Reimbursement Pathways Research Articles

Scenario analysis and multi-criteria decision analysis to explore alternative reimbursement pathways for whole genome sequencing for blood cancer patients

BackgroundWhole genome sequencing (WGS) has transformative potential for blood cancer management, but reimbursement is hindered by uncertain benefits relative to added costs. This study employed scenario planning and multi-criteria decision analysis (MCDA) to evaluate stakeholders’ preferences for alternative reimbursement pathways, informing future health technology assessment (HTA) submission of WGS in blood cancer. MethodsKey factors influencing WGS reimbursement in blood cancers were identified through a literature search. Hypothetical scenarios describing various evidential characteristics of WGS for HTA were developed using the morphological approach. An online survey, incorporating MCDA weights, was designed to gather stakeholder preferences (consumers/patients, clinicians/health professionals, industry representatives, health economists, and HTA committee members) for these scenarios. The survey assessed participants' approval of WGS reimbursement for each scenario, and scenario preferences were determined using the geometric mean method, applying an algorithm to improve reliability and precision by addressing inconsistent responses. ResultsNineteen participants provided complete survey responses, primarily clinicians or health professionals (n = 6; 32 %), consumers/patients and industry representatives (both at n = 5; 26 %). “Clinical impact of WGS results on patient care" was the most critical criterion (criteria weight of 0.25), followed by "diagnostic accuracy of WGS" (0.21), "cost-effectiveness of WGS" (0.19), "availability of reimbursed treatment after WGS" (0.16), and "eligibility criteria for reimbursed treatment based on actionable WGS results" and "cost comparison of WGS" (both at 0.09). Participants preferred a scenario with substantial clinical evidence, high access to reimbursed targeted treatment, cost-effectiveness below $50,000 per quality-adjusted life year (QALY) gained, and affordability relative to standard molecular tests. Reimbursement was initially opposed until criteria such as equal cost to standard tests and better treatment accessibility were met. ConclusionPayers commonly emphasize acceptable cost-effectiveness, but strong clinical evidence for many variants and comparable costs to standard tests are likely to drive positive reimbursement decisions for WGS.

A Clinically Immersive Medical Innovation Program for US MD Students: Curricular Description and Program Outcomes.

There is growing need for physician-innovators to address the mounting challenges within the US healthcare system. Despite this, there remains a significant gap in understanding of the efficacy of innovation programs for US MD candidates. We present initial program outcomes of a novel, clinically immersive medical innovation program offered to MD candidates at the David Geffen School of Medicine (DGSOM) at UCLA. A novel clinically immersive medical innovation curriculum was developed based on existing and reputable medical innovation frameworks and tailored for medical students. Curricular topics broadly included clinical ethnography, interviewing techniques, mind mapping, needs formulation and prioritization, quality improvement, intellectual property, reimbursement pathways, solution landscaping and prioritization, regulatory processes. The program was trialed during an unscheduled summer with voluntary enrollees from DGSOM Class of 2024. The traditional four-level Kirkpatrick model was employed to assess program outcomes. Program outcomes were positive on all four Kirkpatrick levels. Students rated enjoyment at 9.5/10 for lectures and 9.1/10 for clinical immersion. Student-perceived confidence in key skills increased by 43%, and 75% of faculty directly perceived improvement in ethnographic skills. Students were highly engaged in both didactics and clinical immersion, discovering on average 2.6 faculty-verified needs per week. Faculty largely felt their students discovered important unmet clinical needs and added value to their clinical practice. We developed and trialed a novel clinically immersive medical innovation curriculum tailored for medical students. This program achieved positive outcomes on all four levels of the Kirkpatrick model. Our findings have driven the local adoption of this program into our institution's medical school curriculum. We hope that the program efficacy demonstrated herein catalyzes more institutions to trial similar medical innovation programs.

Prospective Acceptability of Digital Therapy for Major Depressive Disorder in France: Multicentric Real-Life Study.

