RULES AND REGULATIONS
STATE BOARD OF MEDICINE
[49 PA. CODE CH. 16]
Continuing Medical Education
[34 Pa.B. 4686] The State Board of Medicine (Board) amends § 16.1 (relating to definitions) and adds § 16.19 (relating to continuing medical education) to read as set forth in Annex A.
A. Effective Date
The final-form rulemaking is effective upon publication in the Pennsylvania Bulletin.
B. Statutory Authority
Under section 910 of the Medical Care Availability and Reduction of Error (MCARE) Act (act) (40 P. S. § 1303.910), the Board is required to establish requirements for continuing medical education for physicians as a condition for renewal of their licenses.
C. Background and Purpose
The final-form rulemaking implements section 910 of the act, which requires completion of continuing medical education as a condition of biennial license renewal of physician licenses by the Board.
D. Description of the Final-Form Rulemaking
Section 16.1 is amended to include new definitions that relate to the continuing medical education requirement. Acronyms for the Accreditation Council for Continuing Medical Education (ACCME), the American Medical Association (AMA) and the American Medical Association Physician's Recognition Award (AMA PRA) have been included. The ACCME is the national oversight body for continuing medical education. The AMA PRA is the Nationally recognized standard for continuing medical education. Continuing medical education activities that adhere to the published standards of the AMA PRA are eligible for continuing medical education credit.
Because continuing medical education activities are much broader than typical didactic course work and may include activities such as rounds, research, independent study, teaching, and the like, the final-form rulemaking changes the definition of ''approved course'' to ''approved activity.'' This definition also has been amended to more accurately reflect that in the field of continuing medical education activities are accepted for credit in a decentralized process by organizations designated by the ACCME. Definitions have also been added to identify that continuing medical education activities are delineated under the AMA PRA standard into Category 1 activities and Category 2 activities. ''Category 1'' and ''Category 2'' are terms of art in the continuing medical education field and are well understood by the physician and continuing medical education communities, accordingly, further defining these terms is unnecessary and likely to generate confusion rather than clarity.
Section 16.19 has been amended in final rulemaking in several respects. Because of the short time period remaining between publication of this final-form rulemaking and the January 1, 2005, deadline for renewal of license, the Board has determined to significantly reduce the continuing education requirement for this renewal period. However, the Board has determined that it is important to implement at least a minimum continuing education requirement. Accordingly, § 16.19 has been amended in the final-form rulemaking so that the licensure renewal period beginning January 1, 2005, proof of completion of 25 credit hours of continuing medical education in the preceding biennial period running January 1, 2003, through December 31, 2004, will be required. The 25 credit hours for the January 1, 2005, license renewal period may be completed in either AMA PRA Category 1 or AMA PRA Category 2 and must include 3 hours of patient safety and risk management.
Full implementation of the continuing education requirement has been delayed until the licensure renewal period beginning January 1, 2007. At that time, proof of completion of 100 credit hours of continuing medical education in the preceding biennial period running January 1, 2005, through December 31, 2006, will be required for licensure renewal for medical doctors.
Under § 16.19(a), once full implementation occurs, at least 20 credit hours of the 100 will be required to be completed in AMA PRA Category 1 approved activities. Further, at least 12 credit hours of the 100 will be required to be completed in AMA PRA Category 1 or Category 2 activities related to the area of patient safety and risk management. Approved activities in the area of patient safety and risk management may include topics such as improving medical records and recordkeeping, reducing medical errors, professional conduct and ethics, improving communications, preventative medicine and healthcare quality improvement. Credit will not be granted for courses in office management or practice building.
Under § 16.19(b), physicians are required to retain documentation of participation for 2 years after renewal and shall certify they completed continuing medical education activities on a form provided by the Board for that purpose. Documentation proving completion of continuing medical education must be produced, upon Board demand, under random audits of reported credit hours. Electronic submission of documentation is permissible to prove compliance. Noncompliance may result in disciplinary proceedings under section 41(6) of the Medical Practice Act of 1985 (63 P. S. 422.41(6)). Section 16.19(b)(2) and (3) identifies acceptable forms of documentation evidencing completion of continuing medical activities.
