General medical and Managed Medicaid plan information is typically available online. This is in addition to text-messaging outreach services and videoconferencing with which Managed Medicaid companies are experimenting with to bring providers and patients together in new ways. The coordination of health services is critical to improving chronic disease management in the Medicaid program.
Improving care coordination requires better communication among physician specialists. In the fee-for-service model, physician specialists often operate independent of one another leading to duplicative testing and potentially lethal drug interactions. The fragmented approach incentivized by FFS routinely leads to conflicting patient advice and insufficient follow-up care. Conversely, bundled State payments to Managed Medicaid companies encourage plans to address communication issues through case management and new health information technology HIT platforms that are able to draw historical and current patient information from Medicaid cla ims, pharmacy records, lab reports, and other information databases.
Care coordination is most needed in addressing Medicaid long-term care services. The widespread use of the FFS reimbursement is expected to fuel an average growth in long-term care costs of 7. In Tennessee, Managed Medicaid for LTC has facilitated coordinated care in home-based settings, which are preferred by most patients.
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This has also alleviated critical nursing home access issues while reducing the cost burden on the state. Tennessee addressed this crisis by awarding managed long-term care contracts to three Managed Medicaid health plans, and soon thereafter the waiting lists shrank sharply. Achieving meaningful Medicaid reform requires instilling accountability throughout the care delivery system.
By emphasizing provider accountability and quality improvement, States can capture operational efficiencies and optimize Medicaid patient satisfaction. States should focus immediately on provider accountability for fraud, waste, and abuse by contracting with Managed Medicaid plans. To promote accountability among providers for care quality, States can design Managed Medicaid contracts that require rigorous utilization reviews to improve patient outcomes and deter fraud. Finally, States can promote provider accountability by measuring patient satisfaction scores.
The Consumer Assessment of Healthcare Providers and Systems CAHPS survey employed by most states offers a valuable insight into patient satisfaction with health plans and providers alike. Survey results help to identify program weaknesses and opportunities for improvement.
Managed Medicaid plans consistently deliver higher rates of screening and immunization than their fee-for-service counterparts. For example:. Managed Medicaid plans consistently deliver more manageable care to patients suffering from a chronic disease like asthma and diabetes:. This may mean ensuring that specialist treatment centers have productive links with community health and social services.
Managed Care and the Evaluation and Adoption of Emerging Medical Technologies
Such a patient-centered approach recognizes that promising new RM therapies — as with many promising therapies [ 53 ] — should be seen as part of a regime of care, rather than as some sort of technological fix. Such precedents and opportunities need to be considered when assessing the suitability of potential clinical sites for implementing RM therapies, as do the adoption challenges outlined in earlier sections. These considerations are important elements of what can be defined as the IR of a clinical context.
The concept has been developed within the REGenableMED project, and is based on systematic study of the political and social dimensions of innovation in RM. Specifically, IR within healthcare can be defined as:. The IR concept is thus premised on the now commonly held assumption that technology adoption is a problematic aspect of the innovation process, rather than being a straightforward deployment of a fully developed product or practice.
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The value of this approach is that it points to those processes and contexts that shape technology clinical adoption, and so how novel organizational forms, such as the advanced therapy treatment centers can be configured to adopt RM manufacture and implementation most efficiently. IR can thus be used as an analytical frame for examining potential clinical sites for the proposed network of cell and gene therapy centers, and indeed for the longer term and hopefully more widespread implementation of RM technologies within the healthcare system.
In light of the specific adoption challenges related to RM and the precedents and opportunities noted above, Table 1 provides an overview of relevant general criteria for assessing IR for specific RM technologies and techniques. Given that RM represents a diverse field of technologies and techniques requiring vastly different skill sets and supporting infrastructures, the IR of a clinical site will likely differ substantially for any given technology or technique.
The criteria listed traverse the regulatory, commissioning and technological dimensions of technology adoption. Some of the criteria relate to any disruptive therapeutic innovation. These include the site's existing expertise in specific disease areas; its capacity to treat an expected disease cohort; and the ability to secure appropriate funding via established commissioning structures or charitable assistance.
Many of the criteria are likely to be specific to advanced cell and gene therapies, such access to a GMP-licensed facility, access to appropriate bioprocessing systems and necessary skill sets, and appropriately qualified persons and quality assurance mechanisms.
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In regard to skills, recent work [ 55 ] has shown that there is an inadequate supply of technicians in the area, and especially of those who have specialist skills in regard to manufacturing ATMPs. Some of the criteria in Table 1 may be less obvious, but are, in light of the arguments presented above, just as necessary for ensuring successful adoption.
These include the strategic objectives of the organization, the opportunities for meaningful patient involvement in organizational design and service improvement, and time for relevant staff to engage in monitoring and collective evaluation. The list of criteria serves as a useful reminder that an RM technology's market approval and the demonstration of its clinical- and cost-effectiveness are not, on their own, sufficient to guarantee its adoption: there is a diversity of challenges that need to be anticipated and managed.
