43 research outputs found
Vital Access: How Policymakers Can Streamline the Cancer Care Journey
Patients' odds of surviving blood cancer often hinge on their ability to access specialists who can evaluate, diagnose, and treat them with optimal treatments as quickly as possible. But too often, patients encounter roadblocks that prevent them from accessing the best care and, in some cases, benefiting from incredible advancements. Recent data reveal continued disparities in outcomes for minority populations in particular.Accessing medically necessary and high-quality blood cancer care in the United States is a process that remains overly complex and contingent on factors that are steeped in systemic, socioeconomic, and racial disparities. Numerous factors impact access, but a fragmented insurance system and similarly fragmented federal and state policies that set the rules for that insurance system are major contributors. Studies have noted the impact of narrow networks, which can restrict access to some specialty care providers such as hospitals designated as "cancer centers" or "comprehensive cancer centers" by the National Cancer Institute (NCI). Narrow networks are increasingly common in commercial insurance plans in the individual and group markets and in Medicaid-managed care organizations (MCOs). Studies have also shown that cancer patients with certain types of insurance, such as Medicaid–which covers low-income people, a disproportionate share of whom are people of color–are more likely to experience worse mortality rates. These disparities in coverage and access contribute to significant inequities by income, race, ethnicity, and other factors.In the past three-plus decades, we have seen an explosion of new therapies, including immunotherapy (such as CAR T-cell) and other personalized medicine approaches that target therapies to an individual based on a range of phenotypic and genomic factors.The policy frameworks that govern insurance have not kept pace with advances in cancer treatment, and they continue to contribute to systemic inequities that prevent access to high-quality blood cancer care. Recent efforts by federal regulators to update access-related standards still fall short of ensuring equitable access to quality blood cancer care for all. And some elements of these frameworks have remained largely unchanged for decades. Meaning consumers still struggle to navigate their options when purchasing a plan and access medically appropriate treatment when a diagnosis is received.This report offers nine recommendations in five reform pathways for state and federal policymakers to consider, as they work toward developing insurance regulations that advance a more equitable system of care–one that enables patients with blood cancer to access appropriate treatment and that maximizes the potential for long-term survival. Each of these reform pathways addresses specific deficiencies in the current insurance policy frameworks, and each is critical to pursue in order to ensure a more equitable coverage landscape for patients and familie
Crop Updates 2005 - Cereals
This session covers thirty six papers from different authors:
WHEAT AGRONOMY
1. Optimum sowing time of new wheat varieties in Western Australia, Darshan Sharma, Brenda Shackley, Mohammad Amjad, Christine M. Zaicou-Kunesch and Wal Anderson, Department of Agriculture
2. Wheat varieties updated in ‘Flowering Calculator’: A model predicting flowering time, B. Shackley, D. Tennant, D. Sharma and C.M. Zaicou-Kunesch, Department of Agriculture
3. Plant populations for wheat varieties, Christine M. Zaicou-Kunesch, Wal Anderson, Darshan Sharma, Brenda Shackley and Mohammad Amjad, Department of Agriculture
4. New wheat cultivars response to fertiliser nitrogen in four major agricultural regions of Western Australia, Mohammad Amjad, Wal Anderson, Brenda Shackley, Darshan Sharma and Christine Zaicou-Kunesch, Department of Agriculture
5. Agronomic package for EGA Eagle Rock, Steve Penny, Department of Agriculture
6. Field evaluation of eastern and western wheats in large-scale farmer’s trials, Mohammad Amjad, Ben Curtis and Veronika Reck, Department of Agriculture
7. New wheat varieties for a changing environment, Richard Richards, CSIRO Plant Industry; Canberra
8. Farmers can profitably minimise exposure to frost! Garren Knell, Steve Curtin and David Sermon, ConsultAg
9. National Variety Trials, Alan Bedggood, Australian Crops Accreditation System; Horsham
10. Preharvest-sprouting tolerance of wheat in the field, T.B. Biddulph1, T.L. Setter2, J.A. Plummer1 and D.J. Mares3; 1Plant Biology; FNAS, University of Western Australia; 2Department of Agriculture, 3School of Agriculture and Wine, University of Adelaide
11. Waterlogging induces high concentration of Mn and Al in wheat genotypes in acidic soils, H. Khabaz-Saberi, T. Setter, I. Waters and G. McDonald, Department of Agriculture
12. Agronomic responses of new wheat varieties in the Northern Agricultural Region, Christine M. Zaicou-Kunesch and Wal Anderson, Department of Agriculture
