BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date: April 29, 2013 |Bill No:SB | | |304 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Curren D. Price, Jr., Chair Bill No: SB 304Author:Price As Amended: April 24, 2013 Fiscal:Yes SUBJECT: Healing arts: boards SUMMARY: Makes various changes to the Medical Practice Act and to the Medical Board of California. Existing law: 1)Licenses and regulates physicians and surgeons under the Medical Practice Act (Act) by the Medical Board of California (MBC) within the Department of Consumer Affairs (DCA) and states that the protection of the public is the highest priority of the MBC in exercising its functions. (Business and Professions Code (BPC) § 2000 et. seq.) 2)Prohibits an advertisement by a physician and surgeon from including a statement that he or she is board certified by a private or public board or parent association, including a multidisciplinary board or association, unless that board or association meets at least one of several standards, including being a board or association with equivalent requirements approved by the MBC. (BPC § 651) 3)Requires the MBC, to annually send an electronic notice to each applicant and licensee who has chosen to receive correspondence by electronic mail that requests confirmation that the electronic mail address is current. (BPC § 2021) 4)Requires an applicant for a physician and surgeon's certificate to obtain a passing score on step 3 of the United States Medical Licensing Examination (USMLE) with not more than 4 attempts, subject to an exception. (BPC § 2177) SB 304 Page 2 5)Requires that a complaint to the MBC against a physician involving quality of care, before being referred to a field office for further investigation, must be reviewed by one or more medical experts to evaluate the specific standard of care issues raised in the complaint, as specified, and exempts from the requirement complaints involving a physician and surgeon who is the subject of a pending accusation, investigation, or is on probation and physician peer review reports (805 Reports), as specified. (BPC § 2220.08) 6)Requires a health care facility to comply with a request of MBC for certified medical records of a patient, authorized by the patient in writing within 30 days, and provides for a civil penalty of up to $1,000 per day, as specified, imposed on a health care facility that fails to comply with that request. (BPC § 2225.5) 7)Provides that whenever it appears that a healing arts practitioner may be unable to practice his or her profession safely because of an impaired ability due to mental illness or physical illness affecting competency, the licensing board may order the licensee to be examined by a physician and surgeon or psychologist; and, provides that if the board determines that the licensee's ability to practice is impaired because of mental or physical illness affecting competency, that board may, revoke the license, suspend the right to practice, place the licensee on probation, or take any other action deemed proper by the board. (BPC §§ 820, 822) 8)Prohibits a party from bringing expert testimony in a matter brought by the MBC unless certain information regarding the expert witness and a brief summary of the testimony is exchanged in written form with counsel for the other party, within 30 calendar days prior to the hearing. (BPC § 2334) 9)Prohibits corporations and other artificial legal entities from having any medical professional rights, privileges, or powers (known as the "prohibition against the corporate practice of medicine"). (BPC § 2400 et. seq.) 10)Provides for the licensing and regulation of licensed midwives under the Licensed Midwifery Practice Act of 1993, by the MBC, and specifies under that law that a midwife student meeting certain conditions is not precluded from engaging in the practice of midwifery as part of the course of study, if certain conditions are met, including, that the student is under the supervision of a licensed midwife. (BPC § 2514) SB 304 Page 3 11)Provides for the regulation of registered dispensing opticians by the MBC and requires that the powers and duties of the MBC in that regard be subject to review by the Joint Sunset Review Committee as if those provisions were scheduled to be repealed on January 1, 2014. (BPC § 2569) 12)Under the Administrative Procedure Act (APA), establishes within the Office of Administrative Hearings (OAH) a Medical Quality Hearing Panel to conduct adjudicative hearings and proceedings relative to licensees of the MBC under the terms and conditions set forth in the APA, except as provided in the Medical Practice Act. (Government Code (GC) §§ 11371, 11373) 13)Authorizes the administrative law judge of the Medical Quality Hearing Panel to issue an interim suspension order (ISO) suspending a license, or imposing drug testing, continuing education, supervision of procedures, or other licensee restrictions. Requires that an accusation must be filed within 15 days of the date the ISO is granted or else the order will be dissolved. (GC § 11529) 14)Establishes the Health Quality Enforcement Section within the Department of Justice whose primary responsibility is to investigate and prosecute proceedings against licensees and applicants of the MBC and other specified health-care boards. (GC § 12529) a) Provides for the appointment of a Senior Assistant Attorney General to the section to carry out specified duties, and provides that the section to be staffed by a sufficient number of employees capable of handling the most complex and varied types of disciplinary actions. b) Provides for the funding for the section, from the special funds financing the MBC and other specified health-care boards. 15)Requires that all complaints or relevant information concerning licensees that are within the jurisdiction of the MBC, the California Board of Podiatric Medicine, or the Board of Psychology be made available to the Health Quality Enforcement Section. (GC § 12529.5) a) Establishes the procedures for processing the complaints, assisting the boards or committees in establishing training programs for their staff, and for determining whether to bring a disciplinary proceeding against a licensee of the boards. b) Provides for the repeal of those provisions on January 1, SB 304 Page 4 2014. 