Title of Regulation: 12VAC5-403. Certification of Doulas (adding 12VAC5-403-10 through 12VAC5-403-70).

Statutory Authority: §§ 32.1-12 and 32.1-77.1 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: July 23, 2021.

Agency Contact: Robin Buskey, Policy Analyst, Office of Family Health Services, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 863-7253, or email robin.buskey@vdh.virginia.gov.

Basis: The State Board of Health is authorized to make, adopt, promulgate, and enforce regulations by § 32.1-12 of the Code of Virginia. Section 32.1-77.1 of the Code of Virginia requires the board to adopt regulations that set forth the requirements for the use of the title "state-certified doula" and the training and education necessary to satisfy the requirements for certification by the department as a state-certified doula.

Purpose: The purpose of this regulation is compliance with the Code of Virginia and to provide standardized doula certification requirements in the Commonwealth of Virginia. Certification requirements for state-certified doulas shall reflect national best practices pertaining to community-based doula training and certification. Individuals practicing as state-certified doulas will have attained the required training, through entities approved by the State Board of Health, to provide coaching, outreach, and navigation services to Virginia's most hard-to-reach pregnant women to ensure that disadvantaged populations are equipped with the knowledge to receive the most appropriate medical and social supports to meet their needs. A standardized doula certification model is also beneficial to supporting and maintaining the doula workforce. This regulatory action will ensure that the content is clearly written.

Substance: This new regulation will include definitions for community-based and state-certified doulas as well as other relevant terminology. The regulation will outline the minimum training and education requirements for state-certified doulas based on the core competences for doula certification used by national organizations and community based organizations in Virginia. In addition, the regulation will describe the minimum standards required of the entity approved by the board that is to be responsible for confirming state-certified doulas, approving the training and education to meet doula certification requirements, and maintaining a registry of state-certified doulas available to the general public.

Issues: The primary advantage of the proposed regulatory action to the public is the establishment of statewide doula certification requirements and a public registry. Currently, anyone can identify as a certified doula because the Commonwealth of Virginia has no central repository or public registry that identifies certified doulas or that collects data on the number of doulas practicing in the state. Establishing minimum training and education criteria for state certification of doulas based on national standards and best practices will provide assurance to the public that state-certified doulas have met those requirements. A certifying body, which will be approved by the State Board of Health, will verify that doulas practicing in the Commonwealth have completed the required training to attain certification and provide doula care to pregnant women. Health care providers, community-based organizations, and payers may be assured of standardized training requirements when vetting this critical workforce. The public registry will include all doulas certified in Virginia and will make identification of state-certified doulas easier and more accessible to the public. One disadvantage associated with this regulatory action to the public is the potential costs to applicants seeking to become a state-certified doula as they will likely incur an application fee. Another potential issue regarding standardizing doula certification requirements is that the regulation may present a perceived barrier to doulas who are currently practicing without certification. This regulation will be written to ensure that these individuals are not prohibited from continuing to practice.

A primary advantage of the proposed regulatory action to the Commonwealth is that the action supports development of the doula workforce, the need for which aligns with research supporting the benefits of emotional support provided by support personnel, such as doulas, on labor outcomes. The March of Dimes July 2018 position statement, "Statement on Doulas and Birth Outcomes," outlines evidence and guidance in support of doula care. Specifically, the March of Dimes supports increased access to doula care as one tool to help improve birth outcomes and reduce the higher rates of maternal morbidity and mortality among women of color in the United States; advocates for all payers to provide coverage for doula services; and recognizes the importance of increased training, support, and capacity development for doulas, including doulas from racially, ethnically, socioeconomically, and culturally diverse communities. There are no other known disadvantages to the public associated with this regulatory change.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 724 of the 2020 Acts of Assembly, the State Board of Health (Board) seeks to promulgate a new regulation to establish the certification process and related standards for "state-certified doulas." Doulas are "nonmedical professionals who provide critical physical, emotional, and informational support to pregnant women during pregnancy, delivery, and the postpartum period."¹ The proposed regulation aims to establish the minimum requirements to be considered a "state-certified doula" in Virginia, which are based on standards used by national organizations as well as community-based organizations in Virginia. The proposed new regulation also outlines the minimum standards required of the Board-approved entity that would be responsible for confirming state-certified doulas, approving the training and education to meet doula certification requirements, and maintaining a registry of state-certified doulas available to the general public.