13. Agronomic responses of new wheat varieties in the Central Agricultural Region of WA, Darshan Sharma, Steve Penny and Wal Anderson, Department of Agriculture
14. EGA Eagle Rock tolerance to metribuzin and its mixtures, Harmohinder Dhammu, David Nicholson and Chris Roberts, Department of Agriculture
15. Herbicide tolerance of new bread wheats, Harmohinder Dhammu1 and David Nicholson2, Department of Agriculture
NUTRITION
16. The impact of fertiliser placement, timing and rates on nitrogen-use efficiency, Stephen Loss, CSBP Ltd
17. Cereals deficient in potassium are most susceptible to some leaf diseases, Ross Brennan and Kith Jayasena, Department of Agriculture
18. Responses of cereal yields to potassium fertiliser type, placement and timing, Eddy Pol, CSBP Limited
19. Sulphate of Potash, the potash of choice at seeding, Simon Teakle, United Farmers Co-operative
20. Essential disease management for successful barley production, K. Jayasena, R. Loughman, C. Beard, B. Paynter, K. Tanaka, G. Poulish and A. Smith, Department of Agriculture
21. Genotypic differences in potassium efficiency of wheat, Paul Damon and Zed Rengel, Faculty of Natural and Agricultural Sciences, University of Western Australia
22. Genotypic differences in potassium efficiency of barley, Paul Damon and Zed Rengel, Faculty of Natural and Agricultural Sciences, University of Western Australia
23. Investigating timing of nitrogen application in wheat, Darshan Sharma and Lionel Martin, Department of Agriculture, and Muresk Institute of Agriculture, Curtin University of Technology
24. Nutrient timing requirements for increased crop yields in the high rainfall cropping zone, Narelle Hill, Ron McTaggart, Dr Wal Anderson and Ray Tugwell, Department of Agriculture
DISEASES
25. Integrate strategies to manage stripe rust risk, Geoff Thomas, Robert Loughman, Ciara Beard, Kith Jayasena and Manisha Shankar, Department of Agriculture
26. Effect of primary inoculum level of stripe rust on variety response in wheat, Manisha Shankar, John Majewski and Robert Loughman, Department of Agriculture
27. Disease resistance update for wheat varieties in WA, M. Shankar, J.M. Majewski, D. Foster, H. Golzar, J. Piotrowski and R. Loughman, Department of Agriculture
28. Big droplets for wheat fungicides, Rob Grima, Agronomist, Elders
29. On farm research to investigate fungicide applications to minimise leaf disease impacts in wheat, Jeff Russell and Angie Roe, Department of Agriculture, and Farm Focus Consultants
PESTS
30. Rotations for nematode management, Vivien A. Vanstone, Sean J. Kelly, Helen F. Hunter and Mena C. Gilchrist, Department of Agriculture
31. Investigation into the adaqyacy of sealed farm silos in Western Australia to control phosphine-resistant Rhyzopertha dominica, C.R. Newman, Department of Agriculture
32.Insect contamination of cereal grain at harvest, Svetlana Micic and Phil Michael, Department of Agriculture
33. Phosure – Extending the life of phosphine, Gabrielle Coupland and Ern Kostas, Co-operative Bulk Handling
SOIL
34. Optimum combinations of ripping depth and tine spacing for increasing wheat yield, Mohammed Hamza and Wal Anderson, Department of Agriculture
35. Hardpan penetration ability of wheat roots, Tina Botwright Acuña and Len Wade, School of Plant Biology, University of Western Australia
MARKETS
36. Latin America: An emerging agricultural powerhouse, Ingrid Richardson, Food and Agribusiness Research, Rabobank; Sydne
Early ultrasound surveillance of newly-created haemodialysis arteriovenous fistula
IntroductionWe assess if ultrasound surveillance of newly-created arteriovenous fistulas (AVFs) can predict nonmaturation sufficiently reliably to justify randomized controlled trial (RCT) evaluation of ultrasound-directed salvage intervention.MethodsConsenting adults underwent blinded fortnightly ultrasound scanning of their AVF after creation, with scan characteristics that predicted AVF nonmaturation identified by logistic regression modeling.ResultsOf 333 AVFs created, 65.8% matured by 10 weeks. Serial scanning revealed that maturation occurred rapidly, whereas consistently lower fistula flow rates and venous diameters were observed in those that did not mature. Wrist and elbow AVF nonmaturation could be optimally modeled from week 4 ultrasound parameters alone, but with only moderate positive predictive values (PPVs) (wrist, 60.6% [95% confidence interval, CI: 43.9–77.3]; elbow, 66.7% [48.9–84.4]). Moreover, 40 (70.2%) of the 57 AVFs that thrombosed by week 10 had already failed by the week 4 scan, thus limiting the potential of salvage procedures initiated by that scan’s findings to alter overall maturation rates. Modeling of the early ultrasound characteristics could also predict primary patency failure at 6 months; however, that model performed poorly at predicting assisted primary failure (those AVFs that failed despite a salvage attempt), partly because patency of at-risk AVFs was maintained by successful salvage performed without recourse to the early scan data.ConclusionEarly ultrasound surveillance may predict fistula maturation, but is likely, at best, to result in only very modest improvements in fistula patency. Power calculations suggest that an impractically large number of participants (>1700) would be required for formal RCT evaluation
