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NEW JERSEY REGISTER
VOLUME 36, NUMBER 19
MONDAY, OCTOBER 4, 2004
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
MINIMUM STANDARDS FOR THE PERFORMANCE OF NEW OR NOVEL PROCEDURES IN THE OFFICE
SETTING


Proposed New Rule: N.J.A.C. 13:35-6.7

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 2004-368.

Submit comments by December 3, 2004 to:

William Roeder, Executive Director

State Board of Medical Examiners

PO Box 183

Trenton, NJ 08625

The agency proposal follows:

Summary

Pursuant to its rulemaking powers found in N.J.S.A. 45:9-2, the State Board of Medical Examiners (the Board) proposes new rule N.J.A.C. 13:35-6.7, concerning requirements which licensees must meet when performing new or novel procedures in an office setting.

In 1997, the Board proposed a rule prohibiting the performance of rapid opiate detoxification procedures (see December 15, 1997 New Jersey Register at 29 N.J.R. 5180(a)). The Board received several comments regarding this rule, many of which pointed out that rapid opiate detoxification should be permitted in a hospital as the procedures would be governed by the facility's Institutional Review Board (IRB) which would insure that patient protections were in place and informed consent regarding the experimental nature of the procedure was obtained. The Board decided that it should not adopt the rapid opiate detoxification rule and determined that it should establish guidelines for all new or novel procedures performed in settings which are not governed by IRBs.

When a licensee performs a new or novel procedure in a hospital, the institution's IRB provides guidance and standards for the licensee to follow. Similarly, if a procedure is being performed as part of a study, the Federal Drug Administration (the FDA) provides standards a licensee must follow. A licensee who performs a new or novel procedure which is neither part of a study nor performed in a setting governed by an IRB is performing this procedure absent any articulated standards. The proposed new rule provides standards so that licensees will know what they need to do when performing a new or novel procedure and patients will be protected by the provision of adequate information regarding the novel nature of the procedure in order to give informed consent.

Subsection (a) states that the rule sets standards for the performance of new or novel procedures performed in an office setting which is not governed by an IRB.

Subsection (b) sets forth definitions for N.J.A.C. 13:35-6.7. The terms "diagnostic or therapeutic modality," "new or novel procedure," "office setting" and "generally recognized as safe and effective" are defined.

Subsection (c) prohibits licensees from performing procedures that are generally recognized as ineffective and unsafe by experts in the field.

Subsection (d) requires licensees to establish a procedural protocol prior to performing new or novel procedures. This protocol must ensure that the procedure is performed by qualified physicians; ensure that the physician performing the procedure is able to demonstrate the scientific merits of the procedure; ensure that the procedure is supported by animal studies or the weight of scientific and medical literature; contain provisions for pre- operative screening; delineate specific diagnoses for which the procedure is indicated; delineate specific contraindications to the procedure; provide for fully informed consent to the procedure; provide for and demonstrate operator and staff training; provide for post procedure observation and management; provide for written discharge instructions; provide for the documentation of care rendered and recording of any associated morbidity, mortality and clinical outcomes; ensure that procedures are described with specificity and ensure compliance with the rules regarding surgery and anesthesia services performed in an office setting (N.J.A.C. 13:35-4A). The protocol also must provide for the protection of human subjects consistent with Food and Drug Administration (FDA) guidelines. These guidelines, found at 21 C.F.R. 50 and incorporated by reference, set forth the FDA standards for clinical investigations of, amongst other things, drugs for human use, medical devices for human use and biological products for human use. These standards ensure the protection of any person who is subject of such a clinical investigation. The Board believes that these protections should be provided anytime a licensee performs a new or novel procedure in the office setting.

Subsection (e) requires a licensee to provide the Board with a procedural protocol upon request so that the Board can ensure that the licensee is complying with the requirements of subsection (d).

