RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF MEDICINE
[49 PA. CODE CH. 16]
Medical Disciplinary Process and Procedures
[35 Pa.B. 3019] The State Board of Medicine (Board) amends § 16.51 (relating to hearing examiners) and adds §§ 16.55--16.58 to read as set forth in Annex A.
A. Effective Date
The final-form rulemaking will be effective upon 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 the requirements of section 9 of the act.
C. Background and Purpose
The final-form rulemaking codifies the process and procedures that are currently followed in disciplinary matters before the Board. These procedures are derived from sections 901--905 of the Health Care Services Malpractice Act (formerly 40 P. S. §§ 1301.901--1301.905). On March 20, 2002, the Governor signed into law the Medical Care Availability and Reduction of Error (MCARE) Act (MCARE Act) (40 P. S. §§ 1303.101--1303.910). Section 5104 of the MCARE Act repealed sections 901--905 of the Health Care Services Malpractice Act. It is not clear what, if any, impact the repealer provisions have on the procedures followed by the Board. Because the Board's procedures have been effective, the Board has determined that codifying the process will maintain the status quo and avoid unnecessary and unintended confusion. The Board has also included language in § 16.55(c) (relating to complaint process) specifically provided for by the MCARE Act.
D. Summary of Comments and Responses to Proposed Rulemaking
Proposed rulemaking was published at 34 Pa.B. 1963 (April 10, 2004). The Board entertained public comment for 30 days during which time the Board received comments from the Pennsylvania Academy of Family Physicians (Academy). Following the close of the public comment period, the Board received comments from the Independent Regulatory Review Commission (IRRC) and the House Professional Licensure Committee (HPLC). The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) did not comment. The following is a summary of the comments and the Board's response.
The Academy sought the specific statutory authority for the confidentiality provision of § 16.55(c). This language is specifically authorized by section 907 of the MCARE Act (40 P. S. § 1303.907). The Academy also questioned § 16.55(d) in regard to the prosecutor's ability, after failed settlement negotiations, to introduce other evidence to prove factual matters disclosed during negotiation. The Academy's position is that this practice impairs the settlement and raises due process concerns. Respectfully, the Academy's position is mistaken. While statements made during the negotiation process are not admissible, it is common accepted practice to allow other evidence not disclosed during negotiations to be introduced.
The HPLC and IRRC raised similar questions regarding the proposed rulemaking. The HPLC and IRRC questioned whether § 16.58 (relating to appeal from the Board decision) could be interpreted as limiting a respondent's right of appeal. This was not the intent of the Board and the language creating the confusion has been deleted as suggested. IRRC also commented that § 16.55 could be clearer by simplifying the language to indicate that any person could file a complaint. The Board has clarified the language as suggested. Because of this change, the HPLC suggestion that a definition of ''public officer'' be added is moot. The HPLC also suggested that the language regarding the Board's sua sponte review of hearing examiner decisions in § 16.57 (relating to appeal from the hearing examiner's decision) could be clarified if the Board substituted the word ''motion'' for ''notice.'' The document the Board issues when it reviews a matter is entitled ''Notice of Review.'' The Board has adopted the suggestion.
E. Description of Amendments
Section 16.51 is amended to more accurately reflect that, consistent with the Commonwealth Attorneys Act (71 P. S. §§ 732-101--732-506), attorneys, including hearing examiners, are assigned to agencies through the Office of General Counsel. The regulation also provides for the Board's current process that, absent an order of the Board otherwise, all matters would be heard by the Board's hearing examiner.
Section 16.55 is added to provide a description of the complaint process. Section 16.55(a) provides that a person may submit a written complaint to the complaints office. Section 16.55(b)--(d) describes the internal processing of complaints. Specifically, in keeping with the decision in Lyness v. State Board of Medicine, 605 A.2d 1204 (Pa. 1992), the Board prosecutor will cause to be conducted reasonable inquiry and will determine whether to initiate the filing of formal charges. Consistent with section 907 of the MCARE Act, § 16.55(c) reiterates that documents, materials or information obtained during the course of an investigation shall be confidential and privileged unless admitted as evidence during the course of a formal disciplinary proceeding. Section 16.55(d) provides for the Board prosecutor to enter negotiations to settle the case by consent agreement.
Section 16.56 (relating to formal hearings open to public) provides for formal hearings to be open to the public.
Section 16.57 provides for review of the hearing examiner's decision by the Board on the request of either party or on the Board's own motion. Section 16.57(b) provides that, unless otherwise ordered by the Board, neither the filing of an application for review nor the Board's own notice of intent to review would stay the hearing examiner's decision.
Section 16.58 provides for review of the Board's decision under 2 Pa.C.S. § 702 (relating to appeals).
