Preparing for PrEP; the cost of delaying universal access in England.

OBJECTIVES: Pre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention. METHODS: The search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis. RESULTS: There were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral. CONCLUSION: It is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.

Antibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018.

Approval by the US Food and Drug Administration (FDA) of a drug for a given indication is thought to reassure clinicians, other health care providers, and patients that substantial evidence of effectiveness exists for specific indicated populations (patients and diseases). This study examines whether FDA approval of certain antibiotics should be so reassuring for all patient populations identified in the FDA-approved labels. Specifically, this study compared patient populations covered by FDA-approved labels for 21 novel antibiotics approved between 1999 and 2018 to the patient exclusion and inclusion criteria of pivotal trials that supported those approvals. We found that every FDA-approved label for these antibiotics included at least one identifiable patient population that was explicitly excluded from enrolling in the supporting pivotal trials. Two antibiotics, bedaquiline and ceftazidime-avibactam, were approved for use in populations that were fully excluded from enrolling in registration trials.

Emergency Flexibility for States to Increase and Maintain Medicaid Eligibility for LTSS under COVID-19.

Medicaid provides essential coverage for health care and long-term services and supports (LTSS) to low-income older adults and disabled individuals but eligibility is complicated and restrictive. In light of the current public health emergency, states have been given new authority to streamline and increase the flexibility of Medicaid LTSS eligibility, helping them enroll eligible individuals and ensure that current beneficiaries are not inadvertently disenrolled. Though state budgets are under increased pressure during the economic crisis created by the coronavirus, we caution states against cutting Medicaid LTSS eligibility or services to balance their budgets. These services are critical to an especially vulnerable population during a global pandemic.

Update to U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Updated Recommendations for the Use of Contraception Among Women at High Risk for HIV Infection.

"U.S. Medical Eligibility Criteria for Contraceptive Use" (U.S. MEC) 2016 provides evidence-based guidance for the safe use of contraceptive methods among U.S. women with certain characteristics or medical conditions (1). The U.S. MEC is adapted from global guidance from the World Health Organization (WHO) and kept up to date through continual review of published literature (1). CDC recently evaluated the evidence and the updated WHO guidance on the risk for human immunodeficiency virus (HIV) acquisition among women using hormonal contraception and intrauterine devices (IUDs) (2). After careful review, CDC adopted WHO's 2019 updated guidance for inclusion in the U.S. MEC guidance; CDC's updated guidance states that progestin-only injectable contraception (including depot medroxyprogesterone acetate [DMPA]) and IUDs (including levonorgestrel-releasing and copper-bearing) are safe for use without restriction among women at high risk for HIV infection (U.S. MEC category 1 [previously U.S. MEC category 2, advantages outweigh risks]) (Box). CDC's guidance also adds an accompanying clarification for women who wish to use IUDs, which states "Many women at a high risk for HIV infection are also at risk for other sexually transmitted diseases (STDs). For these women, refer to the recommendations in the 'U.S. Medical Eligibility Criteria for Contraceptive Use' for women with other factors related to STDs, and the 'U.S. Selected Practice Recommendations for Contraceptive Use' on STD screening before IUD insertion" (1,3). Recommendations for other hormonal contraceptive methods (including combined hormonal methods, implants, and progestin-only pills) remain the same; there is also no restriction for their use among women at high risk for HIV infection (U.S. MEC category 1). Finally, CDC clarified that the U.S. MEC recommendations for concurrent use of hormonal contraceptives or IUDs and antiretroviral use for treatment of HIV infection also apply to use of antiretrovirals for prevention of HIV acquisition (preexposure prophylaxis [PrEP]).

Targeting subsidised inpatient services to the poor in a setting with limited state capacity: proxy means testing in Myanmar's hospital equity fund scheme.

OBJECTIVES: Many low- and middle-income countries (LMICs) provide subsidised access to health services for the poor. Proxy means tests (PMTs) for income are typically employed to identify eligible beneficiaries for subsidised services but often result in significant mistargeting of benefits. We assessed the PMT approach used in Myanmar's hospital equity fund (HEF). METHODS: We analysed inclusion/exclusion errors by comparing household eligibility under the PMT used for HEF with household consumption (the gold standard proxy for income in LMICs). We assessed receipt of benefits post-hospitalisation against HEF eligibility rules and household income. Focus groups/interviews were conducted to understand administrative factors that influence targeting. We modelled (linear regression) predictors of household consumption to improve PMT accuracy. RESULTS: We found large targeting errors (86% of households in the bottom consumption quartile would be excluded and 15% of households in the top consumption quartile deemed eligible). HEF scores for PMT held little explanatory power for household income: 93% of individuals meeting the HEF eligibility criteria did not receive benefits post-hospitalisation, while 23% of ineligible individuals received programme support. Re-weighting PMT indicators on electricity access, land ownership and livestock ownership, and assigning weights to home-ownership, households with elderly/disabled members and household head education levels could significantly improve targeting accuracy. Poor programme awareness and uneven adherence to official eligibility determination procedures among staff likely affected targeting. CONCLUSIONS: Re-weighting PMT indicators and increasing training and communication about qualification procedures could improve allocation of limited funds, though accurate targeting may continue to be challenging in contexts of low state capacity.

