justicedao/ipfs_state_laws huggingface dataset:
333-046-0040 Clinic Enrollment (1) Only prescribers authorized by the Oregon Health Authority (Authority) may receive federally-purchased vaccines provided by the Vaccines for Children (VFC) program and Vaccine Access Program (VAP) or state-purchased vaccines for billable vaccine provided by the VAP program . (2) Application for the VFC or VAP program requires the clinic’s principal provider, medical director or clinic administrator to complete a VFC Program Agreement that estimates the number of patients served and documents the prescriber’s agreement to ensure that the clinic, and all of its prescribers, complies with all VFC or VAP program requirements. (3) In a solo practice, forms must be signed by the primary prescriber. (4) In a group practice, forms must be signed by the medical director or clinic administrator. The signer will be held accountable for compliance of the entire organization and all prescribers using VFC or VAP vaccine in the practice. (5) Prior to enrollment, clinics must have an enrollment site visit by the Authority. (6) Clinics must re-submit an updated signed VFC or VAP Program Agreement: (a) Annually; and (b) When the number of patients served changes enough to require an adjustment in the amount of vaccine needed; or (c) A clinic changes prescribing providers during a calendar year. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0050 Vaccine Eligibility (1) Enrolled clinics may only provide Vaccines for Children (VFC) vaccine to children under the age of 19 years. (2) Enrolled clinics may only provide VFC vaccine to children in one of the following categories: (a) Children enrolled in the Oregon Health Plan; or (b) Children with American Indian/Alaskan Native heritage; or (c) Uninsured children; or (d) In federally-qualified health centers (FQHCs) or rural health clinics (RHCs) only, children who are underinsured. (3) Clinics may not require patients eligible under subsections (2)(b) or (2)(c) of this rule to prove their eligibility for VFC vaccines. (4) Clinics designated as an FQHC or RHC must vaccinate any VFC-eligible underinsured patients that present at the clinic for immunization. Clinics that are not FQHCs and RHCs may not be required to vaccinate patients that are not established with the clinic. (5) Enrolled clinics may only provide 317 vaccines to adults aged 19 years and older without insurance or whose insurance does not have any coverage for immunizations. (6) Enrolled clinics may provide billable vaccine to insured patients who are ineligible for VFC- or 317-provided vaccines. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0055 Billable Vaccine (1) Clinics that administer billable vaccines will be billed quarterly for the purchase price of the vaccine by the Oregon Health Authority (Authority). (2) The vaccine price list will be updated biannually by the Authority, on January 1 and July 1. (3) Enrolled clinics must submit payment within 60 days of receiving their quarterly bill. (4) Enrolled clinics may not bill more for the vaccine than the published price in effect on the date of administration. (5) Clinics may charge an administration fee for billable vaccines that covers their cost of providing the service. Billable vaccines are not subject to the administration fee limits imposed on Vaccines for Children (VFC) and 317 vaccines. (6) Clinics may bill a patient’s insurer for both the billable vaccine and the administration fee. Statutory/Other Authority: ORS 413.042 & ORS 431.250 Statutes/Other Implemented: ORS 413.042 & ORS 431.250 History: PH 1-2025, adopt filed 01/22/2025, effective 01/22/2025
333-046-0060 Vaccines for Children (VFC) and 317 Vaccine Administration Fees (1) Clinics may not bill any insurer or guarantor for the cost of vaccines provided by the Vaccines for Children (VFC) program or purchased with 317 funds for the Vaccine Access Program (VAP). (2) Clinics may charge a vaccine administration fee for each VFC or 317 vaccine provided. The administration fee may not exceed the limit set for Oregon by the United States Department of Health and Human Services. (3) Vaccine administration fees may be billed to a patient’s insurer, if applicable. (4) If an established patient of the clinic is unable to pay the administration fee, the prescriber must not deny access to VFC vaccines. