Background
Internationally, measures to improve the quality and sustainability of healthcare practice and provision have become a key concern of policy [
1]. As costs and service demands increase against a background of limited resources, priority setting has become a complex and increasingly central component of healthcare policymaking. Within this context, decisions must inevitably be made as to the public reimbursement of new treatments and technologies and the restriction of funding for established services [
2].
An approach to the latter concern, ‘disinvestment’ has emerged as a means of improving healthcare outcomes by evaluating existing services that do not provide sufficiently safe, effective or cost-effective care, and re-directing funding to services deemed superior against these criteria [
3]. While disinvestment has been the focus of some interest in nations increasingly oriented to healthcare system sustainability, it has been operationalised only in minimal terms in a limited number of jurisdictions [
4,
5]. Complexities inherent in the identification of candidate technologies and the specific application of disinvestment criteria have curtailed efforts to establish clear procedures that may engender change
and withstand political challenge. More broadly, the inherently ethical nature of disinvestment decision-making has raised questions as to the appropriate inputs required to support such processes [
6,
7]. Increasing agreement that stakeholder input is required for disinvestment processes to be representative and accountable has also complicated the establishment of pragmatic mechanisms for disinvestment [
8,
9].
Notes on the Australian policy context
At the national (Medicare) level in Australia, a review process of
existing health care services funded via Medicare, has been established under the responsibility of the Department of Health, including the Medical Services Advisory Committee (MSAC), which makes recommendations to the Health Minister about what medical services offer sufficient safety and (cost)effectiveness to warrant public subsidy. Since 2009, a ‘Quality Framework for Australia’s Medicare Benefits Schedule’ has been developed whereby individual health care practices face review as to their appropriateness for continued public subsidy at current levels. Potential outcomes from a review include: an amendment to the item description such that it better captures the patient group/s most likely to benefit from any procedure; an increase, decrease or maintenance of the fee; or a complete stop to public funding of the item [
3,
10]. The present study is aligned within this general policy context.
With these concerns in mind, the present study develops and tests a model whereby different forms of evidence are incorporated into a disinvestment policy process. More specifically, we sought to operationalise a potential disinvestment policy model incorporating evidence of safety and effectiveness, a comparison of policies from a range of jurisdictions, ethical and cost analyses and the informed deliberations of stakeholders with regard to a specific case-study technology: assisted reproductive technologies (ART) with a particular focus on differential effectiveness by age.
ART – a case study
Australians utilise a high number of ART cycles per million population when compared to other countries – partly the result of essentially unlimited public subsidy for ART services (a contrast to many other similarly developed countries). Australians are eligible for this subsidy regardless of their age or any prior treatment attempts. However, as ART in Australia are offered primarily through the private sector, there remains a patient-borne ‘gap’ payment beyond what Medicare (the nation’s universal health insurance scheme) will subsidise. Once a patient’s out-of-pocket expenses reach a threshold amount in any given year, any further gap payments are covered by government through a Safety Net program. The combination of these factors has led to significant cost escalations for Medicare (tax-payers). Hence, the public subsidy of ART has been a perennially contentious health policy issue in Australia. The Australian government – regardless of the party in power at the time – has periodically entered into policy debates around access criteria for ART services (a situation mirrored in the international experience) for more detail see [
11,
12].
Assisted reproductive technologies (with a particular focus on the impact of maternal age and number of cycles on treatment cost and effectiveness) were selected as a potentially useful case study on which to trial an engaged disinvestment process – for two reasons. First, ART meet multiple criteria on a proposed framework for identifying disinvestment candidates [
9]: there exists substantial temporal and geographic variation in ART treatment provision, in addition to evidence of differential effectiveness across patient sub-groups [
11]. Second, as introduced above, considerable public debate and lobby group opinion in relation to previous government-mooted subsidy restrictions in Australia [
11,
12] suggest that ART represents fruitful ground for analysis of the social and ethical evidence needed to inform a representative disinvestment decision.
In light of these reasons, and to incorporate the different forms of evidence flagged by them, a dual approach to data generation was adopted in this study. First, a systematic review assessed evidence of differential ART safety and effectiveness according to maternal age, paternal age and number of treatment cycles [
11]. This review was supplemented by an analysis of ethical considerations relevant to a potential disinvestment decision based on ART effectiveness and maternal age [
13] and the incorporation of a recent Australian analysis of ART cost-effectiveness by maternal age and number of treatment cycles [
14]. In turn, this evidence base informed deliberative forums attended by vested stakeholders (ART clinicians and consumers) as well as by non-partisan citizens. Guided by the ideals of deliberative democracy, these forums involved the provision of detailed information to support participants’ deliberation on the question of how best to structure the public funding of ART, and were designed to elicit colloquial and experiential knowledge to enhance the structured evidence base arising from the review and supplementary analyses.
