Special Physician Edition ---- Significant Proposed Changes to Board of Medical Examiners Regulations As a service to our healthcare clients, the following is provided as a brief summary of regulatory changes as published in the New Jersey Register during October 2004. The summary is provided for informational purposes only and the reader is urged to review the entire text of the changes as such changes appear in the New Jersey Register. Further, this summary represents only selected changes that may affect physicians. As such, please be aware that there are many other regulatory changes that may affect physicians that are not mentioned in this summary. Please note the deadlines for the submission of comments to the proposed changes are December 3, 2004 for the proposed new rule governing new or novel procedures in the office setting and the deadline for the submission of comments to all other proposed changes summarized below is December 17, 2004. This summary is provided by Michael F. Schaff, Esq., Douglas Watson Lubic, Esq., Gordon J. Golum, Esq., Brian F. Kalver, Esq. and John P. Murdoch II, Esq. of the law firm of Wilentz, Goldman & Spitzer, P.A. with offices in Woodbridge, Eatontown, New York City and Philadelphia. If you have any questions, please do not hesitate to contact John Murdoch at 732-855-6008 or via e-mail at jmurdoch@wilentz.com. Proposal of Significant Changes to the State Board of Medical Examiners Regulations. On October 18, 2004, the State Board of Medical Examiners published the proposed readoption of its regulations with significant amendments. The Board s regulations were scheduled to expire on September 20, 2004. However, as the Board filed its notice of proposed readoption prior to the expiration date, the regulations were extended for 180 days to March 19, 2005. The Board had reviewed the existing rules and has determined that they continue to be reasonable, necessary and effective for the purposes for which they were promulgated. The Board proposes to readopt the existing rules with amendments as summarized below. I. General Practice Issues. a. Termination of Patient-Physician Relationship Per Regulations Prohibiting Sexual Misconduct. N.J.A.C. 13:35-6.3 specifies that licensees may not engage in sexual contact with patients with whom the licensee has a patient/ physician relationship. An amendment is
proposed to clarify the procedure by which a physician may actively terminate a patient/ physician relationship and that a minimum of 30 days must pass from the rendition of the last professional service before the patient/physician relationship would be considered to be terminated.. b. Patient Records. An amendment is proposed regarding the allowable fee charged for copying x-rays and other materials within a patient record which cannot be routinely copied or duplicated on a commercial photocopy machine. The fee can not be more than the actual cost of the duplication of the materials, or the fee charged to the licensee for duplication, plus an administrative fee of the lesser of $10.00 or 10 percent of the cost of reproduction to compensate for office personnel time spent retrieving or reproducing the materials and overhead costs. In addition, a proposed amendment provides that a licensee shall not charge a patient for a copy of the patient's record when the licensee has affirmatively terminated a patient from practice in accordance with the requirements of N.J.A.C. 13:35-6.22 or when the licensee leaves a practice that he or she was formerly a member of, or associated with, and the patient requests that his or her medical care continue to be provided by that licensee. c. New or Novel Procedures. While not addressed in the Board s proposed amendments as published in the New Jersey Register on October 18, 2004, a separate proposal published on October 4, 2004, in the New Jersey Register, would establish standards so that (1) a licensee working in a setting which is neither part of a Federal Drug Administration study nor performed in a setting governed by an Institutional Review Board will know what he or she needs to do when performing a new or novel procedure and (2) patients will be protected by requiring licensees to provide them with adequate information regarding the novel nature of the procedure in order to give informed consent. d. Advertising and Solicitation. The Board has proposed amendments to clarify that any licensee advertising certification in a specialty must possess current certification by a specialty board and that the advertising must conspicuously specify in the advertisement the specific board or certifying entity granting the certification. e. Fees charged by the Board. The Board has proposed amendments to make technical changes regarding the types of fees being charged, to remove unnecessary and duplicate references, to set a reinstatement fee at $175.00 which is consistent with other licenses under the Board as well as other professional licensing boards, and to establish an inactive license fee which would be determined by the Director of Consumer Affairs by rule. f. Limited Liability Companies. While not addressed in the Board s proposed amendments as published in the New Jersey Register on October 18, 2004, a separate proposal published on August 2, 2004, if adopted, would clarify the Board's long-standing informal authorization of a limited liability company ( LLC ) as an acceptable professional practice form. (The comment period on this issue has expired as explained in a previous edition of this firm s Regulatory Update.) 2
