Planned cross-border healthcare

Planned cross-border healthcare Reference year 2015 PD S2 Questionnaire Jozef Pacolet & Frederic De Wispelaere - HIVA-KU Leuven June 2016

EUROPEAN COMMISSION Directorate-General for Employment, Social Affairs and Inclusion Unit D/2 European Commission B-1049 Brussels

EUROPEAN COMMISSION Planned cross-border healthcare Reference year 2015 PD S2 Questionnaire Directorate-General for Employment, Social Affairs and Inclusion Network Statistics FMSSFE (Contract No VC/2013/0301 Network of Experts on intra-eu mobility Lot 2: Statistics and compilation of national data ) 2016

Network Statistics FMSSFE This report has been prepared in the framework of Contract No VC/2013/0301 Network of Experts on intra- EU mobility social security coordination and free movement of workers / Lot 2: Statistics and compilation of national data. This contract was awarded to Network Statistics FMSSFE, an independent research network composed of expert teams from HIVA (KU Leuven), Milieu Ltd, IRIS (UGent), Szeged University and Eftheia bvba. Network Statistics FMSSFE is coordinated by HIVA. Authors: Prof Dr Jozef Pacolet, Head of the Welfare State research group, HIVA Research Institute for Work and Society, University of Leuven (KU Leuven). Frederic De Wispelaere, Senior research associate, HIVA Research Institute for Work and Society, University of Leuven (KU Leuven). Peer reviewers: Prof Dr József Hajdú, Head of the Department of Labour Law and Social Security, Szeged University. Dr Gabriella Berki, Professor Assistant at the Department of Labour Law and Social Security, Szeged University. Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). LEGAL NOTICE This document has been prepared for the European Commission however it reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein. More information on the European Union is available on the Internet (http://www.europa.eu). ISBN: 978-92-79-69748-7 doi: 10.2767/600258 Catalogue number: KE-01-17-639-EN-N European Union, 2016 Reproduction is authorised provided the source is acknowledged.

Table of Contents List of Tables... 6 List of Figures... 7 Summary of the main findings... 8 1. Introduction... 9 2. The number of PDs S2 issued and received... 9 2.1. The current flow of PDs S2 between Member States... 9 2.2. Planned healthcare abroad as share of the total insured population... 16 2.3. Evolution of the number of PDs S2 issued and received... 17 3. Treatment of the request for prior authorisation and reasons for refusal... 18 4. Parallel schemes... 21 Annex 1 Evolution of the number of PDs S2 issued and received... 24 Annex 2 The existence of parallel schemes (incl. Directive 2011/24/EU for Member States which reported on this)... 25 Annex 3 PD S2 Questionnaire... 28 Annex 4 Portable Document S2... 32 5

LIST OF TABLES Table 1 Table 2 Table 3 Table 4 Number of PDs S2 issued, breakdown by Member State of treatment, 2015 12 Number of PDs S2 received, breakdown by competent Member State, 2015 13 The percentage of insured persons entitled to receive planned crossborder healthcare on the basis of a prior authorisation, 2015 16 Percentage change of the number of PDs S2 issued and received, 2012-2015 18 Table 5 Number of PDs S2 requests refused and accepted, 2015 19 Table 6 Reasons for refusal to issue a PD S2, 2015 (as a percentage of the total number of refused requests) 20 Table 7 Percentage of contested decisions to refuse to issue a PD S2, 2015 21 Table 8 Care (not) included in the services provided for by the national legislation, 2015 23 6

LIST OF FIGURES Figure 1 Figure 2 Number of PD S2 issued, percentage breakdown by receiving Member State, 2015 14 Number of PDs S2 issued, percentage breakdown by neighbouring Member State or not, 2015 15 Figure 3 Main flows between the competent MS and MS of treatment, 2015 15 7

SUMMARY OF THE MAIN FINDINGS This report presents data on planned cross-border healthcare on the basis of Portable Document S2 (PD S2 - Entitlement to scheduled treatment ) related to the reference year 2015 and it covers the 32 countries that apply the EU social security coordination rules (hereafter referred to as 'Member States') 1. A PD S2 certifies the entitlement to planned health treatment in a Member State other than the the insured person's competent Member State, based on the procedures determined by Regulation (EC) No 883/2004 and (EC) No 987/2009 on the coordination of social security systems. Data was collected through a questionnaire launched in the framework of the Administrative Commission for the Coordination of Social security Systems. This is the second time that data has been provided by Member States on a mandatory basis concerning the use of the PD S2, providing a more complete view on the number of insured persons travelling abroad for the purpose of receiving healthcare. In 2015, a total estimated number of 47,000 PDs S2 were issued. Luxembourg and Germany issued the highest number of PDs S2, while Germany, Switzerland, Belgium and Austria received the highest number of PDs S2. Planned cross-border healthcare seems to be rather limited: in 2015 only about 10 out of 100,000 insured persons received a PD S2. Only Luxembourg shows a rather high volume of patient mobility (roughly 2 in 100 insured persons). Moreover, the figures illustrate a very concentrated use and impact of planned cross-border healthcare within a limited number of EU-15 Member States (LU, DE, AT, BE, NL, FR and NL) and Switzerland. Approximately 9 out of 10 prior authorisations are issued to receive a scheduled treatment in an EU-15 Member State or EFTA country. 2 The number of PDs S2 issued is not necessarily equal to the total number of patients who received planned healthcare abroad. Alongside the procedures determined by EU rules (the Social Security Coordination Regulations and the Patients Rights Directive 3 ), several Member States reported the existence of parallel procedures for planned healthcare abroad. In some Member States such as Belgium, Portugal, Estonia and Malta patient flows abroad are larger under such parallel schemes. Especially bilateral agreements in border areas seem to considerably influence the number of persons travelling abroad to receive planned cross-border healthcare. The assessment of the potential push and pull factors falls outside the scope of this report. Nonetheless, proximity seems to be an important factor as roughly 8 out of 10 PDs S2 are issued to receive a scheduled treatment in a neighbouring Member State. Finally, some 7% of the requests for a PD S2 were refused by the reporting Member States. On average 8.4% of the decisions to refuse a request were contested. 1 28 EU Member States, as well as Iceland, Lichtenstein, Norway and Switzerland. 2 EU-15 Member States: Belgium (BE), Greece (EL), Luxembourg (LU), Denmark (DK), Spain (ES), Netherlands (NL), Germany (DE), France (FR), Portugal (PT), Ireland (IE), Italy (IT), United Kingdom (UK), Austria (AT), Finland (FI) and Sweden (SE). EU-13 Member States: Croatia (HR), Romania (RO), Bulgaria (BG), Poland (PL), Czech Republic (CZ), Latvia (LV), Lithuania (LT), Slovenia (SI), Estonia (EE), Slovakia (SK), Hungary (HU), Cyprus (CY) and Malta (MT). EFTA countries: Iceland (IS), Liechtenstein (LI), Norway (NO) and Switzerland (CH). 3 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients rights in cross-border healthcare. 8

