PROPOSAL and SPECIAL DOCUMENT
Issue Date: November 14, 2016
Volume 43 • Issue 23 • Pages 1287—1289
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 38 BOARD OF PHYSICAL THERAPY EXAMINERS
Authority: Health Occupations Article, §§13-101 and 13-206, Annotated Code of Maryland
Notice of Proposed Action
The Secretary of Health and Mental Hygiene proposes to adopt new Regulations .01—.04 under a new chapter, COMAR 10.38.12 Dry Needling. This action was considered at a public meeting held on October 20, 2015, notice of which was given by publication on the Board’s website at http://dhmh.maryland.gov/bphte pursuant to General Provisions Article, §3-302(c)(3)(ii), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to establish guidelines for the provision of dry needling as an intervention performed by physical therapists.
See “Background and Analysis of Proposal to Establish Guidelines for Dry Needling” in the Special Documents section of this issue of the Maryland Register for further details.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. Physical therapists who have not completed the required training required for dry needling may incur a cost to obtain that training.
II. Types of Economic Impact.
A. On issuing agency:
B. On other State agencies:
C. On local governments:
D. On regulated industries or trade groups:
E. On other industries or trade groups:
F. Direct and indirect effects on public:
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
D. To the extent that a physical therapist has or has not completed the required training to perform dry needling, there will be a cost to the physical therapist. This amount cannot be determined as it will vary between each individual physical therapist.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to firstname.lastname@example.org, or fax to 410-767-6483. Comments will be accepted through December 14, 2016. A public hearing has not been scheduled.
This chapter establishes standards for the provision of dry needling as an intervention performed by physical therapists.
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) 'Board' means the State Board of Physical Therapy Examiners.
(2) 'Dry needling' means a physical therapy intervention, also known as intramuscular manual therapy, that:
(a) Involves the insertion of one or more solid needles, a mechanical device, into the muscle and related tissues to affect change in muscle and related tissues;
(b) Requires ongoing evaluation, assessment, and re-evaluation of the impairments;
(c) Is only utilized in parts of the body with neuromuscular or musculoskeletal links to the impairments; and
(d) Is not performed for:
(i) The purposes of acupuncture as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or
(ii) Any purpose outside the scope of physical therapy.
.03 Minimum Education and Training Necessary to Perform Dry Needling.
A. In order to perform dry needling, a physical therapist shall have at least 80 total hours of instruction, which includes:
(1) A total of at least 40 hours of instruction in the following dry needling-specific course content areas:
(a) Theory and application of dry needling;
(b) Dry needling technique, including spine and extremities;
(c) Dry needling indications and contraindications;
(d) Infection control, the Occupational Safety and Health Administration’s Bloodborne Pathogen Protocol, and safe handling of needles;
(e) Emergency preparedness and response procedures related to complications associated with dry needling; and
(f) Appropriate documentation of dry needling; and
(2) At least 40 hours of practical, hands-on instruction in the application and technique of dry needling, under the supervision of a licensed health care practitioner competent in dry needling procedures who has:
(a) Completed the requisite course work under §A(1) of this regulation; and
(b) Practiced dry needling for at least 5 years.
B. The instruction required under §A(1) of this regulation shall be provided by a continuing education course sponsored by the:
(1) American Physical Therapy Association;
(2) The APTA of Maryland; or
(3) The Federation of State Boards of Physical Therapy.
C. A continuing education course taken before the effective date of this regulation shall qualify for instruction if the same course, in substantially similar form, is later sponsored by the American Physical Therapy Association, the APTA of Maryland, or the Federation of State Boards of Physical Therapy.
D. All instruction required under this regulation shall include an assessment of competency.
E. The instruction required under §A(1) of this regulation shall be offered:
(1) In person at a face-to-face session; or
(2) In real time through electronic means that allow for simultaneous interaction between the instructor and the participants.
F. A physical therapist may not fulfill any portion of the practical, hands-on instruction required under §A(2) of this regulation with online or distance learning.
G. A physical therapist shall have practiced physical therapy for at least 2 years before performing dry needling in the State.
(1) A physical therapist shall be registered with the Board as having the appropriate education and training required by this regulation before the physical therapist may practice dry needling.
(2) In order to be registered to practice dry needling, a phyiscal therapist shall:
(a) Submit a completed application on a form supplied by the Board; and
(b) Pay a registration fee as established by COMAR 10.38.07.
I. A physical therapist who practices dry needling without the education and training required by this regulation shall be subject to discipline pursuant to COMAR 10.38.10.04A(4).
J. This regulation shall take effect 1 year after the effective date of the rest of this chapter.
.04 Standards of Practice in Performing Dry Needling.
A. A physical therapist shall:
(1) Fully explain dry needling to the patient in advance of treatment; and
(2) Obtain written informed consent specific to dry needling that shall be included in the patient’s medical record.