16)Establishes a vertical enforcement and prosecution model for cases before the MBC. (GC § 12529.6) a) Requires that a complaint referred to a district office of the MBC for investigation also be simultaneously and jointly assigned to an investigator and to the deputy attorney general in the Health and Quality Enforcement Section, as provided. b) Provides for the repeal of those provisions on January 1, 2014. 17)Requires the MBC in consultation with the Department of Justice to report to the Governor and Legislature on the vertical prosecution model by March 1, 2012. (BPC § 12529.7) This bill: 1)Repeals the authority of the MBC to approve the equivalency of a multidisciplinary certification board. 2)Requires applicants and licensees who have an electronic mail address to report the email address to the MBC, and provides that the email address is to be considered confidential by the MBC. 3)Clarifies that an applicant must obtain a passing score on all parts of the USMLE examination in not more than 4 attempts, as specified. 4)Specifies that reports submitted to the MBC under BPC § 801.1 regarding a settlement or arbitration award for damages for death or personal injury cause by a physician's negligence, error or omission in practice are not subject to the review by a medical expert before being referred to a field office for investigation. 5)Shortens the time limit to 15 days for a health care facility that uses electronic health records to comply with a request of MBC for certified medical records, as specified. 6)Authorizes the MBC to issue a notification to cease practice immediately to a physician and surgeon who fails to comply with an order related to a mental of physical examination. 7)Requires information regarding expert witness testimony to be exchanged within 90 days from the filing of a notice of defense and SB 304 Page 5 further requires the information to include a complete expert witness report. 8)Provides that the corporate practice of medicine prohibition does not apply to a physician and surgeon enrolled in approved residency postgraduate training program or fellowship program. 9)Clarifies that a student is to be enrolled and participating in a midwifery education program or enrolled in a program of supervised clinical training, in order to practice midwifery under supervision, and additionally authorizes a student to practice under the supervision of a licensed nurse-midwife. 10)Makes the powers and duties of the MBC relative to Registered Dispensing Opticians subject to review by the appropriate policy committees of the Legislature as if those provisions were scheduled to be repealed on January 1, 2018. 11)Extends to 30 days, the time in which the accusation must be filed after an ISO has been granted. 12) Amends GC § 12529 to provide that on January 1, 2014, all persons employed by the MBC who are performing investigations and their staff shall be transferred to the DOJ. a) Provides that upon transfer, the status, position and rights of those persons shall be the same as DOJ employees holding similar positions, including the retention of peace officer status for those persons performing investigations, as specified. b) Requires the MBC to maintain the duty of preserving patient confidentiality. c) Specifies that on and after January 1, 2014, any reference to an investigation conducted by the MBC shall be deemed to refer to an investigation by employees of DOJ. 13)Removes the January 1, 2014 repeal date applicable to the vertical enforcement prosecution provisions (GC §§ 12529, 12529.5, 12529.6), thereby extending the vertical enforcement prosecution provisions indefinitely. 14)Extends the requirement for MBC to submit a report to the Governor and Legislature on the vertical enforcement prosecution model to March 1, 2015. SB 304 Page 6 FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This bill is one of six "sunset review bills" authored by the Chair of this Committee. Unless legislation is carried this year to extend the sunset dates for the Medical Board of California and its executive director they will be repealed on January 1, 2014. This bill makes a number of legislative changes recommended by the MBC as well as recommendations made in the Committee's background paper. 2.Oversight Hearings and Sunset Review of Licensing Boards and Commission of DCA. In 2013, this Committee conducted oversight hearings to review 14 regulatory boards within the DCA. The Committee began its review of these licensing agencies in March and conducted three days of hearings. This bill, and the accompanying sunset bills, is intended to implement legislative changes as recommended in the Committee's Background/Issue Papers for all of the agencies reviewed by the Committee this year. 3.Review of the Medical Board of California (MBC), Issues Identified and Recommended Changes. The following are some of the major issues pertaining to the MBC or areas of concern reviewed and discussed by the Committee during the review of the MBC, along with background information concerning each particular issue. Recommendations were made by Committee staff regarding the particular issues or problem areas which needed to be addressed. a) Issue : Specialty Board Advertising. Background : The MBC raised the following as a new issue in its Sunset Report. In 1990, SB 2036 (McCorquodale), sponsored by the California Society of Plastic Surgeons, sought to prohibit physicians from advertising board certification by boards that were not member boards of the American Board of Medical Specialties (ABMS) by adding BPC § 651(h) to prohibit physicians from advertising they are "board certified" or "board eligible" unless they are certified by: An ABMS approved specialty board. A board that has specialty training that is approved by the Accreditation Council for Graduate Medical Education (ACGME). A board that has met requirements equivalent to ABMS SB 304 Page 7 and has been approved by the MBC. The ultimate effect is to provide that unless physicians are certified by a board, as defined by law, physicians are prohibited from using the term "board certified" or "board eligible" in their advertisements. The law does not, however, prohibit the advertising of specialization, regardless of board certification status. To implement BPC § 651, the MBC adopted regulations which are substantially based on the requirements of ABMS, including the number of diplomates certified, testing, specialty and subspecialty definitions, bylaws, governing and review bodies, etc. The most notable requirement relates to the training provided to those certified by the specialty boards. In the MBC regulations, training must be equivalent