Prescription Drug Prices: An AAN Position Statement.

This position statement serves to establish the AAN's stance on the methods to address the cost of prescription drugs being considered by state and federal policymakers so that the AAN can continue to advocate effectively for its members. Neurologists seek to provide high-value care for patients with neurologic diseases at the lowest cost possible. However, many therapies for neurologic diseases are among the most expensive in the United States. The 3 major cost challenges include (1) unjustified increases in the pricing for drugs used to treat neurologic disorders, (2) the high cost of medications used to treat rare diseases where there are limited or no therapeutic options available, and (3) the high cost of noninnovative (already FDA-approved) therapies that used accelerated FDA approval pathways or Orphan Drug Act designated to expedite approvals in neurologic disorders. In each of these cases, AAN is concerned that the high cost does not deliver sufficient value to patients or society. The AAN's position is that action must be taken to ensure that effective prescription medications are accessible for patients with complex, chronic neurologic conditions. Potential solutions should be affordable, simple, and transparent. Cost-containment efforts must also address the burden on the entire healthcare system because high prescription drug prices may be shifted and absorbed in ways that negatively affect patient and prescriber access to important medications. AAN supports price negotiations, the cost saving potential of generics and biosimilars, development of novel therapeutics, price transparency, and importation.

Guidance for assessment of the inflammation etiologic criterion for the GLIM diagnosis of malnutrition: A modified Delphi approach.

BACKGROUND: The Global Leadership Initiative on Malnutrition (GLIM) approach to malnutrition diagnosis is based on assessment of three phenotypic (weight loss, low body mass index, and reduced skeletal muscle mass) and two etiologic (reduced food intake/assimilation and disease burden/inflammation) criteria, with diagnosis confirmed by fulfillment of any combination of at least one phenotypic and at least one etiologic criterion. The original GLIM description provided limited guidance regarding assessment of inflammation, and this has been a factor impeding further implementation of the GLIM criteria. We now seek to provide practical guidance for assessment of inflammation. METHODS: A GLIM-constituted working group with 36 participants developed consensus-based guidance through a modified Delphi review. A multiround review and revision process served to develop seven guidance statements. RESULTS: The final round of review was highly favorable, with 99% overall "agree" or "strongly agree" responses. The presence of acute or chronic disease, infection, or injury that is usually associated with inflammatory activity may be used to fulfill the GLIM disease burden/inflammation criterion, without the need for laboratory confirmation. However, we recommend that recognition of underlying medical conditions commonly associated with inflammation be supported by C-reactive protein (CRP) measurements when the contribution of inflammatory components is uncertain. Interpretation of CRP requires that consideration be given to the method, reference values, and units (milligrams per deciliter or milligram per liter) for the clinical laboratory that is being used. CONCLUSION: Confirmation of inflammation should be guided by clinical judgment based on underlying diagnosis or condition, clinical signs, or CRP.

Guidance for assessment of the inflammation etiologic criterion for the GLIM diagnosis of malnutrition: A modified Delphi approach.

BACKGROUND & AIMS: The Global Leadership Initiative on Malnutrition (GLIM) approach to malnutrition diagnosis is based on assessment of three phenotypic (weight loss, low body mass index, and reduced skeletal muscle mass) and two etiologic (reduced food intake/assimilation and disease burden/inflammation) criteria, with diagnosis confirmed by fulfillment of any combination of at least one phenotypic and at least one etiologic criterion. The original GLIM description provided limited guidance regarding assessment of inflammation and this has been a factor impeding further implementation of the GLIM criteria. We now seek to provide practical guidance for assessment of inflammation in support of the etiologic criterion for inflammation. METHODS: A GLIM-constituted working group with 36 participants developed consensus-based guidance through a modified-Delphi review. A multi-round review and revision process served to develop seven guidance statements. RESULTS: The final round of review was highly favorable with 99 % overall "agree" or "strongly agree" responses. The presence of acute or chronic disease, infection or injury that is usually associated with inflammatory activity may be used to fulfill the GLIM disease burden/inflammation criterion, without the need for laboratory confirmation. However, we recommend that recognition of underlying medical conditions commonly associated with inflammation be supported by C-reactive protein (CRP) measurements when the contribution of inflammatory components is uncertain. Interpretation of CRP requires that consideration be given to the method, reference values, and units (mg/dL or mg/L) for the clinical laboratory that is being used. CONCLUSION: Confirmation of inflammation should be guided by clinical judgement based upon underlying diagnosis or condition, clinical signs, or CRP.

