Rule Proposal

VOLUME 49, ISSUE 12
ISSUE DATE: MAY 19, 2017
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS

Proposed Amendment: N.J.A.C. 13:35-2.6

Medical Standards Governing Screening and Diagnostic Medical Testing in Practitioner Offices
 
Authorized By: State Board of Medical Examiners, William V. 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 2017-096.
 
Submit written comments by August 18, 2017, to:
 
   William V. Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, NJ 08625-0183
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx
 
The agency proposal follows:
 
Summary

The State Board of Medical Examiners (Board) proposes to amend N.J.A.C. 13:35-2.6, which concerns medical standards for screening and diagnostic medical testing offices. Specifically, the Board is proposing amendments to delineate separate standards for direct requests for specific diagnostic tests and those for referrals for evaluation to determine the appropriate diagnostic tests, and to clarify for the regulated community, the respective obligations borne by the referring practitioner, the requesting practitioner, and the consulting practitioner. The proposed amendments clearly set forth the respective obligations for practitioners directly requesting tests or referring patients for evaluation, practitioners performing or supervising the performance of the diagnostic tests, practitioners managing diagnostic offices, and practitioners owning diagnostic or screening offices. The Board also proposes to set forth the consulting physician's obligations when fraud is suspected. In addition, the Board will now allow closely allied health professionals, as long as the majority interest is held by a plenary-licensed physician, to own a diagnostic or screening office. The Board is also proposing to amend the rule to update references to the Department of Health and Senior Services (DOHSS) to Department of Health (DOH).

The Board became aware that there is confusion amongst members of the regulated community and the insurance industry with respect to the standard of care expected for practitioners performing diagnostic tests. The Board also recognized that the existing rule language needs to be flexible because it applies to a broad range of diagnostic tests, from simple x-rays to cardiovascular testing and MRIs. The Board determined that the proposed amendments are necessary to better reflect the standard of practice in the medical community and to avoid any negative impact on the quality, cost, or access to diagnostic testing services. The Board notes that it is not, and never was, the Board's intent that the existing rule would be used or interpreted to require a practitioner performing a diagnostic test, in response to a direct request by another practitioner, to conduct a separate physical examination or review the patient chart to determine medical necessity for the diagnostic test. The Board believes that the practitioner who makes a direct request for a specific diagnostic test is responsible for determining the medical necessity for the specifically-requested test and the way in which the test results will inform treatment decisions. If the consulting practitioner performing the diagnostic test determines, in the exercise of his or her professional judgment, that there is a need for additional information, outreach to the requestor is appropriate.

The Board proposes to amend the definition of "clinically supported" in N.J.A.C. 13:35-2.6(a) to make it clear that it is the practitioner who identifies a need for the diagnostic test who must evaluate the findings of a physical or psychiatric examination, as applicable, and consider any available previously performed tests relating to the patient's medical condition and the results of such tests. In addition, because the Board recognizes that the definition of "clinically supported" may be applied in a variety of circumstances, the proposed amendment changes the requirement for the physical and/or psychiatric examination to be personally performed to requiring an evaluation of the findings of the examination. The proposed amendment also changes from "any and all previously performed tests" relating to the patient's medical condition and the results, to those that are available.

The Board proposes to amend N.J.A.C. 13:35-2.6(a) to add a definition for "closely allied health professional," which is defined as an individual licensed to practice a health care profession by a regulatory board within the New Jersey Division of Consumer Affairs, as that term is used in N.J.A.C. 13:35-2.6(d), pertaining to the ownership of diagnostic and screening offices. The Board also proposes to amend the [page=1661] definitions of "diagnostic office" and "screening office" to remove "Senior Services" in the references to the Department of Health.

The Board proposes to amend N.J.A.C. 13:35-2.6(b) to delineate the options available to a practitioner who identifies a clinically supported need for the patient to undergo a diagnostic test. Existing paragraphs (b)1, 2, and 3 will be deleted in their entirety. The Board did not intend to require a diagnostic test to have a specific CPT code or that a fee be charged in order for a practitioner who identifies a clinically supported need to perform and interpret the diagnostic test or to request that another practitioner perform the test. The Board, therefore, is proposing to remove the references to the CPT code and fee from proposed new paragraphs (b)1 and 2. Proposed new paragraph (b)1 provides that the practitioner may perform and interpret the diagnostic test if such performance is consistent with the practitioner's scope of practice, education, and training. Proposed new paragraph (b)2 allows the practitioner who has identified the need for a specific test to request another practitioner to perform that specific test if the requesting practitioner is capable of recognizing scientifically supportable and practical indications for the test and understands how to integrate the test results into management of the patient's condition. Proposed new paragraph (b)3 provides that a practitioner may refer a patient to a practitioner for an evaluation to determine the appropriate diagnostic test(s), as long as the consulting practitioner is capable of recognizing scientifically supportable and practical indications for the test, understands how to integrate the test results into management of the patient's condition, has knowledge of the proper administration of the test, and possesses skill in the proper interpretation of the test.

