N.J. Admin. Code § 13:35-2.6

Current through Register Vol. 56, No. 8, April 15, 2024

Section 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.

"Board" means the New Jersey State Board of Medical Examiners.

"Clinically supported" means that a practitioner who has identified a need for a diagnostic test, prior to personally performing or directly requesting that another practitioner administer a specific test, has:

1. 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 available previously performed test(s) relating the patient's medical condition and the results; and

3. Documented in the patient record positive and negative findings, observations and medical indications to justify the test.

"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, 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.

"Diagnostic test" means a medical service utilizing biomechanical, neurological, neurodiagnostic, radiological, vascular or any means, other than bioanalysis, intended to assist in establishing a medical diagnosis, for the purpose of recommending a course of treatment for the tested patient to be implemented by the treating practitioner or by the consultant.

"Emergency care" means all medically necessary treatment of a traumatic injury or a medical condition manifesting itself by acute symptoms of sufficient severity such that absence of immediate attention could reasonably be expected to result in: death; serious impairment of bodily functions; or serious dysfunction of a bodily organ or part. "Emergency care" includes all medically necessary care immediately following a traumatic injury including, but not limited to, immediate pre-hospitalization care, transportation to a hospital or trauma center, emergency department care, surgery, critical and acute care and extends during the period of initial hospitalization until the patient is discharged from acute care by the attending physician.

"Normal" or "normally" means the usual, routine, customary or common experience and conclusion, which may in unusual circumstances differ from the actual judgment or course of treatment. The unusual circumstances shall be based on clinically supported findings of a practitioner. The use of these terms is intended to indicate some flexibility and avoid rigidity in the application of these rules and to recognize the good faith educated judgment of a practitioner.

"Physician" means a medical or osteopathic physician holding a plenary license issued by the New Jersey State Board of Medical Examiners.

"Practitioner" means a physician, podiatric physician, physician assistant or certified nurse midwife licensed by or registered with the New Jersey State Board of Medical Examiners.

"Screening office" means a practice location, whether stationary or mobile, not licensed by the State Department of Health, 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.

"Screening test" means a medical service utilizing biomechanical, neurological, neurodiagnostic, radiological, vascular or any means, other than bioanalysis, performed in the absence of apparent immediate need for medical treatment for the purpose of providing medically useful information in circumstances where the anticipated benefits of the testing for an appropriate category of individual care are reasonably believed to outweigh the assessed risks, resulting in a health care evaluation, analysis or assessment; but does not include screenings such as, but not limited to, hypertension or glaucoma screenings, offered at no cost to examinees by community-sponsored public health services, hospitals or nonprofit professional or civic organizations, providing some means is established to give follow-up advice and referrals.

(b) A practitioner who identifies a clinically supported need for a patient to undergo a diagnostic test may:

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 payor for that test, except that:

1. No practitioner shall bill for any diagnostic tests 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. Spinal diagnostic ultrasonography/ultrasound imaging of the spine;

ii. Iridology;

iii. Reflexology;

iv. Surrogate arm mentoring;

v. Brain mapping, when not done in conjunction with appropriate neurodiagnostic testing;

vi. Surface EMG;

vii. Mandibular tracking and stimulation;

viii. Videofluoroscopy; and

ix. Computer supported range of motion tests.

2. The practitioner may bill for any of the following diagnostic tests which can yield data of sufficient clinical value in the development evaluation or implementation of a plan of treatment, when clinically supported, subject to the limitations relating to timing, frequency and manner as follows:

i. Thermography when used to evaluate pain associated with reflex sympathic dystrophy ("RSD"), in a controlled setting by a physician experienced in such use and properly trained.

ii. Needle electromyography (needle EMG) when used in the evaluation and diagnosis of neuropathies and radicular syndrome where clinically supported findings reveal a loss of sensation, numbness or tingling. A needle EMG is not indicated in the evaluation of TMJD and is contraindicated in the presence of infection on the skin or cellulitis. This test should not normally be performed within 14 days of a traumatic injury and should not be repeated where initial results are negative. Only one followup exam is normally appropriate.

