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How Laws, Regulations, and Guidelines Are Created

EMERGENCY MEDICAL SERVICES AUTHORITY: LEGISLATIVE, REGULATORY & GUIDELINE PROCESS OVERVIEW

THE LEGISLATIVE PROCESS

  1. What is Statute?

    • Legislatively created laws
    • Health and Safety Code, Division 2.5
    • Federal law takes precedence over state law
    • Statute overrides regulations and guidelines
  2. EMS Authority's role

    • Advisor to the Health & Human Services Agency and the Governor's Office
    • Technical/policy consultant on legislation affecting EMS Authority's programs and related issues for the Governor, Legislature, special interest groups and the public
    • Propose legislation to improve, extend, amend or strengthen existing law and programs
  3. How a bill becomes law: The Legislative process

  4. Process for reviewing bills, preparing analyses, and receiving positions

    • EMSA Legislative Director assigns bills to program staff for their expert review and analysis
    • Analyses are reviewed and prepared in final form by Legislative staff after discussion with Director and/or Chief Deputy Director on policy issues and position recommendation
    • Signed analyses are submitted to Health & Human Services Agency for review
      • Agency will only approve one position for all departments on a bill
      • Agency can change requested positions
    • Agency forwards analyses to the Governor's Office for review and approval
    • Department is notified when position is given
      • Sometimes requested positions are not approved
      • Legislative analyses and departmental positions are confidential and not subject to Public Records Act disclosure
  5. Legislative Proposals

    • Program staff prepare legislative proposals
    • Legislative Director prepares final proposal after review and discussion with program staff, the Director and/or Chief Deputy Director
    • A proposal that impacts another department must be discussed and approved by that department before submitting to Health & Human Services Agency
    • Proposal is submitted to Health & Human Services Agency for review
    • Health & Human Services Agency forwards proposal to the Governor's Office for review
    • Legislative Director and Chief Deputy Director meet with Legislative staff in the Governor's Office to discuss issues and need for statutory changes
    • Proposal is either approved or denied by the Governor's Office
    • If approved, locate author for legislation; if denied, department cannot proceed with efforts to make statutory changes

THE REGULATORY PROCESS

  1. What are regulations?

    • Official California Code of Regulations, Title 22: Social Security, Division 9: Prehospital Emergency Medical Services, Chapters 1-9, Articles 100000.1--100334
    • Regulations implement, interpret, or make specific the laws administered by the EMS Authority and govern its procedure
    • Regulations are approved by the Office of Administrative Law (OAL)
    • Statute takes precedence over regulations
  2. How regulations are added or amended (see chart)

    • The Administrative Procedure Act describes the procedures that must be followed when adopting, amending or repealing a regulation
    • Department starts rulemaking file, writes proposed regulations, and prepares Initial Statement of Reasons (justification)
    • A notice of the department's intent to write or amend regulations is printed in the California Regulatory Notice Register
    • A public notice of any proposed changes or additions to regulations must be sent to all persons on the departments mailing list
    • Submit proposed regulations to the EMS Commission for review
    • Hold a 45-day public comment period and make contents of regulatory file available upon request
    • Schedule a public hearing
    • Submit comments, responses, and proposed revisions to the Commission for review and approval
    • Respond in rulemaking file to pertinent comments and questions received
    • Provide additional 15-day comment period to those who submitted comments or requested notification if related changes made to original proposal
    • Submit comments, responses, and proposed revisions to the Commission for review and approval
    • Mail new notice and set another 45-day public comment period if substantive changes are made to original proposal
    • Submit proposed regulations to the Commission for final review and approval
  3. Information the EMS Authority is required to prepare, maintain, and submit to the OAL

    • The public notice must contain specific information as outlined by the OAL
    • A complete record of each rulemaking activity must be maintained and available for public scrutiny
    • Prepare Final Statement of Reasons summarizing primary points of individual comments, and document decisions relative to those comments
    • A complete rulemaking file must be submitted to OAL that also includes:
    • Data and factual information submitted by the public
    • Written comments, petitions, recordings or minutes of public hearing
    • A summary of each comment that was specific to regulatory action proposed or agency procedures, showing how proposal was changed to accommodate each, or reasons for rejection
    • Text as adopted (if different from proposed text)
    • Final statement of reasons
    • Updated Informative Digest
  4. The review and decision process by OALGUIDELINES

    • The OAL has 30 days to review the regulatory file and issue its decision.
    • The regulatory file must document the department's procedures and regulations must meet these legal standards: Necessity, clarity, authority, nonduplication, reference, consistency
    • Approved regulations filed by the OAL with the Secretary of State, become effective 30 days after filing, and are then printed in the Official California Code of Regulations
    • Disapproved regulations are returned to the department and the reasons for the disapproval are printed in the California Regulatory Notice Register
    • Departments may appeal OAL's disapproval to the Governor
    • Departments address OAL's concerns and resubmit

GUIDELINES

  1. What are Guidelines?

    • Department policy and recommended standards
    • Does not have the force of law or regulation
  2. How are guidelines established?Laws, Regulations, and Guidelines: How they impact the Emergency Medical Services Authority (see chart)

    • Developed by the department
    • Must be reviewed and approved by the EMS Commission

Laws, Regulations, and Guidelines: How they impact the Emergency Medical Services Authority (see chart)

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