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HomeMy WebLinkAboutSTATE DPH-California Bridge Access Program_D-23-612.pdf COU Y Count of Fresno Hall of Records, Room301 2281 Tulare Street Fresno,California !`5 Board of Supervisors 93721-2198 0 Telephone:(559)600-3529 FRES) Minute Order Toll Free: 1-800-742-1011 www.co.fresno.ca.us November 7, 2023 Present: 5- Supervisor Steve Brandau,Vice Chairman Nathan Magsig,Supervisor Buddy Mendes, Supervisor Brian Pacheco, and Chairman Sal Quintero Agenda No, 61. Public Health File ID:23-1072 Re: Approve and authorize the Chairman to ratify a Provider Participation Agreement with the California Department of Public Health provided through the California Bridge Access Program to order and receive COVID-19 vaccines at no cost, previously executed on September 20, 2023 by the Director of the Department of Public Health, effective September 20,2023 through December 31, 2024($0);and authorize the Director of the Department of Public Health or designee to sign for any future agreements related to the California Bridge Access Program for COVID-19 vaccines at any time during the term of the recommended agreement APPROVED AS RECOMMENDED Ayes: 5- Brandau, Magsig, Mendes, Pacheco, and Quintero County of Fresno Page 63 coU���. 16 Board Agenda Item 61 DATE: November 7, 2023 TO: Board of Supervisors SUBMITTED BY: David Luchini, RN, PHN, Director, Department of Public Health SUBJECT: Ratification of Provider Participation Agreement with California Department of Public Health through California Bridge Access Program RECOMMENDED ACTIONS: 1. Approve and authorize the Chairman to ratify a Provider Participation Agreement with the California Department of Public Health provided through the California Bridge Access Program to order and receive COVID-19 vaccines at no cost, previously executed on September 20, 2023 by the Director of the Department of Public Health, effective September 20, 2023 through December 31, 2024($0); and 2. Authorize the Director of the Department of Public Health or designee to sign for any future agreements related to the California Bridge Access Program for COVID-19 vaccines at any time during the term of the recommended agreement. There is no increase in Net County Cost associated with the recommended actions. Approval of the first recommended action will ratify the Provider Participation Agreement previously executed on September 20, 2023 by the Director of the Department of Public Health for the California Bridge Access Program (BAP) allowing for the Department to order COVID-19 vaccines from the California Department of Public Health at no cost. These vaccines will be administered to uninsured and underinsured individuals 19 years of age and older. Approval of the second recommended action authorizes the Director and/or designee to sign any future agreements associated with BAP that are related to COVID-19 vaccines, allowing for swift action to be taken if needed without having to return to your Board for approval should a new agreement be required. This item is countywide. ALTERNATIVE ACTION(s): There is no viable alternative action. Should your Board choose not to approve the recommended actions, the Department would not be able to access COVID-19 vaccines from the State through BAP at no cost for the uninsured/underinsured population in the community,which would lead to individuals being unprotected against the current strains of COVID-19. FISCAL IMPACT: There is no increase in Net County Cost associated with the recommended actions. The Provider Participation Agreement will provide the Department with federally funded COVID-19 vaccines through BAP at no cost to the County. The Department Immunization Program staff will be responsible for administering the vaccine. DISCUSSION: County of Fresno Page 1 File Number.23-1072 File Number:23-1072 On September 11, 2023, the U.S. Food and Drug Administration (FDA)approved and authorized the updated Moderna and Pfizer COVID-19 vaccines for the Omicron variant XBB.1.5. The FDA simultaneously deauthorized all prior versions of the COVID-19 vaccines produced by Moderna and Pfizer, requiring that all current stocks of these vaccines across the nation, be destroyed. This marks the end of the Federal program that provided free COVID-19 vaccines to all individuals nationwide. The COVID-19 vaccines are now transitioning to the standard commercial model whereby providers must purchase the vaccines directly from authorized vendors. The majority of individuals in the nation will now be receiving COVID-19 vaccines through their private insurance. This transition unfortunately leaves uninsured and underinsured adults vulnerable to barriers in accessing this vaccine leaving them unprotected against currently circulating variants of COVID-19. The US Department of Health and Human Services created the Bridge Access Program as a temporary measure to prevent loss of access to free COVID-19 vaccines and treatment for the uninsured and underinsured aged 19 and older. BAP will provide the Department with the latest formulations of the COVID-19 vaccine at no cost through December 31, 2024. Eligibility to receive these vaccines is limited to individuals 19 years of age and older who are uninsured or underinsured. To participate in this program, providers such as the Department, are required to sign the Provider Participation Agreement with CDPH. Due to the anticipated impact on local healthcare resources created by influenza, respiratory syncytial virus, and COVID-19 infection this winter, the Department felt it prudent to have the agreement signed as soon as possible to ensure the Department could begin vaccinating this vulnerable population immediately. The vaccine order was placed on September 27, 2023 and was received on October 10, 2023. ATTACHMENTS INCLUDED AND/OR ON FILE: On file with Clerk- Provider Participation Agreement with CDPH CAO ANALYST: Ronald Alexander County of Fresno page 2 File Number:23-1072 D-23-612 Provider Participation Agreement B A P Bridge Access To receive federally funded Section 317 COVID-19 vaccines provided through the California Bridge Access Program at no cost, I agree to the following conditions, on behalf of myself and all the practitioners, nurses, and others associated with the health care location of which I am the medical director or equivalent. 