In this section, first, we present findings of the retrospective qualitative analysis of the HIBP policies, followed by the results of policy options analysis.
Four main issues (i.e. agenda setting, policy development, policy implementation, and evaluation), 10 themes, and 78 sub-themes were identified (table 1).
- Agenda setting: To identify issues related to the Problem stream, Politics stream and Policies stream, the Kingdon multistream model was used (15). Besides, 12 extra sub-themes were identified.
The epidemiological transition fueled the constant increasing of demand for healthcare services, which led into spiraling health expenditures, which in turn revealed the importance of developing a HIBP. During the past four decades, a series of policies are developed and implemented in Iran that indicate the necessity of developing a basic health insurance package (e.g. the NHI Act of 1995, Supreme’s leader mega policies for health, and instruction of strategic purchasing):
"Resource scarcity has always been an important problem for HIBP and, therefore, insurance organization always try to avoid implementing the HIBP …" (R 12).
Until now, no practical policy or scientific method is developed to design the implementation path of macro policies related to the HIBP in Iran. Issues such as lack of scientific criteria or evidence to develop or revise the HIBP and ignoring the epidemiological transition led into exacerbation of this problem:
"Currently, our problem is that we mistakenly consider the HIBP as strategic purchasing, but it must be mentioned which services are covered, based on what evidences and for whom, and why this package should be bought, what criteria should be used, I mean, why a service should be included in the HIBP" (R 26).
In addition to political supports to HIBP that were endorsed by the sequential National Development Plans (NDPs), the Supreme leader’s mega policies for health (2013) were a turning point in providing political support for the HIBP. The mega policies attracted more attention to the health sector and led to allcation of extra funds towards the health sector:
"In the eleventh government, government attention to the health sector problems and challenges significantly increased and continues" (R 11).
Our investigation showed that HIBP -related policies have always been developing, but the three streams of problem, policy, and politics never came together. Inadequate systematic revisions and approaches to the HIBP resulted in insufficient growth of policies stream, which in turn prevented the policy window to become fully open.
- Policy development: two main themes (stewardship of policy making, and method and trend of decision-making) and 15 sub-themes were identified.
- Stewardship of the policy-making
We identified 65 documents containing various policies that were, directly or indirectly, related to the HIBP. The most obvious one was Article 29 of the constitution, which endorses social security as a right for all citizens:
“Having social security, in terms of retirement, unemployment, elderly, inability to work, orphanage, financial needs, accidents, health-care services and medical care, is a universal right for all Iranians” (Article 29 of the constitution).
The MOHME is in charge of drafting health sector policies, while the MOCLSW contributes to developing the draft policies related to the HIBP. The MOHME is also responsible to get the policy approval in liaison with four levels: The ISCHI, the cabinet, parliament, and supreme leader’s office.
- Methods and trends of decision-making
The 3rd National Development Plan (NDP) of Iran endorsed health insurance, health system financing and HIBP -related issues for the first time, which were repeated in the next NDPs. Nevertheless, no organized decision-making process was designed to implement such policies. Consensus-making by officials and policy-makers (traditional negotiation style) was used to define the HIBP, where bargaining power had (and still has) an important role in influencing the decisions. The lack of transparency resulted in weak stewardship for HIBP-related policies:
"A serious problem occurs in the system … because of the bargaining power of some policy-makers, some services won't be included in the HIBP, while some unnecessary services are included, and it’s a serious problem in IHS" (R 6).
- Policy implementation: two main themes (policy implementation timeline and the process of HIBP implementation), plus 38 subthemes were identified here.
- Policy implementation timeline
On the basis of the changes in the content of the benefit package, decision-making method, and the stewardship of decision-making, the implementation and revisions of HIBP-related policies can be categorized into five periods: before 1993, 1994 to 2003, 2004 to 2006, 2007 to 2014, and after 2014. Before 1993 and the enactment of the Universal Health Insurance Act (UHIA), health laws were mainly focused on service coverage, whilst there was no comprehensive document to define the services that each health insurance organization should cover.
In 1993, by the enactment of the UHIA and establishment of the ISCHI, coherence of health insurance policies increased. The ISCHI was initially affiliated to the MOHME, while most of its members came from various health insurance organizations, plus the Iranian Medical Association (IMA). The ISCHI was responsible to make decisions about inclusion and/or exclusion of medical services into the HIBP. No debate among experts took place to make such decisions.