Deliberative processes are underpinned by the theory that an appropriately informed sample of the population can deliberate productively with a view to offering contributions to policy development that are reflective of broader values. Used productively in other contexts to canvass community and stakeholder perspectives on health-related priority setting [
15‐
17], deliberative methods are held to both improve and legitimate policy directives [
18]. In the context of disinvestment decision-making where, it may be argued, there is a particular imperative for “health services to be accountable to users as taxpayers, voters and consumers” [
19], deliberative methods represent a more transparent means of addressing the complex, ethical nature of resource allocation and policymaking.
In this paper we outline the findings of stakeholder engagements that sought to incorporate technical, experiential and colloquial evidence within a hypothetical disinvestment context. In doing so, we propose a disinvestment model that stands to enhance more conventional evidence-based policy with informed stakeholder engagement to support ethical, democratic health governance.
Methods
Below is a summary of the methods employed in this study. A detailed account of the research process is published elsewhere [
6].
Evidence generation
The first phase of the project entailed conducting a systematic review of ART [
11]. This review utilised contemporary health technology assessment methods and policy processes, as appropriate for the Australian context. The protocol was assessed by content experts, and focussed on evidence of effectiveness associated with maternal age and number of treatment cycles. Key outcomes of the systematic review included findings that ART effectiveness decreases with advancing maternal age (noting a particular decrease after age 42) and that, across all age groups, ART effectiveness decreases slightly with each successive cycle of treatment. These findings were consistent with the economic analysis consulted [
14], which found that the cost-effectiveness of ART decreases with both treatment cycle number and, in particular, female age. An ethical analysis was conducted to canvass further relevant considerations. It described different possible conceptions of medical need as well as different respects in which these frameworks, as well as treatment effectiveness and maternal age, could be considered relevant to ART funding policy [
13,
20].
Deliberative engagements
In the second phase, the evidence generated was presented at a series of deliberative stakeholder engagements held in Adelaide, South Australia with groups of ART clinicians, non-partisan citizens and ART consumers (past patients). Each stakeholder group attended two engagement sessions (two ‘rounds’ of engagements spaced a number of weeks apart) in which they were asked to deliberate on the evidence presented, and to generate (and justify) a preferred approach to the public subsidy of ART in Australia
1. These engagements incorporated key elements of deliberative methods, including the provision of accessible information by content experts, facilitation by an independent professional, small and larger group deliberation and the generation of policy guidance [
21].
An outline of the evidence described above was presented at each engagement by the research team, who then remained in attendance to clarify technical and factual issues as they arose. Participants were also presented with an outline of the approach to ART funding currently operating in a range of other national contexts including Israel, Canada, Denmark and the UK. The funding structure applied in New Zealand was also presented, generating discussion around that country’s use of subsidy criteria which include a potential patient’s age, body mass index (BMI) and smoking status [
22].
In light of the information presented, participants were asked to consider the question: Should the criteria for public funding of ART be changed? If yes, why? If no, why not? Each group was also encouraged to address broader issues around the barriers and facilitators to disinvestment and the (potential) role of stakeholders within both ART and health policy decision-making, more broadly.
In the second round, outputs from all first round engagements (i.e. the perspectives of each stakeholder group) were reported to all participants and allowed to inform their subsequent deliberations.
The decision to separate stakeholder groups supported participants to voice partisan opinions freely, without fear of the impact of different degrees of expertise [
23]. At the same time, the ‘feeding back’ of other groups’ deliberative outputs brought together a range of (potentially conflicting) perspectives [
24], which were ultimately presented to relevant policy advisors for consideration.
Recruitment
A detailed account of the recruitment process is outlined elsewhere [
6]. Participants in the consumer forums were purposively recruited on the basis of relevant experience; 9 participants attended Round 1 and 7 returned in Round 2. Community forum participants were randomly sampled (stratification criteria included gender, age and household income) and 14 attended Round 1 while 10 returned for Round 2. Clinician participants were purposively recruited on the grounds of relevant technical experience and as nominees from relevant medical bodies; 8 attended Round 1 while 6 returned for Round 2.
While the sample size for the community engagements was within the range deemed ideal for citizens’ juries [
25,
26], the consumer and clinician forums were slightly smaller owing to the specificity of recruitment requirements (including selection criteria designed to minimise potential harm to past patients). Nonetheless, the sample sizes allowed for fulsome deliberation around a variety of inputs and opinions, and for active participation in “communicative processes and will formation” [
27].
The project received ethics approval from the University of Adelaide’s Human Research Ethics Committee. Participants were assured that their contributions to deliberations would remain anonymous, and that they were at liberty to withdraw their participation at any time. Consent for an experienced stenographer to transcribe deliberations was obtained from all in attendance, and an honorarium was paid to participants at the conclusion of each forum.
