BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:July 1, 2013 |Bill No:AB | | |1308 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Ted W. Lieu, Chair Bill No: AB 1308Author:Bonilla As Amended: June 13, 2013Fiscal: Yes SUBJECT: Midwifery SUMMARY: Authorizes a licensed midwife to directly obtain supplies, devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his or her practice of midwifery; requires the Medical Board of California (MBC) to revise and adopt regulations defining the supervision requirements between a physician and a midwife, and requires a midwife to disclose his or her arrangements for the referral of complications to a physician for consultation. Existing law: 1)Licenses and regulates some 300 licensed midwives under the Licensed Midwifery Practice Act of 1993, by the MBC within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 2505 et seq.) 2)Creates the Midwifery Advisory Council (MAC) which is required to make recommendations on matters specified by MBC. (BPC § 2509) 3)Defines the practice of midwifery as the furthering or undertaking by any licensed midwife, under the supervision of a licensed physician who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. (BPC § 2507) 4)Requires the MBC to adopt regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery by July 1, 2003. (BPC § 2507 (f)) AB 1308 Page 2 5)Permits a licensed midwife to attend cases of normal childbirth and to provide prenatal, intrapartum and postpartum care, including family-planning, care for the mother and immediate care for the newborn under the supervision of a licensed physician and surgeon. (BPC § 2507 (a)) 6)Requires a licensed midwife to disclose orally and in writing: (BPC § 2508) a) The scope of a midwife's practice, as specified; b) Whether the licensed midwife has liability coverage; c) The specific arrangements for the transfer of care during the prenatal period, hospital transfer during the intrapartum and postpartum periods and access to appropriate emergency medical services for mother and baby, if necessary; and, d) The procedure for reporting complaints to the MBC. 7)Requires a licensed alternative birth center, and a licensed primary care clinic that provides services as an alternative birth center, to meet specified requirements, including: (Health and Safety Code (HSC) § 1204.3) a) Meet the standards for certification established by the National Association of Childbearing Centers. b) Require the presence of at least 2 attendants during birth, one of whom shall be either a physician and surgeon or a certified nurse-midwife. This bill: 1)Authorizes a midwife to directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his or her practice of midwifery and consistent with his or her scope of practice. 2)Requires the MBC, by July 1, 2015, to revise and adopt regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery and identify complications necessitating referral to a physician and surgeon. 3)Expands the existing oral and written disclosures required of a AB 1308 Page 3 licensed midwife to a prospective client to include the specific arrangements for the referral of complications to a physician and surgeon for consultation, and specifies that the licensed midwife shall not be required to identify a specific physician and surgeon. 4)Makes legislative findings and declarations. 5)In addition to a physician and surgeon or a certified nurse-midwife, also authorizes a licensed midwife to be present at a licensed alternative birth center. 6)Makes a correcting change to refer to the American Association of Birth Centers rather than the National Association of Childbearing Centers. FISCAL EFFECT: The May 8, 2013 Assembly Appropriations Committee analysis cites negligible state costs. The MBC is already required by statute to adopt regulations. COMMENTS: 1. Purpose. This bill is sponsored by American Congress of Obstetricians and Gynecologists, District IX, California . According to the Author, the bill does the following: Authorizes midwives to order supplies, drugs, tests and devices without an ordering physician listed. Currently, this is included in the scope of practice for licensed midwives. However, in the field, they are often unable to get access to supplies, drugs and tests because the supplier requires listing of an ordering physician. This authority should help provide clarity to what should already be permissible. Requires the MBC to revise regulations regarding licensed midwives before July 1, 2015. With the advent of this legislation, regulations may need to be modified to account for any changes. By pushing back the deadline by when the MBC must draft regulations, we allow for this revision to occur. Clarifies that the regulations should identify complications necessitating referral to a physician or surgeon for purposes of a consultation. As medicine advances and we learn more about underlying health conditions and risk factors, it is important that the Medical Board continue to explore this topic and that patients/clients understand ahead of time, what the referral AB 1308 Page 