Annexes to COM(2014)44 - Report on the application of patients' rights in cross-border healthcare - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)44 - Report on the application of patients' rights in cross-border healthcare. |
|---|---|
| document | COM(2014)44  |
| date | February 3, 2014 |
It is also important to note that any authorisation scheme under the Directive is subject to the requirement that it is necessary and proportionate to the objective to be achieved, and may not constitute an unjustified obstacle to the free movement of patients. This implies that Member States will need to provide data to justify their use of prior authorisation. The current data suggests that extensive systems of prior authorisation under the Directive will be difficult to justify in the absence of robust evidence demonstrating why the situation under the Directive is so different from that under the Regulations.
3.2. Financial consequences for “lump sum” payment arrangements under the Regulations
Section 2 above has described the situation where some groups of people reside in a Member State different from the one which has recognised their rights to social security benefits (the ‘competent Member State’) and the Member State of residence opts for reimbursement on the basis of fixed amounts, or “lump sums”. The calculation method used for these lump sums is defined in Article 64 of Regulation (EC) No 987/2009 and shall be as close as possible to actual expenditure. The amounts involved are therefore adjusted regularly to take into account possible disproportionalities or cases of double payment.
Of these groups of people this report considers lump sum payments for pensioners and does not consider lump sum payments for other groups (such as Erasmus bursary students). This is for reasons of scale: both in terms of the numbers involved and the amount of healthcare used, pensioners will be by some way the most significant group.
The Directive may have an impact on the calculations used to set these amounts, for two reasons.
Firstly, due to different rules on the treatment of pensioners and their family members in their competent Member State, under the Regulations, all Member States paying lump sums receive a 15 per cent reduction on the amount to compensate for the cost of unplanned healthcare received by pensioners and their family members in a Member State other than the Member State of residence. This is because, under the Regulations, it is the competent Member State who will eventually bear this cost (for example via the European Health Insurance Card system). With regard to healthcare in the competent Member State, pensioners and their families usually have only limited rights of access – essentially to care which becomes medically necessary during their stay in that Member State.
Certain Member States choose to give pensioners and their families additional rights of access to healthcare. These Member States are entitled to a 20 per cent reduction in the lump sums by way of compensation for this, and are listed in Annex IV to Regulation 883/2004.
The rules under the Directive are different. Pensioners and their families resident in a lump-sum Member State which is not their competent Member State may seek healthcare in their competent Member State under the terms of the Directive. If the competent Member State is listed in Annex IV then the same terms and conditions apply as for the Regulations. If the competent Member State is not listed in Annex IV then the rules vary depending on whether the treatment in question is subject to prior authorisation in the Member State of residence. If so, then the usual reimbursement rule in the Directive applies: it is the Member State of residence which, as the Member State of affiliation, is responsible for reimbursement. If the treatment is not subject to prior authorisation in the Member State of residence then it is the competent Member State which is responsible for bearing the costs.
This can be summarised thus: under the Directive Member States not listed in Annex IV are nevertheless required to provide healthcare which they are not required to provide under the Regulations. They may therefore consider that they are responsible for a greater proportion of total healthcare costs for the insured persons concerned than they previously were, and that this should be taken into account when adjusting the lump sum amounts.
The second way in which the Directive may have an impact on lump-sum amounts is with regard to unplanned healthcare in a third Member State received by pensioners and their family members resident in a lump-sum Member State which is not their competent Member State. Under the Regulations it is the competent Member State which is responsible for the costs of this healthcare, as noted above, and for which they receive a 15% reduction on the amount of the lump sum. Under the Directive the patient may choose to claim reimbursement directly from the Member State of residence, as this is his or her Member State of affiliation. Therefore the Member State of residence might consider that it is now bearing costs for which it is not being reimbursed via the lump sum, and that this should be taken into account when adjusting the lump sum amounts.
Whether or not these impacts come to pass depends on the decisions made by Member States and individual patients on the use of prior authorisation, the choice of country for planned healthcare, the preferred system of reimbursement and so on. Robust data will therefore be needed to monitor any effects and to assess what this might entail for the lump sum amounts.
Currently, there is no information available to assess the financial consequences of the application of this Directive on ‘lump sum’ Member States. According to a preliminary appraisal from Member States that answered a March 2013 survey on ‘Reporting obligations under Article 20(3) of Directive 2011/24/EU’ regarding the potential impact of the Directive on the adequacy of the lump sums, Member State expectations vary. Some thought that the lump sum amounts would increase; others thought that Annex IV would no longer be relevant; others thought that there would be no significant impact; others thought that there would be an impact only for care not subject to prior authorisation but that this was unquantifiable at present.
