Title of Regulation: 18VAC85-130. Regulations Governing the Practice of Licensed Midwives (amending 18VAC85-130-80; adding 18VAC85-130-81).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.9 of the Code of Virginia.

Public Hearing Information:

June 23, 2011 - 8:30 a.m. - Department of Health Professions, 9960 Mayland Drive, 2nd Floor Conference Center, Board Room 2, Richmond, VA

Public Comment Deadline: August 19, 2011.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4621, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia authorizes the Board of Medicine to promulgate regulations to administer the regulatory system. A specific regulatory mandate for the Board of Medicine regarding midwifery is found in § 54.1-2957.9 of the Code of Virginia.

Purpose: The purpose of the planned regulatory action is compliance with a legislative mandate for the adoption of regulations relating to disclosures of risk to certain patients. Chapter 646 of the 2009 Acts of Assembly requires the board to adopt regulations governing the practice of midwifery, upon consultation with the Advisory Board on Midwifery. The regulations must require midwives to disclose to their patients, when appropriate, (i) options for consultation and referral to a physician and (ii) evidence-based information on health risks associated with birth of a child outside of a hospital or birthing center, as defined in § 32.1-11.5 E of the Code of Virginia, including but not limited to risks associated with vaginal births after a prior cesarean section, breech births, births by women experiencing high-risk pregnancies, and births involving multiple gestation.

The amendments set out the conditions or risks factors for which it is appropriate to disclose the options available for referral and consultation and to provide the evidence-based information to a client about risks associated with birth outside of a hospital or birthing center for women with certain conditions or clinical situations.

The Code of Virginia requires that regulations be consistent with the North American Registry of Midwives' (NARM) current job description for the profession. The NARM Position Paper on the Practice of Midwifery states that: Certified Professional Midwives (CPMs) have demonstrated the knowledge and skills to provide full prenatal, birth, and postpartum care to low-risk women; to recognize deviations from normal; and to refer, consult, or transfer care if appropriate. The proposed regulation is consistent with the NARM model in which midwives are expected to appropriately assess deviations from normal and to disclose to clients those conditions or situations in which an out-of-hospital birth is not appropriate or those that may present certain risks to a woman or her baby.

The goal for the amended regulation is to ensure that women are adequately informed of any risk for home birth associated with certain health conditions or prior birth history. Regulation of risk disclosure requires that women are adequately assessed and informed of a condition that presents increased risk for home birth and ensures that the choice of provider and birth setting are made with full disclosure of risk.

Substance: The proposed regulations include:

1. A requirement that, upon initiation of care, the midwife reviews the woman's medical history, including records from prior pregnancies, to identify pre-existing conditions that require disclosure of risk for home birth. The midwife will also be required to continually assess the pregnant woman in order to recognize conditions that may arise during the course of care that require disclosure of risk for home birth.

2. A listing of those factors or criteria that require disclosure that the client is not an appropriate candidate for an out-of-hospital birth, and a listing of those factors or criteria that require disclosure of options for consultation and referral.

3. If factors or criteria have been identified that may indicate health risks associated with birth of a child outside of a hospital, a requirement for the midwife to provide evidence-based information on such risks. Such information would be specified by the board for certain conditions and would include statements and evidence from both the medical and midwifery models of care.

4. A requirement for documentation in the client record of the assessment, the presence or absence of high risks and, if appropriate, the provision of disclosures and evidence-based information.

Issues: The primary advantage to the public (clients of midwifery) is the assurance that an appropriate assessment of health risks has been made and documented, that disclosure of such risks has been given to the client, and that evidence-based information on risks has been made available. The advantage to licensed midwives is the existence of a clear regulatory standard by which to practice. There are no disadvantages, because consumer choice will not be abridged. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation: Pursuant to Chapter 646 of the 2009 Acts of Assembly, the Board of Medicine (Board) proposes to amend its Regulations Governing Licensed Midwives to include requirements for midwives to disclose evidence-based information on health risks associated with birth of a child outside of a hospital or birthing center. The Board proposes to promulgate a list of for risk factors for which midwives will need to provide information to be determined later in guidance documents.

Result of Analysis. There is insufficient evidence to ascertain whether benefits will outweigh costs for these proposed changes.