The Board believes that existing N.J.A.C. 13:35-2.6(c)1 has led to confusion as to whether a practitioner may charge a patient or bill a third-party payor for any diagnostic test that does not actually yield data of clinical value. The Board does not believe that a practitioner should be precluded from charging for services associated with the rendition of an appropriate test because it failed to yield data. The Board, therefore, proposes to amend N.J.A.C. 13:35-2.6(c)1 to make it clear that the prohibition only applies if the test is not recognized in the scientific community as being capable of yielding data of sufficient clinical value in the development, evaluation, or implementation of a plan of treatment.

The Board proposes to delete and replace N.J.A.C. 13:35-2.6(d). Proposed new subsection (d) concerns the responsibilities of a practitioner who holds a financial interest or investment in a diagnostic or screening office. In proposed new paragraph (d)1, the Board recognizes ownership of a diagnostic or screening office by closely allied health professionals, provided that a majority interest is held by practitioners authorized to perform and interpret all of the tests offered at the diagnostic or screening office. In addition, proposed new paragraph (d)2 expands the list of individuals who may interpret test results to include a practitioner acting within that practitioner's scope of practice. The proposed new paragraph removes the general limitation that the practitioner interpreting the results must be licensed by the Board. In addition, the Board is removing from proposed new subsection (d), the requirement for the test results to be documented in a written report and maintained in accordance with N.J.A.C. 13:35-6.5 because proposed new subsection (m) sets forth the specific requirements for the content of the written reports. Proposed new paragraph (d)3 maintains the requirement that there is a designated physician, or practitioner if all the tests offered are within that practitioner's scope of practice, who is responsible for the management of the office and for compliance with the specific obligations of N.J.A.C. 13:35-2.6. The Board proposes to amend N.J.A.C. 13:35-2.6(e) and (j) to update the references to the Department of Health.

The Board proposes to delete and replace N.J.A.C. 13:35-2.6(k) through (n). The proposed new subsections are intended to make the entire rule streamlined and easier to follow. Existing subsections (o) through (s) are recodified as subsections (p) through (t) with amendments.

Proposed new N.J.A.C. 13:35-2.6(k) requires the practitioner responsible for the management of a diagnostic office to ensure, through the adoption and dissemination of policies and procedures or standing orders, that all personnel performing diagnostic tests are familiar with the methods to be used in the performance of the test, the tasks that may be delegated to other licensed health care professionals, the timing and manner of issuance of the practitioner's oral and written report, and timely notification to the patient or requesting/referring health care professional of results or the need to repeat the test. The specific requirements of proposed new subsection (k) are in addition to the general obligations of a practitioner managing a screening or diagnostic office that are set forth in subsection (e). The recordkeeping provisions and specific report-content requirements of existing subsection (k), which is proposed for deletion, are set forth in proposed new N.J.A.C. 13:35-2.6(m), as discussed below.

Proposed new N.J.A.C. 13:35-2.6(l) sets forth the responsibilities of the practitioner managing the diagnostic office to ensure appropriate practitioner supervision or availability is provided for a variety of tests. Proposed new subsection (l) delineates specific requirements for needle electromyography testing, invasive tests, diagnostic tests requiring anesthesia, non-invasive diagnostic tests that require a sequential analysis, cardiovascular stress tests, diagnostic tests with contrast that are delegated to a trained radiologic technologist, and non-invasive diagnostic tests that do not require anesthesia, contrast, or sequential analysis, and are performed by a trained radiologic technologist. Based upon the Board's consideration of the current standards of practice in the regulated community, the Board specifically recognizes the role that a physician assistant and advanced practice nurse may have in diagnostic offices.

Proposed new N.J.A.C. 13:35-2.6(l)1 sets forth that needle electromyography testing must be personally performed after a focused physical examination and interpreted by a plenary-licensed physician with necessary education and training.

Proposed new N.J.A.C. 13:35-2.6(l)2 sets forth that invasive tests, including transesophageal echocardiography, must be personally performed by a plenary-licensed physician with the necessary education and training, or must be delegated by such physician to a physician assistant or advanced practice nurse with the necessary education and training.

In proposed new N.J.A.C. 13:35-2.6(l)3, for the diagnostic tests requiring anesthesia, the Board proposes cross-referencing to the existing requirements of N.J.A.C. 13:35-4A, which sets forth policies and procedures and staffing and equipment requirements for practitioners and physicians who administer anesthesia services in an office setting.

