GERMANY - MEkipedia - 2017

I. Medical Education: The Current State of Affairs

A. OVERVIEW

In 1999 the German Ärztetag (self-regulating body of German physicians) decided to implement CME as an integral part of the medical education system on a voluntary base. It can be described as a “parliament of physicians” that meets once a year. Delegates (250) from the 17 German regional Chanbers of physicians participate.

The Code of Conduct of physicians, established by the German Medical Association (“Bundesärzteammer”) provided a general, ethical/moral obligation for all physicians to participate in CME activities without any described consequences for non-compliance. o The German Medical Association is the central organization in the system of medical self-administration in Germany. As the joint association of the Chambers of Physicians (Landesärztekammer), it represents the interests of more than 470,000 physicians in matters relating to professional policy, and plays an active role in opinion-forming processes with regard to health and social policy and in legislative procedures. (http://www.bundesaerztekammer.de/weitere-sprachen/english/german-medical-association/)

As of January 2004 CME became mandatory in Germany by law (GMG, Law for the Modernization of the Statutory Health Insurance, §95d Social Security Law) for any physician working within the Statutory Health Insurance system, so called “Vertragsärzte”, independent of specialty or if they are working office based or in the hospital (www.sozialgesetzbuch-sgb.de/sgbv/95d.html).These physicians represent the majority of office based physicians (probably between 80-90%) in Germany.

For physicians working in private practice, outside the SHI system, CME remains voluntary since only the Code of Conduct applies to them not the Social Security Law. These physicians are outside the SHI system and may only treat privately insured patients or patients who pay by themselves for their treatment.

• By mid 2004 the German Ärztetag provided the regulatory framework for the implementation of mandatory CME (www.baek.de).

• Physicians are now obliged to obtain 250 credit points over 5 years in order to receive a CME certificate from their regional physician chamber.

• As part of the legal obligation physicians can only apply with educational measures that have been certified and assigned with credit points by a medical chamber. This is detailed in the regulations (Fortbildungsordnungen) of the regional medical chambers.

• Due to the regional structure of Germany the 17 regional medical chambers have been responsible to translate the master guideline into regional regulations for physicians providing medical care in the respective region.

• Regional regulations show slight modifications of the master guideline

• Number of credits varies between 150 and 250 credits

• Timeframe varies from 3 years to 5 years

• Modifications exist in the recognition of activities

• The National Association of SHI physicians (www.kbv.de) is responsible of controlling compliance of its members and to assign penalties, if applicable

Physicians have to provide their CME certificates to the national association of the Statutory Health Insurance.o SHI physicians don’t get a salary but instead a quarterly honorarium based on a complex credit per activity system. They get points for everything they do based on a structured pregiven book. The points are then transferred into money. While they never know the value of the points, CME activities count toward their points. Non-compliance may lead to a 25% cut in honorarium and ultimately to the loss of the work permit within the SHI-system. o Physicians in general are free in the choice of their educational activities. For example, surgeons do not have to participate in educational activities from the society of surgeons. They can participate in any educational activity from any provider and medical area – the credits still count for their Fortbildungszertifikat (certificate).

Specialists working in the hospital have to obtain 150 credits (of the required 250) in education related to their specialty. The medical chambers do not differentiate between specialty related education and other; the differentiationhas to be done by the physician and approved by the hospital director.

• Non-compliance may only lead to sanctions imposed by the hospital.

• The same holds true for medical education providers. They may offer education in any therapeutic area.

• Pharmaceutical companies should not be providers of educational programs but may sponsor educational activities. Still they are not explicitly excluded in the recommendations of the national physician chamber but rather indirectly by a statement “must be independent from economic interests”. This is different from the European regulations from UEMS / EACCME which clearly excludes pharma from being providers.

• The cooperation between physicians and the pharmaceutical industry is regulated by the anticorruption law as of 2016 even though the impact is controversial (http://www.healthrelations.de/antikorruptionsgesetz-was-duerfen-pharmafirmen-noch/) Contracts between physicians and pharmaceutical companies vary, but payments to physicians (speakers, writers, consultants) have been reduced.

The most recent recommendation for medical education as of 2015(http-//www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/Fortbildung/EmpfFortb_20150424.pdf)provides more detail in relation to quality requirements with a focus on didactic requirements. A new section has been added focusing on neutrality and the quality requirements for eLearning have been included in the recommendation. The provider is to include the most appropriate didactical message to convey a specific learning objective.

