Reimbursement Mechanisms Research Articles

Satisfaction With Quality of Health Care Among Medicare Beneficiaries With Functional Hearing Loss.

Nearly 38 million Americans have hearing loss. Understanding how sensory deficits such as hearing loss, which limit communication, impact satisfaction has implications for Medicare value-based reimbursement mechanisms. The aim of this study was to characterize the association of functional hearing loss and dissatisfaction with quality of health care over the past year among Medicare beneficiaries. Cross-sectional study of satisfaction with quality of health care among Medicare beneficiaries with self-reported trouble hearing from the 2015 Medicare Current Beneficiaries Survey. There were 11,441 Medicare beneficiaries representing a 48.6 million total weighted nationally representative sample. Forty-eight percent of Medicare beneficiaries reported a little or a lot of trouble hearing. Medicare beneficiaries with a little trouble hearing (odds ratio=1.496; 95% confidence interval, 1.079-2.073; P=0.016) and a lot of trouble hearing (odds ratio=1.769; 95% confidence interval, 1.175-2.664; P=0.007) had 49.6% and 76.9% higher odds of being dissatisfied with the quality of their health care over the previous year, respectively. Medicare beneficiaries with functional hearing loss had higher odds of dissatisfaction with health care over the past year compared to those without functional hearing loss. Given Medicare's reliance on patient satisfaction as a value-based measure for hospital reimbursement, interventions to address hearing loss in the health care system are needed.

Value of Anti–Vascular Endothelial Growth Factor Gene Therapy for Neovascular Age-Related Macular Degeneration

To use discounted cash flow (DCF) analysis to estimate the value creation associated with anti-vascular endothelial growth factor (VEGF) genetic therapy for neovascular age-related macular degeneration (nAMD). Economic analysis. Adults undergoing serial intravitreal anti-VEGF injections in 1 eye for nAMD. Discounted cash flow modeling with scenario analysis was used to derive a present value for a 1-time alternative treatment to lifelong anti-VEGF treatment for nAMD. Multiple sensitivity analyses were performed on the basis of patient age at time of first injection and frequency interval of intravitreal injection. Present values of DCF and scenario analyses. Discounted cash flow analysis of intravitreal anti-VEGF treatment for nAMD resulted in a base-case valuation of $208 420.61,$219 093.31, and $17 379.41 for a 1-time alternative treatment to aflibercept, ranibizumab, and bevacizumab, respectively. This figure covaried significantly with anti-VEGF agent according to the patient age at first injection ($78 323.19-$292 449.87) and frequency of injections ($148 422.91-$388 096.81). In addition, for bevacizumab, variability was driven by the hypothetical degree of clinical superiority of 1-time therapy to repeated intravitreal injections due to reduction in adverse events ($17 379.41-$18 250.79) or reduction in direct or indirect costs associated with age-related macular degeneration ($17 379.41-$657 406.55). Anti-VEGF gene therapy approaches can create significantly different value propositions based on the agent modeled, patient age at first injection, frequency of injections, and clinical profile of the medication. Although the use of aflibercept or ranibizumab as a comparative cost metric is logical from a bioequivalence perspective, the disparity in medication costs should not be the primary value driver in applied models. Instead, bevacizumab should be the base case ($17 379.41), with additional value driven from an improvement in quality of life through clinical superiority. A reduction in direct and indirect costs can be used to approximate the value from maintained visual acuity, which is elaborated in the DCF analysis approach described in this article. This model can serve as a basis for assessing the price ceiling of myriad gene therapy approaches. Given the high present values for these therapeutics, innovative costing and reimbursement mechanisms should be further explored, with contingencies for sustained efficacy.

