NEW JERSEY REGISTER
VOLUME 35, NUMBER 20
MONDAY, OCTOBER 20, 2003
RULE PROPOSAL
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF CHIROPRACTIC EXAMINERS
DELEGABLE TASKS OR FUNCTIONS OF UNLICENSED ASSISTANTS; ORDERING OF ELECTRIC
THERAPY DEVICES FOR HOME USE

Proposed Amendment: N.J.A.C. 13:44E-2.7

Proposed New Rule: N.J.A.C. 13:44E-2.7A

Authorized By: State Board of Chiropractic Examiners, Kevin Earle, Executive Director.

Authority: N.J.S.A. 45:9-14.5 and 45:9-41.23.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2003-425.

Submit comments by December 19, 2003 to:

Kevin B. Earle

Executive Director

State Board of Chiropractic Examiners

PO Box 45004

Newark, NJ 07101

The agency proposal follows:

Summary

Pursuant to its rulemaking authority at N.J.S.A. 45:9-41.23, the State Board of Chiropractic Examiners (the Board) proposes an amendment to N.J.A.C. 13:44E-2.7 and proposes new rule N.J.A.C. 13:44E-2.7A dealing with delegable tasks or functions of unlicensed assistants and the ordering of electro-therapy devices for home use. The Board has received numerous inquiries from insurers and chiropractors on the appropriateness of ordering these devices for in-home use, and has determined that these devices when used at home have a positive therapeutic effect on patients. These devices are currently being utilized in chiropractic practices and the proposed amendment and new rule will provide guidance to licensees on the appropriate method and manner for their prescription and use.

The proposed amendment to N.J.A.C. 13:44E-2.7 specifically identifies these electro-therapy devices which may not be delegated to an unlicensed assistant. The Board has previously categorized these devices to be broadly within the prohibition of N.J.A.C. 13:44E-2.7(c)6. The Board has now determined that the rule should specifically articulate the distinction between those devices which may only be administered by licensed healthcare professionals and those which may be ordered for home use.

Proposed new rule N.J.A.C. 13:44E-2.7A details the requirements for the ordering of electro-therapy devices which are appropriate for home use.

Subsection (a) sets forth the definition of the term "electro-therapy devices" for use in the proposed new rule. An electro-therapy device is defined as a device which generates an electrical current that is applied to the skin via electrodes to cause a physiological effect. Included in the definition are such devices as "TENS" (transcutaneous electric nerve stimulation), "MES" (micro- ampere electric stimulation), and "EMS" (electric muscle stimulation) devices.

Subsection (b) prohibits licensees from ordering an electro-therapy device for home use which uses AC electrical currents. The proposed new rule also prohibits the home use of an interferential device, which requires the precise placement of electrodes by a licensed healthcare practitioner to be used safely and effectively.

Subsection (c) permits a licensee to order a battery operated electro-therapy device for home use so long as the patient meets certain criteria. The patient must not be using a cardiac pacemaker, not be an epileptic, not suffer from cognitive impairments affecting his or her ability to follow instructions, be willing to assume responsibility in writing for the use of the device, have adequate home assistance, be provided with complete instructions and have provided a written acknowledgment that the complete set of instructions have been received.

Subsection (d) states that a battery operated electro-therapy device may be ordered for home use if the chiropractor has instructed the patient on the specified medical conditions over which the device should not be applied.

Subsection (e) requires the licensee to document the ordering of care using electro-therapy devices pursuant to the patient record rule at N.J.A.C. 13:44E-2.2. In addition to complying with the patient record requirements, the licensee must also document in the record the specific treatment protocol, an evaluation of the patient's response and any necessary adjustments, the estimated period of time to achieve the treatment goals, regular follow-up evaluations and the patient's acknowledgment that complete instructions for home use have been provided.

As the Board has provided a 60-day comment period on this notice of proposal, this notice is exempted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3.

Social Impact

The Board believes that the proposed amendment and new rule will have a positive impact on licensees and chiropractic patients. Electro-therapies have traditionally been an integral aspect of treatment by many chiropractors. The proposed amendment and new rule provide clarity on the permissibility of the home use of such devices. The proposed amendment and new rule will authorize licensed chiropractors to order such devices for home use by patients, while clearly defining appropriate prescribing parameters, contraindications and patient safety factors, and require licensees to document treatment objectives and record the patient's response to the use of the modality.

Economic Impact

The Board believes that the proposed amendment and new rule will have no economic impact on chiropractic patients. The proposed amendment and new rule may, however, have some economic impact on chiropractors who may order such devices for patients in that the chiropractor would have to provide the patient with a copy of instructions on how to use the device and an acknowledgment that the patient has received the instructions. In addition, the chiropractor is required to document in the patient's record the care provided through the use of the electro-therapy device. The Board believes that the additional time expended by the chiropractor in instructing the patient and documenting the patient's file is of minor economic consequence and is outweighed by ensuring that the patient is fully instructed about the use of the device and the patient record appropriately reflects the patient's care.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment and new rule have no applicable Federal standards or requirements.

Jobs Impact

The Board does not expect that the proposed amendment and new rule will result in the increase or loss of any jobs in the State.

Agriculture Industry Impact

The proposed amendment and new rule will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq. (the Act), requires the Board to give a description of the types and an estimate of the number of small businesses to which the proposed rules will apply. If, for the purposes of the Act, the approximately 3,200 chiropractors licensed by the Board are deemed "small businesses," then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed rules including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs, which is set forth in the Economic Impact statement above, outline the manner in which it has designed the rules to minimize any adverse economic impact upon small businesses, and to set forth whether the rules establish differing compliance requirements for small businesses.