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0070 Program Compliance (1) Clinics must adhere to all terms detailed in the Vaccines for Children (VFC) or Vaccine Access Program (VAP) Program Agreement. (a) The Oregon Health Authority (Authority) may, at its discretion, revise the VFC or VAP Program Agreement as posted on the Oregon VFC website. The Authority will provide 30 days written notice, via listserv electronic mail, to prescribers of revisions to the VFC or VAP Program Agreement. (b) A prescriber’s submission of a vaccine order after receipt of such notice shall be considered the prescriber’s acceptance of the agreement revisions. If a prescriber does not wish to accept and be bound by the revisions to VFC or VAP Program Agreement, the prescriber may contact the Oregon Immunization Program to arrange pick-up of any remaining state-supplied vaccine. (2) Clinics must practice in compliance with the legal requirements of the federal National Childhood Vaccine Safety Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34). (3) Prescribers must chart all vaccinations administered in accordance with federal law. (4) Prescribers must comply with all provisions of ORS 433.103 and OAR chapter 333, division 47. (5) Clinics must participate in compliance site visits conducted by the Authority. Participation includes making available, without unreasonable delay, any staff or documentation necessary to answer questions included on the site visit questionnaire provided by the CDC. (6) Clinics must cooperate with unannounced storage and handling site visits conducted by the Authority. (7) Clinics must complete all necessary trainings as determined by the Authority. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0080 Record Keeping Clinics must keep all records related to the Vaccines for Children (VFC) program or Vaccine Access Program (VAP) for a minimum of three years and make them available to the Oregon Health Authority for review upon request. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0090 Provider Sanctions The Oregon Health Authority (Authority) may terminate a clinic’s or prescriber’s participation in the Vaccines for Children (VFC) program or Vaccine Access Program (VAP) based on the following: (1) Violation of the terms of the program agreement. (2) Conviction of fraud related to any federal, state, or locally financed health care program or commission of an act that is subject to criminal or civil penalties under Medicaid statutes. (3) Conviction of interference with the investigation of health care fraud. (4) An action by a state licensing authority relating to a prescriber’s professional competence, professional conduct, or financial integrity, that results in the prescriber either: (a) Having their license suspended or revoked; or (b) Surrendering the license while a formal disciplinary proceeding was pending before a licensing authority. (5) Suspension or exclusion from participation in a federal or state-administered health care program for reasons related to professional competence, professional performance, or other reason. (6) Improper billing practices, including billing for the cost of state-supplied vaccines, excessive charges or unnecessary vaccination visits. (7) Failure to correct deficiencies in operations after receiving written notice of the deficiencies from the Authority. (8) The Authority shall consider the following factors in determining the sanctions to be imposed (this list includes but is not limited to these factors): (a) Seriousness of the offenses; (b) Extent of violations by the prescriber; (c) History of prior violations by the prescriber; (d) Prior imposition of sanctions; (e) Prior education provided by the Authority; and (f) Prescriber willingness to comply with VFC or VAP rules and procedures. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0100 Clinic Probation (1) Except in cases of suspected fraud, when a clinic is sanctioned by the Oregon Health Authority (Authority) for the first time under OAR 333-046-0090 sections (1), (6) or (7), the Authority will offer a clinic the opportunity to voluntarily sign a probationary agreement before removing the clinic from the Vaccines for Children (VFC) program in accordance with OAR 333-046-0110. (2) The terms of the probationary agreement will be determined by the violations that have been identified by the Authority. The final probationary agreement will be approved by the Oregon Immunization Program manager or their designee. (3) Failure to return a signed copy of the final probationary agreement within 14 calendar days of receipt of the agreement by the clinic will forfeit any right to a probationary agreement under section (1) of this rule. (4) A probationary agreement may be in effect for no longer than 12 months before a final resolution is determined. If the clinic has complied with all clauses of the agreement during the probationary period, the clinic will be returned to regular status with the VFC program or Vaccine Access Program (VAP). If the clinic has not complied with all clauses of the agreement during the probationary period, the clinic will be removed from the VFC or VAP program under OAR 333-046-0110. