BILL ANALYSIS ----------------------------------------------------------------------- |Hearing Date:June 29, 2009 |Bill No:AB | | |120 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Gloria Negrete McLeod, Chair Bill No: AB 120Author:Hayashi As Amended:June 22, 2009 Fiscal: No SUBJECT: Healing arts: peer review. SUMMARY: Makes changes to the due process requirements for physicians and surgeons who are subject to a final proposed action of a peer review body for which a report (commonly referred to as 805 report pursuant to Section 805 of the Business and Professions Code) is required to be filed to the appropriate health care regulatory body. Existing law: 1)Establishes the federal Health Care Quality Improvement Act (HCQIA) of 1986 which created standards for hospital peer review committees, provided immunity for those involved in peer review, and established the National Practitioner Data Bank (NPDB), a system for reporting physicians whose competency has been questioned or when the physician has been sanctioned. (HCQIA is intended to protect peer review bodies from private money damage liability and prevent incompetent practitioners from moving state to state without disclosure or discovery of previous damaging or incompetent performance.) 2)Establishes the Medical Board of California (MBC) to license, regulate and discipline physicians and surgeons in California and states that the protection of the public is the highest priority of the MBC in exercising its functions. 3)Provides for the professional review of specified healing arts licentiates by a peer review body, as defined, including: a) A medical or professional staff of any health care facility or a licensed clinic, or a facility certified to AB 120 Page 2 participate in the federal Medicare Program as an ambulatory surgical center. b) A health care service plan or a disability insurer, as specified. c) Any medical, psychological, marriage and family therapy, social work, dental, or podiatric professional society, as specified. d) A committee organized by any entity that functions for the purpose of reviewing the quality of professional care provided by members or employees of that entity. 4) Defines a licentiate for purposes of item # 3) above, as a physician and surgeon, doctor of podiatric medicine, clinical psychologist, marriage and family therapist, clinical social worker, or dentist. 5)Requires an 805 report to be filed by the chief of staff, chief executive officer, medical director, or administrator of any peer review body and the chief executive officer or administrator of a health facility or clinic, as defined, with the relevant agency having regulatory jurisdiction over a licentiate under the following: a) Within 15 days after the effective date of any of the following that occur as a result of an action of a peer review body : i) A licentiate's application for staff privileges or membership is denied or rejected for a medical disciplinary cause or reason. ii) A licentiate's membership, staff privileges, or employment is terminated or revoked for a medical disciplinary cause or reason. iii) 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. b) Within 15 days if a licentiate does any of the following based on information indicating medical disciplinary cause of reason: AB 120 Page 3 i) Resigns or takes a leave of absence from membership, staff, or employment. ii) Withdraws or abandons an application for staff privileges or membership. iii) Withdraws or abandons the request for renewal of privileges or membership. 6)Requires also for an 805 report to be filed within 15 days after the imposition of a summary suspension of staff privileges, membership, or employment, if the summary suspension remains in effect for over 14 days. 7)Defines the following terms: a) Staff privileges as any arrangement under which a licentiate is allowed to practice in or provide care for patients in a health facility. Such arrangements include, but are not limited to, full staff privileges, active staff privileges, limited staff privileges, auxiliary staff privileges, courtesy staff privileges, locum tenens arrangements, and contractual arrangements to provide professional services, including arrangements to provide outpatient services. b) Denial or termination of staff privileges, membership, or employment includes failure or refusal to renew a contract or to renew, extend, or reestablish any staff privileges, if the action is based on medical disciplinary cause or reason. c) Medical disciplinary cause or reason as the aspect of a licentiate's competence or professional conduct that is reasonably likely to be detrimental to patient safety or to the delivery of patient care. 8)Requires a copy of the 805 report, and a notice advising the licentiate of his or her right to submit additional statements or other information, as specified, to be sent by the peer review body to the licentiate named in the report. 9)Requires the information to be reported in an 805 report to include the name and license number of the licentiate involved, a description of the facts and circumstances of the medical disciplinary cause or reason, and any other relevant information AB 120 Page 4 deemed appropriate by the reporter. 10)Requires a supplemental report to be made within 30 days following the date the licentiate is deemed to have satisfied any terms, conditions, or sanctions imposed as disciplinary action by the reporting peer review body. 11)Indicates that the reporting required under Section 805 does not act as a waiver of confidentiality of medical records and committee reports. Requires that the information reported or disclosed be kept confidential, as specified. 12)Specifies that a willful failure to file an 805 report by any person who is designated or otherwise required by law to file is punishable by a fine not to exceed one hundred thousand dollars ($100,000) per violation; and a ny failure by the administrator of any peer review body, the chief executive officer or administrator of any health care facility, or any person who is designated or otherwise required by law to file an 805 report, shall be punishable by a fine not to exceed fifty thousand dollars ($50,000) per violation. 