Estimated Economic Impact. In 2005, the General Assembly passed a law which required the licensure of midwives and mandated the parameters of that licensure. In 2009, the legislature amended this law (Chapter 646) to require midwives to disclose evidence-based information on risk factors that might influence a patient's choice as to whether she will give birth in a hospital or in some other setting with the aid of a midwife. The Board now proposes to amend its regulations to reflect the requirements of Chapter 646 and to list the risk factors for which midwives will have to provide evidence-based information. The regulations as amended specify that the evidence-based information will be in guidance documents and shall include evidence-based research and clinical expertise from both the medical and midwifery models of care.

To the extent that the evidence-based information provided to the clients of midwives allows them to make informed decisions about whether to continue with a plan to give birth outside of a hospital, these regulations will provide a benefit. For clients who choose to give birth in a hospital when that choice forestalls health problems, or even death, for themselves or their infants, those benefits will be quite large. For licensed midwives, the costs that will be accrued on account of this regulatory change will likely include some minimal costs for copying the information to be provided and lost fees for any individuals who decide on a hospital birth as a direct result of the information provided. To the extent that individuals who could have safely given birth at home are steered by the information toward a hospital delivery instead, they will incur costs that include the price differential between a home birth and a hospital birth, possible thousands of dollars, and the loss of the comfort that being in their home would likely provide them. Whether the benefits of this regulatory change outweigh the costs for this regulatory change will depend on several factors which likely include how well midwives and their potential clients currently assess any risk factors and how balanced, and therefore useful, the information that will be provided turns out to be.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that the Board currently licenses 49 midwives, all of which are independent small businesses. These individuals, any individuals who choose to be licensed in the future and pregnant women who choose home birth and use the services of midwives will all be affected by these regulations.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. This regulatory action will likely have little impact on employment in the Commonwealth given the very small population of individuals that currently practice midwifery.

Effects on the Use and Value of Private Property. This regulatory action may decrease the value of midwife businesses if fewer individuals choose to use midwife services on account of these regulations.

Small Businesses: Costs and Other Effects. Small businesses in the Commonwealth will likely incur minimal costs for copying information to be provided to their clients and may incur lost income.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Costs for small businesses will likely be minimized by providing the best available information on all risk factors so that individuals are not steered away from home birth unnecessarily.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Medicine has the following response to the economic impact analysis prepared by the Department of Planning and Budget for 18VAC85-130, Regulations Governing the Practice of Licensed Midwives.

On page 2 of the EIA, it states: To the extent that individuals who could have safely given birth at home are steered by the information toward a hospital delivery instead, they will incur costs that include the price differential between a home birth and a hospital birth, possible thousands of dollars, and the loss of the comfort that being in their home would likely provide them.

The EIA does not account for the costs associated with a high-risk pregnancy for which disclosures and options for referral were not appropriately provided. If a woman with a high risk pregnancy is not provided information about risks, the result could potentially be a delivery that has become problematic, necessitating a transfer to a hospital, an emergency delivery and care of a newborn in a NICU. Those costs could range from $35,000 to $50,000. If the infant remained in NICU beyond seven days, the costs extend from $3,500 to $4,800 for each additional day.

Ultimately, the goal is a viable, healthy infant, regardless of the birth setting. There can be no comparison of costs for that purpose.

Summary:

The proposed regulation requires midwives to disclose to their clients options for consultation and referral to a physician and evidence-based information on health risks associated with a home birth when certain antepartum or intrapartum conditions exist.

Part III
Practice Standards

18VAC85-130-80. Disclosure General disclosure requirements.

A licensed midwife shall provide written disclosures to any client seeking midwifery care. The licensed midwife shall review each disclosure item and obtain the client's signature as evidence that the disclosures have been received and explained. Such disclosures shall include:

1. A description of the licensed midwife's qualifications, experience, and training;

2. A written protocol for medical emergencies, including hospital transport, particular to each client;

3. A statement as to whether the licensed midwife has hospital privileges;

4. A statement that a licensed midwife is prohibited from prescribing, possessing or administering controlled substances;

5. A description of the midwife's model of care;

6. A copy of the regulations governing the practice of midwifery;

7. A statement as to whether the licensed midwife carries malpractice or liability insurance coverage and, if so, the extent of that coverage;

8. An explanation of the Virginia Birth-Related Neurological Injury Compensation Fund and a statement that licensed midwives are currently not covered by the fund; and

9. A description of the right to file a complaint with the Board of Medicine and with NARM and the procedures and contact information for filing such complaint.