1. COVID-19 vaccines will be administered to any individual aged 19 years and older who is uninsured or underinsured. Insured patients, including patients covered by Medicare and Medi-Cal, are NOT eligible for COVID-19 vaccines provided through the Bridge Access Program (hereafter referred to as BAP). Staff will consult the BAP Eligibility Based on Insurance Status table as needed to determine specific vaccine eligibility for patients. Eligibility screening will be conducted prior to the administration of vaccine doses.Verification of eligibility may be obtained verbally from the individual. All staff, including front office and billing staff, will be knowledgeable of BAP eligibility. 2. COVID-19 vaccines will be administered in compliance with the most recent immunization schedule, dosage, and contraindications established by the Advisory Committee on Immunization Practices (ACIP) and in compliance with all applicable requirements as set forth by the U.S. Food and Drug Administration (FDA), including but not limited to requirements in any Emergency Use Authorization (EUA) fact sheet that covers COVID-19 vaccine. 3. Patients immunized with BAP-supplied vaccines will not be billed for the cost of the vaccine nor be charged an administration fee. All systems will be checked to ensure patients are not charged and vaccine cost will not be billed. 4. Before administering COVID-19 vaccine, an approved EUA fact sheet or vaccine information statement (VIS) will be provided as required to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative. Vaccine administration records will be maintained in accordance with the National Childhood Vaccine Injury Act (NCVIA), which includes reporting clinically significant adverse events to the Vaccine Adverse Event Reporting System (VAERS) https://vaers.hhs.gov/. 5. Within 24 hours of administering a dose of COVID-19 vaccine to a BAP-eligible patient, administration data will be recorded in the recipient's permanent medical record and submitted to the State's Immunization information System (CAIR2 or Healthy Futures/RIDE) no later than 72 hours; providers must ensure that the proper vaccine eligibility category "317" is documented in CAIR. 6. The total number of patients immunized with COVID-19 vaccines and current inventory on hand will be reported to the California Department of Public Health (CDPH) according to the BAP reporting guidelines. The patient's recorded BAP 317 eligibility status and all records related to the Bridge Access Program will be retained for three (3) years. If requested, patient records will be made available to CDPH. Records include, but are not limited to, vaccine administration documentation, billing records, and medical records that verify receipt of vaccine. Release of such records will be bound by federal and state privacy laws. 7. Order vaccines according to the BAP ordering guidance; providers who have not ordered vaccines in a period longer than 6 months may be terminated from the Bridge Access Program. S. The location will comply with all requirements for COVID-19 vaccine management and reporting including the following: A. Store and handle COVID-19 vaccines under proper conditions, including maintaining cold chain conditions and chain of custody at all times in accordance with the manufacturer's package insert, Fact California Department of Public Health, IZ Branch 1 IMM-1471-9/1/23 Sheet for Healthcare Providers Administering the Vaccine, and guidance in CDC's Vaccine Storage and Handling Toolkit and COVID-19 Addendum. B. Monitor and record vaccine storage unit temperatures twice daily following guidance in CDC's Vaccine Storage and Handling Toolkit and COVID-19 Addendum. C. Respond to and report temperature excursions following CDPH guidance. D. Monitor and comply with COVID-19 vaccine expiration and beyond-use dates; never administer expired vaccine. E. Preserve all records related to COVID-19 vaccine management (e.g., vaccine temperature logs, invoices, and packing slips) for a minimum of 3 years. F. Report the number of doses of COVID-19 vaccine and adjuvants that were unused, spoiled, expired, or wasted following CDPH guidance. G. Return all nonviable vaccine to McKesson following CDPH guidance. H. Never borrow BAP-supplied vaccines to supplement private stock, or vice versa. I. Never routinely redistribute BAP-supplied vaccines; report emergency/unplanned vaccine transfers following CDPH guidance. J. Vaccinators, clinicians, vaccine coordinators, and other staff who store, handle, or administer COVID- 19 vaccine must complete the required vaccine product training before receiving shipments to ensure they are prepared to maintain vaccines under proper conditions. 9. Update Vaccines.gov to indicate BAP vaccine availability and make our location profile public according to CDC data guidance and timelines. 10. The location will operate in a manner intended to avoid fraud and abuse of COVID-19 vaccines supplied through the Bridge Access Program. Fraud is an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to himself or some other person. It includes any act that constitutes fraud under applicable federal or state law. Abuse is defined as provider practices that are inconsistent with sound fiscal, business, or medical practices and result in an unnecessary cost to the program or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care. 11. Authorized CDPH representatives will be permitted to visit the location to review compliance with all BAP policies and procedures; provider agrees to implement and complete corrective actions identified during the visit. 12. The term of this agreement is valid from enrollment through December 31, 2024, or until vaccine supply doses are completely depleted. COVID-19 vaccines supplied through the Bridge Access Program may continue to be administered until their expiration date. 13. I understand that either the CDPH Immunization Branch or my location/organization may terminate this agreement at any time. If the agreement is terminated, any unused COVID-19 vaccines will be properly returned to the CDPH Immunization Program, which administers the Bridge Access Program. California Department of Public Health, IZ Branch 2 IMM-1471-9/1/23 By signing this form, I certify, on behalf of myself and all immunization providers in this location,that I have read and agree to the requirements listed above and understand I am accountable (and each listed provider is individually accountable)for compliance with these requirements. Chief Executive Officer Name David Luchini Director of Public Health Signature' —� Date 9/20/209 Chief Medical Officer Name Dr. Rais Vohra, Interim Health Officer Medical License Number A86387 Signature V.6k, vo Date 9/20/2023 Vaccine Coordinator Name Scotti Blanks, SPHN Signature Date 9/5/23 California Department of Public Health, IZ Branch 3 IMM-1471-9/1/23