Proposal for a new practicable categorization system for food for special medical purposes - Enteral nutritional products.

BACKGROUND & AIMS: Changes in the EU regulation on food for specific groups (FSG) [1] and within the German social law [2] combined with various definitions in the legal and the scientific background led to the need for development of a categorization system for "Food for special medical purposes" (FSMP) for enteral use [3]. METHODS: The system was developed by an interdisciplinary working group of two German industry associations, which represent the leading manufacturers and distributors of FSMP in Europe. It aims to minimize the misunderstandings surrounding the different definitions used in relation to enteral nutritional products and incorporate the latest scientific knowledge and medical guidelines [4]. RESULTS: The new proposal consists of a table which shows the product categories and briefly the definitions of the used terms. The text contains the relevant definitions of terms often used within the field of enteral nutrition. CONCLUSION: This provides health care professionals with support and the decision making process for the prescription and use of such products. Additionally it also benefits the responsible authorities to formulate new directives, which are user-friendly and reflect the latest knowledge in medical nutrition.

Enteral nutrition reimbursement - the rationale for the policy: the German perspective.

Both the German statutory and private health insurances cover enteral nutrition (EN) products. Approximately 100,000 patients receive reimbursed EN; 70% are tube fed for an average 9 months. 70% of the tube-fed patients are cared for in institutions (i.e. for the elderly) and 30% at home. The prescription and reimbursement of EN is covered by Volume Five of the Social Legislation Code (Social Code Book No. 5). Reimbursement for EN depends on medical prescription and is in principle guaranteed whenever normal food intake is impaired and modification of normal nutrition and other measurements do not improve nutritional status. It is unclear what effect the reform laws will have on EN but they may impact the prices for medical devices and negotiations between health insurance funds and product manufacturers.