Background. Based on data collected between 2004 and 2013, the Virginia Department of Health (VDH) reports that the maternal mortality rate for African-American women is over two times as high as white women.² This finding has led to increased efforts among policymakers to combat the racial and ethnic disparities in maternal mortality rates in the state.³ These efforts are backed by a growing body of medical research spanning the last three decades, which has informed advocacy efforts by organizations like the March of Dimes.⁴ For example, a 1991 randomized controlled trial found that continuous emotional support during labor significantly reduced the rate of caesarean section deliveries and forceps deliveries. The authors found similar patterns for duration of labor, prolonged infant hospitalization, and maternal fever and concluded by calling for a review of current obstetrics practices.⁵ More recent research has explored a wider range of pregnancy and birth outcomes,⁶ focused on racial/ethnic disparities in obstetric outcomes,⁷ and specifically analyzed the effects of continuous labor support specifically among Medicaid recipients,⁸ as well as the cost-effectiveness of doing so.⁹

Pursuant to these research findings and public advocacy efforts, Chapter 724 of the 2020 Acts of Assembly sought to formalize the doula workforce in Virginia by directing the Board to implement a certification process and develop a registry of state-certified doulas. Specifically, Chapter 724 added a new section, § 32.1-77.1. State-certified doulas; certification to the Code of Virginia (Code) in which a "state-certified doula" was defined as "a trained, community-based nonmedical professional who provides continuous physical, emotional, and informational support to a pregnant person during the antepartum or intrapartum period or during the period up to one year postpartum and who has been certified by a body approved by the Board for such purpose in accordance with the provisions of this section."

The Code directs the Board to set forth (i) the requirements for the use of the title of "state-certified doula," and (ii) the training and education necessary to satisfy these requirements. The Code also authorizes the Board to approve a certifying body that would (i) certify doulas in accordance with the Board's requirements, and (ii) approve entities to provide the required training and education. The Code also specifies that "a person who is certified by a national credentialing organization that is approved by the body approved by the Board [the certifying body] for such purpose," but who did not receive training or education from an entity approved by the body, shall be eligible for state certification.

In addition, the Code also requires VDH to create and maintain a publicly-accessible registry of state-certified doulas, as well as a list of entities that have been approved by the certifying body to provide training and education to doulas. Lastly, the Code does not prohibit doulas who are not state-certified from practicing in Virginia; they would only be prohibited from using the title "state-certified doula" and would not be included in VDH's registry.

The content of the regulation as proposed largely conforms to the stipulations put forth in the Code. Sections of the proposed regulation are summarized:

• Section 10 (Definitions) defines "state-certified doula" identical to the Code and adds definitions for terms contained in that definition, including "doula" and "community-based doula," "antepartum," "intrapartum," and "postpartum," "certifying body" and "training entity."
• Section 20 (State-certified Doula) specifies that any person seeking to be a state-certified doula under this chapter shall be a community-based doula and meet the educational qualifications and hold a certification from the certifying body.
• Section 30 (Qualifications) specifies that persons seeking to be a state-certified doula shall complete 60 hours of training provided by one or more entities approved by the certifying body, unless that person had already obtained an initial level of certification within three years prior to this regulation going into effect. In that case, the individual would have to submit evidence of completed coursework and certification to the certifying body and provide proof of completion of any unmet training requirements within one year of application.
• Section 40 (Minimum standards for certifying bodies) lays out the criteria for the selection of a certifying body,¹⁰ the duties of the certifying body (including maintaining the registry and submitting an annual report to the Board) and the requirements to be enforced by the certifying body (namely, that certificate holders adhere to a code of ethics and complete 60 hours of training.)
• Section 50 (Curriculum requirements) reiterates that persons seeking to be a state-certified doula shall complete a doula training and education program that has been approved by the certifying body, and that the certifying body shall approve the minimum requirements laid out by the Board.¹¹ The minimum curriculum requirements are included in a separate document incorporated by reference (DIBR).¹²
• Section 60 requires all state-certified doulas to undergo a minimum of 15 hours of continuing education every two years from the date of certification, in areas outlined in the curriculum presented in the DIBR.
• Section 70 mirrors the Code in reiterating that this regulation does not require a doula to be certified by a certifying body approved by the Board in order to practice as a doula in Virginia.