Is There Evidence of "Whitening" For Asian/White Multiracial People in Britain?
Growing rates of interracial unions in multi-ethnic societies such as Britain are notable, and point to significant changes in the blurring and possibly shifting nature of ethnic and racial boundaries. Asian Americans who partner with White Americans are assumed to engage in “whitening” – both in terms of their aspirations and their social consequences. Yet little is still known about the aftermath of intermarriage, even in the USA. Drawing on this US literature, this paper considers the whitening thesis in relation to multiracial people in Britain, with a particular focus on Asian/White multiracial people. I draw upon the findings of two British studies – one of multiracial young people in higher education (Aspinall & Song 2013), and another of multiracial people who are parents (Song 2017) – to explore these questions. I argue that conceptualizations of part Asian people (in the USA) as leaning toward their White heritages are often unsubstantiated, and deduced primarily from one key factor: their high rates of intermarriage with White spouses. In addition to the variable ways in which part Asian people may relate to their minority and White ancestries, we must consider the ambivalence, tensions, and contextually variable identifications and practices adopted by multiracial people
O trabalho profissional burocrático: modelo de análise da profissionalização do trabalho em serviço social no setor não lucrativo em Portugal
Bi-allelic Loss-of-Function CACNA1B Mutations in Progressive Epilepsy-Dyskinesia.
The occurrence of non-epileptic hyperkinetic movements in the context of developmental epileptic encephalopathies is an increasingly recognized phenomenon. Identification of causative mutations provides an important insight into common pathogenic mechanisms that cause both seizures and abnormal motor control. We report bi-allelic loss-of-function CACNA1B variants in six children from three unrelated families whose affected members present with a complex and progressive neurological syndrome. All affected individuals presented with epileptic encephalopathy, severe neurodevelopmental delay (often with regression), and a hyperkinetic movement disorder. Additional neurological features included postnatal microcephaly and hypotonia. Five children died in childhood or adolescence (mean age of death: 9 years), mainly as a result of secondary respiratory complications. CACNA1B encodes the pore-forming subunit of the pre-synaptic neuronal voltage-gated calcium channel Cav2.2/N-type, crucial for SNARE-mediated neurotransmission, particularly in the early postnatal period. Bi-allelic loss-of-function variants in CACNA1B are predicted to cause disruption of Ca2+ influx, leading to impaired synaptic neurotransmission. The resultant effect on neuronal function is likely to be important in the development of involuntary movements and epilepsy. Overall, our findings provide further evidence for the key role of Cav2.2 in normal human neurodevelopment.MAK is funded by an NIHR Research Professorship and receives funding from the Wellcome Trust, Great Ormond Street Children's Hospital Charity, and Rosetrees Trust. E.M. received funding from the Rosetrees Trust (CD-A53) and Great Ormond Street Hospital Children's Charity. K.G. received funding from Temple Street Foundation. A.M. is funded by Great Ormond Street Hospital, the National Institute for Health Research (NIHR), and Biomedical Research Centre. F.L.R. and D.G. are funded by Cambridge Biomedical Research Centre. K.C. and A.S.J. are funded by NIHR Bioresource for Rare Diseases. The DDD Study presents independent research commissioned by the Health Innovation Challenge Fund (grant number HICF-1009-003), a parallel funding partnership between the Wellcome Trust and the Department of Health, and the Wellcome Trust Sanger Institute (grant number WT098051). We acknowledge support from the UK Department of Health via the NIHR comprehensive Biomedical Research Centre award to Guy's and St. Thomas' National Health Service (NHS) Foundation Trust in partnership with King's College London. This research was also supported by the NIHR Great Ormond Street Hospital Biomedical Research Centre. J.H.C. is in receipt of an NIHR Senior Investigator Award. The research team acknowledges the support of the NIHR through the Comprehensive Clinical Research Network. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, Department of Health, or Wellcome Trust. E.R.M. acknowledges support from NIHR Cambridge Biomedical Research Centre, an NIHR Senior Investigator Award, and the University of Cambridge has received salary support in respect of E.R.M. from the NHS in the East of England through the Clinical Academic Reserve. I.E.S. is supported by the National Health and Medical Research Council of Australia (Program Grant and Practitioner Fellowship)
Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19
IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.
Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.
DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).
INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days.
MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes.
RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively).
CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570
Federal Agencies Enroll Health Insurers in PrEP School
Ending the HIV epidemic is within reach. Community advocacy and medical advances have provided the tools to prevent the transmission and contraction of HIV, but health care barriers prevent many individuals from accessing this care. Recent guidance aims to clarify practices around the coverage of HIV preventive care but faces a potential threat from the courts. Pre-exposure prophylaxis (PrEP), a medication that prevents the transmission of HIV when used as prescribed, has been an important tool in the effort to curb new transmissions. Approved by the U.S. Food and Drug Administration (FDA) in 2018, PrEP is a remarkably effective biomedical prevention, reducing the risk of getting HIV from sex by 99 percent and from injection drug use by 74 percent. The medication stands as a “core pillar” in the U.S. Department of Health and Human Service’s initiative known as Ending the HIV Epidemic in the United States. PrEP use, however, remains low. Fewer than 25 percent of individuals who could benefit from PrEP are taking it, in part due to the costs associated with the regimen. An effective PrEP regimen is more than just a pill; it includes periodic HIV testing, hepatitis B and C testing, creatinine testing, kidney function tests, pregnancy testing, STI screening, and adherence counseling. Even when PrEP medication is covered by insurance, these additional costs make accessing the regimen prohibitive. Fortunately, the Affordable Care Act (ACA) includes a provision that facilitates access to preventive services with proven clinical efficacy at no additional cost to the consumer. Section 2713 of the ACA requires all non-grandfathered private health plans to cover preventive services at no cost when those services are rated “A” or “B” by the U.S. Preventive Services Task Force (USPSTF). The USPSTF awards its ratings after reviewing clinical data and concluding that the services likely provide a substantial or moderate net benefit. In June of 2019, PrEP received an “A” recommendation from the USPSTF, paving the way for no-cost access beginning in 2021. The USPSTF recommendation was helpful, yet left many unanswered questions as advocates noted that the recommendation alone might not ensure full coverage. For example, the USPSTF recommendation to “offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy” seemed only to consider PrEP as a pill, leaving the question unanswered as to whether additional services needed for an effective PrEP regimen must also be covered without cost sharing. In addition, the USPSTF’s recommendation was released when FDA had only approved one drug for PrEP. Currently, FDA has approved two regimens and a generic competitor available to consumers, and soon FDA may approve a long-acting, injectable version of PrEP. Despite calls from advocates to clarify guidance prior to the start of the 2021 plan year, insurers began rolling out their interpretations of the new USPSTF recommendation without any further details from regulators. As one could expect, implementation came with varying levels of comprehensiveness. Because PrEP medications are also used as part of HIV treatment regimens, many insurers continued to simply list the medication on their drug lists on high cost-sharing tiers, and few explicitly included coverage of the ancillary services for PrEP clearly in plan marketing documents. The U.S. Department of Labor, the U.S. Department of Health and Human Services, and the U.S. Department of the Treasury alleviated much of this confusion by issuing guidance to insurers earlier this summer. This tri-agency interpretation from the departments clarified that PrEP services are included within the USPSTF recommendation and must be covered at no cost. The departments further explained that this coverage requirement extends to services needed before PrEP initiation—for example, initial lab testing and associated visits—and for ongoing monitoring. Recognizing the apparent confusion over the coverage of ancillary services, the departments stated that they would not take enforcement action against any plan or issuer until 60 days post-publication of the FAQ—a period which has now passed— and they urged state regulators to take a similar enforcement strategy. Plans and insurers are now on notice that coverage policies must be restructured accordingly. Ideally, insurers will update public-facing plan materials—formularies and summaries of benefits—to inform individuals shopping for coverage what PrEP medications and services are covered at no cost. Public information about the coverage of PrEP medications and services would not only provide greater transparency to consumers, but