g. Medical Malpractice Coverage. The Board has proposed amendments to implement recent statutory changes to N.J.S.A. 45:9-19.17 concerning mandatory medical malpractice coverage for physicians and to provide additional coverage options for physicians. Specifically, the proposed amendments identify the means by which licensees may be able to obtain the requisite coverage and include a new definition for the term "authorized" which, for the purposes of this section, means recognized by a governmental agency to offer medical malpractice insurance products. More specifically, a proposed amendment to the definition of "not available" includes the following methods by which a physician may be covered: programs relating to risk retention groups deemed eligible by the Department of Banking and Insurance (DOBI), surplus lines registered with the DOBI, self-insurance trusts, and captive insurance companies approved by the New Jersey Health Care Facilities Financing Authority in the Department of Health and Senior Services. In addition, a proposed amendment to the definition of "letter of credit" would include liability bonds and other instruments issued by a bank or saving association as a vehicle for a letter of credit. N.J.A.C. 13:35-6.19 imposes a duty upon licensees to report any changes in the names and addresses of practice locations, health care facilities or HMOs where they practice, medical malpractice insurers, or any disciplinary or criminal action taken against the licensee. Proposed amendments would amend the notification rule to be consistent with recent statutory changes to N.J.S.A. 45:9-19.16 which requires licensees to report to the Board within 10 days of any changes concerning pending or final actions by criminal authorities for violations of listed crimes and other offenses consistent with amendments in P.L. 2004, c.17. N.J.A.C. 13:35-6.20 sets forth the requirements concerning physician delegation of tasks to radiological technicians and nuclear medicine technicians. h. Reporting Requirements for Communicable Disease. The Board has proposed new rules at N.J.A.C. 13:35-6.24 to set forth the reporting requirements for communicable diseases as required by the DHSS reporting rules at N.J.A.C. 8:57. Failure to report may be deemed to be professional misconduct and subject the licensee to penalties. i. Prescriptions. The Board has proposed amendments that would clarify that a New Jersey Prescription Blank ( NJPB ) may contain only one prescription for a controlled dangerous substance, but other prescriptions, other than for controlled dangerous substances, may be written on the NJPB. j. Surgery. The Board has proposed changes to N.J.A.C. 13:35-4.1 to revise the definition of major surgical procedure to include a procedure in which an opening is made into any of the three major body cavities (abdomen, chest or head), if the facility's credentials committee, in conjunction with the chair or chief of the relevant department or division, has delineated the procedure as one requiring a qualified first assistant. The Board noted that this change is necessary to keep in pace with technological advances in medical procedures which allow for minor procedures to be made in body cavities without the risks that would make the presence of a first assistant necessary. Another proposed amendment allows a licensed podiatric physician to act as a qualified first assistant. 3
II. Diagnostic Testing Regulations. The Board s proposed amendments to diagnostic testing regulations stem from an informal request during 2001 by the Radiological Society of New Jersey for modifications to the requirements for physician presence in certain circumstances, record storage by physicians, and notification to another State agency of certain kinds of contractual arrangements. a. Notice to Department of Health and Senior Services. A proposed amendment to N.J.A.C. 13:35-2.6 would delete paragraph(e)6 thereby removing a requirement that a practitioner, who contracts with a licensed health care facility to perform diagnostic or screening tests on the facility premises, must provide a detailed notice to the State Department of Health and Senior Services ( DHSS ). The Board has been advised that DHSS does not presently require such notice, and that, in any event, in light of the recent enactment of P.L. 2004, c.54, which requires entities providing magnetic resonance imaging and computerized axial tomography services to obtain licenses from DHSS, the choice of how best to address the issue lies with DHSS. b. Screening Mammography. The proposed amendment to N.J.A.C. 13:35-2.6(h)2i clarifies