Title of Regulation: 18VAC90-70. Regulations Governing the Practice of Licensed Certified Midwives (adding 18VAC90-70-10 through 18VAC90-70-260).

Statutory Authority: §§ 54.1-2400 and 54.1-2957.04 of the Code of Virginia.

Public Hearing Information:

July 18, 2023 - 9:05 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2, Henrico, VA 23233

Public Comment Deadline: July 21, 2023.

Agency Contact: Jay P. Douglas, R.N., Executive Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 367-4520, FAX (804) 527-4455, or email jay.douglas@dhp.virginia.gov.

Basis: Regulations of the Boards of Nursing and Medicine are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which specifically states that the general powers and duties of health regulatory boards shall be to promulgate regulations in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) that are reasonable and necessary to administer effectively the regulatory system.

The specific legislative authority for this action can be found in Chapters 200 and 201 of the 2021 Acts of Assembly, Special Session I, which amended § 54.1-2900 of the Code of Virginia to create a definition of a licensed certified midwife as an individual licensed as a certified midwife by the Boards of Nursing and Medicine and to include a definition of the practice of licensed certified midwifery. Sections 54.1-2957.04 and 54.1-3005 of the Code of Virginia also provide additional directives to the boards to promulgate regulations to license certified midwives. Sections 54.1-3303 and 54.1-3408 of the Code of Virginia provide licensed certified midwives have prescriptive authority.

Purpose: The rationale of the regulatory change is to comply with a legislative mandate to license certified midwives and to do so while protecting the health and safety of citizens of the Commonwealth. The boards have promulgated a regulation to establish qualifications for licensure and renewal of licensure that ensure minimal competency to protect the health and safety of patients who receive the services of licensed certified midwives. The regulation promulgated is also necessary to provide standards for confidentiality, patient records, dual relationships, and informed consent to protect public health and safety.

Substance: Certified midwives are not currently a regulated health profession in Virginia; therefore the boards created a new regulation for licensed certified midwives. The chapter includes requirements for licensure and practice as required by § 54.1-2957.04 of the Code of Virginia, standard fees related to administrative and disciplinary costs that are levied on all licensees, requirements for renewal and reinstatement, continuing competency requirements, and unprofessional conduct violations.

Issues: The primary advantage to private citizens is that licensed certified midwives will be available to provide care to patients while being regulated by the boards, thereby ensuring the safety of patients who receive care from a licensed certified midwife. There are no disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

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 Code of Virginia (Code) and Executive Order 19. The analysis presented represents DPB's best estimate of these economic impacts.¹

Summary of the Proposed Amendments to Regulation. Pursuant to the identical Chapters 200 and 201 of the 2021 Acts of Assembly, Special Session I,² the Boards of Nursing and Medicine (Boards) propose to establish criteria for the licensure and renewal of a license as a certified midwife.

Background.

Types of Midwives. Prior to the 2021 legislation, there were two types of licensed midwives in the Commonwealth: licensed professional midwives and licensed certified nurse midwives. The legislation established a third category, licensed certified midwives.

GraduateNursingEDU.org describes the work of each type of midwife as follows:³

Professional midwives (PM):

• Monitor a woman's complete (not just physical) well-being from pre-natal through post-natal
• Identify women who need to see an obstetrician and giving them appropriate referrals
• Give each mother individualized education, counseling, and prenatal care, assisting during labor and delivery, and supporting the mother and newborn after the birth
• Use as few technological interventions as possible

Certified Nurse-Midwives (CNMs) and Certified Midwives (CMs) are highly trained health care professionals who provide care for women not only during pregnancy and birth but also from adolescence through the end of life. More specifically:

• CNMs are nurses who have completed a graduate-level nurse-midwife program and passed a certification exam from the American Midwifery Certification Board, while CMs are non-nurses who have complete[d] a graduate-level midwifery degree program and passed a certification exam from the American Midwifery Certification Board.
• CNMs and CMs are qualified to provide the same level of care. All states license CNMs for independent practice but not all states license CMs. The American College of Nurse Midwives reports that CNMs and CMs attended 312,129 births in the U.S. in 2010, representing 11.6% of all vaginal births and 7.8% of total births.