to an ACGME postgraduate specialty training program in "scope, content, and duration." Since the regulations were adopted, the MBC has reviewed a number of specialty board applications, and has approved four boards: American Board of Facial Plastic & Reconstructive Surgery. American Board of Pain Medicine. American Board of Sleep Medicine. American Board of Spine Surgery. The MBC has also disapproved two boards: American Academy of Pain Management. American Board of Cosmetic Surgery. The purpose of the law and regulation is to provide protection to consumers from misleading advertising. Board certification is a major accomplishment for physicians, and while board certification does not ensure exemplary medical care, it does guarantee that physicians were formally trained and tested in a specialty, and, with the ABMS' Maintenance of Certification (MOC) requirements to remain board-certified, offers assurances that ongoing training, quality improvement, and assessment is occurring. At the time the legislation was promoted, a number of television news programs covered stories from severely injured patients that were victims of malpractice from physicians who advertised they were board certified, when, in fact, they had no formal training SB 304 Page 8 in the specialty advertised. The law put an end to physicians' ability to legally advertise board certification if the certifying agency was not a member board of ABMS. Is the Program Still Relevant? As explained, the law addresses advertising, and does not require physicians to be board certified or formally trained to practice in a specialty or in the specialty of which they practice. Physicians only need to possess a valid physician's license to practice in any specialty. As prospective patients usually are covered by insurance, searching for a physician in most specialties is generally done through their insurance directory. At present, insurance companies generally only choose board-certified physicians for their panels, or those physicians whose credentials they have vetted. The same is generally true for the granting of hospital privileges. Hospitals grant privileges after conducting a review of qualifications. This process, called "credentialing" will include looking into the background of a physician, including accredited training and board certification. For that reason, most physicians who are granted privileges will be board-certified in the specialty for which they are granted privileges, or similarly highly, formally trained. Therefore, the "board certification" advertising prohibition is primarily meaningful for elective procedures; that is to say, those procedures that are not reimbursed by insurance or those performed outside of hospitals or hospital clinic settings. Cost of Program. The cost for the MBC to administer the program has been minimal in recent years, since there has only been one recent application. It is likely that non-ABMS certifying boards have been deterred from filing applications due to the law, the strict regulations, the demanding review process, and the fee. Processing the application for meeting the basic requirements can be done by an analyst. The evaluation of the medical training, however, must be performed by a physician consultant that is an expert with academic experience. Therefore, a medical education expert must be hired to perform a review of the specialty board's formal training program. The cost of the expert varies, but when the fee regulations were promulgated in the 1990s, it was estimated that such a review would require from 80 to 160 hours to complete. At present, the cost of hiring an expert would be from $5,000 to $11,000. The current application fee for a SB 304 Page 9 specialty board application is $4,030. Ultimately, the costs of processing specialty board applications has not been the major expense in this program. The cost comes when an application is denied and litigation results, and thereby legal costs. Risk of Lawsuits and Potential Payouts. Since the program's inception, the MBC has only denied two specialty boards. American Academy of Pain Management was denied, and filed four suits against the MBC, including one in Federal Court. American Board of Cosmetic Surgery applied for approval twice, was denied both times, and filed suit on the second denial. The MBC states that it has prevailed in all litigation, but the cost has been considerable. While AG billing methods makes it difficult to ascertain the exact cost of legal representation specific to the suits, MBC estimates its litigation costs conservatively to be in excess of $200,000. Other than the Board, Who Could Fulfill this Function? According to the MBC, three entities have the expertise to review and evaluate the quality of medical specialty boards' training and certification criteria: (1) ABMS, (2) ACGME, and to a lesser degree (3) medical schools that provide ABMS designed and ACGME accredited residency training programs. Unfortunately, according to the MBC, it would be inappropriate for any of these entities to judge a competing specialty board training program. The Board recommends that the Legislature delete the provision requiring the MBC to approve non-ABMS specialty boards. For consumer protection, the law should continue to require physicians to advertise as board certified only if they have been certified by ABMS boards and the four additional boards currently approved by the MBC. In addition, the law could be amended to prevent the use of other misleading terms. Recommendation : The Committee staff recommended amending BPC § 651(h) to delete the MBC's authority to approve non-ABMS specialty boards, and to prevent the use of other misleading terms in physician and surgeon advertising, as recommended by the MBC. [The current language in this measure reflects these recommended changes.] a) Issue : Mandatory Email Address. SB 304 Page 10 Background : The MBC raised the following as a new issue in its Sunset Report. The MBC believes it would be beneficial to require all licensees to provide the Board with an email address if they possess one. Currently, providing an email address to the MBC is optional for applicants and licensees. An email address is requested on the application and renewal forms. When an email address is provided, it is considered confidential. When appropriate, the MBC sends some correspondence electronically instead of mailing to the physical address on record. This practice has proven to be a