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In response to numerous enquiries concerning the possibility of modifying the health policy programmes for which opinions have been issued and which have been implemented, the Agency for Health Technology Assessment and Tariff System (in consultation with the Ministry of Health) has developed a common position. The objective was to answer the individual questions presented below.

Scope of RHPs (regional policy programmes)/HPPs (health policy programmes)

  • As part of the programme implementation, a quality assessment should be carried out, including a participant satisfaction survey. This issue should be monitored and organisational improvements should be introduced. Perhaps it the assessment should also be extended to include a personnel satisfaction survey.

According to AOTMiT, the personnel satisfaction component could be analysed in RHPs/HPPs; this is not obligatory, so the decision in this respect is up to the RHP/HPP provider. Monitoring the issue of the participants’ or personnel’s quality assessment should therefore be included in the RHP/HPP planning. The changes resulting from the assessments may be introduced as long as they are included in a catalogue of changes that can be introduced without another AOTMiT opinion. It should be emphasised that some of the assessment results may refer to the quality of implemented interventions – e.g. the quality of provided training/healthcare services – the provider should continuously strive for the highest quality of the provided interventions.

  • Change in the examination duration (increased or decreased).

The average examination duration should be indicated in the RHP/HPP. The examination duration may vary individually, but it is not possible to reduce the duration of the examination in a way resulting in a change in the type and scope of the examinations/healthcare services – such a change requires another AOTMiT opinion.

  • The beneficiaries would like to change the type of examination and use a different type than the one indicated in RHP/HPP (without prior consent).

A change in the type and scope of examinations/healthcare services requires another AOTMiT opinion.

  • The beneficiaries would like to introduce consultations with specialists other than those indicated in the RHP/HPP.

The addition of other medical consultations (different scope of consultation) than those listed in the project constitutes a change in the scope of intervention. A change in the type and scope of examinations/healthcare services requires another AOTMiT opinion. In the case of a change only in terms of the medical specialty (the scope of the consultation remains the same), this change would be possible provided that the relevant specialist has the knowledge and competence to provide the consultation in question. When drafting the RHP/HPP, it is worth taking into account all specialists who have the appropriate competences to carry out the indicated interventions.

  • The suggestions for modifying the support pathway consisting in carrying out examinations or consultations in a different order than provided for in RHP (within the RHP/HPP scope, but in a different order).

The change in the order in which the examinations determining the diagnosis or the course of treatment should not take place without prior AOTMiT opinion. In the case of healthcare services which are not causally related, it is possible to provide them at any time during their implementation, which should not require another AOTMiT opinion. Nevertheless, to ensure proper due diligence, we encourage keeping in touch with AOTMiT during the works to resolve individual cases.

  • No interest in preventive programmes, which provide for a short pathway, including only diagnostics (no examinations). Non-public healthcare centres are not interested in attracting patients if the treatment is not reimbursed in the project.

Extending the programme by including additional examinations in order to attract a provider is subject to further opinion, as the interventions in the programme are subject to change.

Population, epidemiological data, etc.

  • The size of the population may constitute a problem. In the absence of interested providers, the population covered by the programme may be significantly smaller. The programme is considered to be effective when 70% of the population is examined, which is often very difficult to achieve. So perhaps it is worth considering whether the population (its size) in the programme should not be adjusted to the size actually covered by the programme after the competition has been concluded. This will also result in a change of the amount allocated to the programme.

The size of the target population is crucial to achieving the population effect of the planned actions. The reduction of the population during the project implementation raises doubts as to the legitimacy of its implementation and further fund allocation. In case of recurrent problems with provider selection, it is worth considering whether to a given RHP/HPP should be implemented at all. In AOTMiT’s opinion, programmes should be planned with consideration of the entire target population, and the status of applying to the programme should be monitored on an ongoing basis during its implementation.

  • Update of epidemiological data and the size of the target group in the case of using a health programme that was developed (and received a positive AOTMiT’s opinion) several years ago. It should be emphasised that a change, for example, in the size of the population often results in the introduction of further changes to the programme, such as adjusting the budget, programme objectives and indicators.

If the update concerns the RHP/PPZ, it should be considered as a continuation. In the case where the update of epidemiological data concerns health programmes implemented before 12 August 2009 – the update requires a new AOTMiT opinion.