Major depressive disorder is one of the leading causes of disability worldwide. Although most international guidelines recommend psychological and psychosocial interventions as first-line treatment for mild to moderate depression, access remains limited in France due to the limited availability of trained clinicians, high costs for patients in the context of nonreimbursement, and the fear of stigmatization. Therefore, online blended psychological treatment such as Deprexis could improve access to care for people with depression. It has several advantages, such as easy accessibility and scalability, and it is supported by evidence. This study aims to evaluate the real-life acceptability of Deprexis for people with depression in France outside of a reimbursement pathway. Deprexis Acceptability Study Measure in Real Life (DARE) was designed as a multicenter cross-sectional study in which Deprexis was offered to any patient meeting the inclusion criteria during the fixed inclusion period (June 2022-March 2023). Inclusion criteria were (1) depression, (2) age between 18 and 65 years, (3) sufficient French language skills, and (4) access to the internet with a device to connect to the Deprexis platform. Exclusion criteria were previous or current diagnoses of bipolar disorder, psychotic symptoms, and suicidal thoughts during the current episode. The primary objective was to measure the prospective acceptability of Deprexis, a new digital therapy. Secondary objectives were to examine differences in acceptability according to patient and clinician characteristics and to identify reasons for refusal. All investigators received video-based training on Deprexis before enrollment to ensure that they all had the same level of information and understanding of the program. A total of 245 patients were eligible (n=159, 64.9% were women and n=138, 56.3% were single). The mean age was 40.7 (SD 14.1) years. A total of 78% (n=191) of the patients had moderate to severe depression (according to the Patient Health Questionnaire-9 [PHQ-9]). More than half of the population had another psychiatric comorbidity (excluding bipolar disorder, psychotic disorders, and suicidal ideation). A total of 33.9% (n=83) of patients accepted the idea of using Deprexis; the main reason for refusal was financial at 83.3% (n=135). Multivariate logistic regression identified factors that might favor the acceptability of Deprexis. Among these, being a couple, being treated with an antidepressant, or having a low severity level favored the acceptance of Deprexis. DARE is the first French study aiming at evaluating the prospective acceptability of digital therapy in the treatment of depression. The main reason for the refusal of Deprexis was financial. DARE will allow better identification of factors influencing acceptability in a natural setting. This study highlights the importance of investigating factors that may be associated with the acceptability of digital interventions, such as marital status, medication use, and severity of depression.

PP40 Structuring Unstructured Medical Device Reimbursement In India

IntroductionAs India makes rapid strides towards universal health coverage, focusing on medical device reimbursement is key to ensuring patient access to device-based technologies. The nascent medical device reimbursement process offers a promising opportunity for interventions driven by a diverse group of stakeholders. We conducted policy research to capture these diverse perspectives and highlight key elements to develop a structured framework for reimbursement.MethodsThis research was a two-part process, including secondary research with expert interviews followed by policy research using focus group discussions (FGDs) through an online workshop with key stakeholders. We developed a white paper proposing changes to the reimbursement pathway, based on a benchmarking study of global markets and interviews with experts in the field. As a next step, key changes proposed in the white paper were deliberated upon by three focus groups (six to eight participants). Group participants were selected by quota sampling and represented key stakeholders in the reimbursement process. A discussion guide was used to capture participants’ opinions and an addendum to the white paper was released highlighting small, actionable, and impactful changes to the reimbursement process.ResultsFGDs with key stakeholders highlighted the need to establish a more structured, inclusive, and transparent process. Accordingly, we proposed key recommendations to the medical device reimbursement process in India. A first change is the creation of an online submission portal allowing different healthcare stakeholders to submit new technologies for consideration through a streamlined pathway. Secondly, we proposed enhancing evaluation transparency by improving availability of publicly shared information on the evaluation process, metrics, and assessment timelines. We also suggested adoption of adaptive health technology assessments to leverage existing evidence for faster, efficient decision-making.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care for poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd (now Abbott).