quicker, more convenient, and potentially more reliable delivery method while saving printing and postage costs. For example, the Board's Summer 2012 Newsletter was sent electronically via email to approximately 113,800 licensees and 6,800 applicants. In addition, when there is an FDA alert, it can be relayed in the same day the alert is released. On rare occasions, licensee email addresses are used to send notices of important law changes, emergency regulations, as well as other urgent issues affecting licensees and public health. The MBC states that in such cases Executive and MBC staff review and approve these rare, relatively infrequent emails that are distributed. The Board regularly posts information on its Internet Website to alert licensees of urgent issues. The Board also uses a subscriber list service to notify individuals about items of interest relating to the activities of the Board via email. Subscribers may choose to receive email alerts for some or all of the offered topics. This is a valuable tool to get important information to licensees and other interested parties, but it is not widely used by licensees. As of August 2012, there were less than 4,000 subscribers for each topic. In addition, the MBC is moving to a new information technology (IT) system that will allow licensees to receive renewal notifications and other information via email. The new IT system will allow licensees the opportunity to choose the best method (i.e. electronically or U.S. Postal Service) of receiving information from the Board. SB 1575 Price (Chapter 799, Statutes of 2012) amended BPC § 2424 to allow the MBC to send email notifications for expired licenses. The Board wants to communicate with its licensees to provide the most current, meaningful, and important information in a 21st century manner, that is also respectful of the time that is taken going through email messages. SB 304 Page 11 The MBC recommends a legislative change to require that licensees provide the Board with an email address, if they possess one. In addition, the language should state the email address provided will be confidential. Recommendation : Committee staff recommended amendments regarding licensees providing email addresses to the MBC, if they possess one. The language should additionally require the MBC to keep a provided email address confidential. [The current language in this measure reflects these recommended changes.] b) Issue : United States Medical Licensing Examination Background : In its Sunset Report, the MBC raised the following new issue. Individual state medical boards set their own rules, regulations and requirements for passage of examinations to demonstrate an applicant's qualifications for medical licensure. In California, the MBC receives examination results from the United States Medical Licensing Examination (USMLE) program, which is used to determine if an individual will be granted licensure to practice medicine in California. The examination consists of three steps, which must be passed sequentially in order to be eligible to move on to the next examination step. The steps are defined as: Step 1: Focuses primarily on understanding and application of key concepts of basic biomedical sciences. Step 2: Focuses primarily on knowledge, skills, and understanding of clinical science that forms the foundation for safe and competent supervised practice. Step 3: Focuses primarily on the knowledge and understanding of the biomedical and clinical science essential for the unsupervised, general practice of medicine. The evolution of medical advancements as well as shifts in medical practice and education, have required changes to the format delivery and content of the examinations. However, the original three-step concept remains intact. In 1999, a major change was made to the examination format delivery, which transitioned from paper-based delivery to computer delivery. In 2004, a standardized patient examination was introduced as a component of Step 2. However, the focus and overall structure of the step examinations have remained relatively unchanged. The USMLE Composite Committee and its parent organizations, the Federation of State Medical Boards (FSMB), and the National Board SB 304 Page 12 of Medical Examiners (NBME), have approved plans to change the structure of the USMLE. Step 3 is slated to be the first examination impacted. The USMLE has stated the changes to Step 3 will "occur no earlier than 2014." The plans call to divide Step 3 into two separate exams, one day in length each, and will focus on different sets of competencies. The two examinations will be scored separately and applicants must pass each. There may also be new testing formats to focus on competencies not currently addressed in Step 3. Step 3 of the USMLE will remain known as Step 3; however, it will be a two-part examination. The MBC recommended that the language of BPC § 2177 be amended to accommodate two parts of the Step 3 examination, and any new evolving examination requirement. Recommendation : The Committee staff recommended amending BPC § 2177 to accommodate two parts to Step 3 of the USMLE and to accommodate future examination changes. [The current language in this measure reflects this recommended change.] a) Issue : Medical Expert Review of Medical Malpractice Reports. Background : The MBC raised the following as a new issue in its Sunset Report. BPC § 2220.08 requires that before a quality of care complaint is referred for investigation it must be reviewed by a medical expert with the expertise necessary to evaluate the specific standard of care issue raised in the complaint. While, the rationale for the up-front specialty review makes sense, it may not make sense in the case of Medical Malpractice cases that have been reported to the Board. The Board believes that medical malpractice cases reported pursuant to section 801.01, after the civil action have been concluded, would be appropriate to exclude from the upfront specialty review as well. Unlike complaints filed by the public, medical malpractice cases have had the benefit of review by a number of medical experts. Typically both the plaintiff and the defendant will obtain an expert to review the care provided by the physician and opine as to whether the standard of care was met. Whether the case settles prior to trial or proceeds through the litigation process, it has been subjected to numerous reviews by medical experts. The outcome from the medical malpractice case is required