BILL ANALYSIS Ó SB 1193 Page 1 SENATE THIRD READING SB 1193 (Hill) As Amended August 18, 2016 Majority vote SENATE VOTE: 39-0 -------------------------------------------------------------------- |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+-----------------------+---------------------| |Business & |13-0 |Salas, Bloom, Campos, | | |Professions | |Chávez, Dahle, Dodd, | | | | |Eggman, Gatto, Gomez, | | | | |Holden, Mullin, Ting, | | | | |Wood | | | | | | | |----------------+-----+-----------------------+---------------------| |Appropriations |15-0 |Gonzalez, Bloom, | | | | |Bonilla, Bonta, | | | | |Calderon, Daly, | | | | |Eggman, Eduardo | | | | |Garcia, Holden, | | | | |Obernolte, Quirk, | | | | |Santiago, Weber, Wood, | | | | |McCarty | | | | | | | | | | | | SB 1193 Page 2 -------------------------------------------------------------------- SUMMARY: Extends the sunset date for the Board of Psychology (BOPsych) by four years, until January 1, 2021; amends statutes pertaining to psychological assistants (PA); revises continuing education (CE) requirements; establishes policies for posting licensee information on the BOPsych's Web site; authorizes the BOPsych to issue a retired license; revises the requirements related to approved schools; and makes other technical, clarifying and conforming changes to the BOPsych and the psychology practice act (act). Extends the operation of the Board of Pharmacy (BOPharm) and Pharmacy Law until January 1, 2021, and makes various changes to the Pharmacy Law intended to improve BOPharm oversight of licensees involved in the acquisition, storage, distribution and dispensing of dangerous drugs and dangerous devices, including oversight by the BOPharm for outsourcing facilities; registration with the BOPharm for use of an automated delivery device by a pharmacy; timeline requirements for the BOPharm to approve clinic licenses; and various other technical changes. This bill also makes various changes that are intended to improve the effectiveness of the Veterinary Medical Board (VMB) and extends the VMB's sunset dates, until January 1, 2021. Specifically, this bill: 1)Revises employment restrictions for PAs, as specified. 2)Clarifies that PAs are required to register themselves with the BOPsych, and the registration must be renewed annually in accordance with BOPsych regulations, as specified. 3)Deletes the provision allowing a licensed psychologist to register, employ or supervise more than three psychological assistants at a time with specific authorization from the BOPsych. SB 1193 Page 3 4)Requires on or after January 1, 2020, that an applicant for licensure as a psychologist possess an earned doctorate degree in psychology, in educational psychology or in education with the field of specialization in counseling psychology or educational psychology from a college or institution of higher education that is accredited by a regional accrediting agency recognized by the United States Department of Education (USDE) and authorizes the BOPsych to accept only until January 1, 2020, an applicant who possesses a doctorate degree in psychology, educational psychology, or in education with the field of specialization in counseling psychology or educational psychology from an institution that is not accredited by an accrediting agency recognized by the USDE but is approved to operate by the Bureau of Private Postsecondary Education (BPPE). 5)Specifies that 4) above, does not apply to any student who has enrolled in a doctoral program in psychology, educational psychology, or in education with the field of specializing in counseling psychology or educational psychology at a nationally accredited or approved institution as of December 31, 2016. 6)Changes references to CE to continuing professional development (CPD). 7)Requires applicants for licensure renewal to submit under penalty of perjury that he or she is in compliance with specified CPD requirements. 8)Specifies that CPD means certain continuing education learning activities approved in the following four categories: a) professional; b) academic; c) sponsored continuing education coursework; and, d) Board certification from the American SB 1193 Page 4 Board of Professional Psychology, and authorizes the BOPsych to develop regulations further defining acceptable CPD. 9)Authorizes the BOPsych to develop regulations further defining CPD activities. 10)Deletes the exemption from CE requirements for a licensed psychologist whose practice does not include the direct provision of mental health services. 11)Deletes the requirement that CE instruction be completed in California or be approved for credit by the American Psychological Association or its equivalent and instead specifies that courses must be approved for credit by organizations approved by the BOPsych, and those organizations previously approved by the BOPsych to provide CE is deemed approved, as specified. 12)Revises the BOPsych's authority to accept CE courses from certain entities. 13)Deletes the requirement that a licensed psychologist must choose CE instruction that is related to the assessment, diagnosis, and intervention for the client population that is being served or to the fields of psychology in which the psychologist intends to provide services, as specified. 