In proposed new N.J.A.C. 13:35-2.6(l)4, with respect to diagnostic tests that require a sequential analysis, the Board proposes to change the requirement for direct physician presence to requiring that such tests are conducted by trained personnel, subject to physician supervision, and interpreted by a physician.

Proposed new N.J.A.C. 13:35-2.6(l)5 sets forth that cardiovascular stress tests must be directly supervised by a physician who is immediately available in the office suite.

Proposed new N.J.A.C. 13:35-2.6(l)6 provides that diagnostic tests with contrast that are delegated to a trained radiologic technologist must be performed when a physician, physician assistant, or advanced practice nurse with necessary education and training is present in the office suite, unless there is a documented emergency.

Proposed new N.J.A.C. 13:35-2.6(l)7 sets forth that for diagnostic tests performed by a trained radiologic technologist that are not invasive, are not conducted with anesthesia or contrast, or do not require sequential analysis, if the supervising physician is not in the office suite, he or she must be immediately available by telephone or other electronic means.

Proposed new N.J.A.C. 13:35-2.6(m) sets forth the requirements for a practitioner performing a diagnostic test. Proposed new N.J.A.C. 13:35-2.6(m)1 requires practitioners performing a diagnostic test to retain all test results arising out of a diagnostic test administration, unless the data is part of the patient record at a licensed health care facility and secured custody is maintained. Proposed new paragraph (m)2 retains the requirement (from existing subsection (k), which is proposed for deletion) for the practitioner to prepare a comprehensive report and details the information that must be included in the report. The Board continues to require that the comprehensive report includes the date on, [page=1662] and location at which, the test was performed, an identification of the specific test(s) performed, a description of the pertinent findings, diagnosis, or impression and any recommendations, and the date on which the report was prepared. The report must also include identifying information for the practitioner, including the practitioner's name, degree designation, street address, and telephone number. The Board proposes to remove the requirement that the report be included on the practitioner's letterhead or include the name of the practitioner's office. The Board proposes requiring that the report include the patient's name and summary of the available pertinent medical and/or psychological history. The Board also proposes to remove the requirement to identify any unlicensed individual performing the test. In addition, the Board proposes to change the requirement for the report to include the total duration of electrodiagnostic tests and invasive procedures to specify the start and stop time of the test or procedure. The Board also proposes to limit the requirement for cross-references to other tests performed to those performed on the same patient at the same diagnostic office or those provided along with the referral.

Proposed new N.J.A.C. 13:35-2.6(n) delineates the requirements for a practitioner directly requesting another practitioner perform a specific diagnostic test and referring a patient for evaluation to determine the appropriate diagnostic tests. The Board's proposed changes are intended to reflect the standard of care in the regulated community and to make it clear that, in the context of a direct request, the practitioner making the direct request does not need to do anything more than write a prescription, with a notation of reported symptoms, a suspected medical condition that should be confirmed or ruled out, or a diagnosis, if known. The onus is on the requesting practitioner to discern the appropriateness of the request. In the context of a referral for evaluation to determine the appropriate tests, the consulting practitioner will need additional information to properly discharge his or her role and, thus, new subsection (n) draws an important distinction between direct requests for specific tests and referrals for evaluation.

Proposed new N.J.AC. 13:35-2.6(n) sets forth that, for direct requests for a specific diagnostic test, the requesting practitioner must convey the request via a prescription or other writing or by a personal communication documented in the patient record. The prescription or other writing may be faxed or transmitted electronically. The request must specify: the patient's reported symptoms and objective signs, if any, pertinent to the problem; a suspected medical condition to be confirmed or ruled out; and/or a diagnosis, if known. The requesting practitioner does not need to provide the prior medical history or testing relating to the medical conditions, as set forth in existing N.J.AC. 13:35-2.6(l)2 and 3. However, when a practitioner refers a patient for evaluation to another practitioner to determine the diagnostic test(s) to be performed, in addition to the requirements for a specific diagnostic test described above, the practitioner must also provide a brief history of the reported medical condition or the clinical reason for the referral, and an indication of prior testing or ancillary studies relating to the medical condition and results. The requirements of proposed new subsection (n) do not apply in circumstances involving emergency care.

As in proposed new subsection (n), proposed new subsection (o), which sets forth the requirements for the accepting practitioner, makes an important distinction between direct requests for specific diagnostic tests and referrals for evaluation of the appropriate diagnostic tests. The changes from the existing rules make it even clearer that there is no blanket mandate that the practitioner performing the tests undertake specific tasks to make an independent determination as to medical necessity with respect to direct requests for specific tests.