to be reported to the Board by the insurance carrier or employer who pays the award on behalf of the physician. According to the MBC, there is little benefit to obtain an SB 304 Page 13 initial medical expert review on these cases and this additional review adds approximately two months to the time it takes to refer the case to investigation. The Board recommended that medical malpractice reports be excluded from the requirements of Section 2220.08 consistent with the exception made for 805 Reports. Recommendation : The Committee staff recommended that legislation should be enacted to exclude medical malpractice reports from the requirements of a medical expert review under BPC § 2220.08. [The current language in this measure reflects this recommended change.] b) Issue : Medical Facilities to Produce Medical Records Within 15 Days. Background : The MBC raised the following in its Report. BPC § 2225.5 (a) (1) requires a licensee to produce the certified medical records of a patient, pursuant to the patient's authorization, within 15 business days of the receipt of the request. However, subsection § 2225.5 (b) gives a medical facility 30 days to produce certified records. This disparity may have been seen as appropriate prior to the implementation of Electronic Health Records (EHR), however, today most facilities (hospitals) maintain EHRs, which reduces the time required to retrieve and prepare medical records in response to requests. In an effort to reduce investigation time, consideration should be given to whether there is a need to allow a facility twice the amount of time to produce records than is allowed for production from the office of a licensee. Additionally, if a subpoena duces tecum were served, the facility would have 15 days to produce the same records that they would be allowed 30 days to produce if requested via patient authorization. Therefore, the disparity should be eliminated and consistency established by affording 15 days for production of medical records by both the licensee and facilities. The Board recommends that the law be amended to allow a facility only 15 days to provide medical records, upon request, if the facility has EHRs. Recommendation : Committee staff recommended that BPC § 2225.5 (b) should be amended to require a facility to produce medical records within 15 days, if the facility has implemented SB 304 Page 14 Electronic Health Records (EHR). [The current language in this measure reflects this recommended change.] c) Issue : Cease Practice - Failure To Comply. Background : Under BPC § 820, the MBC may order a physical or mental health examination of a licensee whenever it appears that a licensee's ability to practice may be impaired by physical or mental illness. The examination order is part of the investigation phase, and allows the MBC to make a substantive determination that the licentiate's ability to practice his or her profession actually has become impaired because of mental or physical illness. Failure to comply with an examination order constitutes grounds for suspension or revocation of the individual's certificate or license (BPC 821). However, the process for suspension or revocation for refusal to submit to a duly-ordered examination can be lengthy, as demonstrated by a recent court case in which a licentiate of the Board of Registered Nursing refused a psychiatric examination yet continued to practice for months thereafter (see Lee v Board of Registered Nursing, 209 Cal. App. 4th 793; 147 Cal. Rptr. 3d 269; Sept. 26, 2012). To refuse or delay compliance with an examination order poses risks for consumers because of the possibility that a mentally or physically ill practitioner could continue to see patients until the MBC completes suspension or revocation proceedings under BPC § 821. Public protection would be better served if the MBC has the authority to issue a cease practice order in cases where compliance with an examination order under BPC § 820 is delayed beyond a reasonable amount of time (perhaps 15-30 days). Recommendation : Committee staff recommended amendments to the MBC's authority to issue a cease practice order to expand to situations where, in the course of a fitness to practice investigation, a licensee refuses to undergo a duly ordered physical or mental health examination. [The current language in this measure reflects this recommended change.] d) Issue : Expert Reviewer Reports. Background : The MBC raised the following in its Report. The Administrative Procedure Act (APA) includes limited discovery provisions that do not assist in discovering opposing expert information. The MBC states that in some instances, once the SB 304 Page 15 Board received this information, it has to amend the accusation and thereby increase the timeframe for administrative action. In the civil context, the best tool to find out information from opposing experts would be to depose the expert. However, the APA only allows depositions in extreme circumstances, which do not usually apply to Board cases (GC § 11511). The MBC recommends that the best way to make changes regarding expert testimony as it relates to MBC disciplinary cases is to amend BPC § 2334 which relates to expert testimony in disciplinary cases before the Board. Since its implementation, § 2334 has been beneficial to the DAGs prosecuting Board cases. While § 2334 has been beneficial, the MBC believes it could be improved. The Board requires its own experts to prepare expert witness reports that, under the APA, must be produced in discovery. Requiring respondents to produce expert reports addressing each of the quality-of-care issues raised in the pending accusation would be of enormous benefit to the entire disciplinary process. It is believed that more cases would settle prior to hearing, thus avoiding the months of waiting by both sides while the parties await the commencement of hearings. The deadline for both sides to make the required disclosures is only 30 calendar days prior to the commencement date of the hearing. That deadline is too late in the process and, as a result, can delay early settlement. If the date were 90 calendar days before the commencement date of the hearing or 180 calendar days after service of the accusation on respondent, then settlements could occur earlier, thus the imposition of public protection measures would occur sooner. The Board recommended amending § 2334 to require the respondent to provide the full expert witness report. Additionally, there needs to