Growing a rural family physician workforce: The contributions of rural background and rural place of residency training.

OBJECTIVE: To determine the distinct influences of rural background and rural residency training on rural practice choice among family physicians. DATA SOURCES AND STUDY SETTING: We used a subset of The RTT Collaborative rural residency list and longitudinal data on family physicians from the American Board of Family Medicine National Graduate Survey (NGS; three cohorts, 2016-2018) and American Medical College Application Service (AMCAS). STUDY DESIGN: We conducted a logistic regression, computing predictive marginals to assess associations of background and residency location with physician practice location 3 years post-residency. DATA COLLECTION/EXTRACTION METHODS: We merged NGS data with residency type-rural or urban-and practice location with AMCAS data on rural background. PRINCIPAL FINDINGS: Family physicians from a rural background were more likely to choose rural practice (39.2%, 95% CI = 35.8, 42.5) than those from an urban background (13.8%, 95% CI = 12.5, 15.0); 50.9% (95% CI = 43.0, 58.8) of trainees in rural residencies chose rural practice, compared with 18.0% (95% CI = 16.8, 19.2) of urban trainees. CONCLUSIONS: Increasing rural programs for training residents from both rural and urban backgrounds, as well as recruiting more rural students to medical education, could increase the number of rural family physicians.

Criteria for the procedural fairness of health financing decisions: a scoping review.

Due to constraints on institutional capacity and financial resources, the road to universal health coverage (UHC) involves difficult policy choices. To assist with these choices, scholars and policy makers have done extensive work on criteria to assess the substantive fairness of health financing policies: their impact on the distribution of rights, duties, benefits and burdens on the path towards UHC. However, less attention has been paid to the procedural fairness of health financing decisions. The Accountability for Reasonableness Framework (A4R), which is widely applied to assess procedural fairness, has primarily been used in priority-setting for purchasing decisions, with revenue mobilization and pooling receiving limited attention. Furthermore, the sufficiency of the A4R framework's four criteria (publicity, relevance, revisions and appeals, and enforcement) has been questioned. Moreover, research in political theory and public administration (including deliberative democracy), public finance, environmental management, psychology, and health financing has examined the key features of procedural fairness, but these insights have not been synthesized into a comprehensive set of criteria for fair decision-making processes in health financing. A systematic study of how these criteria have been applied in decision-making situations related to health financing and in other areas is also lacking. This paper addresses these gaps through a scoping review. It argues that the literature across many disciplines can be synthesized into 10 core criteria with common philosophical foundations. These go beyond A4R and encompass equality, impartiality, consistency over time, reason-giving, transparency, accuracy of information, participation, inclusiveness, revisability and enforcement. These criteria can be used to evaluate and guide decision-making processes for financing UHC across different country income levels and health financing arrangements. The review also presents examples of how these criteria have been applied to decisions in health financing and other sectors.

Impact of Primary Care Exception Expansion on Family Medicine Resident Billing During the COVID-19 Pandemic.

BACKGROUND AND OBJECTIVES: The Medicare Primary Care Exception (PCE) permits indirect supervision of residents performing lower-complexity visits in primary care settings. During the COVID-19 pandemic, Medicare expanded the PCE to all patient visits regardless of complexity. This study investigates how PCE expansion changed resident billing practices at a family medicine residency during calendar year 2020. We hypothesized that residents not constrained by the PCE would bill more high-level visits. METHODS: We queried billing codes from attendings' and residents' established evaluation and management visits associated with the University of Washington Family Medicine Residency (UWFMR) from January to December 2020. We used χ2 tests to compare resident and attending physicians' use of low/moderate and high-level codes by quarter. RESULTS: Resident high-complexity code use increased after PCE expansion in Q4 (odds ratio [OR] 3.50 [2.34-5.23]) compared to Q1. No change was observed among attending physicians (OR 1.05 [0.86-1.28]). Resident and attending billing patterns became more similar following PCE expansion. CONCLUSIONS: With the PCE expansion, senior family medicine resident physicians at UWFMR used higher-complexity billing codes at a rate approximating that of attending physicians. The findings of this study have implications regarding the financial well-being and sustainability of primary care residency training and raise a relevant policy question about whether the PCE expansion should persist. More research is needed to determine whether these findings were replicated in other primary care residency practices, the impact on resident education, and the impact on patient outcomes.

The effect of carbon price on low carbon innovation.