  • Adaptation of a health programme developed by the Ministry of Health under PO WER (Knowledge Education Development Operational Programme) to its implementation in the region. The health programme developed under PO WER is implemented at the national level. The Managing Authority of a Regional Operational Programme (RPO) wishing to implement it at the regional level must adjust, i.a. the following elements: at times, the main objective and specific objectives, the size of the target population (its adjustment to the scale of the problem in the voivodeship), provisions on monitoring and evaluation, technical implementation of the programme.

In the case of RPO projects implementing programmes prepared within the framework of PO WER, we propose to allow updating epidemiological data and the population size – the adjustment to the current demographic situation in the voivodeship and, consequently, the adjustment of subsequent elements of the programme – appropriate objectives (if they quantify the scope of support), measures (adjustment to the expected population), budget (adjustment to the expected population). With regard to assessment and evaluation tasks as well as preparation of standards / materials – it is possible to apply to the Ministry of Health to share elements developed under the PO WER programmes.

RHP/HPP personnel

  • The need to expand the personnel that carry out spine screening – allowing nurses without experience in carrying out screening at schools, in addition to school nurses, due to staff shortages.

In the case of a change of medical personnel who can perform a particular healthcare service in relation to the personnel indicated in RHP/HPP, such a change is possible, provided that the personnel in question is entitled to perform this healthcare service.

  • Competences/conditions necessary to implement the programme. Sometimes, in the course of the programme implementation, the Beneficiary reports a problem in finding and employing people who meet the requirements of the programme concerning the personnel competences and experience. In such a situation, the Managing Authority is forced to lower the requirements included in the programme, such as the number of years of experience in implementing educational actions of a similar nature. However, this is not always possible due to the provisions of the relevant Guidelines (Wytyczne w zakresie realizacji przedsięwzięć z udziałem środków Europejskiego Funduszu Społecznego w obszarze zdrowia na lata 2014-2020) , which indicate that “information and educational activities concerning the subject of RHP/HPP must be carried out by persons entitled to provide healthcare services and persons who have acquired professional qualifications to provide healthcare services in a specific scope or in a specific branch of medicine”.

The note concerns the requirements resulting from the Guidelines of the Ministry of Infrastructure and Development the use of which is currently suspended until 31 December 2020 – proposals for their changes were submitted to the Ministry of Infrastructure and Development and are currently subject to external consultations.

RHP/HPP budget

  • Change in prices constitute a significant problem in the RHP/HPP implementation – different at the time of evaluation by AOTMiT, different in the offers, which may have significantly changed the whole cost-effectiveness.
  • The change of the intervention valuation applied in the draft programme. Valuation of healthcare services at the time of drafting and opinioning by AOTMiT of some RHP/HPP projects (2016-2017) might not reflect the current costs. It would be reasonable to adjust the cost of healthcare services by taking into account the inflation rate indicated by the Polish Central Statistical Office.
  • The underestimation of examination costs and remunerations in RHPs/HPPs. The applicants frequently comment that the programme budgets are underestimated.

The average prices or min-max prices should be indicated in the RHPs/HPPs. Introducing budget changes to RHP/HPPs at the time of implementation are possible and do not require a new opinion on the RHP/HPPs, as long as they do not affect the main programme assumptions, including its cost-effectiveness. This decision is up to the institution responsible for the RHP/HPP implementation.

  • There is no economic incentive for potential RHP/HPP providers: no possibility to make purchases that will later be used in the applicant’s work, no possibility to invest in in real estate, etc.

It seems possible to assign some of the funds to the possible retrofitting of the provider, but there are several issues that need to be taken into account:

  • before the implementation of the RHP/HPP, the provider should meet the relevant legal requirements regarding the premises and equipment necessary for specific healthcare services,
  • The equipment should only be a complement to, and not an objective of the RHP/HPP implementation (see the rules applicable under the ESF on 10% cross-financing).

Lack of consent of the Ministry of Health to carry out tasks in the field of real estate investments – the implementation of such tasks using ESF funds is not justified.

  • Introduction of unit rates to RHP/HPPs.

As a rule, average or min-max prices should be indicated in RHP/HPPs. At the stage of RHP/HPP implementation, it is possible to change prices, which does not require a new opinion on the RHP/HPP, as long as it does not affect the main programme assumptions, including its effectiveness. It is up to the institution responsible for the implementation of RHP/HPP to decide in this respect. The inclusion of unit rates in the RHP/HPP is also possible if AOTMiT’s opinion was issued under the assumption that actual costs will be applied. In such a case, if the calculated rate lies within the RHP/HPP framework, which has been given a positive opinion by AOTMIT, a change in the settlement method itself seems possible without the need to seek a new opinion.