1. INTRODUCTION The Portable Document S2 (PD S2) on Entitlement to scheduled treatment certifies the entitlement to planned health treatment in a Member State other than the competent Member State of the insured person, based on the procedures determined by EU rules on the coordination of social security systems: Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009. This report relates to the reference year 2015 and covers the 32 countries that apply the EU social security coordination rules (hereafter referred to as 'Member States'). For the second time data has been provided by Member States on a mandatory basis through a questionnaire launched in the framework of the Administrative Commission for the Coordination of Social security Systems. Data were not provided by France and Germany. This data shows developments regarding the application of Regulation (EC) No 883/2004, 4 and to some extent the impact of Directive 2011/24/EU on Patients' Rights in Cross-border Healthcare. Differences between the two instruments and in procedures for prior authorisation and the reimbursement of costs may have an impact on the evolution of the number of PDs S2 used. The evolution of the number of PDs S2 before and after the transposition of Directive 2011/24/EU could therefore be considered as an indicator to measure the Directive s impact. Taking into account that the transposition deadline of Directive 2011/24/EU was October 2013, and some Member States were late in its transposition, it is too early to assess the impact that this Directive may have had for the reference year 2015. Therefore, the developments in the field of planned treatment abroad will be continuously monitored in the coming years. In addition to the questionnaire on PD S2 for data collection in the framework of the Administrative Commission for the Coordination of Social Security Systems, the European Commission (Directorate-General for Health and Food Safety) will also collect data on the operation of Directive 2011/24/EU through a separate questionnaire. A report published by the DG for Health and Food Safety in September 2015 showed low patient flows for healthcare abroad under Directive 2011/24/EU 5 to date: 17 Member States who introduced a system of prior authorisation under the Directive granted a total of 360 authorisations in 2014. 2. THE NUMBER OF PDS S2 ISSUED AND RECEIVED 2.1. The current flow of PDs S2 between Member States Table 1 gives a detailed overview of the PDs S2 issued by the 29 reporting countries. 6 In 2015, these reporting countries issued a total number of 34,433 PDs S2. 7 This is a strong underestimation of the total number of PDs S2 issued throughout all Member States during the current reporting year given that Germany and France did not provide data. Most of the reported PDs S2 were issued by Luxembourg (15,282 PDs S2 issued). Austria, Italy and the Netherlands 8 issued more than 3,000 prior authorisations in 2015. The UK issued some 1,400 prior authorisations. Romania, Slovakia and Ireland issued less than 1,000 but more than 500 prior authorisations. Greece, Croatia, 4 Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems. See also Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems. 5 See http://ec.europa.eu/health/cross_border_care/docs/2015_operation_report_dir201124eu_en.pdf. 6 Data was not availalbe for the reporting year 2015 in FR, DE and IS. 7 The number of PDs S2 issued is not necessarily equal to the total number of unique patients entitled to received planned healthcare abroad under Regulation (EC) No 883/2004 and (EC) No 987/2009, as it is possible that the same patient has made several requests for planned treatment abroad during the same reference year. 8 Two healthcare insurers have not provided data for this questionnaire. 9

Belgium, Spain, Slovenia, Bulgaria, Cyprus, Hungary, Latvia, Poland, the Czech Republic, Norway issued less than 500 but more than 100 prior authorisations. Finally, Finland, Sweden, Denmark, Portugal, Estonia, Lithuania, Malta and Liechtenstein issued less than 100 prior authorisations. Moreover, Belgium, the Netherlands, Germany, Luxembourg and France are also involved in a large number of cooperation agreements in border areas (IZOM 9, ZOAST 10 etc) where, depending on the cooperation agreement, prior authorisation often becomes a simple administrative authorisation that is granted automatically. A breakdown by receiving Member States makes it possible to determine the main patient flows between the competent Member States and Member States of treatment. Most of the PD S2s issued are authorising patients to access scheduled treatment in Germany, Belgium, France and Switzerland. Table 1 and Figure 1 show that approximately 9 in 10 of the total number of prior authorisations have been issued to receive a scheduled treatment in an EU-15 Member State. This percentage varies markedly across the EU-13 and EU-15 issuing Member States, but also across Member States individually. For instance, 7 out of 10 prior authorisations issued by the EU-13 Member States applied to a scheduled treatment in an EU-15 Member State, compared to 9 out of 10 prior authorisations issued by the EU-15 Member States. Latvia and Slovakia issued most of their prior authorisations to receive a scheduled treatment in an EU-13 Member State. In contrast to most of the EU-15 Member States, the United Kingdom (patients seeking scheduled treatment mainly in Poland), Italy (patients seeking scheduled treatment mainly in Switzerland) and Finland (patients seeking scheduled treatment mainly in Estonia) issued a relatively low percentage of prior authorisations where patients were seeking scheduled treatment in another EU-15 Member State. Based on the breakdown by competent Member States (Table 2), a relatively high percentage of the PDs S2 issued by Germany has been received by Switzerland. It implies that the share of the EU-15 in total number of received PDs S2 is overestimated. In total 26 Member States provided figures on the number of PDs S2 received (Table 2), reporting a total number of 34,433 PDs S2 received. 11, 12 Based on the data from these 26 reporting countries, Switzerland received a high number of PDs S2 (7,715 in total), mainly issued by Germany. 13 At the same time, the figures shown in Table 1 suggest that Germany received a higher number of PDs S2. Austria (5,370 PDs) and the Netherlands (3,516 PDs) also reported a high number of PDs S2 received, again mainly issued by Germany. Luxembourg and the Czech Republic received more than 1,000 prior authorisations. Bulgaria, Norway, Latvia and Malta received less than 10 PDs S2. The technique of data imputation 14 could be applied in order to estimate the total number of PDs S2 issued. Data from an issuing perspective by Member State of treatment (Table 1) is completed with data from a receiving perspective by issuing 9 The agreement facilitates patient mobility in the country triangle of Germany, The Netherlands and Belgium (Meuse-Rhine Euregion). 10 The agreement facilitates patient mobility between Belgium, France and Luxembourg. 11 Different reasons, next to the fact that less MSs were able to provide figures on the number of PDs S2 received, may explain the discrepancy between the reported flows of issuing and receiving PDs S2. Firstly, the period of time between the date of the decision to issue a PD S2 and the date the PD S2 was received by the healthcare institution will have an important impact on the discrepancy between the number of PDs S2 issued and received. Secondly, not every insured person who received a prior authorisation will eventually use this. 12 BE health care funds reported having received 12.383 PDs S2. Attention numbers are in fact higher because one health care fund did not report any data on this question. However, it has to be acknowledged that this number includes a couple of thousand PDs S2 (from France) under different ZOAST agreements. 13 The vast majority of the planned healthcare cases are concentrated in a few Swiss service providers which are specialised in some medical fields and are internationally established. Since many of these providers are located near the Swiss border, the approval given by the competent institutions is facilitated because of the fact that insured persons with serious health problems may be treated faster in Switzerland than in the Member State of residence. 14 Which is a procedure used to estimate and replace missing or inconsistent data. 10

Member State (Table 2). The inclusion of data for Germany and France as issuing Member State on the basis of the number of forms received from both Member States, roughly 11,600 and 9,000 PDs S2 respectively, results in a total number of 55,000 PDs S2 issued by all Member States. However, as propably almost all forms received by Belgium from France relate to the ZOAST agreement, the total number will be lower. This results in a total number of roughly 47,000 PDs S2 issued in case this single flow of approximately 8,000 forms is not taken into account. 11