14)Authorizes the BOPsych to grant an exemption or an extension of the time for compliance with, from CPD, as specified. 15)Deletes the authorization for CE credit to be approved for licensees who serve as commissioners on any examination. SB 1193 Page 5 16)Extends the sunset date for the BOPsych by four years, until January 1, 2021. 17)Authorizes the BOPsych to post on its Internet Web site the following information on the current status of the license for all current and former licensees: a) Whether or not the license has a record of disciplinary action; and, b) Any of the following enforcement actions or proceedings: i) Temporary restraining orders; ii)Interim suspension orders; iii)Revocations, suspensions, probations, or limitations on practice ordered by the BOP or by a court with jurisdiction in the state, including those made part of a probationary order, cease practice order or stipulated agreement; iv)Accusations filed by the BOPsych including those accusations that are on appeal, excluding ones that have been dismissed or withdrawn where the action is no longer pending; and, v) Citations issued by the BOPsych, unless withdrawn, posted for five years from the date of issuance. 18)Authorizes the BOPsych to post on its Internet Web site all of the following historical information in its possession, SB 1193 Page 6 custody, or control regarding all current and former licensees: a) Institutions that awarded the qualifying educational degree and type of degree awarded; and, b) A link to the licensee's professional Web site, and specifies that any link to a professional licensee's professional Web site, once clicked, must be accompanied by a notification that informs the Web site viewer that they are no longer on the BOPsych's Internet Web site.. 19)Permits the BOPsych to post other information as determined through regulation. 20)Deletes the section on appointment of commissioners on examinations, as specified. 21)Permits the BOPsych to issue a retired license, as specified. 22)Authorizes the holder of a retired license to return to active status if specified conditions are met including, the retired license not being issued more than three years for the date of return to active status; not committed acts or crimes constituting grounds for denial; paying the renewal fee; completing CPD, and complying with fingerprint submission requirements. 23)Authorizes the holder of a retired license to return to active status if the retired license was issued three or more years from the application date if specified conditions are met including, completing an application packet, taking and passing the California Psychology Law and Ethics Examination; paying all fees; complying with fingerprint submission requirements, having met educational and experience requirements, as specified, and establishing that he or she has not been subject to denial or discipline of a license. SB 1193 Page 7 24)Extends the operation of the BOPharm and its Executive Officer (EO) until January 1, 2021. 25)Requires, beginning July 1, 2017, each pharmacist, intern pharmacist, pharmacy technician, designated representative-3PL licensed in this state to join the BOPharm's email notification list within 60 days of obtaining a license or at the time of license renewal; requires him or her to update his or her email address with the BOPharm's email notification list within 30 days of a change in the licensee's email address; exempts this email address from being posted on the board's online license verification system; and requires the BOPharm, with each renewal application, to remind licensees of this obligation. 26)Requires the BOPharm to take action against any holder of a license who is guilty of unprofessional conduct, including among others, actions that lead to the revocation, suspension, or other discipline by another state of a license to practice pharmacy, operate a pharmacy, or do any other act for which a license is required, and specifies that the administrative action taken in this state is coterminous with action taken by another state, except as specified. 27)Defines "outsourcing facility" as a facility that is located within the United States at one address that is engaged in the compounding of sterile and nonsterile drugs; has registered with the Food and Drug Administration (FDA); is doing business within or into California; and, is licensed with the BOPharm. 28)Requires a pharmacy using an automated drug delivery system (ADD) to register use of the ADD with the BOPharm within 30 days of installation of the device, and annually thereafter, SB 1193 Page 8 including the address at which the ADD is being used; and, requires a pharmacy to advise the BOPharm within 30 days if the pharmacy discontinues the use of an ADD. 29)Allows a pharmacy to use an ADD only if the pharmacy uses the ADD consistent with legal requirements; the pharmacy's policies and procedures related to the ADD include appropriate security and monitoring measures; the pharmacy reports drug losses as required by law; and, the pharmacy license is unexpired and not subject to disciplinary action. Exempts from registration with the BOPharm an ADD operated by a licensed hospital pharmacy for doses administered in a facility operated under a consolidated license. 