Protecting the Public, Promoting Quality Health Care - Federation of ...

CommentaryMaintenance of Licensure: Protecting the Public,Promoting Quality Health CareHumayun J. Chaudhry, D.O., Janelle Rhyne, M.D., Frances E. Cain,Aaron Young, Ph.D., Martin Crane, M.D. and Freda Bush, M.D.IN BRIEF The authors describe a system in whichphysicians periodically demonstrate ongoing clinicalcompetence as a condition of license renewal.IntroductionThe practice of medicine in the United States,according to the 2010 edition of A Guide to theEssentials of a Modern Medical and OsteopathicPractice Act of the Federation of State Medical Boards(FSMB), is “a privilege granted by the people actingthrough their elected representatives.” 1 Citingpublic health, safety and welfare, and the need forprotection of the public from the “unprofessional,improper, incompetent, unlawful, fraudulent and/ordeceptive practice of medicine,” the Essentials document— formally adopted by the FSMB’s House ofDelegates — acknowledges the historical and constitutionalrole of the state medical and osteopathicboards “to provide laws and regulations to govern thegranting and subsequent use of the privilege to practicemedicine.”While the granting of the initial privilege to practicemedicine is generally viewed as a robust processalong a rigorous continuum of medical educationencompassing both undergraduate and graduatetraining, with multiple assessments and decisionpoints that must be cleared along a prescribedpathway, the process for the subsequent use ofthat privilege has been the focus of increasingcommentary and suggestions for improvement. Thisarticle summarizes the background and history bywhich the FSMB adopted, in April of 2010, a seminalpolicy recommendation outlining a framework bywhich state medical and osteopathic boards couldrequire physicians with active medical licenses toperiodically demonstrate their ongoing clinical competenceas a condition for licensure renewal.Medical Regulation in Service to the PublicWhile the earliest instance of medical regulationin the Americas dates to 1649, 2 and the first localgovernment license to practice medicine wasadopted in 1760 in New York City, 3 the authorityof state governments to regulate health care in theUnited States dates to the adoption, in 1791,of the 10th Amendment to the Constitution: “Thepowers not delegated to the United States by theConstitution, nor prohibited by it to the states, arereserved to the states respectively, or to the people.”Some states initially gave local medical societiesthe power to examine and license prospective doctors,4 while others bestowed such a right to medicalschools. The notion that medical licensure anddiscipline should best be regulated by state-appointedlicensing boards, the majority of whom today includepublic members on their voting bodies, rather thanmedical societies (which ostensibly represent theinterests of practicing physicians) or medical schoolstook several decades to gain traction. It has beenpostulated that what ultimately caused medicalregulation, alongside coincidental public healthlegislation, to flourish between 1850 and 1900 wasa combination of two factors: a failure of pure freeenterprisetheory and the contribution of science: 5While “good” goods, like “good” doctors, shouldhave ultimately driven out “bad” ones in a free market,a better informed public was no longer willing towait that long; people also became aware of the factthat danger lurked in bad food and bad water, anawareness prompted by the discovery of germs, thatprompted calls from many corners for better pro tectionfrom poor sanitation as well as from “bad” doctors.The FSMB, since its establishment in 1912 asthe umbrella organization for all state medicaland osteopathic licensing boards in the UnitedStates and its territories, has actively promoted orsupported during its long history such activitiesas stronger entrance criteria for medical schools,JOURNAL of MEDICAL REGULATION VOL 96, N O 2 | 13