Member State of treatment Planned cross-border healthcare Table 1 Number of PDs S2 issued, breakdown by Member State of treatment, 2015 Competent Member State BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL ** AT PL PT RO SI SK FI SE UK IS LI NO CH Total BE 64 0 3 1 3 18 n.a. 8 85 1 5 1 4,126 1 0 2,163 7 4 0 28 13 0 0 1 46 0 3 4 6,585 BG 0 0 0 0 0 n.a. 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 0 0 0 8 CZ 0 0 0 0 0 n.a. 32 8 0 0 1 14 5 0 0 2 3 0 0 8 572 0 0 77 0 0 1 723 DK 0 0 0 0 1 n.a. 0 1 0 0 0 1 0 0 2 0 0 0 4 0 1 4 20 3 0 9 0 46 DE 71 182 36 21 27 20 100 n.a. 176 705 255 58 12 8,519 46 8 1,021 4,564 67 5 306 99 49 35 3 117 4 16 88 16,610 EE 0 1 0 0 0 n.a. 0 1 0 41 0 0 0 0 2 0 0 0 0 0 0 31 0 3 0 1 0 80 IE 0 0 0 0 0 n.a. 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 10 25 0 0 0 37 EL 0 0 0 0 0 n.a. 0 2 0 0 0 0 0 0 4 0 0 0 0 0 0 0 9 10 0 1 0 26 ES 5 0 2 0 0 1 0 4 24 0 0 0 9 0 0 19 2 1 15 6 0 0 1 3 200 0 2 1 295 FR 147 38 0 11 1 3 65 n.a. 5 553 23 0 1 2,097 5 0 25 3 6 18 60 30 5 3 1 178 0 2 11 3,291 HR 1 0 0 0 0 0 0 n.a. 1 0 0 0 0 0 0 0 5 0 1 0 7 0 0 0 0 0 0 0 15 IT 2 6 2 1 0 2 85 n.a. 29 4 33 2 0 50 5 12 14 4 1 3 170 24 3 1 9 40 0 2 4 508 CY 0 0 0 0 0 0 n.a. 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 3 0 0 0 4 LV 0 0 0 0 0 0 n.a. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 2 LT 0 0 0 0 0 0 n.a. 0 0 0 70 0 0 0 0 0 0 0 0 0 0 0 0 33 0 4 0 107 LU 3 0 0 0 0 0 0 n.a. 0 1 0 0 0 0 0 4 0 0 0 0 0 0 0 8 3 0 0 0 19 HU 1 0 1 0 0 0 0 n.a. 3 0 1 0 0 1 0 6 3 0 0 37 0 2 0 0 42 0 1 0 98 MT 0 0 0 0 0 0 n.a. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 2 NL 161 1 14 3 0 0 0 n.a. 6 10 0 5 1 43 0 0 26 1 0 17 2 1 0 2 27 0 1 5 326 AT 1 27 3 0 0 0 137 n.a. 201 169 19 2 0 17 100 0 5 6 0 116 142 126 2 0 13 1 1 4 1,092 PL 2 0 0 0 3 0 n.a. 0 8 0 0 7 3 1 0 8 0 0 0 0 1 0 3 431 0 20 0 487 PT 0 0 0 0 0 0 n.a. 0 0 0 0 0 18 0 0 0 0 0 0 0 0 0 0 9 0 0 2 29 RO 0 0 0 0 0 0 n.a. 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 5 0 0 0 7 SI 0 1 0 0 0 0 n.a. 19 1 0 0 0 0 1 0 0 1 0 0 0 2 0 0 0 0 0 0 25 SK 0 35 0 0 0 0 n.a. 0 7 0 1 0 0 0 0 0 1 0 0 0 0 0 0 85 0 1 0 130 FI 0 0 2 6 0 3 n.a. 0 0 0 0 0 6 0 0 5 0 0 0 1 0 0 0 4 0 5 0 32 SE 1 3 0 15 0 25 10 n.a. 1 10 0 3 0 8 1 0 11 0 3 0 3 0 1 11 27 0 27 1 161 UK 18 8 6 12 2 574 68 n.a. 1 447 51 6 2 17 0 0 8 9 12 5 14 10 7 2 4 0 0 0 3 1,286 IS 0 0 0 0 0 0 n.a. 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 1 0 3 0 7 LI 0 0 0 0 0 0 n.a. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NO 0 0 1 0 0 0 n.a. 0 2 0 0 0 0 0 0 0 0 0 0 2 0 0 2 1 3 0 0 11 CH 8 0 0 3 1 5 3 n.a. 0 1,323 0 3 10 350 105 0 0 130 4 2 10 0 0 5 1 16 5 1 1,985 Unkn. 399 399 Total 419 331 101 72 38 636 490 399 485 3,364 383 196 35 15,282 270 21 3,297 4,757 108 49 775 335 770 98 78 1,410 10 100 124 34,433 EU-15 409 329 63 68 37 628 487 n.a. 431 2011 382 81 17 14,911 158 21 3281 4,615 101 46 725 320 193 60 70 702 5 69 123 30,343 EU-13 2 2 38 0 0 3 0 n.a. 54 28 1 112 8 18 7 0 16 12 3 1 38 15 577 31 6 688 0 27 1 1,688 EFTA 8 0 0 4 1 5 3 n.a. 0 1,325 0 3 10 353 105 0 0 130 4 2 12 0 0 7 2 20 5 4 0 2,003 * Blank: no data reported. n.a.: no data available. ** NL: Two healthcare insurers have not provided data for this questionnaire. Source PD S2 Questionnaire 2016 12

Competent Member State Planned cross-border healthcare Table 2 Number of PDs S2 received, breakdown by competent Member State, 2015 Member State of treatment BE ** BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL **** AT PL PT RO SI SK FI SE UK IS LI NO CH Total BE 0 0 0 0 0 2 0 1 0 1 743 4 0 1,337 6 0 0 0 2 0 9 0 0 16 2,121 BG 74 0 1 0 0 0 0 8 0 0 2 2 0 0 40 0 0 0 0 0 0 0 0 20 147 CZ 0 0 0 0 0 0 0 0 0 0 0 1 0 14 0 0 0 0 27 0 1 0 0 6 49 DK 6 0 0 0 0 0 0 1 0 0 0 0 0 1 1 0 0 0 0 0 7 0 4 3 23 DE 86 1 57 4 37 0 84 98 27 0 1 91 19 0 1,998 4,443 134 0 11 12 2 7 4 1 4,491 11,608 EE 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 1 3 0 0 1 7 IE 1 0 0 0 0 0 0 0 0 0 0 0 0 3 2 5 0 0 0 0 881 0 0 27 919 EL 17 0 0 2 0 0 0 46 0 0 0 0 0 11 112 0 0 0 0 3 34 0 0 1 226 ES 9 0 2 2 0 0 0 0 7 0 0 3 4 0 12 4 2 0 0 0 4 1 0 1 24 75 FR 7,995 *** 0 0 0 0 0 0 0 20 0 0 340 1 0 18 3 1 0 0 1 0 2 0 0 669 9,050 HR 11 0 21 0 0 0 0 15 0 0 0 9 0 8 208 0 0 29 0 0 0 0 0 0 301 IT 142 0 9 1 0 0 2 0 0 0 1 0 0 18 145 2 0 0 6 1 46 0 0 1,757 2,130 CY 1 0 2 0 0 0 0 0 0 0 0 0 0 0 0 21 0 0 0 0 0 10 0 0 0 34 LV 5 0 0 0 0 0 0 0 0 228 0 0 0 4 4 0 0 0 0 0 0 0 0 4 245 LT 3 0 1 0 0 0 0 0 0 0 0 1 0 12 0 20 0 0 0 0 1 0 0 10 48 LU 2,751 0 5 0 0 0 0 0 2 0 0 1 0 36 13 1 0 0 0 2 3 11 0 0 305 3,130 HU 1 0 1 0 0 0 0 0 3 0 0 0 0 1 82 1 0 0 0 0 0 1 0 101 191 MT 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NL 1,178 0 0 0 0 0 0 0 3 0 0 4 5 0 10 7 0 0 0 3 3 0 0 59 1,272 AT 8 0 6 0 0 0 1 4 3 0 0 0 37 0 3 0 0 1 0 0 2 0 0 117 182 PL 1 0 4 1 0 0 0 0 0 0 0 0 5 0 1 7 0 0 0 0 0 0 0 3 22 PT 1 0 0 1 0 0 0 0 2 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 7 RO 26 0 1 0 0 0 0 0 42 0 0 0 398 0 6 95 0 0 0 0 4 0 1 6 579 SI 4 0 17 0 0 0 0 5 3 0 0 0 0 0 2 89 0 0 0 0 1 0 0 28 149 SK 0 0 761 0 0 0 0 0 3 0 0 0 23 0 1 60 1 0 0 0 6 0 0 3 858 FI 2 0 3 1 6 0 0 0 1 0 0 2 0 1 2 1 1 0 0 0 1 0 0 5 26 SE 1 0 0 8 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 4 1 0 0 1 16 UK 53 4 192 3 6 12 4 0 10 0 22 6 16 0 25 8 266 0 0 53 0 0 1 0 0 13 694 IS 0 0 0 0 0 0 2 0 0 0 0 2 0 0 1 0 2 0 0 0 0 0 0 0 3 10 LI 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 39 39 NO 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 3 7 0 0 1 1 0 0 1 15 CH 6 0 0 1 0 0 0 0 5 0 0 0 0 0 0 13 0 0 0 0 0 0 38 0 63 Unkn. 0 Total 1,2383 5 1,082 25 49 12 95 107 202 0 252 1,194 528 1 3,516 5,370 451 0 41 102 21 1,023 12 43 7 7,715 34,236 EU-15 12,250 5 274 22 49 12 93 102 123 0 24 1,190 88 1 3,464 4,748 420 0 12 74 19 997 12 4 6 7,490 31,479 EU-13 126 0 808 2 0 0 0 5 74 0 228 2 439 0 51 606 22 0 29 27 1 26 0 1 1 182 2,630 EFTA 7 0 0 1 0 0 2 0 5 0 0 2 1 0 1 16 9 0 0 1 1 0 0 38 0 43 127 * Blank: no data reported. n.a.: no data available. ** BE: One union of healthcare insurers has not provided data. *** BE: Including PDs S2 received under the ZOAST cross-border healthcare conventions. **** NL: Two healthcare insurers have not provided data for this questionnaire. Source PD S2 Questionnaire 2016 13

