PROPOSED RULEMAKING
STATE BOARD
OF MEDICINE
[49 PA. CODE CH. 16]
Expert Witness
[37 Pa.B. 4647]
[Saturday, August 25, 2007]The State Board of Medicine (Board) proposes to amend § 16.52 (relating to creation of lists of medical consultants) to read as set forth in Annex A.
A. Effective Date
The proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
B. Statutory Authority
Sections 8 and 9 of the Medical Practice Act of 1985 (act) (63 P. S. §§ 422.8 and 422.9) authorize the Board to promulgate regulations addressing procedures to be followed in proceedings before it consistent with section 9 of the act.
C. Background and Purpose
To enhance the quality of testimony given in disciplinary proceedings before the Board and the hearing examiners who hear matters on behalf of the Board, the Board is proposing to adopt the criteria for qualification as an expert witness established by section 512 of the Medical Care Availability and Reduction of Error (Mcare) Act (Mcare Act) (40 P. S. § 1303.512). The Board has found that expert testimony offered by witnesses who do not possess the same specialty qualifications as the respondent whose conduct is under review has led to the assertion of expert opinions that lack the thoroughness and accuracy that the nature of the proceedings before the Board demands. The Board is of the opinion that a physician is not competent to offer an expert medical opinion in a disciplinary action before the Board alleging medical professional negligence, incompetence or violation of the standard of care unless that physician possesses sufficient education, training, knowledge and experience to provide credible, competent testimony and fulfills the qualifications as set forth in this proposed rulemaking.
D. Description of Amendments
Existing § 16.52 is amended to delete references to the maintenance of lists of expert medical consultants who might serve as expert witnesses and would instead establish qualifications consistent with section 512 of the Mcare Act for experts testifying in proceedings before the Board.
Section 16.52(a) would establish the general rule that a person will not be competent to offer an expert medical opinion in a disciplinary action before the Board unless that person possesses sufficient education, training, knowledge and experience to provide credible, competent testimony and fulfills the additional qualifications set forth in this section, as applicable.
Section 16.52(b) would establish qualifications for an expert to testify on a medical matter, including the standard of care, risks and alternatives, causation and the nature and extent of the injury. Those qualifications would include: (1) possessing an unrestricted physician's license to practice medicine in any state or the District of Columbia; and (2) being engaged in, or having retired within the previous 5 years from, the active clinical practice or teaching of medicine. The Board may waive these requirements for an expert on a matter other than the standard of care if the Board determines that the expert is otherwise competent to testify about medical or scientific issues by virtue of education, training or experience.
Section 16.52(c) would establish additional requirements for experts regarding standard of care issues. The expert would need to: (1) be substantially familiar with the applicable standard of care for the specific care at issue as of the time of the alleged breach of the standard of care; (2) practice in the same specialty and subspecialty as the respondent physician or in a subspecialty that has a substantially similar standard of care for the specific care at issue; and (3) in the event a Board-recognized certifying board certifies the respondent physician, the expert shall also be board certified by the same or a similar approved board.
Under § 16.52(d), the Board may waive the same subspecialty requirement for an expert testifying on the standard of care for the diagnosis or treatment of a condition if the Board determines that: (1) the expert is trained in the diagnosis or treatment of the condition, as applicable; and (2) the respondent physician provided care for that condition and that care was not within the Respondent physician's specialty.
Under § 16.52(e), the Board may waive the same specialty, subspecialty and board certification requirements for an expert testifying as to a standard of care if the Board determines that the expert possesses sufficient training, experience and knowledge to provide the testimony as a result of active involvement in or full-time teaching of medicine in the applicable subspecialty or a related field of medicine within the previous 5-year time period.
Finally, under § 16.52(f), the Board reserves its authority to apply its own expertise in determining the applicable standard of care in disciplinary matters before the Board.
