Title of Regulation: 18VAC85-20. Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (amending 18VAC85-20-320, 18VAC85-20-340, 18VAC85-20-350, 18VAC85-20-370, 18VAC85-20-380).

Statutory Authority: §§ 54.1-2400 and 54.1-2912.1 of the Code of Virginia.

Public Hearing Information:

December 4, 2015 - 8:30 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233-1463

Public Comment Deadline: January 29, 2016.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Medicine the authority to promulgate regulations to administer the regulatory system. Specific authority for regulation of office-based anesthesia is found in § 54.1-2912.1 of the Code of Virginia.

Purpose: A Notice of Intended Regulatory Action was approved by the Board of Medicine on October 16, 2014, in response to a petition for rulemaking from the Medical Society of Virginia. The intent of the board is to address the need for additional public protection in the administration of office-based anesthesia. As more medical and surgical procedures are being performed in office-based settings, there is a greater need for standards in the administration of anesthesia to address possible consequences that could result in an emergency transport to a hospital and even in the death of a patient. Therefore, changes are recommended in the applicability of requirements for office-based anesthesia, documentation of complications, duration of such a procedure, informed consent by patient of the anesthesia plan, discharge planning, and emergency transfer protocols. The board adopted regulatory changes as necessary to protect the health and safety of patients who undergo procedures in office-based settings.

Substance: Amendments to the requirements for office-based anesthesia are adopted to (i) include the administration of 300 milligrams or more of lidocaine under the applicability of the requirements; (ii) ensure that the patient has adequate information in giving informed consent, including knowledge about whether the physician is board certified or board eligible; (iii) require documentation of complications during surgery or recovery; (iv) set a time limit on procedures that may be performed in an office; (v) specify the availability of a hospital to which a patient may be transferred; and (vi) specify that the anesthesia provider or the doctor supervising the anesthesia must give the order for discharge.

Issues: The primary advantage to the public is greater protection for office-based procedures requiring moderate sedation or anesthesia and more information about the physician, the plan for anesthesia and expectations for discharge. There are no disadvantages to the public. There are no advantages or disadvantages to the agency or the Commonwealth. This proposal was carefully negotiated with specialty groups of physicians to ensure that the central issue remained public protection but qualified providers were not excluded.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. In response to a petition for rulemaking from the Medical Society of Virginia, the Board of Medicine (Board) proposes to amend its requirements for office-based anesthesia to: 1) define the administration of 300 milligrams or more of lidocaine (or equivalent doses of local anesthetics) as moderate sedation that is subject to the requirements of this regulation, 2) limit the duration of a procedure that include sedation that falls under the requirements of this regulation to last no longer than four hours if the anesthesia is not administered by an anesthesiologist or a certified registered nurse anesthetist or eight hours if anesthesia is administered by one of these entities and 3) define "reasonable proximity" for the safe transfer of patients to a hospital in case of an emergency as "accessible within 30 minutes of the office." The Board also proposes several clarifying changes that will likely not affect costs.

Result of Analysis. There is insufficient information to ascertain whether benefits will outweigh costs for one proposed substantive change. Benefits likely outweigh costs for all proposed clarifying changes and the two other proposed substantive changes.

Estimated Economic Impact. Current regulation applies to "the administration of moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive block" in an office setting. On the recommendation of the Medical Society of Virginia, and particularly plastic surgeons that are part of that group, the Board proposes to also require that any procedure that involves the administration of 300 milligrams or more of lidocaine (or equivalent doses of local anesthesia) be subject to this regulation. This would mean that doctors who choose to use lidocaine or other local anesthetics in the described dosages as a part of an office surgery or procedure would newly have to follow all the requirements laid out in this regulation including: ensuring a pre-anesthetic check-up is performed, developing an anesthesia plan and having written protocols for office-based anesthesia, procedure selection and patient evaluation. Doctors' offices where such procedures are performed would also newly be required to be within reasonable proximity of a licensed general hospital capable of providing necessary emergency services (within 30 minutes' drive, according to the proposed regulation).