iii. Somasensory evoked potential (SSEP), visual evoked potential (VEP), brain audio evoked potential (BAEP), or brain evoked potential (BEP), nerve conduction velocity (NCV) and H-reflex Study when used to evaluate neuropathies and/or signs of atrophy, but not within 21 days following the traumatic injury.

iv. Electroencephalogram (EEG) when used to evaluate head injuries, where there are clinically supported findings of an altered level of sensorium and/or a suspicion of seizure disorder. This test, if indicated by clinically supported findings, can be administered immediately following a traumatic injury. Repeat testing is not normally conducted more than four times per year.

v. Magnetic resonance imaging (MRI) when used in accordance with the guidelines contained in the American College of Radiology, Appropriateness Criteria to evaluate injuries in numerous parts of the body, particularly the assessment of nerve root compression and/or motor loss. MRI is not normally performed within five days of a traumatic injury. However, clinically supported indications of neurological gross motor deficits, incontinence or acute nerve root compression with neurologic symptoms may justify MRI testing during the acute phase immediately post injury.

vi. Computer assisted tomographic studies (CT or CAT scan) when used to evaluate injuries in numerous aspects of the body. With the exception of suspected brain injuries, CAT scan is not normally administered immediately post injury, but may become appropriate within five days of the trauma. Repeat CAT scans should not be undertaken unless there is clinically supported indications of an adverse change in the patient's condition.

vii. Sonograms/ultrasound when used in the acute phase to evaluate the abdomen and pelvis for intra-abdominal bleeding. These tests are not normally used to assess joints (knee and elbow) because other tests are more appropriate. Where MRI is performed, sonograms/ultrasound are not necessary. These tests should not be used to evaluate TMJD. However, echocardiogram is appropriate in the evaluation of possible cardiac injuries when clinically supported.

3. Notwithstanding the limitations set forth at (c)1 and 2 above, a practitioner may perform an enumerated diagnostic test, for which there shall be no charge to the patient or third party payor, after assuring that written informed consent has been obtained.

4. Notwithstanding the limitations set forth at (c)1 and 2 above, a practitioner may perform and charge for diagnostic tests necessary to provide emergency care.

(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) A practitioner designated to be responsible for the management of a diagnostic or screening office not licensed by the Department of Health (DOH) shall:

1. Establish and make available to personnel written policies and procedures concerning the following:

i. The specific tests which may be performed in the office;

ii. The standards for equipment operation;

iii. The procedures to be followed in obtaining informed consent;

iv. The standards with regard to record documentation;

v. The procedures relating to follow-up reporting to examinees, patients, and/or referring practitioners, as applicable; and

vi. Minimum safety precautions;

2. Delineate or approve billing procedures;

3. Ensure that any equipment which emits radiation shall conform to the applicable sections of N.J.A.C. 7:28 and maintain documentation with respect to those requirements at the office;

4. Verify, through a documented review of credentials, upon hiring and on at least an annual basis, that:

i. All personnel, other than physicians, operating testing equipment which emits radiation are licensed by the New Jersey Radiologic Technology Board of Examiners as shall be required by the Department of Environmental Protection in accordance with 26:2D-1 et seq. and N.J.A.C. 7:28-19;

ii. All personnel, other than physicians, operating magnetic resonance imaging equipment are licensed as may be required by the Department of Environmental Protection (DEP), or demonstrate technical training to perform MRIs and are not otherwise precluded by any requirements of the DEP; and

iii. All personnel, other than physicians, operating ultrasound equipment are certified by the American Registry of Diagnostic Medical Sonographers or by the American Registry of Radiologic Technologists, or demonstrate technical training to perform ultrasounds and are not otherwise precluded by any requirements of the Department of Environmental Protection; and

5. Implement on an ongoing basis a quality assurance program as required by (f) below.

(f) Every diagnostic or screening office shall have a quality assurance program which:

1. On at least a quarterly basis, requires the following:

i. An evaluation of personnel skills and performance;

ii. An assessment of the supervision being provided to employees; and

iii. A review of test performance techniques, accuracy and data recordation; and

2. On at least an annual basis, requires the following:

i. An audit of billing records for accuracy; and

ii. Documented regular inspections of equipment.