B. Accreditation System

The German accreditation system is a credit based system with the obligation to document the acquisition of 150 (250) credits over a time frame of 3 (5) years, with variations among the various regions.

In Germany the term “certification” is used for the recognition of an educational program while “accreditation” is used for the recognition of a provider (medical society, medical education company, hospital, institution) of an educational program, enabling the provider to certify its programs. Not all regions in Germany have implemented provider accreditation, some only allow for program certification by the regional chamber. (See section V Regulatory and Accrediting Bodies for the individual regions’ information on provider accreditation.)

Providers of live events as well as providers of online programs have to fulfill certain quality requirements with regards to organization, speakers and economic interests. For example the requirements of the Saechsiche Landesärztekammer (https://www.slaek.de/de/05/aufgaben/vervarFortb.php?schnelleinstieg_redirect=1&schnelleinstieg_link=%2Fde%2F01%2Ffortbildung%2F60download%2Findex.php) are as follows: “…The provider has experience in planning, organization, implementation and evaluation of educational activities …. If requested they have to submit their internal process for quality assurance…. They have to guarantee that the educational program is objective and independent….” In order to be accredited an educational program has to be certified by the regional medical chamber where the educational program is being implemented. In the case of eLearning the educational program has to be certified by the regional medical chamber where the provider of the educational program is registered.

C. Trends

There seems less discussion around medical education as compared to previous years. Some years ago there was much discussion about quality and much change had been anticipated.o Several regional physician chambers have implemented “Academies for medical education” where they provide direct medical education to their members. (https://www.aerztekammer-bw.de/news/2016/2016-12/bildungszeitgesetz/index.html). It may show that CME has been identified by the chambers as a potential income generator but there is no hard data available on rational for the set up or impact on other providers. For the time being it may be interesting to monitor this trend to see the future impact of it. o Joint sponsorship of programs is not required, nor is it common.

II. Current requirements for medical education

A. Physicians

CME is mandatory for any SHI physician, independent of specialty, hospital or private practice

i. National Regulatory Bodies:The national physician chamber (“Bundesärztekammer”) www.bundesarztekammer.deprovides a national guideline (“Musterfortbildungsordnung”) which is then implemented by each regional physician chamber (“Landesärztekammer”) through regional regulations (“Fortbildungsordnungen”)

ii. State Regulatory Bodies:Each state (“region”) has its own regional physician chamber responsible for establishing the regional regulations (“Fortbildungsordnungen”), for certification of educational events and accreditation of providers (whenever applicable).o The regional physician chamber tracks the credits and provides the CME certificate.o Physicians have to submit the educational certificate to the national association of Statutory Health Insurance Physicians (“Kassenärztliche Vereinigung”), a self-regulatory body representing the interest of all SHI-physicians and responsible for penalties in case of noncompliance of SHI-physicians.

iii. Methods of delivery: Educational measures are categorized in categories from A-H A - Talk and DiscussionB - Congress (National and International) > 1 dayC - Education with participant engagemento Workshopo Working groupo Small groupso Case conferenceo Interdisciplinary case conferenceo Quality circleo Balint groups (where physicians meet regularly and present clinical cases in order to better understand the physician-patient relationship)o Supervisiono Literature conferenceD - Interactive educations with learning impact controlE - Literature studyo Lecture scientific articleo Online without learning impact controlF - Scientific publications and speaker activitiesG - InternshipsH - Learning curriculum, post-graduate courses and studiesI – eLearningK – Blended-Learning

iv. Reciprocity of credits: In general CME activities approved by one regional medical chamber are automatically approved by any other regional medical chamber.Process: Credits received by the participant of an educational program are submitted from the approving regional medical chamber directly via an electronic system called EVI to the regional medical chamber where the participant is registered.Providers have to contact only one regional medical chamber for the certification of a program: For live events the regional medical chamber in charge is where the live event takes place; for distance-learning it is the regional medical chamber of the region where the provider is based.International activities: It is possible to get approval on a European-level by UEMS/EACCME. Events will receive European CME credits that can be transferred into national credits The same is possible for CME credits from the American Medical Association (AMA).Alternatively physicians can submit participation certificates that include information on time and type of theeducational event to the regional medical chamber. The regional medical chamber verifies equivalence andprovides national credits.# of hours/credits: The regional medical chambers decide on the number of credits they assign to a certain activity. Physicians have to obtain credits over a time period. In general 1 credit point reflects 45 minutes of learning. Credits are provided and tracked by the electronic system which allows timely documentation of credits and transmission of credits to the medical chamber in charge. Registration of participants and documentation via participants list has to bedone by the organizer/provider of the educational activity. Physicians are not obliged to participate in the EVI system. They can also send in certificates in paper form.