Whilst many governments have implemented carbon pricing to provide firms with a greater financial incentive to develop low carbon technologies, the effect of the carbon price on the level of low carbon innovation remains unclear. In this study we develop an empirically grounded model of firms' carbon price expectations and innovation processes. We use this model to show that a 1 USD increase in the expected future carbon price is associated with a 1.4% increase in the level of patenting in low carbon technologies, based on data for countries participating in the EU emissions trading system. We also find that firms gradually update their expectations of the future carbon price in response to recent price changes. Our findings indicate that higher carbon prices provide an effective incentive for low carbon innovation.

The Effect of Rural Underserved Opportunities Program Participation on Medical Graduates' Decision to Work in Rural Areas.

PURPOSE: There is a persistent rural physician shortage in the United States. Policies to scale up the health workforce in response to this shortage must include measures to draw and maintain existing and newly trained health care workers to rural regions. Prior studies have found that experience in community medicine in rural practice settings increases the likelihood of medical graduates practicing in those regions but have not accounted for selection bias. This study examined the impact of a community-based clinical immersion program on medical graduates' decision to work in rural regions, adjusting for covariates to control for selection bias. METHOD: Data on sociodemographic characteristics and career interests and preferences for all 1,172 University of Washington School of Medicine graduates between 2009 and 2014 were collected. A logistic model (model 1) was used to evaluate the impact of Rural Underserved Opportunities Program (RUOP) participation on the probability of physicians working in a rural region. Another model (model 2) included the propensity score as a covariate in the regression to control for possible confounding based on differences among those who did and did not participate in the RUOP. RESULTS: Of the 994 students included in the analysis, 570 (57.3%) participated in RUOP training, and 111 (11.2%) were currently working in rural communities after their training. Regression analysis results showed that the odds of working in a rural region were 1.83 times higher for graduates who participated in RUOP in model 1 ( P = .03) and 1.77 times higher in model 2 ( P = .04). CONCLUSIONS: The findings of this study emphasize that educational programs and policies are crucial public health interventions that can promote health equity through proper distribution of health care workers across rural regions of the United States.

The rapid assessment for prostate imaging and diagnosis (RAPID) prostate cancer diagnostic pathway.

OBJECTIVE: To report outcomes within the Rapid Assessment for Prostate Imaging and Diagnosis (RAPID) diagnostic pathway, introduced to reduce patient and healthcare burdens and standardize delivery of pre-biopsy multiparametric magnetic resonance imaging (MRI) and transperineal biopsy. PATIENTS AND METHODS: A total of 2130 patients from three centres who completed the RAPID pathway (3 April 2017 to 31 March 2020) were consecutively entered as a prospective registry. These patients were also compared to a pre-RAPID cohort of 2435 patients. Patients on the RAPID pathway with an MRI score 4 or 5 and those with PSA density ≥0.12 and an MRI score 3 were advised to undergo a biopsy. Primary outcomes were rates of biopsy and cancer detection. Secondary outcomes included comparison of transperineal biopsy techniques, patient acceptability and changes in time to diagnosis before and after the introduction of RAPID. RESULTS: The median patient age and PSA level were 66 years and 6.6 ng/mL, respectively. Biopsy could be omitted in 43% of patients (920/2130). A further 7.9% of patients (168/2130) declined a recommendation for biopsy. The percentage of biopsies avoided among sites varied (45% vs 36% vs 51%; P < 0.001). In all, 30% (221/742) had a local anaesthetic (grid and stepper) transperineal biopsy. Clinically significant cancer detection (any Gleason score ≥3 + 4) was 26% (560/2130) and detection of Gleason score 3 + 3 alone constituted 5.8% (124/2130); detection of Gleason score 3 + 3 did not significantly vary among sites (P = 0.7). Among participants who received a transperineal targeted biopsy, there was no difference in cancer detection rates among local anaesthetic, sedation and general anaesthetic groups. In the 2435 patients from the pre-RAPID cohor, time to diagnosis was 32.1 days (95% confidence interval [CI] 29.3-34.9) compared to 15.9 days (95% CI 12.9-34.9) in the RAPID group. A total of 141 consecutive patient satisfaction surveys indicated a high satisfaction rate with the pathway; 50% indicated a preference for having all tests on a single day. CONCLUSIONS: The RAPID prostate cancer diagnostic pathway allows 43% of men to avoid a biopsy while preserving good detection of clinically significant cancers and low detection of insignificant cancers, although there were some centre-level variations.

