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Purpose The purpose of this manuscript is to describe the regulatory, technological, and training considerations for audiologists investigating telehealth and to offer some examples of audiology services provided through telehealth. Method The authors presented the regulatory components, the technology required for audiology staff and patients, and staff training for the audiology telehealth program at Cincinnati Children's Hospital Medical Center. Four case studies highlighting the successful use of telehealth in providing auditory device services to patients were also presented. Results and Conclusion The described regulatory, technological, and training hierarchy provides a framework for audiologists interested in starting a telehealth program. The cases presented illustrate that telehealth can be used to provide some auditory device services, such as troubleshooting, mapping, and parent consulting.

This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access.

Medicaid’s Path to Value-Based Reform Prominent Medicare value-based payment models are influencing the ways in which clinicians deliver care. CMS and states have also started transforming reimburs...

[Media: see text] Purpose: To describe the US hematology and medical oncology practice landscape and to report findings of the sixth annual ASCO Oncology Practice Census survey. Participants and Methods: ASCO used Medicare Physician Compare data to characterize oncology practices in the United States. Practice size, number of care sites, and geographic distribution were determined. Trends in the number and size of practices from 2013 to 2017 were examined. All US oncology practices were targeted for the survey; survey responses were linked to the practices identified from Physician Compare to augment results and assess generalizability. Results: More than 2,200 hematology/oncology practices provided care to adult patients in 2017. We observed annual decreases in the number of practices and annual increases in practice size. Of the 2017 practices, 394 (18%) completed the survey and accounted for 58% of the US hematologist/oncologist workforce (n = 7,203). Respondents tended to be larger and encompass more sites of care than nonrespondents. Surveyed practices cited payers (58%), competition (38%), and staffing (37%) as primary sources of strain. Prior authorization was dominant among payer pressures (78%). Electronic health records remained a burden on practices, with only 15% reporting full interoperability. Conclusion: The results of ASCO’s 2017 survey indicate that oncology practices are challenged by day-to-day operations, often related to payment, reimbursement, and competition. Our findings likely represent conservative estimates of such burdens because they are driven by responses from midsized to large-sized organizations, which have lower relative administrative burden, greater market influence, and potentially better ability to adapt in a changing health care environment.

ObjectivesTo describe the prevalence of outpatient use and the costs of systemic antibacterials among children and adolescents in Finland during 2008–16 and to examine patterns of use by age and gender.MethodsData were retrieved from the Finnish statistical database Kelasto, based on the Finnish Prescription Registry. Data included information on dispensed reimbursed prescriptions of antibacterials for systemic use in children aged 0–17 years during 2008–16. The prevalence of antibacterial prescriptions per 1000 children and costs per prescription were calculated.ResultsThe overall prevalence of antibacterial prescriptions decreased in the study period and was highest in 2010 (with 708 prescriptions per 1000 children) and lowest in 2016 (with 374 prescriptions per 1000 children). Children aged 1–2 years had the highest prevalence of antibacterial prescriptions. Furthermore, boys had slightly higher prevalences than girls. The 10 most commonly used antibacterial agents covered ∼97% of all prescriptions and broad-spectrum penicillins were the most commonly used antibacterials. The total costs of antibacterials decreased during the study period, but the costs per prescription increased.ConclusionsThis study showed a decreasing trend in the prescribing of antibacterial drugs, regardless of age or gender. Increasing awareness of antimicrobial resistance, reimbursement status changes and pneumococcal and influenza vaccinations are possible reasons for this. Some of the antibacterial oral solutions lost their reimbursement status, but their consumption did not decrease any faster than the consumption of the substances with continuous reimbursability. It is likely that removing the reimbursement status of antibacterials has placed an extra cost burden on families and increased costs per prescription.

New oncology therapies can contribute to survival or quality of life, but payers and policy makers have raised concerns about the cost of these therapies. Similar concerns extend beyond cancer. In seeking a solution, payers are increasingly turning toward value-based payment models in which providers take financial risk for costs and outcomes. These models, including episode payment and bundled payment, create financial gains for providers who reduce cost, but they also create concerns about potential stinting on necessary treatments. One approach, which the Centers for Medicare and Medicaid Services adopted in the Oncology Care Model (OCM), is to partially adjust medical practices' budgets for their use of novel therapies, defined in this case as new oncology drugs or new indications for existing drugs approved after December 31, 2014. In an analysis of the OCM novel therapies adjustment using historical Medicare claims data, we found that the adjustment may provide important financial protection for practices. In a simulation we performed, the adjustment reduced the average loss per treatment episode by $758 (from $807 to $49) for large practices that use novel therapies often. Lessons from the OCM can have implications for other alternative payment models.