Under Virginia law, PMs cannot prescribe medications. However, Virginia law allows CNMs to prescribe medications. The legislation also established that CMs could prescribe medications. In terms of scope of practice, the only substantial difference between CNMs and CMs under the proposed regulation and statute are practice agreements.⁴

Practice Agreements. Section 54.1-2957 H of the Cod of Virginia⁵ states that CNMs who have practiced fewer than 1,000 hours must practice in consultation with either a licensed physician or another CNM who has practiced for at least two years, in accordance with a practice agreement between them. Such practice agreement must address the availability of the physician or the experienced CNM for routine and urgent consultation on patient care. A CNM who has completed 1,000 hours of practice as a certified nurse midwife may practice without a practice agreement.⁶ A CNM authorized to practice without a practice agreement still should consult and collaborate with and refer patients to such other health care providers as may be appropriate for the care of the patient.

The legislation requires CMs to practice in consultation with a licensed physician in accordance with a practice agreement between the licensed certified midwife and the licensed physician. The practice agreement must address the availability of the physician for routine and urgent consultation on patient care. It must be with a licensed physician. The practice agreement remains a requirement regardless of how much experience the CM acquires.

Estimated Benefits and Costs. The following table describes the requirements to obtain initial licensure in the proposed regulation for CMs and in existing regulation for CNMs, respectively.

Obtaining Initial Licensure
CM (Proposed)	CNM (Existing)
Not required to be a registered nurse	Hold a current, active license as a registered nurse (RN) in Virginia or hold a current multistate licensure privilege as an RN; Application fee for RN license is $190;
Graduate degree in midwifery from a program that is accredited by the Accreditation Commission for Midwifery Education (ACME)	Graduate degree in nurse-midwifery from a program that is accredited by ACME
Current certification as a certified midwife by the American Midwifery Certification Board (AMCB) To become certified pass the AMCB Certification Examination in Nurse-Midwifery/Midwifery (same exam for both); Pay the $500 examination fee	Current certification as a certified nurse midwife by AMCB To become certified pass the AMCB Certification Examination in Nurse-Midwifery/Midwifery (same exam for both); Pay the $500 examination fee
Pay the $125 application fee	Pay the $125 application fee

The time and fees to earn a master's degree in midwifery and nurse-midwifery are similar.⁸ CMs would have to pass the same AMCB certification exam and pay the same $500 examination fee to AMCB as CNMs. Also CMs would have to pay the same $125 application fee to the Boards as CNMs. The primary difference is that CMs would not be required to have an RN license. For someone who is not already an RN and wants to do the work of a CNM (or CM), the establishment of CM licensure is substantially beneficial in that the time and cost of acquiring RN licensure could be avoided.

The following table describes the requirements to maintain licensure in the proposed regulation for CMs and in existing regulation for CNMs, respectively.

Maintaining/Renewing Licensure
CM (Proposed)	CNM (Existing)
Not required to be a registered nurse (RN)	Maintain RN licensure Biennial renewal fee for RN license is $140
Maintain AMCB certification by:9 1) Successfully completing three AMCB Certificate Maintenance Modules during the five-year certification cycle (there's a $75 fee to obtain the articles needed to complete the modules); 2) Obtaining 20 contact hours of approved continuing education units; and 3) paying the $70 annual maintenance fee	Maintain AMCB certification by: 1) Successfully completing three AMCB Certificate Maintenance Modules during the five-year certification cycle (there's a $75 fee to obtain the articles needed to complete the modules); 2) Obtaining 20 contact hours of approved continuing education units; and 3) paying the $70 annual maintenance fee
Virginia regulation specifies that eight hours of the continuing education be in pharmacology or pharmacotherapeutics for each biennium.	Virginia regulation specifies that eight hours of the continuing education be in pharmacology or pharmacotherapeutics for each biennium.
Pay the $80 biennial licensure renewal fee	Pay the $80 biennial licensure renewal fee

