The American journal of managed care
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A 2020 federal court ruling requires clinical trial sponsors to report a decade's worth of previously exempted data to the National Institutes of Health (NIH) for publication on ClinicalTrials.gov. In Seife v HHS, the US District Court for the Southern District of New York invalidated NIH regulations that exempted certain clinical trials conducted between 2007 and 2017 from results reporting requirements mandated by the Food and Drug Administration Amendments Act. ⋯ These benefits make the recent decision in Seife particularly significant. However, its impact will be dampened if the government does not take steps to enforce it.
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Alternative payment models (APMs) are part of a growing shift from volume-based, traditional fee-for-service payment models toward payment for value. To date, however, patients have been largely omitted from efforts to design new payment models. We sought to identify key characteristics of outcomes-based quality measures to inform future APMs that are more patient-centered. ⋯ The proposed framework offers a stepping stone on the path to clinically meaningful, patient-centered, high-value care. Next steps may include a broader review of gaps in APM quality measures across multiple therapeutic areas, additional vetting from a more diverse group of stakeholders, or a formal consensus.
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The fall season was accompanied by an urgent warning from the CDC of an impending "twindemic" of coronavirus disease 2019 and influenza. Despite the warnings, Black women are not lining up for vaccinations.
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The evidence supporting early postdischarge hospital follow-up is limited. We implemented a new, multidisciplinary, multistrategy heart failure (HF) team approach that included new clinic slots, predischarge nurse visit, providing a blood pressure cuff and scale, and cardiologist supervision. ⋯ The intervention succeeded in increasing referral to and completion of cardiology appointments within 7 days of discharge. In adjusted analysis, the intervention was associated with lower risk of 30-day all-cause ED visits, all-cause hospitalizations, or death.
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Spinal muscular atrophy (SMA) is a rare, diverse group of inherited neuromuscular disorders that cause degradation of the lower motor neurons, progressive muscle atrophy, and weakness. The natural history of SMA has changed significantly with an increased understanding of SMA pathophysiology and new technologies. As a result, affected individuals now have 3 disease-modifying therapies available for treatment. ⋯ This reinforces the importance of newborn screening as a mechanism for early diagnosis. Pharmacists are highly valued members of the healthcare team who play a pivotal role in the SMA care team. Therefore, pharmacists must be up-to-date on SMA's medical management, including the most current efficacy and safety data to assist providers, caregivers, and patients in selecting these agents and ensuring patients with SMA receive optimal and timely medical care.