1 STATE OF RHODE ISLAND DEPARTMENT OF HEALTH BIRTH CENTERS REGULATIONS ADVISORY COMMITTEE NOTICE Date of Notice: January 15, 2019 The Rhode Island Department of Health (RIDOH) is convening stakeholders in maternal and perinatal health on the Birth Centers Regulatory Advisory Committee (BCRAC) to review the rules and regulations for Birth Centers (216-RICR ). Through a process spanning four (4) scheduled committee meetings, the BCRAC will review the current regulations, pertinent data, and evidence-based guidelines, and will hear testimony from experts and the public in order to create an advisory report that will outline recommendations for changes to the current regulations, which will be presented to the Director of RIDOH. Members of the public are welcome to attend and provide comments, and time will be allotted during each meeting to hear concerns and answer questions pertaining to the Birth Centers regulations. The second BCRAC meeting will be held: Wednesday, January 30, :00PM-6:30PM Rhode Island Department of Health Department Operations Center (DOC) 3 Capitol Hill (Lower Level) Providence, Rhode Island Agenda I. Introduction II. Brief summary of process and review of meeting minutes III. RI data brief on maternity outcomes in the state IV. Expert testimony V. Public comment VI. Request for written comments by February 13 th The third and fourth scheduled committee meetings will take place from 5:00PM-6:30PM on, respectively, February 27, 2019; and March 20, Agendas for these meetings will be published in forthcoming notices. FOR FURTHER INFORMATION CONTACT: Sullivan Roberts, Rhode Island Department of Health, Division of Policy, Information, and Communications, 3 Capitol Hill, Providence, Rhode Island , , This serves as Advance Notice of Proposed Rulemaking. Please see below the minutes of the January 9, 2019 BCRAC meeting, slides from the American Association of Birth Centers presentation that was provided at that meeting, and the text of the currently effective rules and regulations for Birth Centers (216-RICR ).
2 Birth Center Regulatory Advisory Committee ( BCRAC ) Birth Centers Regulations (216-RICR ) ( Regulations ) Meeting Minutes January 9, 2019 BCRAC Members in Attendance: Sandra Powell, Michele Bauer, Shaylene Costa, Lissa DiMauro, Paige Eastman, Elisabeth Howard, Latisha Michel, Anne Murray, James O Brien, Quatia Osorio, James Padbury, Katie Almeida Spencer, Danika Severino Wynn BCRAC Members on Conference Call Line: Michelle Palmer BCRAC Members Not in Attendance: Yvonne Heredia, Susanna Magee, Maureen Pearlman RIDOH Staff: Ana Novais, Mary Bennett, Margaret Clifton, Jaime Comella, Deborah Garneau, Denise Marte, Kristine Campagna, Ellen Amore, Ada Amobi, Morgan Enroth, Mike Dexter, Ailis Clyne, Sullivan Roberts Open Meeting: Sandra Powell opened the meeting at 5:00PM. The meeting began with an introduction from Chairwoman Powell, who explained the nature of the proceeding as a participatory meeting, which will be the first of a series of meetings that will include presentations from experts and opportunities for dialogue between the Rhode Island Department of Health ( RIDOH ), BCRAC members, and members of the public who wish to provide public comments. Chairwoman Powell explained the background for the meeting, including revisions to the Administrative Procedures Act ( APA ) which had required the comprehensive review/revision of all of RIDOH s regulations by December 31, She explained that the pace of the APA didn t allow sufficient time for a more expansive consideration of different viewpoints when the Regulations were last revised, and that the BCRAC meetings were intended to open a broader conversation, with the goal of creating regulations that allow for birth centers to promote healthy births, mothers, and children. She also introduced the roles of the Center for Health Facilities Regulation, who would license any birth center as a facility, Health Equity Institute and the Maternal Child Health program at RIDOH. Chairwoman Powell also asked other RIDOH staff in the room to introduce themselves. Mr. Padbury inquired as to why, as there are no birth centers currently operating in Rhode Island, are there such regulations in effect. Chairwoman Powell explained that the Regulations were created to allow for operation of a birth center if one were to come into the state. She stated that RIDOH had received feedback that the current regulations make such startups tough, and that was one of the issues RIDOH wished to redress via the BCRAC meetings. Mr. Padbury asked if it was a good idea to change the current model, and Mr. Dexter clarified that freestanding birth centers are not disallowed in hospital systems. Each of the BCRAC members in attendance introduced themselves and gave a short summary of their background, and staff gave short introductions of their roles at RIDOH. Chairwoman Powell also cited to the APA, specifically the authority it provides RIDOH in creating a committee, seeking input from regulatory standards, and attempting to reach consensus for recommendations on the regulations. She then introduced Executive Director Novais. Executive Director Novais reflected on a conference she recently attended called Black Mommas Matter, regarding black women s maternal health. She expressed her desire to share some of the thoughts that were generated from that conference with the BCRAC. She explained that there is a narrative in our communities of color that there is a health crisis in terms of maternal health outcomes, that birth is seen as a battle for many, and that because there is inadequate pre- and post-natal care, that people feel the need to take their care into their own hands. She expressed that this narrative needs to be changed, particularly through the introduction of new models of care, increasing black owned and operated maternal healthcare businesses, and reclaiming birth traditions including the de-medicalization of birth. She noted the dichotomy of a safe