4 process will entail. Requires licensed midwives to include in their disclosure the specific arrangements for the referral of complications to a physician for a consultation. In this situation, a licensed midwife may continue care of the client. Current law requires disclosure of the specific arrangements of transfer of care of a client. In this situation, the physician would maintain care of the client/patient. Allows licensed midwives to attend births at an alternative birth center. Licensed midwives are the experts in out of hospital births. It makes policy sense to authorize them to attend births in this setting. Many attend births at birth centers which are not licensed. Birth centers have optional licensing requirements. Makes a technical change to replace the "National Association of Childbearing Centers" with the "American Association of Birth Centers." The National Association of Childbearing Centers changed its name in 2005. 1. Author's Statement. "The California Medical Board is responsible for the oversight of licensed midwives in California. Licensed midwives typically attend out of hospital births. There are many issues regarding access to midwives and their scope of practice. The Medical Board is under sunset review this year and has recommended legislative action on several issues that it has been unable to resolve in past discussions. AB 1308 addresses issues of access to midwives and barriers that impede the practice of licensed midwifery while increasing patient safety. The changes it makes ensure licensed midwives have access to the tools they need to practice safely and that patients have full information regarding referrals during the course of a pregnancy." 2.Background on the Midwifery Program. A licensed midwife is an individual who has been issued a license to practice midwifery by the MBC. As provided under the law, the practice of midwifery authorizes the licensee, under the supervision of a licensed physician in active practice, to attend cases of normal childbirth in a home, birthing clinic or hospital environment. Pathways to midwife licensure include completion of a three-year postsecondary education program in an accredited school approved by the MBC, or through a Challenge Mechanism. (BPC § 2513). Prior to licensure, all midwives must take and pass the North American Registry of Midwives (NARM) examination. AB 1308 Page 5 SB 1638 (Figueroa, Chapter 536, Statutes of 2006) required the MBC to create and appoint a Midwifery Advisory Council. The MAC is made up of licensed midwives (at least half of the MAC must be licensed midwives), a Board Member, a physician and a member of the public (currently an individual who has used a licensed midwife). The MBC specifies issues for the MAC to discuss/resolve and the MAC also identifies issues and obtains approval from the MBC to develop solutions to the various matters. Some items that have been discussed include physician supervision, challenge mechanisms, required reporting and student midwives. SB 1638 also required licensed midwives to make annual reports to OSHPD on specified information regarding birth outcomes, and required the reported data to be consolidated by OSHPD and reported back to the MBC for inclusion in the MBC's annual report. The MBC approves midwifery schools by conducting a comprehensive assessment to evaluate the school's educational program curriculum and the program's academic and clinical preparation equivalent. Schools wishing to obtain approval must submit supporting documentation to verify that they meet the requirements of BPC § 2512.5. Currently, there are 11 approved midwifery schools. A licensed midwife must complete 36 hours of continuing education every two years in areas that fall within the scope of the practice of midwifery as specified by the MBC. The licensee population in the Midwifery Program is small and the number of disciplinary actions filed against licensees is also proportionally small with a total of 5 disciplinary actions being filed over the past 3 fiscal years. Of the 4 disciplinary actions that have been adjudicated, all have been resolved with either revocation or license surrender. 3.Physician Supervision. As noted above, BPC § 2057 authorizes a licensed midwife, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to attend cases of normal childbirth and to provide prenatal, intrapartum and postpartum care, including family-planning care for the mother and immediate care for the newborn. BPC § 2507(f) requires the MBC, by July 1, 2003, to adopt regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery. Due to the inability to reach consensus on the supervision issue, the MBC bifurcated this requirement and in 2006 adopted Standards of Care for Midwifery (CCR § 1379.19). Three previous attempts to resolve the physician AB 1308 Page 6 supervision issue via legislation and/or regulation have been unsuccessful due to the widely divergent opinions of interested parties and their inability to reach consensus. Although required by law, physician supervision is essentially unavailable to