Given the lack of data, no assessment of disproportionalities is currently feasible. Any disagreement between Member States on disproportionalities in the payment and receipt of lump sums related to the actual cost of healthcare received will need to be addressed at a later date.
Article 64(5) of Regulation (EC) No 987/2009 requires the Administrative Commission to presents a report no later than 1 May 2015 on the application of Article 64 of Regulation (EC) No 987/2009, in particular on the reductions under Article 64(3). The aim of the analysis is to ensure that the calculation of fixed amounts comes as close as possible to the actual expenditure incurred and that the reductions referred to in Article 64(3) do not result in any disproportionality or double payments for Member States. The report may contain a proposal for any amendments which may prove necessary in the light of experience of the application of the above provision. In short, each Member State is asked to provide a note with an analysis of whether or not the basic reduction applied to average costs is realistic. To the extent possible, the analysis should be supported by quantitative evidence and data. Member States are to present the data and accompanying notes to the Audit Board no later than 30 June 2014.
4. Data for future reports
To be able to assess the impact of the Directive on the number of patients using the Regulations, a "baseline" zero-measurement needs to be established to capture patient mobility under the Regulations prior to the implementation of the Directive. Next, this zero-measurement needs to be compared with another measurement that will be made after transposition of Directive 2011/24/EU.
It will therefore be necessary to improve the current situation, where there is a dearth of statistical data on cross-border healthcare.
Considerably improved data will, in the majority of cases, also be needed in order for those Member States introducing a prior authorisation system under the Directive to demonstrate that such systems meet the overall requirements of proportionality.
4.1. Zero-measurement
For future analysis within the scope of this report, a zero-measurement baseline is needed against which future impacts could be measured. The Commission has seen that this cannot be established through means of historically collected data. In Annex 1 available statistical data on patient mobility under the Regulations for planned healthcare are presented and discussed. It is found that available data are incomplete across Member States and do not distinguish whether related healthcare is among the basket of publicly covered benefits in the competent Member State. Further, no data on the type of healthcare are available.
For future reports on patient mobility under the system of prior authorisation as required under the Directive, further data collection is needed, for 2012 and 2013, with a greater level of detail. For that purpose, a new round of data collection has been launched within the Administrative Commission. However, certain Member States have communicated that they will not provide data for 2012 or 2013. Moreover, for Member States willing to provide data for 2012 and or 2013, there is no guarantee that they will do so with the level of detail requested, such as the distinction of whether episodes of treatment fell inside or outside of the basket of benefits.
Consequently, to constitute the most likely zero-measurement baseline for all Member States the extrapolation and interpolation of the limited available data will probably be required.
4.2. Measurement after transposition of the Directive
Data for 2014 will be collected for the assessment of the general operation of this Directive within the Implementing Committee of the Directive.
For the purpose of the analyses, data on prior authorisation should:
· be collected by year of request,
· be collected by the Member State of affiliation to which the request was addressed,
· concern requests for healthcare that is covered by the basket of publicly covered goods/services of the Member State of affiliation,
· indicate the number or percentage of requests that have been granted,
· ideally, indicate the number or percentage of granted requests where undue delay was found to apply,
· indicate the percentage of refused requests and the main reasons for refusal,
· ideally, distinguish by type of patient indication (e.g. rare disease patients).
4.3. Impact Measurement
Only if and when the zero-measurement and post-transposition of the Directive measurement have been established, will it be possible for the Commission to analyse:
· Substitution effects (directly compared to zero-measurement): e.g. a drop in authorisations under the Regulations that can be explained by an increase in authorisation under the Directive: Is this a conscious choice of patients (e.g. use of the Directive for free choice of provider)?
· Dynamic impacts: e.g. analysing whether more patients will receive prior authorisation under the Regulations as a result of additional information on undue delay becoming available to patients under the Directive, or as a result of increased awareness about patients' rights.
5. Conclusions
At this point in time – close after the end of transposition deadline of the Directive - it is clearly not possible for the Commission to consider the use that Member States have made of the possibility to introduce prior authorisation systems under the Directive, and the possible substitution effects with the Regulations.
