Vaccine Storage & Handling and VFC Compliance MDPH Immunization - PDF document

Vaccine Storage & Handling and VFC Compliance MDPH Immunization Division Vaccine Management Unit Shumethia Seal, MPH Vaccine Manager MIAP Conference 2019 1 October 17, 2019 1 Presenter Disclosure • I, Shumethia Seal, have been asked to disclose any significant relationships with commercial entities that are either providing financial support for this program or whose products or services are mentioned during my presentations. • I have no relationships to disclose. • I may discuss the use of vaccines in a manner not approved by the U.S. Food and Drug Administration but in accordance with ACIP recommendations. 2 October 17, 2019 MIAP Conference 2019 2 2019 Year in Review January Annual Enrollment July Change Allocation for Flu February Flu Pre-book August Flu Vaccine is available March September April Adult Conference October MIAP May Immunization Updates November June December MIAP Conference 2019 3 October 17, 2019 3 1

Annual Enrollment • Completed in the MIIS. • Confirm all information is accurate. • Ensure that at least the Primary and Backup Vaccine Coordinator at your practice has received a VFC Compliance and Storage and Handling training and received a certificate during the previous year. MIAP Conference 2019 4 October 17, 2019 4 Site Visit • Occurs every two years. • Assessed for compliance with VFC and other federal requirements in accordance with MDPH guidelines. • Issues result in sites entering an educational follow- up process in accordance with CDC guidelines. • At the end of the visit, providers will receive a Provider Follow-up Plan and it must be signed by the Medical Director (or staff authorized to sign on behalf of the organization). MIAP Conference 2019 5 October 17, 2019 5 Unannounced Site Visit In-Person Training • Focused on Storage and • Focused on giving an overview of Handling the program • MDPH is required to do a • Prompted by a new Vaccine specific amount of visits Coordinator at the site MIAP Conference 2019 6 October 17, 2019 6 2

Quiz Providers must be assessed for compliance with VFC and other federal requirements in accordance with MDPH guidelines every other year. What is one of the most frequent findings at provide site visits? MIAP Conference 2019 7 October 17, 2019 7 Resources MIAP Conference 2019 8 October 17, 2019 8 Guidelines for Compliance Vaccine management and VFC requirements and recommendations are detailed in the ‘Guidelines for Compliance with Federal and State Vaccine Administration Requirements’. https://www.mass.gov/service- details/vaccine-management MIAP Conference 2019 9 October 17, 2019 9 3

Standard Operating Procedures (SOP) Providers must have a written SOP in place for proper vaccine management. • SOP should cover both routine and emergency procedures. • All staff who are responsible for vaccines in any way must acknowledge reading their practice’s SOP by signing and dating the document. – annually – as part of employee orientation – change in responsible staff (Vaccine Coordinators) MIAP Conference 2019 10 October 17, 2019 10 Vaccine Information Statements (VIS) • All providers are required to provide a copy of the relevant, current edition of the VIS produced by the CDC before administering a doses of vaccine (NCVIA: 42 U.S.C. Section 300aa-26). • Copies of the most recent VIS can be found at www.immunize.org/vis or on the CDC website at www.cdc.gov/vaccines/hcp/vis/ . • Sign up to receive emails when VISs are updated at www.cdc.gov/vaccines/hcp/vis . MIAP Conference 2019 11 October 17, 2019 11 Vaccine Safety Adverse events should be reported directly to the Vaccine Adverse Events Reporting System (VAERS) through the website or calling. https://vaers.hhs.gov/ or 800-822-7967 MIAP Conference 2019 12 October 17, 2019 12 4

Using State-Supplied Vaccine MIAP Conference 2019 13 October 17, 2019 13 Vaccine Availability Massachusetts supplies vaccines to any child under 19 through state funding for privately insured children and through the federally funded Vaccines for Children (VFC) program to publicly insured children or other children who meet VFC eligibility. All of these vaccines are considered state supplied and can be used according to the Childhood and Adult Vaccine Availability Tables. 14 October 17, 2019 MIAP Conference 2019 14 VFC Eligibility Birth through 18 years of age: • Enrolled in Medicaid • Uninsured • Under-insured and seen at an FQHC • American Indian (Native American) or Alaska Native Providers must screen and document VFC eligibility for all children at every immunization visit. MIAP Conference 2019 15 October 17, 2019 15 5