In 2004, the ISCHI was transferred to the newly established MOCLSW. During this period, the decision criteria to include new services were frequency and utilization patterns, which were based on the insurance organizations’ reports. In 2007, the biggest change occurred in the HIBP governance, when the ISCHI began to uniform the HIBP among all health insurance organizations. All covered services were published in a book, called "basic package of 2007". After the enactment of the fifth NDP in 2012, the MOCLSW started a new reform to evaluate the HIBP. Although those measures were based on a scientific methodology –called "new HIBP"-, the previous package was enacted in reality.
The Health Transformation Plan (HTP) that was implemented in 2014 also affected the HIBP through revising the medical tariffs as well as the new Relative Value Unit (RVU) Book. In this book, all services that are available in Iran’s health system, i.e. procedures, surgeries, imaging, and laboratories are listed; those services which did not cover by any insurance organizations, are marked with an asterisk (*).
"…By 2013, the book of RVU was published. This book includes all new and old health services. It was considered as a HIBP revision, the book was intended to revise the tariff but In fact, there was some kind of review HIBP…” (R 19)
- The process of the HIBP implementation
Since 1993, all decisions about including and/or excluding a service within the HIBP are made by the ISCHI, with the participation of related stakeholders. When a new service is proposed to be included in the HIBP, the ISCHI invites various stakeholders (i.e. permanent members of the HHIC, and representatives of the MOHME, health insurance organizations, and the IMA as well as other members from professional associations), to attend in a meeting and to discuss the agenda. The process and methods of holding these meetings have not changed significantly ever since, with consensus building among members as the dominant method for making decisions. The bargaining power of health insurance organizations is mainly focused on the financial burden of services, while professional associations may attempt to exaggerate the importance of proposed services. Except for a few cases, no specific criteria and/or method (e.g. cost-effectiveness studies, guidelines) is used to make such decisions. As a rule, several meetings (in some cases it may take several years) are held to make a decision. Services with a high financial burden should be confirmed by the cabinet:
"In some cases, health insurance organizations propose a service, all propositions, either from the MoHME or MoCLSW, send to the HCHI for expert analysis. There is a waiting list. Representatives from the different organizations as well as MoHME and MoCLSW debate. If consensus is on its inclusion, the cabined must confirm the decision" (R 3).
- Evaluation of HIBP-related policies: evaluation refers to the investigation of whether the goals of the policies were achieved and whether an implementation gap exists. Three main themes were identified: revision of the HIBP, revising the methods and decisions, and evaluating the aims of HIBP -related policies. 13 sub-themes were also identified.
Since 1993, any revision in the HIBP has been mainly focused on creating a more coherent and evidence-based package. In some cases (e.g. in 2007, 2012, and 2014), revisions were temporary and without a defined methodology. The findings showed that no purposive and fundamental revision was conducted. We identified a series of reactional, vs proactive, changes in the content of HIBP. Rarely, in less than 10 cases, an emerging need led to inclusion or exclusion of some medicines, medical equipment, and services into/from the HIBP:
"It's more than 30-years that we have the HIBP, but there is not a defined method for including a new and better service. Whether it should replace the older service or not"(R 4).
Exclusion of over-the-counter (OTC) drugs was one of the main recent changes. In 2012, an expert panel was established for exclusion of OTC drugs from the HIBP and allocating the released funds for medicines related to special diseases.
- Revising the methods and decisions
Processes that are related to the inclusion and/or exclusion of services/drugs into/from the HIBP are not evaluated and revised yet. Meanwhile, due to technological advances or the introduction of lower-cost interventions, revisions deem necessary, some committed HIBP are not covered:
"We never tried to revise the covered services. As well, we never tried to evaluate the HIBP" (R 12).
- Evaluating the aims of HIBP-related policies
Despite the legislator’s emphasis on the annual revision of necessary commitments by health insurance organizations, this is only available for medicines packages and its execution was not regular. In 2007, Article 3 of the comprehensive welfare and social security system Act resulted in a big improvement towards a more transparent decision making about the HIBP and increasing the awareness about insurance services. According to the RVU Book (2015), coverage of inpatient and Para-clinic services included in the HIBP was 88 and 89.9%, respectively. Moreover, the National Health Accounts (NHA) (2013) showed that financial burden of uncovered services, those excluded from the HIBP, was only 6%.