13)Requires, prior to granting or renewing staff privileges for any physician and surgeon, psychologist, podiatrist or dentist, any licensed health care facility, health care service plan or medical care foundation, or the medical staff of an institution, to request a report from the MBC, the Board of Psychology, the Osteopathic Medical Board of California, or the Dental Board of California to determine if any 805 report has been made, indicating that the applying physician and surgeon, psychologist, podiatrist or dentist has been denied staff privileges, been removed from medical staff, or had his or her staff privileges restricted as provided in Section 805. Prohibits providing any report in the following circumstances: a) If the denial, removal, or restriction was imposed solely because of the failure to complete medical records. b) If the MBC found the information reported is without merit. c) If a period of three years has elapsed since the report was submitted. 14)Specifies findings and declarations on the reasons California opted out of some of the provisions of the federal HCQIA. AB 120 Page 5 Further states that peer review be performed by licentiates, and specifies the duties of the governing bodies of acute care hospitals in the peer review process. 15)States that a licentiate who is the subject of a final proposed action of a peer review body for which a report is required to be filed under Section 805 shall be entitled to written notice of the final proposed action. Requires the written notice to include the following information: a) That an action against the licentiate has been proposed by the peer review body which, if adopted, shall be taken and reported pursuant to Section 805. b) The final proposed action. c) That the licentiate has the right to request a hearing on the final proposed action d) The time limit, within which to request a hearing. 16)Specifies that if a hearing is requested on a timely basis, the peer review body shall give the licentiate a written notice stating all of the following: the reasons for the final proposed action taken or recommended, including the acts of omissions with which the licentiate is charged; and the place, time, and date of the hearing. 17)Defines final proposed action as the final decision or recommendation of the peer review body after an informal investigatory activity or prehearing meetings. 18)Specifies certain hearing requirements, if a licentiate timely requests a hearing concerning a final proposed action, including the following: a) The hearing to be held, as determined by the peer review body, before a trier of fact, which shall be an arbitrator/s selected by a process mutually acceptable to all the parties or before a panel of unbiased individuals who shall gain no financial benefit from the outcome; b) If a hearing officer is selected, the hearing officer shall gain no financial benefit from the outcome, shall not AB 120 Page 6 act as a prosecuting officer or advocate, and not entitled to vote. 19)Specifies that the licentiate has a right to the following during a hearing: The right to voir dire the panel members and any hearing officer, and the right to challenge the impartiality of any member or hearing officer. 20)Specifies that both parties have a right to the following: a) Inspect and copy documents; b) all information made available to the trier of fact; c) To have a record made of the proceedings; d) To call, examine and cross-examine witnesses; e)To present and rebut evidence; and f) To submit a written statement at the close of the hearing. 21)Specifies who has the burden of presenting evidence and proof during a hearing. 22)States that upon completion of a hearing concerning a final proposed action for which an 805 report is required to be filed, the licentiate and the peer review body have the right to receive all of the following: a) A written decision of the trier of fact, including findings of fact, and a conclusion, as specified. b) A written explanation of the procedure for appeal of the decision, as specified. c) The right to appear and respond. d) The right to be represented by an attorney or any other representative designated by the party. e) The right to receive the written decision of the appellate body. 23)Allows a peer review body to immediately suspend or restrict clinical privileges of a licentiate where the failure to take an action may result in an imminent danger to the health of any individual, provided that the licentiate is subsequently provided with the notice and hearing rights as specified. 24)States that specified peer review proceedings does not apply to state or county hospitals, hospitals owned or operated by the Regents of the University of California or health facilities AB 120 Page 7 which serve as primary teaching facilities, as specified. 25)Requires the MBC to post on the Internet specified information regarding licensed physicians, including information relating to the status of a license, felony convictions, malpractice judgment or arbitration awards, or any hospital disciplinary action that resulted in the termination or revocation of a licensee's hospital staff privileges for a medical disciplinary cause or reason. This bill: 1)Finds and declares that it is essential that California's peer review system generate a culture of trust and safety so that health care practitioners will participate robustly in the process by engaging in critically important safety activities, such as reporting incidents they believe to reflect substandard care or unprofessional conduct and serving on peer review, quality assurance, and other committees necessary to protect patients. 2)States further that the intent of the Legislature that peer review bodies be actively involved in the measurement, assessment, and improvement of quality and that there be appropriate oversight by the peer review bodies to ensure the timely resolution of issues. 3)States that it is the public policy of the state that licentiates who may be providing substandard of care be subject to the peer review hearing and reporting process, as specified. 