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0110 Removal from the Vaccines for Children (VFC) Program or Vaccine Access Program (VAP) (1) When a clinic is sanctioned by the Oregon Health Authority (Authority) under OAR 333-046-0090 sections (2) through (5), the Authority will immediately remove the clinic, and all associated prescribers, from the Vaccines for Children (VFC) program or Vaccine Access Program (VAP) under the provisions of this rule. (2) When the Authority determines that a clinic should be removed from the VFC or VAP program, written notification will be sent by certified mail to the prescriber who signed the VFC or VAP Program Agreement. (3) The written notification will include the rationale behind the removal and inform the clinic of the right to appeal the decision within 60 calendar days. (4) Clinics and prescribers that have been removed from the VFC or VAP program may apply for conditional re-enrollment no sooner than 12 months after their removal from the program. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0120 Clinic Appeals (1) A clinic may appeal an Oregon Health Authority (Authority) decision in which the clinic is directly adversely affected such as the following: (a) A denial of an application for new or continued participation in the Vaccines for Children (VFC) program or Vaccine Access Program (VAP). (b) Sanctions imposed, or intended to be imposed, by the Authority on a clinic. (2) A clinic appeal is initiated by filing a timely request in writing for review by the Authority. (3) A clinic’s appeal request is not required to follow a specific format as long as it provides a clear written rationale from a clinic expressing disagreement with the Authority’s decision. (4) The request must identify the decision made by the Authority that is being appealed and the reason the clinic disagrees with that decision. (5) A clinic’s appeal request is timely if it is received within 60 calendar days of the date of the appealed decision. (6) In the event a clinic’s request for appeal is not timely, the Authority shall determine whether the failure to file the request was caused by circumstances beyond the control of the clinic. In determining whether to accept a late appeal, the Authority requires the request to be supported by a written statement that explains why the request for review is late. In determining timeliness of filing a request for review, the amount of time the Authority determines accounts for circumstances beyond the control of the prescriber is not counted. (7) The burden of presenting evidence to support a clinic’s appeal is on the clinic. (8) Agency appeal proceedings, if any, shall be held in Portland, unless otherwise stipulated to by all parties and agreed to by the Authority. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-046-0130 Conditional Re-enrollment (1) Clinics and prescribers that have been removed from the Vaccines for Children (VFC) program or Vaccine Access Program (VAP) under OAR 333-046-0110 may apply for conditional re-enrollment 12 months after the removal. (2) Re-enrollment will be conditional on the clinic correcting any deficiencies that led to their removal from the VFC or VAP program. (3) Clinics accepted for re-enrollment will be subject to a probationary agreement as detailed in OAR 333-046-0100 for a period of 12 months. (4) Clinics that voluntarily disenroll from the VFC or VAP program in lieu of agreeing to a probationary agreement will be subject to a 12-month waiting period before requesting re-enrollment. Statutory/Other Authority: ORS 413.042 & 431.250 Statutes/Other Implemented: ORS 413.042 & 431.250 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 39-2016, f. & cert. ef. 12-22-16