Figure 1 Number of PD S2 issued, percentage breakdown by receiving Member State, 2015 * ES: No breakdown available n.a.: DE, FR and IS. Source PD S2 Questionnaire 2016 Different push and pull factors may have an impact on the decision of patients to seek authorisation for scheduled treatment abroad. Push factors, for instance when the treatment cannot be provided within a medically justifiable time limit, or the lack of treatment facilities or expertise in the competent Member State for treatments which are covered by the provisions of its legislation, may influence the decision to grant a PD S2. In addition, multiple pull factors are thinkable to receive a scheduled treatment in one particular Member State (e.g. proximity, familiarity, language knowledge, availability, medical expertise/quality, affordability in terms of reimbursement rates and out-of-pocket expenses etc). The assessment of potential push and pull factors falls outside the scope of this report. Nonetheless, based on the current quantitative input, the importance of proximity could be verified. Figure 2 illustrates the percentage of PDs S2 issued by and received from a neighbouring Member State. Roughly 80% of the PDs S2 are issued to receive a scheduled treatment in a neighbouring Member State. At the same time, only 34% of the PDs S2 issued by the EU-13 Member State are for treatment in a neighbouring Member State, compared to 86% of the PD S2 issued by the EU-15 Member States. The Netherlands, Luxembourg and Austria have issued more than 95% of the PDs S2 to receive a scheduled treatment in a neighbouring Member State. 14

Figure 2 Number of PDs S2 issued, percentage breakdown by neighbouring Member State or not, 2015 * ES: No breakdown available n.a.: DE, FR and IS. Source PD S2 Questionnaire 2016 Figure 3 illustrates five main flows of planned cross-border healthcare, namely from Luxembourg to Germany (8,519 PDs S2), from Austria to Germany (4,564 PDs S2), from Germany to Switzerland (4,491 PDs S2), from Germany to Austria (4,443 PDs S2) and finally from Luxembourg to Belgium (4,126 PDs S2). It also illustrates a very concentrated use of planned cross-border healthcare within a limited number of EU-15 Member States (LU, DE, AT, BE, NL, FR and NL) and Switzerland. Figure 3 Main flows between the competent MS and MS of treatment, 2015 Source PD S2 Questionnaire 2016 15

2.2. Planned healthcare abroad as share of the total insured population The absolute figures on prior authorisations for planned treatment abroad can be compared with the total number of insured persons in the countries concernes in order to calculate the relative frequency of patients exercising their rights for accessing cross-border planned healthcare (Table 3). In 2015 approximately 10 in 100,000 insured persons received a PD S2. A rather high patient mobility can be observed for persons insured in Luxembourg (2 in 100 insured persons). Germany has also issued a high number of PDs S2, their estimated relative impact will, however, still be modest as on average 2 in 10,000 German insured persons have received a PD S2. Nonetheless, this will also imply that the total use of planned cross-border healthcare is slightly underestimated. Finally, roughly 18 in 10,000 persons insured in Belgium received planned cross-border healthcare in case the number of forms issued for the parallel schemes are included (+ 19,309 forms). Table 3 The percentage of insured persons entitled to receive planned cross-border healthcare on the basis of a prior authorisation, 2015 MS Number of insured persons (A) Number of PD S2 issued (B) Share of insured population (B/A) in 100,000 insured persons BE ** 11,177,731 419 0.004% 4 BG 6,222,079 331 0.005% 5 CZ 10,430,223 101 0.001% 1 DK 5,600,000 72 0.001% 1 DE *** 70,728,389 n.a. n.a. n.a. EE 1,237,336 38 0.003% 3 IE n.a. 636 n.a. n.a. EL 9,000,000 490 0.005% 5 ES 47,762,374 399 0.001% 1 FR **** n.a. n.a. n.a. n.a. HR 4,326,925 485 0.011% 11 IT 60,216,084 3,364 0.006% 6 CY 606,620 383 0.063% 63 LV 2,264,954 196 0.009% 9 LT 2,959,784 35 0.001% 1 LU 875,066 15,282 1.746% 1,746 HU 9,899,383 270 0.003% 3 MT 219,691 21 0.010% 10 NL ***** 16,825,883 3,297 0.020% 20 AT 8,750,759 4,757 0.054% 54 PL 33,594,006 108 0.000% 0 PT n.a. 49 n.a. n.a. RO 17,191,563 775 0.005% 5 SI 2,177,983 335 0.015% 15 SK 5,163,561 770 0.015% 15 FI 5,490,376 98 0.002% 2 SE 7,841,769 78 0.001% 1 UK 64,875,165 1,410 0.002% 2 IS n.a. n.a. n.a. n.a. LI n.a. 10 n.a. n.a. NO n.a. 100 n.a. n.a. CH 8,140,000 124 0.002% 2 Total * 34,433 0.010% 10 * Total: Selection of the Member States of which the number of insured persons is available. ** BE: Roughly 18 in 10,000 insured persons received planned cross-border healthcare in case the number of forms issued for the parallel schemes are included (+ 19,309 forms). *** DE: The 11,608 reported PDs S2 issued by Germany (see Table 2) were divided by the number of insured persons in Germany. It results in 16 in 100,000 insured persons who received planned cross-border healthcare in 2015. **** FR: The 1,055 reported PDs S2 issued by France (single flow from FR to BE is not included) (see Table 2) were divided by the number of insured persons in France. It results in 2 in 100,000 insured persons who received planned cross-border healthcare in 2015. ***** NL: Two healthcare insurers have not provided data for this questionnaire. Source EHIC and PD S2 Questionnaire 2016 16

2.3. Evolution of the number of PDs S2 issued and received The data for reference year 2015 can be compared with previous years to look into developments in terms of number of persons accessing planned healthcare abroad. The evolution of these numbers could be considered as a first tentative indicator to measure the impact of Directive 2011/24/EU on the number of PDs S2 issued. However, the assessment of such potential impact is only possible in the longer term and based on more in-debt input from Member States. By looking only at the data from Member States which reported figures for both 2015 and 2014, it seems that the number of PDs S2 issued decreased by 11% in 2015 compared to 2014 (Table 4 and Annex I Table A1.1). Significantly lower number of PDs S2 were issued by Italy (-1,552 PDs S2), Luxembourg (-709 PDs S2) and Austria (-634 PDs S2). The decrease observed in the current reporting year follows a similar percentage decrease in the previous reference year. Table 4 shows that the percentage change strongly differs among issuing Member States. A higher number of prior authorisations were issued in 2015 compared to 2014 in the following countries: Portugal (+88%), Hungary (+79%), Estonia (+41%), Poland (+37%), Cyprus (+36%), Finland (+27%), Bulgaria (+9%), Norway (+9%), Croatia (+8%), the United Kingdom (+4%), the Czech Republic (+3%) and Ireland (+2%). This in contrast to countries where a lower number of S2 PDs were issued in 2015: Liechtenstein (-95%), Sweden (-86%), Lithuania (-57%), Denmark (-55%), Italy (-32%), Belgium (-30%) 15, Slovenia (-20%), the Netherlands (-20%), Latvia (- 17%), Greece (-16%), Romania (-13%), Austria (-12%) Spain (-7%), Slovakia (-4%) and Luxembourg (-4%). Luxembourg being the Member State which issued the highest number of PDs S2 in absolute and relative terms shows a continuing decrease of the number PDs S2 issued between 2012 and 2015 (equal to a total decline of 14%). 15 However, there will be an increase for BE when including the PDs S2 issued under the cooperation agreements and other parallel schemes. 17