(g) In addition to the obligations set forth in (e) and (f) above, any practitioner designated to be responsible for the management of a screening office shall:

1. Ensure that all bills accurately describe screening tests performed and do not misrepresent tests to be diagnostic;

2. Establish a written protocol identifying professionally recognized criteria to be evaluated in accepting eligible examinees for each type of screening test and providing a procedure for excluding examinees who do not meet the criteria. For example, for bone densitometry, mammography, and other screening tests, the protocol shall include specific criteria relating to age, family history, personal medical history, and permissible frequency of testing and shall specify contraindications and foreseeable risks;

3. Designate in writing those employees who have been assigned responsibility for the implementation of the protocol and quality control review, reflecting the type of credentials held;

4. Develop informed consent forms or other mechanisms to provide information to examinees;

5. Devise a system by which screening office records are maintained in accordance with the basic information standards set forth in N.J.A.C. 13:35-6.5; and

6. Upon the request of the Board, prepare statistical reports reflecting the total number of screening examinees, and the total number of abnormality reports issued and the advisory letter required by (h) below.

(h) In addition to the obligations set forth in (e) through (g) above, any practitioner designated to be responsible for the management of a screening office at which mammography is offered shall:

1. Ensure that mammography screening tests are performed only under the supervision of a physician who meets the requirements as mandated by the Mammography Quality Standards Act (MQSA), 42 U.S.C. §§ 263(b) et seq., and that such tests are interpreted only by a physician who meets the MQSA requirements. The supervising and interpreting physician(s) shall maintain proof on the premises of having attained such credentials;

2. Establish a written protocol in compliance with the requirements of the Mammography Quality Standards Act, 42 U.S.C. §§ 263(b) et seq., and 21 CFR 900.1 et seq., which protocol shall also include:

i. Guidance to the performer of the test with respect to appropriate positioning preparatory to the test;

ii. Methods for providing instruction in breast self-examination, which may include written materials;

iii. Advice regarding referrals concerning follow-up care with respect to any person who presents as a self-referral for "screening" but who also mentions awareness of symptoms which may be indicative of abnormality, including, but not limited to, nipple discharge, pain or suspicion of a lump. A person who mentions awareness of such symptoms shall be specifically advised to seek follow-up care; and

iv. Procedures for providing in lay language written advice at the time of testing, and on the testing report, that a screening mammography is not a comprehensive examination nor sufficient to detect all abnormalities and that examinees should seek a complex examination from a physician; and

3. Retain baseline mammography images and periodic images for seven years from the date of issuance of the last test interpretation report, except that the physician shall, upon request, release the original of any image, provided that signed documentation thereof is retained in the examinee's file and an interpretation report is retained.

(i) In addition to the obligations set forth in (e) and (h) above, at any screening office which operates without a practitioner on the premises, the practitioner designated to be responsible for the management of a screening office shall also:

1. Specify certain screening tests that may be performed when the responsible physician is not physically present;

2. Designate another licensed health care professional, such as a registered professional nurse or a radiologic technologist, to perform tasks consistent with the test procedure and the delegated person's scope of licensed practice; and

3. Identify tasks of a non-medical nature that may be delegated to non-licensed employees under the supervision of a licensed employee, where not inconsistent with applicable laws or rules, and consistent with accepted standards of practice pertinent to that screening test.

(j) A practitioner designated to be responsible for the management of a screening office not licensed by the Department of Health 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. With respect to those patients who have identified a referring or treating practitioner, the reports are to be sent to the identified practitioner and upon request, sent also to the examinee or other authorized person, to the extent authorized by N.J.A.C. 13:35-6.5. A report delayed pending receipt of additional material shall be issued as soon as possible after the report is complete;

2. With respect to any abnormality warranting follow-up care, the referring practitioner shall be contacted in writing, and, if immediate follow-up care is clinically indicated, shall additionally be contacted promptly by other means (which may be a verbal communication contemporaneously documented in the examinee record) to insure notification to the examinee;

3. When an abnormality has been discovered and no referring or treating practitioner is identified by the examinee, the written notice of abnormality which shall be provided to the examinee shall contain a clear advisory concerning the need to seek follow-up medical consultation as well as appropriate referral information;

