BILL ANALYSIS Ó SB 100 Page 1 Date of Hearing: August 17, 2011 ASSEMBLY COMMITTEE ON APPROPRIATIONS Felipe Fuentes, Chair SB 100 (Price) - As Amended: July 12, 2011 Policy Committee: Business and Professions Vote: 9-0 Urgency: No State Mandated Local Program: Yes Reimbursable: No SUMMARY This bill increases oversight of outpatient settings by the Medical Board of California (Board), the Department of Public Health, and the bodies that accredit outpatient settings. Specifically, this bill: 1)Requires the Board to adopt regulations governing physician availability in settings using laser or intense pulse light devices (so-called "medical spa" treatments), adopt standards governing in vitro fertilization in outpatient settings, and make publicly available specified information regarding accreditation of outpatient settings on its web site. 2)Authorizes the Board to specify procedures that should be provided in accredited facilities. 3)Defines additional standards for outpatient settings, including adoption of protocols for urgent care situations and reporting of adverse events to the Department of Public Health. 4)Requires accrediting agencies to perform a variety of activities that increase oversight of outpatient settings, including complaint investigation, investigation of the prior history of the setting and its licensees, communication to the Board about accreditation status and the results of inspections. 5)Defines processes and protocols that accrediting agencies and outpatient settings must use when outpatient settings do not comply with accreditation standards, including corrective SB 100 Page 2 action plans, reprimands, and public posting of information. 6)Includes clinics that provide in vitro fertilization in the definition of "outpatient setting." FISCAL EFFECT 1)The requirement to provide data via a publicly accessible website will result in one-time workload cost pressure in the range of $50,000. The actual cost pressure may be more or less depending on the complexity of the website development and initial data entry needs. 2)The bill's other requirements, as well as ongoing maintenance of the website, will result in minor and absorbable costs. COMMENTS 1)Rationale . According to the author, this bill provides for greater oversight and regulation of outpatient settings, including "medical spa" facilities and in vitro fertilization clinics, and ensures that quality of care standards are in place at these clinics and checked by the appropriate accrediting agency. The author indicates that this bill increases consumer protections and increases consumer awareness to protect individuals from unscrupulous providers. 2)Background . Outpatient medical care is generally performed in either clinics licensed by DPH, or in outpatient settings that are not licensed by the state but operate under an individual licensed by the Medical Board of California (Board). In addition to operating under a Board licensee, outpatient settings that perform procedures using a specified level of anesthesia must be accredited by one of four private accrediting agencies approved by the Board. In recent years, there has been a significant increase in the volume of elective cosmetic surgeries performed in these outpatient settings, and there is evidence of consumer harm associated with this increase. The well-publicized death of musician Kanye West's mother Donda West in 2007 following a cosmetic procedure in an outpatient setting raised the public profile of these procedures and their safety risks. SB 100 Page 3 Additionally, new technology used in cosmetic procedures is rapidly being introduced, causing concern that there is little oversight over these newer procedures that could pose safety risks to the public. Many of these new technologies do not require the level of anesthesia that would trigger an accreditation requirement. Finally, there is concern that even accredited facilities do not have adequate patient protections in place. By requiring certain patient safety protocols, increased oversight by accrediting agencies, and increased communication between these agencies and the Board, this bill seeks to increase consumer protection for procedures performed in an outpatient setting without requiring more stringent facility licensure. 3)Prior Legislation . a) SB 1150 (Negrete McLeod) in 2010 contained a number similar provisions to this bill as well as some provisions not in this bill, including a provision regarding professional designation health care practitioner advertising. SB 1150 was held on the suspense file of this committee. b) SB 674 (Negrete McLeod) in 2009 was similar to SB 1150. SB 674 was vetoed due to concerns about reliance on external accreditation agencies. Neither SB 1150 nor SB 100 modifies the role of accreditation agencies. Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081