Table 4 Percentage change of the number of PDs S2 issued and received, 2012-2015 2015 compared to 2014 Issued 2014 compared to 2013 2013 compared to 2012 2015 compared to 2012 2015 compared to 2014 Received 2014 compared to 2013 2013 compared to 2012 2015 compared to 2012 BE * -30% -49% -7% -67% 4% 260% -17% 208% BG 9% 29% 82% 157% -44% 80% 150% 150% CZ 3% -2% -64% -64% 68% -31% -4% 11% DK -55% n.a. n.a. n.a. 32% n.a. n.a. n.a. DE n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. EE 41% -48% n.a. n.a. 17% n.a. n.a. n.a. IE 2% -9% -19% -25% 71% 75% -50% 50% EL -16% 20% 53% 54% 64% n.a. n.a. n.a. ES -7% n.a. n.a. n.a. n.a. n.a. n.a. n.a. FR n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. HR 8% n.a. n.a. n.a. 4% n.a. n.a. n.a. IT -32% 0% 6% -28% n.a. n.a. n.a. n.a. CY 36% n.a. n.a. n.a. n.a. n.a. n.a. n.a. LV -17% 36% 12% 26% n.a. n.a. n.a. -100% LT -57% 9% n.a. n.a. 94% 160% n.a. n.a. LU -4% -9% -1% -14% 0% 9% -2% 7% HU 79% -55% 11% -10% 127% 385% 200% 3,200% MT 0% -36% n.a. n.a. n.a. n.a. n.a. NL ** -20% -28% 14% -35% n.a. n.a. n.a. -26% AT -12% n.a. n.a. n.a. -3% n.a. n.a. n.a. PL 37% -10% -25% -8% 9% 1% 69% 87% PT 88% -7% -3% 69% n.a. n.a. n.a. n.a. RO -13% -15% -7% -31% n.a. -100% 0% -100% SI -20% n.a. n.a. n.a. 14% n.a. n.a. n.a. SK -4% 4% 5% 5% 59% -78% -17% -71% FI 27% 31% 31% 118% 31% n.a. n.a. n.a. SE -86% n.a. n.a. -4% n.a. n.a. n.a. n.a. UK 4% 11% 8% n.a. -6% 1% -28% 4% IS n.a. n.a. n.a. n.a. -79% n.a. n.a. n.a. LI -95% -16% n.a. n.a. 617% n.a. n.a. n.a. NO 9% n.a. n.a. n.a. n.a. n.a. n.a. n.a. CH n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. Total -11% n.a. n.a. n.a. n.a. n.a. n.a. n.a. * For all PD S2s including parallel procedures: +676 (i.e. 18,633 in 2014 and 19,309 in 2015); one union of healtcare insurers did not provide data on PD S2s received. ** NL - 2015: Two healthcare insurers have not provided data for this questionnaire. Source Administrative data PD S2 Questionnaire 2016, 2015, 2014 and 2013 3. TREATMENT OF THE REQUEST FOR PRIOR AUTHORISATION AND REASONS FOR REFUSAL About 2,450 requests for prior authorisation for treatment abroad (PD S2) were refused by the 26 Member States who could report such figures for 2015 (Table 5). Luxembourg (790 refusals) refused the highest number of requests (in absolute values) which is clearly correlated to the very high number of requests received compared to other Member States. In order to calculate the authorisation/refusal rate, these absolute values are confronted with the number of PDs S2 issued (Table 5). In 2015, roughly 7% of the requests for a PD S2 were refused, this overall rate is strongly influenced by the low refusal rate of only 5% in Luxembourg. The overall refusal rate is slightly lower compared to the last reporting year (when it was 8%). 18

Finland (50%), Norway (48%), Belgium (47%) 16 and the Czech Republic (42%) show a high refusal rate for reference year 2015, but also for the previous two reference years. Table 5 Number of PDs S2 requests refused and accepted, 2015 Issued Refused Total 2015 % refused in % accepted % refused 2014 2013 BE 419 366 785 53.4% 46.6% 42.0% 23.5% BG 331 36 367 90.2% 9.8% 10.6% 7.5% CZ 101 72 173 58.4% 41.6% 33.8% 20.0% DK 72 6 78 92.3% 7.7% 0.0% n.a. DE n.a. n.a. n.a. n.a. n.a. n.a. n.a. EE 38 4 42 90.5% 9.5% 10.0% 10.3% IE 636 51 687 92.6% 7.4% 6.2% 3.7% EL 490 20 510 96.1% 3.9% 1.8% 6.5% ES 399 n.a. 399 n.a. n.a. n.a. n.a. FR n.a. n.a. n.a. n.a. n.a. 44.5% n.a. HR 485 86 571 84.9% 15.1% 18.0% n.a. IT 3,364 149 3513 95.8% 4.2% 2.1% 2.1% CY 383 n.a. 383 n.a. n.a. 6.6% n.a. LV 196 13 209 93.8% 6.2% 4.0% 7.0% LT 35 11 46 76.1% 23.9% 0.0% 0.0% LU 15,282 790 16,072 95.1% 4.9% 4.9% 3.4% HU 270 79 349 77.4% 22.6% n.a. n.a. MT 21 0 21 100.0% 0.0% 0.0% 0.0% NL 3,297 42 3,339 98.7% 1.3% n.a. n.a. AT 4,757 283 5,040 94.4% 5.6% 3.7% n.a. PL 108 13 121 89.3% 10.7% 19.4% 21.4% PT 49 6 55 89.1% 10.9% 27.8% 28.2% RO 775 59 834 92.9% 7.1% 4.5% 3.1% SI 335 17 352 95.2% 4.8% 8.3% SK 770 63 833 92.4% 7.6% 5.9% 7.0% FI 98 97 195 50.3% 49.7% 57.5% 57.9% SE 78 n.a. 78 n.a. n.a. 35.5% n.a. UK 1,410 65 1,475 95.6% 4.4% 3.9% 0.5% IS n.a. n.a. n.a. n.a. n.a. n.a. n.a. LI 10 0 10 100.0% 0.0% 0.0% 0.0% NO 100 92 192 52.1% 47.9% 54.0% n.a. CH 124 32 156 79.5% 20.5% n.a. n.a. Total 33,563 2,452 36,015 93.0% 7.0% 8.2% n.a. * NL: Two healthcare insurers have not provided data for this questionnaire. Source Administrative data PD S2 Questionnaire 2016, 2015 and 2014 In addition to the number of refused requests for prior authorisation, the reporting Member States were also invited to indicate the reasons for refusal of the prior authorisation: whether the request was refused due to the fact that the treatment shought by the patient was not included in the services provided under the legislation of the competent Member State, if it was refused because it could be provided within a medically justifiable time limit in the competent Member State, or due to other reasons. 47% of refusals were caused by circumstances other than the fact that treatment was not included in the services provided for by the legislation of the competent Member 16 This statement should be nuanced in the light of the large number of PDs S2 which are issued on the basis of more flexible provisions under agreements with neighbouring Member States. Many of these PDs S2 would not have been issued on the basis of the criteria of Article 20 of Regulation (EC) No. 883/2004. 19

State or that it could be provided within a medically justifiable period in that country (Table 6). The United Kingom, Belgium, Estonia, Ireland, Latvia, Lithuania, Luxembourg and Romania indicated other reasons to refuse most of the applications. The fact that care may be delivered within a medically justifiable period in the competent Member State explains 36% of refusals. This was the main reason for most of the Member States (Bulgaria, the Czech Republic, Denmark, Greece, Italy, Cyprus, Poland, Austria, Slovakia, Finland, Norway and Switzerland). Finally, on average 17% of the requests were refused by the reporting competent Member States because the care in question was not included in the services provided for by their legislation. For Croatia, Hungary, the Netherlands and Slovenia this was the most frequent reason to refuse requests. Table 6 Reasons for refusal to issue a PD S2, 2015 (as a percentage of the total number of refused requests) Number of refusals The care in question is not included in the services provided for by the legislation of the MS The care in question may be delivered within a medically acceptable period in the competent MS Other circumstances BE 366 17.5% 29.5% 53.0% BG 36 0.0% 88.9% 11.1% CZ 72 10.0% 80.0% 10.0% DK 6 0.0% 100.0% 0.0% DE n.a. n.a. n.a. n.a. EE 4 0.0% 0.0% 100.0% IE 42 4.8% 0.0% 95.2% EL 20 0.0% 100.0% 0.0% ES n.a. n.a. n.a. n.a. FR n.a. n.a. n.a. n.a. HR 86 46.5% 39.5% 14.0% IT 147 13.6% 76.2% 10.2% CY LV 13 23.1% 7.7% 69.2% *** LT 11 0.0% 9.1% 90.9% LU 790 7.8% 16.3% 75.8% HU *** 79 67.1% 13.9% 19.0% MT 0 NL **** 42 100.0% 0.0% 0.0% AT 283 10.6% 68.2% 21.2% PL 13 15.4% 84.6% 0.0% PT 6 83.3% 0.0% 16.7% RO 59 13.6% 10.2% 76.3% SI 17 64.7% 11.8% 23.5% SK 63 7.9% 55.6% 36.5% FI 97 18.6% 72.2% 9.3% SE n.a. n.a. n.a. n.a. UK 65 4.6% 4.6% 90.8% IS n.a. n.a. n.a. n.a. LI n.a. n.a. n.a. n.a. NO 80 26.3% 37.5% 36.3% CH 29 17.2% 65.5% 17.2% Total 2,426 16.6% 36.1% 47.3% * Total figure differs from the one reported in Table 5 due to lower reported figures by IE, IT and NO. ** HU: these data involve all refusals of planned treatments abroad, and not only refusals of requests for issuing a PD S2. *** LV: of which 4 cases: incomplete files; 4 cases: necessary healthcare services can be provided in Latvia; 1-case: closed (person s death). **** NL: Two healthcare insurers have not provided data for this questionnaire. Source Administrative data PD S2 Questionnaire 2016 20