VDH has indicated that the Department of Medical Assistance Services (DMAS) is conducting a rate study for potential Medicaid reimbursement of doula services. If the General Assembly authorizes DMAS to cover doula services for Medicaid recipients, individuals will need to satisfy doula state-certification requirements in order to receive Medicaid reimbursement. Therefore, the proposed regulation would pave the way for community-based doulas, many of whom already work in low-income and minority communities, to be compensated through Virginia's Medicaid program and potentially serve more individuals in those communities at lower direct cost to them.

Estimated Benefits and Costs. Individuals seeking doula services, health care providers, community-based organizations, and payers would benefit from the state certification process laid out in the proposed regulation by being assured of standardized training requirements when making hiring decisions or insurance reimbursement eligibility decisions. The public registry would include all doulas certified in Virginia, making it easier to not only find a community-based doula but also verify a doula's state certification.

Currently, the registry would benefit individuals who could afford to pay for doula services out-of-pocket or health care providers (including birthing centers) that are specifically looking for doulas who have met the particular training requirements laid out in the proposed regulation. However, if doula services become Medicaid-eligible, and subsequently, if other insurance payers sought to cover doula services, the registry would benefit individuals from a broader range of socio-economic backgrounds, including some of the more vulnerable and at-risk populations.

Costs created by the proposed amendment would primarily fall on individuals seeking to become state-certified doulas. In addition to paying for the 60 hours of mandated training, VDH indicates that applicants for certification would have to pay a fee of $100.¹³ Hospitals already seem to require doulas to present some form of certification in order to be allowed to accompany their clients. Although there are no standardized requirements for doula training or certification, there are nationally recognized organizations that offer both, and some doulas have likely obtained a certification already.¹⁴ VDH clarified that doulas who have already obtained a certification could use it toward meeting the training requirements in the proposed regulation if it had been obtained within the preceding three years, thereby reducing their cost of becoming state-certified.¹⁵

To ensure that state certification is financially accessible to community-based doulas, especially those belonging to low-income and minority communities, the certifying body would need to account for the cost of training in their selection of training entities. The Board could mitigate these costs by requiring the certifying body to selectively approve training entities that offer need-based financial aid, work with community organizations to offer scholarships, or generally keep the training costs low so that it is not a significant barrier to certification for community-based doulas. However, unless the General Assembly approves Medicaid-coverage for state-certified doulas, (or private insurers voluntarily decide to cover it,) it is unclear if community-based doulas would have sufficient incentive to incur the costs of training and state certification.¹⁶

Businesses and Other Entities Affected. As mentioned previously, community-based doulas would be primarily affected by the opportunity to become state-certified and be included in a registry, particularly if that also enables them to receive Medicaid reimbursement in the future. Since there is no central doula registry at present, the number of community-based doulas working in Virginia is unknown. In addition, the proposed regulation also affects individuals and health care providers seeking to hire doulas, as well as payers who may consider covering doula services in the future, by standardizing training requirements and creating a registry of state-certified doulas.

