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Background: Remote monitoring (RM) of pacemakers and implantable cardioverter‐defibrillators (ICDs) is a Class 1, Level of Evidence A recommendation because of its multitude of clinical benefits. However, RM adherence rates are suboptimal, precluding patients from achieving these benefits. There is a need for direct‐to‐patient efforts to improve adherence. Methods: In this national randomized, controlled trial conducted in the Veterans Health Administration (VHA), 2120 patients with a pacemaker or ICD who had not sent an RM transmission for ≥1 year (and usually ≥3 years) while under VHA care for their device were randomly assigned to be mailed a postcard (n = 1076) or a detailed letter (n = 1044). The postcard described what RM does and its key benefits (reduced mortality and fewer in‐person visits). The letter provided a similar message but included more details about RM benefits and the process. The primary outcome was an RM transmission sent within 90 days of mailing, and a secondary outcome was an RM transmission sent within 365 days. Results: The primary outcome was achieved in 121 (11.3%) in the postcard and 96 patients (9.2%) in the letter group (p =.12). The secondary outcome was achieved in 266 (24.7%) and 239 (22.9%), respectively (p =.32). Conclusions: This randomized trial showed no significant difference in the proportion of chronically non‐adherent patients who sent an RM transmission after receiving a low‐cost postcard or a detailed, higher‐cost letter encouraging their participation in RM. However, as only a minority of patients responded to either, further work is needed to engage patients in the life‐saving benefits of RM. [ABSTRACT FROM AUTHOR]

In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval to aducanumab, a monoclonal antibody indicated for the treatment of Alzheimer's disease. The accelerated approval decision was controversial due to concerns about the use of an unvalidated surrogate measure, beta‐amyloid, as the basis for approval and a lack of clinical outcome benefit. Between October 2021 and September 2022, we conducted a survey of a nationally representative group of internists, medical oncologists, and cardiologists to understand perspectives around aducanumab's approval and how this FDA decision may influence trust in other drugs approved through the accelerated approval program. Among 214 physician respondents familiar with the accelerated approval of aducanumab, 184 (86%) would not prescribe or recommend aducanumab. Further, 143 (67%) physicians reported losing trust in other drugs approved through the accelerated approval program due to the FDA's decision with aducanumab. As a growing number of similar novel Alzheimer's disease treatments are on the horizon, the first of which, lecanemab, already has received accelerated approval in January 2023, our survey findings provide insight into the impact of the FDA's regulatory decisions on the perspectives and prescribing behavior of physicians concerning these novel drug treatments. [ABSTRACT FROM AUTHOR]

Policy PointsLow‐value care is common in clinical practice, leading to patient harm and wasted spending. Much of this low‐value care stems from the use of medical device‐based procedures.We describe here a novel academic‐policymaker collaboration in which evidence‐based clinical coverage for device‐based procedures is implemented through prior authorization‐based policies for Louisiana's Medicaid beneficiary population.This process involves eight steps: 1) identifying low‐value medical device‐based procedures based on clinical evidence review, 2) quantifying utilization and reimbursement, 3) reviewing clinical coverage policies to identify opportunities to align coverage with evidence, 4) using a low‐value device selection index, 5) developing an evidence synthesis and policy proposal, 6) stakeholder engagement and input, 7) policy implementation, and 8) policy evaluation. This strategy holds significant potential to reduce low‐value device‐based care. [ABSTRACT FROM AUTHOR]

Prescription drugs and medical devices are increasingly coming to market through expedited US Food and Drug Administration (FDA) pathways that require only limited evidence of safety and efficacy, such as nonrandomized, unblinded trial data in small numbers of patients, or the use of surrogate end points. Reliance on more limited evidence means that there is often greater uncertainty about risks and benefits. Using a modified Delphi process, we sought to identify promising policy approaches that address physician‐patient decision‐making needs about the use of such drugs and medical devices. We convened 13 national leaders from academia, government, nonprofits, payors, and industry who had expertise in medical product regulation, payor policymaking, bioethics, physician practice, patient advocacy, public health expertise/advocacy, clinical trials, the pharmaceutical and device industry, institutional review board oversight, and real‐world evidence. Through multiple rounds of voting and meetings focused on evaluating the feasibility and impact of various interventions, the 13 participants reached the broadest consensus on 4 interventions: strengthening FDA post‐approval study requirements to ensure postmarket evidence is generated in a timely manner, better informing patients about the risks and benefits and level of evidence supporting therapies via simplified and patient‐centered product information "boxes" modeled on nutrition labels, limiting prices for drugs and medical devices approved based on surrogate end point data until confirmatory clinical evidence is generated, and improving health professional education about FDA regulation to better support clinician use of drugs and devices as well as communication with patients. [ABSTRACT FROM AUTHOR]

Purpose: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. Methods: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. Results: At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Conclusions: Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. [ABSTRACT FROM AUTHOR]