The 24 Member State which have been able to provide figures on the number of contested decisions received 175 contestations following the refusal to issue a PD S2. On average 8.4% of the decisions to refuse a request were contested (Table 7). Especially Slovenia (41%), Slovakia (35%) and Bulgaria (25%) show a high percentage of contested decisions to refuse authorisation. Table 7 Percentage of contested decisions to refuse to issue a PD S2, 2015 Number of contested decisions (A) Number of refusals (B) % of contested decisions of the refusal (A/B) % contested in 2014 2013 BE n.a. n.a. n.a. 1.8% n.a. BG 9 36 25.0% 33.3% 15.8% CZ 6 72 8.3% 20.0% 24.0% DK 0 6 0.0% 0.0% n.a. DE n.a. n.a. n.a. n.a. n.a. EE 0 4 0.0% 0.0% IE 9 51 17.6% 29.3% 15.4% EL 0 20 0.0% 45.5% 25.0% ES n.a. n.a. n.a. n.a. n.a. FR n.a. n.a. n.a. n.a. n.a. HR 14 86 16.3% n.a. n.a. IT 21 149 14.1% n.a. n.a. CY n.a. n.a. n.a. 15.0% n.a. LV 0 13 0.0% 10.0% 15.4% LT 0 11 0.0% 0.0% n.a. LU 45 790 5.7% app. 12% 9.1% HU * 5 79 6.3%* 17.0%* 42.3% MT 0 0 0.0% n.a. NL ** 5 42 11.9% n.a. n.a. AT 4 283 1.4% 0.4% n.a. PL 2 13 15.4% 26.3% n.a. PT 0 6 0.0% 0.0% 0.0% RO 2 59 3.4% 2.4% 0.0% SI 7 17 41.2% 28.9% n.a. SK 22 63 34.9% 2.0% 20.7% FI 12 97 12.4% 17.3% 15.8% SE n.a. n.a. n.a. 3.0% n.a. UK 3 65 4.6% 0.0% 0.0% IS n.a. n.a. n.a. n.a. n.a. LI n.a. n.a. n.a. n.a. n.a. NO 6 92 6.5% 27.8% n.a. CH 3 32 9.4% n.a. n.a. Total 175 2086 8.4% 10.7% n.a. * HU: percentage applies to the contested decisions to refuse planned treatment abroad and not only to the refusals to issue a PD S2. ** NL: Two healthcare insurers have not provided data for this questionnaire. Source Administrative data PD S2 Questionnaire 2016 4. PARALLEL SCHEMES Most of the reporting Member States issued PDs S2 exclusively for care that is included in the services provided for by their legislation (BG, IE, EL, LV, LT, MT, PL, RO, SK and NO) (Table 8). In Denmark, Croatia and Portugal PDs S2 were issued exclusively for care that is not included in the services provided for by the legislation of these countries. 21

Alongside the procedures determined by the EU rules (Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009, along with Directive 2011/24/EU 17 ), several Member States reported the existence of parallel procedures (BE, DK, EE, EL, HR, IT, CY, MT, PT, FI, UK and NO) (Annex II Table A2.1). These parallel procedures are mostly the result of provisions in national legislation (e.g. reported by DK, EE, EL, HR, HU, CY, PT, FI and NO) or in (bilateral) agreements (for instance the Malta/UK bilateral agreement reported MT, IZOM, ZOAST). Belgium 18, Estonia, Cyprus and Hungary issue in specific cases a letter of guarantee for their insured persons to seek treatment abroad. The volume of these parallel schemes (in terms of number of treatments provided abroad) is, however, only available for a number of countries. For Belgium, patient flows abroad are much larger under such parallel schemes. A total of 19,309 PDs S2 were issued to the more flexible procedures, of which already 17,779 within the IZOMagreement. Portugal reported that 323 patients were authorised to receive treatment abroad under its national legislation (compared to only 49 PDs S2 issued in 2015). Estonia made 212 decisions to send a person for a specific treatment to another EU/EFTA country (compared to only 38 PDs S2 issued in 2015). 482 Maltese patients received planned treatment under the Malta-UK bilateral agreement (compared to 21 PDs S2 issued). Finally, 285 patients received private healthcare abroad on the basis of the provisions in national legislation of Cyprus (compared to 383 PDs S2 issued in 2015). Some Member States reported the number of cases of planned cross-border healthcare based on the procedures determined by Directive 2011/24/EU. This information is included in the current report, however as of the next reporting year the Member States will be invited to only report on parallel procedures outside of the EU rules on social security coordination and Directive 2011/24/EU, for a more consistent overview and considering that data on the Directive 2011/24/EU is collected by a separate questionnaire. Under the Directive 2011/24/EU Luxembourg granted 255 authorisations, which is much lower compared to the 15,282 PDs S2 it issued in 2015. Latvia reports that no requests were received for issuing prior authorisation since the implementation of the Directive (compared to 196 PDs S2 issued in 2015). Finally, according to Cyprus 5 patients used their right to receive cross-border healthcare under the Directive. 17 The patient flows for healthcare abroad under the Directive were recently reported by the Commission. See http://ec.europa.eu/health/cross_border_care/docs/2015_operation_report_dir201124eu_en.pdf. 18 For hadron therapy. 22

Table 8 Care (not) included in the services provided for by the national legislation, 2015 Care included in the services provided by the legislation of your MS Care not included in the services provided by the legislation of your MS BE * 93.3% 6.7% BG 100.0% 0.0% CZ 12.9% 87.1% DK 0.0% 100.0% DE n.a. n.a. EE 5.3% 94.7% IE 100.0% 0.0% EL 100.0% 0.0% ES n.a. n.a. FR n.a. n.a. HR 0.0% 100.0% IT 93.2% 6.8% CY n.a. * LV 100.0% 0.0% LT 100.0% 0.0% LU n.a. n.a. HU 1.9% 98.1% MT 100.0% 0.0% NL *** n.a. n.a. AT 97.9% 2.1% PL 100.0% 0.0% PT 0.0% 100.0% RO 100.0% 0.0% SI 0.8% 99.2% SK 100.0% 0.0% FI 94.7% 5.3% SE n.a. n.a. UK 95.4% 4.6% IS n.a. n.a. LI n.a. n.a. NO 100.0% 0.0% CH n.a. n.a. * BE: In Belgian legislation there is (i) a (general) procedure which makes it possible for Belgian patients to seek for healthcare services abroad that are not provided for by Belgian legislation, and (ii) a (specific) procedure which makes it possible for Belgian patients to receive hadron therapy abroad. ** CY: The majority of PDs S2 issued concerned care that is not included in the services provided by the National Health Scheme and the public hospitals of Cyprus. *** NL: Two healthcare insurers have not provided data for this questionnaire. Source Administrative data PD S2 Questionnaire 2016 23