4)Indicates that to ensure that the peer review process is not circumvented, prohibits requiring a member of a medical or professional staff, by contract or otherwise, from altering or surrendering staff privileges, status, or membership solely due to the termination of a contract between that member and a health care facility. States, however, that with respect to services that may only be provided by members who have, or who are members of a medical group that has, a current exclusive contract for those identified services, termination of the contract or termination of the member's employment by the medical group holding the contract, may result in the member's ineligibility to provide the services covered by the contract. 5)Entitles a peer review body of a health care facility to review and make timely recommendations to the governing body of the facility and its designee regarding quality considerations relating to clinical services whenever the selection, performance evaluation, or AB 120 Page 8 any change in the retention or replacement of licentiates with whom the health care facility has a contract occurs. Requires the governing body to give great weight to the recommendations. 6)States that the provisions contained in items #3) through # 5) do not impair a governing body's ability to take action against a licentiate, as specified. 7)States that it is the policy of the state that in certain limited circumstances, external peer review may be necessary to promote and protect patient care in order to eliminate perceived bias, obtain needed medical expertise, or respond to other particular circumstances. 8)Encourages a peer review body to obtain external peer review for the evaluation or investigation of an applicant, privilegeholder, or member of the medical staff in the following circumstances: a) Committee or department reviews that could affect a licentiate's membership or privileges do not provide a sufficiently clear basis for action or inaction. b) No current medical staff member can provide the necessary expertise in the clinical procedure or area under review. c) To promote impartial peer review. 9)Defines external peer review as peer review provided by licentiates who do not practice in the same health care facility as the licentiate under review, who are impartial, and who have the necessary expertise in the clinical procedure or area under review. 10)Finds and declares that the sharing of information between peer review bodies is essential to protect the public health. 11)Requires a peer review body, upon receipt of reasonable copying and processing costs, to respond to the request of another peer review body and produce the records reasonably requested concerning a licentiate under review to the extent not otherwise prohibited by state or federal law. Provides that the responding peer review body has the discretion whether to produce minutes from peer review body meetings. States that the records produced by a peer review body pursuant to this provision will be used solely for peer review purposes and not subject to discovery, as specified. Entitles the peer review body responding to the request to all confidentiality protections and privileges provided by law as to the information and AB 120 Page 9 records disclosed pursuant to this provision. 12)States that a licentiate under review by a peer review body requesting records pursuant to item # 11) above must release the responding peer review, its members, and the health care entity for which the responding peer review body conducts peer review, from liability for the disclosure of records, and the contents of the records, as specified. Provides that if a licentiate does not provide a reasonable release that is acceptable to the responding peer review body, the responding peer review body is not obligated to produce records. 13)Requires the following of a hearing officer : a) Disclose all actual and potential conflicts of interest within the last five years reasonably known to the hearing officer. b) Be an attorney licensed to practice law in the State of California. This provision does not apply to a hearing held before a panel of dental professional peer review body. c) States that unless agreed by the parties, an attorney from a firm utilized by the hospital, the medical staff, or the involved licentiate within the preceding two years is not eligible to serve as a hearing officer. d) Endeavor to ensure that all parties maintain proper decorum and have a reasonable opportunity to be heard and present all relevant oral and documentary evidence. Entitles the hearing officer to determine the order of, or procedure for, presenting evidence and argument during the hearing and have the authority and discretion to make all rulings on questions pertaining to matters of law, procedure, or the admissibility of evidence. Further requires the hearing officer to take all appropriate steps to ensure a timely resolution of the hearing, but may not terminate the hearing process, unless in the case of flagrant noncompliance with the procedural rules governing the hearing process or egregious interference with the orderly conduct of the hearing, the hearing officer may recommend that the hearing panel terminate the hearing, provided that this activity is authorized by the applicable bylaws of the peer review body. 14)Gives both parties the right to be represented by an attorney of the party's choice at the party's expense. 15)Prohibits a peer review body from being represented by an attorney AB 120 Page 10 if the licentiate notifies the peer review body in writing no later than 15 days prior to the hearing that he or she has elected not to be represented by an attorney. States that unless otherwise agreed agreed by the parties, this election is binding. 16)States that if a licentiate does not provide the written notice, as specified within the required timeframe, the peer review body may be represented by an attorney even if the licentiate later elects not to be represented by an attorney. FISCAL EFFECT: Unknown. This bill has been keyed "nonfiscal" by Legislative Counsel. COMMENTS: 1.Purpose. According to the California Medical Association (CMA), the Sponsor of this measure, this bill will improve the peer review system in California to ensure quality health care is being provided to patients. Currently, the peer review system works very well in most facilities, but it can be open to manipulation and unreasonable delay in others. According to the Author, this bill promotes peer review in a number of ways. For example, it provides better tools to ensure that peer review bodies have adequate information concerning licentiates by mandating the sharing of peer review records. It also prevents schemes that circumvent the peer review process through contractual arrangements, and provides increased fairness for the licentiate under review, making it more likely that all physicians will participate in the peer review system. 