Title of Regulation: 18VAC112-20. Regulations Governing the Practice of Physical Therapy (adding 18VAC112-20-121).

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

Public Hearing Information:

June 27, 2019 - 9 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, 2nd Floor Conference Center, Hearing Room 3 Henrico, VA 23233

Public Comment Deadline: July 6, 2019.

Agency Contact: Corie Tillman Wolf, Executive Director, Board of Physical Therapy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4674, FAX (804) 527-4413, or email ptboard@dhp.virginia.gov.

Basis: Regulations Governing the Practice of Physical Therapy (18VAC112-20) are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Physical Therapy the authority to promulgate regulations to administer the regulatory system.

Purpose: The purpose of the action is to specify the qualifications for and limitations of the practice of dry needling as performed by physical therapists. For physical therapists, dry needling is not an entry level skill for which competency has been assured through an accredited educational program and national examination. It is an advanced procedure that requires additional training, referral and direction, and informed consent. Without a regulatory standard, the board cannot hold a physical therapist accountable for requirements specific to dry needling. Therefore, the board has determined that regulations are necessary to protect the health and safety of patients who may receive dry needling in the course of a physical therapy treatment.

Substance: Upon recommendation of a regulatory advisory panel, which was convened to consider comment on proposed regulations and to identify any additional safeguards that should be included in regulation, the following clarifications and changes have been proposed:

18VAC112-20-121 B states that dry needling is not an entry level skill but an advanced procedure that requires additional training. The term "post-graduate" is added to clarify that the additional training must occur subsequent to a physical therapist's graduate education in physical therapy.

18VAC112-20-121 B 2 specifies that the training must consist of didactic and hands-on laboratory education and must include passage of a theoretical and practical examination. The hands-on laboratory education shall be face-to-face.

18VAC112-20-121 B 3 specifies that the training must be in a course certified by the Federation of State Boards of Physical Therapy or approved or provided by a sponsor listed in regulations on continuing education.

18VAC112-20-121 B 4 specifies that the practitioner shall not practice beyond the scope of the highest level of the practitioner's training.

18VAC112-20-121 C is amended to delete a requirement that the informed consent must clearly state that the patient is not receiving an acupuncture treatment.

18VAC112-20-121 D is added to provide that dry needling can only be performed by a physical therapist trained pursuant to 18VAC112-20-121 B and cannot be delegated to a physical therapist assistant or other support personnel.

Issues: The board believes the proposed regulation offers the advantage of protection for patients who receive a dry needling procedure during the course of physical therapy treatment. Regulatory requirements for referral, training, and informed consent provide greater assurance of competency and accountability than the guidance document that currently exists. The board does not believe there are disadvantages to the public as the procedure is limited in scope and relatively safe to perform.

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. The Board of Physical Therapy (the board) proposes to add to its main regulation provisions regarding the practice of dry needling including referral, training, informed consent, and disclosure requirements.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Dry needling is a technique used in the practice of physical therapy to treat muscle tension and pain by inserting a special type of needle into areas of the muscle known as trigger points. According to the board, dry needling has been performed by physical therapists in Virginia for more than a decade. Currently, physical therapists performing the procedure are subject to the board's guidance document 112-9, which sets out referral, training, informed consent, and disclosure requirements for practice of dry needling.¹ The board proposes to add to this regulation provisions that are substantially similar to those in the guidance document. Adding these provisions to the regulation should not create any significant economic effects as there will be no change in practice. One notable exception is that 54 hours of post-professional training is required under the guidance while the proposed regulation does not state a specific number of training hours. This provision is not being added because the scope and content of each training may be different. However, a practitioner is not permitted to perform dry needling beyond the scope of the highest level of his training.

According to the board, if a physical therapist who has not received education and training in dry needling chooses to add it as a modality for his/her patients, there are a variety of courses offered. Most involve multi-day seminars with hands-on training and cost approximately $1,000. Thus, under the regulations, some physical therapists may be able to obtain sufficient training at less than the current cost while some others may have to incur a larger cost. In any event, practice of dry needling is voluntary, and by choosing to offer it as a modality, a therapist reveals that expected benefits to him or her are greater than the expected costs.

The board also notes that without a regulatory standard, a physical therapist cannot be held accountable for requirements specific to dry needling. Thus, having the requirements in regulations could improve enforcement, should there be a violation.²

Businesses and Entities Affected. Currently, there are 7,786 physical therapists licensed in Virginia. Not all of the physical therapists perform dry needling.

Localities Particularly Affected. The proposed changes apply statewide.

Projected Impact on Employment. No impact on employment is expected.

Effects on the Use and Value of Private Property. No impact on the use and value of private property is expected.

Real Estate Development Costs. No impact on real estate development costs is expected.

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. Most if not all of the physical therapists work in offices that are small business.

Alternative Method that Minimizes Adverse Impact

No adverse impact on small businesses is expected.

Adverse Impacts:

Businesses. The proposed amendments do not have an adverse impact on businesses.

Localities. The proposed amendments will not adversely affect localities.

Other Entities. The proposed amendments will not adversely affect other entities.

________________________

¹This guidance document posted on the Regulatory Town Hall on August 2010 can be found at: http://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\GuidanceDocs\223\GDoc_DHP_3650_v2.pdf

²DHP is unaware of any complaints regarding the practice of dry needling by physical therapists at least since 2010 when the guidance was adopted.

Agency's Response to Economic Impact Analysis: The Board of Physical Therapy concurs with the analysis of the Department of Planning and Budget.

Summary:

This action establishes the qualifications for and limitations of the performance of dry needling by physical therapists, including referral and direction from a medical practitioner, training, requirements for additional post-graduate training, the content of the post-graduate training, and informed consent.

18VAC112-20-121. Practice of dry needling.

A. Dry needling is an invasive procedure that requires referral and direction in accordance with § 54.1-3482 of the Code of Virginia. Referral should be in writing; if the initial referral is received orally, it shall be followed up with a written referral.

B. Dry needling is not an entry level skill but an advanced procedure that requires additional [ post-graduate ] training.

[ 1. ] The training shall be specific to dry needling and shall include emergency preparedness and response, contraindications and precautions, secondary effects or complications, palpation and needle techniques, and physiological responses.

[ 2. The training shall consist of didactic and hands-on laboratory education and shall include passage of a theoretical and practical examination. The hands-on laboratory education shall be face-to-face.

3. The training shall be in a course certified by FSBPT or approved or provided by a sponsor listed in subsection B of 18VAC112-20-131.

4. The practitioner shall not perform dry needling beyond the scope of the highest level of the practitioner's training. ]

C. Prior to the performance of dry needling, the physical therapist shall obtain informed consent from the patient or his representative. The informed consent shall include the risks and benefits of the technique [ and shall clearly state that the patient is not receiving an acupuncture treatment ]. The informed consent form shall be maintained in the patient record.

[ D. Dry needling shall only be performed by a physical therapist trained pursuant to subsection B of this section and shall not be delegated to a physical therapist assistant or other support personnel. ]