E. Input from the Regulated Community
In drafting and promulgating this proposed rulemaking, the Board solicited input and suggestions from the regulated community and other parties who have identified themselves as interested in the Board's regulatory agenda. The Board received comments from the Hospital and Healthsystem Association of Pennsylvania (HAP), the Pennsylvania Medical Society (PMS) and the Pennsylvania Academy of Family Physicians (PAFP). Comments from HAP and PMS were supportive of this proposed rulemaking. PAFP suggested the standards should only apply to experts testifying against the respondent physician and not those testifying on behalf of the respondent physician. The Board disagrees. Improvement in the quality of expert testimony on all sides can only serve to benefit the quality of the entire proceeding. PAFP also believes only licensed physicians from this Commonwealth should be qualified to testify. The Board believes that PAFP's position is not supported by the act, Mcare Act or the Pennsylvania Rules of Evidence (see 225 Pa. Code).
F. Fiscal Impact and Paperwork Requirements
There is no adverse fiscal impact or paperwork requirement imposed on the Commonwealth, political subdivision or the private sector.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 15, 2007, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
I. Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding the proposed rulemaking to Gerald S. Smith, Senior Counsel in Charge, Department of State, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Refer to 16A-4923: Expert Witnesses when submitting comments.
CHARLES D. HUMMER, Jr., M. D.,
ChairpersonFiscal Note: 16A-4923. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE--GENERAL PROVISIONS
Subchapter E. MEDICAL DISCIPLINARY PROCESS AND PROCEDURES
HEARING EXAMINERS AND MEDICAL CONSULTANTS § 16.52. [Creation of lists of medical consultants] Expert witnesses.
[The Board, through the cooperation of various State and local professional societies, has created lists of licensed physicians and surgeons of varied expertise, specialty and training from which medical consultants can be selected to serve on a part-time basis as resource personnel, with medical expertise required for the individual case.]
To enhance the quality of expert testimony given in disciplinary proceedings before the Board and its hearing examiners, the Board adopts the criteria for qualification as an expert established by section 512 of the Medical Care Availability and Reduction of Error (Mcare) Act (40 P. S. § 1303.512), as follows:
(1) General rule. A person will not be competent to offer an expert medical opinion in a disciplinary action before the Board unless that person possesses sufficient education, training, knowledge and experience to provide credible, competent testimony and fulfills the additional qualifications in this section, as applicable.
(2) Medical testimony.
(i) An expert testifying on a medical matter, including the standard of care, risks and alternatives, causation and the nature and extent of the injury, shall:
(A) Possess an unrestricted physician's license to practice medicine in any state or the District of Columbia.
(B) Be engaged in, or have retired within the previous 5 years from, active clinical practice or teaching of medicine.
(ii) The Board may waive the requirements of this subsection for an expert on a matter other than the standard of care if the Board determines that the expert is otherwise competent to testify about medical or scientific issues by virtue of education, training or experience.
(c) Standard of care. In addition to the requirements in subsections (a) and (b), an expert testifying as to a physician's standard of care shall:
(1) Be substantially familiar with the applicable standard of care for the specific care at issue as of the time of the alleged breach of the standard of care.
(2) Practice in the same specialty and subspecialty as the respondent physician or in a subspecialty that has a substantially similar standard of care for the specific care at issue, except as provided in subsection (d) or (e).
(3) In the event a Board-recognized certifying board certifies the respondent physician, the expert shall also be board certified by the same or a similar approved board, except as provided in subsection (e).
(d) Care outside specialty. The Board may waive the same subspecialty requirement for an expert testifying on the standard of care for the diagnosis or treatment of a condition if the Board determines that:
(1) The expert is trained in the diagnosis or treatment of the condition, as applicable.
(2) The respondent physician provided care for that condition and the care was not within the respondent physician's specialty.
(e) Otherwise adequate training, experience and knowledge. The Board may waive the same specialty, subspecialty and Board certification requirements for an expert testifying as to a standard of care if the Board determines that the expert possesses sufficient training, experience and knowledge to provide the testimony as a result of active involvement in or full-time teaching of medicine in the applicable subspecialty or a related field of medicine within the previous 5-year time period.
(f) Application of Board's own expertise. Nothing in this subsection shall be construed to preclude the Board from applying its own expertise in determining the applicable standard of care in disciplinary matters before the Board.
[Pa.B. Doc. No. 07-1550. Filed for public inspection August 24, 2007, 9:00 a.m.]
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