Section 16.19(c) provides for exemption from the continuing medical education requirement for a physician who is applying for licensure in this Commonwealth for the first time,; holds a current training license; is a retired physician providing care only to immediate family members or is on inactive status, except that a physician seeking to reinstate an inactive or lapsed license shall show proof of compliance with the continuing education requirement for the preceding biennium. Section 16.19(d) provides that a physician suspended for disciplinary reasons is not exempt from the requirements of this section.
Section 16.19(e) authorizes the Board to grant discretionary waivers of the continuing medical education requirements in cases of serious illness, military service or other good cause provided that the granting of the waiver will not jeopardize the public's safety and welfare.
E. Public Comment
Proposed rulemaking was published at 34 Pa. B. 56 (January 3, 2004). In drafting and promulgating the final-form 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 entertained public comment for 30 days during which time the Board received comments from individuals and organizations including the Hospital and Healthsystem Association of Pennsylvania (HAP), several hospitals and the Pennsylvania Medical Society. 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 responses.
The comments were in the main supportive of the proposed rulemaking but expressed concern regarding the amount of time remaining in the renewal period and whether it would be practicable to fully implement the continuing medical education requirement for the January 1, 2005, renewal. The HPLC and IRRC echoed this concern. The Board agrees that full implementation is not practicable at this point in time and has amended the final-form rulemaking to delay full implementation until January 1, 2007. However, the Board has provided for a minimum continuing medical education requirement for the upcoming renewal.
The HAP also requested that the final-form rulemaking clarify that the existing Nationally recognized AMA PRA Category 1 and Category 2 system of accepting continuing medical education would continue. The Board agrees that the proposed rulemaking was not clear in this intent and has made the suggested amendments to the final-form rulemaking.
The HPLC and IRRC pointed out that the proposed rulemaking appeared in error in regard to the counting of patient safety and risk management activities in relation to the full 100-hour requirement. The Board corrected the final-form rulemaking to clarify that patient safety and risk management was part of the over 100 hours of required continuing medical education. The Board increased the number of required hours in patient safety and risk management from 10 to 12 in keeping with the Governor's Plan For Medical Malpractice Liability Reform of June 9, 2003.
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. Citizens of this Commonwealth will benefit in that this final-form rulemaking promotes patient safety and welfare as a consequence of maintaining physician participation in continuing medical education activities.
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 January 3, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 56, 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 and the Committees 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 House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on June 30, 2004, the final-form rulemaking was approved by the HPLC. On July 28, 2004, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on July 29, 2004, and approved the final-form rulemaking.
I. Contact Person
Further information may 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. 56.
(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 § 16.1 and by adding § 16.19 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(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 34 Pa.B. 4528 (August 14, 2004).)
Fiscal Note: Fiscal Note 16A-4914 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--GENERAL PROVISIONS
Subchapter A. BASIC DEFINITIONS AND INFORMATION § 16.1 Definitions.
The following words and terms, when used in this chapter and Chapters 17 and 18 (relating to State Board of Medicine--medical doctors; and State Board of Medicine--practitioners other than medical doctors), have the following meanings, unless the context clearly indicates otherwise:
ACCME--The Accreditation Council for Continuing Medical Education.
AMA--American Medical Association.
AMA PRA--American Medical Association Physician's Recognition Award.
* * * * * Approved activity--A continuing medical education activity accepted for AMA PRA credit.
* * * * * Category 1 activities--Continuing medical education activities approved for AMA PRA Category 1 credit.
Category 2 activities--Continuing medical education activities approved for AMA PRA Category 2 credit.
* * * * * Immediate family member--A parent, spouse, child or adult sibling residing in the same household.