ABSTRACT With most providers accepting private and public funding, the US exemplifies hybridization, which results in both systemic benefits and harms. While this practice stimulates innovation, encourages practices to be efficient, and increases choice, it has also been linked to gaps in patient safety and overtreatment. We propose three lessons from the US for navigating a public and private system: hybridization allows for innovation; hybridization leads to administrative complexity; and if the costs of participation outweigh the benefits, practices may undergo dehybridization.

The history of neuromuscular electrical stimulation has been well documented. Depending upon how far back in time one chooses to go, it is clear that the field has a checkered past. It is generally agreed that the experiments of Volta, Galvani, and Lyden demonstrated the early potential of activating neural tissue by electrical currents. However, over the following decades individuals who we now most likely would describe as charlatans claimed miracle cures from the delivery of electricity to various parts of the human anatomy. The lack of a regulatory body and reimbursement mechanism enabled these individuals to make incredibly spurious claims and find desperate patients who would accept these treatments and had the capability to pay for them. It is safe to say that the more recent applications now achieving true clinical impact are not a direct result of this early experimentation. The modern-day approach to electrical stimulation of human tissue was born from the evolution of electronic technology, the development of implantable devices within the body, a growing understanding of modern physiology and anatomy, and successful collaborations between physicians and engineers.

Background In an effort to optimize diagnostic testing for Clostridioides difficile infection (CDI) our health system changed from stand-alone PCR testing to a “2-step” approach wherein all positive PCR results reflexed to an EIA. We report the effects of this change on publicly reported CDI metrics and treatment days of therapy (DOT). Methods The setting includes 10 Cleveland Clinic Health System hospitals in northeast Ohio and one in Florida. On June 12, 2018, 9 NE Ohio hospitals changed from PCR alone to PCR followed by EIA. Stand-alone PCR testing remained at one and GDH / EIA / PCR for discordant for another. Testing volumes were obtained from the microbiology laboratory. C. difficile LabID event SIRs were obtained from NHSN. Public reporting interpretative categories were identified based on SIR for second half of 2018. DOT for CDI agents were obtained from an antimicrobial stewardship database. Results Among hospitals that changed strategy the volume of PCR testing and the percent PCR + was similar between time periods. EIA positivity ranged from 23% to 53%. 4/11 hospitals improved their public reporting category: 3/9 that changed testing strategy and 1/2 that did not (Table 1). Two of 3 that changed strategy and improved public reporting also had a decrease in DOT. DOT increased in the 2 hospitals that did not change strategy. Conclusion Six months after adopting a 2-step CDI testing strategy 7 of 9 hospitals had a lower SIR with 3 also demonstrating an improvement in public reporting category favorably impacting reputational and reimbursement risk for our healthcare system. CDI agent DOT was similar before and after the change. The impact of choice of test on publicly reported metrics demonstrates the difficulty of utilizing a proxy for hospital onset CDI, the CDI LabID event, as a measure of quality of care provided. Disclosures All authors: No reported disclosures.

Speech-language pathologists (SLPs) who treat patients with vocal disorders find they are the exception —rather than the rule—when it comes to Medicare policy. This article addresses statute, regulations, and policies related to acoustical assessments, endoscopy, electronic speech aids, and tracheo-esophageal prostheses (TEPs). Acoustical assessments have limited recognition in the Medicare program and are only reimbursed in certain states, despite advocacy efforts by the American Speech-Language-Hearing Associaiton and members of the State Medicare Administrative Contractor (SMAC) Network. For endoscopy evaluations, confusion is still prevalent related to the level of physician supervision required, primarily due to the changing policies in 2011. Electronic speech aids are a benefit that is often forgotten, though the national policy allows relatively broad coverage. Finally, TEPs are the subject of SLPs, patients, manufacturers, and Congressional attention due to their limited available secondary to poor reimbursement rates and a 2010 enforcement of distribution policy. Clarification regarding the provision of traditional Medicare services (not Medicare Advantage or supplemental plans managed by private companies) and statute is discussed.

The fact that doctors have a long tradition of writing medical history to interpret and direct their profession is well established. But readers (particularly modern physician readers) can also understand physician-authored histories as offering commentary and analysis of the world beyond medicine. In this essay, we offer a reading (perhaps a modern one) of J. Marion Sims's 1877 article, 'The Discovery of Anaesthesia' which exemplifies the stance of looking both inward and outward from the medical field. We begin by discussing Sims, including the complicated legacy he left as a physician. Next, we review late 19th-century history with a focus on Reconstruction. Finally, we show how the modern reader can use Sims's article both to trace the first use of ether and nitrous oxide for surgical anaesthesia and to provide a window into the 19th-century medical profession and the post-Civil War period. Through this study, we hope to show how to read both medicine and the world around it in physician histories.