Billing and Charging for State Supplied Vaccine • The vaccine administration fee is up to $23.29 /dose for non-Medicaid VFC-eligible patients. • Providers may not bill for the cost of any state- supplied vaccines. • Providers may not deny state-supplied vaccine to an established patient due to the inability to pay the administration fee. MIAP Conference 2019 16 October 17, 2019 16 Clarification of billing practices in the VFC Program Starting January 1, 2020 , providers who bill vaccine administration fees to non-Medicaid VFC-eligible children after the date of service may issue only a single bill to the patient within 90 days of vaccine administration. Patients cannot be turned away or reported to collections for the inability to pay the vaccine administration fee. MIAP Conference 2019 17 17 Borrowing Vaccines Borrowing is the use of state-supplied vaccine for a child not eligible for state-supplied vaccine when privately purchased vaccine is not readily available or vice versa. • State-supplied vaccine may never be borrowed for use in someone 19 years of age or older. • If a provider borrows state-supplied vaccine, a Vaccine Borrowing Report Form must be completed and sent to the Vaccine Unit. MIAP Conference 2019 18 18 6

Documentation • Records related to the immunization program should be kept for at least three years. Ex. Patient eligibility, vaccine packing slips, borrowing reports, etc. • Providers must ensure that the permanent medical record of the recipient contains all the required documentation for immunizations. MIAP Conference 2019 19 19 Quiz MA is universal for all routinely recommended pediatric vaccines except? a) Tdap b) Men B c) HPV4 d) Menactra A doctor is requiring a 21 year old to be revaccinated due to a specific medical reason, is this patient eligible for State-Supplied Vaccines? Yes or No MIAP Conference 2019 20 20 Responsibilities of Provider MIAP Conference 2019 21 21 7

Medical Director • Responsible for ensuring that state-supplied vaccine is administered in compliance with federal requirements. • Ensuring that annual enrollment is completed to receive vaccines. • Understands and agrees that MDPH Immunization Division staff are required to make site visits. • Responsible for designating Primary and Backup Vaccine Coordinators. MIAP Conference 2019 22 22 Primary and Back-Up Vaccine Coordinator • Responsible for all oversight of all vaccine storage and handling including vaccine ordering and acting as the vaccine shipping contact. • Responsible for communicating vaccine policy, vaccine availability, updates and alerts to staff. Any changes in the Vaccine Coordinators must be reported within 10 days. MIAP Conference 2019 23 23 Fraud and Abuse Improper use of state-supplied vaccine may constitute fraud and abuse. • Fraud – intentional deception made by a person with the knowledge that it could result in some unauthorized benefit to themselves or some other person. • Abuse – provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in unnecessary cost to the Medicaid program, Immunization Division, Health Insurance Company, or patient. MIAP Conference 2019 24 24 8

Restitution MDPH requires providers to replace any doses of state- supplied vaccines that have been lost due to the provider’s failure to properly receive, store, or use vaccines if: – 1st incident and the total loss is over $10,000 – 2nd incident (or greater) regardless of total value – Due to a failure to immediately open a vaccine shipment from McKesson or Merck resulting in damaged vaccine regardless of total value – Due to a failure to store refrigerated vaccine in a refrigerator or failure to store frozen vaccine in a freezer MIAP Conference 2019 25 25 Quiz Sites are encourage to transfer vaccine to prevent wastage, this is also considered borrowing. My state- supplied flu vaccine hasn’t arrived, but I have a flu clinic scheduled next week. I should just use my private vaccine so there aren’t any missed opportunities? MIAP Conference 2019 26 26 Vaccine Management MIAP Conference 2019 27 27 9