Small Businesses¹⁷ Affected. Most doulas (community-based or otherwise) likely work as independent contractors, but there is currently no data on the number of doulas practicing in Virginia, whether they are community-based, or if they are affiliated with specific health care providers. However, the proposed regulation only affects doulas seeking to become state certified, and certification is not necessary to continue to provide doula services.

Localities¹⁸ Affected.¹⁹ The proposed amendments do not introduce new costs for local governments and are unlikely to affect any locality in particular.

Projected Impact on Employment. The proposed regulation would create "state-certified doulas" as a category of nonmedical health care workers, with standardized training requirements and tiered oversight by the Board and the certifying body. Thus, the proposed regulation could lead to increased employment of state-certified doulas by individuals, health care providers, especially private practices specializing in obstetrics and gynecology, as well as birth centers. This would be more likely if doula services were covered by Medicaid or private payers as a result of the proposed regulation. Although the number of state-certified doulas who are employed cannot be predicted at this time, the certifying body could collect such data once it starts issuing certifications.

Effects on the Use and Value of Private Property. The proposed regulation is unlikely to affect the use and value of private property. Real estate development costs are not affected.

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¹Agency Background Document (page 1) https://townhall.virginia.gov/L/GetFile.cfm?File=58\5574\9209\AgencyStatement_VDH_9209_v1.pdf

²See https://www.vdh.virginia.gov/content/uploads/sites/18/2016/04/PAMSS-Ten-Year-Trends-Report-2004-2013_final.pdf

³See https://www.governor.virginia.gov/newsroom/all-releases/2019/june/headline-840941-en.html

⁴The March of Dimes' July 2018 position statement, Statement on Doulas and Birth Outcomes, outlines evidence and guidance in support of doula care. Specifically, See https://www.marchofdimes.org/materials/Doulas and birth outcomes position statement final January 30 PM.pdf

⁵Kennell J, Klaus M, McGrath S, Robertson S, Hinkley C. Continuous emotional support during labor in a US hospital. A randomized controlled trial. JAMA 1991 May 1;265(17):2197-201. https://pubmed.ncbi.nlm.nih.gov/2013951/.

⁶Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. https://pubmed.ncbi.nlm.nih.gov/28681500/

⁷Bryant AS, Worjoloh A, Caughey AB, Washington AE. Racial/ethnic disparities in obstetric outcomes and care: prevalence and determinants. Am J Obstet Gynecol. 2010 Apr;202(4):335-43. https://pubmed.ncbi.nlm.nih.gov/20060513/.

⁸Kozhimannil KB, Hardeman RR, Attanasio LB, Blauer-Peterson C, O'Brien M. Doula care, birth outcomes, and costs among Medicaid beneficiaries. Am J Public Health. 2013 Apr;103(4):e113-21. https://pubmed.ncbi.nlm.nih.gov/23409910/.

⁹Kozhimannil KB, Hardeman RR, Alarid-Escudero F, Vogelsang CA, Blauer-Peterson C, Howell EA. Modeling the Cost-Effectiveness of Doula Care Associated with Reductions in Preterm Birth and Cesarean Delivery. Birth. 2016 Mar;43(1):20-7. https://pubmed.ncbi.nlm.nih.gov/26762249/.

¹⁰Specifically, the proposed regulation states that "The Board of Health shall approve a certifying body that has adopted standards from a nationally recognized organization that has a doula certification that reflects national best practices pertaining to community-based doula training and certification to establish certified doula training and education programs and to approve or accept continuing education courses for renewing doula certification in Virginia." When asked for clarification by the Department of Planning and Budget (DPB), VDH stated that "the Virginia Certification Board will be recommended to the Board of Health as the certifying entity, but that recommendation will not be made until after the regulation has taken effect."

¹¹VDH communicated to DPB that "The Virginia Certification Board, if approved by the Board of Health, will use the minimum curriculum requirements proposed by the Board."