3 birth versus a happy birth, and the issue of shifting attention from mothers to babies immediately after birth. She stated that birth justice, including being able to choose the place and manner of giving birth, is an essential part of the discussion to provide for both healthy full-term babies and empowerment of women in their reproductive decisions. Chairwoman Powell then introduced Susan Stapleton, a representative of the American Association of Birth Centers ( AABC ). Ms. Stapleton presented on birth centers nationwide, including information on the regulatory frameworks in other states and the number of birth centers in such states (and the relationship between the level of regulatory oversight and number of birth centers). She explained the model of clientled midwifery care espoused by AABC, including the involvement of an inter-disciplinary team, implementing a maximized home versus minimized hospital model, separating normal birth from acute care, and minimizing factors that disrupt physiologic birth. Ms. Stapleton also presented data on birth center outcomes, with the stated implication that the studies she presented indicated better birth outcomes and lower costs at birth centers. Ms. Stapleton then took questions from BCRAC members. Ms. Eastman inquired whether most birth centers were owned by certified professional midwives ( CPMs ). Ms. Stapleton responded that most birth centers are owned by certified nurse midwives ( CNMs ), with the three hundred sixty five (365) birth centers accredited by AABC being about 60% owned by CNMs, and about 40% owned by CPMs. Ms. Howard inquired whether alongside birth center requests were increasing, to which Ms. Stapleton responded in the affirmative. Chairwoman Powell asked if there are any risk factors that AABC considers as disqualifying mothers from utilizing birth centers, to which Ms. Stapleton responded that they don t take breaches, twins, or mothers with hypertensive disorders or gestational diabetes. She elaborated that other risk factors are more dependent on the community in which the birth center resides. Ms. Almeida Spencer related her experience with her home birth, in that the laundry list of risk factors would have precluded her from using a birth center, and she had a healthy, easy, no-problem labor. Ms. Stapleton stated that certain risk factors, such as age or BMI limits, as well as requirements for physician medical directors and written agreements with hospitals, are not evidence-based. Ms. Osorio inquired on how many birth centers accept Medicaid, and how many were black owned? Ms. Stapleton responded that a handful of birth centers are black owned, but more than half of birth centers accept Medicaid. Dr. Padbury stated that risk factors would need to be included and could vary by population, and asked why, according to the data presented by Ms. Stapleton and the enhanced pre-natal care she described, was the preterm birth rate for birth centers not zero percent. Ms. Stapleton stated that some risk factors, though they may appear to make intuitive sense, are not evidence based, and stated that the preterm birth rate is not zero because AABC tracks those patients who transfer to hospitals and include the data on outcomes for completeness. Ms. Eastman stated that there was not a laundry list of prohibited services in the regulations for professions. Chairwoman Powell pointed out that the regulations fall under the auspices of Facilities Regulation versus under Professional Regulations. However the department is seeking comment and recommendation from the BCRAC as we review the existing regulatory guidelines. Chairwoman Powell asked the committee for agreement to extend the meeting by 10 minutes and then opened the meeting for public comments. Dr. Clyne inquired why Minnesota was represented as the AABC s ideal regarding regulatory framework, to which Ms. Stapleton responded that this designation was based on Minnesota s substantial adoption of the Commission on Accreditation of Birth Center s ( CABC ) requirements. Dr. Clyne also had a question regarding malpractice insurance, specifically if those states with no or smaller lists of prohibitive risk factors had consequent increases in malpractice insurance costs or requirements. Ms. Stapleton responded that many malpractice insurance carriers require accreditation. Orla Brandos, Vice President of Nursing at Newport Hospital, cautioned that the state consider transfer criteria and collaboration with community hospitals, in order to ensure the protection of patients. Ms.