Approach to data analysis
Transcripts of the deliberative forums were analysed thematically [
28,
29]. Given the project’s dual focus on the specific case of ART, and broader questions around approaches to disinvestment, analysis attended to both the deliberative and analytical outputs of the engagements [
30]. That is, we aimed to represent the content of each deliberation, while engaging with the broader policy implications of the perspectives articulated.
Analysis of each group’s deliberations is presented separately to illustrate areas of within-group disagreement and consensus. To highlight pervasive themes, we attend to participants’ responses to questions concerning (1) the key values that should inform potential ART subsidy restrictions, and (2) whether it would be appropriate to restrict subsidies on the basis of personal patient characteristics (including BMI, smoking status, maternal age, or number of treatment cycles). Participants’ perspectives on patient contributions to the cost of ART treatments are also addressed and insights applicable to broader disinvestment questions are considered.
Discussion
In combination, the outcomes of these deliberative engagements represent an informative contribution to funding policy debates in this arena. Our results inform the application of this engagement method, (a) in disinvestment deliberations generally, and (b) specifically in terms of ART, including suitability of the method for contested (ethical) domains.
Firstly in relation to general contributions, it was clear that all participants understood the finite nature of health funding, and the notion that difficult decisions must be made when treatment costs expand within a context of limited resources. This underscores a key tenet of deliberative democracy: that all citizens, when provided with sufficiently detailed background material, can participate thoughtfully and meaningfully in the process of policy formation [
27].
More significantly, it was evident that participants were open to genuine consideration of funding options that did not always align with their own interests. The willingness of ART consumers and clinicians to countenance restrictions, and for community members cognizant of ‘opportunity costs’ to be open to continued expenditure, speaks to the capacity of invested stakeholders in taking up the challenge of deliberative democracy [
33]. Reductionist, deterministic characterizations of stakeholder ‘self-interest’ proved unfounded as each group sought to prioritise universal values (in particular, ‘equity’ and ‘responsibility’) over specific, within-group concerns. This result has significance, as previously it has been documented that decision-makers reveal an inclination to shy away from disinvestment decisions due to their allotting weight to the voices of resistant, vocal minorities [
12]. Our results suggest such weighting to be disproportionate to the broader stakeholder response and incongruent with an aversion to act based on perceived risk of stakeholder backlash.
With ART forming the background context, numerous outcomes were necessarily ART specific. Yet agreement on a range of broad values was evident across the engagements, and these have implications for the transferability and applicability of this method beyond ART. As we have shown, each forum emphasized a need for subsidy restrictions to be ‘grounded in medical evidence’ rather than governmental decree. Interestingly,
population-based medical evidence of a drop in treatment effectiveness with advancing maternal age (suggesting the potential usefulness of an age-based subsidy restriction) was somewhat undermined by another shared value: the importance of
individualizing treatment decisions. A pervasive feature of contemporary health discourse [
34], this latter principle underscored the preference of the consumer and clinicians’ forums that any potential restriction to be based upon (individual) physiological markers rather than maternal age or cycle number. Future research could elucidate the practicality of this suggested approach by outlining the state-of-the-science behind tests for ovarian reserve and other physiological markers, and asking, for instance, whether test accuracy is superior to age in predicting ART prognosis.
On the controversial topic of whether BMI and smoking status represent legitimate grounds for subsidy restrictions, not one forum reached consensus. In each group, concerns around fairness (‘singling out’ ART; punishing people ‘for their lifestyle’) came up against concerns around ‘maximising treatment effectiveness’ and ‘the best interests of the child’. These principles are applicable within ART and beyond. The fact that the deliberations of each group were so similar underscores the capacity of ‘lay’ people to contribute to the ethical aspects of health policymaking [
35]. Despite disparate levels of technical knowledge, the groups were similarly equipped to engage with the social and moral complexities of restricting on these grounds.
The importance of canvassing different groups of stakeholders separately [
23] also became evident when differences across the groups were observed. For example, while the clinicians agreed that infertility should be treated ‘no differently than cancer’, both the consumer and community groups engaged in heated debate on this issue – debate that may have been less freely expressed in the presence of medical experts. Similarly, while the community and clinician groups argued that the ‘judgment of doctors’ should be paramount in decisions regarding likely treatment effectiveness, consumers were less deferential, emphasizing a need for guidelines to ensure that doctors are ‘transparent’ about costs and likely outcomes. Again, such resistance to wholesale ‘doctor deference’ may have been expressed less explicitly in the presence of clinicians.