Subsection (f) allows a licensee to perform a new or novel procedure even if the licensee cannot comply with subsection (d), as long as the licensee receives Board approval prior to performing the procedure. A licensee requesting such Board approval must tell the Board which protocols from subsection (d) cannot be met and the reasons why. A licensee also must demonstrate that: the procedure may be effective for its intended use and will not expose patients to an unreasonable and significant additional risk of illness or injury; the procedure is intended to treat a serious or immediately life-threatening disease, no comparable therapeutic alternatives are available and there is a reasonable likelihood that death will occur within a matter of months; the procedure is under investigation in controlled clinical trials and the licensee has provided the Board with all information regarding these clinical studies.

The Board has determined that the comment period for this proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this proposal is excepted from the rulemaking calendar requirement.

Social Impact

The Board believes that the proposed new rule will have a positive impact on society. The rule allows licensees to perform new or novel procedures which may be necessary to safeguard a patient's health. Additionally, the rule provides guidelines so that a licensee may perform new or novel procedures subject to Board approval in life-threatening situations. The requirements also provide patients with sufficient knowledge to make an informed decision about a new or novel procedure.

Economic Impact

The Board believes that the proposed new rule will impose an economic impact on licensees who wish to perform new or novel procedures in an office. Such licensees will incur costs in developing a procedural protocol that complies with the requirements on N.J.A.C. 13:35-6.7(d). Licensees may also incur a cost if they are required to provide the Board with a copy of this protocol. A licensee is permitted to request Board approval when a procedure cannot be performed pursuant to the requirements on N.J.A.C. 13:35-6.7(d). The cost of presenting such a request to the Board is borne by the licensee. The proposal may impose an economic impact on patients as physicians will be able to charge patients for new or novel procedures.

Federal Standards Statement

The proposed new rule will require licensees who perform new or novel procedures in an office setting to establish a procedural protocol that provides for protections of human subjects consistent with FDA guidelines set forth in 21 C.F.R. 50 (2004). The Board does not believe that there are any other Federal laws or standards applicable to this proposed new rule.

Jobs Impact

The Board does not believe that the proposed new rule will result in an increase or decrease of jobs in the State.

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

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to give a description of the types and an estimate of the number of small businesses to which the proposed new rule will apply. If, for purposes of the Act, Board licensees are considered "small businesses" within the meaning of the statute, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed new rule 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 of the proposed new rule with an indication of the varying impact on small businesses of differing types and sizes and to outline the manner in which it has designed the rules to minimize any adverse economic impact upon small businesses.

The costs imposed on small businesses by the proposed new rule are the same costs that are imposed on all businesses as outlined in the Economic Impact statement above.

The Board does not believe that licensees will need to employ any professional services to comply with the requirements of the proposed new rule.

The rules does not impose any reporting requirements. The rule does impose compliance requirements. Subsection (c) prohibits licensees from performing ineffective and unsafe procedures. Subsection (d) requires licensees to comply with a procedural protocol when performing new or novel procedures. Subsection (e) requires licensees to provide the Board with procedural protocols upon request. Subsection (f) requires licensees to obtain Board approval if a procedure cannot be performed pursuant to a procedural protocol which complies with subsection (d).

Subsection (d) also imposes a recordkeeping requirement in that licensees are required to maintain documentation of care rendered and any associated morbidity, mortality and clinical outcomes.

The Board believes that since the proposed new rule provides for the safe performance of new or novel procedures, the rule should be applied uniformly to all licensees regardless of size.

Smart Growth Impact

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

Full text of the proposal follows :

<< NJ ADC 13:35-6.7 >>

13:35-6.7 <<-(Reserved)- >> <<+Minimum standards for the performance of new or novel procedures in the office setting+ >>

<<+(a) This section contains minimum standards for the performance of new or novel procedures as defined in (b) below which are performed in the office setting and are not performed under the jurisdiction of an Institutional Review Board (IRB) which complies with the requirements of the Federal Food and Drug Administration.+ >>

<<+(b) The following words and terms, when used in this section, shall have the following meanings, unless the context indicates otherwise:+ >>

<<+"Diagnostic or therapeutic modality" means a modality intended for use in the diagnosis of disease or conditions in humans or in the cure, mitigation, treatment or prevention of disease in humans or a modality intended to affect the structure of or any function of the human body.+ >>

