Some experts believe that routine mask-wearing should continue in health care settings

Embargoed for release until 5:00 p.m. ET on Monday 21 August 2023
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.
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1. Some experts believe that routine mask-wearing should continue in health care settings

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1230 
URL goes live when the embargo lifts
In a new commentary, public health experts from several prominent universities suggest that both patients and healthcare professionals should draw upon lessons learned during the COVID-19 pandemic and continue to mask up in the health care setting. This is important because infection from SARS-CoV-2 is still a threat, especially to the most vulnerable patients, and masks are a proven method for preventing transmission. The commentary is published in Annals of Internal Medicine.

Although rates of severe COVID-19 have decreased because of increasing community immunity and access to medical countermeasures, severe outcomes attributable to COVID-19 are still occurring. Many health care workers and people in the general community no longer take the same precautions they did at the height of the pandemic and have returned to normal activities despite ongoing circulation of SARS-CoV-2 and other endemic respiratory viruses.

Authors from Public Health – Seattle & King County and the University of Washington advocate for updating approaches to masking in healthcare facilities to prioritize both patient and healthcare worker safety. They highlight that many patients in healthcare facilities are at higher risk of mortality and morbidity from COVID-19, and argue that facilities have a responsibility to promote widespread

safety measures to limit the spread of hospital-acquired infections. They also argue that many healthcare workers still come into work with COVID-19, both symptomatic and asymptomatic. They note that pre-pandemic sick leave policies and more limited testing options make healthcare workers more likely to work while sick. Finally, they argue that several policies could be implemented to improve patient and employee safety. They assert that masking could be implemented across health care

spaces year-round; in targeted settings, such as transplant, oncology, and geriatric units; in specified months during the local respiratory viral season; or when community burden of respiratory viruses approaches a critical threshold.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author Eric J. Chow, MD, MS, MPH, please contact Sharon Bogan at Sharon.Bogan@kingcounty.gov.

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2. CMS criteria for appropriate use of cardiac imaging create confusion around reimbursement

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1011
URL goes live when the embargo lifts
A review of the Appropriate Use Criteria (AUC) program has found that the limited, currently available criteria for coronary artery disease (CAD) imaging are inconsistent and unclear, potentially leaving clinicians and patients uncertain about whether the care clinicians are delivering will be reimbursed by the Centers for Medicare and Medicaid Services (CMS). The analysis is published in Annals of Internal Medicine.

Congress established the AUC Program to reduce unnecessary advanced imaging studies. The program further stipulates that the AUC used by clinical decision support mechanisms must be developed by CMS-qualified organizations composed of practitioners providing direct patient care, so-called provider-led entities (PLEs). However, some questions remain about the development of AUC and adherence to the requirements outlined in the AUC program.

Researchers from several institutions reviewed website for the authorized PLE’s and found that only a minority have developed AUC related to CAD, one of the identified “priority clinical areas”. The AUC that have been developed for CAD are substantially heterogeneous the methods used and the structure and content of their AUC recommendations. They add that the current patchwork of AUC from different PLEs allows for conflicting assessment of appropriateness that may leave frontline clinicians uncertain about whether the care they are delivering will ultimately be reimbursed by CMS. The authors offer possible modifications to the current program, including: restricting CMS approval of PLEs to medical societies, academic institutions, or organizations with an established track record of producing AUC published in peer-reviewed scientific journals; approving narrower AUCs for a single priority clinical area; or requiring all PLEs for a priority clinical area to work collaboratively on creating a single unified AUC.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author David E. Winchester, MD, MS, please contact David.Winchester@va.gov.

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3. FDA approval of controversial drug highlights need for patient safety reforms

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1073 
URL goes live when the embargo lifts
The U.S. Food and Drug Administration’s (FDA) controversial approval of eteplirsen (Exondys 51) for Duchenne muscular dystrophy in 2016 demonstrates the need for new safety reforms according to authors from PORTAL at the Department of Medicine, Brigham and Women’s Hospital. The commentary is published in Annals of Internal Medicine.

The FDA approved eteplirsen for Duchenne muscular dystrophy (DMD) in 2016 via its accelerated approval program on the basis of a study of 12 boys. After a contentious review process and a high-profile meeting of an external advisory committee, FDA leaders concluded that very small increases in treated patients’ levels of dystrophin were reasonably likely to predict clinical benefit. Although the FDA initially set a November 2020 deadline for eteplirsen’s manufacturer to complete a clinical trial, the company will not complete the trial until 2024 or later, during which time the drug will remain on the market. The eteplirsen approval, which was followed by approvals of other drugs in the same class via the same pathway, has been controversial because of the questionable evidence underlying these decisions, delays in mandated post-approval testing, and high U.S. prices.

The authors argue that eteplirsen has served as an unfortunate precedent for other drugs in the same class and may have also affected the FDA’s decision making regarding other therapies. They note that while patients with DMD and other serious diseases urgently need disease-modifying interventions, premature approvals may lead to patient harm and stifle meaningful innovation. The authors also argue that the FDA should be given more authority to ensure that drugs granted accelerated approval are subsequently tested in rigorous, randomized confirmatory trials with appropriate comparator groups in a timely fashion. Finally, they advise that policymakers should support efforts to align the cost of drugs with the benefits that these products provide to patients and the U.S. health system, rather than allowing unproven drugs to enter the market at whatever high price the manufacturer chooses to set.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author Aaron S. Kesselheim, MD, JD, MPH, please contact akesselheim@bwh.harvard.edu

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Also in this issue:

Voices Behind Bars: Ethical, Legal, and Practical Considerations for Surrogates Who Are Incarcerated

Holland Kaplan, MD; Marc Robinson, MD; and Astrid Grouls, MD

Ideas and Opinions

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1144