As the flu shot season starts, PAAS National^® wants to make sure you are ready to properly document these routine vaccines in case of an audit. Now is the time to check that you have all required documentation in place for this year’s flu shot season.

What is needed upon an audit:

1.   Authority to administer

·        A signed order from an authorized prescriber or

·        A signed protocol or Collaborative Practice Agreement (CPA) that is up to date and includes specific vaccination(s) to be administered

·        A copy of state law or a reference to the legal citation that gives pharmacist independent authority to vaccinate

·        The amended Public Readiness and Emergency Preparedness (PREP Act)¹ has extended the authority for pharmacists to order and administer vaccines through December 31, 2029.

2.   Signed prescription or placeholder prescription (when using a protocol, CPA, or independent authority to vaccinate per state law) that contains all prescriptions elements required by state and federal regulation (a VAR may suffice)

3.      Vaccine Information Statement (VIS)

·        Required to be given to patient prior to each administration

·        Be sure you have the most current VIS forms²

- Multiple languages of VIS are available at immunize.org³

4.      Screening Checklist

·        Not requested by PBMs, however, should be retained for your records

5.      Vaccination Administration Record (VAR)*

·        Date of administration

·        Name and manufacturer of vaccine administered

·        Lot and Expiration Date of vaccine given

·        Site of administration (i.e., right arm)

·        Signature or initials and title of person administering

·        What VIS form was given

-   Date printed on the VIS

-   Date the VIS was given to the patient or parent/guardian

*Caremark audit notices have started requiring the vaccine NDC and the NPI of the person administering the vaccine.

VAR and VIS forms, and information regarding what the CDC requires for health care providers to record, can be found on the CDC website⁴.

PAAS Tips:

• Check dates and vaccine types on applicable protocols to ensure they are up to date
• Have current VIS forms printed for each vaccine administered
• Have VAR forms printed and educate all staff on how to complete the forms
• All vaccines should be submitted using a days’ supply of “1” per NCPDP recommendations
• All vaccines administered via protocol, CPA or pursuant to pharmacists’ independent authority to vaccinate should be submitted with origin code of “5” (pharmacy created) per NCPDP recommendations
• Be sure the correct metric quantity is billed
• Keep vaccine documentation stored in a system that makes retrieval easy in case of an audit
• Some PBMs prohibit billing claims outside regular pharmacy hours – consider billing for vaccine claims during regular business hours
• When billing for vaccine clinics, DO NOT bill prior to the vaccine being administered

o You may submit claims after the date of service, but the date of administration must be correct on the claim

By Trenton Thiede, PharmD, MBA, President at PAAS National^®, expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

References:

1.      https://www.federalregister.gov/documents/2024/12/11/2024-29108/12th-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

2.      https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html

3.      https://www.immunize.org/vaccines/vis-translations/spanish/

4.      https://www.cdc.gov/vaccines/hcp/admin/document-vaccines.html

Copyright © 2025 PAAS National, LLC.