BILL ANALYSIS Ó AB 154 Page 1 Date of Hearing: April 23, 2013 ASSEMBLY COMMITTEE ON HEALTH Richard Pan, Chair AB 154 (Atkins) - As Amended: March 19, 2013 SUBJECT : Abortion. SUMMARY : Authorizes a nurse practitioner (NP), certified nurse midwife (CNM), and physician assistant (PA) to perform abortion by medication or aspiration techniques in the first trimester of pregnancy upon completion of training, as specified. Specifically, this bill : 1)Makes it unprofessional conduct for any NP, CNM, or PA to perform an abortion, as specified, without prior completion of training and validation of clinical competency. 2)Provides that a person is not subject to the prohibition on the unauthorized practice of medicine, as specified, if he or she performs an abortion by medication or aspiration techniques in the first trimester of pregnancy, and at the time of so doing, has a valid, unrevoked, and unsuspended license or certificate obtained in accordance with some other provision of law, including but not limited to the Nursing Practice Act or the Physician Assistant Practice Act, as specified, that authorizes him or her to perform the functions necessary for an abortion by medication or aspiration techniques. 3)Deletes existing law which requires that a physician and surgeon perform or assist in performing nonsurgical abortion. 4)Deletes existing law which defines nonsurgical abortion to include termination of pregnancy through the use of pharmacological agents. Deletes existing surgical and nonsurgical abortion terms. 5)Deletes an existing provision which makes it unprofessional conduct for a physician and surgeon to perform, assist, procure or aid, abet, attempt, agree, or offer to procure an illegal abortion under the Reproductive Privacy Act (RPA). 6)Requires a NP or CNM, in order to perform an abortion by aspiration techniques, to complete training recognized by the AB 154 Page 2 Board of Registered Nursing (BRN). Requires, beginning January 1, 2014 and until January 1, 2016, the competency-based training protocols established by Health Workforce Pilot Project (HWPP) No. 171 through the Office of Statewide Health Planning and Development (OSHPD) to be used. 7)Authorizes a NP or CNM who has completed training and achieved competency through HWPP No. 171 to perform abortions by aspiration techniques. 8)Requires a PA, in order to receive authority from his or her supervising physician and surgeon to perform an aspiration abortion by aspiration techniques, to complete training either through training programs approved by the Physician Assistant Board (PAB) or by training to perform medical services which augment his or her current areas of competency pursuant to regulations, as specified. Requires, beginning January 1, 2014, and until January 1, 2016, the training and clinical competency protocols established by HWPP No. 171 through OSHPD to be used as training and clinical competency guidelines for PAs. 9)Requires the training protocols established by HWPP No. 171 to be deemed to meet the standards of the PAB. Authorizes a PA who has completed training and achieved clinical competency through HWPP No. 171 to perform abortions by aspiration techniques. 10)Deletes provisions in the RPA which makes assisting in performing abortion unauthorized if the health care provider assisting in performing abortion is not an authorized provider, as specified. 11)Makes other technical and conforming changes. EXISTING LAW : 1)Establishes the RPA which provides that every individual possesses a fundamental right of privacy with respect to personal reproductive decisions. Provides that it is the public policy of the state that: a) Every individual has a fundamental right to choose or refuse birth control; AB 154 Page 3 b) Every woman has the fundamental right to choose to bear a child or to choose and to obtain an abortion, except as specified; and, c) Prohibits the state from denying or interfering with a woman's fundamental right to choose to bear a child or to choose to obtain an abortion, except as specified. 2)Indicates the following in the RPA: a) The state may not deny or interfere with a woman's right to choose or obtain an abortion prior to viability of the fetus, or when the abortion is necessary to protect the life or health of the woman; and, b) The performance of an abortion is unauthorized if either of the following is true: i) The person performing or assisting in performing the abortion is not a health care provider authorized to perform or assist in performing an abortion, as specified; or, ii) The abortion is performed on a viable fetus, and both of the following are established: (1) In the good faith medical judgment of the physician, the fetus was viable; and, (2) In the good faith medical judgment of the physician, continuation of the pregnancy posed no risk to life or health of the pregnant woman. 3)Establishes the Medical Practice Act, administered by the Medical Board of California, to regulate the practice of medicine. 