333-047-0010 Definitions Used in the Vaccine Accountability Rules (1) All definitions of ORS 433.090 and 433.235 apply to OAR chapter 333,, division 47. (2) In addition to the definitions of ORS 433.090 and 433.235, the following definitions apply: (a) "Authority" means the Oregon Health Authority. (b) "Authority’s Immunization Registry" means the immunization information system (IIS) established by the Authority under ORS 433.094 and OAR chapter 333, division 49. (c) "Certify" means to attest, in writing, on a form prescribed by the Oregon Health Authority that at least two employees, owners or partners have completed required vaccine-related trainings as provided or approved by the Oregon Health Authority. (d) "Entity" means a health clinic or provider, pharmacy or pharmacist who receives state-supplied vaccine. (e) "Oregon Immunization Program" means the Oregon Health Authority, Public Health Division, Immunization Program. (f) "Public Health Division" means the Oregon Health Authority, Public Health Division. (g) "Receives vaccines" means an entity is supplied with vaccines by the Oregon Immunization Program, including vaccines acquired with federal and state funds, including the Vaccines for Children (VFC) program, the Vaccine Access Program (VAP), state Special Project vaccine, and state Billable Project vaccine. (h) "State supplied vaccine" means vaccine provided by the federal government or the Oregon Immunization Program. Statutory/Other Authority: ORS 433.103 Statutes/Other Implemented: ORS 433.103 History: PH 1-2025, amend filed 01/22/2025, effective 01/22/2025 PH 76-2021, amend filed 10/11/2021, effective 10/11/2021 PH 30-2021, amend filed 07/12/2021, effective 07/12/2021 PH 5-2021, temporary amend filed 01/22/2021, effective 01/22/2021 through 07/20/2021 PH 14-2011, f. 12-28-11, cert. ef. 1-1-12
333-047-0030 Training (1) Any entity receiving state supplied vaccine shall require that at least two currently employed staff persons, owners or partners complete immunization related training at least once every two years as follows: (a) Clinical administration of vaccines; and (b) Storage, handling and inventory management of vaccines. (2) An entity shall provide Authority staff with written documentation that it has met the requirements of section (1) of this rule or that it is exempt from training upon request or at every official Vaccines for Children site visit. (3) An entity receiving state-supplied vaccine is responsible for retaining documentation that at least two currently employed staff persons, owners, or partners have completed the required clinical administration and vaccine management training course at least once every two years. (4) The Authority will make available to entities no-cost internet based training available in on-demand format. (5) Web-based training will include an official certification receipt for staff meeting competence standards. (6) The Authority will exempt an entity from the training requirement in section (1) of this rule if an entity demonstrates to the satisfaction of the Authority that it, or that a licensing board with jurisdiction over some employees of the entity, requires training that is substantially similar to the training available from the Authority. An entity may submit a request for an exemption on a form prescribed by the Authority. (7) The training requirements required by section (1) of this rule are effective January 1, 2013. Statutory/Other Authority: ORS 433.103 Statutes/Other Implemented: ORS 433.103 History: PH 14-2011, f. 12-28-11, cert. ef. 1-1-12
333-047-0040 Accounting for Vaccine (1) Any entity receiving state supplied vaccine shall account for all vaccines the clinic administers (state-supplied and privately purchased) through data submission and inventory management via the Authority’s Immunization Registry, as outlined in OAR 333-049-0010 through 333-049-0040 and for COVID-19 vaccine, as outlined in OAR 333-047-1000. (2) An entity receiving state supplied vaccine may only transfer or redistribute vaccine to another Authority enrolled provider. Statutory/Other Authority: ORS 433.103 Statutes/Other Implemented: ORS 433.103 History: PH 76-2021, amend filed 10/11/2021, effective 10/11/2021 PH 30-2021, amend filed 07/12/2021, effective 07/12/2021 PH 5-2021, temporary amend filed 01/22/2021, effective 01/22/2021 through 07/20/2021 PH 14-2011, f. 12-28-11, cert. ef. 1-1-12