30)Authorizes the BOPharm to prohibit a pharmacy from using an ADD if specified conditions are not met; requires the BOPharm to give the pharmacy written notice explaining the basis for the determination; and allows the pharmacy to appeal the decision within 30 days. 31)Requires a pharmacy that issues a recall notice regarding a nonsterile compounded drug product to contact the recipient pharmacy, prescriber, or patient (as applicable) and the BOPharm within 12 hours of the recall notice if both the use or exposure to the recalled drug may cause serious adverse health consequence or death, and if the recalled drug was dispensed or intended for use in this state. 32)Requires a pharmacy to report to MedWatch within 72 hours if the pharmacy has been advised that a patient has been harmed by using a nonsterile compounded product potentially attributable to the pharmacy. 33)Requires outsourcing facilities, as defined under federal SB 1193 Page 9 law, to be licensed by the BOPharm; prohibits an outsourcing facility to be simultaneously licensed with the BOPharm as a sterile compounding pharmacy at the same location; prohibits a licensed outsourcing facility from filling patient specific prescriptions; requires an outsourcing facility to notify the BOPharm of any disciplinary or other action taken by another state or the FDA or of any recall notices or any adverse events potentially attributable to an outsourcing facility's products; requires the BOPharm to inspect the location of a nonresident outsourcing facility to ensure that the facility is in compliance with all laws and regulations before issuing or renewing a nonresident outsourcing facility's license; and, authorizes the BOPharm to issue a cease and desist order to an outsourcing facility if the BOPharm has reasonable belief that the products produced by the facility poses an immediate threat to the public health or safety. 34)Establishes a fee for the issuance of an in-state outsourcing facility license fee of $2,270 that may be increased to up to $3,180 by the BOPharm; establishes a renewal fee of $1,325 that may be increased to up to $1,855 by the BOPharm. 35)Establishes a fee for the issuance of a nonresident outsourcing facility license of $2,380 that may be increased to up to $3,335 by the BOPharm; establishes the fee for the renewal of a nonresident outsourcing facility license of $2,270 that may be increased to up to $3,180 by the BOPharm, as specified. 36)Includes pharmacists in the list of licensed professionals authorized to establish a professional corporation. 37)Extends the sunset date for the VMB and its executive officer until January 1, 2021. SB 1193 Page 10 38)Authorizes a veterinarian and Registered Veterinary Technician (RVT), who is under the director supervision of a veterinarian with a current and active license, to compound a drug for anesthesia, the prevention, cure, or relief of a wound, fracture, bodily injury, or disease of an animal in a premises currently and actively registered with the VMB, as specified, and would authorize the BOPharm and the VMB to ensure compliance with these requirements. 39)Requires veterinarians engaged in the practice of veterinary medicine and employed by the University of California or by Western University of Health Sciences, while engaged in the performance of specific duties, to be licensed as a veterinarians in the state or hold a university license issued by the VMB, and that the applicant for a university license to meet certain requirements, including that the applicant passes a specified exam. 40)Provides that a veterinary premise registration may be canceled after five years of delinquency, unless the VMB finds circumstances or conditions that would justify a new premise registration to be issued. 41)Makes technical changes to the BPC regarding the BOPsych, BOPharm and the VMB. FISCAL EFFECT: According to the Assembly Appropriations Committee, the provisions of this bill related to the BOPsych will result in: 1)Approximately $5 million (fee-supported Psychology Fund) per year to continue operation of the BOPsych for an additional four years. SB 1193 Page 11 2)Minor and absorbable costs to issue regulations to implement a retired license type, and to make necessary information technology changes (Psychology Fund). 3)Unknown, likely minor, ongoing revenue loss to the Psychology Fund, as well as reduced administrative workload, to the extent some individuals apply for a retired license ($75 one-time fee and application) instead of an inactive license ($50 every two years). According to the Assembly Appropriations Committee, the provisions of this bill related to the BOPharm (All costs are fee-supported - Pharmacy Board Contingent Fund) will result in: 1)Ongoing costs of $20.1 million per year for the continued operation of the BOPharm. 