For similar reasons, it is not possible for the Commission to conclude that there are or are not any disproportionality resulting from the implementation of the Directive.
It is, however, possible at this point to draw some conclusions with a view to addressing both of these points fully in the report on the general operation of the Directive, which the Commission is required to present by 25 October 2015. This will be the first in a series of triennial reports.
With regard to prior authorisation systems the concept of a medically-justifiable time limit should be the same under both instruments. Similarly, the procedural guarantees established under the Directive should be applied to any authorisation system under the Regulations.
Member States wishing to introduce a prior authorisation system under the Directive would need to review their current systems of data collection as the current data would, in most cases, not seen sufficient to justify an extensive system of prior authorisation.
In order to be able to properly examine the effects of the Directive on the use of the Regulations and on the adequacy of the lump sums, it would be useful to develop the way in which data is collected as set out in 4.2, above.
The development by Member States of a monitoring system under the Directive will pose a challenge of coordination with that established under the Regulations. Methodological issues need to be discussed to adjust these systems to the statistical international standards. Member States should unify – as far as possible - the collection of information, for the sake of efficiency.
Annex 1: Historical data on patient flows
A 2008 note of Directorate General Employment, Social Affairs and Inclusion reporting on a questionnaire related to the E112 form sent to delegates in the Administrative Commission pointed to some interesting observations: Small numbers of prior authorisation requests and high rates of authorisations granted upon requests are reported for most Member States[11]. With some notable exceptions, according to the information provided by Member States, requests for prior authorisation were refused mainly for absence of undue delay, with a very low rate of contested refusals[12]; the mobility of patients mainly concerns neighbouring Member States or those using the same language; and the parallel existence of other procedures (such as specific bilateral agreements between Member States) covering cross-border healthcare was noted by six Member States (DK, EE, CY, LT, MT and NL).
Furthermore, the note raises two relevant data issues:
· Data on clinical indication (diagnosis and/or specific procedure) would not fall within the traditional competence of the Administrative Commission.
· Distinguishing the number of applications from the actual number of patients who have applied for authorisation is not straightforward, as often more than one authorisation refers to the same patient case.
An overview of available data of E112 forms requested by Member State for the year 2006, 2007 and 2008 is presented below. Data are only available for 24 Member States. There is a great variability between countries in the number and evolution of prior authorisations issued. The highest rates (per head of population) are observed in LU, AT, SI, CY (above average in 2008) as shown in Annex 1. The average rate without LU (that presents 36,046 issued authorisations per million inhabitants) is 55 authorisations per million inhabitants. Member States above this average are AT, SI, CY, SK, BE, IE, EL and LV.
It is important to underline, therefore, that historical data collection exercises within the Administrative Commission do not distinguish whether the healthcare for which prior authorisation was requested was within the basket of entitlements in the Member State of residence and offer no insight into the mix of clinical indications involved.
In addition, they do not provide a complete picture as these figures do not include mobility of patients under parallel schemes (e.g. bilateral agreement between Member States or regions planning and organising transfers of patients).
Number of E112 requests forms by year of receipt of request
Member State || 2006 || 2007 || 2008
Requested || Issued || % Issued / Requested || Requested || Issued || % Issued / Requested || Issued
AT || 3,643 || 3,566 || 98 || 2,946 || 2,835 || 96 || 2,935
BE || 1,222 || 1,066 || 87 || 1,322 || 1,094 || 83 || 1,165
BG || NA || NA || || 81 || 4 || 5 || 10
CY || NA || NA || || 156 || 156 || 100 || 146
CZ || NA || NA || || 425 || 411 || 97 || 328
DK || 396 || 65 || 16 || 733 || 64 || 9 || 84
EE || 8 || 8 || 100 || 1 || 1 || 100 || 5
IE || 656 || 630 || 96 || 690 || 648 || 94 || 372
EL || 813 || 768 || 94 || 795 || 770 || 97 || 816