4. In the circumstances set forth in (j)3 above and where immediate clinical follow-up is warranted, efforts shall be made additionally to personally contact the examinee by telephone to confirm that the examinee was made aware of the need to follow up, which efforts shall be documented in the examinee record. When efforts to contact the examinee have been unsuccessful over a period not to exceed 10 days, a letter shall be forwarded to the examinee's address of record by certified mail, return receipt requested, or other proof of delivery, with a copy maintained in the chart, advising of the abnormality and the need for follow-up and referral; and

5. If the examinee with a discovered abnormality cannot be reached as required by (j)4 above, but the examinee has listed the name and address of a treating practitioner, efforts shall be made to contact the treating practitioner listed. The treating practitioner shall be requested to make reasonable efforts to notify an examinee, last seen by that practitioner within the last 12 months, about the report.

(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:

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 and interpreted by a plenary-licensed physician with necessary education and training after a focused physical examination;

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, 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, 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.

(p) A practitioner performing a diagnostic test in all locations, whether or not licensed by the 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 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 issued as soon as possible thereafter. All abnormalities shall be clearly identified for the attention of a physician or other treating practitioner.

(q) Bills for diagnostic or screening tests submitted for payment to either the patient or a third party payor shall reflect:

1. The name of provider and licensure status;

2. The office address of the billing practitioner;

3. The location where the test was performed, if different from the billing practitioner's office addresses;

4. The date on which the test was performed; and

5. No charge for any test:

i. Designated pursuant to (c) above to be without apparent clinical value and thus lacking validity;

ii. Performed at a stage or frequency or in a manner not consistent with the limitations set forth in (c) above; or

iii. Where the result is professionally incomplete as to the intended view or study or non-diagnostic due to inadequate equipment or technique, except that when the reason for the deficiency relates to an unanticipated physical condition of the patient which precludes completion of the intended examination, such study shall not be deemed professionally incomplete for billing purposes.

(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. Be responsible for ascertaining and documenting, identifying the indications for and the medical necessity of the diagnostic or screening test;

2. Understand the purpose and use of the equipment including benefits, risks and contraindications for the patient;

3. Recognize proper calibration and other functioning of the equipment used;

4. Be capable of properly using the equipment in the performance of the diagnostic testing;

5. Be competent to interpret the resulting data;

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 (r)1 above;

7. Not provide the lessor with a "certificate of medical necessity" or any document which implies authority to issue a bill for services to anyone other than the leasing practitioner;

8. Not allow the lessor entity or its technician prior or subsequent access to any portion of a patient or examinee record regarding treatment or billing or financial information;

9. Not allow the technician to conduct a clinical interview of the patient or to make any decisions regarding which tests are to be performed or their sequence or the method of performance of the test;

10. Not be a party to a contract, whether written or verbal, with the lessor of the equipment, its technicians or any other agent, whereby the lessor or agent would recommend or provide a consultant practitioner to read or overread and interpret the test data;

11. (Reserved);

12. Be fully responsible for the reasonableness of the fee charged.

(s) Consistent with 13:35-6.17(c), a consulting practitioner shall not request or receive, offer or pay, directly or indirectly, any form of remuneration from the practitioner/professional office for accepting a referral of a patient.

1. A referring practitioner shall not request or receive, offer or pay, directly or indirectly, any form of remuneration from the consulting practitioner for providing a referral.

2. A practitioner shall not request or receive any form of remuneration from the company providing testing equipment or technicians to that practitioner or to his or her office, whether in the form of a shared fee, or for "rent" (whether on premises or off-premises) or for "administrative services" or under any other description.

3. A referring or consulting practitioner shall not be deemed an independent contractor to anyone associated with the testing of a specific patient; thus, the bill, if any, for any component of the testing shall be submitted solely in the name of the referring or consulting practitioner, as applicable.

N.J. Admin. Code § 13:35-2.6

Amended by 50 N.J.R. 209(a), effective 1/2/2018

Amended by 52 N.J.R. 890(b), effective 4/20/2020