2.Background. a. What is Peer Review? In peer review, physicians evaluate their colleagues' practice to determine compliance with the standard of care. Peer reviews are intended to detect incompetent or unprofessional physicians early and terminate, suspend, or limit their practice if necessary. Peer review is triggered by a wide variety of events including patient injury, disruptive conduct, substance abuse, or other medical staff complaints. A peer review committee investigates the allegation, comes to a decision regarding the physician's conduct, and takes appropriate remedial actions. However, there is reluctance among physicians to serve on peer review AB 120 Page 11 committees due to the risk of involvement in related future litigation, including medical malpractice lawsuits against a physician under review. In addition, there has been rising concern relating to "sham peer review." Sham peer review is the use of the peer review system to discredit, harass, discipline, or otherwise negatively affect a physician's ability to practice medicine or exercise professional judgment for a non-medical or patient safety related reason. Other criticisms of peer review include over legalization of the process, lack of transparency in the system, and burdensome human and financial toll peer review brings not only to the hospital but also to a physician under review. b. Federal Requirements. Recognizing that peer review is necessary to maintain and improve quality medical care, Congress, in 1986, enacted the HCQIA. HCQIA established standards for hospital peer review committees, provided immunity for those who participate in peer review, and created the NPDB. The NPDB is a confidential repository of information related to the professional competence and conduct of physicians, dentists, and other health care practitioners. Credentialing bodies are required to check the NPDB database before granting privileges to physicians or re-appointing them. Entities such as hospitals, professional societies, state boards, and plaintiffs' attorneys are given access to the NPDB. In enacting the NPDB, the United States Congress intended to improve the quality of health care by encouraging State licensing boards, hospitals, and other health care entities, and professional societies to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action history. The NPDB is a central repository of information about: (1) malpractice payments made for the benefit of physicians, dentists, and other health care practitioners; (2) licensure actions taken by State medical boards and State boards of dentistry against physicians and dentists; (3) professional review actions primarily taken against physicians and dentists by hospitals and other health care entities, including health maintenance organizations, group practices, and professional societies; (4) actions taken by the Drug Enforcement Administration (DEA), and (5) Medicare/Medicaid Exclusions. AB 120 Page 12 It appears that hospitals may not be complying with the reporting requirements of the NPDB. On May 27, 2009, the Public Citizen released a report on the failure of hospitals to discipline and report substandard physicians entitled "Hospitals Drop the Ball on Physician Oversight Failure of Hospitals to Discipline and Report Doctors Endanger Patients." The report indicated that although federal law requires hospitals to report to a national databank physicians whose admitting privileges are revoked or restricted for more than 30 days, hospitals fail to report and take appropriate actions against physicians practicing substandard care. The report pointed out that this failure deprives state medical boards of critical information needed for regulatory oversight and creates the potential for patient harm. It should be noted that this report is consistent with findings that have been made since tracking of reporting since 1990. In a 1995 report, the Office of Inspector General of the Department of Health and Human Services found that for the period September 1, 1990, when the NPDB became operational, to December 1993, about 75 percent of all hospitals in the country did not report an adverse action. More current data indicates that for the period September 1990 through September 30, 1998 about 67% of hospitals have never reported an adverse action. The most recent numbers suggest many of the trends highlighted above continue. The 2006 NPDB Annual Report highlights many of the same issues reported above continue to be a problem; including a diminishing number of reports. The 15,843 Medical Malpractice Payment Reports received during 2006 are 8.3 percent less than the number of Malpractice Payment Reports received by the NPDB during 2005. This decrease comes after a decrease of 2.2 percent in 2005 in comparison to 2004. Of those hospitals currently in "active" registered status with the NPDB, 48.9 percent have never submitted a Clinical Privileges Action Report. This percentage has slowly decreased over the years, from 53.4 percent in 2004 and 52.0 percent in 2005. c. Medical Board of California and 805 Peer Review Reporting Requirements. The MBC is responsible for regulating and licensing physicians in California. The MBC revokes, suspends, or limits the practice of any physicians and surgeons. In exercising regulatory authority over physicians and surgeons the MBC has as its highest priority the protection of the public. Currently, the MBC regulates 125,612 physicians and surgeons, of which 97,878 reside in AB 120 Page 13 California. The MBC investigates complaints against physicians and adopts final decisions in disciplinary matters against physicians and surgeons. In 1975, the California Legislature passed the Medical Injury Compensation Reform Act of 1975 (commonly referred to as MICRA) to limit the legal liability of health care providers and