<<+"Generally recognized as safe and effective" means there exists substantial evidence by means of at least two well-controlled clinical studies that the new or novel procedure will have the effect that is represented and the procedure does not pose a significant risk to the physical or emotional health of the patient and has a low reported incidence of adverse reactions or significant side effects.+ >>

<<+"New or novel procedure" means a diagnostic or therapeutic modality performed by a Board licensee that:+ >>

<<+1. Is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use and poses a potential risk of physical or emotional harm to a patient; or+ >>

<<+2. Is a new application of a procedure which has been generally recognized as safe and effective for its traditional use but is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its new application and the new application poses a potential risk of physical or emotional harm to a patient.+ >>

<<+"Office setting" means a location at which medical, surgical or podiatric services are rendered and is not licensed by the New Jersey Department of Health and Senior Services.+ >>

<<+(c) A licensee shall not perform a procedure in an office setting that is generally recognized as ineffective and unsafe by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use.+ >>

<<+(d) A licensee shall establish a procedural protocol prior to performing a new or novel procedure in the office setting. The protocol shall at a minimum:+ >>

<<+1. Provide for protection of human subjects consistent with FDA guidelines set forth in 21 C.F.R. 50 (2004) available from the United States Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-0001, which are incorporated by reference herein, and as may be amended and supplemented;+ >>

<<+2. Ensure the procedure is performed by physicians qualified by training, education, or experience to perform such procedure;+ >>

<<+3. Ensure the physician performing the procedure is able to demonstrate the scientific merits of the procedure;+ >>

<<+4. Ensure the procedure is supported by adequate and well-controlled animal studies or the weight of the sacrifice and medical literature;+ >>

<<+5. Contains provisions for pre-operative screening;+ >>

<<+6. Delineate specific diagnoses for which the procedure is indicated;+ >>

<<+7. Delineate specific contraindications to the procedure, if any;+ >>

<<+8. Provide for fully informed consent in accordance with prevailing New Jersey law, including full explanation of risks, benefits, alternative treatments and likely outcome without treatment;+ >>

<<+9. Provide for and demonstrate operator and staff training, experience, and ongoing competency;+ >>

<<+10. Provide for a period of post procedure observation and management commensurate with the complexity, invasiveness and risks of the procedure and any concomitant anesthesia;+ >>

<<+11. Provide for written discharge instructions, follow-up and any associated aftercare;+ >>

<<+12. Maintain documentation of complete care rendered in accordance with Board rules, N.J.A.C. 13:35-6.5, and maintain records of any associated morbidity, mortality and clinical outcomes;+ >>

<<+13. Ensure that procedures are described with specificity including use of pharmaceutical agents and their dosages, anticipated side effects, and projected short and long-term treatment; and+ >>

<<+14. Where applicable, ensure compliance with the rules regarding surgery and anesthesia services performed in an office setting (N.J.A.C. 13:35- 4A).+ >>

<<+(e) A licensee shall provide the Board with a procedural protocol upon request in order to ensure that the licensee has complied with the requirements of (d) above.+ >>

<<+(f) If the requirements of (d) above cannot be met, a licensee may request Board approval to perform a new or novel procedure. Such request shall include a statement identifying which protocols in (d) above cannot be met and the reason therefor. The Board shall not approve a request under this subsection unless the licensee demonstrates to the satisfaction of the Board that:+ >>

<<+1. The procedure may be effective for its intended use and will not expose patients to an unreasonable and significant additional risk of illness or injury;+ >>

<<+2. The procedure is intended to treat a serious or immediately life-threatening disease and no comparable or satisfactory therapeutic alternatives are available to treat that stage of the disease in the intended patient population and there is a reasonable likelihood that death will occur within a matter of months or premature death is likely without early intervention;+ >>

<<+3. The procedure is under investigation in controlled clinical trials or all clinical trials have been completed but not yet reported; and+ >>

<<+4. The licensee has provided to the Board all information known to the licensee, regarding the studies referred to in (f)3 above.+ >>



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