Other than maintaining RN licensure, the requirements for CM license renewal under the proposed regulation are the same as the requirements for CNM license renewal in 18VAC90-30-10 Regulations Governing the Licensure of Nurse Practitioners. The establishment of the CM license would allow a CNM who does not mind maintaining a practice agreement with a licensed physician to choose to abandon RN and CNM licensure, and obtain CM licensure instead. Instead of paying $220 in biennial license renewal fees to the Boards, she would only have to pay $80. Additionally, the $120 application fee for CM licensure would still be less than the $140 RN license renewal fee. As stated above, other than practice agreements, the scope of practice for CMs is essentially the same as for CNMs.

Businesses and Other Entities Affected. The proposed regulation potentially affects people who wish to become CMs, the 443 licensed CNMs in the Commonwealth,¹⁰ and potential employers of CMs. The 51 licensed inpatient hospitals that have obstetric services in the Commonwealth may be particularly affected.¹¹ As mentioned above, outside of being able to work without a practice agreement, the scope of practice for CNMs and CMs is essentially the same. Other than solo private practice, seeing where CNMs work may indicate where licensed CMs would work. According to survey data from a December 2021 report (the most recent available) from the Virginia Healthcare Workforce Data Center,¹² the primary employers of CNMs in the Commonwealth are distributed as follows:

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.¹³ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. The proposed regulation neither increases net costs nor reduces net revenue. Thus, no adverse impact is indicated.

Small Businesses¹⁴ Affected:¹⁵ The proposed regulation does not adversely affect small businesses.

Localities¹⁶ Affected:¹⁷ The proposed regulation neither disproportionally affects particularly localities nor introduces costs for local governments.

Projected Impact on Employment. By making it less costly to obtain licensure to provide CNM-type services, the establishment of the CM license may increase the number of individuals who pursue this type of employment.

Effects on the Use and Value of Private Property. As mentioned, by making it less costly to obtain licensure to provide CNM-type services, the establishment of the CM license may increase the number of individuals who pursue this type of employment. A larger labor pool of qualified practitioners may reduce labor costs for their employers, moderately increasing their value. The proposed regulation does not affect real estate development costs.

_______________________

¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²See https://lis.virginia.gov/cgi-bin/legp604.exe?212+ful+CHAP0200

³https://www.graduatenursingedu.org/careers/certified-nurse-midwife/what-is-a-midwife/, accessed on October 4, 2022.

⁴For CNMs, 18VAC90-30-10 Regulations Governing the Licensure of Nurse Practitioners defines "practice agreement" as "a written or electronic statement, jointly developed by the collaborating patient care team physician and the licensed nurse practitioner that describes the procedures to be followed and the acts appropriate to the specialty practice area to be performed by the licensed nurse practitioner in the care and management of patients. The practice agreement also describes the prescriptive authority of the nurse practitioner, if applicable. For a nurse practitioner licensed in the category of certified nurse midwife, the practice agreement is a statement jointly developed with the consulting physician or a certified nurse midwife with at least two years of clinical experience.”

For CMs, the proposed regulation defines "practice agreement” as "a written or electronic statement, jointly developed by the consulting licensed physician and the licensed certified midwife, that describes the availability of the physician for routine and urgent consultation on patient care.”

⁵See https://law.lis.virginia.gov/vacode/54.1-2957/

⁶Ibid

⁷See https://www.amcbmidwife.org/amcb-certification

⁸Source: Department of Health Professions

⁹AMCB also allows AMCB certification maintenance via taking and passing the current AMCB Certification Examination and paying the $500 examination fee.

¹⁰Data source: Department of Health Professions

¹¹Data source: Virginia Department of Health

¹²See https://www.dhp.virginia.gov/media/dhpweb/docs/hwdc/nurse/2021NPComparison.pdf

¹³Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

¹⁴Pursuant to § 2.2-4007.04, 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."

¹⁵If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

^16"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.

¹⁷Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to the Economic Impact Analysis: The Boards of Nursing and Medicine concur with the economic impact analysis of the Department of Planning and Budget.