v. Recertification:Does not exist in Germany

vi. Penalties/Rewards:According to Code of Conduct & Social Security Code (www.sozialgesetzbuch-sgb.de/sgbv/95d.html)physicians are obliged to continuously update their knowledge. Still the Code of Conduct describes no consequences in case of non-compliance. Consequences are only defined for SHI-physicians in the Social Security Code: Non-compliance can lead to financial cuts and ultimately to the loss of permit to work with in the statutory health insurance system.o Honorarium cut of 10% (for the first 4 quarters),o Honorarium cut of 25 % starting with the 5th quartero In the case that non-compliance continues 2 years after termination of the 5 years timeframe, withdrawal of license (“Approbation“) may be requested. However, there is no public record of doctors who have either incurred warnings or penalties vii. Specialty Boards:Educational measures provided by the specialty societies also have to be certified by the regional medical chamber. In addition specialty societies can be accredited by a regional medical chamber as accredited providers and can certify educational activities themselves (common approach).

B. Pharmacists

The national chamber for pharmacists (www.abda.de) has developed comparable guidelines for pharmacists (http://www.abda.de/rl-empfehlungen_bak.html). Pharmacists are obliged to participate in CME and to obtain a CME certificate. Still participation in CME is not regulated by law and no penalties are being described in case of non-compliance.

C. Nurses

No comparable requirements and regulations exist for nurses. The German association of nurses, DBfK, (www.dbfk.de) represents the interests of nurses. As part of its activities they provide educational programs. But participation is not mandatory, nor structured nor does it have a legally binding base. Some major physician congresses have added a satellite congress for nurses and other non-physicians in the health care sector.

III. Policies, requirements, and regulations affecting funding of medical education

A. Accreditation requirements

i. Accrediting bodies

The 17 regional physician chambers are in charge of certification of activities and accreditation of providers.

ii. Program vs. provider

According to the national medical chamber both options are possible but regional medical chambers handle the process differently.

Provider-accreditation is possible in Bayern, Sachsen, Saarland, Hamburg, Schleswig-Holstein & Brandenburg with the requirement that the provider is based in this region (Exception: Sachsen – where appropriate providers based in Sachsen or in any EU member state can be accreditedo Provider accreditation is not possible in Baden-Württemberg, Berlin, Bremen, Thüringen, Mecklenburg-Vorpommern according to the local regulations.o In some regions provider accreditation is possible according to the regulations but has not been implemented The more common approach in Germany is to choose program certification vs. provider accreditation.

iii. Level of company involvement in planning, delivery

Pharmaceutical companies may act as sponsors (including single sponsoring) but not be providers of an educational activity. However this stipulation is a “should not” vs a “must not”“ As long as type, content & presentation of educational events are solely determined by the medical organizer, sponsorships for the costs of the event are permitted. Relationships to the sponsor have to be made public in the announcement of the activity as well as during implementation.”Pharmaceutical companies may cover costs for travel and overnight stays “at an appropriate level” for certified educational events; but not cover costs for additional guests (family, partners etc.). There is no clear definition of what is deemed “appropriate”. Pharmaceutical companies for the most part have created their own definitions.

B. Pharmaceutical association requirements/code of ethics

Pharma-Kodex: Compendium of important guidelines, regulations and laws for the health care sector (www.pharma-kodex.de/index.php?seite=start) FSA-Kodex, 2017: Voluntary self-control of the pharmaceutical industry; legally binding (https://www.fsa-pharma.de/fileadmin/Downloads/Pdf_s/Kodizes__Empfehlungen/Kodex_Fachkreise_Web_inkl_Leitlinien_06_2017.pdf)

IV. GAME Members Currently Active in Producing / Sponsoring Medical Education Activities in Germany

V. Medical Education Resources (website, contact info)

RoleWebsiteNational AuthoritiesBÄKNational chamber for physicians, provides the regulatory framework which has to be transformed into regional regulations & laws be the regional physician associationswww.bundesaerztekammer.deDeutscher ÄrztetagAnnual meeting of the national chamber with 250 delegates (“parliament of German physicians”); establishes Code of Conduct & master regulationshttp://www.bundesaerztekammer.de/page.asp?his=0.2BAKNational chamber for pharmacists, provides regulatory framework for pharmacistswww.abda.deKassenärztliche BundesvereinigungNational association of SHI physicians provides regulatory framework for the work of all physicians within the SHI system. www.kbv.deArbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften eVAssociation of the 156 specialty societies existing in Germany.Provides a list of all these specialty societies and boardswww.awmf.orgDeutscher Berufsverband für PflegeberufeNational association for nurseswww.dbfk.deFSAAssociation for voluntary self-control of the German pharmaceutical industry, founded by the industry. Provides Code of Conduct for the industrywww.fs-arzneimittelindustrie.de