2)One-time costs of $335,000 and ongoing costs of $320,000 per year, for licensing and inspection activities relating to outsourcing facilities. The BOPharm also estimates $288,000 in revenue from an outsourcing facilities fee authorized by this bill in the first year, and $244,000 annually in the second year. Costs related to other provisions, including information technology costs, are expected to be minor and absorbable. According to the August 11, 2016, Assembly Appropriations Committee, the provisions of this bill related to the VMB provisions (All costs are fee-supported-Veterinary Medical Board Contingent Fund), this bill will result in: 1)Ongoing costs of about $5.0 million per year for the continued operation of the VMB. All costs to operate the VMB are funded SB 1193 Page 12 with licensing fees. 2)Costs related to VMB-related provisions are anticipated to be minor and absorbable. COMMENTS: Purpose. This bill is sponsored by the author, and is one of five "sunset bills" the author is sponsoring this year. According to the author, this bill is necessary to make changes to the Pharmacy Law and Veterinary Practice Act in order to strengthen the laws to improve [BOPharm] and VMB oversight of licensees. Background. Joint Oversight Hearings and Sunset Review of the DCA Licensing Boards. In March of 2016, the Assembly Committee on Business and Professions and the Senate Committee on Business, Professions and Economic Development (Committees) conducted multiple joint oversight hearings to review 11 regulatory boards within the DCA and one regulatory entity outside of the DCA. The sunset bills are intended to implement legislative changes recommended in the respective background reports drafted by the Committee staff for the agencies reviewed this year. Board of Psychology. The BOPsych regulates licensed psychologists, registered PAs, and registered psychologists. Only licensed psychologists can practice psychology independently in the private sector in California. In order to be a licensed psychologist, an individual must obtain a doctorate degree in psychology, educational psychology, or education within the field of specialization in counseling psychology or educational psychology from an accredited or approved institution, and have completed two years (3,000) hours SB 1193 Page 13 of supervised professional experience, where at least 1,500 of those hours be completed post-doctoral. PAs are registered to a licensed psychologist or to a board-certified psychiatrist as employees who provide limited psychological services. Those registered psychologists are registered with the BOPsych and work and train under supervision in non-profit agencies that receive government funding. PAs are employed and supervised by a qualified licensed psychologist as employees who may provide limited services. PAs are required to have a master's degree, but no specified experience requirements. Joint Oversight Hearings and Sunset Review of DCA Licensing Boards. In March of 2016, the Assembly Business and Professions Committee and the Senate Business, Professions and Economic Development Committee (Committees) conducted multiple joint oversight hearings to review 11 regulatory boards within the DCA and one regulatory entity outside of the DCA. The sunset bills are intended to implement legislative changes recommended in the respective background reports drafted by the Committee staff for the agencies reviewed this year. The Sunset Review Process. The sunset review process provides a formal mechanism for the DCA, the Legislature, the regulatory boards, bureaus and committees, interested parties, and stakeholders to make recommendations for improvements to the authority of consumer protection boards and bureaus. This is performed on a standard four-year cycle and was mandated by SB 2036 (McCorquodale), Chapter 908, Statutes of 1994. Each eligible agency is required to submit to the Committees a report covering the entire period since last reviewed that includes, among other things, the purpose and necessity of the agency and any recommendations of the agency for changes or reorganization in order to better fulfill its purpose. During the sunset review hearings, the Committees take public testimony and evaluate the eligible agency prior to the date the agency is scheduled to be repealed. An eligible agency is allowed to sunset unless the Legislature enacts a law to extend, SB 1193 Page 14 consolidate, or reorganize the eligible agency. The BOPsych was last reviewed in 2011 and received a four-year sunset extension at that time The legislation pertaining to this bill is based on specific issues raised and addressed in the report released by the Senate Committee on Business and Professions along with the sunset review hearing on March 14, 2016. Approved Schools and National Accreditation. California is the only state that allows students from unaccredited schools to sit for psychology licensing examinations. Current law requires the BOPsych to accept doctoral degrees in psychology from either accredited or approved institutions. An institution is deemed approved if it is not a franchise, was approved by the former Bureau of Private Postsecondary Vocational Education on or before 1999, and has not moved to a new location since 1999. There are six schools meeting these criteria, with approvals and oversight conducted solely by the BPPE. This issue was raised during the previous review of the BOPsych. At that time, the BOPsych noted that it was concerned that there is little quality control over the schools' operations or curriculum and students have a low pass rate on the national exam, among other issues. At that time, the BOPsych stated that the students from these schools should not be eligible for licensure and expressed their preference for a change in law to prohibit applicants