Proposed N.J.A.C. 13:35-2.6(o)1i through vi set forth requirements for the accepting practitioner, for both direct requests and referrals for evaluation and determination. The accepting practitioner must receive the direct request or referral via a prescription or other writing, which may be faxed or transmitted electronically, or a personal communication documented in the patient record consistent with the information requirements of subsection (n). The Board proposes retaining the requirement for the accepting practitioner to retain a copy of the request or document the personal communication in the patient record. In addition, the Board proposes requiring the accepting practitioner to consult with the requesting practitioner when the accepting practitioner believes that additional information is needed to determine whether the diagnostic test requested is the most appropriate test to elicit the clinical information sought. The Board also proposes to continue to require the accepting practitioner to prepare a report containing the information required in proposed new subsection (m), and to assure that an explanation was provided to the patient and, where there is a significant risk or likelihood of side effects, obtain informed consent.

Proposed N.J.A.C. 13:35-2.6(o)1vi sets forth the accepting practitioner's obligation to make inquiry of the requesting practitioner as to the appropriateness of the testing, or to decline to perform the test when fraud is suspected. The proposed rule, as changed, provides that fraud may be suspected if the pattern of requests is suggestive of fraud, or improper sequencing of testing, as may be reflected by an inordinate number of patients presenting for the performance of the same test, repetitive selection of complex testing, when less complex testing would be likely to generate comparable clinical data, or the frequent ordering of testing unlikely to generate useful information. For practitioners accepting direct requests to perform specific tests, the Board proposes removing the requirements for the accepting practitioner to institute a procedure to assure that sufficient clinical data has been provided to justify the requested test and, as deemed necessary, for performing a focused clinical examination, as specified in existing N.J.A.C. 13:35-2.6(m)3.

Proposed new subsection (o) also omits, in the context of a direct request, any suggestion that the testing practitioner has an independent obligation to perform "a focused clinical examination" or "verify the indications for and appropriateness of" the request, as provided in existing N.J.A.C. 13:35-2.6(m)5 and 6. Existing paragraph (m)5, relating to the conduct of a focused clinical examination, had, by the plain language of the rule, been a task that was within the testing practitioner's discretion. In the many contexts in which this rule has applicability, the Board does not believe that the consulting practitioner will have the clinical competency to perform a physical examination. The Board is also proposing to omit any reference, as is set forth in existing paragraph (m)6, that a different standard applies when the request has been made by a licensee with a limited license. If the practitioner performing the test needs additional information, or questions the need for a requested test, practitioner-to-practitioner consultation is encouraged and consistent with appropriate medical practice standards.

When the practitioner accepts a referral for the evaluation and determination of the appropriate diagnostic tests, in addition to the requirements set forth in paragraph (o)1, under proposed N.J.A.C. 13:35-2.6(o)2 the accepting practitioner must institute a procedure to assure that sufficient clinical data has been provided to assist in determining the appropriateness of the testing, determining which tests to perform, and generating the clinical information necessary to inform treatment decisions. The accepting practitioner must perform a focused clinical examination if, in the practitioner's discretion, such examination is necessary and the accepting practitioner has the competency to perform the examination. The requirements of proposed subsection (o) do not apply in circumstances involving emergency care.

The Board proposes recodifying subsections (o) through (s) as (p) through (t). The Board proposes to amend recodified N.J.A.C. 13:35-2.6(p) and (t) to update the reference to the Department of Health. The Board proposes to amend recodified N.J.A.C. 13:35-2.6(r)6 to update the citation reference due to the recodification.

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

Social Impact

The Board of Medical Examiners believes that the proposed amendments will have a positive social impact upon the public by continuing to safeguard the public health and safety and by assuring that the rules are not interpreted in such a way as to have a negative impact on the quality, cost, or access to diagnostic testing or screening services. In addition, the Board believes that the proposed amendments will have a positive social impact upon the medical community by providing consistency between the rules and the standard of practice.[page=1663]

Economic Impact

The Board of Medical Examiners does not believe that the proposed amendments will have any economic impact upon practitioners, the diagnostic testing or screening offices, or the public.
 
Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments are governed by N.J.S.A. 45:9-1 et seq., and are not subject to any Federal law, requirements, or standards.
 
Jobs Impact

The Board does not believe that the proposed amendments will result in the creation or loss of jobs in the State.
 
Agriculture Industry Impact

The proposed amendments will have no impact on the agriculture industry in the State because the proposed amendments concern the medical standards governing screening and diagnostic medical testing in practitioner offices.
 
Regulatory Flexibility Analysis

Currently, the Board licenses approximately 36,530 physicians and 1,170 podiatric physicians. If Board licensees are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendments do not impose any new reporting requirements on licensees. The proposed amendments will continue to impose various recordkeeping and compliance requirements upon members of the regulated community, which are discussed in the Summary above. No additional professional services will be needed to comply with the proposed amendments. As stated in the Economic Impact statement above, the Board does not anticipate that any costs will be incurred in complying with the proposed amendments. The Board believes that the amendments should be uniformly applied to all licensees in order to ensure the health, safety, and welfare of the general public and, therefore, no differing compliance requirements for any licensees are provided based upon the size of the business.
 