ANNEX 1 EVOLUTION OF THE NUMBER OF PDS S2 ISSUED AND RECEIVED Table A1.1 Number of PDs S2 issued and received, 2012-2015 Issued Received 2015 2014 2013 2012 2015 2014 2013 2012 BE 419 601 1,190 1,280 12,383 11,932 3,318 4,019 BG 331 303 235 129 5 9 5 2 CZ 101 98 100 281 1,082 645 934 973 DK 72 161 n.a. n.a. 25 19 n.a. n.a. DE n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. EE 38 27 52 n.a. 49 42 n.a. n.a. IE 636 622 683 847 12 7 4 8 EL 490 584 486 318 95 58 n.a. n.a. ES 399 428 n.a. n.a. n.a. n.a. n.a. n.a. FR n.a. 683 n.a. n.a. n.a. n.a. n.a. n.a. HR 485 450 n.a. n.a. 107 103 n.a. n.a. IT 3,364 4,916 4,933 4,661 202 n.a. n.a. n.a. CY 383 282 n.a. n.a. n.a. n.a. n.a. n.a. LV 196 237 174 156 0 0 0 1 LT 35 81 74 n.a. 252 130 50 n.a. LU 15,282 15,991 17,538 17,765 1,194 1,198 1,095 1,120 HU 270 151 334 300 528 233 48 16 MT 21 21 33 n.a. 1 n.a. n.a. n.a. NL 3,297 4,126 5,745 5,050 3,516 n.a. n.a. 4,782 AT 4,757 5,391 n.a. n.a. 5,370 5,548 n.a. n.a. PL 108 79 88 118 451 413 408 241 PT 49 26 28 29 n.a. n.a. n.a. n.a. RO 775 890 1,049 1,131 0 0 2 2 SI 335 419 n.a. n.a. 41 36 n.a. n.a. SK 770 803 769 730 102 64 292 353 FI 98 77 59 45 21 16 n.a. n.a. SE 78 541 n.a. 81 n.a. 218 n.a. 216 UK 1,410 1,350 1,216 1,126 1,023 1,092 1,080 1,491 IS n.a. n.a. n.a. n.a. 12 56 n.a. n.a. LI 10 220 261 n.a. 43 6 n.a. n.a. NO 100 92 n.a. n.a. 7 n.a. n.a. n.a. CH 124 n.a. n.a. n.a. 7,715 n.a. n.a. n.a. Total 34,433 39,650 35,047 34,047 34,236 21,825 7,236 13,224 Source Administrative data PD S2 Questionnaire 2016 24

ANNEX 2 THE EXISTENCE OF PARALLEL SCHEMES (INCL. DIRECTIVE 2011/24/EU FOR MEMBER STATES WHICH REPORTED ON THIS) Table A2.1 The existence of parallel schemes, 2015 MS BE BG CZ DK DE EE IE EL ES FR HR Description The Belgian legislation foresees the possibility for persons whose principal residence is in a border region to be reimbursed for the costs of healthcare received in the neighbouring country (number of authorisations: 987). A total of 282 authorisations were also issued for functional rehabilitation services in Germany for insured persons who live in the German-speaking community. Belgium is also party to a large number of cooperation agreements which make it easier to obtain prior authorisation in border areas. In such cases authorisation is granted on the basis of a more flexible procedure. Depending on the cooperation agreement, prior authorisation (the S2 form) often becomes a simple administrative authorisation that is granted automatically: - IZOM: 17.779 authorisations, - ZOAST arrangements: 129 authorisations. Belgium also issued 132 S2 for pregnant woman further to the consensus reached at the 254th meeting of the Administrative Commission regarding a broad interpretation of Article 22(1)(c)(i) of Regulation (EEC) No 1408/71 (now Article 20 of Regulation (EC) No 883/2004) for the benefit of pregnant women who, for personal reasons, wish to give birth in another Member State. In 2015, a total of 19.309 S2 forms were issued further to the more flexible procedures. PDs S2 for treatment not covered by the NHIF s budget are issued by the Ministry of Health. Another option is to use crossborder healthcare services abroad under Directive 2011/24/EC. Directive 2011/24/EC. National legislation in Denmark complements the Danish patients rights under Regulation (EC) No 883/2004. According to Danish national legislation a patient has the right to get highly specialised hospital treatment abroad if necessary treatment cannot be given in Denmark because of a lack of expertise or medical equipment. Patients do also have the opportunity to get treatment in a clinical research trial abroad if appropriate treatment cannot be offered at a Danish hospital. If a patient has a life-threatening disease and cannot be offered treatment in Denmark or abroad as a highly specialised treatment or treatment in a clinical research trial, the patient has the opportunity to get experimental treatment abroad if the treatment can cure the patient or prolong the patient s life. The hospital authorities can also offer patients treatment abroad for instance if the waiting time in DK is too long even though treatment can be offered in Denmark. In addition, it is possible for patients to get reimbursement of expenses for treatment in other EU/EEA countries according to national rules implementing Directive 2011/24/EU. The treatment can take place in the public as well as in the private healthcare system and is not limited to the EU/EEA area except for reimbursement of expenses according to Directive 2011/24/EU. If a patient is referred for treatment to a public hospital in another EU/EEA, according to Danish legislation the authorities can issue an S2 form. The Estonian Health Insurance Fund (EHIF) issues letters of guarantee/agreement to insured persons (applicable in all countries worldwide) as a parallel scheme to the S2 system. Prior authorisation is given when all of the following criteria are met: 1) the health service applied for or alternatives to such health service cannot be provided to the insured person in Estonia; 2) provision of the health service applied for is medically indicated for the insured person; 3) the medical efficacy of the health service applied for has been proven; 4) the average probability of the aim of the health service applied for being achieved is at least 50%. The number of positive decisions by the EHIF granting prior authorisation for the person to receive planned treatment abroad in 2015: 218 decisions, of which 212 decisions concerned EU countries. According to national legislation, the EOPYY may undertake the costs for urgent treatments (exempt from waiting lists) not available in Greece, and offered by European private clinics or public/university hospital private wings. The same authorisation procedure is followed as under the S2 scheme, and a Health Board referral is taken into account. Patients privately admitted for treatment, are subject to a 10% (5% for children up to 16 years of age) charge on the total treatment costs. Yes, it is possible that the number of S2 forms is not representative of the number of patients covered for healthcare abroad for Croatia. There is indeed a parallel authorisation procedure in place. According to the Act on Compulsory Health Insurance (Article 26.3), every insured person is entitled to treatment abroad (both in EU and non-eu countries) if such treatment cannot be provided for by a contracted healthcare provider in Croatia, but can successfully be performed abroad. The procedure of authorisation is elaborated in detail in Article 25-33 of the Ordinance on entitlements, conditions and usage of cross-border healthcare. There is no stipulation that the treatment abroad has to be provided for within contracted healthcare facilities abroad, or that it has to be within the healthcare system of the State of treatment. Therefore, there are cases where the S2 form cannot be used, namely if the treatment is to be provided by a private healthcare facility, or if the treatment in question is outside of the scope of the healthcare system of the MS of treatment. If the authorisation for such a procedure has been granted, the Croatian health insurance fund will pay the healthcare facility which provides the treatment directly, and issues a letter of affidavit. 25