Summary:

Pursuant to Chapters 200 and 201 of the 2021 Acts of Assembly, Special Session I, the proposed action establishes a new regulation to license and provide practice requirements for certified midwives. Section 54.1- 2957.04 of the Code of Virginia specifies the credential that will be considered as qualification for licensure and renewal, the requirement for a practice agreement, and the prescriptive authority for the profession. The proposed regulation establishes requirements similar to other licensed professions for a fee structure, renewal or reinstatement, continuing competency, and standards of practice.

Chapter 70

Regulations Governing the Practice of Licensed Certified Midwives

Part I

General Provisions

18VAC90-70-10. Definitions.

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

"Acute pain" means pain that occurs within the normal course of a disease or condition or as the result of surgery for which controlled substances containing an opioid may be prescribed for no more than three months.

"Approved program" means a midwifery education program that is accredited by the Accreditation Commission for Midwifery Education or its successor.

"Boards" means the Virginia Board of Nursing and the Virginia Board of Medicine.

"Chronic pain" means nonmalignant pain that goes beyond the normal course of a disease or condition for which controlled substances containing an opioid may be prescribed for a period greater than three months.

"Committee" means the Committee of the Joint Boards of Nursing and Medicine.

"Licensed certified midwife" means an advanced practice midwife who is jointly licensed by the Boards of Nursing and Medicine pursuant to § 54.1-2957.04 of the Code of Virginia.

"MME" means morphine milligram equivalent.

"Practice agreement" means a written or electronic statement, jointly developed by the consulting licensed physician and the licensed certified midwife, that describes the availability of the physician for routine and urgent consultation on patient care.

"Prescription Monitoring Program" means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

18VAC90-70-20. Delegation of authority.

A. The boards hereby delegate to the Executive Director of the Virginia Board of Nursing the authority to issue the initial licensure and the biennial renewal of such licensure to those persons who meet the requirements set forth in this chapter and to grant extensions or exemptions for compliance with continuing competency requirements as set forth in 18VAC90-70-90 E and F. Questions of eligibility shall be referred to the Committee of the Joint Boards of Nursing and Medicine.

B. All records and files related to the licensure of licensed certified midwives shall be maintained in the office of the Virginia Board of Nursing.

18VAC90-70-30. Committee of the Joint Boards of Nursing and Medicine.

A. The Committee of the Joint Boards of Nursing and Medicine, appointed pursuant to 18VAC90-30-30 and consisting of three members appointed from the Board of Medicine and three members appointed from the Board of Nursing, shall administer this chapter.

B. In accordance with 18VAC90-30-30, the committee may, in its discretion, appoint an advisory committee. The advisory committee shall include practitioners specified in 18VAC90-30-30.

18VAC90-70-40. Fees.

Fees required in connection with the licensure of certified midwives are:

	1. Application	$125
	2. Biennial licensure renewal	$80
	3. Late renewal	$25
	4. Reinstatement of licensure	$150
	5. Verification of licensure to another jurisdiction	$35
	6. Duplicate license	$15
	7. Duplicate wall certificate	$25
	8. Handling fee for returned check or dishonored credit card or debit card	$50
	9. Reinstatement of suspended or revoked license	$200

Part II

Licensure

18VAC90-70-50. Licensure generally.

A. No person shall perform services as a certified midwife in the Commonwealth of Virginia except as prescribed in this chapter and when licensed by the Boards of Nursing and Medicine.

B. The boards shall license applicants who meet the qualifications for licensure as set forth in 18VAC90-70-60 or 18VAC90-70-70.

18VAC90-70-60. Qualifications for initial licensure.

An applicant for initial licensure as a licensed certified midwife shall:

1. Submit evidence of a graduate degree in midwifery from an approved program;

2. Submit evidence of current certification as a certified midwife by the American Midwifery Certification Board;

3. File the required application; and

4. Pay the application fee prescribed in 18VAC90-70-40.

18VAC90-70-70. Qualifications for licensure by endorsement.