Affordability of in vivo gene therapy. Problems and potential solutions

Aim. To review foreign approaches to the evaluation and financing of in vivo gene therapy drugs. Materials and Methods. The first stage of the review included the systematic search for publications of clinical-economic studies (CES) on in vivo gene therapy drugs registered on the international pharmaceutical market. The analysis of the methodology used in the found CESs was performed based on the given criteria. The second and third stages of the review included the search for the information on the approaches and results of the evaluation of in vivo gene therapy drugs by foreign agencies on the assessment of healthcare technologies (AHT) and the implemented approaches to the financing of expensive medical technologies. Results. Totally, four in vivo gene therapy drugs registered on the foreign markets were found: talimogene laherparepvec (Imlygic), voretigene neparvovec (Luxturna), onasemnogene abeparvovec (Zolgensma), and alipogene tiparvove (Glybera). The analysis of the methodology of CES on in vivo gene therapy drugs did not reveal general methodological peculiarities. The analysis of the approaches to the reimbursement for the cost of these four drugs in the European countries showed that there were no special procedures intended for gene drugs. However, in the majority of countries, there are some mechanisms of reimbursement for orphan drugs and the majority of the above-mentioned in vivo gene therapy drugs are orphan. It was revealed that the most perspective methods of payment for in vivo gene therapy drugs were installment payments, risk-sharing agreements, and their combinations. Still, none of these payment methods are implemented in Russia because of the lack of regulatory and legal framework. Conclusion. The design and methodological peculiarities of CES on in vivo gene therapy drugs are similar to orphan drugs (in some countries, there is a special flexible procedure). In the Russian Federation, there is no special procedure of ATH for orphan drugs, which can provide difficulties in the reimbursement for these drugs. Besides, in the Russian Federation, the issue of the implementation of innovative models for drugs provision (risk-sharing, installment payments is acute). The changes in this area would also lead to the optimization of the influence of expensive healthcare technologies on the budget of the system of healthcare.

Challenges and Adverse Outcomes of Implementing Reimbursement Mechanisms Based on the Diagnosis-Related Group Classification System: A systematic review.

In health insurance, a reimbursement mechanism refers to a method of third-party repayment to offset the use of medical services and equipment. This systematic review aimed to identify challenges and adverse outcomes generated by the implementation of reimbursement mechanisms based on the diagnosis-related group (DRG) classification system. All articles published between 1983 and 2017 and indexed in various databases were reviewed. Of the 1,475 articles identified, 36 were relevant and were included in the analysis. Overall, the most frequent challenges were increased costs (especially for severe diseases and specialised services), a lack of adequate supervision and technical infrastructure and the complexity of the method. Adverse outcomes included reduced length of patient stay, early patient discharge, decreased admissions, increased re-admissions and reduced services. Moreover, DRG-based reimbursement mechanisms often resulted in the referral of patients to other institutions, thus transferring costs to other sectors.

International Experience in Therapeutic Value and Value-Based Pricing: A Rapid Review of the Literature

ObjectivesTo characterize at a global level the concept of therapeutic value (TV) and describe the experience of value-based pricing (VBP) policies in 6 reference countries. MethodsWe conducted a rapid review of the literature that addressed 2 exploratory research questions. A systematic and exhaustive search was carried out up to July 2018 in MEDLINE (Ovid), Embase, Scopus, and Web of Science. ResultsThe concepts of TV and VBP are related; value frameworks for medicines should include social preferences, comparative effectiveness, safety, adoption viability, social impact, high quality of evidence, severity of illness, and innovation. The added therapeutic value (ATV) is the manner of measuring the therapeutic advantages of new medicines compared with existing ones in terms of comparative effectiveness and safety. There are variations in the mechanisms of reimbursement and drug pricing regulation between the countries of study. ConclusionIn a VBP system it is essential to establish the TV and ATV of a new medicine. Although there are no methodological guidelines for the implementation of VBP policies, the process implies from the beginning the definition of TV categories that will be included in the drug pricing and reimbursement systems. Agreements between the pharmaceutical industry and governments have become a useful tool as a negotiating mechanism in most countries.

Challenges of Payment Methods in the Iranian Health System and Solutions: A Qualitative Study

Background: The implementation of different reimbursement methods has various positive and negative effects on the health system of different countries. Identifying the challenges of these methods is essential to improve these reimbursement methods and modify them if required. This article aimed to qualitatively assess the challenges of current hospitals' payment systems in the Iranian health system and determine the required solutions for modifying these payment systems. Methods: This qualitative study was conducted in 2019. Semi-structured interviews were conducted recruiting 20 experts including operational, middle and top managers working in three different levels of health systems. Data collection was continued until it reached a saturation point. MAXQDA 10 was used for data analysis. The data content analysis method was used to analyze the data and the themes and categories were determined. Results: The challenges of the payment systems were categorized into four main themes regarding policy, cost, regulatory and functional challenges, and 15 sub-themes. The findings related to the proposed strategies were presented in six main themes consisting of legal solutions, structural reform, cost, quality improvement, service provider and client, and monitoring and evaluation; and 12 sub-themes. Conclusion: This study showed that the health systems in Iran face various structural and procedural challenges in terms of reimbursement mechanisms. Therefore, it is recommended that policymakers pay attention to these challenges before making any changes. Using hybrid payment systems can be one of the proper solutions.