Ultimately, each stakeholder forum reached a different decision as to their preferred ART funding structure, emphasizing different guiding principles (See Table
1). For the consumer group, an outer limit of 45 years with means-tested co-payments represented a model informed by concern with the financial aspects of the ART journey, and a unique framing of an ART age cut-off as important for psychological ‘closure’. For community members, a limit to the subsidized funding of 5 cycles per child (up to a maximum of two children), restrictions on smoking and BMI (with room for appeal) and two free cycles with co-payments required thereafter, arose within an often genuinely hypothetical deliberation process that attended to ethical issues around equity of access, opportunity cost and capacity to benefit. The clinicians’ model, advocating the continuation of co-payments with the addition of a free cycle for those unable to pay, also oriented to equity of access, their desire for a mandated age ceiling (45) argued to support them in ‘making their call’(i.e. to deny ART treatment on grounds of medical futility).
Table 1
The ART public funding arrangements commended by different stakeholders
Consumers
| No publically subsidized access <21 or >45 | - | - | Means-tested co-payment for all cycles |
Community members
| No publically subsidized access <18 or >45 and; limit of 2 cycles >40 | 5 cycles per child to max. 2 children | Current smokers; BMI in obese range (option to appeal); Convicted paedophiles, child abusers; Illicit drug users | 2 free cycles; co-payment on subsequent cycles |
Clinicians
| No publically subsidized access >45 | - | - | Co-payment for all cycles; option of free cycles for those unable to pay |
As these outcomes illustrate, all stakeholder groups advocated in favour of patient co-payments for ART treatment programs, which may reflect the broader experience Australians have with co-payments across the health care system. This compares to the findings of Rauprich [
31] whose survey canvassed patient and professional opinions on the financing of ART in Germany. In that study, co-payments for ART were deemed acceptable by only one-third of patients, two-thirds of ART physicians and three-quarters of other groups (including academics, social lawyers and health politicians). Among these groups, a preference for full public subsidy was strongly correlated with the conceptualization of infertility as ‘a disease’ or ‘medical need’. Our findings contrast with those of Rauprich et al., in that our patient and clinician participants, who most frequently framed infertility as an issue of ‘medical need’, were as supportive of continued co-payments as members of the broader community.
More noteworthy is the finding that each forum explicitly incorporated into their preferred funding arrangement policy elements aimed at increasing equity of access. Again, although this principle was articulated specifically for ART it may well be a broader concern. While the policy elements differed from group to group, this finding echoes concerns noted elsewhere [
31,
36] that co-payments currently do, but ought not to, put ART out of the reach of the less affluent. This consensus is indicative of a concern not currently addressed in the Australian context, namely that access to fully subsidised ART treatment within the public system is severely limited and co-contributions for private patients are not differentiated by income.
In terms of the full range of opinions regarding ART subsidies, our study was limited to the extent that all participants in the consumer forum had been successful in their ART journey; for ethical reasons we did not recruit unsuccessful former patients. In addition, the study was informed by ethical and cost analyses, as well as studies of treatment effectiveness, but did not draw media representations of ART (arguably an important informant of public discourse on this topic) into the discussion (for analysis on this element see Street et al [
12]). However, by involving a range of stakeholders including ‘average taxpayers’, a group rarely canvassed within health policy development [
26], this study indicates important possibilities for ensuring accountability in the health policymaking process – a particularly important concern in the context of what are largely ethical decisions.
Selecting ART as a case study was strategic given the ethically charged nature of the debate in Australia and elsewhere. The engagement sessions proved highly instructive, with outcomes being relevant for ART specifically, but also in capturing underlying principles that have broader relevance in disinvestment decision-making. It has been argued that, for disinvestment decisions, a different level of evidence is required than that required for investment, in large part because of the social and/or political baggage involved in ‘taking something away’ [
7,
10,
37]. Indeed, the nature of such decision-making may also require different
kinds of evidence than those typically incorporated, namely the qualitative, experiential, socially-negotiated evidence that is attainable using deliberative methods and that may have a central role to play in the future of disinvestment policymaking. The ART evidence base, in terms of safety and effectiveness, is relatively well dotted with signposts from which to navigate a debate on these complementary qualitative, experiential matters. Not all existing health care services are as well informed, so it may be that a yet-unknown threshold of safety/effectiveness evidence is required such that productive engagement at this level is possible. Where the technical evidence is relatively robust, our results highlight that democratically informed disinvestment decision-making is feasible. In addition, it is revealed that such decisions could be potentially less controversial than often presumed [
11,
12,
22], including for such highly ethically charged cases as ART.
Competing interests
The authors declare no competing interests. The funding organisation (NHMRC) had no role in the study design, data collection, analysis and interpretation, or the writing and publication of this article.
Authors’ contributions
JEH, AGE, ABM and JRM are Chief Investigators of The ASTUTE Health Study and as such were responsible for the initial grant writing and methodological planning. They were later joined by JS, DC, KH and AW to further plan and carry out these engagement sessions. All authors made substantial contributions to conception and design, acquisition of data, analysis and interpretation of data (with KH as principal analyst); and were involved in drafting the manuscript and revising it critically for important intellectual content. All authors read and approved the final version of the manuscript.