An applicant for licensure by endorsement as a licensed certified midwife shall:

1. Provide verification of a license as a certified midwife in another United States jurisdiction with a license in good standing or, if lapsed, eligible for reinstatement;

2. Submit evidence of current certification as a certified midwife by the American Midwifery Certification Board;

3. File the required application; and

4. Pay the application fee prescribed in 18VAC90-70-40.

18VAC90-70-80. Renewal of licensure.

A. Licensure of a licensed certified midwife shall be renewed biennially.

B. The renewal notice of the license shall be sent to the last known address of record of each licensed certified midwife. Failure to receive the renewal notice shall not relieve the licensee of the responsibility for renewing the license by the expiration date.

C. The licensed certified midwife shall attest to current certification as a certified midwife by the American Midwifery Certification Board and submit the license renewal fee prescribed in 18VAC90-70-40.

D. The license shall automatically lapse if the licensee fails to renew by the expiration date. Any person practicing as a certified midwife during the time a license has lapsed shall be subject to disciplinary actions by the boards.

18VAC90-70-90. Continuing competency requirements.

A. In order to renew a license biennially, a licensed certified midwife shall hold a current certification as a certified midwife by the American Midwifery Certification Board.

B. A licensed certified midwife shall obtain a total of eight hours of continuing education in pharmacology or pharmacotherapeutics for each biennium.

C. The licensed certified midwife shall retain evidence of compliance with this section and all supporting documentation for a period of four years following the renewal period for which the records apply.

D. The boards shall periodically conduct a random audit of at least 1.0% of their licensed certified midwives to determine compliance. The licensed certified midwives selected for the audit shall provide the evidence of compliance and supporting documentation within 30 days of receiving notification of the audit.

E. The boards may grant an extension of the deadline for continuing competency requirements for up to one year for good cause shown upon a written request from the licensee submitted prior to the renewal date.

F. The boards may delegate to the committee the authority to grant an exemption for all or part of the continuing education requirements in subsection B of this section for circumstances beyond the control of the licensee, such as temporary disability, mandatory military service, or officially declared disasters.

18VAC90-70-100. Reinstatement of license.

A. A licensed certified midwife whose license has lapsed may be reinstated within one renewal period by payment of the current renewal fee and the late renewal fee.

B. An applicant for reinstatement of license lapsed for more than one renewal period shall:

1. File the required application and reinstatement fee; and

2. Provide evidence of current professional competency consisting of:

a. Current certification by the American Midwifery Certification Board;

b. Continuing education hours completed during the period in which the license was lapsed, equal to the number required for licensure renewal during that period, not to exceed 120 hours; or

c. If applicable, a current, unrestricted license as a certified midwife in another jurisdiction.

C. An applicant for reinstatement of a license following suspension or revocation shall:

1. Petition for reinstatement and pay the reinstatement fee; and

2. Present evidence that he is competent to resume practice as a licensed certified midwife in Virginia, to include:

a. Current certification by the American Midwifery Certification Board; and

b. Continuing education hours taken during the period in which the license was suspended or revoked, equal to the number required for licensure during that period, not to exceed 120 hours.

The committee shall act on the petition pursuant to the Administrative Process Act (§ 2.2-4000, et seq. of the Code of Virginia).

Part III

Practice of Licensed Certified Midwives

18VAC90-70-110. Practice of licensed certified midwives.

A. All licensed certified midwives shall practice in accordance with a written or electronic practice agreement as defined in 18VAC90-70-10.

B. The written or electronic practice agreement shall include provisions for the availability of the physician for routine and urgent consultation on patient care.

C. The practice agreement shall be maintained by the licensed certified midwife and provided to the boards upon request. For licensed certified midwives providing care to patients within a hospital or health care system, the practice agreement may be included as part of documents delineating the licensed certified midwife's clinical privileges or the electronic or written delineation of duties and responsibilities; however, the licensed certified midwife shall be responsible for providing a copy to the boards upon request.

D. The practice of licensed certified midwives shall be consistent with the standards of care for the profession.

E. The licensed certified midwife shall include on each prescription issued or dispensed the licensed certified midwife's signature and Drug Enforcement Administration (DEA) number, when applicable.