This new requirement will likely increase costs (or decrease revenue) for doctors who perform office-based procedures or surgeries under lidocaine or other local anesthetics; these doctors will either incur additional bookkeeping and other time costs for any procedure that requires these local anesthetics, have to stop performing those procedures if they know or suspect that the patient will require 300 milligrams or more of lidocaine (or equivalent for other local anesthetics) or will have to switch to other, presumably less optimal, forms of anesthesia. Specifically, doctors will definitely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether. Affected patients will likely also incur costs on account of pre-anesthesia checkup requirements as well as other requirements that would extend the time and doctor resources required to care for them.

Research indicates that lidocaine is given in doses that vary according to the weight of the patient. Specifically, Drugs.com¹ reports that the usual adult dose for lidocaine used as a local anesthetic "varies with procedure, degree of anesthesia needed, vascularity of tissue, duration of anesthesia required and physical condition of (the) patient" but can go up to a maximum dosage of 4.5 milligrams per kilogram of weight not more than every two hours. The website for the University of Iowa Healthcare System² reports that the maximum safe dosage of lidocaine without epinephrine for pediatric patients is 4 milligrams per kilogram of weight. This means that for adults, any procedure involving administration of the maximum safe dosage of lidocaine for patients weighing more than approximately 147 lbs.³ would automatically fall under the more stringent rules for moderate or deep sedation or general anesthesia even if that patient is in excellent general health and would otherwise not need the heightened scrutiny and care plans required under this regulation.

In addition to disproportionately affecting patients that weigh more than 147 pounds, this requirement may have a disproportionate adverse impact on patients that live in rural parts of Virginia that do not have a local hospital within 30 minutes. Patients that now can have minor procedures or surgeries involving lidocaine (300 milligrams of more) in a local doctor's office would, under the proposed requirement, have to incur travel expenses, and possibly higher medical costs to have that procedure or surgery done either at a hospital or at a non-local doctor's office that is close enough to a hospital to meet the requirements of this regulation. All of these potential costs would have to be measured against the possible benefits to patients of limiting the absolute amount of lidocaine that can be used in a procedure without enhanced requirements kicking in. There is currently insufficient information on the magnitude of potential benefits that may accrue on account of this change to ascertain whether benefits will outweigh costs.

Current regulation does not set a limit on the duration of in-office surgeries using moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive blocks but only requires that such surgeries be "of a duration and degree of complexity that will permit the patient to recover and be discharged from the facility in less than 24 hours." The Board now proposes to specify that surgeries occurring under the auspices of this regulation may last no longer than four hours if the anesthesia is not administered by an anesthesiologist or a certified registered nurse anesthetist or eight hours if anesthesia is administered by one of these entities. Because research indicates⁴ that the odds of a whole host of potential side effects and adverse outcomes increase as the length of time spent under anesthesia increases, patients will likely benefit from this restriction. Patient benefits will likely outweigh any costs doctors incur for not being able to perform surgeries over four (or eight) hours in their offices.

Current regulation requires that doctors who perform in-office surgery using moderate sedation/conscience sedation, deep sedation, general anesthesia or regional anesthesia consisting of a major conductive blocks be able to transfer their patients to a hospital in "reasonable proximity" to their office. The Board now proposes to specify that reasonable proximity is within 30 minutes of the doctor's office. Although the actual specified time is new, it is likely that the Board already enforced this provision using the same or similar time limits. In any case, all affected entities in both the regulated and regulating community will likely benefit from the additional certainty that this change will bring.

Businesses and Entities Affected. Board staff reports that these changes will potentially affect all Board licensed doctors of medicine, osteopathy and podiatry that perform surgeries in their offices as well as all of these doctors' patients.

Localities Particularly Affected. Rural communities that are not in close proximity to a hospital will be disproportionately affected by these proposed changes.

Projected Impact on Employment. These proposed changes may moderately decrease employment in doctors' offices that currently are not subject to these regulations but will become subject to them on account of the proposed changes.