improvements in undergraduate medical education,closure of underperforming medical schoolsfollowing the 1910 Flexner Report, passage ofstate medical practice acts, the formation of theAmerican Board of Medical Specialties (ABMS)and the Educational Commission for Foreign MedicalGraduates and, in 1991, the creation —in partnership with the National Board of MedicalExaminers (NBME) — of the United States MedicalLicensing Examination (USMLE). Physicians withthe D.O. (doctor of osteopathic medicine) degreetypically take the Comprehensive OsteopathicMedical Licensing Examination (COMLEX-USA)of the National Board of Osteopathic MedicalExaminers (NBOME).The FSMB, as stated in its current mission statement,seeks to lead by “promoting excellence inmedical practice, licensure, and regulation as thenational resource and voice on behalf of state medicalboards in their protection of the public.” The FSMBhas more recently served the public and its 70state medical and osteopathic boards through thedevelopment of a national database of licensedADOPTION OF AN MOL FRAMEWORK By THEFSMB, WITHIN THIS CONTExT, IS CONSISTENTWITH STATE BOARDS’ DESIRE TO PROTECTTHE PUBLIC AND PROMOTE qUALITy HEALTHCARE WITH ROBUST STANDARDSFOR PHySICIAN LICENSURE.physicians and physician assistants, a disciplinaryalert service, a Federation Credentials VerificationService (FCVS) and a Uniform Application to speedstate processing of licensure applications and facilitatelicense portability without infringing the states’autonomy or rights. Adoption of a Maintenance ofLicensure (MOL) framework by the FSMB, withinthis context, is consistent with state medical andosteopathic boards’ desire to protect the public andpromote quality health care with robust standards forphysician licensure.Medical Regulation to Promote Health Care QualitySignificant technological and scientific advancementshave been pioneered by physicians andscientists in the United States but there are severalreasons why we do not have the very best healthcare system in the world (e.g., insufficient accessto primary care services, a lack of coor dination ofhealth care delivery, defensive medicine practices)despite all of our expenditures. 6,7 The quality of thehealth care that is delivered is an area of inquirythat has garnered great attention in the last twodecades. These analyses have sometimes offeredspecific recommendations to medical educators,health care leaders, medical regulators and federaland state government officials to help reform thehealth care workforce, decrease medical errors andpromote best practices among health care providers.Many of these reports have also made specificrecommendations about the standards and practicesfor renewal of medical licenses.In 1995, the Pew Charitable Trust Health ProfessionsCommission recommended that states “requireeach licensing board to develop, implement andevaluate continuing competency requirements toassure the continuing competence of regulatedhealth care professionals.” 8 In 1999, the Instituteof Medicine (IOM) said that consumers generallybelieve they are protected within the health carearena because “licensure and accreditation confer,in the eyes of the public, a ‘Good HousekeepingSeal of Approval,’ and suggested greater assessmentof the physicians’ performance of skillsafter initial licensure.” 9 Two years later, the IOMobserved that in a profession with “a continuallyexpanded knowledge base,” a mechanism wasneeded to ensure that practitioners remain up todate with current best practices. 10 It also notedthat medical regulation, when properly conceivedand executed, “can both protect the public’sinterest and support the ability of health careprofessionals and organizations to innovate andchange to meet the needs of their patients.”Rationale for Enhanced Medical RegulationIn the United States and United Kingdom, accordingto a survey of 18 countries conducted last year,more than 80 percent of the public consider physiciansto be trustworthy. 11 To continue to earn suchhigh regard in a climate of greater accountability andregulation, consistent with their own professionalobligations to remain competent and up-to-date,physicians need to demonstrate to their patientsand peers what most are already doing. The rationaleto do so, however, is multifaceted and not limitedto well-intentioned policy reports or professionalobligations. While unequivocal, comprehensive androbust research in support of a multi-componentprogram for maintenance of licensure is not yet available,simply because no medical regulatory authority14 | JOURNAL of MEDICAL REGULATION VOL 96, N O 2