Table 1; Policy "process" Analysis of HIBP
Issues
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Themes
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Sub-themes
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Agenda setting
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Problem stream
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1. Increasing the number of services that can be provided
2. Soaring health expenditures
3. Unavailability of information about inequality within insured populations
4. Inadequacy of resources
5. 5. Parallel budgets (insurances, hygiene, special programs, etc.)
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Policies stream
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6. Managing services that can be provided
7. Deficiencies in legislation and decision-making process that are related to the HIBP
8. Lack of clear criteria for including services in the HIBP
9. Not using professional and related staffs (not only those who are experienced) in implementation and support of the HIBP
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Politics stream
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10. Prioritizing health, and therefore its related policies, in the twelfth government
11. Increasing health sector budget in the 11th government
12. 13. Notifying OHP and making decision about the HIBP
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Policy development
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Stewardship of the policy making
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13. Developing the article 29 of the constitution
14. Developing policy's draft by the MoHME and MoCLSW
15. HCHI as the steward of developing and notifying the HIBP's strategies
16. Confirming policies by the National Expediency Council
17. Enacting policies by the Parliament
18. Final approval and notifying OHP by the supreme leader’s office
19. The MoHME is the steward of developing the HIBP based on the OHP
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Method and trend of decision-making
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20. Endorsing the HIBP by the third NDP for the first time
21. Lack of a defined methodology to include/exclude services into/from the HIBP
22. Drafted policies are different from notified policies, up to 70%
23. The ISCHI makes decision about the strategic policies of the HIBP
24. Developing polices according to the available resources
25. A defined contribution approach in developing HIBP-related policies
26. Inadequate attention to people's preference/demand
27. 28. Using a top-down approach in developing HIBP-related policies in OHP
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Policy implementation
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Policy implementation timeline
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Before 1993
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28. Article 29 of the constitution, requires the government to cover all necessary services
29. Lack of a clear distinction between service provision in public and private sectors
30. Lack of defined criteria to cover services by health insurance organizations
31. 33. Considering the availability of services when deciding to provide a service
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Between 1993 to 2003
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32. Developing the UHI Act in 1993 and notifying it in 1994
33. Establishing the HCHI within the MoHME
34. HCHI became responsible about the HIBP
35. Experts debating in joint meetings
36. Commitment to provide all services that can be provided
37. Determining the covered services by the health insurance organizations
38. Political top-down decisions, without expert debates
39. Stakeholders or head of the meeting have greater influence
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2004 to 2006
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40. Transferring the ISCHI from the MoHME to the MoCLSW
41. Insurance-related stakeholders had more influence
42. Services/medicines were included based on the frequency and compensation patterns
43. Including Services/medicines based on the reviewing less expensive services and equipment
44. Top-down political decisions, without expert debates
45. Introducing complementary insurance to cover services that were not covered by the basic insurance
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2007 to 2014
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46. Developing the first comprehensive package
47. Using the most frequent services criterion to develop the HIBP
48. It takes a long time to decide whether to include a service/medicine or not
49. HCHI decides based on the consensus criteria
50. Special packages or separate resources/stewards (e.g. special diseases)
51. In 2010, the MoHME and the MoCLSW started strategic purchasing
52. New mandatory criteria were introduced (i.e. safety studies, effectiveness, cost-effectiveness) to include new medicines to the national formulary
53. In 2012, new RVU Book was developed
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Since 2014
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54. In 2014, the OHP were notified by the Supreme Leader’s office
55. In 2014, the MoHME was mandated to develop the new HIBP
56. The MoCLSW was selected as the steward of financing and implementing the HIBP
57. In 2014, health transformation plan was started
58. The new HIBP was defined in the form of the RVU Book
59. Services that are not included in the HIBP were clearly mentioned in the new RVU Book
60. Defining and providing services that were not previously covered in the HIBP, as a part of the HTP
|
|
Process of HIBP implementation
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61. Sending a request to the ISCHI
62. Expert review of the request
63. Deciding about the request
64. If it has low financial burden, notifying its inclusion to the HIBP
65. If it has high financial burden, the cabinet confirmation is required
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Evaluation
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HIBP Revision
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66. Lack of fundamental and purposive revision(s)
67. Before 2014, there was no significant change occurred in the HIBP
68. Due to changes in the treatment methods, some services/drugs are automatically excluded
69. Mandating the ISCHI to annually revise the HIBP
70. Temporary and non-methodological changes (three times, in 2007, 2012, and 2014)
71. Unorganized revision of the OTC drugs
72. In 2003, some performance-enhancing drugs were excluded
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Revising the methods and decisions
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73. Process and criteria for including/excluding services are not revised
74. No evaluation has been performed, and laws and regulations are not revised
75. In 2013, service prioritizing program was begun, without clear outcomes
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Evaluating the aims of HIBP-related policies
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76. The impact of HIBP-related policies on achieving universal health insurance coverage
77. The impact of HIBP-related policies on developing basic and complementary HIBPs
78. The impact of HIBP-related policies on unifying the HIBP among all health insurance organizations
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Limitations and Solutions
After analyzing the interviews, fourteen challenges and constrains regarding the HIBP policies were identified. A summary of identified issues and problems is described in table 2; it is worth noting that there are no priorities in the identified limitations.