Effects on the Use and Value of Private Property. The value of some medical, osteopathic or podiatric practices may decrease if they incur costs on account of these proposed changes.

Real Estate Development Costs. These proposed changes will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant 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."

Costs and Other Effects. Small business doctors will likely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether.

Alternative Method that Minimizes Adverse Impact. Doctors and their patients would incur fewer costs if lidocaine standards were written so that any imposed limit on the amount of lidocaine is evidence based and varies directly with the weight of the patient as that appears to be the way lidocaine is administered.

Adverse Impacts:

Businesses: Doctors who own their practices will likely incur additional costs that accrue on a per patient basis (such as time spent either performing pre-anesthesia checkups or ensuring that such checkups have been performed) but will only incur time and other costs for writing and keeping required protocols if they only perform in-office surgeries that are currently exempt from this regulation but will not be exempt under the proposed regulation. Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal, anesthesia or stop performing the surgeries they now offer altogether.

Localities: Rural localities that currently do not have a hospital in close proximity (as defined by this proposed regulation) may see a disproportionate adverse impact on the availability of minor out-patient surgical services offered.

Other Entities: The proposed changing categorization of lidocaine in doses at or over 300 milligrams (or like amounts of other local anesthetics) may have a disproportionate adverse impact on patients that live in rural parts of Virginia who do not have a local hospital within 30 minutes. Patients who now can have minor procedures or surgeries involving lidocaine (300 milligrams of more) in a local doctor's office would, under the proposed requirement, have to incur travel expenses and possibly higher medical costs to have that procedure or surgery done either at a hospital or at a non-local doctor's office that is close enough to a hospital to meet the requirements of this regulation.

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¹http://www.drugs.com/dosage/lidocaine.html

²https://wiki.uiowa.edu/display/protocols/Maximum+Recommended+Doses+and+Duration+of+Local+Anesthetics

³300/4.5= 66.6666666667 kilograms which is just shy of 147 pounds.

⁴See, for instance, "Duration of General Anesthesia and Surgical Outcome": Yoho, Robert, et al. (http://www.dryoho.com/dr-yoho/clinical/duration_anesthesia.pdf). This study notes that research found the odds of patient death, post-operative nausea and vomiting, venous thromboemboli, post-operative surgical site S. aureus infection, post-operative core hypothermia and cardiopulmonary complication increased either as time under anesthesia increased or in surgeries over a certain duration (in this study, either two or three hours).

Agency's Response to Economic Impact Analysis: The Board of Medicine submits the following response to the analysis of the Department of Planning and Budget (DPB) of amendments to 18VAC85-20, Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry and Chiropractic, relating to rules for office-based anesthesia.

As the petitioner for the proposed regulations, the Medical Society of Virginia (MSV) was asked to comment on the DPB analysis. The board concurs with the comments listed below:

MSV agrees with the DBP analysis that "Benefits likely outweigh costs for all proposed clarifying changes and two other proposed substantive changes.

As to DPB's analysis of what we presume they are referring to as "one proposed substantive change," we do concur that the ability to accurately quantify whether or not the benefits exceed the costs is not a precise calculation. However, several of the items noted by the DPB analysis as potentially increasing costs may indeed already be part of a physician's routine standard of care. For example, a pre-anesthetic check-up, an anesthesia plan, and written protocols for office-based anesthesia, procedure selection, and patient evaluation are accepted, specialty developed standards of care for physicians routinely performing these procedures. Though the proposed regulations may increase costs for those physicians not currently following these standards, we believe that number to be relatively limited, that some may elect to do this voluntarily, but that for those who choose not to follow accepted quality and safety standards, appropriate regulations may create the added incentive needed for proper patient care.

The analysis also suggests that "Doctors who now only perform surgery and procedures requiring minor, local or topical anesthesia, and whose offices are more than 30 minutes from a hospital would either have to move offices, switch to using other, presumably less optimal anesthesia or stop performing the surgeries they now offer altogether" and therefore would incur higher costs or less revenue. It is the MSV's understanding that doctors only performing surgery that involves the administration of topical anesthesia, local anesthesia, minor conductive blocks, or minimal sedation/anxiolysis that do not result in alteration of consciousness beyond minimal pre-operative tranquilization are not subject to these regulations. (See 18VAC85-20-320 A 1 - Applicability of requirements for office-based anesthesia). Therefore, additional costs would not be incurred.

