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PA Bulletin, Doc. No. 21-1572

PROPOSED RULEMAKING

STATE BOARD OF MEDICINE

[ 49 PA. CODE CHS. 16 AND 17 ]

Examinations

[51 Pa.B. 6042]
[Saturday, September 18, 2021]

 The State Board of Medicine (Board) proposes to amend §§ 16.1, 17.11, 17.12 and 17.12c to read as set forth in Annex A.

Effective Date

 The amendments will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.

Statutory Authority

 Section 24(a) of the Medical Practice Act of 1985 (act) (63 P.S. § 422.24(a)) gives the Board authority to require an applicant to take and pass an examination to the satisfaction of the Board. Under section 24(d) of the act, when the Board accepts an examination given by an examining agency, the Board may establish the criteria for passing or may accept the criteria for passing established by the examining agency.

 Section 8 of the act (63 P.S. § 422.8) authorizes the Board to adopt such regulations as are reasonably necessary to carry out the purposes of the act, including the licensure of qualified individuals as physicians.

Background and Need for Amendments

 The Federation of State Medical Boards (FSMB) is a National non-profit organization representing all 71 state medical and osteopathic boards within the United States and its territories that license and discipline allopathic and osteopathic physicians and, in some jurisdictions, other health care professionals. FSMB membership provides state medical boards, board members and staff with a variety of opportunities to expand their professional networks; gain access to valuable resources and relationships; and develop leadership roles in the field of medical regulation. The Board is an FSMB member board. The United States Medical Licensing Examination (USMLE) is the National examination co-sponsored and administered by the FSMB and the National Board of Medical Examiners (NBME).

 The USMLE was created in response to the need for one path to medical licensure for allopathic physicians in the United States. Before the USMLE, multiple examinations (the NBME Parts examination and the Federation Licensing Examination (FLEX)) offered paths to medical licensure. It was desirable to create one examination system accepted in every state, to ensure that all licensed medical doctors (MD) pass the same assessment standards regardless of where individuals received education and training. Today, all state medical boards in the United States utilize the USMLE. The USMLE is used for licensure of graduates of accredited MD-granting medical schools in the United States and graduates of International Medical Schools recognized by the Education Commission for Foreign Medical Graduates (ECFMG).

 While section 24(d) of the act authorizes the Board to establish, by regulation, a time period in which the entire examination must be successfully completed and a maximum number of examination attempts it will recognize for the purpose of receiving a passing score on an examination recognized but not given by the Board, it also authorizes the Board to accept the criteria for passing established by the examining agency (the FSMB and NBME). The Board has adopted the USMLE and has determined that accepting the FSMB and NBME criteria for passing the USMLE will ensure that Pennsylvania examination standards are consistent with National standards. Thus, the Board intends to rely on the FSMB and NBME established USMLE eligibility requirements, including the order in which the steps may be taken, the number of attempts permitted for any one step of USMLE, the time required in between attempts and the score necessary to pass each step.

 In addition to updating its regulations to conform to the current National examination for medical licensure, the Board also considered existing regulatory provisions related to former medical licensure examinations and determined that some updates were necessary. While the Board's existing regulations refer to examinations that are no longer administered, the Board proposes updates to those provisions to ensure that the regulations appropriately reflect examination standards for those former examinations so that MDs who have taken those older examinations or combinations of the older examinations may apply for licensure or participate in graduate medical training in this Commonwealth.

Description of Proposed Amendments

 In § 16.1 (relating to definitions), the Board proposes to amend the definition of ''FLEX'' and delete the definitions of ''FLEX I'' and ''FLEX II.'' The FLEX has not been offered since 1993; therefore, detailed definitions of the FLEX are no longer necessary. The Board proposes to amend the definition of the ''USMLE'' to clarify that the USMLE includes a three-step examination, which replaced the two-component FLEX and NMBE Parts examination. The Board proposes to delete the definitions of each of the three steps of the USMLE (''USMLE, Step 1;'' ''USMLE, Step 2;'' and ''USMLE, Step 3''). The steps of the USMLE are subject to change and are established through the FSMB and NBME. For example, recently, in January of 2021, the two component Step 2, which formerly consisted of Step 2 Clinical Knowledge and Step 2 Clinical Skills, was modified by the FSMB and NBME to permanently discontinue the Step 2 Clinical Skills component.

