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Market access for medical technologies in Romania

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Romania


Key topics

There is only one key theme describing market access for medical technologies in Romania: 

  • Reimbursement: payment mechanism via the global budget adjusted for DRGs, case payments, and fee-for-service tariffs; Coverage in the Curative National Programs for complex procedures


Romanian hospitals operate within a global budget, which is calculated by using a mix of qualitative and quantitative indicators. Regarding quantitative indicators, the following payment mechanisms are considered in determining the budget:

  • DRGs;
  • Case-payments (average tariff per solved case in that specialty, negotiated by the health insurance and the hospital);
  • Fee-for-service tariffs for specialized outpatient and day case procedures.

The DRG cost weights, case-payments, and fee-for-service tariffs are defined nationally in the ‘Framework Contract’.

Romania uses the Ro.DRG system. DRGs are determined by the combination of a procedure code (Romanian Nomenclature of procedures) and a diagnosis code (ICD-10-AM). Both the procedure coding nomenclature and the DRG system are maintained by the DRG Center of the National Institute for Health Services Management (INMSS).  DRG base rates are determined for each hospital individually. There are limited possibilities to implement changes in the Romanian DRG system.

Certain groups of complex, highly specialized, and expensive services can be covered by one of 15 Curative National Programs. Services provided within these programs have a separate budget.


Specifics for IVD tests

IVD tests provided in outpatient specialist settings are reimbursed on a fee-for-service basis according to relevant annexes of the national ‘Framework Contract’.

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