included special rules for medical malpractice cases. MICRA encompasses all of the following: 1) limits the contingency fee counsel may receive in medical malpractice cases; 2) vests the MBC with the responsibility to protect the public from incompetent physicians; 3) permits a health care provider charged with medical malpractice to introduce evidence of a patient's receipt of compensation from "collateral sources" such as insurance policies; 4) limits the time in which a medical malpractice action can be commenced; 5) requires a patient to provide 90 days' notice of his or her intent to sue to encourage settlement; 6) permits a contract for medical services to include a binding arbitration requirement; 7) permits periodic payment awards, rather than a lump sum award, for future damages; and 8) imposes a strict limit of $250,000 on non-economic damages. Legislative analyses, when MICRA was adopted, indicates that the primary purpose of MICRA was to reduce the cost of medical malpractice litigation and restrain a perceived explosion in the cost of medical malpractice insurance while preserving the rights of medical malpractice victims to receive sufficient compensation for their injuries. As part of MICRA, the California Legislature enacted the basic provisions of state law governing medical peer review and mandatory reporting to the MBC. Section 805 requires any peer review body to report certain information to the MBC or other relevant physician licensing agency when specified criteria are met. Generally, an 805 report is required whenever a doctor's application for membership or staff privileges is denied for medical disciplinary reasons, or membership, staff privileges, or employment is terminated, revoked, or restricted for medical disciplinary reasons. In addition, if a doctor resigns in the face of an investigation by a medical peer review body, a report is required. Although the primary reporting obligation lies with hospitals, health plans, physician groups, professional societies and clinics also have reporting obligations. According to the MBC, it received one hundred thirty-eight 805 AB 120 Page 14 reports in 2007-2008 from hospitals/clinics (74), health care service plans (17), and medical group/employers (47). Out of all of these reports, one accusation was filed, 92 cases are pending disposition and 45 cases were closed. The number of 805 reports varies from year to year, but it appears that when adjusted to the number of physicians and surgeons licensed and living in California, or the number of people living in California, the trend shows a downward direction. d. Due Process Provisions (Section 809 et seq.). In 1989, several due process provisions for physicians subject to an 805 report were adopted and codified under Section 809 et seq. of the Business and Professions Code. Committee analysis on SB 1211 (Keene, Chapter 336, Statutes of 1989), which contained the provisions of Section 809, indicated that the California Medical Association (CMA) was the sponsor of the legislation, and on the due process provisions of the measure, CMA indicated that "the clear procedural standards in SB 1211 will reduce the risk of erroneous peer review decisions." Under Section 809, any physician, for which an 805 report may be required to be filed, is entitled to specified due process rights, including notice of the proposed action, an opportunity for a hearing with full procedural rights (including discovery, examination of witnesses, formal record of the proceedings and written findings). Furthermore, a physician may seek a judicial review in the Superior Court pursuant to Code of Civil Procedure Section 1094.5 (writ of mandate). It should be noted that the due process requirements do not apply to peer review proceedings conducted in state or county hospitals, to the University of California hospitals or to other teaching hospitals as defined. e. Industry Standards. Private standard setting is also common in peer review. Organizations like the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations or JCAHO), which accredits over 4,000 hospitals, health care providers and other health care settings across the country have established peer review standards for the entities it accredits. In order to receive Joint Commission accreditation, hospitals must have peer review and other quality assurance measures. Eligibility for federal funds such as Medicare and Medicaid often depends on accreditation. In 2004, the Joint Commission renamed peer review into "Focused Review of Practitioner Performance" which was later renamed to Focused Professional Practice AB 120 Page 15 Evaluation (FPPE). In 2007, the Joint Commission defined two types of reviews aimed at assuring physician competence: the FPPE and "ongoing professional practice evaluation" (OPPE.) The FPPE applies to new applicants for medical staff membership and to existing practitioners requesting new privileges for which the hospital has no documented evidence of their competence. FPPE may also apply to a practitioner whose current abilities are questioned because of negative performance issues or because an adequate volume of cases are not available to assess current competence. In the case of initial medical staff appointments, the hospital must check with primary sources to determine whether the practitioner requesting medical staff membership and privileges has the requisite current training, knowledge, skills and abilities. These same parameters must be evaluated for practitioners during the re-credentialing process, with the additional requirement that granting of privileges is based in part on the results of peer review and OPPE. Proctoring is a form of focused evaluation involving one-on-one evaluation of a practitioner's performance by another peer practitioner (a proctor). Direct observation is used to gauge the ability of the proctoree to perform a procedure or use a new technology. Focused proctoree evaluation may occur retrospectively through peer review if on-site, real-time evaluations are not feasible. In the case where same specialty peer reviewers are not available internally, external peer review can be used as a viable substitute for on-site proctoring. In 2007, the Joint Commission established OPPE because of the recognition