licensed midwives performing home births, as California physicians are generally prohibited by their malpractice insurance companies from providing supervision of licensed midwives who perform home births. According to insurance providers, if physicians supervise or participate in a home birth they will lose their insurance coverage resulting in loss of hospital privileges. The physician supervision requirement creates numerous barriers to care in that, if the licensed midwife needs to transfer a patient/baby to the hospital, many hospitals will not accept a patient transfer from a licensed midwife as the primary provider who does not have a supervising physician. California, along with Arkansas and Louisiana, are currently the only states that require physician supervision of licensed midwives. Among states that regulate midwives, most require some sort of collaboration between the midwife and a physician. The MBC, through the MAC, has held many meetings regarding physician supervision of licensed midwives and has attempted to create regulations to address this issue. The concepts of collaboration such as required consultation, referral, transfer of care and physician liability have been discussed among the interested parties with little success. There is disagreement over the appropriate level of physician supervision with licensed midwives expressing concern with any limits being placed on their ability to practice independently. The physician and liability insurance communities have concerns over the safety of midwife-assisted homebirths. Specifically, they are concerned with delays and/or the perceived reluctance of midwives to refer patients when the situation warrants referral or transfer of care. The MBC has stated that it ultimately believes that the physician supervision requirement needs to be addressed through the legislative process. In the MBC oversight hearing earlier this year, staff recommended that the MBC should reach a consensus with stakeholders on this issue and then submit a specific legislative proposal to the Committee regarding the appropriate level of supervision required for the practice of midwifery. Relative to the current bill, there has been a significant amount of AB 1308 Page 7 talk about physician supervision. A number of licensed midwives and those advocating for licensed midwives have strongly urged the Author and the Committee to address physician supervision in this bill. Recommendations have been to remove the physician supervision requirement altogether or to replace it with some type of a physician collaboration requirement. To this point, physician supervision is not addressed in the bill. The fact that it is not addressed does not mean that the bill is an endorsement of what may be deemed to be an unworkable policy in the law. It is simply that the issue is not addressed in the bill. 4.Diagnostic lab accounts. This bill echoes an issue raised by the MBC in its Sunset Report. Licensed midwifes have difficulty securing diagnostic lab accounts, even though they are legally allowed to have lab accounts. Many labs require proof of physician supervision. In addition, licensed midwives are not able to obtain the medical supplies they have been trained and are expected to use including: oxygen, necessary medications and medical supplies that are included in approved licensed midwifery school curriculum (CCR § 1379.30). The inability for a licensed midwife to order lab tests often means the patient will not obtain the necessary tests to help the midwife monitor the patient during pregnancy. In addition, not being able to obtain the necessary medical supplies for the practice of midwifery adds additional risk to the licensed midwife's patient and child. The MBC, through the MAC held meetings regarding the lab order and medical supplies/medication issues and has attempted to create regulatory language to address this issue. However, based upon discussions with interested parties, it appears the lab order and medical supplies/medication issues will need to be addressed through the legislative process. This bill authorizes midwives to order supplies, drugs, tests and devices without an ordering physician listed. 5.Oversight Hearings of the Medical Board of California (MBC) and SB 304. Earlier this year, this Committee, along with the Assembly Business, Professions and Consumer Protection Committee, conducted oversight hearings to review 14 regulatory boards within the DCA. The Committees began the review of these licensing agencies in March and conducted three days of hearings. Seven bills, authored by Senator Curren D. Price Jr., were introduced to implement legislative changes recommended in the Committees' Background/Issue Papers for all of the agencies reviewed this year. As a part of the AB 1308 Page 8 review of the MBC, the Committees reviewed the MBC's administration of the licensed midwifery program and recommendations were made for a number of the programs and operations of the MBC. As a result, SB 304 (Price) was introduced to address a number of issues raised in the Sunset Oversight hearings. As a result, the two bills, AB 1308 and SB 304, work in concert with one another regarding midwifery issues. The following summarizes issues directly related to licensed midwives in the bill: a) Clarify Midwifery Education and Clinical Training. 