be specificity in the timeframes for providing the reports, such as 90 days from the filing of an accusation. This would provide enhanced consumer protection, as the physician who is found to be in violation of the law would be placed on probation, monitored, or sanctioned in a more expeditious manner, according to the MBC. Recommendation : The Committee staff recommended amending BPC § 2334 to: e) (1) require a respondent to provide the full expert witness report; (2) clarify the timeframes for providing the reports, SB 304 Page 16 such as 90 days from the filing of an accusation. [The current language in this measure reflects these recommended changes.] f) Issue : Residency Training Program Employment Clarification. Background : The MBC raised the following as a new issue in its Sunset Report. A question has been raised regarding whether the employment of residents is a violation of the prohibition against the corporate practice of medicine. BPC § 2052, provides that any person who practices or attempts to practice [medicine] without a valid, unrevoked, or unsuspended certificate is guilty of a public offense. In addition, BPC § 2400 provides: "Corporations and other artificial entities shall have no professional rights, privileges, or powers." The policy in BPC § 2400 against the corporate practice of medicine is intended to prevent unlicensed persons from interfering with or influencing the physician's professional judgment. The MBC has a long-standing interpretation that physicians in an accredited postgraduate training (accredited residency) and/or fellowships do not meet the criteria for the prohibition against the corporate practice of medicine. However, the MBC believes that the corporate practice of medicine issue regarding accredited residency programs and their residents should be clarified, and addressed as a specific exemption. This will ensure California accredited residency/fellowship programs are not in danger of closing due to the concerns regarding the prohibition of the corporate practice of medicine. Recommendation : The Committee staff agreed that the Business and Professions Code should be amended to clarify that participation in an accredited physician residency training program is not a violation of the prohibition against the corporate practice of medicine. [The current language in this measure reflects this recommended change.] g) Issue : Clarify Midwifery education and clinical training. Background : The MBC raised the following in its Report. BPC § 2514 authorizes a "bona fide student" who is enrolled or participating in a midwifery education program or who is enrolled in a program of supervised clinical training to engage in the practice of midwifery as part of that course of study if: (1) the student is under the supervision of a physician or a licensed SB 304 Page 17 midwife who holds a clear and unrestricted California midwife license and who is present on the premises at all times client services are provided; and (2) the client is informed of the student's status. There has been disagreement between the MBC and some members of the midwifery community regarding what constitutes a "bona fide student." The MBC believes the current statute is very clear regarding a student midwife. Some members of the midwifery community hold that an individual who has executed a formal agreement to be supervised by a licensed midwife but is not formally enrolled in any approved midwifery education program qualifies the individual as a student in apprenticeship training. Many midwives consider that an individual may follow an "apprenticeship pathway" to licensure. The original legislation of the Midwifery Practice Act, included the option to gain midwifery experience that will then allow them to pursue licensure via the "Challenge Mechanism" detailed in BPC § 2513 (a) which allows an approved midwifery education program to offer the opportunity for students to achieve credit by examination for previous clinical experience. According to the MBC, this provision was included to allow for those who had been practicing to meet the requirements for licensure. The statute clearly states a midwife student must be formally enrolled in a midwifery educational institution in order to participate in a program of supervised midwifery clinical training. A written agreement between a licensed midwife and a "student" does not qualify as a "program of supervised clinical training". Accordingly, these types of arrangements are not consistent with the provisions of BPC § 2514. A Task Force consisting of members of the Midwifery Advisory Council has recently been formed to examine this issue. However, the issue of students/apprenticeships may need to be addressed through the legislative process, according to the MBC. Recommendation : The Committee staff recommended that legislation should be enacted to clarify when an individual is considered a bona fide student, and to clarify that a written agreement does not meet the requirement of a program of supervised clinical training. [The current language in this measure reflects these recommended changes.] h) Issue : Interim Suspension Authority. Background : Government Code § 11529 authorizes the administrative law judge of the Medical Quality Hearing Panel in the Office of SB 304 Page 18 Administrative Hearings to issue an interim order suspending a license of a physician, or imposing drug testing, continuing education, supervision of procedures, or other license restrictions. Interim orders may be issued only if the affidavits in support of the petition show that the licensee has engaged in, or is about to engage in, acts or omissions constituting a violation of the Medical Practice Act or the appropriate practice act governing each allied health profession, or is unable to practice safely due to a mental or physical condition, and that permitting the licensee to continue to engage in the profession for which the license was issued will endanger the public health, safety, or welfare. When an ISO is issued, the MBC has 15 days to file and serve a formal accusation under the Government Code to revoke the license of the physician. This interim suspension order (ISO) authority was the first of its kind for the DCA's regulatory boards, and was established in 1990 by SB 2375 (Presley, Chapter 1597, Statutes of 1990). This provision was intended to immediately halt the practice of very dangerous physicians in egregious cases. A number of the recent newspaper articles