In response to numerous inquiries concerning the possibility of modifying the assessed and implemented health policy programs, the Agency for Health Technology Assessment and Tarification (in consultation with the Ministry of Health) developed a common position. It was prepared as an answer to the questions presented below.
Scope of PCP/PSP
– Quality assessment, including participant satisfaction assessment, should be conducted as part of the program implementation. It is worth monitoring this issue and introducing organizational improvements. It might also be worth extending the evaluation to the staff satisfaction survey.
In the opinion of AOTMiT the element of staff satisfaction can be analysed in PCP/PCP, but it is not obligatory. Monitoring of the issue of quality assessment of the participant or staff should be planned within the PCP/PD. Changes resulting from evaluations can be introduced if they fit into the catalog of changes possible to conduct without re-opining the opinion of AOTMiT. It should be emphasized that some of the assessment results may relate to the quality of implemented interventions – e.g. quality of provided training/provided services – the implementer should continuously strive for the highest possible quality of provided interventions.
– Change in study duration (increased or decreased).
In the PCP/APP the average duration of the study should be indicated. The duration of the study may change individually, but it is not possible to reduce the duration of the study in such a way that it results in a change of the type and scope of the study / services – such a change results in the necessity to apply to the AOTMiT for re-issue of the opinion.
– Beneficiaries would like to change the type of study and use a different one than the one indicated in the RPZ/PPZ (obviously there is no consent for this).
The change of the type and scope of tests/services results in the necessity to apply to AOTMiT for re-issue of the opinion.
– Beneficiaries would like to introduce consultations with other specialists than those indicated in the PCP/PPD.
Adding other medical consultations (different scope of advice) than those listed in the draft constitutes a change in the scope of intervention. A change in the type and scope of examinations/ services results in the need to apply to AOTMiT for a re-issue of the opinion. In the case of a change only in the medical specialty (the scope of advice remains the same) this change would be possible to implement, provided that the specialist has the knowledge and competence to conduct the given advice. At the stage of RPZ/PPZ project, it is worth taking into account all specialists who are competent to carry out the indicated interventions.
– Suggestions for path modification in the scope of support consisting in performing examinations or consultations in a different order than provided in the PCP (in accordance with the scope of the PCP/PCP, but in a different order).
Changing the order of tests that determine the diagnosis or the course of treatment should not take place without consulting AOTMiT. In case of services which are not connected with each other by a cause – effect sequence, there is a possibility of discretion in the time of their realization, which should not result in the necessity of repeating the AOTMiT opinion. However, in order to exercise due caution, we encourage you to contact AOTMiT in order to resolve an individual case.
– Lack of interest in prophylactic programs, which provide a short procedural pathway, including only diagnostics (no tests). NZOZs are not interested in obtaining patients if the treatment will not be reimbursed in the project.
Expanding the program to include additional tests in order to attract a provider is subject to re-evaluation as the interventions in the program change.
Target group, epidemiological data, etc.
– Population size can be an issue. In the absence of interested implementers the population covered by the program may be much smaller. The program is considered effective when the population is 70% screened, which is often very difficult to achieve. Therefore, it may be worth considering whether the population (its size) should not be adjusted in the program to the size actually covered by the program after the competition has been settled. The amount committed to the program will also result from this fact.
The size of the target population is crucial to achieve the population effect of the planned activities. Decreasing of the population in the course of project realization calls into question the validity of its realization and further expenditures. If there are repeated problems with the selection of the provider, it is worth considering whether to implement the PCP/ PCD at all. AOTMiT is of the opinion that programmes should be planned with the whole target population in mind and that the enrolment status should be monitored on an ongoing basis.
– Updating of epidemiological data and size of the target group in the case of using a health programme, which was developed (and positively approved by AOTMiT) a few years earlier. It should be emphasized that often a change in e.g. the size of the target group results in further changes to the programme, such as adjustment of the budget, programme objectives, indicators.
If the update relates to PCP/PPD, it should be considered as a continuation. If the update of epidemiological data concerns health programmes implemented before 12 August 2009. – the update requires another opinion of AOTMiT.
