NEW JERSEY - MEDICAL STANDARDS GOVERNING SCREENING AND DIAGNOSTIC MEDICAL TESTING OFFICES

January 1, 2008

New Jersey state laws and regulations that affect your medical practice

1. What is a diagnostic test?

Any 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.

2. Who may perform diagnostic tests?

A. 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;

B. 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

C. May refer the patient to a practitioner who is deemed to meet the criteria identified at (B) i through iv above.

3. Who may bill for diagnostic tests?

A practitioner who meets the qualifications of (2) above may charge patients or bill a third party payor for that test.

4. What tests may a practitioner bill for?

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:

A. 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.

B. 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 follow-up exam is normally appropriate.

C. 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.

D. 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.

E. 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.

F. 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.

G. 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.

F. A practitioner may perform and charge for diagnostic tests necessary to provide emergency care.

Note: 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.

5. What tests may a practitioner not bill for?

No practitioner shall bill for any diagnostic tests which fail to yield data of sufficient clinical value in the development, evaluation or implementation of a plan of treatment, including the following:

A. Spinal diagnostic ultrasonography/ultrasound imaging of the spine;

B. Iridology;

C. Reflexology;

D. Surrogate arm mentoring;

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

F. Surface EMG;

G. Mandibular tracking and stimulation;

H. Videofluoroscopy; and

I. Computer supported range of motion tests.

6. What are the requirements for entities which offer diagnostic tests?

Any entity offering diagnostic or screening tests for a fee shall:

A. 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);

B. Ensure that all test results are interpreted by a practitioner licensed by the SBME and acting within the scope of licensed practice, documented in a written report and maintained in accordance with the requirements records keeping requirements discussed in the Medical Records chapter; and

C. 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.

7. What are the requirements for management of a diagnostic or screening office not licensed by the Department of Health and Senior Services (DHSS)?

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

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

2. The standards for equipment operation;

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

4. The standards with regard to record documentation;

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

6. Minimum safety precautions;

B. Delineate or approve billing procedures;

C. 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 office1;

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

1. All personnel, other than physicians, operating testing equipment which emits radiation are licensed by the New Jersey Radiologic Technology Board of Examiners as required by the Department of Environmental Protection;

2. 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

3. 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;

E. Implement on an ongoing basis a quality assurance program;

F. Ensure that, when entering into a contract for the provision of diagnostic or screening test to be provided by a mobile entity for or on the premises of any licensed health care facility, notice is given by the health care facility to DOHSS of the name of the testing entity and the identity of the physician(s) designated to be responsible for the provision of the diagnostic or screening tests.

G. Develop a quality assurance program which:

1The most recent regulations can be accessed at: http:// http://www.state.nj.us/dep/rpp/njacdown.htm

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.

H. Any physician 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 the Medical Records chapter; and

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

I. In addition to the obligations set forth in (H) above, any physician 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.2, which shall include:

i. Guidance 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 both verbal and 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.

J. Any screening office which operates without a physician on the premises, the physician 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

242 U.S.C. § § 263(b) et seq., and 21 CFR 900.1 et seq

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.

K. A physician designated to be responsible for the management of a screening office not licensed by 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. With respect to those patients who have identified a referring or treating physician, the reports are to be sent to the identified physician and upon request, sent also to the examinee or other authorized person, to the extent authorized by law. 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 physician 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 physician 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, 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, 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 physician, efforts shall be made to contact the treating physician listed. The treating physician shall be requested to make reasonable efforts to notify an examinee, last seen by that physician within the last 12 months, about the report.

L. Any physician 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 physician's full name and title or degree ("Dr." alone is insufficient) and office name, address and telephone number. 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 physician, 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 physician, 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.

M. Pursuant to (b)2 above, a physician in any location, whether or not licensed by the DOHSS, may directly request that another physician (such as a radiologist, neurologist, physiatrist, psychiatrist, or other licensed physician) 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.

N. Any physician, 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 physician 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 physician's discretion, such examination is necessary;

6. Verify the indications for and appropriateness of diagnostic testing, if the referral has been made by a physician 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.

O. Any physician 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 physician, 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.

P. A physician performing a diagnostic test in all locations, whether or not licensed by the DOHSS, shall promptly issue the results of the test, by preliminary verbal report when necessary and no later than three business days from the date of receipt of the report by the testing entity, to the referring physician 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 physician.

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 physician;

3. The location where the test was performed, if different from the billing physician'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 physician 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 physician, and subject to professional supervision, provided that the physician 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 physician pursuant to (Q)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 physician;

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 physician to read or overread and interpret the test data;

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

S. A consulting physician shall not request or receive, offer or pay, directly or indirectly, any form of remuneration from the physician/professional office for accepting a referral of a patient.

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

2. A physician shall not request or receive any form of remuneration from the company providing testing equipment or technicians to that physician 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 physician 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 physician, as applicable.

T. A physician who transmits diagnostic test data/records for interpretation by a consultant who is not a licensee of the SBME shall assure that advance written consent for such interpretation service by such consultant has been obtained from the patient/third party payor.

(N.J.A.C. 13:35-2.6 )

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.