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PA Bulletin, Doc. No. 05-989

RULES AND REGULATIONS

STATE BOARD OF OSTEOPATHIC MEDICINE

[49 PA. CODE CH. 25]

Continuing Medical Education

[35 Pa.B. 3021]

   The State Board of Osteopathic Medicine (Board) amends §§ 25.1 and 25.271 (relating to definitions; and requirements for renewal) to read as set forth in Annex A.

Effective Date

   The final-form rulemaking is effective upon publication in the Pennsylvania Bulletin.

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.

Background and Purpose

   The final-form rulemaking implements section 910 of the act, which requires completion of 100 credit hours of continuing education as a condition of biennial licensure renewal of physician licenses by the State Board of Medicine and the Board. Although the Board already required 100 credit hours of continuing medical education each biennium, the act imposed a requirement that the Board establish a minimum number of hours in the areas of patient safety and risk management.

Summary of Comments and Responses on Proposed Rulemaking

   Notice of proposed rulemaking was published at 34 Pa.B. 563 (January 31, 2004). The Board received comments from the Independent Regulatory Review Commission (IRRC), the House Professional Licensure Committee (HPLC) and the Pennsylvania Medical Society (PMS).

   IRRC questioned whether the definition of ''approved course'' in § 25.1 would allow the Board to accept courses accredited by other organizations such as state medical associations or the American Medical Association. The Board has determined that these courses would be acceptable for all credits except for 20 credit hours which, under § 25.271(c)(1), must be completed in American Osteopathic Association (AOA) category 1-A activities. The AOA has four categories: 1-A (formal educational programs and osteopathic medical teaching); 1-B (activities such as publications, preceptoring, passing a recertification examination, participating in non-AOA accredited institution activities, participating in nonosteopathic continuing medical education programs, journal reading, faculty development programs and test construction committee work); 2-A (formal educational programs that are Accreditation Council for Continuing Medical Education (ACCME) accredited, American Academy of Family Physicians approved or programs sponsored by AOA accredited Category 1 continuing medical education sponsors that do not meet the faculty/hours requirement for Category 1-A credit); and 2-B (activities that include these experiences as preparation and presentation of scientific exhibits at professional meetings, home study and reading medical journals). IRRC also suggested that the definition of ''approved course'' include credits not formally accredited by the ACCME and the AOA or that the Board amend § 25.271 to allow other credits for the remaining credit hours. The PMS also noted that the ACCME and the AOA do not accredit sponsors of Category 2 continuing medical education and that much Category 2 continuing medical education is self-directed and has no sponsor. The PMS suggested removing the word ''approval'' and substituting ''medical educational activities'' to correct the problem. The Board agreed with the PMS and has changed the term ''approved course'' to ''approved activity.'' The Board has also defined ''approved activity'' to mean a continuing medical education activity accepted for AOA credit, ACCME credit or American Medical Association Physician's Recognition Award credit.

   The Board, in the final-form rulemaking, also considered Governor Rendell's recommendation made as part of his March 2004 medical malpractice liability proposal that physicians should be required to complete 12 hours of continuing medical education pertaining to patient safety each biennium period. The Board has agreed with this recommendation and has amended the regulations to require 12 hours rather than 10 hours in patient safety and risk management.

   IRRC and the HPLC questioned whether licensees would have received sufficient notice to complete continuing education by the deadline for license renewal. The Board has amended § 25.217(c) to require proof of completion of the continuing education credits for the 2006 renewal period. Because the Board currently requires 100 hours of continuing education credits for renewal of licenses, the 2006 biennial renewal date will apply specifically to the requirement that 12 hours of continuing education must be completed in the area of patient safety and risk management. IRRC also asked whether the credit hours in patient safety and risk management are required to be completed in Category 1 or Category 2 courses. The Board has amended § 25.271(c)(1) to clarify that the 12 credit hours may be in either Category 1 or Category 2 approved activities.

   IRRC, the HPLC and the PMS asked whether the reference to ''remaining 75 credit hours'' in § 25.271(c)(1) is a typographical error and should instead read as the ''remaining 70 credit hours.'' The Board agrees that ''75'' is incorrect and has substituted ''the remaining credit hours'' in its place because the patient safety hours may be either Category 1 (and go toward the 20 required Category 1 credits) or Category 2. Therefore, it is not clear exactly how many credit hours will be remaining.

Fiscal Impact and Paperwork Requirements

   The final-form rulemaking will require the Board to alter its license renewal forms to include data regarding the physician's compliance with the continuing education requirements and will also require physicians to maintain their own records of continuing education credits, but otherwise, will have no adverse fiscal impact on the Commonwealth or its political subdivisions.