B. A physical therapist shall perform dry needling in a manner consistent with standards set forth in the Maryland Occupational Safety and Health Act, Labor and Employment Article, Title 5, Annotated Code of Maryland.
C. A physical therapist shall document the provision of dry needling services in accordance with the documentation requirements of COMAR 10.38.03.02-1.
D. A physical therapist who practices dry needling in a manner inconsistent with the standards of practice enumerated in this regulation shall be subject to discipline pursuant to COMAR 10.38.10.04A(14).
E. Dry needling is not within the scope of practice of limited physical therapy and shall only be performed by a licensed physical therapist.
VAN T. MITCHELL
Secretary of Health and Mental Hygiene
Issue Date: November 14, 2016
Volume 43 • Issue 23 • Page 1321—1322
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
BACKGROUND AND ANALYSIS OF PROPOSAL TO ESTABLISH GUIDELINES FOR DRY NEEDLING COMAR 10.38.12
On August 31, 2012, the Secretary of Health and Mental Hygiene released a call for public comment on proposed regulations developed by the Board of Physical Therapy Examiners for dry needling as an intervention performed by physical therapists. During the 30-day period following the call for comment, the Department received over 950 comments. Approximately 800 of the comments were in support of physical therapists providing dry needling; a significant portion of those comments were from patients, with additional comments from physical therapists and other health care providers. Approximately 153 of the comments received were in opposition to the practice; these comments were primarily from licensed acupuncturists and organizations representing licensed acupuncturists in Maryland and other states. Following the public comment period, the Secretary requested that the Board modify the regulations in three key areas – adequacy of training, a transition plan for the practice, and oversight of the practice.
After reviewing the Secretary’s request and the public comments, the Board made significant changes to the draft regulations, particularly in the areas identified by the Secretary. The Department is now proposing these regulations, pursuant to State Government Article, §10-101, that would set guidelines for the practice of dry needling by physical therapists beginning July 1, 2017. The Department and the Board have carefully considered input from multiple stakeholders in the development of these regulations and believe that the citizens of Maryland will be served by these proposed regulations.
In the 1980s, Maryland became the first jurisdiction in the United States to allow dry needling by licensed physical therapists, after the Board opined that dry needling was within the scope of the practice of physical therapy. On August 17, 2010, the State Attorney General responded to a request from the State Board of Acupuncture for an opinion concerning the provision of dry needling by physical therapists. Specifically, the questions posed were whether the insertion of “acupuncture needles” into a patient was within the definition of “practice of physical therapy” in Maryland and whether it was appropriate for the Board to include dry needling within the scope of the practice of physical therapy without legislation.[i][i]
The Attorney General noted in his Opinion that “[t]he authority to use acupuncture needles for therapeutic purposes is not necessarily reserved exclusively to licensed acupuncturists.”[ii][ii] The Opinion also states:
“In our opinion, the Physical Therapy Board may determine that dry needling is within the scope of practice of physical therapy if it conducts rulemaking under the State Administrative Procedure Act and adopts a regulation that relates dry needling to the statutory definition of practice of physical therapy.”[iii][iii]
The Opinion clearly noted that the Board should consider standards for education and training that would best ensure public safety during the provision of dry needling.[iv][iv] Following the issuance of the Opinion, the Board set out to adopt a regulation formally relating dry needling to the practice of physical therapy.
The Board engaged many stakeholders during the process of developing the regulations, including experts in the field, the Federation of State Boards of Physical Therapy, the American Physical Therapy Association, physical therapy licensing boards in other states, physical therapy educators, the Board of Acupuncture, the public (including physical therapy licensees in the State), and the Secretary. The Board began by hosting a Dry Needling Task Force, which met on January 6, 2011, to discuss a framework for the regulations. The Board also formed a committee of the Board that met on a regular basis to draft the regulations and met with certain stakeholders, including the Board of Acupuncture. Following the public comment period initiated by the Secretary, the Board undertook some of these steps again to implement the changes requested by the Secretary. This multi-year process has ultimately benefited the citizens of Maryland by increasing the safeguards required for public protection, including those related to education and training.
The Board considered the following topics to be of utmost importance during the development of regulations:
Adequacy of education and training
Definition of dry needling and other terminology
Clean needle requirements and needle management
Limitations on the application of dry needling
Delegation to other personnel
Transition plan for physical therapists currently practicing dry needling
Standards for education and training for physicians who perform acupuncture
As noted above, Maryland became the first jurisdiction to specifically allow dry needling by licensed physical therapists. As of November 30, 2014, 31 of the 53 United States jurisdictions that regulate the practice of physical therapy, including Virginia, West Virginia, and the District of Columbia, specifically allow dry needling by licensed physical therapists; only ten jurisdictions specifically prohibit licensed physical therapists from practicing dry needling.[v][v] In addition, physical therapists in the United States Army and with the United States Department of Veteran Affairs currently utilize dry needling to treat patients. With the proposed regulations, the Board is attempting to regulate this growing area of physical therapy practice in a progressive and proactive fashion, while maintaining its efforts to adequately and responsibly protect the public.