it would also be an essential tool for regulators to hold insurers accountable to their Section 2713 obligations. With respect to the frequency of coverage, the departments have clarified that plans and insurers may not use medical management techniques that limit how often someone can access PrEP services. In particular, the departments have noted that because individuals start, stop, and re-start PrEP regimens as appropriate, restricting how often individuals may start PrEP when determined appropriate by their health care provider is not reasonable. The departments have only provided one example of what would constitute reasonable medical management—insurers may cover the generic version of PrEP without cost-sharing and impose cost-sharing on the equivalent branded PrEP. Even this example has limits as the departments noted that plans must accommodate individuals for whom a particular PrEP medication is clinically appropriate via an exceptions process or mechanism to facilitate no-cost access. Even though this guidance is a win for people with and at risk of contracting HIV, advocates may not want to celebrate just yet as another legal challenge to the ACA makes its way through the courts. In the federal district court case, Kelley v. Becerra, the plaintiffs argue that the authority vested in the USPSTF by Section 2713 is unconstitutional, taking aim squarely at the preventive coverage provision that the departments’ guidance is built on. Citing the appointments clause of the Constitution, the plaintiffs argue that the Constitution prohibits bodies such as the USPSTF from wielding authority because its members are not appointed by the President or a head of an agency. The plaintiffs also cite the non-delegation doctrine and argue that the USPSTF’s authority is too broad and unbridled to influence national coverage mandates. Although the Kelley case has a long way to go before it could have a significant impact, if the plaintiffs prove successful, the case could wind up reversing the ACA’s work in expanding no-cost preventive services and limiting the federal government’s authority to regulate health insurance
Federal Agencies Enroll Health Insurers in PrEP School
Ending the HIV epidemic is within reach. Community advocacy and medical advances have provided the tools to prevent the transmission and contraction of HIV, but health care barriers prevent many individuals from accessing this care. Recent guidance aims to clarify practices around the coverage of HIV preventive care but faces a potential threat from the courts. Pre-exposure prophylaxis (PrEP), a medication that prevents the transmission of HIV when used as prescribed, has been an important tool in the effort to curb new transmissions. Approved by the U.S. Food and Drug Administration (FDA) in 2018, PrEP is a remarkably effective biomedical prevention, reducing the risk of getting HIV from sex by 99 percent and from injection drug use by 74 percent. The medication stands as a “core pillar” in the U.S. Department of Health and Human Service’s initiative known as Ending the HIV Epidemic in the United States. PrEP use, however, remains low. Fewer than 25 percent of individuals who could benefit from PrEP are taking it, in part due to the costs associated with the regimen. An effective PrEP regimen is more than just a pill; it includes periodic HIV testing, hepatitis B and C testing, creatinine testing, kidney function tests, pregnancy testing, STI screening, and adherence counseling. Even when PrEP medication is covered by insurance, these additional costs make accessing the regimen prohibitive. Fortunately, the Affordable Care Act (ACA) includes a provision that facilitates access to preventive services with proven clinical efficacy at no additional cost to the consumer. Section 2713 of the ACA requires all non-grandfathered private health plans to cover preventive services at no cost when those services are rated “A” or “B” by the U.S. Preventive Services Task Force (USPSTF). The USPSTF awards its ratings after reviewing clinical data and concluding that the services likely provide a substantial or moderate net benefit. In June of 2019, PrEP received an “A” recommendation from the USPSTF, paving the way for no-cost access beginning in 2021. The USPSTF recommendation was helpful, yet left many unanswered questions as advocates noted that the recommendation alone might not ensure full coverage. For example, the USPSTF recommendation to “offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy” seemed only to consider PrEP as a pill, leaving the question unanswered as to whether additional services needed for an effective PrEP regimen must also be covered without cost sharing. In addition, the USPSTF’s recommendation was released when FDA had only approved one drug for PrEP. Currently, FDA has approved two regimens and a generic competitor available to consumers, and soon FDA may approve a long-acting, injectable version of PrEP. Despite calls from advocates to clarify guidance prior to the start of the 2021 plan