Sunset Date

   The Board continuously monitors the cost effectiveness of its regulations. Therefore, no sunset date has been assigned.

Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 31, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 563, to IRRC and the Chairpersons of the HPLC and the Senate Consumer Protection and Professional Licensure Committee (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 30, 2005, the final-form rulemaking was approved by the HPLC. On April 13, 2005, the final-form rulemaking was deemed approved by SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on April 14, 2005, and approved the final-form rulemaking.

Contact Person

   Interested persons may obtain information regarding the final-form rulemaking by contacting to Beth Sender Michlovitz, Board Counsel, State Board of Osteopathic Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, bmichlovit@state.pa.us.

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)  The final-form rulemaking is necessary and appropriate for administration and enforcement of the act.

   (4)  The amendments to the final-form rulemaking are necessary and appropriate for administration and enforcement of the act and do not enlarge the purpose of the proposed rulemaking published at 34 Pa.B. 563.

Order

   The Board orders that:

   (a)  The regulations of the Board, 49 Pa. Code Chapter 25, are amended by amending §§ 25.1 and 25.271 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 to 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.

THOMAS R. CZARNECKI, D.O.,   
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-5313 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 25. STATE BOARD OF OSTEOPATHIC MEDICINE

Subchapter A. GENERAL PROVISIONS

§ 25.1 Definitions.

   The following words and terms, when used in this chapter, have the following meanings unless the context clearly indicates otherwise:

   ACCME--The Accreditation Council on Continuing Medical Education.

   AMA PRA--American Medical Association Physician's Recognition Award.

   AOA--The American Osteopathic Association.

   Act--The Osteopathic Medical Practice Act (63 P. S. §§ 271.1--271.18).

   Agreement of affiliation--A written document evidencing the agreement between an approved hospital and an urgent care center, emergency center, surgicenter, office of a private practitioner or other health care facility for the training of osteopathic interns, residents or fellows.

   Approved activity--A continuing medical education activity accepted for AOA credit, ACCME credit or AMA PRA credit.

   Approved graduate osteopathic medical training--An approved internship or an approved residency.

   Approved internship--An osteopathic rotating internship program approved by the AOA and the Board.

   Approved residency--A training program approved by the AOA and the Board leading toward certification in a specialty or subspecialty.

   Board--State Board of Osteopathic Medicine.

   Bureau--Bureau of Professional and Occupational Affairs of the Department of State of the Commonwealth.

   Category 1 activities--Continuing medical education activities approved for AOA Category 1-A credit, AOA Category 1-B credit, ACCME Category 1 credit or AMA PRA Category 1 credit.

   Category 2 activities--Continuing medical education activities approved for AOA Category 2 credit, ACCME Category 2 credit or AMA PRA Category 2 credit.

   Emergency medical services personnel--Individuals who deliver emergency medical services and who are regulated by the Department of Health under the Emergency Medical Services Act (35 P. S. §§ 6921--6938).

   FLEX--The uniform written examination of the Federation of State Medical Boards of the United States, Inc.

   Immediate family member--A parent, a spouse, a child or an adult sibling residing in the same household.

   NBOME--The National Board of Osteopathic Medical Examiners.

   National Board Examination--The uniform written examination of the NBOME.

Subchapter G. LICENSING, EDUCATION AND GRADUATE TRAINING

LICENSURE RENEWAL AND CONTINUING EDUCATION

§ 25.271 Requirements for renewal.

   (a)  A licensee shall biennially renew his license by completing a form obtained from the Board in advance of October 31 of every even-numbered year, and by paying the required fee. The application shall indicate the following:

   (1)  Other states where the applicant is licensed.

   (2)  Disciplinary action taken against the applicant by the licensing boards in other states.

   (3)  A verdict of guilty, guilty plea or plea of nolo contendere by the applicant to a felony, crime of moral turpitude or crime related to the practice of osteopathic medicine in this or another jurisdiction occurring within the 2 years immediately preceding renewal.

   (b)  A penalty fee as specified by § 25.231 (relating to schedule of fees) will be imposed on a licensee who continues to practice without having timely renewed his license. The licensee may also be subject to other criminal, civil or administrative penalties.

   (c)  Proof of completion of 100 credit hours of continuing medical education in the preceding biennial period will be required for licensure renewal for osteopathic physicians.

   (1)  Beginning with the licensure renewal period commencing November 1, 2006, at least 20 credit hours shall be completed in AOA category 1-A approved activities. At least 12 credit hours shall be completed in Category 1 or 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 any Category 1 or 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 attendance shall be produced, upon Board demand, pursuant to 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 15(a)(6) of the act (63 P. S. § 271.15(a)(6)).

   (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 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)  Requests 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. 05-989. Filed for public inspection May 20, 2005, 9:00 a.m.]



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