Reimbursement mapping: FRANCE

1. Reimbursement mapping: FRANCE 2011

2. Content • Key Economic Indicators • Healthcare Overview • Reimbursement Systems • Market Access • Funding Mechanisms • HTA • Decision makers, Acronyms and Links • Austerity Measures 2011

3. Key Economic Indicators France

4. Healthcare system overview • The mandatory health insurance (HI) system (Assurance MaladieObligatoire - AMO) covers the entire population. • Expenditure target is fixed annually by the parliament which votes the Social Security Funding Law (loi de financement de la sécuritésociale). • The general scheme (régime general) is the largest insurance, covering salaried workers and their families (some 80% of the population in 2007), and is administered by the CaisseNationaled’AssuranceMaladie des TravailleursSalariés (CNAMTS). • The two other major ones are the MutualitéSocialeAgricole (MSA) for farmers and the Régime Social des Indépendants (RSI) for self-employed.

5. Reimbursement system • The Health Minister determines if a device will be admitted to reimbursement, based on the opinion emitted by the CNEMiDTS; the price or tariff is fixed by the CEPS and the reimbursement rate is determined by the UNCAM. • The Economic Committee on Health Care Products is composed by representatives of the concerned department within the Health ministry, the Ministry of Industry, the Ministry of Finance, the representatives of the statuary health insurances and the complementary insurances. It determines the price or the tariff after the negotiation with the manufacturer. • The main purpose of the Union Nationale des Caisses d’Assurance Maladie is the coordination of the three mandatory sickness funds and the maintenance of the links with the complementary schemes and with the health care professionals to obtain a better health insurance management.

6. Pricing & Reimbursement process for MD Average application processing times (in number of days)

7. Market Access • MD used in hospitals: funded through DRG tariffs. • Assessment by CNEDiMTS and enlistment on the LPPR positive list: It concerns ambulatory MD and expensive MD used in hospitals which are funded in addition to the DRGs tariffs. • Medical device funded through a medical procedure: Assessment by CEAP. Most devices are included in the DRG tariff funded by the Health Insurance and in that case, hospitals are purchasers in the context of public tender regulations and there is no health technology assessment at the national level.

8. Market access pathway for MD

9. Funding Mechanisms (DRG system) • The Ministry of health is accountable for the regulation of DRG financing and there is an uniform national application of French DRGs, so called GHM (GroupeHomogene de Malades). • Drugs and medical devices, except if they are on a list of very expensive and innovative products, are incorporated in the GHM system. • Considering the future trends related to the DRG system, by 2012 there will be 100% GHM-financing for not for profit hospitals and a convergence of GHM-tariffs between for profit and not for profit hospitals. • There will be also the incorporation of more drugs and implants in the tariffs and the GHM system will be extended towards psychiatrics and rehabilitation.

10. HTA • Haute Autorité de Santé (HAS) (HealthAuthority): HAS activities range from assessment of drugs, medical devices, procedures for the accreditation of healthcare organizations and certification of doctors. • Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS) (National Commission for the Evaluation of MedicalDevices and Health Technologies): The purpose of the CNEDiMTS as part of HAS body is to provide scientific opinion concerning the usefulness, interest and good use of medical devices or technologies. • Commission Nationale des Actes Professionnels et Prestations (CEAP) Commission of Evaluation of Professional Behaviour: The purpose of the CEAP, as part of the HAS body, is to provide a scientific opinion concerning the definition of medical procedures and to assess their utility before the coding decision.

11. Introduction of a New Code • When the medical device is delivered to the patient only within a medical procedure that is not already coded for reimbursement, the enlistment of the new procedure is mandatory, in order to obtain MD reimbursement in ambulatory or hospital setting. • A double assessment is required: the device by the CNEDiMTS and the procedure by the Assessment Committee for Diagnostic & Therapeutic procedures (CEAP – Commission d’Evaluation des ActesProfessionnels), in charge of assessing new medical techniques whether they are therapeutic or diagnostic procedures.

12. Decisions Makers at National Level

13. Links

14. Links

15. Austerity measures France aims to achieve a 3% deficit by 2013 through: • The withdrawal of temporary economic stimulus measures • A three-year freeze on public sector spending from 2011, through, in part, not replacing some retiring civil servants • Raising retirement age from 60 to 62 and the full state pension age from 65 to 67 from July 2011 • Revenue raising measures, including higher taxes on income, stock option benefits, retirement packages, capital gains and dividend income along with closing tax loopholes and introducing new green taxes

16. FRANCE