Table 2; Limitations and problems of the HIBP policy process
Limitations and issues that can be investigated
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· Lack of clear criteria to include services into the HIBP
· Not considering the epidemiological transitions to increase the effectiveness of included services.
· Scientific evidences were not adequately used
· Health Technology Assessment (HTA) studies were not used
· Bargaining power had an important role in the ISCHI decisions
· The extensive HIBP list regardless of the priorities and costs
· Policies on HIBP and the strategic purchasing were not implemented
· Cultural, social and economic issues were not considered
· Passive performance of health insurance organizations to include new proposed services within the HIBP
· Lack of revision and evaluation systems
· OTC drugs are included in the HIBP
· Unproportioned percentage of the health expenditures are created by a small percentage of patients
· Development and implementation of programs and policies are not permanent
· Inadequate resources
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11 solutions and 25 policy options were extracted, at least two policy options per each solution. Consequently, based on the pros and cons of each one as well as appropriateness and feasibility criteria, they were prioritized by an expert panel (Table 3).
Table 3: Solutions and policy options derived from the policy process analysis for the HIBP
Solutions
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Policy options/description
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Pros
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Cons
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Average
Necessity and feasibility (+_) standard deviation
(1-10)
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Differentiating between HIBP(s) from services that can be provided
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Defining necessary services benefit package and financing it by government and defining the higher level package that its financing is elective
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Creating elective options for patients/ people and financial savings for the government
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Establishing limitations on access to higher level services
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7.8 ± 1
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Defining “necessary primary services HIBP” and financing it by the MoHME and also a “ HIBP for secondary and tertiary necessary services” and financing it by insurance organizations
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Ensure easy and free access to primary services, more effective management of curative services with stewardship of health insurance organizations
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Inadequate attention of insurance organizations to the importance of preventive and screening services
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5 ± 2.55
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Developing a HIBP that can be provided in all levels and financing it by health insurance organizations
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Matching the HIBP with society's health needs
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Probability of increasing the number of covered services without considering available resources of health insurance organizations has increased
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5.3±2.3
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Using scientific evidences to make HIBP-related decisions
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Collecting and reviewing demographic information
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Prioritizing services and evidence-based decision-making, indeed the HIBP should be targeted
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Lack of precise information systems to determine the burden and pattern of diseases, by age groups
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7.6±1.5
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Conducting HTA studies
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Developing a cost effective HIBP based on the comprehensive needs
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These studies are cost driven and adequate experts to conduct them are not available
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6.9±1.6
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Considering cultural problems and needs in developing the HIBP (i.e. religious beliefs and cultural behaviors)
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Increasing the acceptability of services for targeted populations, increasing equity in health
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Increasing the probability of health expenditure soaring for the health system
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4.6±1.7
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Considering intervention's QALY and DALY (analyzing the epidemiologic profile, and determining interventions based on it)
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Prioritizing services that have more influence on life expectancy and quality of life
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Ethical and social criteria are neglected
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6.7±1
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Estimating the financial burden of diseases
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Direct, indirect and intangible costs
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Creating a systemic view or considering costs carried out by patients and avoiding catastrophic expenditures
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Ignoring the necessity of covering some services that based on economic terms should not be covered
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6.6±1.6
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Employing multi-criteria decision-making methods to develop the HIBP
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Considering criteria that are related to economic aspects of services (cost effectiveness, budget impact, reducing poverty, quality and quantity of evidences and equity in better access to health-care services
|
More economic mix of services and avoiding exorbitant costs; transparency of definitions and prioritizing economic criteria
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Some decision have unethical economic consequences