Housing Affordability Impact Analysis

The proposed amendments will have an insignificant impact on the housing production costs or housing affordability in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern the medical standards governing screening and diagnostic medical testing in practitioner offices.
 
Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments 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 amendments concern the medical standards governing screening and diagnostic medical testing in practitioner offices.
 
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
SUBCHAPTER 2.    LIMITED LICENSES: PODIATRY, DIAGNOSTIC TESTING CENTERS, AND MISCELLANEOUS
 
13:35-2.6   Medical standards governing screening and diagnostic medical testing offices; determinations with respect to the validity of certain diagnostic tests
 
(a) As used in this section, the following terms shall have the following meanings, unless the context clearly indicates otherwise.
 
...
 
"Clinically supported" means that a practitioner who has identified a need for a diagnostic test, prior to [selecting,] personally performing or [ordering the administration of a diagnostic test] directly requesting that another practitioner administer a specific test, has:
 
1. [Personally performed] Evaluated the findings of a physical and/or psychiatric examination, as applicable, making an assessment of any current and/or historical subjective complaints, observations, objective findings, and neurological indications;
 
2. Considered any [and all] available previously performed test(s) relating the patient's medical condition and the results; and
 
3. (No change.)
 
"Closely allied health professional" means an individual licensed to practice a health care profession by a regulatory board within the New Jersey Division of Consumer Affairs.
 
"Diagnostic office" means a practice location, whether stationary or mobile, not licensed by the State Department of Health [and Senior Services], which provides equipment and staff necessary for the offering or performance of diagnostic tests and related services to any branch of the medical profession or to the public.
 
...
 
"Screening office" means a practice location, whether stationary or mobile, not licensed by the State Department of Health [and Senior Services], which provides equipment and staff necessary for the offering or performance of screening tests and related services to any branch of the medical profession or to the public, either upon referral or by walk-in.
 
...
 
(b) A practitioner who identifies a clinically supported need for a patient to undergo a diagnostic test may:
 
[1. Is authorized, if consistent with the practitioner's scope of practice, to perform the diagnostic test, for which a specific CPT code is assigned and for which a fee shall be charged, upon the attainment of education and supervised training in the pertinent test;
 
2. May directly request a specific diagnostic test, for which a specific CPT code is assigned and for which a fee shall be charged, when clinically supported, provided that referring practitioner:
 
i. Is capable of recognizing scientifically supportable and practical indications for the test;
 
ii. Has knowledge in the proper administration of the test;
 
iii. Possesses skill at proper interpretation of the test; and
 
iv. Has obtained training in how to integrate the test results into management of the patient's condition; or
 
3. May refer the patient to a practitioner who is deemed to meet the criteria identified at (b)2i through iv above.]
 
1. If consistent with the practitioner's scope of practice, education, and training, perform and interpret the diagnostic test;
 
2. Directly request a specific diagnostic test, provided that the requesting practitioner:
 
i. Is capable of recognizing scientifically supportable and practical indications for the test; and
 
ii. Understands how to integrate the test results into management of the patient's condition; or
 
3. Refer a patient for an evaluation to determine the appropriate diagnostic test(s) to a practitioner who meets the criteria identified at (b)2i above and:
 
i. Has knowledge of the proper administration of the test; and
 
ii. Possesses skill in the proper interpretation of the test.
 
(c) A practitioner, qualified pursuant to (b) above to perform a diagnostic test, may charge the patient or bill a [third party] third-party payor for that test, except that:
 
1. No practitioner shall bill for any diagnostic tests [which fail to yield] that are not recognized in the scientific community as being capable of yielding data of sufficient clinical value in the development, evaluation, or implementation of a plan of treatment, including the following:
 
i.-ix. (No change.)
 
2.-4. (No change.)
 
[(d) Any diagnostic or screening office offering diagnostic or screening tests for a fee shall:
 
1. Be solely owned and under the responsibility of one or more physicians (or practitioners, in the case of an office offering only tests within the scope of that practitioner's practice);
 
2. Ensure that all test results are interpreted by a practitioner, licensed by the Board and acting within the scope of licensed practice, documented in a written report and maintained in accordance with the requirements of N.J.A.C. 13:35-6.5; and
 
[page=1664] 3. Designate a physician owner or employee (or practitioner owner or employee, in the case of an office offering only tests within the scope of that practitioner's practice) to be responsible for the management of the office and the specific obligations set forth in this section.]
 