4)Provides the following under the Medical Practice Act: a) The failure to comply with the RPA in performing, assisting, procuring or aiding, abetting, attempting, agreeing, or offering to procure an illegal abortion constitutes unprofessional conduct; b) A person is subject to the prohibition on the AB 154 Page 4 unauthorized practice of medicine if he or she performs or assists in performing a surgical abortion, and at the time of so doing, does not have a valid license to practice as a physician and surgeon, or if he or she assists in performing a surgical abortion and does not have a valid, unrevoked, and unsuspended license or certificate to perform the functions necessary to assist in performing a surgical abortion; c) A person is subject to the prohibition on the unauthorized practice of medicine if he or she performs or assists in performing a nonsurgical abortion, and at the time of so doing, does not have a valid license to practice as a physician and surgeon, or does not have a valid license that authorizes him or her to perform or assist in performing the functions necessary for a nonsurgical abortion; and, d) Defines nonsurgical abortion to include the termination of pregnancy through the use of pharmacological agents. 5)Establishes the Nurse Practice Act, administered by the BRN, to regulate the practice of nursing, including advance practice registered nurses, which include NPs and CNMs. 6)Establishes the Physician Assistant Practice Act, administered by the PAB, to regulate the practice of PAs. 7)Provides that any person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person without a valid certificate to practice medicine is guilty of a public offense, punishable by a fine not exceeding $10,000, by imprisonment, as specified, or both. Provides that any person who conspires with or aids or abets another to commit this act is guilty of public offense, subject to the same penalties. FISCAL EFFECT : This bill has not yet been analyzed by a fiscal committee. COMMENTS : AB 154 Page 5 1)PURPOSE OF THIS BILL . The sponsors of this bill are: ACCESS Women's Health Justice, American Civil Liberties Union of California (ACLU), Black Women for Wellness, California Latinas for Reproductive Justice, NARAL Pro-Choice California, and, Planned Parenthood Affiliates of California (PPAC). According to the author: "The Guttmacher Institute indicates that 52% of California counties lack an abortion provider. This lack of access causes women to delay the termination of their pregnancies into the second, or even third, trimesters. It also forces rural women to travel long distances, in the case of some rural areas, up to five hours; women have to raise money to cover these travel costs, further delaying care. Even women in urban areas face long wait-times to receive first trimester abortion care. This bill will address this access shortage by allowing advance practice clinicians (APCs) to perform this procedure under the terms of their licenses. This bill helps to ensure that women are getting safe and early care. Furthermore, the bill will help provide comprehensive and better coordinated reproductive health care in areas such as miscarriage management, post-abortion follow-up, and contraception. Women should be able to receive care from clinicians they know and trust. When performed by physicians as well as by APCs, first trimester aspiration abortion has been proven to be effective, safe, and acceptable. A multi-year study conducted by The University of California's San Francisco's (UCSF) Bixby Center for Global Reproductive Health, under a waiver from OSHPD, evaluated the safety, effectiveness, and acceptability of APCs in providing aspiration abortion. Over the five years of the study, HWPP No. 171, almost 8,000 patients were provided care by an APC and over 6,000 patients were provided care by a physician. The results of the study show comparable rates of safety, effectiveness and acceptability between the two categories of providers. 2)BACKGROUND . a) RPA . The RPA codified the constitutional principles of Roe v. Wade (1973) 410 U.S. 959, 35 L.Ed.2d 694 ( Roe v. Wade ) and replaced in its entirety the Therapeutic Abortion Act. In 1967, Governor Ronald Reagan signed the Therapeutic Abortion Act, which expanded legal abortion in AB 154 Page 6 California under very restrictive criteria. Most of those restrictions were subsequently ruled unconstitutional in the 1972 California Supreme Court case, People v. Barksdale (1972) 8 Cal.3d 320, 105 Cal.Rptr 1 ( People v. Barksdale ). The US Supreme Court issued its landmark Roe v. Wade and Doe v. Bolton 410 U.S. 179 (1973), decisions in 1973, which invalidated two of the three remaining provisions of the Therapeutic Abortion Act. Although Roe v. Wade and People v. Barksdale rendered much of the Therapeutic Abortion Act obsolete, the Act itself was not repealed by the Legislature until 2003, pursuant to SB 