The proposed amendment and new rule contain no reporting requirements. The recordkeeping requirements in subsection (e) require that a licensee must document the ordering of care using electro-therapy devices in the patient record pursuant to N.J.A.C. 13:44E-2.2 and lists additional documentation requirements for licensees which include specific treatment protocols, evaluation of patient responses, estimated time necessary to complete treatment goals, follow-up evaluations and the patient's acknowledgment of receipt of complete instructions.

Proposed new rule N.J.A.C. 13:44E-2.7A also contains several compliance requirements. Subsection (b) states that licensees may not order electro- therapy devices for home use which use an AC electrical current or use interferential devices which cross two medium frequency currents through the body. Subsection (c) states that a licensee may order a battery operated electro-therapy device for home use provided that the patient does not have specified medical conditions, will have adequate home assistance if necessary, is provided with a complete set of instructions and has provided written acknowledgment that the complete instructions have been received. Subsection (d) states that a battery operated electro-therapy device may be ordered for home use provided that the licensee has instructed the patient that the device should not be applied over specified areas or medical conditions.

No other professional services are necessary for compliance. The Board believes that the proposal should be uniformly applied to all licensees regardless of size, in order to ensure the health, welfare and safety of the general public. Therefore, no differing or lesser requirements are provided for small businesses.

Smart Growth Impact

The Board does not anticipate that the proposed amendment and new rule will have any impact on the achievement of smart growth and the implementation of the State Development and Redevelopment Plan, otherwise known as the State Plan.

Full text of the proposal follows:

<< NJ ADC 13:44E-2.7 >>

13:44E-2.7 Delegable tasks or functions of unlicensed assistants

(a)-(b) (No change.)

(c) A licensee shall not permit an unlicensed assistant to:

1.-4. (No change.)

5. Administer the following physical modalities:

i. (No change.)

<<+ii. Electro-therapy devices powered by an alternating current or any interferential devices, as set forth in N.J.A.C. 13:44E-2.7A; or+>>

6. (No change.)

(d)-(f) (No change.)

<< NJ ADC 13:44E-2.7A >>

<<+13:44E-2.7A Ordering of electro-therapy devices for home use+>>

<<+(a) For purposes of this section and N.J.A.C. 13:44E-2.7(c)5ii, "electro-therapy devices" such as "TENS" (transcutaneous electric nerve stimulation), "MES" (micro-ampere electric stimulation), or "EMS" (electric muscle stimulation) devices, means devices which generate an electrical current that is applied to the skin via electrodes to cause a physiological effect.+>>

<<+(b) A licensee may not order an electro-therapy device for home use which:+>>

<<+1. Uses AC electrical current; or+>>

<<+2. Is an interferential device which crosses two medium frequency alternating currents through the body.+>>

<<+(c) A licensee may order a battery operated electro-therapy device for home use provided that the patient:+>>

<<+1. Is not using a cardiac pacemaker;+>>

<<+2. Is not epileptic;+>>

<<+3. Does not suffer from any cognitive impairment which affects the patient's ability to follow instructions;+>>

<<+4. Is willing and able to assume responsibility in writing for use of the electric therapy device;+>>

<<+5. Will have adequate home assistance where such assistance may be necessary in the opinion of the treating chiropractor, especially when the electrodes are to be placed paraspinally;+>>

<<+6. Is provided with a complete set of instructions for home use which includes:+>>

<<+i. The operation of the unit;+>>

<<+ii. Battery charging or changing;+>>

<<+iii. Care of the unit and supplies;+>>

<<+iv. The preferred and alternative electrode placements and stimulation parameters;+>>

<<+v. The suggested schedule of treatment times and rest periods;+>>

<<+vi. Precautions against misuse of the unit including using the device for any purpose other than that for which it was ordered;+>>

<<+vii. The avoidance and treatment of skin irritation;+>>

<<+viii. The address and phone number of an information source for troubleshooting; and+>>

<<+ix. The chiropractor's name and phone number; and+>>

<<+7. Has provided a written acknowledgment that a complete set of instructions for home use has been received.+>>

<<+(d) A battery operated electro-therapy device may be ordered for home use, provided that the chiropractor has instructed the patient that the electro-therapy device should not be applied over:+>>

<<+1. The carotid sinus;+>>

<<+2. Blood vessels with thrombosis or emboli;+>>

<<+3. Tissue or blood vessels vulnerable to hemorrhage or inflammation;+>>

<<+4. Lumbar or abdominal areas of pregnant women;+>>

<<+5. The eyes or internally;+>>

<<+6. A malignancy; or+>>

<<+7. Trans-thoracic applications in asthenic patients.+>>

<<+(e) The licensee shall document the ordering of care using an electro- therapy device in the patient record pursuant to N.J.A.C. 13:44E-2.2, which shall also include the following:+>>

<<+1. A specific treatment protocol, including the specific electro- modality to be used, the electrode type, and the electrode placement;+>>

<<+2. An evaluation of the patient's response and documentation of any necessary adjustments to the treatment;+>>

<<+3. The estimated period of time necessary to achieve the treatment goals of the electro-stimulation device;+>>

<<+4. Regular follow-up evaluations of the patient's participation in the at-home electro-therapy device program; and+>>

<<+5. The acknowledgment from the patient that a complete set of instructions for home use has been received pursuant to (c)7 above.+>>



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