In addition, the DPB analysis discusses the application of the 300 milligrams or more of lidocaine as the base threshold for complying with these regulations and the extent to which it would apply based upon a dosage to weight ratio. The MSV work group that developed these proposed regulations consisted of board certified physicians from several specialties, including family practice, plastic surgery, orthopedics, and pediatrics. The 300 milligrams dosage was chosen for these proposed regulations in order to provide for an amount that was easily understood, measurable, applicable across the board, and recognized by other states with comparable regulations on office-based anesthesia. Further, the use of 300 mg or more of lidocaine for certain prolonged invasive procedures when it is not used primarily as a local anesthetic is not always the best practice and will signal to the physician that an alternative, more appropriate anesthetic agent should be used. Guidelines and trigger warnings like these can be readily captured in written protocols for office-based anesthesia, leading to better and safer quality of care.

Summary:

The proposed amendments (i) define the administration of 300 milligrams or more of lidocaine as moderate sedation, (ii) address informed consent by patients, including knowledge about whether the physician is board certified or board eligible, (iii) require documentation of complications during surgery or recovery, (iv) establish a time limit on procedures that may be performed in an office, (v) address proximity to a hospital to which a patient may be transferred, and (vi) specify that the anesthesia provider or the doctor supervising the anesthesia must give the order for discharge.

18VAC85-20-320. General provisions.

A. Applicability of requirements for office-based anesthesia.

1. The administration of topical anesthesia, local anesthesia, minor conductive blocks, or minimal sedation/anxiolysis, not involving a drug-induced alteration of consciousness other than minimal preoperative tranquilization, is not subject to the requirements for office-based anesthesia in this part. A health care practitioner administering such agents shall adhere to an accepted standard of care as appropriate to the level of anesthesia or sedation, including evaluation, drug selection, administration, and management of complications.

2. The administration of moderate sedation/conscious sedation, deep sedation, general anesthesia, or regional anesthesia consisting of a major conductive block are subject to these requirements for office-based anesthesia in this part. The administration of 300 milligrams or more of lidocaine or equivalent doses of local anesthetics shall be deemed to be subject to these requirements for office-based anesthesia in this part.

3. Levels of anesthesia or sedation referred to in this chapter shall relate to the level of anesthesia or sedation intended and documented by the practitioner in the preoperative anesthesia plan.

B. A doctor of medicine, osteopathic medicine, or podiatry administering office-based anesthesia or supervising such administration shall:

1. Perform a preanesthetic evaluation and examination or ensure that it has been performed;

2. Develop the anesthesia plan or ensure that it has been developed;

3. Ensure that the anesthesia plan has been discussed with the patient or responsible party preoperatively and informed consent has been obtained;

4. Ensure patient assessment and monitoring through the pre-, peri- preprocedure, periprocedure, and post-procedure phases, addressing not only physical and functional status, but also physiological and cognitive status;

5. Ensure provision of indicated post-anesthesia care; and

6. Remain physically present or immediately available, as appropriate, to manage complications and emergencies until discharge criteria have been met; and

7. Document any complications occurring during surgery or during recovery in the medical record.

C. All written policies, procedures, and protocols required for office-based anesthesia shall be maintained and available for inspection at the facility.

18VAC85-20-340. Procedure/anesthesia selection and patient evaluation.

A. A written protocol shall be developed and followed for procedure selection to include but not be limited to:

1. The doctor providing or supervising the anesthesia shall ensure that the procedure to be undertaken is within the scope of practice of the health care practitioners and the capabilities of the facility.

2. The procedure or combined procedures shall be of a duration and degree of complexity that shall not exceed four hours and that will permit the patient to recover and be discharged from the facility in less than 24 hours. The procedure or combined procedures may be extended for up to eight hours if the anesthesia is provided by an anesthesiologist or a certified registered nurse anesthesist.