– Adaptation of the health program developed by MZ within PO WER to its implementation in the region. The health programme developed under OP WER is implemented at the national level. The ROP MA wishing to implement it at the regional level must adjust e.g. the following elements: sometimes the main objective and detailed objectives, size of the target group (its adjustment to the scale of the problem in the voivodship), provisions concerning monitoring and evaluation, technical implementation of the programme.
For projects implementing programmes prepared under the ROP within the framework of the OP WER, we propose to accept the possibility of updating the epidemiological data and the size of the group – adjustment to the current demographic situation in the voivodship and, consequently, adjustment of the following elements of the programme – appropriate objectives (if they quantify the scope of support), measures (adjustment to the predicted population), budget (adjustment to the predicted population). Tasks of assessment and evaluation and preparation of standards / materials – it is possible to apply to the Ministry of Health to transfer the elements developed under the programs of OP WER.
Staff of PCD/PCSP
– The need to expand the staff that performs spinal screening – allowing, in addition to school nurses, nurses without experience in screening at school, due to staff shortages of the professional group.
In the event of a change in the medical staff that can perform a given service in relation to the staff indicated in the PCP/PPD, such a change is possible, as long as the staff in question is authorized to perform that service.
– Competencies/conditions necessary to implement the program. In the course of programme implementation it happens that the Beneficiary reports a problem with finding and employing people who fulfil the requirements included in the programme concerning competence and experience of the staff. In such a situation the MA is forced to reduce the requirements included in the programme, such as e.g. the number of years of experience in the implementation of educational actions of a similar nature. However, it is not always possible due to the provisions of the Guidelines in the field of health, which indicate that “the information and education activities on the topics of PCD/ PCP must be carried out by persons authorized to provide services and persons who have acquired professional qualifications to provide services within a specified scope or in a specified field of medicine”.
This comment relates to the requirements resulting from the Guidelines of MIR – proposals for their changes have been submitted to MIR as the author of the Guidelines and are currently subject to external consultations.
Budget for PCD/PCSP
– A significant problem in the implementation of PCP/PCP was the prices, different at the stage of evaluation by AOTMiT, different in the offers, which could change the whole cost-effectiveness.
– Change in valuation of interventions used in the program design. The drafts of some PCPs/PPs were developed and evaluated by AOTMiT in 2016 or 2017 and at the same time the valuations of benefits were also prepared, which may not reflect the current costs. It would be reasonable to valorize the cost of benefits by the inflation rate indicated by the CSO.
– Underestimation of research and salary costs in the PCP/PPD. Applicants very often claim that programs are underestimated.
PCD/PSP should indicate average or min-max prices. At the stage of PCD/PSP implementation, prices can be changed, which does not require a renewed opinion on the PCD/PSP, provided that this does not affect the main assumptions of the programme, including its effectiveness. The decision in this regard belongs to the institution responsible for the implementation of the PCD/PPP.
– The PCD/PPP lacks an economic incentive for potential applicants: no possibility to make purchases that will later be used in the applicant’s work, no possibility to make investments in real estate, etc.
It seems possible to allocate some funds for possible retrofitting of the implementer, but several issues need to be kept in mind:
– the provider, before starting the implementation of the PCP/PHC, should meet the relevant legal requirements for the premises and equipment necessary for specific health services,
– The equipment should be only a supplement to, and not the aim of, the implementation of the PCP/PSP (see the rules under the ESF concerning 10% cross-financing).
Lack of approval by the Ministry of Health to implement tasks in the field of real estate investments – implementation of such tasks from ESF funds is unjustified.
– Introduction of unit rates to PCO/PSP.
As a rule, PCO/PSP should indicate average or min-max prices. At the stage of PCO/PSP implementation, it is possible to change prices, which does not require another opinion on PCO/PSP, as long as it does not influence the main assumptions of the programme, including its effectiveness. The decision in this respect belongs to the institution responsible for the implementation of PCO/PSP. Entering unit rates in PCP/PPD is possible also in the situation when AOTMiT opinion was issued with the assumption of using real costs. In this case, as long as the calculated rate is within the framework defined in RPZ/PPZ, which was positively assessed by AOTMIT, the change of the settlement method itself seems possible without the need to apply for another opinion.