¹²A link to the minimum requirements can be found at https://townhall.virginia.gov/L/ViewXML.cfm?textid=14908. When asked why these requirements were included in a DIBR, VDH reported that, "it is unlikely that changes to the actual regulatory text will be sought once the regulation is approved and in effect. However, curriculum topics will likely change based on updates to national best practices pertaining to doula training. When those changes occur, amendments to the DIBR will be submitted for review and approval as a regulatory action."

¹³See page 5: https://townhall.virginia.gov/l/GetFile.cfm?File=58\5574\9209\AgencyStatement_VDH_9209_v1.pdf. Although the fee is not mentioned in the Code or in the proposed text, VDH clarified that "the Virginia Certification Board, if approved by the Board of Health to be the certifying entity, will assess and collect a $100 application fee."

¹⁴See for example DONA International, the International Childbirth Education Association, Childbirth and Postpartum Professional Association, and BirthWorks. They all offer training and certification and maintain directories of their own members.

¹⁵Specifically, VDH reported that, Doulas who have already obtained a certification through an organization such as DONA would provide documentation of having completed a certification within three years and the minimum community-based doula training requirements. The certifying body will accept documentation of certification obtained through DONA, ICEA, CAPPA, BirthWorks, etc. The minimum community-based doula training requirements (see DIBR) are not automatically satisfied with a certification obtained through a doula certifying organization; therefore, an individual may have to take additional courses to satisfy the requirements to be considered a state-certified doula.

¹⁶As per the 2020 report of the workgroup convened to develop recommendations for a Virginia Medicaid Doula Benefit, Medicaid coverage for doulas would pay for itself and could yield modest cost-savings. See https://rga.lis.virginia.gov/Published/2020/RD629/PDF.

¹⁷Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

¹⁸"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹⁹§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

Pursuant to Chapter 724 of the 2020 Acts of Assembly, the proposed new regulation (i) establishes the minimum requirements to be considered a certified doula in Virginia based on the core competences for doula certification used by national organizations and community based organizations in Virginia and (ii) outlines the minimum standards required of the certifying body, which will be approved by the board and which will be responsible for confirming state-certified doulas, approving the training and education to meet doula certification requirements, and maintaining a registry of state-certified doulas available to the general public.

Chapter 403

Certification of Doulas

12VAC5-403-10. Definitions.

The following words and terms shall have the following meanings when used in this chapter unless the context clearly indicates otherwise:

"Antepartum" means the period of pregnancy prior to labor and delivery.

"Certifying body" means an organization approved by the State Board of Health that has as one of its purposes the certification of doulas.

"Community-based doula" means a doula who often has shared lived experiences and is trained to provide extended, culturally congruent support to families throughout pregnancy to include antepartum, intrapartum, during labor and birth, and up to one year postpartum. Community-based doulas provide an expanded set of services and play a crucial role in improving outcomes and experiences for communities most affected by discrimination and disparities in health outcomes.

"Doula" means a trained nonmedical professional who provides continuous physical, emotional, and informational support to a pregnant person during the antepartum or intrapartum period or during the period up to one year postpartum.

"Intrapartum" means the period of pregnancy after the onset of labor through delivery.

"Postpartum" means the period of pregnancy following birth.

"State-certified doula" means a trained, community-based nonmedical professional who provides continuous physical, emotional, and informational support to a pregnant person during the antepartum or intrapartum period or during the period up to one year postpartum who has been certified by a certifying body approved by the State Board of Health.

"Training entity" means an organization that has a training and education programs that are approved by a certifying body approved by the State Board of Health to meet the curriculum requirements for community-based doula certification.

12VAC5-403-20. State-certified doula.

Any person seeking to be a state-certified doula under this chapter shall be a community-based doula and shall (i) meet the qualifications and education requirements established in this chapter and (ii) hold a certification as a certified doula from a certifying body approved by the State Board of Health.

12VAC5-403-30. Qualifications.

A. Any person seeking to be a state-certified doula under this chapter shall complete at least 60 hours of doula training. Training shall be provided by one or more entities approved by a certifying body approved by the State Board of Health.