A scoping review of the payment mechanisms in childbirth of country members and non-members of the Organisation for Economic Cooperation and Development

Payment mechanisms serve to put into operation the function of purchasing in health. Payment mechanisms impact the decisions that healthcare providers make. Given this, we are interested in knowing how they affect the generalized increase of C-section rates globally. The objective of this review is to describe existing payment mechanisms for childbirth in countries members of the Organization for Economic Co-operation and Development (OECD) and non-members. We conducted a scoping review following the five methodological steps of the Joanna Briggs Institute. The search was conducted by researchers independently, achieving inter-reliability among raters (kappa index, 0.96). We searched electronic databases, grey literature, and governmental and non-governmental websites. We screened on three levels and included documents published in the last ten years, in English and Spanish. Results were analyzed considering the function of the reimbursement mechanism and its effects on providers, payers, and beneficiaries. Evidence from 34 countries was obtained (50% OECD members). Sixty-four percent of countries report the use of more than one payment mechanism for childbirth. Diagnosis-Related Groups (47.6%), Pay-for-performance (23.3%), Fee-for-service (16.6%) and Fixed-prospective systems (13.3%) are among the most frequently used mechanisms. Countries use payment mechanism architecture to improve maternal-perinatal health indicators. Therefore, it is necessary to explore the best combination of mechanisms that improve the provision of health care and welfare of the population in the field of sexual and reproductive health.

Abstract P4-15-02: Lessons learned: Implementing the WISDOM study using private payors to cover study services and generate evidence

Abstract Background: Generating real world evidence in support of value-based healthcare solutions has traditionally been difficult due to the nature of funding and reimbursement mechanisms. Pragmatic, comparative effectiveness studies need additional funding to cover study costs, and systems are not in place to incorporate evidence generation into improving health outcomes. In 2005, the Centers for Medicare and Medicaid Services (CMS) identified the need to broaden access to innovative therapies and practices, and implemented a Coverage with Evidence Development (CED) model. This model has not been adapted by private payers. Methods: The WISDOM (Women Informed to Screen Depending on Measures of risk) Study in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), addressed this challenge by co-developing a private payer coverage with evidence progression (CEP) model, based upon Medicare’s CED policy. Since the study began in 2016, numerous payers cover the WISDOM Study using CEP, including private, Medi-Cal, and self-insured employer groups, across six states (California, Illinois, Iowa, New Jersey, North Dakota and South Dakota). The payers helped cover study services used for risk assessment and high-risk counseling in the WISDOM Study. Results: The first barrier was the payer’s fiscal concerns over adopting CEP, which was overcome by establishing the case for evidence generation as a route to better outcomes, cost savings and overall healthcare value. The second barrier was that health insurance companies may only control benefits for a fraction of their members. To overcome this barrier, WISDOM Study Investigators extended CEP to self-insured employers, who have been enthusiastic proponents in covering and recruiting participants. In implementing CEP, a third significant barrier was billing for individual services on a national scale. In response, WISDOM investigators established a scalable and replicable billing infrastructure for pre-approving and submitting claims for study services. Discussion: The WISDOM Study is a pragmatic, comparative effectiveness trial that provides a framework for future research studies to adopt and build upon. For CEP to be scalable, an established simple mechanism is essential. For every limitation, we have identified important lessons that have been learned during the study’s implementation to address what started as insurmountable barriers and ended as a critical demonstration of feasibility. Conclusion: These obstacles may inform subsequent implementations of coverage for evidence generation purposes as a means to promote value-based improvements in care. Citation Format: Yash S Huilgol, Kenneth Wimmer, Erick Lin, Marcus Thygeson, Allison S Fiscalini, Karyn DiGiorgio, David Kraus, Lisa M Latts, Laura Tauber, Trent T Haywood, Athena Breast Health Network Investigators and Advocate Partners, Laura J Esserman. Lessons learned: Implementing the WISDOM study using private payors to cover study services and generate evidence [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-15-02.