critical of the MBC's enforcement practices have highlighted the time it takes to remove a dangerous doctor from practice. Enforcement statistics from the MBC's sunset report show that for the last 3 fiscal years, an average of 23 ISOs or temporary restraining orders (TRO) have been issued. In 2004, the MBC Enforcement Monitor's Initial Report stated: "MBC's enforcement output statistics indicate a troubling decline in the efforts to use the powerful ISO/TRO authority in the recent past. ISOs/TROs sought by HQE on behalf of the MBC diminished from a high of 40 in 2001-2002 to 26 in the 2003-04 fiscal year (a decline of 40%). Given the importance of these public safety circumstances, a decline in the use of these tools is a source of concern to the Monitor." Since that time, ISO/TROs have remained low. According to the MBC, it sought 36 ISOs in FY 2011/12 although there were only 28 granted. In discussing the challenges faced with obtaining an ISO, regulatory boards often point out the level of standard that must be demonstrated to obtain the ISO, and the difficulty in filing a formal accusation within 15 days from the time the ISO is issued. The Committee staff raised the issue of whether there should be a lower standard in order for an ALJ to issue an ISO. Furthermore, SB 304 Page 19 should there be lengthier timeframes (longer than 15 days) for the filing of an accusation after an ISO has been issued? In addition, in cases where the MBC is seeking to simply restrict a physician's prescribing privileges (rather than suspend the entire license), it may be an appropriate consumer protection tool to lower the standard for obtaining an ISO and for lengthening the timeframes for filing an accusation against a physician. Recommendation : The bill extends the time for filing a formal accusation to 30 days from the time the ISO is issued. [The current language in this measure reflects this recommended change.] i) Issue : Continuation of Vertical Enforcement Prosecution (VE). Background : In 2005, SB 231 (Figueroa, Chapter 674, Statutes of 2005) created a pilot program establishing a vertical prosecution model, also known as vertical enforcement (VE) program to handle MBC investigations and prosecutions. VE requires Board investigators and Attorney General (AG) Health Quality Enforcement Section (HQES) prosecutors to work together from the beginning of an investigation to the conclusion of legal proceedings. The MBC and the HQES have used the VE program since 2006, and a number of modifications have been made since its inception to make the program more efficient. In 2010, VE was extensively studied by Benjamin Frank, LLC. The report, titled Medical Board of California - Program Evaluation made several conclusions, including that the insertion of DAGs into the investigative process did not translate into more positive disciplinary outcomes or a decrease in investigation completion times, and recommended scaling back and optimizing DAG involvement in investigations. The AG's Office took great exception to certain portions of the report, namely the cost of VE in the investigation phase of the case and that greater DAG involvement under the VE model has not translated into greater public protection. The MBC states that although the investigation timelines have shortened, it is unknown if this is due to VE or if it is due to increased efficiencies in enforcement processes and procedures in general. In order to more fully determine the level of success of the VE program, the MBC and the AG have engaged in discussions of the accumulated data from the VE cases. At this time, the analysis of the VE program by the MBC and the AG has not been SB 304 Page 20 fully completed. The Committee anticipates greater detail to be furnished by the Board and the AG's office later in 2013. What the MBC has concluded thus far is that significant improvements in actions taken have occurred and are identified below: Comparing fiscal year (FY) 2006/2007 to FY 2011/2012: 47% more cases were referred to the Attorney General's Office. 74% more probation violation cases were referred to the Attorney General's Office. 49% more license restrictions/suspensions were imposed while administrative action was pending. 203% more cases were referred for criminal action. 35% more revocations were issued. 25% more cases resulting in probation were issued. 26% more disciplinary actions were issued. The Committee staff strongly recommends that the VE program should continue and further ways should be explored to make the collaborative relationship between investigators and prosecutors more effective to carrying out a vigorous enforcement process to protect the public. Recommendation : The Committee staff recommends continuing the VE program, removing the sunset provisions, thereby making VE a permanent program. In addition, further ways should be explored to improve the collaborative relationship between investigators and prosecutors to improve the effectiveness of the MBC enforcement program. [The current language in this measure reflects this recommended change.] a) Issue : Transfer of Investigators to DOJ. Background : As stated above, SB 231 (Figueroa, Chapter 674, Statutes of 2005) created and established a (VE) pilot program to handle MBC investigations and prosecutions. VE pairs MBC investigators and HQES prosecutors from the AG's office from the beginning of an investigation to the conclusion of any legal proceedings. The VE program has been operational since 2006. As originally recommended by the MBC Enforcement Monitor in 2005, and initially drafted in SB 231, the VE program would have transferred the MBC's investigators to the HQES in the AG's SB 304 Page 21 office. This would have placed the investigator and prosecutor in the same office under the same agency, a practice, as is done in numerous other law enforcement shops throughout the country. Very late in the legislative process the transfer of investigators was taken out of the bill, but the bill with the amendments transferring the board investigators to DOJ had received support from both the MBC and the California Medical Association. The impetus to revisit the issue of transferring investigators to the AG's office, comes from the clear need to improve the enforcement activities and results in MBC enforcement cases. The case for changes in the MBC's enforcement processes has been further made by events such as the 2012, the Los Angeles Times series "Dying For Relief" which was the outcome