from approved schools. The law was not changed during the previous sunset review. In an effort to increase the quality of educational programs in California, the California Private Postsecondary Education Act of 2009 was amended in 2014. SB 1247 (Lieu), Chapter 840, Statutes of 2014, required degree granting institutions to be accredited by an agency recognized by the USDE by July 1, 2020, in order to receive BPPE approval. Further, AB 2099 (Frazier), Chapter 676, Statutes of 2014 also established requirements for SB 1193 Page 15 unaccredited degree granting programs participating in Title 38, the program that provides educational awards for eligible active duty military members and veterans. While the BOPsych recognizes recent Legislative actions as significant progress, there remains a concern that these changes may be insufficient to raise California's psychologists to the national standard. As a result, in the 2016 Committee Staff Background Paper, it was recommended that current language authorizing graduates with degrees from unaccredited institutions to sit for licensure by the BOPsych be removed, and ensure that timeframes for this change accommodate current students. Additionally, it was requested for the BOPsych to provide information to the Committees as to whether regional accreditation may be preferable to other types of accreditation, and the Committees should specify the type of accreditation that should be required of institutions offering degrees intended to lead to licensure. As a result of that recommendation, this bill will delete the current requirements pertaining to school approval and instead require that an applicant for a psychologists' license graduate from an institution that is accredited by a regional accrediting agency recognized by the USDE. This bill will allow the BOPsych to continue to accept applicant who possesses a doctorate degree from an institution that is not accredited by an agency accredited by an accrediting agency recognized by the USDE, but is approved to operate in this state by the BPPE until January 1, 2020; thereby giving persons who may be in a current program time to complete a program. Continuing Professional Development. Traditional models of CE entail formal learning activities conducted in classroom or workshop settings. As referenced earlier in the report, the BOPsych seeks changes to their CE program to accommodate a broader competency model called CPD. The CPD model provides additional avenues for maintaining competence. These options are meant to expand the ways licensees can increase their learning and to include performance-based assessments of SB 1193 Page 16 licensees' competence. In the 2016 Committee Staff Background Paper, it was recommended that the BOPsych provide recommendations to the Committee with respect to establishing changes in CE requirements. To address the issues raised by the BOP, this bill will change current references to CE and replace it with CPD. This bill will define CPD to include activities in four different categories including professional, academic, sponsoring CE coursework, and board certification from the American Board of Professional Psychology. This bill will allow the BOPsych to grant an extension in addition to an exemption from CPD requirements. This bill requires licensees to certify under penalty of perjury that he or she has completed the required CPD instead of submitting all documentation. This bill will require CPD courses to be approved by organizations that are approved by the BOPsych. Psychological Assistants. In order to become a licensed psychologist, applicants must accrue 3,000 hours of supervised professional experience. Individuals who have a Master's degree and are admitted into a doctoral program may obtain these hours by registering with the BOPsych as a PA. A PA provides psychological services to individuals or groups while under the supervision of a licensed psychologist or a board certified psychiatrist. Current law requires that a PA be employed only by a psychological or medical corporation, a California licensed psychology clinic, a Bronzan-McCorquodale contract clinic, a licensed psychologist, or a board certified psychiatrist. The BOPsych recognizes that these statutes are outdated and do not reflect the employment, contract, or volunteer opportunities available in settings beyond current limitations, such as hospitals, nursing homes, and rehabilitation centers. In the 2016 Committee Staff Background Paper, it was recommended that the BOPsych should provide recommendations to the Committees for updating PA statutes to focus on appropriate supervision, rather than the physical setting. This bill makes changes related to SB 1193 Page 17 PAs by deleting outdated employment restrictions and deletes the option for a licensed psychologist to supervise, register, or employ more than three PAs. In addition, this bill makes it clear that a PA registers with the BOPsych and not the PAs supervisor. Retired License. The Psychology Act does not authorize a retired license. Under existing law, a retired licensee may choose only between "inactive" status, which costs $25 per year, or "delinquent" status. These have negative connotations and may not respect a long and honorable career. The BOPsych is seeking to establish