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Although the European Union’s medical device approval process applies uniformly across all member states, obtaining reimbursement for a medical device varies from country to country. Whether a medical device qualifies for reimbursement depends largely upon the health care policies of a particular government.
Emergo Group has extensive experience with medical device reimbursement in Europe, including Germany, the EU’s largest single medical device market. Our European team’s expertise in navigating the complex German medical device reimbursement system will maximize your ability to meet the country’s reimbursement requirements.
Germany’s health care financing mechanism, the G-DRG, functions similarly to the Australian DRG System. Now, flat-rate payments are made for performed procedures and treatments. Main questions focus on which codes apply for specific products, and how these codes are obtained. Some of the important players in this respect are the Federal Ministry of Health (Bundesministerium für Gesundheit), the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the Federal Joint Committee (Gemeinsamer Bundesausschuss) that oversees Germany’s statutory health insurance, the Institute for Hospital Renumeration System (Institut für das Entgeldsystem im Krankenhaus, or InEK) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, or IQWiG).
For clients unfamiliar with the German reimbursement system, Emergo Group offers a Reimbursement Roadmap. This service includes a high level review of the German reimbursement process that provides an overview of how Germany’s health care system works and how federal and state health care policies dictate reimbursement rates and schedules. Our Reimbursement Roadmap services include:
Emergo Group offers a Reimbursement Assessment for clients already familiar with Germany’s reimbursement system and seeking support in developing a reimbursement strategy. Our Reimbursement Assessment service is tailored to your specific needs, and could include the following components:
Our Reimbursement Assessment offerings may include coding and funding services to assist you in determining how your device will be categorized and funded according to German health care law. We have extensive experience dealing with both categories of medical device reimbursement under the German model: in-patient care devices for use in hospitals and clinics, and out-patient devices typically prescribed to patients by physicians.
Diagnosis-related groups (DRGs) regulate reimbursement of in-patient devices, and list which devices can be used on patients depending on particular diagnoses. Emergo Group can help you satisfy DRG requirements according to the nature of your device in order to obtain the maximum level of reimbursement possible and minimize delays.
In addition, we offer literature reviews of Health Technology Assessments (HTAs) and other current and pending federal- and state-level health care policies and procedures impacting how medical device manufacturers obtain reimbursement in the German market. This service also includes reviews of existing clinical literature that can support your ability to obtain appropriate reimbursement based on how the German reimbursement system has already dealt with devices providing similar functions.