEMENT
COVID-19 vaccines previously distributed by the United States government at no cost will not be eligible for additional reimbursement by the Company.
As of May 7, 2023, Janssen COVID-19 vaccine is no longer manufactured and has been withdrawn from market; therefore, it is not eligible for reimbursement.
BILLING REQUIREMENTS
The updated monovalent COVID-19 vaccine is covered under Part B regardless of whether the vaccine is administered without a physician's order and without physician supervision.
REQUIRED DOCUMENTATION
The individual's medical record must reflect that the care provided is according to the pertinent FDA EUAs criteria and requirements. These medical records may include, but are not limited to, records from the professional providers' office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation must be made available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Coding
CURRENT PROCEDURAL TERMINOLOGY (CPT) CODES
ELIGIBLE
0041A
0042A
0044A
90480
91304
91318
91319
91320
91321
91322
NOT MEDICALLY NECESSARY
0001A
0002A
0003A
0004A
0011A
0012A
0013A
0051A
0052A
0053A
0054A
0064A
0071A
0072A
0073A
0074A
0081A
0082A
0083A
0091A
0092A
0093A
0094A
0111A
0112A
0113A
0121A
0124A
0134A
0141A
0142A
0144A
0151A
0154A
0164A
0171A
0172A
0173A
0174A
91300
91301
91305
91306
91307
91308
91309
91311
91312
91313
91314
91315
91316
91317
THE FOLLOWING CODES REPRESENT JANSSEN (JOHNSON & JOHNSON) COVID-19 VACCINE AND ADMINISTRATION, WHICH IS NO LONGER MANUFACTURED AND HAS BEEN WITHDRAWN FROM THE MARKET:
HEALTHCARE COMMON PROCEDURE CODING SYSTEM (HCPCS) CODES
ELIGIBLE
M0201 COVID-19 vaccine administration inside a patient's home; reported only once per individual home, per date of service, when only COVID-19 vaccine administration is performed at the patient's home
