BILL ANALYSIS Ó AB 614 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 614 (Brown) As Amended June 2, 2015 Majority vote -------------------------------------------------------------------- |ASSEMBLY: | 77-0 | (May 7, 2015) |SENATE: |37-0 | (August 17, | | | | | | |2015) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: HEALTH SUMMARY: Authorizes the California Department of Public Health (DPH) to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are referenced in the California Code of Regulations (CCR). The Senate amendments update the definition of eating disorders to reference the Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association. EXISTING LAW: Establishes DPH to license health facilities and requires DPH to adopt, amend or repeal, as specified, any reasonable rules and regulations as may be necessary or proper to carry out the exercise of its power. Establishes, under the Administrative Procedures Act (APA), a process for adopting, AB 614 Page 2 amending, or repealing regulations. FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. COMMENTS: According to the author, this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice when applicable. The author states that this will result in an efficient and cost effective method for ensuring that health facilities and DPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards, improving the quality of patient care provided in licensed health facilities. The regulatory process, governed by the APA and enforced by the Office of Administrative Law (OAL) is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. Generally, there are two types of rulemaking procedures that a state agency can pursue: regular or emergency. The regular rulemaking process requires that a state agency meet certain public hearing and notice requirements. The emergency rulemaking process has different requirements, which generally include a brief public notice period, a finding of emergency, a brief public comment period, review by OAL and an OAL decision. For the regular rulemaking process, once a state agency decides to conduct a rulemaking action, it develops four documents required during the preliminary stage: 1) the proposed text; 2) the Initial Statement of Reasons; 3) the Fiscal Impact Statement; and, 4) the Notice of Proposed Regulatory Action (notice). The APA requires at a minimum a 45-day opportunity to comment to AB 614 Page 3 the agency, in writing, on the proposed regulation. An agency has the option as to whether it will hold a public hearing on a proposed rulemaking action. However, if an agency does not schedule a public hearing, any interested person can submit a written request within a specified timeframe requesting one to be held, and the agency must then give notice and hold a public hearing. A rulemaking agency must summarize and respond on the record to timely comments that are directed at the proposal or at the procedures followed by the agency during the regulatory action. With each comment, the agency must either: 1) explain how it has amended the proposal to accommodate the comment; or, 2) explain the reasons for making no change to the proposal. The summary and response to comments is included as part of the rulemaking file in the Final Statement of Reasons. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15 months to 18 months, regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments. Nationally recognized professional organizations use industry expertise, information gathered through research, patient outcomes, and best practices to develop standards that are accepted in various medical professions for providing the highest quality of care possible. For example, the American Academy of Pediatrics publishes a wide variety of clinical practice guidelines on a range of subjects including: The Diagnosis, Management, and Prevention of Bronchiolitis, Management of Newly Diagnosed Type 2 Diabetes Mellitus in Children and Adolescents, and Treatment of the School-Aged Child With Attention-Deficit/Hyperactivity Disorder, to name a few. There are approximately 30 references to outdated standards of practice in CCR Title 22 (which apply to various health facilities, including clinics, and general acute care AB 614 Page 4 hospitals), some of which are referenced in more than one place, and dating as far back as 1961. The American Dietetic Association standards of practice referenced for educational programs for dietetic service staff in general acute care hospitals were adopted in June 1974. DPH is currently in the process of updating Title 22. Some of the regulatory packets could be completed later this year, other more complex packets will take several years to complete, and due to the volume (Title 22 effects up to 30 different types of health facilities) DPH estimates that the entire update will not be complete until sometime in 2025. Currently, health facilities affected by regulations which reference outdated standards of practice are requesting program flexibility from DPH to allow them to operate using more current medical standards. DPH is the sponsor of this bill and notes they are the enforcement and regulatory agency for approximately 30 different types of health care facilities and clinics, and they have a backlog of regulations that are subject to the APA. DPH contends that in order to remain compliant with up-to-date clinical practices instead of being errantly held to antiquated practices in state regulations, facilities must request program flexibility from DPH, and this additional step creates hurdles for health facilities and clinics. DPH concludes that this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice. There is no known opposition to this bill. Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001201 AB 614 Page 5