1301 (Kuehl), Chapter 385, Statutes of 2002, the Reproductive Privacy Act. One rationale for the passage of the Reproductive Privacy Act was the concern that the US Supreme Court may overturn Roe v. Wade , and it would, therefore, be important to have a state law which would protect reproductive rights in California. In 2003, the California Assembly passed AJR 2 (Jackson), Resolution Chapter 63, Statutes of 2003, urging Congress and the President to uphold the intent and substance for Roe v. Wade and reiterated the elements of reproductive rights. b) Aspiration Abortion . According to the UCSF Medical Center, surgical abortion, also known as suction aspiration abortion can be performed in a one-day procedure, usually around three hours if less than 12 weeks pregnant or five to six hours if 12 to 14 weeks pregnant. Suction is created with either an electric pump or a manual pump. Both methods use the same level of suction, and so can be considered equivalent in terms of effectiveness and safety. Vacuum or suction aspiration uses aspiration to remove uterine contents through the cervix. It may be used as a method of induced abortion, a therapeutic procedure used after miscarriage, or a procedure to obtain a sample for endometrial biopsy. Vacuum aspiration is most commonly used for first-trimester abortions. The rate of infection is lower than any other surgical abortion procedure at 0.5%. When used for uterine evacuation, vacuum aspiration is 98% effective in removing all uterine contents. Retained products of conception require a second aspiration procedure. This is more common when the procedure is performed very early in pregnancy, before six weeks gestational age. Other complications occur at a rate of less than one per 100 procedures and include excessive AB 154 Page 7 blood loss, injection injury to the cervix or uterus, including perforation, and uterine adhesions. c) Medication Abortion . Medication abortion, also referred to as medical abortion is brought about by taking medications that will end a pregnancy. Two medications, mifepristone (RU-486) or methotrexate can be used for medical abortion. Each of these medications is taken together with another medication, misoprostol, to induce an abortion. d) OSHPD HWPP No. 171 . The HWPP No. 171at OSHPD permits temporary legal waivers of certain practice restrictions or educational requirements to test expanded roles and accelerated training programs for health care professionals. In March 2007, OSHPD approved HWPP No. 171 Access Through Primary Care Project Demonstrating the Role of Advanced Practice Clinicians in Expanding Early Pregnancy Care. The applicant/sponsor of HWPP No. 171 is the Advancing New Standards in Reproductive Health (ANSIRH) at UCSF. HWPP No. 171 sought to demonstrate and evaluate the role of APCs in providing first trimester aspiration abortion and miscarriage management as part of coordinated early pregnancy care. The sponsor states that training APCs in aspiration abortion as part of early pregnancy care will address the critical shortage of abortion providers in California. It will create providers in underserved areas that need them most, assist them with better follow-up and complication management, and integrate abortion services into previously existing health care networks. Under HWPP No. 171, there were 41 trainees and five training sites. The total project cost was $3,943.00, funded by various foundations. Under HWPP No. 171, NPs, CNMs, and PAs from five partner organizations (four Planned Parenthood affiliates and Kaiser Permanente of Northern California) were trained to competency in the provision of aspiration abortion. A total of 28 NPs, five CNMs and seven PAs and 96 physicians (trained in either family medicine or obstetrics and gynecology) completed procedures during the duration of the project. Physicians had a mean of 14 years of experience providing abortions compared with a mean of 1.5 years among NPs, CNMs, and PAs. AB 154 Page 8 e) Curriculum and Training Requirements for HWPP No. 171 . Under HWPP No. 171, to conduct training, trainers are experienced providers currently offering abortion services at an institution participating in HWPP No. 171. All physician trainers are required to have performed at least 200 procedures and to have an excellent safety record; and, have received formal "train-the-trainer" instruction prior to training advanced practice clinicians at their own institution. To participate in the project, NPs, CNMs, and PAs must have at least 12 months successful clinical experience in a health care facility and be licensed to practice in California, demonstrate maintenance of Professional Certification or equivalent credentialing, have at least three months experience in the provision of early medication abortion or equivalent experience, demonstrate maintenance of certification of Basic Life Support, and have a desire to work in the area of women's reproductive health, including