has fully implemented such a plan, there is growingevidence in the medical literature about 1.) the practiceof physicians over time, and 2.) the value ofenhanced continuing medical education or continuedprofessional development. Both of these categoriesare addressed by the FSMB’s MOL framework.Several studies over the years have found, forinstance, that practicing physicians who performA COMPREHENSIVE PROGRAM FORMAINTENANCE OF LICENSURE, IF ADOPTEDBy ALL STATE MEDICAL AND OSTEOPATHICBOARDS, COULD LOGICALLy ANDOBjECTIVELy DEMONSTRATE WHICHPHySICIANS ARE ENGAGED IN CLINICALACTIVITy AND HOW MUCH.a lower volume of clinical or surgical procedures,or who have less experience with specific conditionsor diseases, have higher rates of complicationscompared with their physician colleagues. As oneresearcher and his colleagues hypothesized in1987, in the treatment of disease it would appearthat practice makes perfect. 12 Kimmel andcolleagues in 1995 studied more than19,000 patients undergoing coronaryangioplasty procedures by interventionalcardiologists at cardiaccath eterization laboratoriesacross the United States andCanada and, after adjustingfor case mix, found an inverseassociation between cardiaccatheterization laboratoryprocedure volume and majorcomplications. 13 An inverseassociation between the numberof coronary artery bypass graftsurgeries performed by cardiacsurgeons and subsequent mortality rates,after adjustment for clinical risk factors, has also14, 15 16been described.In a 1996 study of 403 adult male patients with theAcquired Immunodeficiency Syndrome (AIDS) whowere cared for by 125 primary care physicians, aftercontrolling for the severity of illness and the yearof diagnosis, patients cared for by physicians withthe most experience had a 31 percent lower risk ofdeath than patients cared for by physicians with theleast experience. 17 Nash and colleagues found alower mortality rate from acute myocardial infarctionamong patients of both primary care physicians andcardiologists who had higher patient volumes thanthose physicians who provided care for this conditionless frequently. 18 A study by Tu and colleaguesin 2001 found that patients with acute myocardialinfarction who are treated by “high-volume admittingphysicians” for that condition are comparativelymore likely to survive at 30 days and at one year. 19And Freeman and colleagues found a substantialvariation in the clinical outcomes of gastrointestinalendoscopy based on the ongoing case volume of thegastroenterologist. 20Choudhry and colleagues conducted a systematicreview of the relationship between clinical experienceand quality of health care in 2005 and foundthat physicians who have been in practice longermay be at risk for providing lower quality care andthat this subgroup of physicians may benefit fromquality improvement interventions. 21 While underperformanceamong physicians is neither verywell studied nor defined, it has been suggestedthat age-related cognitive decline, impairment dueto substance use disorders and other psychiatricPerformancein PracticeAssessment ofKnowledge and SkillsReflectiveSelf-AssessmentDemonstration of accountabilityfor performance in practice, usingmethods that incorporate referencedata to assess performance andguide improvementDemonstration of knowledge, skillsand abilities necessary to providesafe, effective patient care.Participation in an ongoing processof reflective self-assessmentand practice assessment, withcompletion of a appropriateeducational activities as needed.illness may contribute to underperformance, diminishingphysicians’ insight into their level of performanceas well as their ability to benefit from aneducational experience. 22As for enhanced continuing medical education(CME) and continued professional development(CPD), the Johns Hopkins Evidence-based PracticeCenter for Healthcare Research and QualityJOURNAL of MEDICAL REGULATION VOL 96, N O 2 | 15