year, insurers began rolling out their interpretations of the new USPSTF recommendation without any further details from regulators. As one could expect, implementation came with varying levels of comprehensiveness. Because PrEP medications are also used as part of HIV treatment regimens, many insurers continued to simply list the medication on their drug lists on high cost-sharing tiers, and few explicitly included coverage of the ancillary services for PrEP clearly in plan marketing documents. The U.S. Department of Labor, the U.S. Department of Health and Human Services, and the U.S. Department of the Treasury alleviated much of this confusion by issuing guidance to insurers earlier this summer. This tri-agency interpretation from the departments clarified that PrEP services are included within the USPSTF recommendation and must be covered at no cost. The departments further explained that this coverage requirement extends to services needed before PrEP initiation—for example, initial lab testing and associated visits—and for ongoing monitoring. Recognizing the apparent confusion over the coverage of ancillary services, the departments stated that they would not take enforcement action against any plan or issuer until 60 days post-publication of the FAQ—a period which has now passed— and they urged state regulators to take a similar enforcement strategy. Plans and insurers are now on notice that coverage policies must be restructured accordingly. Ideally, insurers will update public-facing plan materials—formularies and summaries of benefits—to inform individuals shopping for coverage what PrEP medications and services are covered at no cost. Public information about the coverage of PrEP medications and services would not only provide greater transparency to consumers, but it would also be an essential tool for regulators to hold insurers accountable to their Section 2713 obligations. With respect to the frequency of coverage, the departments have clarified that plans and insurers may not use medical management techniques that limit how often someone can access PrEP services. In particular, the departments have noted that because individuals start, stop, and re-start PrEP regimens as appropriate, restricting how often individuals may start PrEP when determined appropriate by their health care provider is not reasonable. The departments have only provided one example of what would constitute reasonable medical management—insurers may cover the generic version of PrEP without cost-sharing and impose cost-sharing on the equivalent branded PrEP. Even this example has limits as the departments noted that plans must accommodate individuals for whom a particular PrEP medication is clinically appropriate via an exceptions process or mechanism to facilitate no-cost access. Even though this guidance is a win for people with and at risk of contracting HIV, advocates may not want to celebrate just yet as another legal challenge to the ACA makes its way through the courts. In the federal district court case, Kelley v. Becerra, the plaintiffs argue that the authority vested in the USPSTF by Section 2713 is unconstitutional, taking aim squarely at the preventive coverage provision that the departments’ guidance is built on. Citing the appointments clause of the Constitution, the plaintiffs argue that the Constitution prohibits bodies such as the USPSTF from wielding authority because its members are not appointed by the President or a head of an agency. The plaintiffs also cite the non-delegation doctrine and argue that the USPSTF’s authority is too broad and unbridled to influence national coverage mandates. Although the Kelley case has a long way to go before it could have a significant impact, if the plaintiffs prove successful, the case could wind up reversing the ACA’s work in expanding no-cost preventive services and limiting the federal government’s authority to regulate health insurance
Recommended from our members
Place-Based Environmental Health Justice Education: A Community-University-Government-Middle School Partnership
In collaboration with the Woonasquatucket River Watershed Council and the Department of Environmental Management, the Brown University Superfund Research Program's Community Engagement Core piloted an environmental health justice program with middle school students in Rhode Island. Our curriculum introduces students to environmental justice and the nearby Superfund site, with the goal of building environmental health justice literacy and encouraging civic engagement in local environmental remediation. Although little research has been done on teaching middle school students about environmental justice, popular education approaches rooted in community-based participatory research methods are regularly used in community outreach activities to organize and engage local residents in community issues. With this particular program, we present a place-based, student-centered, standards-aligned model for teaching environmental health justice. © Mary Ann Liebert, Inc