(d) A practitioner who holds a financial interest or investment in a diagnostic or screening office shall ensure that:
 
1. The office is wholly owned through an authorized business structure, comprised of practitioners alone or with closely allied health professionals, so long as a majority interest is held by practitioners authorized to perform and interpret all of the tests offered at the diagnostic or screening office;
 
2. All test results are interpreted by a practitioner acting within that practitioner's scope of practice; and
 
3. There is a designated physician (or practitioner if all the tests offered are within that practitioner's scope of practice), who has responsibility for the management of the office and for compliance with the specific obligations set forth in this section.
 
(e) [Any] A practitioner designated to be responsible for the management of a diagnostic or screening office not licensed by the Department of Health [and Senior Services (DOHSS)] (DOH) shall:
 
1.-5. (No change.)
 
(f)-(i) (No change.)
 
(j) A practitioner designated to be responsible for the management of a screening office not licensed by the Department of Health [and Senior Services (DOHSS)] shall ensure that reports with respect to screening tests, which yield abnormal results are prepared in writing, include clear direction as to necessary follow-up, and are issued within three business days from the date of receipt of the report by the testing entity.
 
1.-5. (No change.)
 
[(k) Any practitioner performing a diagnostic test in any location, whether or not licensed by the Department of Health and Senior Services, shall retain raw data or graphs arising out of a diagnostic test administration and shall prepare and retain a comprehensive report, on professional letterhead bearing the practitioner's full name and title or degree ("Dr." alone is insufficient) and office name, address and telephone number. (However, raw data, graphs and reports, for example, but not limited to, radiographic images, which have been prepared as part of the patient record for a licensed health care facility such as a hospital or nursing home, may be entrusted by the preparing/interpreting practitioner to the secured custody of the licensed health care facility as part of the facility's permanent records.) The report shall include at least the following:
 
1. The date on which the test was performed;
 
2. The location at which the test was performed;
 
3. A summary of the pertinent medical/psychological history;
 
4. An identification of the specific test(s) performed;
 
5. An identification of any unlicensed individual performing the test unless reflected in the patient record or in a logbook maintained by the supervising practitioner, who shall be identified as the supervisor;
 
6. The length of time of all electrodiagnostic tests (including EMG and NCV) and invasive procedures, unless reflected in the patient record or in a logbook maintained by the supervising practitioner, who shall be identified as the supervisor;
 
7. A description of the pertinent findings, diagnosis or impression and any recommendations;
 
8. Cross-references to any other tests performed on the same patient pertinent to the patient's presenting medical condition or injuries, if not addressed in a consolidated report; and
 
9. The date on which the report was prepared.
 
(l) Pursuant to (b)2 above, a practitioner in any location, whether or not licensed by the DOHSS, may directly request that another practitioner (such as a radiologist, neurologist, physiatrist, psychiatrist, or other licensed practitioner) perform diagnostic tests, which request shall, except when relating to emergency care, be in writing or by a personal communication documented in the patient record, for which the patient shall not be separately charged, setting forth:
 
1. The patient's reported symptoms and objective signs, if any, pertinent to the problem;
 
2. A brief history of the reported medical condition; and
 
3. An indication of prior testing relating to the medical condition and results thereof.
 
(m) Any practitioner, in any location, whether, or not licensed by DOHSS, accepting a referral for the performance of a diagnostic test, except with respect to emergency care, shall:
 
1. Require that the referral be preceded by verbal communication or delivery of the written request (which may be faxed) as set forth in (l) above;
 
2. Retain a copy of the referring request or document the personal communication in the patient record;
 
3. Institute a procedure to assure that sufficient clinical data has been provided to justify the requested test;
 
4. Personally consult with the referring practitioner in advance of performing the test, if additional information is needed to determine if the diagnostic test requested is the most appropriate test to elicit the clinical information sought;
 
5. Perform a focused clinical examination if, in the practitioner's discretion, such examination is necessary;
 
6. Verify the indications for and appropriateness of diagnostic testing, if the referral has been made by a practitioner with a limited license to a plenary licensee;
 
7. Prepare a report containing the information set forth in section (k) above; and
 
8. Assure that explanation has been provided to the patient and, where there is significant risk or likelihood of side effects, obtain informed consent.
 
(n) Any practitioner designated to be responsible for the management of a diagnostic office which operates without the full-time presence of an appropriately licensed and trained physician shall ensure that:
 
1. All invasive tests, including transesophageal echocardiography and needle electromyography, are personally performed and interpreted by a physician;
 
2. Direct personal supervision by the physician, whereby the physician is immediately available, is provided for all diagnostic tests requiring anesthesia or contrast as set forth in N.J.A.C. 13:35-4A and, in particular, N.J.A.C. 13:35-4A.8 through 4A.11;
 
3. Direct physician presence, supervision and interpretation is provided for all diagnostic tests which, although not invasive, require a sequential analysis with respect to the extent of medically necessary testing, for example, nerve conduction studies, somatosensory evoked potentials, and similar studies;
 
