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How Laws, Regulations, and Guidelines Are Created

DATE: September 24, 1997

TO: Commission on EMS

FROM: Richard E. Watson, Interim Director

PREPARED BY: Shirley Tsagris, Legislative Coordinator

SUBJECT: Information on the Legislative Process

RECOMMENDED ACTION(s):

Receive information concerning the legislative process.

FISCAL IMPACT:

None.

DISCUSSION:

Attached is an overview of the discussion of the Legislative and Regulatory Process that will be presented at the upcoming meeting. This discussion is intended to inform and educate the Commission members and the general public of the procedures the EMS Authority must follow when legislation, regulations, and guidelines are created. It also discusses the differences and the authority given to each.

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 or guidelines
2. EMS Authority's role
  - Advisor to the Health & Welfare 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
  - Sponsor legislation to improve, extend, amend or strengthen existing law and programs
3. How a bill becomes law: The Legislative process
  - The Senate and Assembly
  - Standing committees and their roles, other Legislative committees
  - The Legislature as policy-making body, directing department programs with policy and funding decisions
4. Process for reviewing bills, preparing analyses, and receiving positions
  - Flow chart for bill analysis process
  - Legitech
    - Contracted by Health & Welfare Agency for all their departments
    - Used for searching, tracking, and printing of legislation
  - Legislative Coordinator assigns bills to program staff for their review and analysis
  - Analyzes are reviewed and prepared in final form by Legislative Coordinator after discussion with Director and/or Chief Deputy Director on policy issues and position recommendation
  - Analyzes are sent to Health & Welfare Agency for review and approval
    - 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
    - The Governor's Office can stipulate that the contents of the analysis not be released even though the position is approved
5. Lobbying Legislation
  - Departments cannot release their analyses or lobby until they have an approved position from the Governor's Office
  - Send position letter to the author, committees hearing bill, committee members
  - Contact the sponsor and constituent groups
  - Testify on approved issues and positions at hearings
6. Legislative Proposals
  - Program staff prepare legislative proposal
  - Legislative Coordinator prepares final 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 & Welfare Agency
  - Proposal is submitted to Health & Welfare Agency for review
  - Legislative Coordinator and Chief Deputy Director meet with Agency staff to discuss issues in legislation proposal before approval can be given
  - Proposal is forwarded to the Governor's Office for review
  - Legislative Coordinator 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 OAL
  - 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?
  - 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)