BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 396| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- UNFINISHED BUSINESS Bill No: SB 396 Author: Hill (D) Amended: 6/29/15 Vote: 21 SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 9-0, 4/20/15 AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski SENATE HEALTH COMMITTEE: 9-0, 4/29/15 AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/28/15 AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen SENATE FLOOR: 40-0, 6/1/15 AYES: Allen, Anderson, Bates, Beall, Berryhill, Block, Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall, Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning, Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Runner, Stone, Vidak, Wieckowski, Wolk ASSEMBLY FLOOR: 79-0, 8/20/15 (Consent) - See last page for vote SUBJECT: Health care: outpatient settings and surgical clinics: facilities: licensure and enforcement SOURCE: Author DIGEST: This bill requires a Medicare-certified clinic and an SB 396 Page 2 accredited outpatient setting, as specified, to request a report from the appropriate healthcare regulatory board regarding the filing of a peer review report; requires licensees who perform procedures in outpatient settings to be subject to peer review every two years and that the governing body review the findings of those reports; and, specifies that inspections of accredited outpatient surgical centers may be unannounced with a 60-day warning of the pending inspection. Assembly Amendments: 1)Strike requirements that an outpatient setting and a facility certified to participate in the federal Medicare Program as an ambulatory surgical center are required to report specified information and a fee to the Office of Statewide Health Planning and Development. 2)Strike provisions permitting a physician, podiatrist, or dentist to apply for licensure by the Department of Public Health (DPH) and strike provisions stating that a surgical clinic shall be eligible for licensure by the DPH regardless of physician, podiatrist, or dentist ownership. 3)Require that the findings of the peer review be reported to the governing body instead of the accrediting agency. Require that the peer review process that results in the findings be reviewed by the accrediting agency at the next survey to determine if the outpatient setting meets applicable accreditation standards. SB 396 Page 3 4)Permit, rather than require, that visits subsequent to the initial accreditation inspection be unannounced. Require the accrediting agency to notify the outpatient setting that such inspections will occur within 60 days. ANALYSIS: Existing law: 1)Defines an "outpatient setting" to mean any facility, clinic, unlicensed clinic, center, office, or other setting that is not part of a general acute care facility, as specified, and where anesthesia or peripheral nerve blocks, or both, is used when in compliance with the community standard of practice, in doses that, when administered have the probability of placing a patient at risk for loss of the patient's life-preserving protective reflexes; and, specifies that "outpatient setting" also means facilities that include in vitro fertilization. (Health and Safety Code (HSC) § 1248(b). 2)Defines an "accreditation agency" to mean a public or private organization that is approved to issue certificates of accreditation to outpatient settings by the Medical Board of California (MBC), as specified. (HSC § 1248(c)) 3)Requires the MBC to adopt standards for accreditation and, in approving accreditation agencies to perform accreditation of outpatient settings, must ensure that the certification program meet specified standards and requirements. (HSC § 1248.15) 4)Defines "peer review" to mean a process in which a peer review body reviews the basic qualifications, staff privileges, employment, medical outcomes, or professional conduct of licentiates to make recommendations for quality improvement SB 396 Page 4 and education, if necessary, in order to determine whether a licentiate may practice or continue to practice in a health care facility, clinic, or other setting providing medical services, and, if so, to determine the parameters of that practice and assess and improve the quality of care rendered in a health care facility, clinic, or other setting providing medical services. (Business and Professions Code (BPC) § 805(a)(1)(A)) 5)Requires the chief of staff of a medical or professional staff or other chief executive officer, medical director, or administrator of any peer review body and the chief executive officer or administrator of any licensed health care facility or clinic to file an "805 report" with the relevant agency within 15 days after the effective date on which any of the following occurs as a result of an action of a peer review body: a) A licentiate's application for staff privileges or membership is denied or rejected for a medical disciplinary cause or reason; b) A licentiate's membership, staff privileges, or employment is terminated or revoked for a medical disciplinary cause or reason; or, c) Restrictions are imposed, or voluntarily accepted, on staff privileges, membership, or employment for a cumulative total of 30 days or more for any 12-month period, for a medical disciplinary cause or reason. (BPC § 805(b)) 6)Requires a health facility, health