the subparagraph, that currently requires that the office protocol required of a mammography screening office shall provide guidance on positioning of the examinee, to indicate that such guidance is to be provided to the practitioner performing the mammography. The change to subparagraph (h)2iv would delete the current requirement that verbal advice be given to the examinee in addition to the requirement for the written test report, reminding that a screening mammography is not a comprehensive examination sufficient to detect all abnormalities. Thus, the written notice would suffice. Neither change conflicts with requirements of the Federal rules implementing the Mammography Quality Standards Act, 21 CFR 900.1 et seq. c. Telephone Notice of Abnormal Results in Screening Test. N.J.A.C. 13:35-2.6(j) currently requires telephone notice to an examinee of any abnormal result on a screening test in addition to a written notice. The proposed amendment would continue the written notice requirement, but the proposed amendment would limit the additional requirement to speedily issue a notice by telephone to circumstances where immediate clinical follow-up is warranted. d. Diagnostic Testing Records. i. N.J.A.C. 13:35-2.6(k) currently requires every practitioner to maintain a complete record of diagnostic testing. The proposed amendment would allow a practitioner who has performed a diagnostic test of a patient within a licensed health care facility to entrust the reports and raw data of the test, including radiographic images, to the secured custody of that licensed health care facility as part of the facility's permanent patient records. This change should simplify recordkeeping requirements, avoiding unnecessary duplication while still providing reasonably secure and accessible record preservation. ii. N.J.A.C. 13:35-2.6(o) deals with issuance of diagnostic test reports and currently requires a practitioner performing a diagnostic test to issue a report of test results no 4
later than three business days from determining the result. The proposed amendment would require that the report be issued sooner, including by a preliminary verbal report, in those circumstances when immediate follow-up care is indicated. iii. The proposed amendment to N.J.A.C. 13:35-2.6(s), would clarify that the opportunity to request a billable consultation regarding diagnostic test interpretation, from a practitioner unlicensed in this State, 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 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, therefore, must be licensed by the New Jersey Board of Medical Examiners. Note: The requirement does not apply to bioanalytic specimens sent to a clinical laboratory under the jurisdiction of the DHSS. However, physician to physician contacts where information, which may include patient specific information, is exchanged between a licensee and a physician licensed in another state, possession of the United States or the District of Columbia would not be deemed to be rendering medical services under this subsection. Editor s note: The Board has elected to adopt the standard of 10 or more New Jersey patients treated on an annual basis as this is the number recommended by the Federation of State Medical Boards of the United States in their Model Act for regulating the practice of medicine across state lines. III. Performance of New or Novel Procedures in the Office Setting. In addition to the above proposed changes, the Board proposed new rule N.J.A.C. 13:35-6.7 as published in the October 4, 2004 edition of the New Jersey Register that seeks to govern the performance of new or novel procedures in the office setting. Due to the importance of this issue, the entire text of the proposed new rule is provided for your review below. Minimum standards for the performance of new or novel procedures in the office setting: (a) This section contains minimum standards for the performance of new or novel procedures as defined in (b) below which are performed in the office setting and are not performed under the jurisdiction of an Institutional Review Board (IRB) which complies with the requirements of the Federal Food and Drug Administration. (b) The following words and terms, when used in this section, shall have the following meanings, unless the context indicates otherwise: "Diagnostic or therapeutic modality" means a modality intended for use in the diagnosis of disease or conditions in humans or in the cure, mitigation, treatment or prevention of disease in humans or a modality intended to affect the structure of or any function of the human body. "Generally recognized as safe and effective" means there exists substantial evidence by means of 5