Future perceptions of the value of curative therapies will likely reflect debates happening today about preferences for funding of preventive versus treatment programs, as well as funding orphan drugs. Little is known about how society will value curative therapies versus standard treatments, and the significant role of a host of psychological factors compared to overarching concerns about opportunity costs will likely lead to significant tension between payers and the public. More research to clarify societal preferences and healthcare goals in regards to curative therapies and in light of the potential for significant opportunity costs will be required. Given what we know about preferences for the funding of prevention and treatment measures, we should expect that cures will not be held to a different measure.

Pediatric dermatology is one of the smallest subspecialties, and expanding the availability of care is of great interest. Teledermatology has been proposed as a way to expand access and improve care delivery, but no current assessment of pediatric teledermatology exists. The objective of the current study was to assess usage and perspectives on pediatric teledermatology. Surveys were distributed electronically to all 226 board-certified U.S. pediatric dermatologists; 44% (100/226) responded. Nearly all respondents (89%) have experience with teledermatology. Formal teledermatology reimbursement success rates have increased to 35%. Respondents were positive about teledermatology's present and future prospects, and 41% want to use teledermatology more often, although they viewed teledermatology as somewhat inferior to in-person care regarding accuracy of diagnosis and appropriation of management plans. Significant differences were found between formal teledermatology users and nonusers in salary structure, practice environment, sex, and region. Substantial increases in pediatric teledermatology have occurred in the last 5 to 10 years, and there remains cause for optimism for teledermatology's future. Concerns about diagnostic confidence and care quality indicate that teledermatology may be best for care of patients with characteristic clinical presentations or management of patients with established diagnoses.

Recent media coverage has highlighted discrepancies in the entitlements of children to free ADHD medication across the country. The Department of Health has since ruled that children with ADHD under 16 are entitled to receive free medications.This study examines the cost to the State of ADHD medication and implications for universal coverage under the long-term illness (LTI) scheme for under 16s. We estimate a potential cost for universal coverage for under 16s.Drug reimbursement entitlements were explored for children with ADHD. Data were retrieved from the Primary Care Reimbursement Services for the Community Drug Schemes for 2011. The cumulative and percentage-spent on the LTI scheme was calculated.€107,894 (4.4 %) of the €2.4 million State spent on ADHD medicines was under the LTI scheme in 2011. We estimate a potential cost of €8.4 million for costs of ADHD medicines for the state based on current prescribing patterns.There appears to be a significant underutilisation of the LTI scheme affording children free ADHD medication. Public and professional awareness campaigns are required to ensure families get the benefits to which they are entitled, and cost does not become a barrier to treatment adherence and improved outcomes. Leading from this, we propose suggestions for cost-effective prescribing to minimise potential cost implications.

OBJECTIVE. The purpose of this article is describe the origins and provisions of breast density legislation and to evaluate these mandates with regard to the balance between the potential benefit of supplementary screening and the substantial risk of false-positive findings and the adjunctive tests they necessitate. CONCLUSION. Many states have passed breast density notification legislation, and federal legislation is pending. These mandates present a number of challenges for patients and physicians. There is no consensus regarding the need for supplementary testing solely because a woman has dense breasts. The failure of density legislation to require insurance coverage in many states further complicates implementation of the mandates.

As reimbursement transitions from a volume-based to a value-based system, innovation in health care delivery will be needed. The process of innovation begins with framing the problem that needs to be solved along with the strategic vision that has to be achieved. Similar to scientific testing, a hypothesis is generated for a new solution to a problem. Innovation requires conducting a disciplined form of experimentation and then learning from the process. This manuscript will discuss the different types of innovation, and the key steps necessary for successful innovation in the health care field.

Purpose: Provincial public drug formularies in Canada have different mechanisms for reimbursement of direct-acting oral anticoagulants (DOACs). We investigate how these differences influence DOAC utilization and expenditure across the country. Methods: We conducted a population-based, cross-sectional study of all out-patient prescriptions for OACs dispensed to public beneficiaries between January 1, 2010, and June 30, 2015. We calculated quarterly rates of OAC use and expenditures stratified by OAC type and province. Results: The greatest increase in quarterly rates of DOAC utilization occurred in provinces with more liberal mechanism of drug coverage: Ontario by 462%, Alberta by 425% and Quebec by 1,924%. This translated to increased expenditure on overall OAC by 270%, 204% and 390%, respectively. In contrast, provinces with more stringent mechanisms had low rates of DOAC utilization and expenditure. Conclusions: DOAC utilization and expenditure is considerably different across Canada, associated with provincial difference in reimbursement mechanism.