of an intensive review of the epidemic of prescription drug-related deaths in four Southern California counties. That investigation revealed cases where doctors had 3 or more patients who had died of drug overdoses who continued to practice, while being investigated by the MBC. Other doctors continued to have clean records with the MBC, according to the Times. On April 1, 2013, the Authors of this bill, Senator Price and Assemblymember Gordon, sent a letter calling upon the MBC to take a more proactive approach to its consumer protection mission, including its enforcement operations, and suggesting that that strong consideration should be given to taking steps to further align MBC's investigators with prosecutors. Transferring the investigatory operations from the MBC to the HQES in the AG's office is a good initial start to proactively addressing enforcement issues. Recommendation : Committee staff recommends strengthening the VE program by transferring the MBC investigators to the HQES in the Department of Justice. [The current language in this measure reflects this recommended change.] 4. Current Related Legislation. SB 305 (Price, 2013). Extends until January 1, 2018, the provisions establishing the Naturopathic Medicine Committee and the Respiratory Care Board of California, and extends the term of the executive officers of the Respiratory Care Board of California and the California State Board of Optometry. Specifies that the Osteopathic Medical Board of California is subject to review by the appropriate policy SB 304 Page 22 committees of the Legislature. Exempts individuals who have performed pulmonary function tests in Los Angeles County facilities for at least 15 years, from licensure as a respiratory care therapist. Specifies that any board under the Department of Consumer Affairs is authorized to receive certified records from a local or state agency to complete an applicant or licensee investigation and authorizes them to provide those records to the board. ( Note : This bill will also be heard before the BP&ED Committee during today's hearing) SB 306 (Price, 2013). Extends until January 1, 2018, the provisions establishing the State Board of Chiropractic Examiners, Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board, the Physical Therapy Board of California and the California Board of Occupational Therapy and extends the terms of the executive officers of the Physical Therapy Board of California and the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board. This bill also subjects the boards to be reviewed by the appropriate policy committees of the Legislature. ( Note : This bill will also be heard before the BP&ED Committee during today's hearing) SB 307 (Price, 2013) Extends, until January 1, 2018, the term of the Veterinary Medicine Board, which provides for the licensure and registration of veterinarians and registered veterinary technicians and the regulation of the practice of veterinary medicine by the Veterinary Medical Board. ( Note : This bill will also be heard before the BP&ED Committee during today's hearing) SB 308 (Price, 2013). Extends, until January 1, 2018, the term of the Interior Design Law. Specifies that a certified interior designer provides plans and documents that collaborates with other design professionals. Requires a certified interior designer to use a written contract when contracting to provide interior design services to a client. Extends, until January 1, 2018, the State Board of Guide Dogs for the Blind and extends an arbitration procedure for the purpose of resolving disputes between a guide dog user and a licensed guide dog school. Extends until January 1, 2016, the State Board of Barbering and Cosmetology and requires a school to be approved by the board before it is approved by the Bureau for Private Postsecondary Education. The bill would also authorize the board to revoke, suspend, or deny its approval of a school on specified grounds. ( Note : This bill will also be heard before the BP&ED Committee during today's hearing) SB 304 Page 23 SB 309 (Price, 2013). Extends the term of the State Athletic Commission, which is responsible for licensing and regulating boxing, kickboxing, and martial arts matches and is required to appoint an executive officer until January 1, 2018. ( Note : This bill will also be heard before the BP&ED Committee during today's hearing) 5.Arguments in Support. This bill is supported by the Center for Public Interest Law (CPIL) whose Administrative Director, Julianne D'Angelo Fellmeth writes that because of problems at MBC's enforcement program in 2002, she was appointed as the MBC Enforcement Monitor by the Director of DCA. In two exhaustive reports the Monitor made 65 recommendations to strengthen MBCs enforcement program. The reports centered around two centerpiece recommendations (1) full implementation of the VE model in which in which investigators and prosecutors closely collaborate starting at the point of the referral of a complaint for formal investigation, and (2) to achieve full implementation of VE, transfer MBC's investigators into the HQES in the AG's office. CPIL further writes: "Both proposals were contained in SB 231 (Figueroa) in 2005. That bill was supported by all of the relevant stakeholders, including MBC, HQES/DOJ, California Medical Association, Kaiser Permanente, CPIL, and eight former Medical Board Presidents. Unfortunately, during the final days of the 2005 legislative year, the Schwarzenegger Administration insisted that the transfer provision be removed from SB 231." CPIL adds: "VE could be more seamless implemented if the investigators and prosecutors worked for the same agency, with easy access to each other and to the same electronic tracking system." CPIL concludes stating: "Time and experience have proven that this critically important change is long overdue. The transfer would permit investigators and prosecutors to work for the same team in the same agency, under the same procedures and protocols, and with access to the same electronic case tracking system . . . the transfer would enable improved efficiency and effectiveness due to better communication and coordination of efforts; improved training for both prosecutors and investigators; and the potential for improved morale, recruitment, and retention of experienced investigators." SUPPORT AND OPPOSITION: SB 304 Page 24 Support: Center for Public Interest Law Opposition: None received as of April 24, 2013 Consultant:G. V. Ayers