 The Board proposes to amend § 17.11(a) (relating to examination information for license without restriction) to delete the detailed description of the FLEX and to clarify that a passing score on a previously taken FLEX I and FLEX II, as outlined in subsection (a)(1)(ii), satisfies the requirement for a license without restriction. The FLEX I and FLEX II have not been offered since 1993 and have since been replaced with the nationally accepted USMLE. The FLEX examination, which consisted of two components and required a passing score on each component, remains a valid examination for licensure for those physicians who passed the examination prior to 1993, the date it was discontinued.

 The Board proposes amendments to § 17.11(b) to delete details about the FSMB examination, which was offered from June 1968 through December 1984. The Board proposes to add language to clarify that this licensing examination, also called the FLEX, was the forerunner to FLEX I and FLEX II since no name for this examination is otherwise specified in the regulations. The FLEX forerunner remains a valid examination for licensure for those physicians who passed the three-part examination during June 1968 through December 1984, the dates it was administered. The Board proposes to add a cross reference to § 17.1(a)(1)(iii) to clarify passing scores for this examination and to specify that a passing score on the FLEX forerunner satisfies the examination requirement for a license without restriction.

 The Board further proposes amendments to update examination requirements for the USMLE. In § 17.11(d), the Board proposes to clarify that the USMLE consists of Steps 1, 2 and 3 and that the USMLE is given throughout the year by the FSMB and NBME. The Board also proposes to delete outdated USMLE requirements, including the eligibility requirements to take each step of the USMLE. As set forth in the ''Eligibility for the USMLE Requirements'' in the USMLE Bulletin of Information, which may be found at https://www.usmle.org/bulletin, if an examinee does not pass Steps 1 and 2 of the USMLE, they are not eligible to sit for Step 3. The only eligibility requirement for Steps 1 and 2, which can be taken in any order, is that the examinee be officially enrolled in, or a graduate of, a United States or Canadian Medical School leading to an MD degree that is accredited by the Liaison Committee on Medical Education (LCME) or a medical school that is outside of the United States and Canada that meets the ECFMG eligibility requirements. Additionally, under the USMLE eligibility requirements, currently examinees become ineligible to take a step or step component if they have six or more prior attempts on that step or step component, including incomplete attempts. In July of 2021, the USMLE eligibility requirements will be modified. Under the updated requirements, an examinee will be ineligible to take a step or step component if the examinee has made four or more prior attempts on that step or step component, including incomplete attempts. This policy change will reduce the total number of attempts an examinee may take per step or step component from six to four.

 The Board proposes to delete § 17.12 (relating to failure on the FLEX I or FLEX II), because information relating to failures on the FLEX I and FLEX II is no longer necessary since the examination has not been offered since 1993.

 The Board proposes to delete § 17.12c (relating to failure on USMLE) it its entirety because the language is outdated and is addressed in other sections of the Board's current regulations and proposed regulations. Section 17.12c(a) relates the retaking of the USMLE and the time period for passing the entire examination. The 7-year period is currently outlined in § 17.1(a)(1)(ii) and it is not necessary to repeat it here. Section 17.12c(b) relates to the number of attempts for Step 3 of the USMLE. This information is outdated and has been updated in § 17.11(d). Section 17.12c(c) is also outdated. The Board has determined that it is not necessary to update this provision because the Board already outlines which step of the USMLE must be successfully completed before advancing in graduate medical training as outlined in § 17.5 (relating to graduate license). For example, under § 17.5(d), to participate in graduate medical training at a second-year level, the licensee shall secure a passing score on Step 1 and Step 2 of the USMLE. Under § 17.5(e), to participate in graduate medical training at a third-year level or higher, the licensee shall secure a passing score on Steps 1, 2 and 3 of the USMLE (or a combination of previously administered examinations). The Board relies on § 17.5 as it relates to passing examination scores and advancing in graduate training. Therefore, it is unnecessary to repeat this information here.

Fiscal Impact and Paperwork Requirements

 This proposed rulemaking will not have any fiscal impact on licenses, the Board or the Commonwealth, nor is any additional paperwork anticipated.

Sunset Date

 The Board continuously monitors 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 September 2, 2021, 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 Senate Consumer Protection and Professional Licensure Committee (SCP/PLC), and the House Professional Licensure Committee (HPLC). 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 in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) 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.

Public Comment

 Interested persons are invited to submit written comments, recommendations or objections regarding this proposed rulemaking to Board Counsel, State Board of Medicine, P.O. Box 69523, Harrisburg, Pennsylvania, 17106-5923, RA-STRegulatoryCounsel@pa.gov within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference 16A-4948 (Examinations) when submitting comments.

MARK B. WOODLAND, MS, MD, 
Chairperson

Fiscal Note: 16A-4948. 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 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:

*  *  *  *  *

ECFMG—The Educational Commission for Foreign Medical Graduates.