provision of early abortion care. Additionally, each project participant must participate in at least six days of simulated and hands on clinical training to perform a minimum of 40 first trimester abortions, participate in didactic teaching-learning in core content: orientation and simulation lab, values clarification and options counseling, complication prevention and management, and post-procedure care and contraception. Required readings included the ANSIRH workbook and chapters relating to "Management of Unintended and Abnormal Pregnancy." Each trainee must also successfully complete all case-based exercises, achieve 90% on final written exam, and complete all required evaluation instruments. For clinical training, each trainee will complete abortion training at one of the participating health care facilities. The trainee will work one-on-one with an experienced abortion provider and staff to practice counseling, ultrasonography, pre-procedure assessment, first trimester vacuum aspiration, and abortion aftercare. During clinical training in early aspiration abortion care, each trainee will: i) Review the training program, meet training faculty and staff, and receive an orientation to clinic AB 154 Page 9 policies and procedure for abortion care; ii) Participate in values clarification around pregnancy options, including practice in pre-abortion counseling; iii) Follow client(s) through an abortion visit from counseling to recovery; iv) Receive training in first trimester vacuum aspiration abortion techniques: supervised practice performing manual and electrical vacuum aspiration using simulated model and "no touch" method; observe faculty performing first trimester vacuum aspiration abortions; and, under the direct supervision of faculty, perform aspiration abortion procedures until assessed as competent; v) Perform tissue examinations until competent at identifying pregnancy elements consistently and accurately; vi) Perform routine post-procedure and follow-up care; vii) Discuss case studies involving abortion-related complications and manage complications when they occur; viii) Complete evaluation instruments to assess trainee knowledge and competence and to provide feedback about the training program; and, ix) Continue to participate in tracking of cases with review of complicated cases by a supervising physician during the post-procedure employment utilization period. f) Peer Review Study . In January 2013, the American Journal of Public Health published "Safety of Aspiration Abortion Performed by Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants Under a California Legal Waiver." This study examined the impact on patient safety if NPs, CNMs, and PAs were permitted to provide aspiration abortions in California, as authorized by HWPP No. 171. The study was designed to answer the following question: "What would be the impact on patient safety if NPs, PAs, and CNMs were permitted to provide aspiration abortions in California?" The study compared complications of early aspiration abortions completed by physicians and those completed by newly trained NPs, CNMs, and PAs. According to the study authors, a non-inferiority design was used with a predetermined acceptable risk difference of 2%. They indicate that unlike a superiority analysis, a AB 154 Page 10 non-inferiority study design determines whether the effect of a new treatment is not worse than that of an active control by more than a specified clinically acceptable margin of difference. A non-inferiority design was selected because the authors were not seeking to replace physicians as abortion providers, or to determine whether NPs, CNMs, and PAs were better than current providers of care, but to identify additional, comparably safe providers to supplement the provider pool. Patients involved HWPP No. 171 were between the ages of 16 years (18 years for Planned Parenthood affiliates) and 40 years old, were seeking first trimester aspiration abortion, and could speak English or Spanish. These patients were enrolled at 22 clinical facilities between August 2007 and August 2011. Patients were excluded if general anesthesia was requested or did not meet specified health-related criteria. The final sample size for the project was 11,487, and of these procedures, 5,812 were performed by physicians and 5,675 were performed by NPs, CNMs or PAs. A sampling of the outcomes is as follows: "Overall complications were rare. Out of 11,487 aspiration abortions, 1.3% (152) resulted in a complication; 1.8% for NP, CNM, and PA-performed aspirations while 0.9% complications resulted from physician performed aspirations. The majority of complications (146/152) were minor and included cases of incomplete abortion (nine among physicians and 24 among NPs, CNMs, and PAs); failed abortion (seven among physicians and 11 among NPs, CNMs and PAs); hematometra or collection of blood in the uterus (three among physicians and 16 among