…PHySICIANS ENROLLED IN THE ABMS’MAINTENANCE OF CERTIFICATION (MOC)PROGRAM, OR THE AMERICAN OSTEOPATHICASSOCIATION BUREAU OF OSTEOPATHICSPECIALISTS’ OSTEOPATHIC CONTINUOUSCERTIFICATION (OCC) PROGRAM, COULDSUBSTANTIALLy COMPLy WITH A STATE LICENS-ING BOARD’S ExPECTATIONS FOR MOL.medical and osteopathic boards to protect thepublic and promote quality health care, the FSMB,under its Board Chair, Thomas D. Kirksey, M.D.,convened a special committee to make recommendationsabout the possibility of a system forthe periodic assessment of the ongoing clinicalcompetence of actively licensed physicians, whatcame to be known as “maintenance of licensure”(MOL). 30 Following discussions and review ofexisting practices, the committee recommendeda substantive policy statement that was adoptedthe following year by the FSMB’s House ofDelegates: “State medical boards have a responsibilityto the public to ensure the ongoing competence31, 32of physicians seeking relicensure.”Beginning in 2005, the FSMB sought input andcommentary from leaders and representatives ofmajor health care organizations and federal andstate governmental agencies to consider options andprograms by which state medical and osteopathicboards should or could implement maintenanceof licensure. During the last seven years, multiplediscussions, meetings and conferences have beenheld, with periodic surveys of state medical andosteopathic boards to continuously gauge theirconcerns and interests. To perform a comprehensivereview and to make final recommendations to theBoard of Directors about maintenance of licensure,the FSMB, under then Board Chair, Martin Crane,M.D., convened an Advisory Group on ContinuedCompetence of Licensed Physicians in 2009. TheAdvisory Group was charged to issue an opinionto the FSMB Board of Directors concerningFSMB’s Maintenance of Licensure initiative and,more specifically, whether the framework proposedin the report of the Special Committee on Maintenanceof Licensure was feasible, reasonable, consistentwith a series of guiding principles adoptedby FSMB’s House of Delegates in May 2008, andsuitable for use by state medical and osteopathicboards in ensuring the continued competence oflicensed physicians.The Maintenance of Licensure framework adoptedby the FSMB House of Delegates in 2010 notes thatas a condition of license renewal, physicians “shouldprovide evidence of participation in a program ofprofessional development and lifelong learning thatis based on the general competencies model:medical knowledge, patient care, interpersonal andcommunication skills, practice-based learning,professionalism and systems-based practice.” Oneof the framework’s guiding principles is that “maintenanceof licensure should not compromise patientcare or create barriers to physician practice.”Discussion and analysis is now under way withan FSMB-sponsored MOL Implementation Groupthat is guided by the framework and that receivesregular input from an advisory council of chief executivesfrom a range of health care organizations. Adraft report from the MOL Implementation Groupthat outlines specific options for state boardswill be reviewed this summer by the FSMB’s Boardof Directors, then by state medical and osteopathicboards and then by other stakeholders in healthcare and in government. It is anticipated thata starter (pilot) plan for MOL may be initiated byinterested state medical and osteopathic boardsas early as the end of the calendar year.Components of Maintenance of LicensureWhile the specific details, methodologies and optionsby which state medical and osteopathic boards couldimplement a program for Maintenance of Licensureare being formulated at press time, several themeshave emerged around the three specific componentsidentified in the MOL framework document adoptedby the FSMB’s House of Delegates.The first component of MOL, reflective selfassessment,addresses physicians’ professionalobligation to commit to lifelong learning to maintaintheir skills and acquire updated knowledge affectingtheir practice. This could involve the use of anassessment tool such as an accredited continuingmedical education (CME) pre-test, as one example,to identify needs or opportunities for improvement,followed by a tailored improvement activity basedon those outcomes. State licensing boards willlikely need to modify or enhance, where appropriate,their existing CME requirements.While the second component of MOL, the assessmentof knowledge and skills, does not mandate theJOURNAL of MEDICAL REGULATION VOL 96, N O 2 | 17