Osteohistological and taphonomic life-history assessment of Edmontosaurus annectens (Ornithischia: Hadrosauridae) from the Late Cretaceous (Maastrichtian) Ruth Mason dinosaur quarry, South Dakota, United States, with implication for ontogenetic segregation between juvenile and adult hadrosaurids.

The Late Cretaceous (Maastrichtian) Ruth Mason Dinosaur Quarry (RMDQ) represents a monodominant Edmontosaurus annectens bonebed from the Hell Creek Formation of South Dakota and has been determined as a catastrophic death assemblage likely belonging to a single population, providing an ideal sample to investigate hadrosaurid growth and population dynamics. For this study, size-frequency distributions were constructed from linear measurements of long bones (humeri, femora, tibiae) from RMDQ that revealed five relatively distinct size classes along a generally right-skewed distribution, which is consistent with a catastrophic assemblage. To test the relationship between morphological size ranges and ontogenetic age classes, subsets from each size-frequency peak were transversely thin-sectioned at mid-diaphysis to conduct an ontogenetic age assessment based on growth marks and observations of the bone microstructure. When combining these independent datasets, growth marks aligned with size-frequency peaks, with the exclusion of the overlapping subadult-adult size range, indicating a strong size-age relationship in early ontogeny. A growth curve analysis of tibiae indicated that E. annectens exhibited a similar growth trajectory to the Campanian hadrosaurid Maiasaura, although attaining a much larger asymptotic body size by about 9 years of age, further suggesting that the clade as a whole may have inherited a similar growth strategy. This rich new dataset for E. annectens provides new perspectives on other hypotheses of hadrosaurid life history. When the RMDQ population was compared with size distributions from other hadrosaurid bonebed assemblages, juveniles (categorized as ages one and two) were either completely absent from or heavily underrepresented in the samples, providing support for the hypothesized segregation between juvenile and adult hadrosaurids. Osteohistological comparison with material from polar and temperate populations of Edmontosaurus revealed that previous conclusions correlating osteohistological growth patterns with the strength of environmental stressors were a result of sampling non-overlapping ontogenetic growth stages.

Testing the contextual Interaction theory in a UHC pilot district in South Africa.

BACKGROUND: World-wide, there is growing universal health coverage (UHC) enthusiasm. The South African government began piloting policies aimed at achieving UHC in 2012. These UHC policies have been and are being rolled out in the ten selected pilot districts. Our study explored policy implementation experiences of 71 actors involved in UHC policy implementation, in one South African pilot district using the Contextual Interaction Theory (CIT) lens. METHOD: Our study applied a two-actor deductive theory of implementation, Contextual Interaction Theory (CIT) to analyse 71 key informant interviews from one National Health Insurance (NHI) pilot district in South Africa. The theory uses motivation, information, power, resources and the interaction of these to explain implementation experiences and outcomes. The research question centred on the utility of CIT tenets in explaining the observed implementation experiences of actors and outcomes particularly policy- practice gaps. RESULTS: All CIT central tenets (information, motivation, power, resources and interactions) were alluded to by actors in their policy implementation experiences, a lack or presence of these tenets were explained as either a facilitator or barrier to policy implementation. This theory was found as very useful in explaining policy implementation experiences of both policy makers and facilitators. CONCLUSION: A central tenet that was present in this context but not fully captured by CIT was leadership. Leadership interactions were revealed as critical for policy implementation, hence we propose the inclusion of leadership interactions to the current CIT central tenets, to become motivation, information, power, resources, leadership and interactions of all these.

NHS 111 Clinical Assessment Services: paediatric consultations.

Around the UK, commissioners have different models for delivering NHS 111, General Practice (GP) out-of-hours and urgent care services, focusing on telephony to help deliver urgent and emergency care. During the (early phases of the) COVID-19 pandemic, NHS 111 experienced an unprecedented volume of calls. At any time, 25%-30% of calls relate to children and young people (CYP). In response, the CYP's Transformation and Integrated Urgent Care teams at NHS England and NHS Improvement (NHSE/I) assisted in redeploying volunteer paediatricians into the integrated urgent care NHS 111 Clinical Assessment Services (CAS), taking calls about CYP. From this work, key stakeholders developed a paediatric 111 consultation framework, as well as learning outcomes, key capabilities and illustrations mapped against the Royal College of Paediatrics and Child Health (RCPCH) Progress curriculum domains, to aid paediatricians in training to undertake NHS 111 activities. These learning outcomes and key capabilities have been endorsed by the RCPCH Curriculum Review Group and are recommended to form part of the integrated urgent care service specification and workforce blueprint to improve outcomes for CYP.