NPs, CNMs, and PAs); infection (seven among physicians and seven among NPs, CNMs, and PAs); endocervical injury (two among physicians and two among NPs, CNMs, and PAs); anesthesia-related reactions (one among physicians and one among NPs, CNMs, and PAs); and uncomplicated uterine perforation (three among NPs, CNMs, and PAs). Complications without clear etiology but accompanied by patient symptoms were classified as symptomatic intrauterine material (16 among physicians and 24 among NPs, CNMs, and PAs). Only six major complications occurred (three in each provider group), which included two uterine perforations, three infections, and one hemorrhage." The study found that there was no difference in risk of major complications AB 154 Page 11 between provider groups. The study concluded that abortion complications were clinically equivalent between newly trained NPs, CNMs, and PAs and physicians. g) Legislative Counsel Opinion . In 2012, Senator Kehoe asked Legislative Counsel whether existing law authorizes a CNM, NP, or PA to perform an aspiration abortion. It is the opinion of Legislative Counsel that existing law does not authorize a NP, CNM, or PA to perform an aspiration abortion. Legislative Counsel concluded that aspiration abortion is a surgical abortion as that term is used in the Medical Practice Act, and consequently, may be performed only by a licensed physician and surgeon. 3)SUPPORT . The California Women's Health Alliance comprising of 30 organizations, including ACLU, ACCESS Women's Health Justice, Black Women for Wellness, California Latinas for Reproductive Justice, NARAL Pro-Choice California, and PPAC, states that this bill will reduce barriers to care by broadening the types of health professionals who can provide early abortions and allows women to receive a wide spectrum of reproductive health care including family planning, birth control, miscarriage management, abortion, and post-abortion follow-up from the same practitioner, allowing for continuity of care. The National Center for Youth Law, the Khmer Girls in Action, the National Latina Institute for Reproductive Health, and the California Latinas for Reproductive Justice state that despite California's history of supporting comprehensive reproductive health care, almost half of the counties do not have an accessible abortion provider. This creates barriers to care in both rural and urban areas; and in rural areas, some women have to travel five hours by train or bus and also arrange for child care and missed work. These barriers can force women to delay abortions into advanced stages of pregnancy, which could result in more complicated procedures. 4)OPPOSITION . The Concerned Women for American and the California Catholic Conference state that this bill lowers the standard of care for women and points out that upon review of the peer review study, the data demonstrates that the mid-level clinicians in the pilot project averaged twice the complication rate as that of licensed physicians. In arguing that this bill lowers the standard of care, the California Nurses for Ethical Standards points out that standard of care AB 154 Page 12 means that the person performing the procedure must be trained not only to simply perform the procedure, but also to deal with complications that may arise. Serious complications such as hemorrhage, infection, uterine perforation, cervical injury, and shock can occur during surgical abortions. Even specifically trained surgeons and OB/GYNs have a known expected complication rate of 3% to 6% in these procedures. When complications arise, a physician with a depth of training and hospital privileges should be there to deal with them. The proposed legislation does not require physician supervision of non-physicians performing these surgical procedures, even in remote areas. The Coalition for Women and Children and the Pro-Life Mission: International indicate that this bill contradicts Roe v. Wade by authorizing non-physicians to perform first trimester abortions in California. 5)RELATED LEGISLATION . SB 491 (Ed Hernandez) deletes the requirement that NPs perform certain tasks, including examination of patients and establishing a medical diagnosis, pursuant to standardized procedures and/or consultation with a physician or surgeon and authorizes a NP to perform those tasks independently. Requires, after July 1, 2016, that NPs possess a certificate from a national certifying body in order to practice 6)PREVIOUS LEGISLATION . a) SB 623 (Kehoe), Chapter 450, Statutes of 2012, extends until January 1, 2014 HWPP No. 171 to evaluate the safety, effectiveness, and acceptability of NP's, CNMs, and PAs in providing aspiration abortions. b) SB 1338 (Kehoe) of 2012 would have allowed NPs, CNMs, and PAs who have completed training in under HWPP No. 171on or before January 1, 2013 to continue to perform abortions by aspiration techniques. SB 1338 died in Senate Business, Professions and Economic Development Committee. 