|
7.6±1.1
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Mixing cost and effectiveness and economic and socio-economic criteria in related decisions (using multi-criteria decisions)
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Creating a comprehensive view or considering all criteria that affects the decisions; increasing cost-effectiveness of the HIBP
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Collecting information is time-consuming, and such decisions are costly
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7.9±1
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Controlling inclusion of drugs, services and equipment that their effectiveness is not proved
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The MoHME's intervention in licensing new drugs and technologies or developing and implementing laws and regulations to restrict and control them
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Increasing the control over services that can be provided, and, therefore, preventing the inclusion of services that are not cost effectiveness
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A prolonged period is required to update health services of the country
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8±1.1
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Organizing services/ drugs list that are covered or not covered
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Developing a waiting list to include/exclude services/drugs (due to technological changes, policy change, new diseases patterns)
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More efficient management of decisions to include/exclude services/drugs and facilitating annual revisions
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More health human resources as well as continuous monitoring are required
|
8±0.7
|
Creating a decision-making framework based on mathematical models and defined criteria
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Weighting predetermined criteria and determining how to mix them by mathematical models
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Transparency of method and process of decision-making and determining weights of criteria to make decisions
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Possibility of conflict with ethical values in decision's outcomes
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6.7±1
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Expanding the package of services that can be provided
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Expanding the HIBP by providing extra resources
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Increasing access to health-care services
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Services utilization is out of control and is creating exorbitant costs
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5.8±1.3
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Expanding the HIBP along with developing guidelines and standards for services provision
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Increasing cost-effectiveness of services, reducing induced demand
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Access to services can potentially be decreased
|
7±1.2
|
Expanding the HIBP along with developing specialized packages for each level of the health system
|
Increasing cost -effectiveness of services, reducing induced demand
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Access to services can potentially be decreased
|
7.7±1.2
|
Policies should be based on study’s findings and expert’s opinions
|
Macro decisions be made at higher levels and following that performing expert studies to increase efficacy of implementation
|
Clear tasks of middle and lower levels, converging tasks at lower levels
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Environmental problems and issues are not reflected in macro decisions
|
7±1.2
|
Proposing policies by expert level and following that developing and notifying policies at macro level
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Developing evidence-based policies
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Prolonging decision-making process
|
7.3±1.2
|
Determining macro-level decisions orientation and following that developing expert-based policies
|
Transparency of overall strategies and finally making evidence-based decisions
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Possibility of different interpretations that may be different from macro policies
|
7.9±1.3
|
Organizing ISCHI meeting on including/excluding a service/drug/ equipment
|
Developing specialized forms which contain key criteria such as cost-effectiveness
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Increasing efficacy of decisions through systematic process and defined participation of stakeholders
|
Challenges may arise in exceptional cases
|
8.3±1
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Revision and evaluation of the HIBP, both services-and- drugs related
|
Categorizing services/ drugs in three different lists (i.e. must be under coverage, can be covered, and must not be covered). Then, conducting cost-effectiveness studies for those services that can be covered
|
Making the HIBP cost-effective by spending minimum time and cost
|
HTA studies are not performed for all services; categorization may be biased
|
7.9±1.3
|
Conducting HTA studies for all services/drugs that can be provided, then revising the HIBP
|
Having a HIBP with cost-effective services, as much as possible
|
HTA studies are highly time and cost consuming; social criteria may be neglected
|
6.1±1.6
|
Perform the first method for the services in the package and the requirement for the HTA to include the new services / drug into the package
|
The HIBP will be cost-effective; these studies will be institutionalized in deciding about including services/ drugs
|
HTA studies are not performed for all services; categorization may be biased
|
7.5±1.1
|
Conducting second method and mandating HTA studies
|
Having a HIBP with highest possible of cost-effective services/drugs; these studies will be institutionalized in deciding about including services/ drugs
|
HTA studies are highly time and cost consuming; social criteria may be neglected
|
6.6±1.8
|
Determining the minimum expected level of health with measurable indicators to identify the situation or measuring the gap between coverage level and defined standards
|
Developing the HIBP based on the country's needs
|
Lack of scientific evidences and field studies; conducing required studies require extra resources
|
5.8±1.7
|