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Reimbursement Processes around the World Germany Description of Healthcare System The German health insurance system is based on the Bismarckanian social insurance system, first established as a social health insurance for workers in 1883. Today, 242 sickness funds collect contributions, and purchase proactively or pay retroactively for health services for members. Since 1996 almost every insured person has had the right to choose a sickness fund freely, while funds are obliged to accept any applicant. Since 2004, decision-making in statutory health insurance has been integrated into a trans-sectoral federal joint committee that is supported by an independent institute for quality and efficiency in health care, the German IQWiG. Since 2008, according to the new Competition Enhancement Act, the IQWiG has to evaluate the cost-benefit ratio of pharmaceuticals in Germany. In 2005, health expenditure in Germany comprised 10.7% of GDP, and 79% was covered by public funds, giving the country the fourth rank among countries in the Organisation for Economic Co-operation and Development (OECD). In the same year, German total per capita expenditure amounted to US$ 3287 and public per capita expenditure ranked tenth among OECD count. Out of the total expenditure (239.5 billion EUR), 56.6% of the funds came from statutory health insurance, 7.6% from statutory long-term care insurance, 3.1% from other statutory insurance schemes and 5.7% from government sources. Private health insurers financed 9.2%, employers 4.2% and non-profit-making organizations and households 13.6%. Most out-of-pocket payments went to purchase over-the-counter drugs and to co-payments for prescribed drugs. On 1 January 2004, co-payments were introduced for outpatient visits and raised for virtually all other benefits. Within the statutory-health-insurance, a risk-compensation scheme among sickness funds aims to level out differences in the age, sex and health-status structure of those insured through the different schemes. This system has been complemented by a high-risk pool since 2001 and by incentives for disease-management programs for the chronically ill since 2003. In 2009, a new morbidity adjusted risk-compensation scheme covering up to 80 different diseases will be introduced, while the rate of contribution to all statutory sickness funds will be set by the government. Until then, statutory health funds can set their rate of contribution by themselves. In ambulatory physician care, a regional physicians’ association negotiates a collective contract with a single sickness fund in the form of a quasi-budget for physician services. The association distributes the funds among general practitioners (GPs) and specialists who claim reimbursement mainly on a fee-for-service basis; limitations of service volumes apply. Hospitals are financed on a dual basis: investments are planned by the governments of the 16 Bundesländer, and subsequently co-financed by the Bundesländer as well as the federal government, while sickness funds finance recurrent expenditures and maintenance costs. Since January 2004, the German adaptation of the Australian diagnosis-related group (DRG) system is the sole system of paying for recurrent hospital expenditures, except for psychiatric care where per diem charges still apply. In 2009, a new health care reform act will be established to redefine the hospital financial system, while the DRG base rate will be harmonized on a state (Bundesland) level. Reimbursement Approval Process and Time Frame In contrast to the majority of other health care systems, market access of most pharmaceuticals approved by the EMEA or the German Federal Insitute for Drugs and Medical Device (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) means coverage by the German statutory sickness funds. But there exist some exceptions:
The German Institute for quality and efficiency in health care is responsible for the scientific evaluation of the benefits and harms as well as the quality and efficiency of health care services. Since April 2007, a new cost-benefit-assessment is established by federal law. The responsibilities include the evaluation of clinical practice guidelines, the submission of recommendations on disease management programmes, the evaluation of the benefits, harms and a cost-benefit-ratio of pharmaceuticals, and the publication of health information for patients and consumers. The IQWiG-HTA-process is described within their methodological paper (Version 2.0 as at 31. December 2007). For detailed reports, the process can be describes as follows:
Furthermore, the IQWiG can conduct rapid reports. Rapid reports can be commissioned by the FJC, the Federal Ministry of Health, and by the IQWiG itself. The two main differences between a full (detailed) report and the rapid report are the missing ‘intermediate’ products (project plan, preliminary report) and the missing possibility of hearings. In March 2008, the IQWiG will publish their new methodological paper on cost-benefit-assessment.Pricing Approval Process In Germany, manufactures are free to set their drug prises (for limitations please compare the reimbursement part). Reimbursement Organizations/HTA Organizations
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