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VOLUME 46, ISSUE 19
ISSUE DATE: October 6, 2014
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
State Board of Medical Examiners


Proposed New Rule: N.J.A.C. 13:35-2.4

Podiatrist Supervision and Administration of Hyperbaric Oxygen Therapy
 
Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-2.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2014-168.
 
Submit written comments by December 5, 2014, to:
 
   William Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, New Jersey 08625-0183
   or electronically at: www.NJConsumerAffairs.gov/proposal/comment/.
 
The agency proposal follows:
 
Summary

The Board of Medical Examiners (Board) proposes new N.J.A.C. 13:35-2.4 to establish standards for the administration of hyperbaric oxygen therapy by licensed podiatrists. "Hyperbaric oxygen therapy" is a treatment during which patients breathe 100 percent pure oxygen inside a pressurized chamber. The treatment is used to promote healing by increasing the amount of oxygen delivered to body tissues by the blood. A licensed podiatrist who meets the requirements of proposed new N.J.A.C. 13:35-2.4 will be permitted to provide hyperbaric oxygen therapy to his or her patients to treat conditions of the lower leg, foot, or ankle.

A licensed podiatrist who wishes to provide hyperbaric oxygen therapy must receive educational training in its administration and be credentialed by a licensed hospital to provide this therapy. A licensed podiatrist may provide hyperbaric oxygen therapy only in a licensed hospital where a physician with relevant knowledge is present to respond to complications. Prior to receiving hyperbaric oxygen therapy from a licensed podiatrist, a patient must be cleared to receive such treatment by a licensed physician. A licensed podiatrist must maintain documentation of the physician's clearance for hyperbaric oxygen therapy.

As the Board has provided a 60-day comment period on this notice of proposal, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
 
Social Impact

The proposed new rule will benefit society by increasing the pool of individuals able to provide hyperbaric oxygen therapy to treat conditions of the lower leg, foot, or ankle.
 
Economic Impact

The proposed new rule would require licensed podiatrists to complete education in hyperbaric oxygen therapy if they wish to provide this therapy. The costs of completing this education would be borne by licensed podiatrists. The proposed new rule would have a beneficial impact on licensed podiatrists in that the proposed new rule would permit qualified licensed podiatrists to provide hyperbaric oxygen therapy for which they would be able to charge patients a fee. The Board does not anticipate that the proposed new rule will have any other economic impact.
 
Federal Standards Statement

A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed new rule.
 
Jobs Impact

The proposed new rule will not increase or decrease the number of jobs in New Jersey.
 
Agriculture Industry Impact

The Board does not believe that the proposed new rule will have any impact on the agriculture industry of this State.
 
Regulatory Flexibility Analysis

Since licensed podiatrists are individually licensed by the Board, they may be considered "small businesses" under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq.

The proposed new rule would impose costs on licensed podiatrists as discussed in the Economic Impact statement. The Board does not believe that licensed podiatrists will need to employ any professional services to comply with the proposed new rule. The proposed new rule does not impose any reporting requirements, but does impose compliance and recordkeeping requirements as detailed in the Summary above.

As the proposed new rule ensures that licensed podiatrists are properly prepared to provide hyperbaric oxygen therapy in a safe and effective manner, the Board believes that the new rule must be uniformly applied to all licensed podiatrist and no exemptions are provided based on the size of a business.
 
Housing Affordability Impact Analysis

The proposed new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the proposed new rule would evoke a change in the average costs associated with housing because the proposed new rule concerns standards for the performance of hyperbaric oxygen therapy by licensed podiatrists.
 
Smart Growth Development Impact Analysis

The proposed new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed new rule would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed new rule concerns standards for the performance of hyperbaric oxygen therapy by licensed podiatrists.
 
Full text of the proposed new rule follows (additions indicated in boldface thus; deletion indicated in brackets [thus]):
 
SUBCHAPTER 2.    LIMITED LICENSES: PODIATRY, DIAGNOSTIC TESTING CENTERS AND MISCELLANEOUS
 
13:35-2.4   [(Reserved)] Podiatrist supervision and administration of hyperbaric oxygen therapy
 
(a) The purpose of this section is to set forth standards for the supervision and/or administration of hyperbaric oxygen therapy by a licensed podiatrist. A licensed podiatrist who meets and complies with all requirements of this section may supervise and/or administer hyperbaric oxygen therapy to his or her patient, for the purpose of treating conditions of the lower leg, foot, or ankle, provided such conditions are within the scope of the practice of podiatry, as defined in N.J.S.A. 45:5-7.
 
(b) For purposes of this section, "hyperbaric oxygen therapy" or "HBOT" means a treatment in which a patient intermittently breathes 100 percent pure oxygen while inside a treatment chamber at two to three times the atmospheric pressure at sea level.
 
(c) A licensed podiatrist may supervise and/or administer HBOT treatment for conditions of the lower leg, foot, or ankle, provided such conditions are within the scope of the practice of podiatry, as defined in N.J.S.A. 45:5-7, and provided that he or she has:
 
1. Received educational training in the administration of HBOT; and
 
[page=2009] 2. Been credentialed to perform the supervision and administration of HBOT by a hospital licensed by the Department of Health pursuant to N.J.S.A. 26:2H-1 et seq.
 
(d) A licensed podiatrist shall supervise and administer HBOT only:
 
1. Within the confines of a hospital licensed by the Department of Health pursuant to N.J.S.A. 26:2H-1 et seq., where a plenary licensed physician with knowledge of hyperbaric medicine is physically present on-site and readily available to manage any complications that may occur; and
 
2. When the patient has been cleared to receive HBOT by a plenary licensed physician prior to the initiation of treatment. The podiatrist supervising and/or administering HBOT shall maintain documentation of physician clearance to receive HBOT in the patient's medical record.

 

If you wish to submit comments about this rule proposal, please fill out the form below. When you have completed the form, click the "Submit Your Comments" button below.

Last Name :

First Name:

Professional Organization, Association or Affiliation, if any:

E-Mail Address:

PRN 2014-168

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