Undue delay: the EU s waiting time guarantee? Venice, 13 November 2015 Willy Palm, Dissemination development Officer
Waiting times: only a national matter? Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices (art. 35 Charter of fundamental rights of the EU) Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them (art. 168.7 Treaty on the Functioning of the European Union)
Waiting times: only a national matter? 1. Access to health care services in another Member State Directive 24/2011/EU on the application of patients rights in cross-border health care 2. Increased monitoring of health systems European Semester: country-specific recommendations on access Investing in Health: health systems performance assessment (HSPA) Joint Assessment Framework (JAF) monitoring self-reported unmet need for health care European Core Health Indicators (ECHI) 3. Accessibility as core value and pillar Facilitating access to better and safer healthcare under the 3rd Health programme 2014-2020 EU agenda for effective, accessible and resilient health systems (COM 2014)
Towards modern, responsive and sustainable health systems (Council conclusions 2011) Source: Commission Communication on effective, accessible and resilient health systems COM (2014) 215 final, 4 April 2014
Increasing the accessibility of health systems From: Commission Communication on effective, accessible and resilient health systems COM (2014) 215 final, 4 April 2014
Expert Panel on effective ways of investing in health (EXPH) Opinion on access to health services Aspects: Information, literacy, convenience of services, people with disabilities, waiting times Problem of definition and scope of manipulation Data on self-reported unmet needs due to waiting lists need to be interpreted with caution Waiting time initiatives can create perverse effects Enhancing transparency and accountability through information and maximum waiting times EU can support Member states by harmonising definition and collecting waiting time indicators From: Access to health services in the European Union, opinion approved for public consultation (25 sept. 2015)
Cross-border care: the escape route? Source: Eurobarometer 2015 and 2007
Information on waiting times Source: Eurobarometer 2015
Directive 2011/24/EU on the application of patients rights in cross-border health care Legal certainty about rights and entitlements to care in another Member State Conditions for reimbursement of cross-border health care (benefit basket, level, formalities) Prior authorisation (scope, undue delay, administrative procedures) Guarantees of information and equal treatment (prices) Access to safe and high-quality cross-border healthcare Information on applicable quality and safety standards and on available providers Access to medical record Guarantees of non-discrimination, complaints and compensation, professional liability, data protection Cooperation on healthcare between Member States Basic duty of mutual assistance and cooperation Mutual recognition of medical prescriptions Areas of cooperation: European reference networks, Rare diseases, e-health, Health technology assessment, border regions National Contact Points 9
The right to cross-border care Art. 7: reimbursement of treatment according to the same conditions as MS of affiliation (coverage, level of coverage, conditions and formalities) Gatekeeping and referral mechanisms must be justified by planning requirements Art. 8: Prior authorisation: limited to health care subject to planning requirements requiring overnight hospital accomodation or highly specialised and cost-intensive medical infrastructure or medical equipment Necessary and proportionate Notify and publish what care is subject to prior authorisation Art 8.5: prior authorisation (reimbursement) cannot be refused if patient is entitled to the healthcare in question this healthcare cannot be provided on its territory within a time limit which is medically justifiable, based on an objective medical assessment of the patient s medical condition, the history and probable course of the patient s illness, the degree of the patient s pain and/or the nature of the patient s disability at the time when the request for authorisation was made or renewed. Except if overriding reasons (substantial safety risk) Art. 8.3: When the conditions laid down in Regulation 883/2004 are met, prior authorisation will be granted pursuant that Regulation unless the patient requests otherwise
Dual system for reimbursement of XB-care Procedure Directive 24/11 Regulation 883/04 Reimbursement level and conditions Prior authorisation (PA) MS of affiliation (MSoA) (exception) (necessary + proportional) hospital and highly specialised care (art. 8) MS of treatment (MSoT) (rule) All treatments, except care during stay (EHIC) PA cannot be refused When undue delay When undue delay (*) Qualifying providers All providers Only public or statutorily contracted providers Third party payer system No (optional) Yes Based on R. Baeten, OSE (*) Priority if conditions are met unless patient requests otherwise
Waiting lists and undue delay National authorities are entitled to institute a system of waiting lists in order to manage the supply of that treatment and to set priorities on the basis of the available resources and capacities. (Watts 2008) BUT The sole existence of waiting lists is not sufficient to refuse authorisation. Waiting times should be based on objectives relating to the planning and management of the supply of hospital care on the basis of generally predetermined clinical priorities. Waiting times should be acceptable in the light of an objective medical assessment of the clinical needs of the person concerned in the light of his medical condition and the history and probable course of his illness, the degree of pain he is in and/or the nature of his disability at the time when the authorisation is sought. Setting of the waiting times should be done flexibly and dynamically
Undue delay = powerful concept Prior authorisation for cross-border care can only be refused if the same or equally effective treatment (to which patient is entitled) can be obtained without undue delay from a contracted provider (Smits-Peerbooms 2001) the competent institution is required to have regard to all the circumstances of each specific case, also the lack of medication and basic medical supplies and infrastructure in that Member State (Petru 2014) If the benefit lists of the competent state does not expressly and precisely stipulate the method of treatment applied but defines types of treatment reimbursed prior authorisation can not be refused if no alternative treatment which is equally effective can be given without undue delay in the Member State on whose territory the insured person resides (Elchinov, 2010) When it is established according to international medicine that the treatment abroad is indeed more effective, the state may no longer justify prioritising its own offer of treatment (Rindal/Slinning EFTA Court 2008)
National undue delay practices Variation (Evaluative study on the cross-border healthcare Directive - March 2015): Standardised maximum waiting times (DK, NL) Individual assessment Additional rights (extended choice) for patients beyond max waiting times ( cross-region, private, cross-border route) DK, IRL Information about waiting times by national contact points (EE, SP, SW, LU) Also information duty for healthcare providers under art. 4.2(b) Measures to ensure access for domestic patients against inflows of patients (art. 4.3 2) Principle of non-discrimination but no obligation to accept or prioritise foreign patients for planned treatment! (recital 21)
Conclusions Waiting times increasingly monitored by EU EU law does not prevent Member States from applying waiting lists (as long as they are not considered undue delay ) Undue delay = powerful concept but variation in application Undue delay always needs to be assessed on an individual case basis. Directive might help to improve transparency and accountability! Regulation is the preferred route for reimbursement (better protection)
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