Why is reducing bureaucracy for the medical device and home care industry necessary?
German statutory health insurance funds pay more than € 9 billion annually for the supply of orthopedic and rehabilitation equipment (Prosthetics, Orthotics, Technical Aids, HomeCare services) as well as enteral nutrition and home emergency call services.
The number of service providers (medical supply stores, orthopaedic technology, home care and care facilities) totaled 72,400 companies in 2019.
Since 2019, prequalification has been carried out by notifed prequalification bodies accredited by the German Accreditation Body (DAkkS) at the request of a service provider.
Pharmacists' and medical device associations have been calling for years for the reduction of prequalification bureaucracy. The effort and benefit of this extremely bureaucratic procedure cannot be brought into any reasonable relation for the companies concerned.
The extremely bureaucratic and time-consuming procedure not only produces direct costs, but also very high fulfillment expenditures in form of valuable working time.
Prequalification certificates cause total costs for affected companies of EURO 112 million for the 5-year cycle or EURO 22 million per year.
EURO funding by German statutory health insurers for the prequalification procedure established in Germany's health care system since 2008 to obtain the suitability test of a service provider in advance of a contract award.
EURO bureaucratic costs for service providers every 20 months. For a 5-year cycle of the prequalification procedure, the total bureaucratic costs are EURO 1,536.
EURO fees for a notified Conformity Assessment Agency to obtain accreditation with German Accreditation Body (DAkkS). With 13 accredited Conformity Assessment Agencies, this results in fees of EURO 350,000 per year.
Why this Book?
In spring of 2021, the author started as managing director at a conformity assessment body accredited by the German Accreditation Body (DAkkS) (prequalification according to § 126 para. 2 SGB V).
What was initially seen as an expedient, useful and successful business model developed over time into a bureaucratic monster.
The daily work is aligned with various recommendations of the National Association of Statutory Health Insurance Funds and specifications of the DAkkS. These requirements differ so much from each other that there could be no talk of reducing bureaucracy and good legislation.
The necessity of checking documents, normative references, self-declarations and factual requirements could not be communicated to affected enterprises or pharmacists.
For service providers and prequalification bodies, the procedure is a black box. After three years, there is lack of empirical evidence for the sensible use of funds in the DAkkS testing system and the promotion of reduction of bureaucracy.
The book explains the complex interlocking of different areas of law: Very different logics and orientations have developed through health law, EU legislation, professional law, medical device law and business law. Business GAP analysis is used to analyse all essential areas of the prequalification process.
The first edition gives foreign companies a deep insight into the legally prescribed prequalification procedure in Germany.
The book analyzes reimbursement mechanisms in Gemany and shows statutory health insurance as the dominant financing mechanism and contracting is the primary way of reimbursing providers.
Chapter "Solution and Prognosis", describes a possible change in German law in order to eliminate all deficits and different legal opinions and to enable the path to modern health system research in the field of orthopedic and rehabilitation equipment (prosthetics, orthotics, technical aids and home care services).
In order to strengthen the competitiveness of medium-sized service providers (home care, pharmacy, medical supply store), technical, syntactic and semantic standards for the prequalification procedure are presented.
If one views the prequalification procedure as a sub-legislative standard-setting procedure, aspects of scientific knowledge, relevant expert knowledge and the acceptance of professional expertise must be prerequisites for the legislative procedure.
The legislator must examine whether medical devices qualify as a special legal regulation that constitutes an exceptional circumstance and whether medical devices for th euse at home are regarded compulsory services under accreditation law at all.
Legislation concerning prequalification in the statutory health insurance system is so poor that business and administration find it difficult to comprehend the content of the rules.
Recommendations and criteria catalogue of the National Association of Statutory Health Insurance Funds must be subject to approval by the Federal Ministry of Health and the ministry must exercise its supervisory role.
The parliamentary discourse.
In November 2022, the print version of the GAP-analysis was made available to the Federal Government Coordinator for the Better Regulation and Bureaucracy Reduction Unit, concerned Federal Ministries and all parliamentary party leaders represented in the Bundestag in order to start the parliamentary discourse.
The English edition is intended to promote discourse with the European Union.
Author Thomas Bade
Born 1955 in Berlin.
Studied business administration at the University of Hamburg.
Professional and life experiences were gained in very different places of residence: Berlin, Hamburg, New York, Stuttgart, Helsingborg, Bad Oldesloe and Eichstätt.
After completing his education, he held various positions in marketing in Germany and the USA. From 1989 to 1996 managing director of a medical technology company and first involvement with the German health care system. European representative of the American medical technology company Rehablicare Inc. in Sweden.
For the Asklepios Kliniken GmbH & Co. KGaA from 2017 to 2020 responsible for business development and execution in the business areas of discharge management, outpatient services and home care.
From March 2021 to March 2023 Managing Director of the notified prequalification body HAWE-Systems GmbH in Röthenbach.
Now as a "retired manager", various freelance activities, including consulting for patient portals in discharge management, age-appropriate neighbourhood projects and patient rights, participation and self-determination.
Member of Transparency International Deutschland e.V., Berlin since 2015.
Member of Bundesforum Gesundheitsrecht e.V., Berlin since 2013.
Hede, K; Silva, T.; Bade, T.: Das zertifizierte Management System Ermündigung® zur Integration von Technik und Dienstleistungen, Conference: Zukunft Lebensräume - Kongress, 20.04.2016 - 21.04.2016 in Frankfurt/Main, Germany.
Korruption vs. Kooperation – Ein schmaler Grat, aut idem, Ausgabe 2015, carenoble.de.
Comprehensive Outcome Assessment in a shared care model and Budget Impact Analysis of therapeutic appliances for patients with diabetic foot disease: 2013; Academia.edu, San Francisco, CA 94104.
Sektorenübergreifende Versorgung unter Berücksichtigung prioritärer ambulanter Versorgungsstrukturen der Hilfsmittel- und HomeCare-Branche in Sachsen: 2014; Academia.edu, San Francisco, CA 94104.
Fraud Prevention in Germany; Why is the Government still amending the Wording of Law?, EUROPEAN HEALTHCARE FRAUD AND CORRUPTION NETWORK, Krakow, 2011.
Hilfsmittel- & HomeCare-Versorgung in Deutschland: Analyse des GKV-Wettbewerbsstärkungsgesetzes / Autor: Thomas Bade Hrsg. Salenus GmbH; 978-3-00-025142-9, 2008.
Musculoskeletal diseases and product warnings in product information provided by the computer industry; Versicherungsmedizin. 2002 Jun 1;54(2):90-1.
English release 03/15/2023