MS IT CY LV LT LU HU MT NL AT PL PT Description Sometimes the same patient requiring therapeutic continuity might receive more than one PD S2. For this reason it is possible that the number of S2 forms does not always correspond to the number of patients. Planned treatments are granted both in a direct way (meaning that the competent State bears the costs first) and in an indirect way (meaning that the patient pays first and is reimbursed afterwards). Sometimes competent institutions authorise planned treatment in the border Member States in private health structures as well. The applied legislation, which of course complies with the EC Regulations, also includes Ministry Decree 3/11/1989, and Directive 2011/24/UE (transposed by Legislative Decree 38/2014), and if applicable, rules at local level as well. I. The Ministry implements a sponsored patients abroad scheme under specific terms and conditions. According to the scheme, patients who need medical care that is not included or cannot be implemented within medically acceptable time limits by the National Health Scheme and the public hospitals of Cyprus, are sponsored for treatment in another country. Patients are sent mostly via the S2 route except for certain cases such as: 1. Agreements of the Ministry of Health with private Medical Centres for certain/special/rare treatments/operations; 2. Refusals of public hospitals in other countries to accept patients within a reasonable, medically acceptable time frame; 3. Very urgent cases. According to our data, 285 patients received private healthcare abroad while 383 received public healthcare (S2). II. Additionally, in 2015, 5 patients used their right to cross-border healthcare according to the relevant EU Directive. Another legal instrument that facilitates access to planned healthcare in another MS of the European Union is Directive 2011/24/EU. This Directive was implemented into the Latvian legal system on 25.10.2013. After the implementation, the prior authorisation system was introduced in Latvia. The NHS is the institution which is to decide on the issuing of the prior authorisation. The prior authorisation system was introduced in order to ensure sufficient and permanent access to a balanced range of high-quality treatment, as well as in order to control costs and avoid, as far as possible, any waste of financial, technical and human resources, especially considering services involving the use of highly specialised and costintensive medical infrastructure or medical equipment. Since the implementation of Directive 2011/24/EU there have not been requests for prior authorisation. No parallel schemes. There is the parallel scheme based on Directive 2011/24/EU. 255 authorisations were granted by Luxembourg under this scheme. The number of S2 forms is definitely not representative of the numbers for planned treatment abroad. There are treatments in the EEA and Switzerland where the healthcare providers are private providers; these providers do not accept S2 forms. No S2 form is used for genetic testing. If care cannot be delivered in Hungary and there is a real chance for improving the patient s quality of life, the NHIF gives authorisation for planned treatments in third countries. For genetic and biochemical analysis or bone marrow donor search the NHIF does not issue S2 forms, because these centres request direct payment. In these cases the NHIF issues a guarantee letter for payment. The number of patients referred to treatment abroad under parallel schemes: 482 Maltese patients were referred to the UK for treatment under the Malta/UK Bilateral Agreement. A patient can have access to healthcare services in the UK as a government-sponsored patient after successfully going through the procedure outlined below. The patient must be receiving treatment in a government healthcare entity in Malta and must be under the care of a local government-employed consultant. The patient must have received all possible treatment and undergone all possible investigations locally. The local consultant requests that the patient be referred for further treatment when all local options have been exhausted. The patient will be referred for further investigations and/or treatment to an NHS hospital abroad by his or her local caring consultant. The patient s caring consultant will fill in a referral form for consideration by the Treatment Abroad Committee. A medical summary must be drawn up and attached to the referral form. The referral form should be endorsed by the Clinical Chairperson of the referring specialty. The referral form and medical summary will be reviewed by the Treatment Abroad Committee who will take the ultimate decision whether the patient is approved for treatment abroad. Medical records and scans are sent abroad for evaluation and advice by the Foreign Consultants. The Dutch healthcare insurance has under Dutch law worldwide coverage; the insurance is not limited tot he EU-Member States and EFTA. 1. The Portuguese National Health System has in force legislation that recognises the right of patients to have access to specialised healthcare abroad which, for lack of technical or human means, cannot be provided within the Portuguese Health System. 2. The process of medical assistance abroad is organised by the public hospital of the National Health Service where the patient is being treated and is subject to prior authorisation of the Director-General of Health. 3. The hospital must specify the following in the process: the reasons that underlie the impossibility, material and human, of the medical assistance to be provided in a national health institution; the clinical aim of the displacement; the foreign healthcare Institutions (inside or outside the EU or EEA) where the patient can receive medical care and its fundaments; the maximum period for the medical assistance, otherwise, it will not produce its normal, useful effect; whether the patient needs to be accompanied by a person, with or without adequate technical training; a report with resource to consultants and experts of recognised competence in the clinical issues under appreciation. 4. If the Director-General of Health authorises the patient to travel abroad, the National Health Service will assume the full payment of all medical expenses, accommodation, travel, meals and medication. 5. The requests for medical assistance must be concluded within 15 days and, in cases of exceptional urgency, within 5 days. 6. In 2015, 323 patients were authorised for treatment abroad under this legislation. 7. The Director- General of Health has not authorised only two cases, insofar as the treatment was available in Portugal within reasonable time. 8. In order to ensure greater efficiency, effectiveness and transparency in the decision-making processes, the procedure has been dematerialised and is now electronic, covering also the PD S2 issued by the Directorate-General of Health under the National Health Service. 26

MS RO SI SK FI SE UK IS LI NO CH Description Another legal instrument that facilitates access to planned healthcare during a stay in a MS of the European Union, is Directive 2011/24/EU, transposed by Law No 95/2006 on healthcare reform, republished, as amended and supplemented subsequently by HG No 304/2014 for approving detailed rules on cross-border healthcare into force on 30 April 2014. HG No 304/2014 sets out the types of healthcare subject to prior authorisation and the criteria to be met in order to obtain prior authorisation. In order to obtain prior authorisation for reimbursement of cross-border healthcare, the insured, a family member (parent, husband/wife, son/daughter) or a person authorised by him or her must submit to the health insurance house, an application together with certain documents provided by the same law. After the application has been filed, the health insurance house checks if the applicant is an insured person and analyses the documents submitted and whether the conditions are met, before issuing the prior authorisation for the reimbursement of cross-border healthcare. If a patient wants to receive healthcare abroad, the public healthcare in Finland can also if necessary purchase this healthcare abroad. In these cases the public healthcare unit in Finland also pays directly to the healthcare provider abroad and the patient receives the healthcare as in Finland (same client fee etc). The European Cross Border Healthcare Directive (2011/24/EU) is another route for patients to seek planned healthcare abroad. Northern Ireland Health and Social Care Board has in place a Service Level Agreement with Republic of Ireland for paediatric Cardiac/cardiology services. There are also arrangements for situations where hospitals in Norway lack the necessary skills and/or equipment in which the patients can be sent abroad. These arrangements are based on national legislation and are in line with the relevant EU law. Source Administrative data PD S2 Questionnaire 2016 27

ANNEX 3 PD S2 QUESTIONNAIRE 1/ Countries in which patients have been authorised to receive care by the reporting Member State (= number of issued S2 forms) Each Member State shall indicate "not applicable" in its own row. N.B. This is determined by the dates of the decisions to issue authorisation for issuing an S2 form, even if the request for authorisation was received in year N-1. Member State BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK IS LI NO CH Total number of S2 forms issued by the reporting country for care in other Member State Number of S2 forms issued in year N for each State 28

2/ Countries from which patients have been authorised to receive care in the reporting Member State (= number of received S2 forms) Each Member State shall indicate "not applicable" in its own row. N.B. This is determined by the dates the S2 form was received by the appropriate healthcare institution in the reporting country under in year N. Member State BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK IS LI NO CH Total number of S2 forms received by the reporting Member State Number of S2 forms received in year N from each State 29

3/ Countries in which patients have been refused by the reporting Member State authorisations to receive care (= number of refused S2 forms) Each Member State shall indicate "not applicable" in its own row. N.B. This is determined by the dates of the decisions to refuse authorisation for issuing an S2 form, even if the request for authorisation was received in year N-1. Member State BE BG CZ DK DE EE IE EL ES FR HR IT CY LV LT LU HU MT NL AT PL PT RO SI SK FI SE UK IS LI NO CH Total number of S2 forms refused by the reporting country for care in other Member State Number of S2 forms refused in year N for each State 30

4/ Reasons for refusals to issue an S2 form (Reason 1): the care in question is not included in the services provided for by the legislation of your Member State (Reason 2): the care in question may be delivered within a medically acceptable period in the competent State (Reason 3): other circumstances (for example: incomplete file, non-compliance with procedures, institution requesting a second opinion). N.B. This is determined by the dates of decisions to refuse authorisation for issuing an S2 form, even if the request for authorisation was received in year N-1. Year N Number of refusals for Reason 1 Number of refusals for Reason 2 Number of refusals for Reason 3 5/ Number of contested decisions to refuse authorisation to issue an S2 form in year N Year N Number of contested decisions to refuse to issue an S2 form 6/ Number of S2 forms issued -For care that is included in the services provided for by the legislation of your Member State -For care that is not included in the services provided for by the legislation of your Member State 7/ It is possible that the number of S2 forms is not representative of the number of patients covered for healthcare abroad for certain Member States, on account of the existence of parallel procedures allowing patients to seek healthcare abroad. Please describe, if applicable, the existence of parallel schemes to the S2 system, the procedures how these schemes work and their consequences for the people concerned. 8/ Your explanatory comments on the data forwarded If necessary, please make any comments that may make it easier to understand the data transmitted in accordance with your national legislation or practice. 31

ANNEX 4 PORTABLE DOCUMENT S2 32

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