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 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. 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 by legislation, and SB 304 has been amended 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. b) Supervision of Midwifery Students by Certified Nurse-Midwives. The MBC's MAC has indicated that BPC § 2514 does not include certified nurse midwives (CNM) as being able to supervise midwifery students. The MBC recommended amending the law to include CNMs, who are licensed by the Board of Registered Nursing (BRN), as individuals who can supervise midwifery students. Currently both physicians and CNMs are identified as being able to sign off on clinical experience for license midwife students AB 1308 Page 9 pursuant to BPC § 2513, but supervision of training is not specifically identified in law. Accordingly, SB 304 has been amended to include CNMs as those who may supervise midwifery students. 6.Related Legislation. SB 304 (Price, 2013) as it relates to midwifery, clarifies that a "bona fide student" means an individual who is enrolled and participating in a midwifery education program or who is enrolled in a program of supervised clinical training as part of a board-approved postsecondary midwifery education program, and includes certified nurse-midwives as one of those who may supervise midwifery students. SB 304 makes a number of additional changes to enhance the MBC's ability to take action against dangerous doctors. The bill revises the Vertical Enforcement (VE) pilot program in state Attorney General's (AG's) office in which MBC investigators are paired with AG prosecutors from the beginning of the complaint investigation through the prosecution of the case, and deletes the January 1, 2014 sunset date, thus making VE a permanent program. The bill additionally transfers the investigators from the MBC to the AG's office, in keeping with the recommendation of the MBC enforcement monitor made in 2005. This will locate investigators and prosecutors in the same unit, under the same management, and allow full coordination throughout the enforcement process. SB 304 further makes a number of other enhancements to enable the MBC to more effectively carry out its mandates to protect consumers in a timely manner: requires Medical Malpractice cases reported to the MBC to be immediately referred for investigation, cutting up to 2 months off of these types of cases; requires medical facilities using electronic records to produce those records within 15 days when a signed patient release is given for an investigation; requires a quicker exchange of information about expert witness testimony in disciplinary cases, helping to stop defense lawyers from sandbagging and delaying cases; doubles the timeframe for the Board to file a formal accusation against a doctor, when that doctor's license is suspended by a judge, enabling the MBC to more quickly get a dangerous doctor out of practice without having to first put together a complete case for a formal disciplinary action; authorizes the MBC to immediately require a doctor to cease practicing medicine when the doctor fails to comply with an order by the MBC to submit to psychiatric or medical evaluation of the doctor's fitness to practice medicine; and makes other changes related to the MBC's regulatory programs. ( Status : This bill is awaiting hearing before the Assembly Business, Professions and AB 1308 Page 10 Consumer Protection Committee.) 7.Prior Legislation. SB 1575 (B&P Comm., Chapter 799, Statutes of 2012) was an omnibus bill which established a retired license status for licensed midwives. SB 1638 (Figueroa, Chapter 536, Statutes of 2006) required the MBC to create and appoint a MAC. Required licensed midwives to make specified annual reports to OSHPD regarding birth outcomes; required a licensed midwife who assists or supervises childbirth occurring in an out-of-hospital setting to annually report to OSHPD specified information regarding his or her practice for the previous year; and required the data to be consolidated by OSHPD and reported back to the MBC for inclusion in the Board's annual report. SB 1950 (Figueroa, Chapter 1085, Statutes of 2002) required the MBC to adopt regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery. SB 1479 (Figueroa, Chapter 303, Statutes of 2000) expanded the disclosures required to be given by licensed midwives and also required midwives to register birth certificates for home births. SB 350 (Killea, Chapter 1280, Statutes of 1993) enacted the "Licensed Midwifery Practice Act of 1993" to provide for the licensing and regulation of non-nurse and non-physician assistant midwives by the MBC. 8.Arguments in Support. The American Congress of Obstetricians and Gynecologists, District IX, California (ACOG) who is the