passage of a secure or proctored examinationas part of its second component, it notes thatphysicians enrolled in the ABMS’ Maintenance ofCertification (MOC) program, or the AmericanOsteopathic Association Bureau of OsteopathicSpecialists’ Osteopathic Continuous Certification(OCC) program, could substantially comply witha state licensing board’s expectations for MOL.Because more than 30 percent of actively licensedphysicians are not specialty board certified, 33 mostphysicians with time-unlimited (“grandfathered”)specialty certificates have chosen not to becomerecertified 34 and a plurality of physicians withtime-limited specialty certificates are not seekingrenewal of specialty board certification, 35 statelicensing boards will need to consider additionaloptions (e.g., computer-based clinical casesimulations, hospital procedural privileging)for physicians to demonstrate ongoing clinicalcompetence. The FSMB’s MOL ImplementationGroup, guided by the adopted framework and itsadvisory council, is reviewing those options now.For the third component, performance in practice,physicians could use data derived from their ownpractices supplemented by practice improvementactivities already being implemented by specialtysocieties, hospitals, physician groups and qualityimprovement organizations. As this component issimilar to the fourth part of MOC and the“Practice Performance Assessment” part of OCC,state boards may elect to substantially qualifylicensees engaged in such activities. Accordingto Kathleen Sebelius, Secretary of Health andHuman Services, 20 percent of doctors and 10percent of hospitals currently use basic electronichealth records.” 36 As “meaningful use” regulationsto promote electronic health records and healthinformation technology advance, 37 and data-drivenchanges in physician practice gradually take hold,component three of MOL is also the most likely toevolve over time. Regina Benjamin, M.D., M.B.A.,U.S. Surgeon General and Past Chair of the FSMB’sBoard of Directors, recently wrote of her priorexperience with health information technology andhow “practicing medicine became easier for theclinicians and better for the patients” followingthe adoption of electronic health records in herprivate practice setting. 38As the MOL Implementation Group deliberates thespecifics of how the states could proceed with MOLadoption, the group’s members have agreed thatthe overall process of implementation by the statesshould be evolutionary, not revolutionary, whilerecognizing the need to be anticipatory.International Perspectives on MOLThe same year that the FSMB’s House of Delegatesadopted its statement of responsibility in relationto the ongoing clinical competence of physicians,the Federation of Medical Regulatory Authorities ofCanada (FMRAC) adopted its framework for maintenanceof licensure, a program called revalidation bysome Canadian provincial authorities. The FMRACannounced in 2004 that all licensed physicians inCanada must participate in a recognized revalidationprocess in which they demonstrate their commitmentto continued competent performance in a frameworkthat is fair, relevant, inclusive, transferable andformative. The Revalidation Working Group thatstudied the issue said, “The demonstration of ongoingcompetence and performance of physicians isa pillar of professional self-regulation.” 39 SeveralCanadian provinces have mandated that physiciansparticipate in an educational program, suchas the Royal College of Physicians and Surgeons’Maintenance of Certification program or the Collegeof Family Physicians’ Maintenance of Proficiencyprogram, to maintain licensure. 40 Physicians in theseprograms report their participation in educationalactivities annually, with random audits of the documentationby the colleges and/or a peer reviewprocess involving office visits by physician colleagues.In England, where the administration of HenryVIII passed legislation in Parliament aimed atAS THE MOL IMPLEMENTATION GROUPDELIBERATES…THE GROUP’S MEMBERS HAVEAGREED THAT THE OVERALL PROCESS OFIMPLEMENTATION By THE STATES SHOULD BEEVOLUTIONARy, NOT REVOLUTIONARy, WHILERECOGNIzING THE NEED TO BE ANTICIPATORy.regulating and licensing medical practitioners thatendured without any amendments for 300 years, 41the General Medical Council began in 1998 todevelop a means by which doctors’ practices couldbe appraised and objectively assessed annuallyover a five-year period as a mandatory conditionfor what it also calls revalidation. 42 While formalimplementation of such a system has now beendelayed by a year under the newly elected governmentin the United Kingdom, when it gets underway itis expected to include as part of its appraisal of18 | JOURNAL of MEDICAL REGULATION VOL 96, N O 2