that there is need to evaluate practitioners on an ongoing basis rather than at the usual two year reappointment process and allow practitioners to take steps to improve performance on a more timely basis. OPPE applies to practitioners who have already been granted patient care privileges, to revise existing privileges, or to revoke an existing privilege prior to or at the time of renewal. The revised OPPE process requires a clearly defined process for the evaluation of each practitioner's professional practice which would include the following: who will be responsible for reviewing performance data, how often the data will be received, the process to be implemented to make a decision on whether to continue, limit or revoke privileges, and how the data will be incorporated into the credentials' files? OPPE standards require an evaluation for all practitioners and not just those with performance issues. AB 120 Page 16 f. Lumetra Report - Comprehensive Study of Peer Review in California. SB 231 (Figueroa) Chapter 674, Statutes of 2005, required the MBC to contract with an independent entity to conduct a comprehensive study of the existing peer review process. SB 231 required specific components of the study, including: a comprehensive description of the various steps of and decision makers in the peer review process; a survey of peer review cases to determine the incidence of peer review; assessment of the cost of peer review to licentiates and the facilities which employ them and the average time consumed on peer review proceedings and an assessment of the need to amend Section 805 and Section 809 of the Business and Professions Code to ensure that they continue to be relevant to the actual conduct of peer review. Lumetra was chosen by the MBC to conduct the study and the report was submitted to the Legislature on July 31, 2008. In the report, Lumetra concluded that "the present peer review system is broken for various reasons and is in need of a major fix, if the process is to truly serve the citizens of California." The study surveyed California's peer review bodies, including hospitals, healthcare plans, professional societies, and medical groups/clinics. The survey included entities from the entire state of California and represented both urban and rural entities as well as public and private entities. The chart below identifies study participation: ------------------------------------------------------- |Entity type |Population|Final |% of | | | |Sample |Population | |----------------+----------+-----------+---------------| |Hospitals |366 |132 |36.1% | |----------------+----------+-----------+---------------| |Health care |51 |28 |54.9% | |plans | | | | |----------------+----------+-----------+---------------| |Professional |9 |9 |100% | |Societies | | | | |----------------+----------+-----------+---------------| |Medical |123 |76 |61.8% | |groups/clinics | | | | |----------------+----------+-----------+---------------| |Total |549 |245 |46.5% | | | | | | ------------------------------------------------------- AB 120 Page 17 i. Findings of Lumetra's Study: (1) Variation and inconsistency in entity peer review policies and standards. Variations exist on the definition, procedures, commencement, practice and subject of peer review. Peer review means different activities to different entities, and can be triggered by a number of ways but is mostly part of the quality/safety/risk process of an entity. In addition, risk management/peer review issues are combined with mundane issues related to the "business" of an entity. All medical entities set their own standards for peer review, some more rigorous than others, and some adhere to them more meticulously than others. Additionally, each entity creates its own peer review policies, which can vary substantially. If a physician is found to have provided substandard care, that physician may leave or be forced to leave the entity but can practice elsewhere, potentially endangering other patients. The peer review process is often lengthy and can take months or even years. There are also variations on the name of the peer review body, the number of members and the length of time a member serves on a committee (usually could be years before a peer review action is taken). (2) Poor tracking of peer review events. Many entities, especially hospitals, expressed anxiety and concern in providing documents for review, particularly peer review minutes, due to fear of legal discovery. Most entities do not have their documents in electronic form and do not have readily accessible tracking systems that would allow staff members to efficiently follow events over time. (3) Confusion regarding 805 reporting. Few cases lead to actual 805 reporting because of (a) disagreement or legal interpretation on whether 809 due process is required before every 805 report is submitted, and, (b) 809 due process leads to a substantial delay in the process (often 2 to 5 years). In addition, although entities make a sincere effort to conduct peer review, it rarely leads to actual 805 or 809 actions, perhaps due to the confusion over when to file a report. In addition, entities have devised other methods to correct a physician behavior before filing an 805 report. The most common cases being referred to a high level peer review are: disruptive physician behavior/impairment, substandard technical skills, substance AB 120 Page 18 abuse, and failure to document/record patient treatment. It is also possible that some physicians would never be subject to peer review because they have practices that are not subject to any peer review requirements. (4) Lack of coordination among state agencies, and licensing agencies. There is no systematic communication or coordination among various boards and agencies that would coordinate patient quality and safety issues. There is much complexity on the complaint process, enforcement process, and the public disclosure rules that apply to the MBC. There is also criticism that the MBC may not quickly investigate all 805 reports, or if reports were investigated, the MBC often did not find any wrongdoing. In addition, others indicated that MBC's follow-up for 805 reports took as long as one year after submission of a report. It is unclear what factors provide barriers to a more effective and efficient process. It is also not clear that MBC receives valid and complete information from entities or individuals when investigating 805 reports, even with subpoena power. (5) Burdensome costs of peer review. Latest data indicates that an estimated 0-250 hours was spent on peer review activities. Most of the respondents (68%) indicated that the cost estimate in the last calendar year was between $0-50,000 excluding physician costs in time. Cost to an individual physician ranged from $0-$50,000; focus group participants indicate that an 809 hearing would never cost less than $100,000, excluding estimates of physician costs in time and legal representation for the person being reviewed, and could cost upwards of several million dollars. 