Sponsor of the bill states: "For the twenty years licensed midwives have been authorized to practice in California, there never has been a workable system where licensed midwives and medical professionals can seamlessly work together. This system failure is bad for licensed midwives, physicians, the Medical Board (whom is responsible for regulating license midwives), hospitals, hospital staff and most importantly, the pregnant woman, her pregnancy and family." ACOG decided to sponsor the bill in an effort to address some of the problematic issues relating to licensed midwives and physicians. According to ACOG, the bill began with some of the most direct issues that present barriers to licensed midwifery care. ACOG believes the bill in its current form better implements the intent of the law, by being clear that licensed midwives may obtain the tools they need to practice their profession and that they are able to practice in alternative birth center settings. AB 1308 Page 11 ACOG states that physician supervision as called for in the statute has been difficult to impossible to obtain for various reasons. In reality the liability issues are such that if a physician should work with a license midwife or patient for a planned home birth, and that any lawsuit could financially devastate a physician due to lack of insurance coverage. ACOG states that they are not intending to fault insurance companies who determine it is too risky to cover this exposure. ACOG feels that "somehow we must find a solution for an integrated system where the physician is not at risk of losing all of their personal assets by working with this population." According to ACOG, "physicians must work very discretely and carefully with license midwives to try to create boundaries as to their relationship in and attempt to work within the confines of the liability coverage." 9.Support if Amended. The California Association of Midwives (CAM) has a support if amended position on the bill. Previously CAM had expressed a support position, because they were hopeful the bill would be amended to address their needs and concerns. However because the bill contains a provision that reinstates a requirement that the MBC adopt regulations for physician supervision. CAM states: "Specifically, AB 1308 currently imposes a requirement on the Medical Board to adopt 'regulations defining the appropriate standard of care and level of supervision required for the practice of midwifery.' (See page 3, line 34-36)." CAM indicates that if the bill is amended to remove the above-referenced requirement, CAM will support the bill. CAM reiterates that its primary objective is to eliminate the physician supervision requirement for licensed midwives in BPC § 2507, "which has proven to be an unworkable restraint on the profession." CAM finally states: "Although removing the new rulemaking requirement will not, standing alone, eliminate all problems posed by BPC § 2507, it will allow other positive aspects of AB 1308 to go into effect for the benefit of licensed midwives." The Medical Board of California (MBC) also is concerned with the bill as it related to the amendments which would require MBC to adopt regulations by July 1, 2015, stating: "The bill would also require the Board ot adopt regulations to address physician supervision and to identify complications necessitating referral to a physician; however, in the past the Board has been unsuccessful in endeavors to adopt regulations regarding physician supervision. The Board is supportive of this bill if it is amended to better clarify what the supervision requirements should be in statute, versus in regulation. 10.Arguments in Opposition. California Families for Access to Midwives AB 1308 Page 12 (CFAM), a statewide nonprofit coalition committed to improving the health of mothers and babies in California by protecting and increasing access to midwifery care. CFAM argues that the bill threatens Californians access to outofhospital maternity care by restating and implementing the unobtainable (and previously unenforced) requirement that licensed midwives have physician supervision... It is time for Califo11.rnia law to be modernized to match the practical reality of out-ofhospital maternity care, and AB1308 is a step in the wrong direction. CFAM further states that the physician supervision requirement prevents MediCal from recognizing midwives as independent providers, and therefore serves as a barrier to access for low-income families and families of color, despite the demonstrable benefits of midwifery care." 12.Concern Among Licensed Midwives. The Committee has received a number of communications from licensed midwives and families expressing concern that AB 1308 would ultimately prohibit licensed midwives from practicing or working with expectant mothers who desire in-home births. This concern stems from the provision of existing law which specifies that a midwife is to practice under the supervision of a licensed physician and surgeon. This concern has been raised in conjunction with the provision in SB 304 which would