Educational, promotional activities, etc.
– In PCD/PPD educational activities, especially in organized campaigns, it is useful to include information for people who are not covered by the program, there should be explanations why the program is targeted to a particular age group and why a particular risk factor is included.
Content aimed at people outside the target population can be included as part of the information campaign and should include clear information on why the group is not covered. Argumentation can refer to either clinical guidelines (e.g., for age narrowing) or the direction of regional health policy (e.g., disease entity selection priorities).
– Training modules/training requirements for medical staff/patient training activities – Applicants need to provide a training service, which is relatively difficult for them (as they are generally engaged in treatment activities, not in providing training).
This is a problem related to the preparation and implementation of the PCD/PPD, not to possible changes. It seems doubtful that PCO/PSP indicated that the medical personnel is responsible for the organization of trainings. In projects it is possible to employ a person responsible for such a task. It is recommended to emphasize, either in the call for proposals documentation or during trainings for the applicants, that they do not have to carry out such a task on their own.
deadlines for PCD, PCP, PCP, etc.
– Extending the PCD/PCP deadline in case of already implemented projects. In connection with the fact that beneficiaries have problems with programme implementation (e.g. due to prolonged procedures for selection of suppliers and service providers under public procurement procedures), some of them asked for the possibility of extending the deadline for implementation of their projects.
In case of identified difficulties it is possible to extend the deadline for project realisation – which does not result in renewed opinions on PCP/PCP by AOTMiT.
– In the current practice of PCD/PPD preparation it was used the principle that the year of the beginning and end of the program implementation was given as the program implementation period (e.g. 2019-2021). Experience from the process of selecting PCO/PSP implementers shows that the competition procedure often takes a very long time and ends after the PCO/PSP start date. This forces MA to introduce changes in PCO/PSP that consist in postponing the dates of commencement and completion of program implementation, while maintaining the total time of its realization. We propose to allow the possibility of specifying the period of implementation of the PCD/PSP by giving the number of years or months of its implementation, instead of giving the year of commencement and completion.
The change of date of the ESF project implementing PCD/PCSP does not result in the need to re-opine the PCD program by AOTMiT.
– Expansion/ narrowing of the target group (due to interest/ lack of interest in the originally selected target group).
Changes require an opinion of AOTMiT as they may affect the validity of the programme.
– Is a break in the realization of the program allowed between its termination and continuation?
In unchanged form the program can be considered as continuation, if from its termination till its start no more than 2 years have passed.
– Is a break in the program implementation allowed between receiving the opinion of the AOTMiT President and implementation?
The program can be implemented in an unchanged form, if the period between receiving the opinion and implementation did not exceed 2 years.
– Change of date of PCD/PPD. In connection with the planned announcement of subsequent calls for proposals for co-financing projects implementing PCO/PSP, it is necessary to change the dates of PCO/PSP implementation.
The change of RDP/PSP implementation deadline can be introduced by individual ROP MAs at each stage of RDP implementation. The change of the project implementation deadline does not result in the necessity to renew the opinion on the project by AOTMiT.
Legislative changes, legal environment, etc.
– The necessity to adapt the PCD/PSP to the existing legal acts. The drafts of some PCPs/PPs were developed and opinionated by AOTMiT in 2016 or 2017,
and the legal acts indicated in them are outdated.
Treatment entities should use the current legislation, but for the certainty of implementers, we propose to add information about possible changes in the currently applicable acts. Adjustment of the implemented PCDP/PPPZ to the current legal acts does not result in the need to apply to AOTMiT for re-issue of the opinion.
– Changes resulting from top-down changes in national law, e.g. changes in the reimbursable vaccination system or in the legislation regulating the right to provide medical services (necessity to remove pneumococcal vaccination, palivizumab treatment from the PCP/PCP assumptions).
Changes resulting from legal changes or market situation (e.g. lack of availability of a given product) should be individually consulted with AOTMiT.