a "retired" licensure category, similar to many other healing arts programs such as the Medical Board, Professional Fiduciaries Bureau, Board of Behavioral Sciences, and Board of Optometry. Adding this license designation is a consistent request from licensees and is included in the BOPsych's 2014-2018 Strategic Plan. This bill authorizes the BOPsych to establish a retired license and sets up the criteria for such a license. This bill provides two pathways to return a retired license to active status; 1) for those retired licensees whose retired license is less than three years old, and 2) for those retired licensees who retired license is more than three years old. Web site Information for Consumers. The BOPsych's Web site contains information for the benefit of consumers. As such, the BOPsych has requested additional legislative authority to post historical information on existing and past licensees' approved graduate and post-graduate education on its Web site. This bill will authorize the BOPsych to post specified information about licensees on its Web site including information about disciplinary licenses, enforcement actions or proceedings, information about revocations, probations, or limitations on practice ordered by the BOPsych, accusations filed by the BOPsych, citations issued by the BOPsych, and specified SB 1193 Page 18 information about licensee education, professional information or other information as established by the BOPsych through regulations. Background on the BOP. The BOPharm is responsible for enforcing federal and state laws pertaining to the acquisition, storage, distribution and dispensing of dangerous drugs (including controlled substances) and dangerous devices. The BOPharm has over 140,000 licensees in 23 license categories that include both personal and business licenses. As an agency that regulates the individuals and businesses that dispense, compound, provide, store and distribute prescription drugs and devices and pharmaceutical services to the public, or to other health care practitioners in compliance with state and federal law, the licensing of pharmacists, pharmacies, and pharmacy technicians is the primary focus of BOPharm activity, with consumer protection at the core of the BOPharm's operations. The BOPharm's regulatory authority, as described in the Pharmacy Law, extends over individuals and firms located both within and outside California, if they provide services in California. The BOPharm notes that it also ensures the safety of drug products dispensed to patients and regulates those who handle, store, and ship products from the manufacturer through the supply chain to the pharmacy and ultimately to the patient. Pharmacists also convey information related to drug therapy management and are the health care provider most educated on pharmaceutical care and management. The BOPharm has a highly diverse and detailed licensing program for the individuals and facilities the BOPharm regulates, reflecting the careful and deliberative manner in which the U.S. regulates the manufacturing, distributing, and dispensing of prescription drugs and devices. The BOPharm's enforcement activities are the core of its program, with the majority of its staff and resources dedicated SB 1193 Page 19 to enforcement functions. The BOPharm employs investigators who work from home offices throughout the state and perform random, unannounced inspections to detect violations, investigate complaints, monitor licensees on probation, educate licensees about Pharmacy Law requirements, serve as expert witnesses in disciplinary hearings and identify violations and issues that non-pharmacists may not be able to identify. Background on the VMB. The mission of the VMB is to protect consumers and animals through development and maintenance of professional standards, licensing of veterinarians, Registered Veterinary Technicians (RVTs), and premises, and diligent enforcement of the California Veterinary Medicine Practice Act. The VMB is composed of eight members: four veterinarians, one RVT, and three public members. The VMB licenses 12,086 Veterinarians and 6,424 RVTs. The licensee population has increased steadily over the past five years. The VMB also requires registration of all premises where veterinary medicine, veterinary dentistry, veterinary surgery, and the various branches thereof, is being practiced. The VMB currently registers 3,636 veterinary premises. The VMB conducts regular practice analyses to validate the licensing examinations for both veterinarians and RVTs. Additional eligibility pathways have also been approved for licensure of internationally trained veterinary graduates and certification of RVTs to allow qualified applicants from other states in the U.S. and countries around the world to come to California and to improve the provision of veterinary health care for consumers and their animals. The VMB's goals, as stated in its Strategic Plan, include decreased enforcement cycle times, enhanced quality and training of hospital inspectors, inspecting existing hospitals within one year of registration, and working with DCA to reduce the amount of unlicensed activity occurring in the marketplace. SB 1193 Page 20 Analysis Prepared by: Gabby Nepomuceno, Elissa Silva / B. & P. / (916) 319-3301 FN: 0004548