PP20 Vaccines market access pathways in Asia-Pacific (APAC) – analysis and recommendations for improvement

IntroductionImmunization is one of the most effective public health interventions, saving millions of lives annually. However, complex and heterogenous market access pathways can impact timely and equitable population access to vaccines. Focusing on five Asia-Pacific (APAC) countries, this study described the current vaccine market access landscape and analyzed the success factors for National Immunization Program (NIP) inclusion.MethodsThe study was conducted in two phases (i) pragmatic literature review to map current regulatory and funding pathways and identify information gaps in China, Japan, Korea, Taiwan and Australia (ii) targeted interviews with market access and policy experts in each market to identify drivers and barriers to NIP inclusion.ResultsRegulatory approval, driven by safety and efficacy data, followed by introduction in the private market was commonly observed in all markets. However, pathways to NIP inclusion varied within and between markets. In all markets expert panels such as National Immunization Technical Advisory Groups (NITAG) were identified to play a crucial role in providing advice to governments on NIP inclusion. Health technology assessment was increasingly used to inform decision making. However, the assessment frameworks utilized were typically designed for medicines, rather than the unique features of vaccines.Japan, Korea and Australia provided relatively consistent coverage via national programs, despite the different processes employed to review, recommend and reimburse vaccines. In some cases, the reimbursement timeframe varied significantly for different vaccines within the same market. China and Taiwan provided coverage at the regional level, which required engagement with multiple local authorities to enable access. The key barriers to patient access were budget limitations, long reimbursement timeframes and a lack of coverage consistency. Early stakeholder engagement, local epidemiology and cost-effectiveness evidence were the main success factors for NIP inclusion.ConclusionsFunding pathways for vaccines in APAC are heterogenous. Adopting the Asia-Pacific Economic Cooperation (APEC) Action Plan on Vaccination Across the Life Course could increase vaccine coverage through alignment, collaboration, and improvement of reimbursement pathways in APAC.

Diabetes technology: Continuous glucose monitoring and the role of ambulatory care pharmacists

This commentary discusses the role of ambulatory care pharmacists in diabetes care and the evolving use of continuous glucose monitoring (CGM) technology. As the clinical burden and costs related to care for diabetes grows, ambulatory care pharmacists are uniquely positioned to realize the potential of and implement technology in the patient care process. Although previous technologies often focused on phone-based interventions, rapidly evolving technology, such as CGM, offers great insight related to disease state management. Despite the growth of CGM technology, there is still limited recognition of the value of pharmacists in the utilization of diabetes technology. Ambulatory care pharmacists have the appropriate resources and training to navigate barriers and support effective use of CGMs. They can provide guidance in selecting the best device based on patient-specific needs and accessibility. Pharmacists can also educate patients on how to use devices, interpret data, and integrate it with mobile applications for monitoring and data sharing. In addition, pharmacists can assist in ongoing management by reviewing data reports and making necessary adjustments to therapy. Pharmacist-led education and multidisciplinary coordination can support integration of CGMs in clinical settings. Pharmacists can deliver in-service education, provide clinical support to administrative workflow related to care, and provide consultations to increase provider comfort in prescribing CGMs. Pharmacists’ potential with CGM and diabetes technology in primary care would be best realized through better characterization of pharmacists’ interventions in diabetes care, increased recognition of their role on the interprofessional team, and describing viable reimbursement pathways available to pharmacists. This article describes how pharmacists in ambulatory care can use CGM as an example of diabetes technology to improve patient care through a patient case. A call to action is provided for further education, research, and support for pharmacists leveraging technology in these roles.

Stakeholders' Perceptions Regarding Digital Therapeutics Reimbursement in South Korea: Qualitative Study.

Digital therapeutics (DTx) are therapeutic interventions driven by software and directly provided to patients, allowing them to manage their health with ease in any setting. A growing interest in DTx has spurred a discussion concerning their reimbursement pathways. However, DTx are still at a premature stage, with insufficient evidence on effectiveness, efficiency, and safety. Currently, although industries desire to quickly enter the market, especially by getting their products reimbursed by the National Health Insurance (NHI) fund, the NHI is cautious about DTx due to their uncertainties. Thus, public discussion and social consensus are crucial in deciding whether to reimburse DTx by the NHI fund. This study examined multiple stakeholders' awareness and attitudes toward DTx and perceptions of regulatory pathways for adopting DTx. In-depth interviews were conducted with 11 stakeholders in South Korea (industry: n=4, health care: n=3, academia: n=2, and consumer: n=2) using semistructured guidelines. They were purposively sampled to identify individuals with expertise in DTx and NHI policies. The interviews were conducted either in person or via a videoconference for 45-70 minutes. Qualitative data were analyzed using directed content analysis, which uses interview guidelines as an analytical framework. Findings were divided into three categories: (1) awareness and attitude toward DTx, (2) perception of whether DTx are worth entering the market and being reimbursed by the NHI fund, and (3) perception of how to enter the market and how to reimburse DTx by the NHI fund if they are worth it. Although consumer stakeholders were not familiar with the basic concept of DTx, the other stakeholders understood it thoroughly. However, all participants showed positive attitudes and acceptance of DTx. Most of them responded that DTx are worth entering the market, but they could not reach an agreement on the pathways for DTx to enter the market. Although participants were in favor of the reimbursement of DTx in principle, they responded that a conservative approach is required due to insufficient clinical evidence for DTx. We found that stakeholders in South Korea had positive attitudes toward DTx, perceived them as worth using, and agreed to allow them to enter the market. The main issue was not the problem of the technology itself but the difference in opinion as to the pathways for reimbursement. Therefore, this study concluded that the NHI fund, which is operated very conservatively, is insufficient to quickly adopt and implement DTx. Various reimbursement methods, including tax-based financing, raising innovation funds for new technologies, and pilot studies using the NHI fund, should be used to rapidly generate clinical evidence and reduce the uncertainties of DTx to secure a stable market.