F. The licensed certified midwife shall disclose to patients at the initial encounter that the licensed certified midwife is a licensed certified midwife. Such disclosure may be included on a prescription or may be given in writing to the patient.

G. A licensed certified midwife who provides health care services to a patient outside of a hospital or birthing center shall disclose to that patient, when appropriate, information on health risks associated with births outside of a hospital or birthing center, including 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.

H. The licensed certified midwife shall disclose, upon request of a patient or a patient's legal representative, the name of the consulting physician, and information regarding how to contact the consulting physician.

Part IV

Prescribing

18VAC90-70-120. Prescribing for self or family.

A. Treating or prescribing shall be based on a bona fide practitioner-patient relationship, and prescribing shall meet the criteria set forth in § 54.1-3303 of the Code of Virginia.

B. A licensed certified midwife shall not prescribe a controlled substance to himself or a family member, other than Schedule VI as defined in § 54.1-3455 of the Code of Virginia, unless the prescribing occurs in an emergency situation or in isolated settings where there is no other qualified practitioner available to the patient, or it is for a single episode of an acute illness through one prescribed course of medication.

C. When treating or prescribing for self or family, the licensed certified midwife shall maintain a patient record documenting compliance with statutory criteria for a bona fide practitioner-patient relationship.

18VAC90-70-130. Waiver for electronic prescribing.

A. A prescription for a controlled substance that contains an opioid shall be issued as an electronic prescription consistent with § 54.1-3408.02 of the Code of Virginia, unless the prescription qualifies for an exemption as set forth in § 54.1-3408.02 C.

B. Upon written request, the boards may grant a one-time waiver of the requirement of subsection A of this section for a period not to exceed one year, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the prescriber, or other exceptional circumstances demonstrated by the prescriber.

Part V

Management of Acute Pain

18VAC90-70-140. Evaluation of the patient for acute pain.

A. The requirements of this part shall not apply to:

1. The treatment of acute pain related to (i) cancer, (ii) sickle cell, (iii) a patient in hospice care, or (iv) a patient in palliative care;

2. The treatment of acute pain during an inpatient hospital admission or in a nursing home or an assisted living facility that uses a sole source pharmacy; or

3. A patient enrolled in a clinical trial as authorized by state or federal law.

B. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. If an opioid is considered necessary for the treatment of acute pain, the practitioner shall give a short-acting opioid in the lowest effective dose for the fewest possible days.

C. Prior to initiating treatment with a controlled substance containing an opioid for a complaint of acute pain, the prescriber shall perform a history and physical examination appropriate to the complaint, query the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia, and conduct an assessment of the patient's history and risk of substance misuse as a part of the initial evaluation.

18VAC90-70-150. Treatment of acute pain with opioids.

A. Initiation of opioid treatment for patients with acute pain shall be with short-acting opioids.

1. A prescriber providing treatment for a patient with acute pain shall not prescribe a controlled substance containing an opioid in a quantity that exceeds a seven-day supply as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the medical record. This shall also apply to prescriptions of a controlled substance containing an opioid upon discharge from an emergency department.

2. An opioid prescribed as part of treatment for a surgical procedure shall be for no more than 14 consecutive days in accordance with manufacturer's direction and within the immediate perioperative period, unless extenuating circumstances are clearly documented in the medical record.

B. Initiation of opioid treatment for all patients shall include the following:

1. The practitioner shall carefully consider and document in the medical record the reasons to exceed 50 MME per day.

2. Prior to exceeding 120 MME per day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist.

3. Naloxone shall be prescribed for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME per day, or concomitant benzodiazepine are present.

C. Due to a higher risk of fatal overdose when opioids are used with benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

D. Buprenorphine is not indicated for acute pain in the outpatient setting, except when a prescriber who has obtained a U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) waiver is treating pain in a patient whose primary diagnosis is the disease of addiction.

18VAC90-70-160. Medical records for acute pain.

The medical record shall include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan, and the medication prescribed or administered to include the date, type, dosage, and quantity prescribed or administered.

Part VI

Management of Chronic Pain

18VAC90-70-170. Evaluation of the chronic pain patient.