3. The level of anesthesia used shall be appropriate for the patient, the surgical procedure, the clinical setting, the education and training of the personnel, and the equipment available. The choice of specific anesthesia agents and techniques shall focus on providing an anesthetic that will be effective, and appropriate and will address the specific needs of patients while also ensuring rapid recovery to normal function with maximum efforts to control post-operative pain, nausea, or other side effects.

B. A written protocol shall be developed for patient evaluation to include but not be limited to:

1. The preoperative anesthesia evaluation of a patient shall be performed by the health care practitioner administering the anesthesia or supervising the administration of anesthesia. It shall consist of performing an appropriate history and physical examination, determining the patient's physical status classification, developing a plan of anesthesia care, acquainting the patient or the responsible individual with the proposed plan, and discussing the risks and benefits.

2. The condition of the patient, specific morbidities that complicate anesthetic management, the specific intrinsic risks involved, and the nature of the planned procedure shall be considered in evaluating a patient for office-based anesthesia.

3. Patients who have pre-existing medical or other conditions that may be of particular risk for complications shall be referred to a facility appropriate for the procedure and administration of anesthesia. Nothing relieves the licensed health care practitioner of the responsibility to make a medical determination of the appropriate surgical facility or setting.

C. Office-based anesthesia shall only be provided for patients in physical status classifications for Classes I, II and III. Patients in Classes IV and V shall not be provided anesthesia in an office-based setting.

18VAC85-20-350. Informed consent.

A. Prior to administration, the anesthesia plan shall be discussed with the patient or responsible party by the health care practitioner administering the anesthesia or supervising the administration of anesthesia. Informed consent for the nature and objectives of the anesthesia planned shall be in writing and obtained from the patient or responsible party before the procedure is performed. Such consent shall include a discussion of discharge planning and what care or assistance the patient is expected to require after discharge. Informed consent shall only be obtained after a discussion of the risks, benefits, and alternatives, contain the name of the anesthesia provider, and be documented in the medical record.

B. The surgical consent forms shall be executed by the patient or the responsible party and shall contain a statement that the doctor performing the surgery is board certified or board eligible by one of the American Board of Medical Specialties boards, the Bureau of Osteopathic Specialists of the American Osteopathic Association, or the American Board of Foot and Ankle Surgery. The forms shall either list which board or contain a statement that doctor performing the surgery is not board certified or board eligible.

C. The surgical consent forms shall indicate whether the surgery is elective or medically necessary. If a consent is obtained in an emergency, the surgical consent form shall indicate the nature of the emergency.

18VAC85-20-370. Emergency and transfer protocols.

A. There shall be written protocols for handling emergency situations, including medical emergencies and internal and external disasters. All personnel shall be appropriately trained in and regularly review the protocols and the equipment and procedures for handing handling emergencies.

B. There shall be written protocols for the timely and safe transfer of patients to a prespecified hospital or hospitals within a reasonable proximity. For purposes of this section, "reasonable proximity" shall mean that a licensed general hospital capable of providing necessary services is normally accessible within 30 minutes of the office. There shall be a written or electronic transfer agreement with such hospital or hospitals.

18VAC85-20-380. Discharge policies and procedures.

A. There shall be written policies and procedures outlining discharge criteria. Such criteria shall include stable vital signs, responsiveness and orientation, ability to move voluntarily, controlled pain, and minimal nausea and vomiting.

B. Discharge from anesthesia care is the responsibility of the health care practitioner providing or the doctor supervising the anesthesia care and shall only occur when patients have:

1. The patient has met specific physician-defined criteria; and

2. The health care practitioner providing or the doctor supervising the anesthetic care has given the order for discharge.

C. Written instructions and an emergency phone number shall be provided to the patient. Patients shall be discharged with a responsible individual who has been instructed with regard to the patient's care.

D. At least one person trained in advanced resuscitative techniques shall be immediately available until all patients are discharged.