Educational and promotional activities, etc.

  • Educational activities under RHPs/HPPs, especially in organised information campaigns, should include information for people who are not covered by the programme, i.a. an explanation as to why the programme is addressed to a given age group and why a given risk factor is taken into account.

The content addressed to people outside the target population may be included in the information campaign and should include clear information on why the group is not covered by the programme. The arguments may refer to either clinical guidelines (e.g. in the case of age restriction) or the regional health policy goals (e.g. priorities for the selection of the disease unit).

  • Training modules/requirements for additional training of the medical personnel/patient training activities –- the applicants must provide a training service, which they find to be relatively difficult (as they usually focus not practising medicine rather than training).

 This is a problem related to the preparation and implementation of RHPs/HPPs, not to possible changes thereto. It seems unlikely that the medical personnel would be indicated as responsible for organising training within RHPs/HPPs. The projects provide for the possibility of hiring a person responsible for such a task. We recommend emphasising, whether in the competition documentation or during training sessions for the applicants, that they do not have to carry out this task on their own.

 RHP, HPP and HP implementation timeframe.

  • Extension of the RHP/HPP timeframe in case of already implemented projects. Due to the fact that beneficiaries experience problems with the implementation of programmes (e.g. through lengthy supplier and service provider selection procedures under public procurement procedures), some of them have asked for the possibility of extending the implementation period of their projects.

 In the case of identified difficulties, it is possible to extend the project implementation period – which does not require a new AOTMiT opinion on the RHP/HPP.

  • Previously, when developing RHP/HPP, the principle used to be applied that the programme implementation period was defined as the year of the beginning and end of its implementation (e.g. 2019-2021). Experience from the process of selecting RHP/HPP providers demonstrates that often the competition procedure takes a very long time and ends after the implementation date specified in the RHP/HPP. This forces the Managing Authority to introduce changes in the RHP/HPP, which consist in postponing the start and end dates of the programme implementation, while maintaining the total time of its implementation. We propose that it should be possible to determine the RHP/HPP implementation period by determining the number of years or months of implementation, instead of determining the year of its beginning and end.

The change of the date of the ESF project implementation which implements the RHP/HPP does not require a new AOTMiT opinion on the RHP.

  • Expanding/limiting the target population (due to interest / lack of interest of the originally selected target population).

The changes require the opinion of AOTMiT, as they may affect the merits of a given programme.

  •  Is a break allowed between the end of the programme and its continuation?

An unchanged programme may be deemed a continuation of a previous programme if no more than 2 years have passed between its end and the new implementation.

  • Is a break in programme implementation allowed between receiving the opinion of the President of AOTMiT and implementation?

 An unchanged programme may be implemented if no more than 2 years have passed between the date of issuing an opinion and the start of the new implementation.

  • Change of the RHP/HPP date. In connection with the planned announcement of subsequent calls for applications for the financing of projects implementing RHP/HPP, it is necessary to change the dates of RHP/HPP implementation.

The change of the RHP/HPP implementation date may be introduced by individual ROP Managing authorities, at each stage of RHP implementation. The change of the project implementation date does not result in the need for AOTMiT to issue a new opinion on the project.

Legislative changes, legal environment, etc.

  • The need to adapt an RHP/HPP to existing legal acts. The drafts of some RHP/HPP were developed and opinioned on by AOTMiT in 2016 or 2017,
    and the legal acts indicated therein might not remain in force.

Healthcare providers should comply with the current legislation, but for the sake of avoiding any doubts on the part of the providers, we propose adding information on possible changes to the current legislation. The adaptation of the implemented RHP/HPP to the legal acts in force does not result in the need to request the AOTMiT to issue an opinion again.

  • The changes resulting from top-down changes in national law, e.g. changes in the system of reimbursed vaccinations or in the legislation regulating the right to provide medical services (the need to remove pneumococcal vaccination, palivizumab treatment from the RHP/HPP assumptions).

The changes resulting from legal changes or the market situation (e.g. lack of product availability) should be consulted with AOTMiT on a case-by-case basis.