4 Stapleton stated that CABC looks closely at collaborative agreements with hospitals, and that distance doesn t factor as much as would be intuitively expected. Ms. Osorio asked if there are separate CPM/CNM in other states, and Ms. Stapleton explained that the framework for CPMs and CNMs was varied between many states. Ms. Severino Wynn spoke to the need for the regulations to be respectful of other classes of licensure and expertise, and to look for development of relationships between different types of facilities/systems, with the goal of respectful integration of the whole system. Chairwoman Powell announced the next meeting scheduled for January 30 th, and stated the opportunity for further input and the request for committee members or the public to submit written comments or presentations that could be provided at the next meeting. She asked that names or recommended presenters be sent to Jaime Comella of the Health Equity Institute. Chairwoman Powell closed the meeting at 6:45PM.
5 Birth Centers in the United States Susan Stapleton, CNM, DNP, FACNM
6 What is a Birth Center?
7 A Birth Center Is People Place Program Practice of Midwifery Physiologic Birth Part of the Healthcare System 3
8 People 4
9 Interdisciplinary Team Transfer Hospital Community Partners Client-Led Midwifery Care Collaborating Physicians Support Staff Birth Assistants 5
10 Place 6
11 7 A Birth Center is a Maximized Home A Maximized Home where the attributes of home are emphasized & enhanced vs. A Minimized Hospital where attributes of a hospital are hidden as much as possible
14 Birth Center Prenatal Care is Enhanced Prenatal Care Relationship-based: trust, support, respect & shared decision-making Continuity of care with same providers 10
15 Practice of Midwifery 11
16 Physiologic Birth 12
17 Factors That Disrupt Physiologic Birth 13
18 Part of the Health System 14
19 Birth Center Care is Primary Maternity Care Care-Consensus-Series/Levels-of-Maternal-Care
22 A Solid Foundation for U.S. Birth Centers Standards Licensure Accreditation Data
23 National Standards Multi-disciplinary, evidencebased approach to standards development Leaders from midwifery, obstetrics, pediatrics, nursing & consumers participate in development and review Reviewed regularly to reflect new evidence Available data on safety & outcomes are based on these Available at standards 19
24 AABC Guidelines for Birth Center Regulations 20
25 Birth Center Licensure in the U.S. 21
26 Founded 1985 by AABC became separate entity in 2002 Only national accrediting body specifically for birth centers - both freestanding & alongside birth centers (Alongside Maternity Centers) AABC standards used as basis for accreditation Can be used by state for deemed status Sentinel Event Review & Complaint Process
27 Online registry for prospective collection of perinatal data Initiated in 2007 currently nearly 150,000 courses of care Over 300 variables - from initial prenatal to final postpartum visit Demographics Social, medical, pregnancy history AP, IP, PP, NB events & procedures Maternal & newborn transfers Perinatal outcomes 23
28 24 What Do We Know About Birth Center Outcomes?
29 National Birth Center Study II (Stapleton, et al, 2013) 84% gave birth in birth center as intended 93% had vaginal birth (including IP transfers) 6% had cesarean birth 25
30 National Birth Center Study II - Transfers Antepartum 13.7% Intrapartum 12.4% (11.5% non-emergent) 2/3 for prolonged labor 81.6% were having first baby Postpartum 2.4% (1.9% non-emergent) Neonatal 2.6% (1.7% non-emergency)
31 National Birth Center Study II - Mortality Fetal & newborn mortality rates were low & comparable to low-risk births in hospitals 0.47 stillbirths per 1,000 women (.047%) 0.40 newborn deaths per 1,000 women (.04%) No maternal deaths 27
32 Using the Birth Center Model to Improve Outcomes in At-Risk Populations Strong Start for Mothers & Newborns Initiative AABC
33 29 Preterm & Low Birth Weight Rates in Strong Start Birth Centers Compared to U.S. AABC SS All Races U.S. SS All Races AABC SS Black U.S. Black Preterm Birth a 4.42% 9.85% 4.97% 13.77% Very Preterm Birth b 0.67% 1.59% 1.05% 3.18% Low Birth Weight c 3.28% 8.17% 5.89% 13.68% Very Low Birth Weight d 0.58% 1.40% 1.12% 2.95% a <37 weeks b <32 weeks c <2500g d <1500g
34 30 CMS Findings: Women who received prenatal care in Strong Start Birth Centers had better birth outcomes and lower costs relative to similar Medicaid beneficiaries not enrolled in Strong Start. In particular, rates of preterm birth, low birthweight, and cesarean section were lower among Birth Center participants, and costs were $2,010 lower per mother-infant pair during birth and the following year. These promising Birth Center results may be useful to state Medicaid programs seeking to improve the health outcomes of their covered populations.