3.Informational Hearing on the Peer Review Process - Reforms Needed. On March 9, 2009, this Committee held an informational hearing on physician peer review entitled "Is the Physician Peer Review A Broken System?" The informational hearing provided a brief overview of peer review in California and included discussions on how hospitals and other entities conduct peer review. The hearing also included a discussion on a legislatively mandated report on peer review authored by Lumetra, as discussed above, which pointed out that the peer review process in California is broken and in need of a major fix for it to truly serve the people. In addition to representatives from Lumetra, who presented the study, stakeholders, including representatives from the MBC , California Medical Association , California Ambulatory Surgery Association , various AB 120 Page 19 hospitals including Cedars-Sinai Health System , Kaiser Permanente Medical Group , and UC Davis Medical Center , Department of Managed Health Care , DPH and the Joint Commission testified during the hearing. The MBC testified that it does not usually get an 805 report until later and if there is a process whereby it receives information from hospitals earlier, then this would speed up consumer protection. In addition, MBC pointed out that smaller hospitals and surgery centers, because of their size and cost limitations, usually escape or have little peer review and outside or external peer review may be appropriate. A few physicians echoed these sentiments and indicated that to help eliminate inadequate and malicious peer review, an independent body should perform it. During the hearing, hospital representatives indicated that the peer review process is not broken and disagreed with the findings of the Lumetra report. It appears that hospitals have created different levels of peer review, depending on the circumstances or cases. Some hospitals pointed out that practice restrictions may be imposed on a physician that does not necessarily require an 805 report and the remedy imposed is usually continuing education or other performance enhancing activities or corrective actions. One hospital representative indicated that if impartiality is compromised, it is not unusual to send a case to another hospital within the system or to utilize external peer review. Hospital representatives however cautioned that removing peer review from hospitals may have unintended consequences and further jeopardize patient care. In addition, a couple of hospital representatives indicated that if an interim report or informal reporting mechanism to the MBC is created, this may improve the process and enhance patient care. It should be noted that this bill creates an early reporting mechanism to the MBC of specific cases, similar to the concept specified during the hearing. In addition, DPH testified during the hearing on its oversight of acute care hospitals and the peer review process. It appears that DPH has no specific authority on peer review but it assures that elements of professional review by peers exists, usually included in a hospital bylaws. Finally, on discussions of how to improve the peer review process, one physician indicated that there is a need to audit peer review and DPH must audit hospitals that conduct the peer review, and impose penalty on hospitals that do not have a peer review process. In addition, to expand 805 reporting, a mechanism must be created where complaints about physicians are reported to the MBC and the MBC conducts its own investigation of the physician and surgeon AB 120 Page 20 independent of a hospital's investigation. 4.Recent California Supreme Court Decision on Physician Peer Review. On April 6, 2009, the California Supreme Court issued an opinion relating to peer review in Mileikowsky v. West Hills Hospital Medical Center (available at http://www.courtinfo.ca.gov/opinions/documents/S156986 ). In this case, the Supreme Court discussed the importance of the peer review process and pointed out the following: "The primary purpose of the peer review process is to protect the health and welfare of the people of California by excluding through the peer review mechanism those healing arts practitioners who provide substandard care or who engage in professional misconduct. This purpose also serves the interest of California's acute care facilities by providing a means of removing incompetent physicians from a hospital's staff to reduce exposure to possible malpractice liability. Another purpose, if not equally important, is to protect competent practitioners from being barred from practice for arbitrary or discriminatory reasons." 5.Similar Legislation this Session. a. SB 58 (Aanestad) among other provisions, provides for changes in a physician and surgeon's central file of individual historical records and the information that is publicly disclosed regarding licensing and enforcement actions; requires a peer review body to annually report to the MBC on its peer review activities; defines an external peer review organization; encourages external peer review under certain conditions; mandates external peer review for specific circumstances; and, establishes an early detection and resolution program for physicians and surgeons in lieu of the filing of an 805 report. SB 58 is currently pending in Senate Appropriations suspense file. b. SB 700 (Negrete McLeod) Makes various changes relating to the peer review process in which a final proposed action may be imposed on a licentiate, if certain conditions are met, for which a report (commonly referred to as 805 report pursuant to Section 805 of the Business and Professions Code) is required to be filed to the appropriate health care regulatory body. Requires the Medical Board of California to include in a licensee's central file a finding by a court AB 120 Page 21 that a peer review resulting in an 805 report was conducted in bad faith. Prohibits disclosure by certain health care regulatory bodies of any summaries of hospital disciplinary actions that result in the termination or revocation of a licensee's staff privileges for medical disciplinary cause or reason if a court finds that the peer review resulting in the disciplinary action was conducted in bad faith and the licensee notifies the board of such finding. 