Importantly, the list as it is presented here should be seen as highly provisional. As the RM field unfolds, and further challenges and opportunities are specified in greater depth, new IR criteria are likely to be identified. RM is championed as having the potential to transform healthcare.
The realization of its clinical and economic potential, however, requires initiatives that identify and mitigate various innovation challenges, particularly, as this paper has argued, those relating to the adoption of RM therapies within clinical delivery contexts such as hospitals and clinics. As previous social science studies of adoption processes in healthcare have illustrated, these challenges are diverse and relate to regulation, commissioning and funding, logistical and manufacturing requirements, skill base and expertise, and professional and institutional interests.
It is also necessary to ensure that patient groups are provided with opportunities to meaningfully contribute to the organizational design and service improvement of RM therapy providers. In light of anticipated adoption challenges and existing precedents and opportunities, this paper has presented a provisional list of criteria for assessing the IR of potential clinical sites for delivering an RM technology or technique.
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Preparing a fuller, more detailed list of IR criteria should be the first step in the initial phase preparing healthcare systems for the implementation of RM therapies. Given the degree of incommensurability between existing healthcare delivery infrastructures and RM technologies, and given that most promising developments in RM are still many years away if not decades from receiving marketing authorization, we suggest that it is necessary to plan the long-term implementation of RM over several phases. This would involve horizon scanning to identify which specific therapies are likely to receive marketing authorization and positive assessments from Health Technology Assessment agencies e.
Almost certainly, these are likely to be treatments for relatively small patient groups, or, if larger patient cohorts are envisaged, based on trialing via a performance-based risk assessment over time. It would also require keeping abreast of developments in bioprocessing and logistics technologies for which clinical sites will need to be suitably prepared.
Ideally, during Phase I, the network of treatment centers will provide the stability necessary for consolidating supply chain and manufacturing infrastructures and other supporting technologies, the development and testing of business models, and ultimately encourage further investment in the field as a whole. Phase II will involve preparing the healthcare system for the more widespread implementation of RM. It will begin when horizon scanning has identified promising therapies on the near horizon that cannot be delivered solely in the network of already-established advanced therapy treatment centers, perhaps due to the prevalence of the indication.
An example of this might be a cell therapy for Parkinson's, although such a therapy is likely to be many years away. Ideally, Phase II would involve the application of the IR analysis: to determine the relative impact of institutional change at the advanced therapy treatment centers and how this varies by disease area; and to then deploy the approach to envisage the scale of change needed for novel therapies, in order to move to a much higher order of magnitude in terms of availability.
It is important that a range of stakeholders are involved in these deliberations, notably: relevant patient groups and associations, industry representatives, other experts in the field such as the Cell and Gene Therapy Catapult, the Department of Health, Health Education England, Commissioning agencies such as NICE or Clinical Commissioning Groups and front-line clinicians and other staff from NHS foundation trusts. Phase III would begin once the therapy has received a positive health technology assessment or has been placed on the list of highly specialized services for specialized commissioning.
It would entail the actual establishment of a wider array of RM therapy providers, and the implementation of the therapy within these providers. This would require articulating RM with other concurrent developments in biomedical innovation and its deployment, such as large-scale data collection, precision medicine and new early diagnostics. Establishing a program for the phased implementation of RM may help to provide further confidence among potential investors. Importantly, the careful, well-planned phasing-in of RM technologies will ensure that scarce resources are responsibly deployed, that new clinical services provide comprehensive care to patients and their families, and that already much-stressed healthcare systems are not subjected to unnecessary disruption.
There are good reasons to think that the UK in particular is well prepared for such a responsible implementation of RM: it has active, well-informed patient charities and associations; it has world-leading hospitals with a commitment to RM; it has extensive expertise in regulation and commissioning and bioprocessing The Cell and Gene Therapy Catapult being a good example of this ; there is a commitment to exploring alternative reimbursement and commissioning models; and there is ongoing research into the day-to-day challenges of developing and implementing RM, for example [ 55 , 56 ], which will provide an important reservoir of knowledge.
Adoption is the result of active, ongoing work by creative agents such as front-line clinicians, hospital managers, administrators who are constrained by bounded rationality and limited resources. Diverse agents need to be actively enrolled in adopting a technology or technique. This means that their expectations and workloads need to be explicitly aligned.
Adoption requires regular opportunities for relevant staff to engage in reflexive evaluation of the technology and the service. This helps staff to be re-enrolled in the adoption process. Recent reports have identified the implementation of regenerative medicine RM therapies within existing healthcare delivery systems as a major challenge. Hospitals and clinics are structured to provide drug and device-based therapies and surgical interventions, and may be poorly suited to delivering cell- and gene-based therapies. Obdurate infrastructures and routines, multiple professions with conflicting viewpoints, funding pressures and resource constrains complicate the uptake of new technologies and practices within hospitals.
Case studies illustrate that proof of clinical and cost—effectiveness are not sufficient to guarantee a medical technology's adoption. RM presents specific challenges relating to logistics and manufacturing requirements, quality assurance, clinical expertise and staff training, and commissioning.
Related Managed Care and the Evalutation and Adoption of Emerging Medical Technologies: Executive Summary
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