FLEX[This examination provided by the Federation of State Medical Boards of the United States, Inc., comprised of FLEX I and FLEX II, was used by the Board to test applicants for a license to practice medicine and surgery without restriction. This uniform examination was administered simultaneously in most of the states, territories and possessions of the United States] The Federation Licensing Examination, which was used by the Board to test applicants for a license to practice medicine and surgery without restriction. The examination was comprised of two components, FLEX I and FLEX II. The last regular administration of FLEX I and FLEX II was in December 1993.

[FLEX I—The examination component of the FLEX designed to evaluate measurable aspects of knowledge and understanding of basic and clinical science principles and mechanisms underlying disease and modes of therapy. This component will be last regularly administered in December 1993.

FLEX II—The examination component of the FLEX designed to measure a core of competence involved in the diagnosis and management of selected clinical problems frequently encountered by a physician engaged in the independent practice of medicine. This component will be last regularly administered in December 1993.]

Federation—The Federation of State Medical Boards of the United States, Inc.

*  *  *  *  *

Treatment regimen—The provision of care and practice of a component of the healing arts by a Board-regulated practitioner.

USMLE—The United States Medical Licensing Examination, a single, uniform examination for medical licensure consisting of three steps. The examination is provided by the Federation of State Medical Boards (FSMB) and the National Board of Medical Examiners (NBME) and replaces the FLEX and the NBME National Boards Parts examination.

[USMLE, Step 1—Assesses whether an examinee understands and can apply key concepts of basic biomedical science, with an emphasis on principles and mechanisms of health, disease and modes of therapy.

USMLE, Step 2—Assesses whether an examinee possesses the medical knowledge and understanding of clinical science considered essential for the provision of patient care under supervision, including emphasis on health promotion and disease prevention.

USMLE, Step 3—Assesses whether an examinee possesses the medical knowledge and understanding of biomedical and clinical science considered essential for the unsupervised practice of medicine.]

Unaccredited medical college—An institution of higher learning which provides courses in the arts and sciences of medicine and related subjects, is empowered to grant professional and academic degrees in medicine, is listed by the World Health Organization or is otherwise recognized as a medical college by the country in which it is situated, and is not accredited by an accrediting body recognized by the Board.

CHAPTER 17. STATE BOARD OF MEDICINE—MEDICAL DOCTORS

Subchapter B. EXAMINATION INFORMATION

§ 17.11. Examination information for license without restriction.

 (a) FLEX. [This is the examination offered by the Board for a license without restriction. The last regular administration of FLEX I and FLEX II was in December 1993. The examination is comprised of two components—FLEX I and FLEX II. Both components are given every December and June. FLEX I may be taken after graduating from a medical college but, beginning July 1, 1986, shall be passed prior to commencing a second-year level of graduate medical training if the medical doctor has not already passed Parts I and II of the National Boards or a licensing examination acceptable to the Board under §  17.1(a)(1)(iii), (viii) and (ix) (relating to license without restriction), or secured a license without restriction in this Commonwealth or an equivalent license issued by a state, territory or possession of the United States or the Dominion of Canada. FLEX II may be taken after graduating from a medical college but, for a medical doctor to begin a third-year level of graduate medical training he shall first pass FLEX I and FLEX II or a licensing examination acceptable to the Board under § 17.1(a)(1)(iii), (viii) and (ix), or have secured a license without restriction in this Commonwealth or an equivalent license issued by another state, territory or possession of the United States or the Dominion of Canada. Both FLEX I and FLEX II may be taken by a student in a medical college if the student is in the last semester or a similar school term, the dean of the medical college certifies to the Board that the student's graduation is imminent and the semester or similar school term will conclude shortly after the administration of FLEX I and FLEX II.] A passing score on [this examination] FLEX I and FLEX II, as outlined in § 17.1(a)(1)(ii) (relating to license without restriction), satisfies the examination requirement for a license without restriction.

 (b) Licensing examination of Federation from June 1968 through December 1984. [This examination is the forerunner of the present FLEX.] This three-part examination, also called the FLEX, is the forerunner of the two-component FLEX provided for under subsection (a). A passing score on this three-part examination, as outlined in § 17.1(a)(1)(iii), satisfies the examination requirement for a license without restriction. [This examination is no longer offered as a licensing examination by the Board. A passing score on this examination shall have been achieved in an individual attempt, that is, a passing score cannot be achieved by combining scores received on separate parts of the examination obtained in more than one examination attempt.]