An initiative to implement immediate postpartum long-acting reversible contraception in rural New Mexico

Over the past decade, many states have developed approaches to reimburse for immediate postpartum long-acting reversible contraception. Despite expanded coverage, few hospitals offer immediate postpartum long-acting reversible contraception. Immediate postpartum long-acting reversible contraception implementation is complex and requires a committed multidisciplinary team. After New Mexico Medicaid approved reimbursement for this service, the New Mexico Perinatal Collaborative developed and initiated an evidence-based implementation program containing several components. We sought to evaluate timing of the implementation process and facilitators and barriers to immediate postpartum long-acting reversible contraception in several New Mexico rural hospitals. The primary study outcome was time from New Mexico Perinatal Collaborative program component introduction in each hospital to the hospital's completion of the corresponding implementation step. Secondary outcomes included barriers and facilitators to immediate postpartum contraception implementation. In this mixed-methods study, conducted from April 2017 to May 2018, we completed semistructured questionnaires and interviews with 20 key personnel from 7 New Mexico hospitals that planned to implement immediate postpartum long-acting reversible contraception. The New Mexico Perinatal Collaborative introduced program components to hospitals in a stepped-wedge design. Participants contributed baseline and follow-up data at 4 time periods detailing the steps taken towards program implementation and the timing of step completion at their hospital. Qualitative data were analyzed using directed qualitative content analysis principles based on the Consolidated Framework for Implementation Research. Investigators conducted 43 interviews during the 14-month study period. Median time to complete steps toward implementation-patient education, clinician training, nursing education, charge capture, available supplies, and protocols or guidelines-ranged from 7 days for clinician training to 357 days to develop patient education materials. Facilitators of immediate postpartum contraception readiness were local hospital clinical champions and institutional administrative and financial stability. Of the 7 hospitals, 4 completed all Perinatal Collaborative implementation program components and 3 of those piloted immediate postpartum long-acting reversible contraception services. Two publicly funded hospitals currently offer immediate postpartum long-acting reversible contraception without verification of payment for the device or insertion. The third hospital piloted the program with 8 contraceptive devices, did not receive reimbursement due to identified flaws in Medicaid billing guidance and does not currently offer the service. The remaining 3 of the 7 hospitals declined to complete the NMPC program; the hospital that completed the program but did not pilot immediate postpartum long-acting reversible contraception did so because Medicaid billing mechanisms were incompatible with their automated billing systems. Participants consistently reported that lack of reimbursement was the major barrier to immediate postpartum long-acting reversible contraception implementation. Despite the New Mexico Perinatal Collaborative's robust implementation process and hospital engagement, most hospitals did not offer immediate postpartum long-acting reversible contraception over the study period. Reimbursement obstacles prevented full service implementation. Interventions to improve immediate postpartum long-acting reversible contraception access must begin with implementation of seamless billing and reimbursement mechanisms to ensure adequate hospital payments.

Ensuring intervention success: Assessing fit as an overlooked step of the implementation process.

Ensuring fit between a service and the implementing context is a critical but often overlooked precursor of implementation success. This commentary proposes five key considerations that should be evaluated when exploring fit: alignment with needs and metrics; alignment with organizational resources and capabilities; alignment with organizational priorities and culture; alignment with reimbursement mechanisms for long-term sustainability; and alignment with the regulatory environment. Successful uptake and implementation hinges on careful planning and, most importantly, appropriate fit between the service and the implementing environment.

Intelligent Industries of Ukraine: Major Players and Trends in the Pharmaceutical Industry

The results of a study of the current state and development trends of domestic enterprises-manufacturers of pharmaceutical products and drugs, the relevance of which is due to the need for scientific and methodological support of digital transformation of business models of enterprises in the real sector of the Ukrainian economy, are presented. In the context of aggravated competition, the need to create conditions for the development of the domestic pharmaceutical industry is characterized by specific innovative processes, a complex structure, a large number of high-tech jobs, high investment attractiveness, is an essential condition for improving the quality and competitiveness of pharmaceutical products in the domestic market, intellectualization of enterprises. The purpose of the article is to establish trends in the development of pharmaceutical enterprises to further determine the methods of functioning and development of intellectualized industries in Ukraine. It has been determined that during crisis periods, the dynamics of industrial production of enterprises with a high level of intellectualization is characterized by relative stability against the background of a general decline in business activity. The influence of changes in the direction of global trends in the development of the world pharmaceutical market on the domestic pharmaceutical industry has been established: a double-digit growth trend in sales of prescription drugs (double-digit growth) persists due to the implementation of the reimbursement mechanism, as well as an increase in hospital purchases. Maintaining the market growth trend and the corresponding prolongation of state programs such as “Affordable Medicines” contributes to an increase in demand in the domestic market, which can become a stimulating factor for the further development of domestic pharmaceutical manufacturers – the growth of their business, innovation and investment activity. The analysis indicates a high level of resilience of the pharmaceutical industry and the enterprises that form it to crisis influences, optimistic expectations regarding further moderate growth in the industry, potential growth in the investment attractiveness of domestic enterprises and their high adaptability to transformations of the business model towards its further digitalization and intellectualization.