ES || NA || 722 || || NA || 722 || || 800
FR || 1,169 || 695 || 59 || NA || NA || NA || NA
HU || 209 || 193 || 92 || 185 || 215 || 116 || 232
LT || 7 || 6 || 86 || 19 || 14 || 74 || 12
LU || 17,825 || 17,290 || 97 || 17,280 || 16,800 || 97 || 17,439
LV || 46 || 29 || 63 || 132 || 110 || 83 || 127
MT || NA || NA || NA || 0 || 0 || || 0
NL || 3,482 || 2,912 || 84 || NA || NA || NA || NA
PL || 12 || 10 || 83 || 25 || 13 || 52 || NA
PT || 218 || 200 || 92 || 207 || 178 || 86 || 166
RO || NA || NA || || 213 || 124 || 58 || 562
SE || 163 || 81 || 50 || 330 || 115 || 35 || NA
SI || 493 || 340 || 69 || 504 || 262 || 52 || 442
SK || 679 || 640 || 94 || 792 || 743 || 94 || 685
UK || 560 || 366 || 65 || 634 || 552 || 87 || NA
Source: ADMINISTRATIVE COMMISSION FOR THE COORDINATION OF SOCIAL SECURITY SYSTEMS || ||
Number of E112 issued forms per million inhabitants by year of receipt of request
Member State || 2006 || 2007 || 2008
AVERAGE || 110 || 112 || 163
AT || 432 || 342 || 353
BE || 101 || 103 || 109
BG || || 1 || 1
CY || || 200 || 185
CZ || || 40 || 32
DK || 12 || 12 || 15
EE || 6 || 1 || 4
IE || 150 || 150 || 85
EL || 69 || 69 || 73
ES || 16 || 16 || 18
FR || 11 || ||
HU || 19 || 21 || 23
LT || 2 || 4 || 4
LU || 36,859 || 35,280 || 36,046
LV || 13 || 48 || 56
MT || || 0 || 0
NL || 178 || ||
PL || 0 || 0 ||
PT || 19 || 17 || 16
RO || || 6 || 26
SE || 9 || 13 ||
SI || 170 || 130 || 220
SK || 119 || 138 || 127
UK || 6 || 9 ||
Source: own calculations on the basis of ADMINISTRATIVE COMMISSION FOR THE COORDINATION OF SOCIAL SECURITY SYSTEMS
[1] See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF
[2] Generally, the Member State that is competent to grant to the insured person a prior authorisation to receive appropriate treatment in another Member State according to Regulation (EC) 883/2004 and (EC) No 987/2009. For a third country national in a cross-border situation within the EU it is according to Regulation No 859/2003 or Regulation (EU) No 1231/2010. As regards the latter, in special cases, where no Member State is competent according to those Regulations, the Member State of affiliation shall be the Member State where the person is insured or has the rights to sickness benefits according to the legislation of that Member State. It is important to notice that the concept of Member State of affiliation in the Directive was based on the concept of competent Member State, which is a concept defined by the Regulations on social security coordination.
[3] See Article 8(5) of Directive 2011/24/EU
[4] The Member State where the competent institution is situated. In turn, the competent institution means:
. "(i) the institution with which the person concerned is insured at the time of the application for benefit;
or
(ii) the institution from which the person concerned is or would be entitled to benefits if he/she or a member or members of his/her family resided in the Member State in which the institution is situated;
or
(iii) the institution designated by the competent authority of the Member State concerned;
or
(iv) in the case of a scheme relating to an employer's obligations in respect of the benefits set out in Article 3(1) of Regulation (EC) No 883/2004, either the employer or the insurer involved or, in default thereof, the body or authority designated by the competent authority of the Member State concerned".
[5] Article 20(2) of Regulation (EC) No 883/2004.
[6] This will be the case if the actual amount of the expenses for the benefits received is not shown in the accounts of the institution that provided them
[7] See Article 63, paragraph 1 of 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
[8] Article 63(1) of the 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, and listed in its Annex 3.
[9] Or, in the case of Denmark, who satisfy the conditions of the legislation of the Member State of affiliation for entitlement to benefits and are in a situation which is not confined in all respects within a single Member State.
[10] According to Article 20(3) of the Directive, these financial consequences should be addressed in cases covered by Articles 20(4) and 27(5) of the Regulation. For the sake of clarity, and considering the methodological nature of the report, the report will be focused on pensioners as presented to Member States in the Administrative Commission on 17 April 2013 and in the Cross-border Healthcare Committee on 3 June 2013.
[11] Only one Member State (LU) reported over 17,000 and two Member States (BE and AT) over thousands; the majority of them reported few hundred (CZ, DK, IE, EL, CY, HU, PT, RO, SI, SK, SE, UK, ); and the rest (BG, EE, LT and PL) reported fewer than 100.
[12] At less than 1% for most Member States.