Complementing traditional care with digital therapeutics for chronic non-communicable disease management

Abstract We will examine the role of digital therapeutics in diabetes care, where we will discuss how Digital Therapeutics can supplement face-to-face consultations by facilitating data exchange between patients and healthcare professionals, improving disease monitoring, and promoting patient empowerment. In the context of mental health, we will present evidence supporting the effectiveness of computer-assisted cognitive behaviour therapy (CCBT) as a valuable adjunct to treatment as usual (TAU) in primary care settings. Throughout the presentation, we will highlight the importance of integrating digital therapeutics into existing healthcare systems and addressing barriers to their adoption, such as socio-demographic disparities and healthcare professional attitudes through tools such as regulatory frameworks and reimbursement pathways. By exploring the complementary role of digital therapeutics in chronic NCD management, we aim to encourage dialogue on the potential synergies between traditional care and digital interventions to improve patient outcomes and inform public health policy.

Impact of the COVID-19 Pandemic on the Community Pharmacy Workforce.

This study sought to describe the impact of the COVID-19 pandemic on community pharmacy practice and its workforce. Interviews were conducted with 18 key informants from pharmacy associations and community pharmacists representing chain and independent pharmacy organizations across the United States from January to May 2022. Interview notes were analyzed using a rapid content analysis approach. Four themes resulted: (a) patient care at community pharmacies focused on fulfilling COVID-19 response needs; (b) pharmacists' history as immunizers and scope of practice expansions facilitated COVID-19 response efforts; (c) workforce supply shortages impeded COVID-19 response efforts and contributed to burnout; and (d) maintaining community pharmacy workforce's readiness will be critical to future emergency preparedness and response efforts. Formalizing scope of practice expansion policies and reimbursement pathways deployed during the COVID-19 pandemic could facilitate the community pharmacy workforce's ability to address ongoing public health needs and respond to future public health emergencies.

What could health technology assessment learn from living clinical practice guidelines?

A "living" approach to clinical practice guidelines is when the identification, appraisal and synthesis of evidence is maintained and repeated at an agreed frequency, with a clear process for when and how new evidence is to be incorporated. The value of a living approach to guidelines was emphasised during the COVID-19 pandemic when health professionals and policymakers needed to make decisions regarding patient care in the context of a nascent but rapidly evolving evidence base. In this perspective, we draw on our recent experience developing Australian and international living guidelines and reflect on the feasibility of applying living guideline methods and processes to a lifecycle approach to health technology assessment (HTA). We believe the opportunities and challenges of adopting a living approach in HTA fall into five key themes: identification, appraisal and synthesis of evidence; optimising the frequency of updates; embedding ongoing multi-stakeholder engagement; linking the emergence of new evidence to reimbursement; and system capacity to support a living approach. We acknowledge that the suitability of specific living approaches to HTA will be heavily influenced by the type of health technology, its intended use in the health system, local reimbursement pathways, and other policy settings. But we believe that the methods and processes applied successfully to guideline development to manage evidentiary uncertainty could be applied in the context of HTA and reimbursement decision-making to help manage similar sources of uncertainty.