333-047-1000 COVID-19 Vaccine Requirements (1) A person or entity receiving, storing, administering, or transferring COVID-19 vaccine must report: (a) All COVID-19 vaccine dose administration and adjuvant (if applicable) within 24 hours of administration. (b) All on-hand inventory of COVID-19 vaccine on a weekly basis, no later than 5 p.m. Pacific Time on Sunday. (c) All spoiled, expired, or wasted COVID-19 vaccine to the Authority’s Immunization Registry or through a survey managed by the Authority within 24 hours of knowledge or discovery of the spoilage, expiration or wasting. (d) All transfers of COVID-19 vaccine within 24 hours of the transfer. (2) A person or entity must report the information required under this rule in the Registry in accordance with OAR chapter 333, division 49. (3) A person or entity receiving state-supplied COVID-19 vaccine must promptly (within 24 hours) respond to requests for information from the Authority or a Local Public Health Authority about its COVID-19 vaccine storage, handling, use, administration plans, transfers, or inventory, including temperature logs. (4) If the Authority determines that a person or entity with COVID-19 vaccine cannot make immediate use of the vaccine and that the vaccine is needed more urgently elsewhere, the Authority may request the vaccine be transferred to another enrolled provider and the vaccine must be transferred within 24 hours of the Authority’s request. (5) If the Authority determines that a person or entity with COVID-19 vaccine is not appropriately storing or handling COVID-19 vaccine, the Authority may demand return of the vaccine or appear on-site to collect and remove the vaccine. (6) A person or entity receiving state-supplied COVID-19 vaccine must, in addition to any requirements in OAR 333-047-0030, complete trainings identified on the Authority’s COVID-19 Training for Vaccine Provider’s webpage: https://www.oregon.gov/oha/ph/PreventionWellness/VaccinesImmunization/RulesLaws/Pages/index.aspx. (7) A person or entity who violates any provision of this rule is subject to a civil penalty of $500 per day per violation. Statutory/Other Authority: ORS 433.103 & 431A.010 Statutes/Other Implemented: ORS 433.103 & 431A.010 History: PH 30-2021, adopt filed 07/12/2021, effective 07/12/2021 PH 5-2021, temporary adopt filed 01/22/2021, effective 01/22/2021 through 07/20/2021
333-047-2000 COVID-19 Vaccine Guidance and Consent Requirements (1) For purposes of this rule "COVID-19 vaccine administration site" means any location where COVID-19 vaccines are administered. (2) A person or entity receiving state-supplied COVID-19 vaccine must comply with OAR 333-003-5000 regarding minor consent to vaccination. (3) A COVID-19 vaccine administration site must: (a) Have a designated site coordinator. (b) Post signs, in conspicuous locations with contact information for the designated site coordinator, so people know who to contact if there are concerns about the site or services provided. (c) Provide people who received their first dose of a vaccine at the site, with the date and time to return for their second dose of a vaccine, if applicable. (d) Provide a person who is vaccinated with a vaccine card that shows at a minimum the date of the COVID-19 vaccination, the location of the vaccine administration site, which vaccine was administered, and the due date of the second dose, if applicable. (4) A COVID-19 vaccine administration site and staff and volunteers at the site are prohibited from: (a) Asking a person seeking to be vaccinated to provide their social security number. The site may choose to ask for a social security number for purposes of billing insurance, but it must be made clear that providing a social security number is optional and will only be used for purposes of insurance billing and is not a condition to receive the vaccine. (b) Denying a COVID-19 vaccine to someone who is otherwise eligible on the basis that a person: (A) Is uninsured; (B) Is a citizen of another country; (C) Is a resident of another state; or (D) Is a resident of another county. (c) Charging a person seeking to be vaccinated for the vaccine or the vaccine administration fee. A provider may bill insurance for the administration fee but cannot charge the person seeking to be vaccinated. (d) Requiring a person to provide: (A) Proof of health insurance information. This information may be requested but it cannot be required and it must be made clear that providing the information is optional. (B) Government issued identification. (5) A person or entity who violates any provision of this rule is subject to a civil penalty of $500 per day per violation. Statutory/Other Authority: ORS 433.103 & ORS 431A.010 Statutes/Other Implemented: ORS 433.103 & ORS 431A.010 History: PH 82-2021, adopt filed 11/22/2021, effective 11/22/2021 PH 28-2021, temporary adopt filed 07/09/2021, effective 07/09/2021 through 11/22/2021 PH 21-2021, temporary adopt filed 05/27/2021, effective 05/27/2021 through 11/22/2021