The commercial development of advanced therapy medicinal products (ATMPs) represents great opportunity for therapeutic innovation but is beset by many challenges for its developers. Although the ATMP field continues to progress at a rapid pace, evidenced by the increasing number of clinical trials conducted over the past few years, several factors continue to complicate the introduction of ATMPs as a curative treatment for multiple disease types, by blocking their translational pathway from research to the patient. While several recent publications (Trounson and McDonald, 2015; Abou-El-Enein et al., 2016a,b) as well as an Innovative Medicines Initiative consultation (IMI, 2016) this year have highlighted the major gaps in ATMP development, with manufacturing, regulatory, and reimbursement issues at the forefront, there remains to be formulated a coherent strategy to address these by bringing the relevant stakeholders to a single forum, whose task it would be to design and execute a delta plan to alleviate the most pressing bottlenecks. This article focuses on two of the most urgent areas in need of attention in ATMP development, namely manufacturing and reimbursement, and promotes the concept of innovation-dedicated research infrastructures to support a multi-sector approach for ensuring the successful development, entry, and ensuing survival of ATMPs in the healthcare market.

Enthusiasm for performance-based risk-sharing arrangements (PBRSAs) continues but at variable pace across countries. Our objective was to identify and characterize publicly available cases and related trends for these arrangements. We performed a review of PBRSAs from 1993 to 2016 using the University of Washington PBRSA Database. Arrangements were categorized according to a previously published taxonomy. Macro-level trends were identified related to the timing of adoption, countries involved, types of arrangements, and disease areas. Our search yielded 437 arrangements. Among these, 183 (41.9%) were categorized as currently active, while 58.1% have expired. Five main types of arrangements have been identified, namely coverage with evidence development (149 cases, 34.1%), performance-linked reimbursement (104 cases, 23.8%), conditional treatment continuation (78 cases, 17.8%), financial or utilization (71 cases, 16.2%), and hybrid schemes with multiple components (35 cases, 8.0%). The pace of adoption varies across countries but has renewed an upward trend after a lull in 2012/2013. Conditions in the USA may be changing toward a more favorable environment of PBRSAs. Interest in PBRSAs remains high, suggesting they are a viable coverage and reimbursement mechanism for a wide range of medical products.

Background. Despite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europeand estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF). Materials and methods Web-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes. Results The recommended BRAF inhibitor (BRAFi)+MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r=0.662; p Previous article in issue

Measurement in health care today is pervasive. But the question is, are we measuring what matters? What is measured, particularly when it affects payment, drives what we do. It is important to measure what matters. It is time to eliminate the review of systems (ROS). Long revered as a central

This study assessed the financial implications of providing all forms of breast reconstruction at a single academic institution with insurance as the primary mode of reimbursement.Billing records of 152 patients who underwent postmastectomy breast reconstruction offered at the University of Michigan for the 2012 fiscal year were reviewed. Professional and facility revenue, cost, and earnings for the first stage of reconstruction were calculated by applying actual collections and charges. Similar financial data were compiled for a subset of 49 patients who went on to complete reconstruction.The professional revenue and expenses allocated to breast reconstruction were $647,437 and $591,184, respectively (8.7 percent margin). Health care system facility revenue and costs were $2,762,797 and $2,773,131, respectively (-0.4 percent margin). Physician reimbursement by surgical time was highest for delayed tissue expander placement ($3505 per operating room hour). Abdominal free flap reconstructions resulted in greater professional revenue for the first stage of reconstruction ($7801 versus $2961) and for completed reconstructions ($14,943 versus $7703) relative to implant reconstructions. The facility also did better fiscally after the first stage of abdominally based reconstruction compared with implant reconstructions (10 percent versus -10.4 percent margin).Postmastectomy breast reconstruction for this academic surgical practice remains fiscally profitable. Implant-based reconstruction compared with abdominal flap reconstruction produces greater revenue per operative hour but ultimately generates less total revenue and results in financial losses for the facility. Abdominally based perforator flap reconstruction reimbursed through standard insurance plans can be financially advantageous for the academic surgical practice and health care system.

The outgoing editor-in-chief outlines the advances made during her 6-yr tenure and provides recommendations for AJOT’s future