OpenSAFELY: impact of national guidance on switching anticoagulant therapy during COVID-19 pandemic.

BACKGROUND: Early in the COVID-19 pandemic, the National Health Service (NHS) recommended that appropriate patients anticoagulated with warfarin should be switched to direct-acting oral anticoagulants (DOACs), requiring less frequent blood testing. Subsequently, a national safety alert was issued regarding patients being inappropriately coprescribed two anticoagulants following a medication change and associated monitoring. OBJECTIVE: To describe which people were switched from warfarin to DOACs; identify potentially unsafe coprescribing of anticoagulants; and assess whether abnormal clotting results have become more frequent during the pandemic. METHODS: With the approval of NHS England, we conducted a cohort study using routine clinical data from 24 million NHS patients in England. RESULTS: 20 000 of 164 000 warfarin patients (12.2%) switched to DOACs between March and May 2020, most commonly to edoxaban and apixaban. Factors associated with switching included: older age, recent renal function test, higher number of recent INR tests recorded, atrial fibrillation diagnosis and care home residency. There was a sharp rise in coprescribing of warfarin and DOACs from typically 50-100 per month to 246 in April 2020, 0.06% of all people receiving a DOAC or warfarin. International normalised ratio (INR) testing fell by 14% to 506.8 patients tested per 1000 warfarin patients each month. We observed a very small increase in elevated INRs (n=470) during April compared with January (n=420). CONCLUSIONS: Increased switching of anticoagulants from warfarin to DOACs was observed at the outset of the COVID-19 pandemic in England following national guidance. There was a small but substantial number of people coprescribed warfarin and DOACs during this period. Despite a national safety alert on the issue, a widespread rise in elevated INR test results was not found. Primary care has responded rapidly to changes in patient care during the COVID-19 pandemic.

Development of Policy-Relevant Indicators for Injury Prevention in British Columbia by the Key Decision-Makers.

Indicators can help decision-makers evaluate interventions in a complex, multi-sectoral injury system. We aimed to create indicators for road safety, seniors falls, and 'all-injuries' to inform and evaluate injury prevention initiatives in British Columbia, Canada. The indicator development process involved a five-stage mixed methodology approach, including an environmental scan of existing indicators, generating expert consensus, selection of decision-makers and conducting a survey, selection of final indicators, and specification of indicators. An Indicator Reference Group (IRG) reviewed the list of indicators retrieved in the environmental scan and selected candidate indicators through expert consensus based on importance, modifiability, acceptance, and practicality. Key decision-makers (n = 561) were invited to rank each indicator in terms of importance and actionability (online survey). The IRG applied inclusion criteria and thresholds to survey responses from decision-makers, which resulted in the selection of 47 road safety, 18 seniors falls, and 33 all-injury indicators. After grouping "like" indicators, a final list of 23 road safety, 8 seniors falls, and 13 all-injury indicators were specified. By considering both decision-maker ranking and expert opinion, we anticipate improved injury system performance through advocacy, accountability, and evidence-based resource allocation in priority areas. Our indicators will inform a data management framework for whole-system reporting to drive policy and funding for provincial injury prevention improvement.

Will the Quest for UHC be Derailed?

COVID-19 has shocked all countries' economic and health systems. The combined direct health impact and the current macro-fiscal picture present real and present risks to health financing that facilitate progress toward universal health coverage (UHC). This paper lays out the health financing mechanisms through which the UHC objectives of service coverage and financial protection may be impacted. Macroeconomic, fiscal capacity, and poverty indicators and trends are analyzed in conjunction with health financing indicators to present spending scenarios. The analysis shows that falling or reduced economic growth, combined with rising poverty, is likely to lead to a fall in service use and coverage, while any observed reductions in out-of-pocket spending have to be analyzed carefully to make sure they reflect improved financial protection and not just decreased utilization of services. Potential decreases in out-of-pocket spending will likely be drive by households' financial constraints that lead to less service use. In this way, it is critical to measure and monitor both the service coverage and financial protection indicators of UHC to have a complete picture of downstream effects. The analysis of historical data, including available evidence since the start of the COVID-19 pandemic, lay the foundation for health financing-related policy options that can effectively safeguard UHC progress particularly for the poor and most vulnerable. These targeted policy options are based on documented evidence of effective country responses to previous crises as well as the overall evidence base around health financing for UHC.