TAILORED ACTIVITY PROGRAM (TAP) COSTS: OPPORTUNITIES TO STREAMLINE DELIVERY AND PURSUE REIMBURSEMENT

TAP intervention costs captured alongside the randomized controlled study included labor of program staff, mileage, supplies and materials. Staff time costs were converted to $US 2017 by multiplying hours spent by the appropriate wage rate plus fringe benefits; mileage was costed using the federal reimbursement rate. Research costs were excluded to approximate real world implementation. Costs varied based on number of visits required but mean component costs per dyad were: occupational therapist training ($133.50), home visit time ($527.57), travel ($718.02), work outside of intervention delivery ($57.14), program screening for eligibility ($3.73), supervision for quality assurance ($250.23), activity supplies ($51.64), and program materials ($29.32). Findings will be compared to a 2008 TAP pilot study post hoc cost analysis to identify how broader scale implementation impacts intervention costs. Opportunities to streamline program delivery will be discussed as well as potential reimbursement mechanisms via Medicare part B, Medicare Advantage, and Medicaid waiver programs.

An empirical analysis of the appeals of primary medical staff from a district in Shanghai

Objective To understand the status quo and differences of the rights and interests of primary medical staff in a community, and to provide targeted suggestions for improving the rights of such staff. Methods From October to November 2018, a questionnaire survey was conducted on all the medical staff of 8 community health service centers in a district of Shanghai, and 562 valid samples were obtained. Results The primary medical staff had the highest demands for pay rise (4.783±0.598), paid vacation (4.569±0.873)and additional reserve fund (4.553±0.963); the lowest demands were placed on education-based promotion (3.797±1.382), refresher training (3.801±1.314), and opinion feedback mechanism (4.018±1.223). At the same time, the rights and interests of these staff in different occupational categories were significantly different(P<0.05)in daily reimbursement , housing subsidy , refresher training and opinion feedback mechanism . Conclusions The salary demands of the primary medical staff are the most obvious, and there are differences in the demands of medical staff in different occupational categories. It is suggested to establish a more reasonable salary system and pay attention to the differentiated appeals of different medical personnel. Key words: Community health center; Primary medical staff; Appeals for rights and interests; Incentive mechanism; Shanghai

PMD39 HOSPITAL REIMBURSEMENT PATHWAYS FOR NEW EXAMINATION AND TREATMENT METHODS IN GERMANY

The German health care system is characterized by a sectoral division into an outpatient and an inpatient sector with different reimbursement mechanisms. For new examination and treatment methods (German: Neue Untersuchungs- und Behandlungsmethoden, NUB) within the hospital, several reimbursement pathways have been created in recent years, including §§ 137e/h SGB V and NUB payments. The aim of this research is to provide a quantitative overview of success rates for inpatient NUB reimbursement pathways. Decisions publicly available on the website of the Joint Federal Committee (German: Gemeinsamer Bundesausschuss, G-BA) up to May 21th 2019 were analyzed descriptively for all existing § 137h procedures and testing guidelines pursuant to § 137e SGB V. Furthermore, the outcomes of all NUB applications submitted to the Institute for the German Hospital Reimbursement System (InEK) between 2016 and 2018 were evaluated. Evidence was screened and analyzed by two individual reviewers. Out of 24 procedures for medical devices under § 137h assessment, twelve (50%) met the § 137h requirements. Assessment was completed for eight (66,7%) of the twelve procedures with no benefit attributed to any of them. “Potential” was assigned to two procedures (25%), six (75%) received the rating “no potential”. Regarding the § 137e procedures, the G-BA approved six testing guidelines. Of the NUB applications submitted in 2016, 139 out of 710 (19.6%) received NUB status 1 which enabled them to negotiate a NUB payment. In 2017, 154 (22,4%) of the 686 applications received NUB status 1 and in 2018, 171 (24,3%) of 705. Out of the 171 applications rated with NUB status 1 in 2018, 57 (33.3%) were medical devices. The chances of success for NUB reimbursement pathways in the inpatient sector are rather moderate and hold many hurdles for the manufacturer. A well-prepared market access strategy is therefore essential.