19. Tu JV, Austin PC, Chan BTB. Relationship betweenannual volume of patients treated by admitting physicianand mortality after acute myocardial infarction. JAMA.285(24):31163122; June 27, 2001.20. Freeman ML. Training and competence in gastrointestinalendoscopy. Rev Gastroenterol Disord. 1(2):73-86; 2001.21. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review:the relationship between clinical experience and quality ofhealth care. Ann Intern Med. 142:260-273; 2005.22. Williams BW. The prevalence and special educationalrequirements of dyscompetent physicians. J Cont Ed inHealth Prof. 26:173-191; 2006.23. Bordage G, Carlin B, Mazmanian PE. Continuing medicaleducation effect on physician knowledge: effectiveness ofcontinuing medical education. Chest. 135:Suppl.36S; 2009.24. Davis D, Galbraith R. Continuing medical education effect onpractice performance: effectiveness of continuing medicaleducation. Chest. 135:Suppl.48S; 2009.25. Forsetlund L, Bjorndal A, Rashidian A, et al. ContinuingEducation Meetings and Workshops: Effects on ProfessionalPractice and Health Care Outcomes. Update of CochraneDatabase Syst Rev. 2001;(2):CD003030;PMID:11406063.Cochrane Database of Systematic Reviews. CD003030; 2009.26. Freed GL, Dunham KM, Abraham L. Protecting the public:state medical board licensure policies for active and inactivephysicians. Pediatrics. 123(2):643-652; February 2009.27. Chantler C, Ashton R. The purpose and limits toprofessional self-regulation. JAMA. 302(18):2032-2033;November 11, 2009.28. Chantler C, Ashton R. The purpose and limits toprofessional self-regulation. JAMA. 302(18):2032-2033;November 11, 2009.29. Cain FE, Benjamin RM, Thompson JN. Obstacles tomaintaining licensure in the United States. BMJ.330:1443-1445; 2005.30. While alternate labels for a system for the assessment ofthe ongoing competency of physicians have been discussedfrom time to time at various FSMB committees, the terms“maintenance of licensure” and “MOL” have endured as acolloquialism and initialism, respectively, among physicians,medical regulators and others in the United States.31. Chaudhry HJ. Charting dynamism in medical education,licensure and regulation. J Med Licensure and Regulation.95(3):5-8; December 2009.32. While the term “relicensure” could be applied to both theroutine periodic renewal of medical licensure as well as tophysician reentry following a period of absence from clinicalpractice, in this case it is understood to imply the former.33. Hawkins R, Roemheld-Hamm B, Ciccone A, et al.A multimedia study of needs for physician assessment:implications for education and regulation. J Cont Ed inHealth Prof. 29(4):220-234; 2009.34 Levinson W, King TE Jr. Enroll in the MOC program ascurrently configured. N Eng J Med. 362(10):949-950;March 11, 2010.35. Goldman L, Goroll AH, Kessler B. Do not enroll in the currentMOC program. N Eng J Med. 362(10):950-952;March 11, 2010.36. Pear R. New Rules on Electronic Health Records. The NewYork Times. July 14, 2010. Page A16.37. Blumenthal D, Tavenner M. The “meaningful use” regulationfor electronic health records. N Eng J Med. Published onJuly 13, 2010 at NEJM.org. Accessed July 13, 2010.38. Benjamin R. Finding my way to electronic health records.N Engl J Med. Published on July 13, 2010 at NEJM.org.Accessed July 13, 2010.39. Federation of Medical Regulatory Authorities of Canada.Physician Revalidation: Maintaining Competence andPerformance. Position Paper. July 4, 2007.40. Shaw K, Cassel CK, Black C, Levinson W. Shared medicalregulation in a time of increasing calls for accountabilityand transparency: comparison of recertification in theUnited States, Canada, and the United Kingdom. JAMA.302(18):2008-2014; November 11, 2009.41. Hughes JT. The licensing of medical practitioners in TudorEngland: legislation enacted by Henry VIII. Vesalius.12:4-11; 2006.42. General Medical Council. Revalidation Update. London,United Kingdom. March/April 2010.43. Shaw K, Cassel CK, Black C, Levinson W. Shared medicalregulation in a time of increasing calls for accountabilityand transparency: comparison of recertification in theUnited States, Canada, and the United Kingdom. JAMA.302(18):2008-2014; November 11, 2009.44. Chantler C, Ashton R. The purpose and limits toprofessional self-regulation. JAMA. 302(18):2032-2033;November 11, 2009.20 | JOURNAL of MEDICAL REGULATION VOL 96, N O 2