4. Direct supervision by a knowledgeable physician present in the office suite, immediately available to furnish assistance, is provided for cardiovascular stress tests
 
5. Direct supervision is provided for diagnostic tests delegated to a trained radiologic technologist (LRT(R)). Such tests include but are not necessarily limited to MRI with contrast and CT with contrast. Except in a documented emergency, such studies shall not be scheduled or performed in the absence of the physician. Studies utilizing contrast material shall be performed only as permitted by N.J.A.C. 13:35-6.20;
 
6. Standing orders shall be issued in the event that a physician is unable to be present to direct the performance of the test. The standing orders shall pertain to the methods to be used in the performance of the test, the timing and manner of issuance of the physician's oral and written report, and timely notification to the patient or referring physician of results or the need to repeat the test.
 
i. The standing orders shall be specific in nature and disseminated to those responsible for implementation, indicating certain tasks that may be delegated to another licensed health care practitioner, such as a registered professional nurse or radiologic technologist, consistent with the applicable scope of practice; and
 
7. Physician availability (by telephone or in person) be provided for the following diagnostic tests:
 
i. Plain film radiology;
 
ii. CT or MRI studies without contrast, and without sedation; and
 
iii. Electrocardiograms.]
 
(k) In addition to the obligations set forth in (e) above, a practitioner responsible for the management of a diagnostic office shall ensure, through the adoption and dissemination of policies and procedures, or standing orders, that:
 
[page=1665] 1. All personnel performing diagnostic tests are familiar with the methods to be used in the performance of the test;
 
2. The tasks that may be delegated to other licensed health care professionals;
 
3. The timing and manner of issuance of the practitioner's oral and written report; and
 
4. Timely notification to the patient or requesting or referring health care professional of results or the need to repeat the test.
 
(l) In addition to the obligations set forth in (e) and (k) above, a practitioner responsible for managing the diagnostic office shall ensure that appropriate practitioner supervision or availability is provided. Specifically, a practitioner responsible for managing the diagnostic office shall ensure that:
 
1. Needle electromyography testing is personally performed after a focused physical examination and interpreted by a plenary-licensed physician with necessary education and training;
 
2. Invasive tests, including transesophageal echocardiography, are personally performed by a plenary-licensed physician with the necessary education and training, or are delegated by such physician to a physician assistant or advanced practice nurse with the necessary education and training;
 
3. Diagnostic tests requiring anesthesia are performed in compliance with N.J.A.C. 13:35-4A;
 
4. Diagnostic tests that, although not invasive, require a sequential analysis, such as nerve conduction studies, somatosensory evoked potentials, and similar studies, are conducted by trained personnel, subject to physician supervision and interpreted by a physician;
 
5. Cardiovascular stress tests are directly supervised by a physician who is immediately available in the office suite;
 
6. Diagnostic tests with contrast, such as MRIs and CTs, when delegated to a trained radiologic technologist (LRT(R)), are scheduled to be, and are, performed when a physician or a physician assistant or advanced practice nurse, with necessary education and training is present in the office suite, unless there is a documented emergency; and
 
7. Diagnostic tests, which are not invasive, not conducted with anesthesia or contrast, or which do not require sequential analysis, such as plain film radiology, CT or MRI studies without contrast and without sedation, are performed by a trained radiologic technologist (LRT(R)), with a supervising physician immediately available by telephone or other electronic means, if not in the office suite.
 
(m) A practitioner performing a diagnostic test in any location, whether or not licensed by the Department of Health, shall:
 
1. Retain test results (such as the images, raw data, graphs or tracings of nerve conduction studies, as appropriate to the test performed) arising out of a diagnostic test administration, unless that data is part of the patient record at a licensed health care facility, at which secured custody is maintained; and
 
2. Prepare a comprehensive report, which shall include at least the following:
 
i. The practitioner's full name, degree designation, street address, and telephone number;
 
ii. The date on which the test was performed;
 
iii. The location at which the test was performed;
 
iv. The patient's name and a summary of any available pertinent medical and/or psychological history;
 
v. An identification of the specific test(s) performed;
 
vi. The start and stop time of electrodiagnostic tests (including EMG and NCV) and invasive procedures, unless maintained in the patient record;
 
vii. A description of the pertinent findings, diagnosis, or impression and any recommendations;
 
viii. Cross-references to any other tests performed at that diagnostic office or provided along with the direct request or referral, on the same patient, which, in the opinion of the practitioner, are pertinent to the patient's presenting medical condition or injuries; and
 
ix. The date on which the report was prepared.
 