766. Telehealth Practices, Barriers, and Future Interest among Pediatric Infectious Disease Clinicians in the United States: Results from the 2019 Pediatric Infectious Diseases Society (PIDS) Telehealth Working Group Survey

BackgroundThere is a paucity of access to pediatric infectious diseases (PID) physicians in the United States. To improve access, PID clinicians spend significant time providing nonreimbursed curbside consultations (CCs) to community providers. While there is increasing utilization of telehealth technologies to increase access to PID physicians, there is limited knowledge regarding adoption of these technologies and how they may be used to improve care and reimbursement.MethodsThe PIDS Telehealth Working Group developed a 33-question online survey to collect individual- and practice-level data on the burden of CCs, current telehealth practices and barriers, and interest in providing future telehealth services. It was emailed to the PIDS Listserv (n = 1,213) in April 2019.ResultsA total of 161 (13%) providers completed the survey (100% MD/DO), representing 37 states; most are university- (n = 100, 62%) and/or hospital- (n = 74, 46%) employed. Respondents’ practices provide a mean of 1–10 CCs/week to outside institutions (median 3–5 hours/week), with a median of 6–10% resulting in referrals. Outside nonreimbursed CCs are performed by phone/paging systems (n = 156, 98%), secure email (n = 66, 42%), text messaging (n = 46, 29%), and EMR-messaging (n = 38, 24%); they include a variety of services (Figure 1). Only 46 (29%) of individual respondents provide any type of reimbursed telehealth at their practices (Figure 2). Reimbursement mechanisms include fee-for-service (31%), Medicaid/Medicare (25%), private insurance (24%), and internal institutional (i.e., internal RVU) payments (16%). The majority of respondents were unaware of credentialing (n = 90, 64%) and liability coverage needs for telehealth (n = 68, 47%). Though most respondents (n = 81, 57%) were not satisfied with their current telehealth program and barriers were significant (Figure 3), the majority (n = 144, 95%) were interested in implementing a variety of reimbursable telehealth services and modalities (Figure 4).ConclusionPID survey respondents indicated a lack of knowledge on key aspects of telehealth and perceive significant barriers to implementing telehealth at their institutions. Nonetheless, there is a strong interest in participating in a variety of telehealth services to increase access to care, with appropriate institutional support. Disclosures All authors: No reported disclosures.

Sağlık Hizmet Sunumunun Çıktılarını Değerlendirmede Değer Bazlı Satın Alma Yaklaşımı Kullanılabilir mi?

ABSTRACTIn spite of increasing expenditures for health services, the lack of improvement in the quality and patient safety at the desired level brought about the search for reform of the reimbursement mechanisms. The main purpose of the present review is a search for a comprehensive answer for the question of “Can Value-based Purchasing (VPB) approach emerged as such kind of quest and applications developed in this context be used to evaluate the outputs of health service delivery?”. According to the studies, the VBP approach and especially Hospital Value-based Purchasing Program and Hospital-Acquired Conditions Program which are the two applications developed under this approach can provide effective results in evaluating the outputs in health services and improving quality and patient safety. The data show that the VBP approach in health care has the potential to contribute significantly to improving the quality and patient safety level of the health care service and to keep costs under control. In this context, Hospital Value-based Purchasing and Hospital-Acquired Conditions Programs draw attention in terms of its potential to be implemented especially in the public sphere in our country. The realization of the research and applications in our country aimed at revealing the potential benefits of the mentioned programs will facilitate the evaluation.

A saúde no STF: o ressarcimento interfederativo à luz do Recurso Extraordinário nº 855.178