B. The training and education requirements outlined in 12VAC5-403-50 shall not apply to doulas who have already obtained an initial level of certification within three years prior to (insert the effective date of this regulation) and are applying to be a state-certified doula through the certifying body approved by the State Board of Health, provided that the applicant provides proof of completion of any unmet training and education requirements within one year of application.

12VAC5-403-40. Minimum standards for certifying bodies.

A. The State Board of Health shall approve a certifying body that has adopted standards from a nationally recognized organization that has a doula certification that reflects national best practices pertaining to community-based doula training and certification to establish certified doula training and education programs and to approve or accept continuing education courses for renewing doula certification in Virginia.

B. The certifying body shall:

1. Maintain a registry of state-certified doulas that is accessible to the public and displays the certification status of doulas.

2. Submit to the State Board of Health an annual report by the end of every fiscal year that identifies the number of new and cumulative state-certified doulas and the number of new and cumulative training programs approved for the purpose of providing doula certification.

C. The certifying body shall require its certificate holders to:

1. Adhere to a code of ethics set forth by the certifying body.

2. Complete at least 60 hours of training and education provided by one or more training entities approved by the certifying body.

12VAC5-403-50. Curriculum requirements.

A. Unless the exception in 12VAC5-403-30 B is met, any person seeking to be a state-certified doula under this chapter shall complete doula training and education programs that have been approved by the certifying body. The curriculum requirements for the certified doula training and education programs are outlined in the Virginia Curriculum Requirements for the State-Certified Doula and shall be approved by the certifying body.

B. The curriculum requirements for the certified doula training and education programs shall include a minimum of 60 hours in the following topics:

1. Maternal and Infant Health Concepts and Approaches (2 hours).

a. Provision of perinatal support services from 1st trimester to telve months postpartum.

b. Provision of emotional and social support, including navigating pregnancy loss.

2. Lactation anticipatory guidance and support (10 hours).

3. Service Coordination and System Navigation (20 hours).

a. Provision of in-home prenatal and postpartum care support.

b. Assessing psychosocial and health needs, including perinatal mood and anxiety disorders (PMADs) screening.

c. Goal setting and prioritization of psychosocial and health needs.

d. Antepartum (high-risk) maternal care support.

e. Labor support.

f. Education and referrals for developmental screenings.

g. Resource navigation for wraparound services (i.e. intimate partner violence, domestic violence, oral health, family planning).

4. Health Promotion and Prevention (8 hours).

a. Provision of perinatal health education.

b. Provision of newborn parenting education

c. Provision of wellness and self-care coaching.

5. Advocacy, Outreach and Engagement (5 hours).

a. Serving as an advocate for respectful maternal care.

b. Intentional reflection of the community served.

c. Care coordination and social service navigation.

d. Provision of reproductive rights education, informed choice and decision making, and birth planning.

e. Child abuse and neglect mandatory reporting.

6. Communication (2 hours).

a. Respectful, client-centered maternal care.

b. Active listening.

c. Navigating patient families, medical support staff, and other support systems.

d. Responding to challenges.

7. Cultural Humility and Responsiveness (8 hours).

a. Intersectionality and cultural humility, including language access.

b. Health literacy.

c. Trauma-informed care.

8. Ethical Responsibilities and Professionalism (5 hours).

a. Code of Ethics, Standards of Practice, and HIPAA.

b. Required charting and documentation.

c. Serving as an accountability partner.

12VAC5-403-60. Continuing education.

Any person seeking to be a state-certified doula under this chapter shall be required to complete a minimum of 15 hours of continuing education every two years from the date of certification from a training entity approved by the certifying body pursuant to 12VAC5-403-40. These hours shall be in courses outlined in the Virginia Curriculum Requirements for the State-Certified Doula.

12VAC5-403-70. Certification not required.

This regulation does not require a doula to be certified by a certifying body approved by the State Board of Health in order to practice as a doula in Virginia.