at least two well-controlled clinical studies that the new or novel procedure will have the effect that is represented and the procedure does not pose a significant risk to the physical or emotional health of the patient and has a low reported incidence of adverse reactions or significant side effects. "New or novel procedure" means a diagnostic or therapeutic modality performed by a Board licensee that: 1. Is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use and poses a potential risk of physical or emotional harm to a patient; or 2. Is a new application of a procedure which has been generally recognized as safe and effective for its traditional use but is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its new application and the new application poses a potential risk of physical or emotional harm to a patient. "Office setting" means a location at which medical, surgical or podiatric services are rendered and is not licensed by the New Jersey Department of Health and Senior Services. (c) A licensee shall not perform a procedure in an office setting that is generally recognized as ineffective and unsafe by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use. (d) A licensee shall establish a procedural protocol prior to performing a new or novel procedure in the office setting. The protocol shall at a minimum: 1. Provide for protection of human subjects consistent with FDA guidelines set forth in 21 C.F.R. 50 (2004) available from the United States Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-0001, which are incorporated by reference herein, and as may be amended and supplemented; 2. Ensure the procedure is performed by physicians qualified by training, education, or experience to perform such procedure; 3. Ensure the physician performing the procedure is able to demonstrate the scientific merits of the procedure; 4. Ensure the procedure is supported by adequate and well-controlled animal studies or the weight of the sacrifice and medical literature; 5. Contains provisions for pre-operative screening; 6
6. Delineate specific diagnoses for which the procedure is indicated; 7. Delineate specific contraindications to the procedure, if any; 8. Provide for fully informed consent in accordance with prevailing New Jersey law, including full explanation of risks, benefits, alternative treatments and likely outcome without treatment; 9. Provide for and demonstrate operator and staff training, experience, and ongoing competency; 10. Provide for a period of post procedure observation and management commensurate with the complexity, invasiveness and risks of the procedure and any concomitant anesthesia; 11. Provide for written discharge instructions, follow-up and any associated aftercare; 12. Maintain documentation of complete care rendered in accordance with Board rules, N.J.A.C. 13:35-6.5, and maintain records of any associated morbidity, mortality and clinical outcomes; 13. Ensure that procedures are described with specificity including use of pharmaceutical agents and their dosages, anticipated side effects, and projected short and long-term treatment; and 14. Where applicable, ensure compliance with the rules regarding surgery and anesthesia services performed in an office setting (N.J.A.C. 13:35-4A). (e) A licensee shall provide the Board with a procedural protocol upon request in order to ensure that the licensee has complied with the requirements of (d) above. (f) If the requirements of (d) above cannot be met, a licensee may request Board approval to perform a new or novel procedure. Such request shall include a statement identifying which protocols in (d) above cannot be met and the reason therefor. The Board shall not approve a request under this subsection unless the licensee demonstrates to the satisfaction of the Board that: 1. The procedure may be effective for its intended use and will not expose patients to an unreasonable and significant additional risk of illness or injury; 2. The procedure is intended to treat a serious or immediately life-threatening disease and no comparable or satisfactory therapeutic alternatives are available to treat that stage of the disease in the intended patient population and there is a reasonable likelihood that death will occur within a matter of months or premature death is likely without early intervention; 3. The procedure is under investigation in controlled clinical trials or all clinical trials have been completed but not yet reported; and 7
4. The licensee has provided to the Board all information known to the licensee, regarding the studies referred to in (f)3 above. Any comments to the above proposed changes must be submitted by December 17, 2004 except for comments pertaining to proposed new rule N.J.A.C. 13:35-6.7 must be submitted by December 3, 2004 to: William Roeder, Executive Director State Board of Medical Examiners PO Box 183 Trenton, NJ 08625 The information provided in this summary is for discussion purposes only and shall not be considered legal advice or legal opinion on any specific facts or circumstances. The contents of this summary and any related information and/or materials are intended solely for general information purposes only. You are urged to consult your own attorney concerning your own situation and any specific legal questions that you may have. You may also contact John Murdoch of the law firm of Wilentz, Goldman & Spitzer, P.A. at (732) 855-6008 or via e-mail at jmurdoch@wilentz.com. 8