Objetivo: fazer uma análise crítica sobre a tese da responsabilidade solidária pelo fornecimento de medicamentos, fixada pelo Supremo Tribunal Federal com repercussão geral, no Recurso Extraordinário nº 855.178/SE, ao interpretar a competência administrativa comum da União, Estados e Municípios prevista na Constituição Federal relativamente à saúde, de maneira a chamar atenção para a necessidade de se regulamentar os mecanismos de ressarcimento intergovernamental, com vistas a restabelecer o equilíbrio no pacto federativo. Metodologia: pesquisa teórica e documental sobre o ressarcimento interfederativo de ações e prestações de saúde, tendo como norte o caso que ensejou na fixação da tese. A revisão documental foi o procedimento técnico adotado para fazer a observação indireta do objeto pesquisado, por meio de documentos oficiais, adotando-se como fonte secundária a proposição de Súmula Vinculante nº 4 e o Projeto de Lei nº 4.869/2016, disponíveis em sítios oficiais do governo brasileiro. Resultados: a sistemática fixada pelo SupremoTribunal Federal privilegia o acesso à justiça, de maneira a tornar mais célere a concessão judicial de medicamentos e, em razão disso, tende a fomentar a judicialização da saúde. Conclusões: vislumbra-se o descumprimento da segunda parte da tese, referente ao ressarcimento interferativo, haja vista a complexidade e fragilidade da sistemática atual de reembolso intergovernamental.

An outcomes-based, innovative reimbursement mechanism for curative medicines

An outcomes-based, innovative reimbursement mechanism for curative medicines

Reimbursement of Apps for Mental Health: Findings From Interviews.

BackgroundAlthough apps and other digital and mobile health tools are helping improve the mental health of Americans, they are currently being reimbursed through a varied range of means, and most are not being reimbursed by payers at all.ObjectiveThe aim of this study was to shed light on the state of app reimbursement. We documented ways in which apps can be reimbursed and surveyed stakeholders to understand current reimbursement practices.MethodsIndividuals from over a dozen stakeholder organizations in the domains of digital behavioral and mental health, care delivery, and managed care were interviewed. A review of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCSPCS) codes was conducted to determine potential means for reimbursement.ResultsInterviews and the review of codes revealed that potential channels for app reimbursement include direct payments by employers, providers, patients, and insurers. Insurers are additionally paying for apps using channels originally designed for devices, drugs, and laboratory tests, as well as via value-based payments and CPT and HCSPCS codes. In many cases, it is only possible to meet the requirements of a CPT or HCSPCS code if an app is used in conjunction with human time and services.ConclusionsCurrently, many apps face significant barriers to reimbursement. CPT codes are not a viable means of providing compensation for the use of all apps, particularly those involving little physician work. In some cases, apps have sought clearance from the US Food and Drug Administration for prescription use as digital therapeutics, a reimbursement mechanism with as yet unproven sustainability. There is a need for simpler, more robust reimbursement mechanisms to cover stand-alone app-based treatments.

Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study

BackgroundOnabotulinumtoxinA (BOTOX®, Allergan plc, Dublin, Ireland) is approved for the preventive treatment of headaches in adult patients with chronic migraine (CM) in Australia by the country’s reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS). To our knowledge, this study represents the first focused report evaluating real-world evidence of onabotulinumtoxinA treatment via the PBS in Australian clinics.MethodsThis study reviewed the medical records of adults with inadequately controlled CM from 7 private neurology practices in Australia who, beginning in March 2014, received PBS-subsidized onabotulinumtoxinA per product labelling for the first time. The primary effectiveness measure was the percentage of patients achieving a response defined by 50% or greater reduction in headache days from baseline after 2 treatment cycles. Additional data were recorded in the case report form when available and included demographics, clinical characteristics, headache severity and frequency, Headache Impact Test (HIT-6) score, medication use, and days missed of work or study at baseline, after 2 treatment cycles, and at last follow-up. Differences in mean changes from baseline were evaluated with a 1-tailed t-test or Pearson’s chi-squared test (p < 0.05).ResultsThe study population included 211 patients with a mean (SD) of 25.2 (5.3) monthly headache days at baseline. In the primary outcome analysis, 74% of patients achieved a response, with a mean (SD) of 10.6 (7.9) headache days after 2 treatment cycles (p < 0.001). Secondary effectiveness outcomes included mean (SD) reductions in HIT-6 score of − 11.7 (9.8) and − 11.8 (12.2) after 2 treatment cycles (p < 0.001) and final follow-up (p < 0.001), respectively, and mean (SD) decreases in days per month of acute pain medication use of − 11.5 (7.6) after 2 treatment cycles (p < 0.001) and − 12.7 (8.1) at final follow-up (p < 0.001).ConclusionThis study provides additional clinical evidence for the consistent effectiveness of onabotulinumtoxinA for the treatment of CM in Australia. This effectiveness was made evident by reductions in migraine days, severe headache days, and HIT-6 scores from baseline.