F. Fiscal Impact and Paperwork Requirements
There is no adverse fiscal impact or paperwork requirement imposed on the Commonwealth, political subdivisions 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 March 30, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 1963, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on March 15, 2005, this final-form rulemaking was approved by the HPLC. On April 13, 2005, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on April 14, 2005, and approved the final-form rulemaking.
I. Contact Person
Further information can be obtained by contacting Gerald S. Smith, Counsel, State Board of Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, gerasmith@ state.pa.us.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of proposed rulemaking published at 34 Pa.B. 1963.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing acts identified in Part B of this preamble.
K. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 16, are amended by amending § 16.51 and by adding §§ 16.55--16.58 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
CHARLES D. HUMMER, Jr., M.D.
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 35 Pa.B. 2703 (April 30, 2005).)
Fiscal Note: Fiscal Note 16A-4918 remains valid for the final adoption of the subject regulations.
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
Subchapter E. MEDICAL DISCIPLINARY PROCESS AND PROCEDURES
HEARING EXAMINERS AND MEDICAL CONSULTANTS § 16.51. Hearing examiners.
Hearing examiners are appointed by the Governor's Office of General Counsel to hear matters before the Board. Unless otherwise ordered by the Board, disciplinary matters shall be heard by a hearing examiner.
§ 16.55. Complaint process.
(a) A person may submit a written complaint to the complaints office alleging a violation of the act or this chapter or Chapter 17 or 18 (relating to State Board of Medicine--medical doctors; and State Board of Medicine--practitioners other than medical doctors), specifying the grounds therefore.
(b) The complaints office will assign a complaint to the prosecution and investigatory staff who, together with medical consultants as may be required, will make a determination that the complaint merits consideration. The Board prosecutor will cause to be conducted reasonable inquiry or investigation that is deemed necessary to determine the truth and validity of the allegations in the complaint. The Board prosecutor will provide reports to the Board at its regular meetings on the number, nature, procedure and handling of the complaints received.
(c) Upon review of the complaint, documentation, records and other materials obtained during the course of an investigation, the Board prosecutor will determine whether to initiate the filing of formal charges. The documents, materials or information obtained during thecourse of an investigation shall be confidential and privileged unless admitted as evidence during the course of a formal disciplinary proceeding. A person who has investigated or has access to or custody of documents, materials or information which are confidential and privileged under this subsection will not be required to testify in any judicial or administrative proceeding without the written consent of the Board.
(d) The Board prosecutor may enter into negotiations at any stage of the complaint, investigation or hearing process to settle the case by consent agreement.
(1) Consent agreements must be approved as to form and legality by the Office of General Counsel and adopted by the Board.
(2) Until the Board approves a consent agreement, the terms of the agreement are confidential.
(3) Admissions made by a respondent during the course of negotiations may not be used against the respondent in any formal disciplinary proceeding if a consent agreement cannot be reached.
(4) Admissions made by a respondent in a consent agreement that is ultimately rejected by the Board may not be used against the respondent in any formal disciplinary proceeding.
(5) This subsection does not preclude the Board prosecutor from offering, at a formal disciplinary hearing, other evidence to prove factual matters disclosed during the negotiation process.
§ 16.56. Formal hearings open to public.
Formal disciplinary proceedings are open to the public. Members of the press may request in advance of the hearing permission from the presiding officer for the electronic recording of the proceedings. Upon the consideration of objections by the parties, the hearing examiner may permit the electronic recording of the proceeding by members of the press if the presiding officer determines that the recording will not interfere with the efficient conduct or impartiality and fairness of the proceedings.
§ 16.57. Appeal from the hearing examiner's decision.
(a) Unless otherwise ordered by the Board, the decision of the hearing examiner becomes final 20 days after its issuance.
(1) Upon application for review by any party or upon the Board's own motion, the Board will review the hearing examiner's decision.
(2) The Board will review the entire record and, if it deems it advisable, may hear additional testimony from persons already deposed or from new witnesses as well as arguments of counsel to make a Board decision.
(3) Additional testimony will be taken as soon as practicable.
(4) The Board will issue its final decision, along with its findings of fact and conclusions of law, which will be sent by mail to the parties involved.
(b) Unless otherwise ordered by the Board, neither the filing of an application for review nor the Board's own notice of intent to review will stay the hearing examiner's decision.
§ 16.58. Appeal from the Board decision.
The respondent may, within 30 days from the date of the decision of the Board, appeal to the Commonwealth Court under 2 Pa.C.S. § 702 (relating to appeals).
[Pa.B. Doc. No. 05-988. Filed for public inspection May 20, 2005, 9:00 a.m.]
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