 (c) National Boards. This examination comprised of Parts I, II and III was given in most accredited medical colleges. A passing score on this examination satisfies the examination requirement for a license without restriction.

 (d) USMLE. This examination is a uniform examination for licensure which replaces the National Boards Parts I, II and III and FLEX I and FLEX II. [Each step is given twice a year. To be eligible for Step 1 or 2 of the examination, an individual shall be a medical student officially enrolled in, or a graduate of, an accredited medical school or a graduate of an unaccredited medical school. Steps 1 and 2 may be taken in any sequence. To be eligible for Step 3 of the USMLE, the individual shall have obtained a medical doctor degree or equivalent, shall have achieved a passing score on both Step 1 and Step 2 or equivalent, and shall be enrolled in a graduate medical training program. Additionally, a graduate of an unaccredited school shall be currently certified by ECFMG or shall have successfully completed a ''Fifth Pathway'' program. All Steps of the examination shall be completed within 7 years.] Steps 1, 2 and 3 of USMLE are given throughout the year at times and places designated by the FSMB and NBME. USMLE eligibility requirements for each step or step component of the USMLE are jointly set by the FSMB and NBME. A passing score on [this examination] all three steps of USMLE, as determined by FSMB and NBME and as outlined in § 17.1(a)(1)(i), satisfies the examination requirement for a license without restriction.

 (e) Examination of the Medical Council of Canada. This is an examination offered in Canada which has been adopted as a licensing examination in most of the provinces of Canada. A passing score on this examination, as determined by the Medical Council of Canada, satisfies the examination requirement for a license without restriction if the examination was taken in English in or after May 1970.

 (f) State Board Examination. This is an examination for a license to practice medicine and surgery without restriction, other than USMLE, FLEX or the forerunner of FLEX, which is used by a licensing authority in another state, territory or possession of the United States. A passing score on this examination, as determined by the licensing authority in the other jurisdiction, satisfies the examination requirement for a license without restriction if the examination was taken in English prior to December 1973.

§ 17.12. [Failure on FLEX I or FLEX II] Reserved.

[(a) Retaking examination. An individual who fails either FLEX I or FLEX II is permitted to retake that component of the FLEX in this Commonwealth after the expiration of 6 months and within 2 years from the prior examination date.

(b) Repeating year of graduate medical training. If an individual fails to secure a passing grade on FLEX I in a second attempt, the individual shall repeat a year of graduate medical training at a first-year level before retaking FLEX I in this Commonwealth. If the individual fails to secure a passing grade on FLEX II in a second attempt, the individual shall repeat a year of graduate medical training at a first or second-year level before retaking FLEX II in this Commonwealth.

(c) Awaiting examination results. Effective July 1, 1986, if an individual scheduled to go into a second-year level of graduate medical training is awaiting the FLEX I score, the individual may not begin training at a second-year level until the individual has notified the Board that FLEX I has been passed, and the Board has issued the appropriate license, but may continue to train at a first-year level until that time, if the individual has renewed the first-year level license. An individual scheduled to go into a third-year level of graduate medical training who is awaiting the FLEX II score, may not begin training at a third-year level until the individual has notified the Board that FLEX II has been passed, and the Board has issued the appropriate license, but may continue to train at a first or second-year level until that time, if the individual has renewed the first or second-year level license.]

§ 17.12c. [Failure on USMLE] Reserved.

[(a) Retaking examination. An individual is permitted to retake any component of the USMLE. Steps 1, 2 and 3 shall be completed within a 7-year period. Because Steps 1 and 2 may be taken in any sequence, the 7-year period begins with the passage of the first step taken.

(b) Repeating year of graduate medical training. If an individual fails to secure a passing score on Step 3 in a third attempt, the individual shall repeat a year of graduate medical training at a first or second-year level before retaking Step 3.

(c) Awaiting examination results. If an individual scheduled to go into a second-year level of graduate medical training is awaiting examination scores, the individual may not begin training at a second-year level, but may continue to train at a first-year level, if the individual has renewed the first-year level license, until the individual has notified the Board that Steps 1 and 2 have been passed and the Board has issued the appropriate license. If an individual scheduled to go into a third-year level of graduate medical training is awaiting examination scores, the individual may not begin training at a third-year level, but may continue to train at a first or second-year level, if the individual has renewed the first or second-year level license, until the individual has notified the Board that Step 3 has been passed and the Board has issued the appropriate license.]

[Pa.B. Doc. No. 21-1572. Filed for public inspection September 17, 2021, 9:00 a.m.]



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