BILL NUMBER: AB 822AMENDED BILL TEXT AMENDED IN ASSEMBLY MARCH 25, 2009 INTRODUCED BY Assembly Member Fletcher ( Coauthor: Senator Wyland ) FEBRUARY 26, 2009 An act to amend Section 1276 of, and to add Chapter 2 (commencing with Section 101990) to Part 6 of Division 101 of the Heath and Safety Code, relating to health facilities. LEGISLATIVE COUNSEL'S DIGEST AB 822, as amended, Fletcher. Health facilities: program flexibility. Under existing law, the State Department of Public Health has licensing authority over several categories of clinics and health facilities, including hospital. Existing law requires the building standards published in the California Building Standards Code and the regulations adopted by the department to prescribe standards for adequacy, safety, and sanitation of the physical plant, of appropriate staffing, and of services, based on the type of health facility and the needs of the persons served. These regulations are required to permit program flexibility in various contexts, as long as statutory requirements are met, and the use has the prior written approval of the department or of the Office of Statewide Health Planning and Development. Existing law requires the department to develop a standardized form and format for requests by health facilities for program flexibility. Health facilities shall thereafter apply to the department for program flexibility in the prescribed manner. After the department receives a complete application requesting program flexibility, it is required to approve, approve with conditions or modifications, or deny the application within 60 days. Denials and approvals with conditions or modifications are required to be accompanied by an analysis and a detailed justification for any conditions or modifications imposed. This bill would require the department to approve or approve with conditions or modifications a complete application requesting program flexibility for the use of alternate concepts, methods, procedures, techniques, or equipment by a general acute care hospital whenever the hospital demonstrates to the department that this use meets or exceeds the quality of care and patient safety in effect on January 1, 2010. The bill would also require the department to establish a pilot program to gather clinical data on, and provide general acute care hospitals experience with, the use of alternate concepts, methods, procedures, techniques, equipment, and care from what is authorized pursuant to specified regulations, but meet certain statutory requirements. It would require, by January 1,20122014 , the department to prepare aspecifiedreport to the Legislature on the pilot program . Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. (a) The Legislature hereby finds and declares all of the following: (1) The provision of health care in general acute care hospitals has improved dramatically in recent years, due in part to technological and methodological advances in health care that have greatly improved patient outcomes. (2) California's hospital licensing regulations, found in Division 5 of Title 22 of the California Code of Regulations, were adopted in 1976. Although there have been limited revisions over the past decades, the regulations have not kept pace with state-of-the art technology, equipment, and practices now available to provide optimum patient care. (3) Due to these outdated regulations, California hospitals are not able to provide patients with some of the cutting-edge technology, equipment, procedures, and care that are available elsewhere. (4) It is appropriate to gather clinical data and experience in California regarding the state-of-the-art technology, equipment, procedures, and care now available. (b) It is the intent of the Legislature that the State Department of Public Health develop and implement a pilot program for the purposes specified in subdivision (a). SEC. 2. Section 1276 of the Health and Safety Code is amended to read: 1276. (a) The building standards published in the State Building Standards Code by the Office of Statewide Health Planning and Development, and the regulations adopted by the department shall, as applicable, prescribe standards of adequacy, safety, and sanitation of the physical plant, of staffing with duly qualified licensed personnel, and of services, based on the type of health facility and the needs of the persons served thereby. (b) These regulations shall permit program flexibility by the use of alternate concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or conducting of pilot projects as long as statutory requirements are met and the use has the prior written approval of the department or the office, as applicable. The approval of the department or the office shall provide for the terms and conditions under which the exception is granted. A written request plus supporting evidence shall be submitted by the applicant or licensee to the department or office regarding the exception, as applicable. (c) While it is the intent of the Legislature that health facilities shall maintain continuous, ongoing compliance with the licensing rules and regulations, it is the further intent of the Legislature that the department expeditiously review and approve, if appropriate, applications for program flexibility. The Legislature recognizes that health care technology, practice, pharmaceutical procurement systems, and personnel qualifications and availability are changing rapidly. Therefore, requests for program flexibility require expeditious consideration. (d) (1) The department shall, on or before April 1, 1989, develop a standardized form and format for requests by health facilities for program flexibility. Health facilities shall thereafter apply to the department for program flexibility in the prescribed manner. After the department receives a complete application requesting program flexibility, it shall have 60 days within which to approve, approve with conditions or modifications, or deny the application. Denials and approvals with conditions or modifications shall be accompanied by an analysis and a detailed justification for any conditions or modifications imposed. Summary denials to meet the 60-day timeframe shall not be permitted. (2) Notwithstanding paragraph (1), the department shall approve or approve with conditions or modifications a complete application requesting program flexibility for the use of alternate concepts, methods, procedures, techniques, or equipment by a general acute care hospital whenever the hospital demonstrates to the department that this use meets or exceeds the quality of care and patient safety in effect on January 1, 2010. (e) Notwithstanding any other provision of law or regulation, the department shall provide flexibility in its pharmaceutical services requirements to permit any state department that operates state facilities subject to these provisions to establish a single statewide formulary or to procure pharmaceuticals through a departmentwide or multidepartment bulk purchasing arrangement. It is the intent of the Legislature that consolidation of these activities be permitted in order to allow the more cost-effective use and procurement of pharmaceuticals for the benefit of patients and residents of state facilities. SEC. 3. Chapter 2 (commencing with Section 101990) is added to Part 6 of Division 101 of the Health and Safety Code, to read: CHAPTER 2. HEALTH FACILITY INNOVATION 101990. (a) The State Department of Public Health shall establish a pilot program to gather clinical data on, and provide general acute care hospitals, as defined in subdivision (a) of Section 1250, experience with, the use of alternate concepts, methods, procedures, techniques, equipment, and care to what is authorized pursuant to regulations adopted pursuant to Chapter 2 (commencing with Section 1250) of Division 2 in effect on January 1, 2010, but otherwise meet the statutory requirements of that chapter. (b) The department shall identify alternate concepts, methods, procedures, techniques, equipment, or care that the department determines will promote innovation and improvements in services and patient care. The department shall also solicit and receive proposals from general acute care hospitals to use alternate concepts, methods, procedures, techniques, equipment, and care that will promote innovation and improvements in services and patient care. (c) The department shall, by July 1,20102011 , authorize at least two, but not more than 10, general acute care hospitals to use an alternate concept, method, procedure, technique, equipment, or care that was identified by the department or proposed by a hospital pursuant to subdivision (b). At least one general acute care hospital shall be located within the County of San Diego and shall be associated with a two-hospital system operated by a health care district. A general acute care hospital participating in the pilot program shall staff the alternate concepts, methods, procedures, techniques, equipment, and care with licensed nurses pursuant to the requirements of Section 1276.4. (d) The department may charge a general acute care hospital authorized to participate in the program an annual fee to participate in the pilot program that does not exceed the amount of the direct costs to the department of overseeing and evaluating the pilot program. The moneys collected from this fee shall be deposited in the State Department of Public Health Licensing and Certification Program Fund. (e) By January 1,20122014 , the department shall prepare and submit a report to the Legislature on the results of the pilot program and its impact upon the quality of service and patient care.