(n) Pursuant to (b) above, in circumstances not involving emergency care, a practitioner in any location, whether or not licensed by the Department of Health, who:
 
1. Directly requests that another practitioner perform specific diagnostic tests, shall convey that request via a prescription or other writing (which may be faxed or transmitted electronically) or by a personal communication documented in the patient record, setting forth:
 
i. The patient's reported symptoms and objective signs, if any, pertinent to the problem;
 
ii. A suspected medical condition to be confirmed or ruled out; and/or
 
iii. A diagnosis, if known; and
 
2. Refers a patient for evaluation to another practitioner to determine the diagnostic test(s) to be performed, shall transmit that referral via a prescription or other writing or by a personal communication documented in the patient record, setting forth information as required by subsection (n)1i, ii, and iii above, and:
 
i. A brief history of the reported medical condition or the clinical reason for the referral; and
 
ii. An indication of prior testing or ancillary studies relating to the medical condition and results thereof.
 
(o) A practitioner, in circumstances not involving emergency care, in any location, whether, or not licensed by the Department of Health, who:
 
1. Accepts a direct request for the performance of a specific diagnostic test, shall:
 
i. Require that the direct request be preceded by delivery of the prescription or other writing (which may be faxed or transmitted electronically), or a personal communication documented in the patient record, as set forth in (n) above;
 
ii. Retain a copy of the request or document the personal communication in the patient record;
 
iii. Personally consult with the requesting practitioner in advance of performing the test if, in the opinion of the accepting practitioner, additional information is needed to determine whether the diagnostic test requested is the most appropriate test to elicit the clinical information sought;
 
iv. Assure that an explanation has been provided to the patient and, where there is significant risk or likelihood of side effects, obtain informed consent;
 
v. Prepare a report containing the information set forth in section (m) above; and
 
vi. Make inquiry of the requesting practitioner as to the appropriateness of the testing or decline to perform the test if the pattern of requests is suggestive of fraud, or improper sequencing of testing, as may be reflected by an inordinate number of patients presenting for the performance of the same test, repetitive selection of complex testing, when less complex testing would be likely to generate comparable clinical data, or the frequent ordering of testing unlikely to generate useful information; and
 
2. Accepts a referral for the evaluation and the determination as to the appropriate diagnostic test shall, in addition to meeting the obligations of (o)1 above, shall also:
 
i. Institute a procedure to assure that sufficient clinical data has been provided to assist in determining the appropriateness of testing, determining which tests to perform, and generating the clinical information necessary to inform treatment decisions; and
 
ii. Perform a focused clinical examination if, in the practitioner's discretion, such examination is necessary and the practitioner has the competency to perform the examination.
 
[(o)] (p) A practitioner performing a diagnostic test in all locations, whether or not licensed by the [DOHSS] DOH, shall promptly issue the results of the test, by preliminary verbal report when immediate follow-up care is indicated and in any event no later than three business days [in any event] from the date of receipt of the report by the testing entity, to the referring practitioner and upon request to the patient or other authorized person, to the extent authorized by N.J.A.C. 13:35-6.5. An interpretation delayed pending receipt of additional material shall be [page=1666] issued as soon as possible thereafter. All abnormalities shall be clearly identified for the attention of a physician or other treating practitioner.
 
[(p)] (q) (No change in text.)
 
[(q)] (r) A practitioner responsible for the management of a diagnostic or screening office may arrange to utilize or lease testing equipment owned by another person or entity or, if permissible as to a given test, to utilize or engage unlicensed technicians who are not employed by the practitioner, and subject to professional supervision, provided that the practitioner shall:
 
1.-5. (No change.)
 
6. Ensure that no technician or other unlicensed person conducts an intake inquiry through direct questioning or by the use of a "checklist" of sample signs and symptoms to elicit information from the patient as the sole historical or other basis for the performance of a diagnostic test, which shall be determined by the practitioner pursuant to [(q)1] (r)1 above;
 
7.-12. (No change.)
 
[(r)] (s) (No change in text.)
 
[(s)] (t) A practitioner who transmits diagnostic test data/records, other than bioanalytical specimens to a clinical laboratory under the jurisdiction of the Department of Health [and Senior Services] pursuant to N.J.S.A. 45:9-42.27 et seq., for interpretation by a consultant who is not a licensee of the Board shall assure that advance written consent for such interpretation service by such consultant has been obtained from the [patient/third party] patient/third-party payor. Utilization of the provisions in this subsection shall be consistent with the requirements of [(n)] (l) above. This subsection is intended to be available for special, occasional, or emergent consultations only. A consultant or consultant entity rendering medical services interpreting diagnostic test data/records, whether in or out of this State, by means of any media, for 10 or more patients under treatment in New Jersey on an annual basis is deemed to be rendering medical services in this State and requires licensure by the Board. However, the exchange of information, which may include patient specific information, between a licensee and a physician licensed in another state, a possession of the United States, or the District of Columbia shall not be deemed to be rendering medical services.