A. The requirements of this part shall not apply to:

1. The treatment of chronic pain related to (i) cancer, (ii) sickle cell, (iii) a patient in hospice care, or (iv) a patient in palliative care;

2. The treatment of chronic pain during an inpatient hospital admission or in a nursing home or an assisted living facility that uses a sole source pharmacy; or

3. A patient enrolled in a clinical trial as authorized by state or federal law.

B. Prior to initiating management of chronic pain with a controlled substance containing an opioid, a medical history and physical examination, to include a mental status examination, shall be performed and documented in the medical record, including:

1. The nature and intensity of the pain;

2. Current and past treatments for pain;

3. Underlying or coexisting diseases or conditions;

4. The effect of the pain on physical and psychological function, quality of life, and activities of daily living;

5. Psychiatric, addiction, and substance misuse histories of the patient and any family history of addiction or substance misuse;

6. A urine drug screen or serum medication level;

7. A query of the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia;

8. An assessment of the patient's history and risk of substance misuse; and

9. A request for prior applicable records.

C. Prior to initiating opioid analgesia for chronic pain, the practitioner shall discuss with the patient the known risks and benefits of opioid therapy and the responsibilities of the patient during treatment to include securely storing the drug and properly disposing of any unwanted or unused drugs. The practitioner shall also discuss with the patient an exit strategy for the discontinuation of opioids in the event they are not effective.

18VAC90-70-180. Treatment of chronic pain with opioids.

A. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids.

B. In initiating opioid treatment for all patients, the practitioner shall:

1. Carefully consider and document in the medical record the reasons to exceed 50 MME per day;

2. Prior to exceeding 120 MME per day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist;

3. Prescribe naloxone for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME per day, or concomitant benzodiazepine are present; and

4. Document the rationale to continue opioid therapy every three months.

C. Buprenorphine mono-product in tablet form shall not be prescribed for chronic pain.

D. Due to a higher risk of fatal overdose when opioids, including buprenorphine, are given with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

E. The practitioner shall regularly evaluate for opioid use disorder and shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation for treatment if indicated.

18VAC90-70-190. Treatment plan for chronic pain.

A. The medical record shall include a treatment plan that states measures to be used to determine progress in treatment, including pain relief and improved physical and psychosocial function, quality of life, and daily activities.

B. The treatment plan shall include further diagnostic evaluations and other treatment modalities or rehabilitation that may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

C. The prescriber shall record in the medical records the presence or absence of any indicators for medication misuse or diversion and take appropriate action.

18VAC90-70-200. Informed consent and agreement to treatment of chronic pain.

A. The practitioner shall document in the medical record informed consent, to include risks, benefits, and alternative approaches, prior to the initiation of opioids for chronic pain.

B. There shall be a written treatment agreement, signed by the patient, in the medical record that addresses the parameters of treatment, including those behaviors that will result in referral to a higher level of care, cessation of treatment, or dismissal from care.

C. The treatment agreement shall include notice that the practitioner will query and receive reports from the Prescription Monitoring Program and permission for the practitioner to:

1. Obtain urine drug screen or serum medication levels, when requested; and

2. Consult with other prescribers or dispensing pharmacists for the patient.

D. Expected outcomes shall be documented in the medical record, including improvement in pain relief and function or simply in pain relief. Limitations and side effects of chronic opioid therapy shall be documented in the medical record.

18VAC90-70-210. Opioid therapy for chronic pain.

A. The practitioner shall review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health at least every three months.

B. Continuation of treatment with opioids shall be supported by documentation of continued benefit from the prescribing. If the patient's progress is unsatisfactory, the practitioner shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

C. Practitioners shall check the Prescription Monitoring Program at least every three months after the initiation of treatment.

D. The practitioner shall order and review a urine drug screen or serum medication levels at the initiation of chronic pain management and thereafter randomly at the discretion of the practitioner but at least once a year.

E. The practitioner shall regularly evaluate for opioid use disorder and shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation for treatment if indicated.

18VAC90-70-220. Additional consultation.