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies

A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. Time from FDA authorization to the first coverage milestone. Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40). In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

HPR20 Are We Ready for Reimbursement of Software As a Medical Device in Asia-Pacific (APAC) Region?

Software as a medical device (SaMD) is one type of digital health technologies, which refers to a program designed for use as a medical device. In recent years, clearer regulatory guidelines regarding SaMD have been released in many Asian countries. Moreover, assessments of the value of SaMD and reimbursement pathways have also been a hot topic for discussions. Therefore, we aim to compare the policy readiness and potential reimbursement pathways, trying to understand the policy landscapes in APAC region.

Exploring Reimbursement Pathways for Lifestyle Medicine and Health Promotion Services in Occupational Therapy.

Occupational therapy practitioners are uniquely qualified and positioned to offer both preventive and rehabilitative models of care. However, the status quo of current reimbursement models has created a barrier to occupational therapy practitioners receiving adequate reimbursement, if any, for doing health promotion and lifestyle-focused work. In this Health Policy Perspectives article, we emphasize the need for reimbursement and propose pathways for new and perhaps untapped or underutilized models of reimbursement for occupational therapy practitioners. These pathways require education and advocacy efforts to showcase our distinct value as key reimbursable and interdisciplinary players in lifestyle medicine and health promotion work.

Effect of the copayment reduction system on accessibility to orphan drugs in South Korea

ABSTRACT Objective This study aims to analyze the effect of the copayment reduction system on accessibility to orphan drugs (ODs) in South Korea. Methods Data on approval and reimbursement for drugs designated as ODs for the last 10 years (2012–2021) in South Korea were extracted. Among them, with 136 approved products as of 31 December 2022, the reimbursement rates and lead time to reimbursement between drugs for rare diseases (DRDs) and nondrugs for rare diseases (non-DRDs) were analyzed. The pricing and reimbursement (P&R) pathways between drugs for only rare diseases (DORDs) and drugs for rare and cancerous diseases (DRCDs) were compared. Results The reimbursement rates for DRDs and non-DRDs were 54.8% and 33.3%, respectively, and the lead time to reimbursement for DRDs and non-DRDs were 16.1 months and 31.2 months, respectively. The P&R pathways for DORDs and DRCDs were pharmacoeconomic evaluation waivers (21.7% and 52.6%), weighted average price (52.2% and 13.2%), and risk-sharing agreement (30.4% and 81.6%). Conclusion The copayment reduction system may act as a driver and also barrier for the reimbursement of ODs. To expand treatment accessibility to ODs, it is necessary to consistently grants benefits in all processes from OD designation to market access.

Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges.

Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular attention is paid to software-based in vitro diagnostics (IVDs). With this point of view, a strong connection between DTx and IVDs is observed. We investigated the current regulatory scenarios and reimbursement approaches adopted for DTx and IVDs. The initial assumption was that countries apply different regulations for the access to the market and adopt different reimbursement systems for both DTx and IVDs. The analysis was limited to the US, European countries (Germany, France, and UK), and Australia due to maturity in digital health product adoption and regulatory processes, and recent regulations related to IVDs. The final aim was to provide a general comparative overview and identify those aspects that should be better addressed to support the adoption and commercialization of DTx and IVDs. Many countries regulate DTx as medical devices or software integrated with a medical device, and some have a more specific pathway than others. Australia has more specific regulations classifying software used in IVD. Some EU countries are adopting similar processes to the Digital Health Applications (DiGA) under Germany's Digitale-Versorgung Gesetz (DVG) law, which deems DTx eligible for reimbursement during the fast access pathway. France is working on a fast-track system to make DTx available to patients and reimbursable by the public system. The US retains some coverage through private insurance, federal and state programs like Medicaid and Veterans Affairs, and out-of-pocket spending. The updated Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU includes a classification system specifying how software integrated with medical devices, and IVDs specifically must be regulated. The outlook for DTx and IVDs is changing as they are becoming more technologically advanced, and some countries are adapting their device classifications depending on specific features. Our analysis showed the complexity of the issue demonstrating how fragmented are regulatory systems for DTx and IVDs. Differences emerged in terms of definitions, terminology, requested evidence, payment approaches and the overall reimbursement landscape. The complexity is expected to have a direct impact on the commercialization of and access to DTx and IVDs. In this scenario, willingness to pay of different stakeholders is a key theme.

Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Development of an interactive web dashboard to facilitate the reexamination of pathology reports for instances of underbilling of CPT codes

Current Procedural Terminology Codes is a numerical coding system used to bill for medical procedures and services and crucially, represents a major reimbursement pathway. Given that pathology services represent a consequential source of hospital revenue, understanding instances where codes may have been misassigned or underbilled is critical. Several algorithms have been proposed that can identify improperly billed CPT codes in existing datasets of pathology reports. Estimation of the fiscal impacts of these reports requires a coder (i.e., billing staff) to review the original reports and manually code them again. As the re-assignment of codes using machine learning algorithms can be done quickly, the bottleneck in validating these reassignments is in this manual re-coding process, which can prove cumbersome. This work documents the development of a rapidly deployable dashboard for examination of reports that the original coder may have misbilled. Our dashboard features the following main components: (1) a bar plot to show the predicted probabilities for each CPT code, (2) an interpretation plot showing how each word in the report combines to form the overall prediction, and (3) a place for the user to input the CPT code they have chosen to assign. This dashboard utilizes the algorithms developed to accurately identify CPT codes to highlight the codes missed by the original coders. In order to demonstrate the function of this web application, we recruited pathologists to utilize it to highlight reports that had codes incorrectly assigned. We expect this application to accelerate the validation of re-assigned codes through facilitating rapid review of false-positive pathology reports. In the future, we will use this technology to review thousands of past cases in order to estimate the impact of underbilling has on departmental revenue.

국내 인슐린 주입기기 요양비 지원 정책 현황 및 개선 방안

Intensive insulin therapy is the primary treatment option for patients with type 1 and uncontrolled type 2 diabetes. Insulin pump therapy and multiple daily insulin injections (MDI) are the principal methods of intensive insulin therapy. The clinical utility of an insulin pump is generally greater than an MDI regimen. An artificial pancreas, which is an insulin pump with an integrated continuous glucose monitor (CGM), has recently been introduced on the market with emerging clinical evidence. Although it may offer clinical benefits and reduce the self-management burden among patients with diabetes, its potential for inappropriate use and unaffordability are the major barriers to its universal utilization. Despite the medical assistance program offered by the Korean National Healthcare System, which provides coverage for consumables and devices for diabetes treatment, some patients cannot afford to use an advanced insulin delivery system (i.e., the artificial pancreas). Under the current reimbursement policy, the healthcare system considers an insulin pump and a CGM as separate items for regulatory and reimbursement purposes. In other words, the artificial pancreas is categorized as an insulin pump and reimbursed at the same amount as a traditional insulin pump. The fundamental operating function may be the same between the artificial pancreas and a traditional insulin pump; however, there should be a different reimbursement pathway to make a novel category for the artificial pancreas instead of categorizing it under insulin pumps and to differentiate pricing based on the comparative (cost-) effectiveness among insulin delivery devices. Other countries such as the United States, the United Kingdom, Germany, and France are moving toward rapid and universal adoption of the artificial pancreas supported by their clinical governance and regulatory affairs. In this review, we highlight the need to improve the accessibility and affordability of advanced diabetes technology by discussing the current issues in the reimbursement policy that limit the universal use of advanced insulin delivery devices in Korea.

Inequalities in Health Impact of Alternative Reimbursement Pathways for Nirsevimab in the United States.

The target populations and financing mechanisms for a new health technology may affect health inequalities in access and impact. We projected the distributional consequences of introducing nirsevimab for prevention of respiratory syncytial virus in a US birth cohort of infants through alternative reimbursement pathway scenarios. Using the RSV immunization impact model, we estimated that a vaccine-like reimbursement pathway would cover 32% more infants than a pharmaceutical pathway. The vaccine pathway would avert 30% more hospitalizations and 39% more emergency room visits overall, and 44% and 44%, respectively, in publicly insured infants. The vaccine pathway would benefit infants from poorer households.

HPR30 Reimbursement Pathway for Advanced Therapy Medicinal Products in Bulgaria

The aim of this study is to examine the reimbursement pathway and the current status of payer coverage of ATMPs in Bulgaria.