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 a report with the relevant agency within 15 days after completion of a formal investigation of a licentiate if the investigation resulted in any of the following findings of fact: the licentiate departed from the standard of care; the licentiate suffered from mental illness or substance abuse; or, the licentiate engaged in sexual misconduct. SB 700 is pending on the Senate floor. c. AB 834 (Solorio) authorizes a peer review body to impose, and a licentiate may accept, voluntary remediation when deemed appropriate by the peer review body, including for a medical disciplinary cause or reason; makes changes relating to the qualifications of a hearing officer. AB 834 is pending in the Assembly Business and Professions Committee. 6.Policy Issue : Should this part of the peer review process be changed without dealing with the problems surrounding the entire peer review process? As indicated above, there are several bills currently pending in the Legislature, which are now two year-bills, including SB 58 (Aanestad) and AB 834 (Solorio) dealing with remedial actions for physicians and surgeons, and SB 700 which makes changes to the 805 reporting process. The Committee may want to consider whether this measure should be considered in the context of all bills which are attempting to improve and reform the peer review process; that in adding additional requirements to the 809 due process protections for physicians it may burden an otherwise dysfunctional process that currently exists. As indicated in this analysis, the 805 reporting process has serious flaws and there is confusion as to the requirement of 805 reporting, as well substantial delays in the MBC receiving information regarding disciplinary actions taken against physicians by hospitals. Lumetra states that few cases lead to AB 120 Page 22 actual 805 reporting because the 809 due process leads to a substantial delay in the process (often 2 to 5 years). Will increasing due process requirements, which could cause further delays and impede the ability of the MBC to pursue actions against incompetent physicians, be in the best interest of the public? As indicated above, the Section 805 reporting process was codified in 1975 as part of MICRA. According to a legislatively appointed enforcement monitor, when discussing the evolution of the MBC's enforcement program, in exchange for among other things, capping non-economic damages (pain and suffering) at $250,000 in medical malpractice actions, the medical profession agreed to accept and support enhanced regulations of physicians and surgeons with emphasis on policing the quality of medical care provided and the removal of incompetent and negligent physicians from the marketplace. This was the original intent of Section 805 reporting and up until 1989, hospitals and other entities submitted 805 reports to the appropriate healthcare regulatory agencies without the requirement to offer due process to licensees. The advent of the 809 process has overshadowed the 805 reporting of physicians who may have serious competency issues, and as indicated, has resulted in significant delays in both resolving peer review matters and in a hospital finally issuing an 805 report and taking appropriate disciplinary action against the physician. As indicated by Governor Deukmejian in 1988, when the first measure ( SB 2565 , Keene) to adopt the 809 provisions was vetoed, the Governor said "I am concerned that under this bill it will take longer and be more costly for health facilities and peer review bodies to take action against a licensee's staff privileges. This means an incompetent licensee will be practicing unrestricted that much longer, and it will be longer before a report is made to the appropriate licensing board under Section 805 of the Business and Professions Code. This would have an adverse impact on health care consumers." Furthermore, an analysis of SB 1211 (Keene, Chapter 336, Statutes of 1989), opposition to the bill indicated that "Any benefit of the doubt with regard to the notion of 'due process' must be given to the patient. Patients suffer when licentiates who should be 'disciplined' are not and continue to practice while litigating the issue of their competency." Unless the entire peer review process is "fixed" and the MBC is made immediately aware of serious cases of incompetent physicians, then any attempt to change other aspects of the peer review process would appear to AB 120 Page 23 be premature at this time. This measure for now may compound an otherwise protracted process that has as its primary mission to timely discipline physicians who have serious competency issues regarding their medical practice . 7.Staff Recommendation. The importance of the peer review process and the remedies necessary to improve the system are complex. This bill should be considered in the context of all bills which are attempting to improve and reform the peer review process. It is recommended that this bill along with other related bills be considered during an interim study of both the Senate and Assembly Business and Professions Committees. NOTE : Double-referral to Rules Committee. This bill is double-referred. Should it pass out of this Committee, it will be referred to the Senate Rules Committee. SUPPORT AND OPPOSITION: Support: California Medical Association (Sponsor) Kaiser Permanente Opposition: None on file as of June 24, 2009 Consultant:Rosielyn Pulmano