A. When necessary to achieve treatment goals, the prescriber shall refer the patient for additional evaluation and treatment.

B. When a practitioner makes the diagnosis of opioid use disorder, treatment for opioid use disorder shall be initiated or the patient shall be referred for evaluation and treatment.

18VAC90-70-230. Medical records.

The prescriber shall keep current, accurate, and complete records in an accessible manner and readily available for review to include:

1. The medical history and physical examination;

2. Past medical history;

3. Applicable records from prior treatment providers or any documentation of attempts to obtain those records;

4. Diagnostic, therapeutic, and laboratory results;

5. Evaluations and consultations;

6. Treatment goals;

7. Discussion of risks and benefits;

8. Informed consent and agreement for treatment;

9. Treatments;

10. Medications, including date, type, dosage and quantity prescribed, and refills;

11. Patient instructions; and

12. Periodic reviews.

Part VII

Disciplinary Provisions

18VAC90-70-240. Grounds for disciplinary action against the license of a certified midwife.

The boards may deny licensure or relicensure, revoke or suspend the license, or place on probation, censure, reprimand, or impose a monetary penalty on a licensed certified midwife for the following unprofessional conduct:

1. Has had licensure to practice midwifery in this Commonwealth or in another jurisdiction revoked or suspended or otherwise disciplined;

2. Has directly or indirectly held himself out or represented himself to the public as a physician or is able to, or will practice independently of a physician;

3. Has performed procedures or techniques that are outside the scope of practice as a licensed certified midwife and for which the licensed certified midwife is not trained and individually competent;

4. Has violated or cooperated in the violation of the laws or regulations governing the practice of medicine, nursing, or certified midwifery;

5. Has become unable to practice with reasonable skill and safety as the result of physical or mental illness or the exces­sive use of alcohol, drugs, narcotics, chemicals, or any other type of material;

6. Has violated or cooperated with others in violating or attempting to violate any law or regulation, state or federal, relating to the possession, use, dispensing, administration, or distribution of drugs;

7. Has failed to comply with continuing competency requirements as set forth in 18VAC90-70-90;

8. Has willfully or negligently breached the confidentiality between a practitioner and a patient. A breach of confidentiality that is required or permitted by applicable law or beyond the control of the practitioner shall not be considered negligent or willful;

9. Has engaged in unauthorized use or disclosure of confidential information received from the Prescription Monitoring Program; or

10. Has practiced as a licensed certified midwife during a time when the practitioner's certification as a certified midwife by the American Midwifery Certification Board has lapsed.

18VAC90-70-250. Hearings.

A. The provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) shall govern proceedings on questions of violation of 18VAC90-70-240.

B. The Committee of the Joint Boards of Nursing and Medicine shall conduct all proceedings prescribed in this chapter and shall take action on behalf of the boards.

18VAC90-70-260. Delegation of proceedings.

A. Decision to delegate. In accordance with subdivision 10 of § 54.1-2400 of the Code of Virginia, the committee may delegate an informal fact-finding proceeding to an agency subordinate upon determination that probable cause exists that a licensed certified midwife may be subject to a disciplinary action.

B. Criteria for delegation. Cases that involve intentional or negligent conduct that caused serious injury or harm to a patient may not be delegated to an agency subordinate, except as may be approved by the chair of the committee.

C. Criteria for an agency subordinate.

1. An agency subordinate authorized by the committee to conduct an informal fact-finding proceeding may include current or past board members, professional staff, or other persons deemed knowledgeable by virtue of their training and experience in administrative proceedings involving the regulation and discipline of health professionals.

2. The Executive Director of the Board of Nursing shall maintain a list of appropriately qualified persons to whom an informal fact-finding proceeding may be delegated.

3. The committee may delegate to the executive director the selection of the agency subordinate who is deemed appropriately qualified to conduct a proceeding based on the qualifications of the subordinate and the type of case being heard.

DOCUMENTS INCORPORATED BY REFERENCE (18VAC90-70)

Standards for the Practice of Midwifery, revised 2011, American College of Nurse-Midwives