7)DOUBLE-REFERRED . This bill is double-referred. It passed out of the Assembly Business, Professions and Consumer Protection Committee on April 9, 2013 on a 9-4 vote. 8)AUTHOR'S AMENDMENTS . In an effort to address concerns raised AB 154 Page 13 by the California Medical Association, the author would like to amend this bill to require that in order to perform abortion by aspiration techniques, an NP, CNM or PA shall adhere to standardized procedure or protocols that specify: a) The extent of supervision by a physician and surgeon with relevant training and expertise; b) Procedures for transferring patients to the care of the physician and surgeon or a hospital; c) Procedures for obtaining assistance and consultation from a physician and surgeon; d) Procedures for providing emergency care until physician assistance and consultation is available; and, e) The method of periodic review of the provision of the standardize procedure or protocols. 9)SUGGESTED AMENDMENTS . This bill makes it unprofessional conduct for any NP, CNM, or PA to perform an abortion pursuant to the Medical Practice Act (Section 2253 of the Business and Professions Code (BPC)) without prior completion of training and validation in clinical competency. However, BPC Section 2253 refers to abortion by medication or aspiration techniques. Is it the author's intent to also require that NPs, CNMs, or PAs also obtain training and validation in clinical competency when performing abortion by medication? It should be noted that CNMs, (see BPC Section 2746.51), and NPs (see BPC Section 2836.1) are authorized to furnish or order drugs or devices in accordance with standardized procedures and protocols developed by these practitioners and the supervising physician. Additionally, PAs may administer or provide medication to a patient pursuant to a delegation authority between the PA and the supervising physician (see Section 3502.1). Also, the unprofessional conduct provisions are included in the general code section of the Business and Professions Code. Since the practice of NPs, CNM, and PAs are governed by their own Practice Acts, the author may wish to amend this bill to place those provisions in those Practice Acts. 10)POLICY QUESTIONS . This bill requires the PAB to approve training programs by regulations for PAs who want to perform abortion by aspiration techniques. However, for purposes of NPs and CNMs, the BRN is not required to approve such training programs. In general, what is BRN's role in approving training programs? AB 154 Page 14 REGISTERED SUPPORT / OPPOSITION : Support ACCESS Women's Health Justice (cosponsor) American Civil Liberties Union of California (cosponsor) Black Women for Wellness (cosponsor) California Latinas for Reproductive Justice (cosponsor) NARAL Pro-Choice California (cosponsor) Planned Parenthood Affiliates of California (cosponsor) ACT for Women and Girls American Association of University Women American College of Nurse-Midwives American Nurses Association of California Bay Area Communities for Health Education Business and Professional Women of Nevada County California Academy of Physician Assistants California Association for Nurse Practitioners California Church IMPACT California Family Health Council California Nurse-Midwives Association California Women's Health Alliance California Women's Law Center Cardea Institute Center on Reproductive Rights and Justice at UC Berkeley Choice USA Choice USA at California State University Long Beach Choice USA at California State University Sacramento Choice USA at Mills College Choice USA at San Jose State Choice USA at Scripps College Forward Together Fresno Barrios Unidos Khmer Girls in Action Law Students for Reproductive Justice League of Women Voters of California National Asian Pacific American Women's Forum National Association for Youth Law National Association of Social Workers, California Chapter National Center for Lesbian Rights National Center for Youth Law National Council of Jewish Women California State Policy Advocates National Health Law Program National Latina Institute for Reproductive Health AB 154 Page 15 National Network of Abortion Funds Nevada County Citizens for Choice Nursing Students for Choice at UCSF Physicians for Reproductive Health Planned Parenthood Mar Monte Planned Parenthood of the Pacific Southwest Reproductive Justice Coalition Reproductive Justice Coalition of Los Angeles Students for Reproductive Justice at Stanford University Women's Community Clinic Women's Health Specialists of California Opposition California Catholic Conference California Nurses for Ethical Standards California Right to Life Committee Capitol Resource Center Coalition for Women and Children Concerned Citizens of California Concerned Women for America Life Legal Defense Foundation Pregnancy Counseling Center Pro-Life Mission: International Several individuals Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916) 319-2097