18VAC85-130-81. Disclosures on health risks.

A. Upon initiation of care, a midwife shall review the client's medical history in order to identify pre-existing conditions or indicators that require disclosure of risk for home birth. The midwife shall offer standard tests and screenings for evaluating risks and shall document client response to such recommendations. The midwife shall also continually assess the pregnant woman and baby in order to recognize conditions that may arise during the course of care that require disclosure of risk for birth outside of a hospital or birthing center.

B. If any of the following conditions or risk factors are presented, the midwife shall request and review the client's medical history, including records of the current or previous pregnancies; disclose to the client the risks associated with a birth outside of a hospital or birthing center; and provide options for consultation and referral. If the client is under the care of a physician for any of the following medical conditions or risk factors, the midwife shall consult with or request documentation from the physician as part of the risk assessment for birth outside of a hospital or birthing center.

1. Antepartum risks:

Conditions requiring ongoing medical supervision or ongoing use of medications;

Active cancer;

Cardiac disease;

Severe renal disease -- active or chronic;

Severe liver disease -- active or chronic;

HIV positive status with AIDS;

Uncontrolled hyperthyroidism;

Chronic obstructive pulmonary disease;

Seizure disorder requiring prescriptive medication;

Psychiatric disorders;

Current substance abuse known to cause adverse effects;

Essential chronic hypertension over 140/90;

Significant glucose intolerance;

Genital herpes;

Inappropriate fetal size for gestation;

Significant 2nd or 3rd trimester bleeding;

Incomplete spontaneous abortion;

Abnormal fetal cardiac rate or rhythm;

Uterine anomaly;

Platelet count less than 120,000;

Previous uterine incision and/or myomectomy with review of surgical records and/or subsequent birth history;

Isoimmunization to blood factors;

Body mass index (BMI) equal to or greater than 30;

History of hemoglobinopathies;

Acute or chronic thrombophlebitis;

Anemia (hematocrit less than 30 or hemoglobin less than 10 at term);

Blood coagulation defect;

Pre-eclampsia/eclampsia;

Uterine ablation;

Placental abruption;

Placenta previa at onset of labor;

Persistent severe abnormal quantity of amniotic fluid;

Suspected chorioamnionitis;

Ectopic pregnancy;

Pregnancy lasting longer than 42 completed weeks with an abnormal nonstress test;

Any pregnancy with abnormal fetal surveillance tests;

Rupture of membranes 24 hours before the onset of labor;

Position presentation other than vertex at term or while in labor; or

Multiple gestation.

2. Intrapartum risks:

Current substance abuse;

Documented intrauterine growth retardation (IUGR)/small for gestational age (SGA) at term;

Suspected uterine rupture;

Active herpes lesion in an unprotectable area;

Prolapsed cord or cord presentation;

Suspected complete or partial placental abruption;

Suspected placental previa;

Suspected chorioamnionitis;

Pre-eclampsia/eclampsia;

Thick meconium stained amniotic fluid without reassuring fetal heart tones and birth is not imminent;

Position presentation other than vertex at term or while in labor;

Abnormal auscultated fetal heart rate pattern unresponsive to treatment or inability to auscultate fetal heart tones;

Excessive vomiting, dehydration, or exhaustion unresponsive to treatment;

Blood pressure greater than 140/90 that persists or rises and birth is not imminent;

Maternal fever equal to or greater than 100.4°F; or

Labor or premature rupture of membrane (PROM) less than 37 weeks according to due date.

3. If a risk factor first develops when birth is imminent, the individual midwife must use judgment taking into account the health and condition of the mother and baby in determining whether to proceed with a home birth or arrange transportation to a hospital.

C. If the risks factors or criteria have been identified that may indicate health risks associated with birth of a child outside of a hospital or birthing center, the midwife shall provide evidence-based information on such risks. Such information shall be specified by the board in guidance documents and shall include evidence-based research and clinical expertise from both the medical and midwifery models of care.

D. The midwife shall document in the client record the assessment of all health risks that pose a potential for a high risk pregnancy and, if appropriate, the provision of disclosures and evidence-based information.