transfer the investigators from the MBC to the Office of the Attorney General's Health Quality Enforcement Section. The concern is that moving the investigators from the MBC to the AG's office would "take enforcement away from the MBC, and result in the Department of Justice taking action against licensed midwives who do not have a supervising physician." It has been expressed that the MBC has not pursued disciplinary cases against licensed midwives who do not have a physician supervisor because the MBC clearly understands that physician supervision is simply unworkable as the law now exists. The fear is that once the investigators are transferred to the AG's office, they will now pursue disciplinary actions against licensed midwives. However, these concerns are based upon a misunderstanding of how the MBC's enforcement process would work under SB 304. SB 304 only transfers investigators to the AG's office. This is done so that investigators who work the case and attorneys who prosecute the MBC enforcement cases can work together in the same office under the same management and organizational structure. In this way, the timeliness and quality of disciplinary cases will be enhanced. SB 304 does not transfer the enforcement process out from under the MBC. First, complaints will still be filed by consumers with the MBC and the MBC's enforcement analysts will still review cases for AB 1308 Page 13 jurisdiction and validity. Cases will still be reviewed by the MBC's expert reviewers, and cases will only be sent for investigation at the AG's office if it is first determined by the MBC that an investigation needs to be opened. The AG's office will not open investigations independent of the MBC. Second, once an investigation is completed, and a case has been prepared for filing a disciplinary action, the MBC's executive director must sign off on the case in order for the disciplinary case to go forward. Third, when disciplinary action is initiated against a licensee and a case is heard before an administrative law judge and a proposed decision is rendered, the MBC must adopt the proposed decision in order for the decision to become final. In short, the MBC initiates the investigation, the MBC executive director signs off on the case once the investigation is completed and the MBC adopts the final decision in a case. Clearly the MBC makes the critical decisions at the beginning, in the middle and at the end of an enforcement case. The AG's office will simply not be taking action against a licensed midwife independently from the MBC. 13.Working Toward Solutions. The Sponsor has indicated that this bill is still a work in progress and that the greater goal is to achieve a solution where physicians and licensed midwives can work together in an acceptable way where the licensed midwife and pregnant woman can freely consult with medical professionals and have systems in place in case of complications and transfer to the hospital if needed. The Sponsor states, "We do not yet know how we will be able to redefine the relationship to a more workable one due to the many factors to be considered. If we are able to find resolution prior to the end of session, we expect the bill to be brought back before this committee." Finally, recognizing that the bill will be changing, the Sponsors commit to working with the Senate and Assembly Business and Professions Committees, as well as with the MBC and the licensed midwives. It should be noted that once this measure is voted out of this Committee, there will not be another chance to review this measure unless the bill is completely rewritten or is considered as a new bill. Making substantive amendments to this measure as it moves through the Legislature is not sufficient justification for the bill to be referred back to this Committee for consideration or a subsequent vote. The members of this Committee may wish to direct Committee staff to work closely with the Author and other stakeholders to come to agreement on changes to the bill. 14.Recommended Technical Amendment. Discussions of this bill between Committee staff, the Author's staff, the MBC and the California AB 1308 Page 14 Association of Midwives have determined that the requirement in the bill for the MBC to adopt regulations under BPC § 2507 (g) is not needed. It is noted that the MBC already has broad authority under the Medical Practice Act to adopt, amend or repeal in accordance with the Administrative Procedure Act those regulations necessary to enable it to carry into the effect the provisions of the Act. (BPC § 2018). Therefore, the following technical amendment to strike out paragraph (g) from Section 2507 will be offered as an Author's amendment in Committee. On page 3, strike out lines 31 through 37, inclusive. SUPPORT AND OPPOSITION: Support: American Congress of Obstetricians and Gynecologists, District IX, California (Sponsor Support if Amended: California Association of Midwives Medical Board of California Numerous Individuals AB 1308 Page 15 Opposition: California Families for Access to Midwives Consultant:G. V. Ayers