care service plan, medical care foundation, or medical staff , as specified, request a report prior to granting or renewing staff privileges for any physician and surgeon, psychologist, podiatrist, or dentist, from the MBC, the Board of Psychology, the Osteopathic Medical Board, or the Dental Board of California to determine if any 805 report indicating that the applying physician and surgeon, SB 396 Page 5 psychologist, podiatrist, or dentist has been denied staff privileges, been removed from a medical staff, or had his or her staff privileges restricted, as specified. (BPC § 805.5(a)) This bill: 1) Requires an ambulatory surgery center (ASC) certified to participate in the federal Medicare program and an accredited outpatient setting, as specified, to request a report from the appropriate regulatory board prior to granting or renewing staff privileges for any physician and surgeon, psychologist, podiatrist, or dentist to determine if any report has been made indicating that the applicant has been denied staff privileges, been removed from a medical staff, or had his or her staff privileges restricted. 2) Extends by one year, until March 1, 2016, the due date for the report regarding the vertical enforcement and prosecution model required of the MBC, in consultation with the Department of Justice and the Department of Consumer Affairs. 3)Requires each licensee who performs procedures in an outpatient setting that requires accreditation to be peer reviewed at least every two years. The peer review shall be a process in which the basic qualifications, staff privileges, employment, medical outcomes, or professional conduct of a licensee is reviewed to make recommendations for quality improvement and education, if necessary, including when the outpatient setting has only one licensee. The peer review shall be performed by licensees who are qualified by education and experience to perform the same types of, or similar, procedures. 4)Requires that the findings of the peer review be reported to the governing body. SB 396 Page 6 5)Requires that the accrediting agency review the peer review process at the next survey to determine if the outpatient setting meets applicable accreditation standards. 6)Permits visits subsequent to the initial accreditation inspection to be unannounced. Requires the accrediting agency to notify the outpatient setting that such inspections will occur within 60 days. 7) Makes technical and minor clarifying changes. Background ASC regulation. ASCs are facilities for surgical patients who do not need to be admitted to a hospital and remain on site for less than 24 hours. As medical care continues to shift from inpatient (hospital) type settings to clinics, many patients are using ASCs or "same-day" surgery centers for a wide variety of procedures. According to a study of ASCs by the California Healthcare Foundation there are at least 750 ASCs in California. This number is likely larger because there is no centralized source for data on ASCs due to their diffuse regulation. Generally, ASCs which are non-physician owned are regulated by DPH, and physician-owned ASCs are regulated by the MBC, which, in turn, requires accreditation by one of four approved accrediting agencies. Peer Review. Peer review is a process in which physicians evaluate colleagues' work to determine compliance with the standard of care. A negative peer review report triggers the filing of an "805 report" to the appropriate regulatory body. This bill will expand the list of entities which must request an 805 report to include a facility certified to participate in the Medicare program as an ASC or an accredited outpatient setting, as specified, to determine if a report has been made indicating SB 396 Page 7 that a licensee has had staff privileges revoked or restricted. This bill will also require physicians working in accredited outpatient settings to be subjected to the peer review process every two years, and requires the findings from those reports to be reported to the governing body. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: Yes According to the Assembly Appropriations Committee, there are minor and absorbable costs to the MBC (Contingent Fund of the MBC). SUPPORT: (Verified8/24/15) California Ambulatory Surgery Association Medical Board of California OPPOSITION: (Verified8/24/15) None received ARGUMENTS IN SUPPORT: The Medical Board of California writes in support, "[This bill] would require peer review evaluations every two years for physicians and surgeons working in ambulatory surgery centers and would allow the accredited outpatient setting facility inspections performed by accreditation agencies to be unannounced (after the initial inspection) and would require at least a 60 day window to be given to facilities for unannounced inspections?The [MBC] believes that for consumer protection, physicians working in [ambulatory surgery centers] should be subject to peer review evaluations, which would be given to the governing body of the outpatient setting and be reviewed by the accreditation agency SB 396 Page 8 at the next inspection of the outpatient setting" ASSEMBLY FLOOR: 79-0, 8/20/15 AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins NO VOTE RECORDED: Chu Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104 8/24/15 13:21:59 **** END ****