Regulatory & accrediting bodies:

LÄK BayernRegional accreditation bodywww.blaek.deLÄK Baden-WürttembergRegional accreditation bodywww.aerztekammer-bw.deLÄK BerlinRegional accreditation bodywww.aerztekammer-berlin.deLÄK BrandenburgRegional accreditation bodywww.laekb.deLÄK BremenRegional accreditation bodywww.aekhb.deLÄK HamburgRegional accreditation bodywww.aerztekammer-hamburg.deLÄK HessenRegional accreditation bodywww.laekh.deLÄK Mecklenburg-VorpommernRegional accreditation bodywww.aek-mv.deLÄK NiedersachsenRegional accreditation bodywww.aekn.deLÄK NordrheinRegional accreditation bodywww.aekno.deLÄK Rheinland-PfalzRegional accreditation bodywww.laek-rlp.deLÄK Westfalen-LippeRegional accreditation bodywww.aekwl.deLÄK SaarlandRegional accreditation bodywww.aerztekammer-saarland.deLÄK SachsenRegional accreditation bodywww.slaek.deLÄK Sachsen-AnhaltRegional accreditation bodywww.aeksa.deLÄK Schleswig-HolsteinRegional accreditation bodywww.aeksh.deLÄK ThüringenRegional accreditation bodywww.laek-thueringen.de

Medical Societies (there are 177 in Germany – these are the more significant ones):

Arbeitsgemeinschaft der Wissenschaftlichen 

Medizinischen Fachgesellschaften 

e.V (association of all medical societies) www.awmf.de Deutsche Gesellschaft für Innere Medizinwww.dgim.de Deutsche Diabetes Gesellschaft (DDG) www.deutsche-diabetes-gesellschaft.de Deutsche Gesellschaft für Kardiologie (DGK )www.dgk.de Deutsch Gesellschaft für Neurologie (DGN) www.dgn.de Deutsche Gesellschaft für Rheumatologie (DGRh) www.dgrh.de Deutsch Gesellschaft für Hämatologie & Medizinsche Onkologie (DGHO) www.dgho.de Gesellschaft für Virologie (GfV) www.d-g-v.org Deutsche Gesellschaft für Allergologie & klinische Immunologie (DGAKI) www.dgaki.de Deutsche Gesellschaft für Immunologie (DGfI) www.dgfi.org Deutsche Gesellschaft für Verdauungs und Stoffwechselkrankheiten (DGVS) www.dgvs.de Deutsche Dermatologische Gesellschaft www.derma.de Deutsche Gesellschaft für Pneumologe www.pneumologie.de Deutsche Gesellschaft für Gastroenterologie www.dgvs.de Deutsche Gesellschaft für Kinder- und Jugendmedizin www.dgkj.de Deutsche Gesellschaft für Infektiologie www.dgi-net.de Deutsche Gesellschaft für Pharmakologie www.dg-pharmakologie.de

Important Publications & Regulations

NameLink

RegulationBerufssordnung für die deutschen Ärztinnen und Ärzte, BÄK, 1997 last update 2006www.baek.deLawSGB V, 1988, last update 2010www.sozialgesetzbuch-sgb.de/sgbv/95d.htmlLawGKV Modernisierungsgesetz, 2004www.gkv-spitzenverband.de/LawAntikorruptionsgesetz, 2016RegulationMusterfortbildungsordnung, BÄK, 2013www.baek.deRecommendationEmpfehlungen der Bundesärztekammer zur ärztlichen Fortbildung, 2015www.baek.deRecommendationEmpfehlungen der BAK für Richtlinien zum Erwerb des Fortbildungszertifikates für Apothekerhttp://www.abda.de/rl-empfehlungen_bak.htmlPublicationIncreased understanding of medical education pathways in Europe as a potential quality factor in CME – a comprehensive assessment of the current landscapeJournal of European CME Jan 2012, Vol. 1, No. 1: 9–17http://informahealthcare.com/toc/cme/1/1