* * * * *
Subchapter B. GENERAL LICENSE, CERTIFICATION AND REGISTRATION PROVISIONS § 16.19 Continuing medical education.
(a) Beginning with the licensure renewal period commencing January 1, 2005, proof of completion of 25 credit hours of continuing medical education in the preceding biennial period will be required for licensure renewal for medical doctors. The 25 credit hours for the January 1, 2005, license renewal period may be completed in either AMA PRA Category 1 or AMA PRA Category 2 activities, and must include 3 hours in patient safety and risk management.
(b) Beginning with the licensure renewal period commencing January 1, 2007, proof of completion of 100 credit hours of continuing medical education in the preceding biennial period will be required for licensure renewal for medical doctors.
(1) At least 20 credit hours shall be completed in AMA PRA category 1 approved activities. At least 12 credit hours shall be completed in AMA PRA Category 1 or AMA PRA Category 2 approved activities in the area of patient safety and risk management. Approved activities in the area of patient safety and risk management may include topics such as improving medical records and recordkeeping, reducing medical errors, professional conduct and ethics, improving communications, preventative medicine and healthcare quality improvement. The remaining credit hours shall be completed in AMA PRA Category 1 or AMA PRA Category 2 approved activities. Credit will not be granted for courses in office management or practice building.
(2) Physicians shall retain official documentation of attendance for 2 years after renewal, and shall certify completed activities on a form provided by the Board for that purpose, to be filed with the biennial renewal form. Official documentation proving completion of continuing medical education activities shall be produced, upon Board demand, under random audits of reported credit hours. Electronic submission of documentation is permissible to prove compliance with this subsection. Noncompliance may result in disciplinary proceedings under section 41(6) of the Medical Practice Act of 1985 (63 P. S. 422.41(6)).
(i) Acceptable documentation for Category 1 activities are:
(A) AMA PRA certificates.
(B) Certificate of completion of a Category 1 activity sponsored by an organization accredited by ACCME or designee of the ACCME.
(C) Certificates from a medical professional society or specialty certification by a member organization of the American Board of Medical Specialties.
(D) Healthcare system credential certification.
(E) Third party payor credentialing certification.
(F) Certification by a CME organization whose standards meet or exceed those established by AMA PRA.
(ii) Acceptable documentation for Category 2 activities are:
(A) Documentation from sources acceptable for Category 1 activities.
(B) Documentation maintained by the physician contemporaneous to the CME activity such as personal log books, diaries, journal notes or applications for credentialing or certification by an organization recognized by the ACCME or designee of the ACCME. The documentation shall identify the activity and the amount of time spent in the activity.
(3) The following exemptions apply for certain physicians:
(i) A physician applying for licensure in this Commonwealth for the first time shall be exempt from the continuing medical education requirement for the biennial renewal period following initial licensure.
(ii) A physician holding a current temporary training license shall be exempt from the continuing medical education requirement.
(iii) A retired physician who provides care only to immediate family members shall be exempt from the continuing medical education requirement.
(iv) A physician who is on inactive status shall be exempt from the continuing medical education requirement, except that a physician who is seeking to reinstate an inactive or lapsed license shall show proof of compliance with the continuing education requirement for the preceding biennium.
(4) A physician suspended for disciplinary reasons is not exempt from the requirements of this section.
(5) Waiver of the CME requirements may be permitted, as follows:
(i) The Board may grant a hardship waiver of all or a part of the continuing medical education requirement in cases of serious illness, military service or other good cause provided that the public's safety and welfare will not be jeopardized by the granting of the waiver.
(ii) A request for waiver must be made in writing, with appropriate documentation, and include a description of circumstances sufficient to show why compliance is impossible.
(iii) Waiver requests will be evaluated by the Board on a case-by-case basis. The Board will send written notification of its approval or denial of a waiver request.
[Pa.B. Doc. No. 04-1587. Filed for public inspection August 27, 2004, 9:00 a.m.]
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