OBJECTIFS: De nombreux pays à revenu faible ou intermédiaire (PRFI) offrent un accès subventionné aux services de santé pour les pauvres. Les tests des proxys moyens (TPM) de revenus sont généralement utilisés pour identifier les bénéficiaires éligibles pour les services subventionnés, mais aboutissent souvent à un ciblage erroné important des avantages. Nous avons évalué l'approche TPM utilisée dans le fonds d'équité des hôpitaux (FEH) du Myanmar. MÉTHODES: Nous avons analysé les erreurs d'inclusion/exclusion en comparant l'éligibilité d'un ménage selon le TPM utilisé pour le FEH avec la consommation du ménage (indicateur de référence par excellence du revenu dans les PRFI). Nous avons évalué la réception des prestations après l'hospitalisation par rapport aux règles d'éligibilité du FEH et au revenu du ménage. Des discussions de groupes ont été menées pour comprendre les facteurs administratifs qui influencent le ciblage. Nous avons modélisé (régression linéaire) les prédicteurs de la consommation des ménages afin d'améliorer la précision du TPM. RÉSULTATS: Nous avons constaté d'importantes erreurs de ciblage (86% des ménages du quartile de consommation le plus bas seraient exclus et 15% des ménages du quartile de consommation le plus haut jugés éligibles). Les scores FEH du TPM ont peu de pouvoir explicatif sur le revenu du ménage: 93% des personnes répondant aux critères d'éligibilité du FEH ne bénéficiaient pas de prestations post hospitalisation, tandis que 23% des personnes non éligibles recevaient un soutien du programme. La repondération des indicateurs du TPM sur l'accès à l'électricité, la propriété foncière et la propriété du bétail, et l'attribution de pondérations à la propriété du logement, aux ménages composés de personnes âgées/handicapées et au niveau d'éducation des chefs de ménage pourraient améliorer considérablement la précision du ciblage. La faible sensibilisation du programme et le respect inégal des procédures officielles de détermination de l'éligibilité parmi le personnel ont probablement affecté le ciblage. CONCLUSIONS: Une repondération des indicateurs du TPM et une augmentation de la formation et de la communication sur les procédures de qualification pourraient améliorer l'allocation de fonds limités, bien qu'un ciblage précis puisse continuer à être un défi dans des contextes de faible capacité de l'Etat.

Implications of eligibility category churn for pediatric payment in Medicaid.

OBJECTIVES: To describe the extent and implications of "churn" between different Medicaid eligibility classifications in a pediatric population: (1) aged, blind, and disabled (ABD) Medicaid eligibility, determined by disability status and family income; and (2) Healthy Start Medicaid eligibility, determined by family income alone. STUDY DESIGN: As a result of a 2013 policy change, children with ABD eligibility transitioned from fee-for-service to capitated care. We used Ohio Medicaid claims data from July 2013 through June 2015 to explore the relationships among instability in eligibility category, demographics, and utilization. METHODS: To examine the potential financial effect of categorical churn, an effective capitation rate was created to capture the proportion of the maximum potential capitation rate that was realized. RESULTS: More than 20% of children exited ABD-based eligibility at least once. Switching was associated with younger age and rural residence and was not associated with healthcare use. CONCLUSIONS: Switching between eligibility categories is common and affects average capitation but not health service use.

Does external medical review reduce disability insurance inflow?

This paper investigates the effects of introducing external medical review for disability insurance (DI) in a system relying on treating physician testimony for eligibility determination. Using a unique policy change and administrative data from Switzerland, I show that medical review reduces DI incidence by 23%. Incidence reductions are closely tied to difficult-to-diagnose conditions, suggesting inaccurate assessments by treating physicians. Due to a partial benefit system, reductions in full benefit awards are partly offset by increases in partial benefits. More intense screening also increases labor market participation. Existing benefit recipients are downgraded and lose part of their benefit income when scheduled medical reviews occur. Back-of-the-envelope calculations indicate that external medical review is highly cost-effective. Under additional assumptions, the results provide a lower bound of the effect on the false positive award error rate.

Innovative Service Delivery Models for Serving Children with Speech Sound Disorders.

Service delivery variables that may have an impact on the treatment outcomes of children with speech sound disorders include the number and duration of intervention sessions, distribution of the sessions over time, and the format (group intervention or individual intervention). In this article, we briefly review these variables and the recommendations for the most effective service delivery components for children with speech sound disorders. We then describe innovative, collaborative service delivery models for preschoolers and school-age children with speech sound disorder. The models include "Quick Articulation!" conducted in a local elementary school by clinical MS-SLP students from Purdue University, as well as Summer Speech and Literacy Laboratory, which takes place in the department of Speech, Language, and Hearing Sciences at Purdue and involves participation from clinical and research faculty, and graduate and undergraduate students. The article provides useful information to help guide clinicians and clinical supervisors in implementing components of these models into their practice with children with speech sound disorder.

Ensuring Program Uniformity at the Hearing and Appeals Council Levels of the Administrative Review Process. Final rule.

We are revising our rules so that more of our procedures at the hearing and Appeals Council levels of our administrative review process are consistent nationwide. We anticipate that these nationally consistent procedures will enable us to administer our disability programs more efficiently and better serve the public.

Are elderly and women under-represented in cardiovascular clinical trials? Implication for treatment.

Elderly and women have been often under-represented in randomised clinical trials testing the effect of treatments on cardiovascular diseases even though these diseases highly affect both of them.Compared to their younger counterparts elderly have a higher incidence of disease-related morbidities, take more medicines and account for more adverse drug-related events. Similarly women present several differences in pathophysiology, clinical manifestations and outcomes in comparison to their male counterparts. For these reasons the results of randomised clinical trials obtained in younger men cannot be simply translated in elderly and women and the conduction of research and clinical trials in these patient populations is a key aspect to acquire evidence-based knowledge in the understanding and management of their conditions and treatment.Although the under-representation of elderly and women has been discussed for several years and several international guidelines or recommendation have been published to suggest how to improve the recruitment of these two populations, their recruitment is still insufficient. In particular, frail elderly and those with co-morbidities are not included questioning the external validity and the safety of most treatments.Aim of this review is to critically analyse how current recommendations for treatments of cardiovascular disease are not adequately devised for elderly and women.