The proposed regulations cover a number of critical areas of concern related to the provision of dry needling, including education and training, needle management techniques, documentation, informed consent, a restriction on delegation, and discipline. The regulations were developed with an understanding that the training of physical therapists, 96% of which is currently at the doctoral level, include significant instruction specific to the musculoskeletal system and the neuromuscular system. Accredited education programs in physical therapy must include extensive instruction in anatomy, histology, physiology, biomechanics, kinesiology, neuroscience, pharmacology, pathology, clinical sciences, clinical interventions, clinical application, and screening. The basic anatomical, physiological, and biomechanical knowledge necessary for the safe and competent provision of dry needing is taught as part of the core education for physical therapists; specific dry needling skills are supplemental to that core knowledge. (Although some physical therapy education programs have begun including dry needling in their curriculum, dry needling training is not specifically required in entry-level education for physical therapists.) Furthermore, certain content areas relevant to the competent provision of dry needling, such as surface anatomy and skeletal muscle physiology, are part of the national physical therapist licensing examination. Taking into consideration the comprehensive basic preparation that all physical therapists receive in entry level programs, the regulations propose two categories of training – dry needling-specific education (40 hours), and hands-on training in the application and technique of dry needling (40 hours). The regulations also require sponsorship for those courses by a national organization or its affiliate, so that they meet the highest standards possible. All education and training must include an assessment of competency for the didactic work and a demonstration of the hands-on techniques.
The 80 total hours of dry-needling specific education and training required by the proposed regulations exceeds the hours of training required by every other jurisdiction that specifically allows for dry needling by licensed physical therapists and delineates specific training requirements for the practice. The Commonwealth of Virginia, in Guidance Document 112-9, indicates that “[a] physical therapist using dry needling must complete at least 54 hours of post professional training.”[vi][vi] North Carolina also requires a minimum of 54 hours of training before a physical therapist can perform dry needling.[vii][vii] Louisiana and Missouri both have minimum dry-needling training requirements of 50 hours for physical therapists; Colorado requires a physical therapist to receive 46 hours of training before practicing dry needling.[viii][viii] In every jurisdiction, as in the proposed regulations, all of the required dry-needling specific training is in addition to the entry-level education of a physical therapist.
The proposed regulations also clarify for patients the status of physical therapists who currently provide dry needling, while also protecting the public from substandard practice. Although the standards of practice regulation will take effect immediately, a one-year delayed effective date of the education and training regulation will allow physical therapists who currently practice dry needling to ensure that they have a sufficient knowledge base for the practice. Additionally, the regulations now provide for retroactive approval of certain continuing education courses, to ensure that experienced, competent physical therapists providing dry needling do not have to start their training over from the beginning. Finally, the regulations now provide for registration by the Board of physical therapists qualified to practice dry needling. Again, a one-year delayed effective date of the registration requirement will allow physical therapists to ensure that they have the education and training necessary to safely and competently perform dry needling.
Although not specifically included in the regulations, the Board has also proposed a number of oversight mechanisms intended to allow the Board to assess the practice of dry needling to determine if the regulations are providing for the safety of patients in the State or if further regulatory changes are needed. Specifically, the Board will:
Provide information on the Board’s website for the public and licensees regarding dry needling, and offer a vehicle for any questions or complaints regarding dry needling from the public;
· Develop a patient feedback/evaluation form;
· Collect and review data on patient complaints pertaining to dry needling;
· Collect information on the content of educational courses used to fulfill the requirements of the regulations;
· Collect information on nationwide trends in dry needling, specifically licensure and discipline;
· Provide annual reports to the General Assembly and the Department, including data on the practice of dry needling in Maryland, for at least the first five years following the promulgation date; and
· Hold at least one public forum, two years following the promulgation date, seeking public feedback on dry needling and its provision in Maryland.
Finally, the regulations recognize that discipline of physical therapists who practice dry needling without the required education and training or without observing the standards of practice is an important part of oversight over the practice. (The Board notes that it has only received two complaints related to the provision of dry needling by physical therapists.) The proposed regulations note specific areas of the existing disciplinary guidelines that may provide the basis for disciplinary actions for dry needling-related violations.
Id. at 22-26.
[i][i] 95 Op. Att’y Gen. 138
[v][v]Federation of State Boards of Physical Therapy, Dry Needling Resource Paper 8-9 (4th ed. 2013).
[viii][viii]Id. at 22-26.