Industry Payments to Cardiology Fellows and Early-Career Cardiologists.

This cohort study evaluates marketing payments from pharmaceutical and medical device manufacturers to physician trainees before and after fellowship graduation.

Funding of evidence included within public comments submitted to inform Medicare national coverage determinations.

The Centers for Medicare & Medicaid Services (CMS) relies on public comments submitted in response to proposed national coverage determinations to assist the agency in determining the coverage of items and services for Medicare beneficiaries. In a cross-sectional study, we characterized the cited evidence and what funding supported the cited evidence submitted in public comments to CMS for all therapeutic medical device national coverage determinations finalized between June 2019 and June 2022. Of 681 public comments, 159 (23%) cited at least 1 identifiable published scientific journal article. Within these 159 public comments, 198 unique articles were cited, 170 (86%) of which included funding statements or author disclosures. Among these, 96 (56%) disclosed funding from manufacturers that would benefit from Medicare coverage and/or were written by author(s) who received funding from these manufacturers. In summary, most public commenters for national coverage determinations did not cite published scientific journal articles to support their positions. Among those who did, more than half of articles were directly funded by manufacturers that would benefit from coverage. Greater funding of independent, non-industry-supported research may help provide unbiased evaluations of benefits and harms to support Medicare coverage decisions.

Effectiveness, utilisation and cost associated with implantable loop recorders versus external monitors after ischaemic or cryptogenic stroke.

OBJECTIVE: Implantable loop recorders (ILRs) are increasingly used for long-term rhythm monitoring after ischaemic and cryptogenic stroke, with the goal of detecting atrial fibrillation (AF) and subsequent initiation of oral anticoagulation to reduce risk of adverse clinical outcomes. There is a need to determine the effectiveness of different rhythm monitoring strategies in this context. METHODS: We conducted a retrospective cohort analysis of individuals with commercial and Medicare Advantage insurance in Optum Labs Data Warehouse who had incident ischaemic or cryptogenic stroke and no prior cardiovascular implantable electronic device from 1 January 2016 to 30 June 2021. Patients were stratified by rhythm monitoring strategy: ILR, long-term continuous external cardiac monitor (>48 hours to 30 days) or Holter monitor (≤48 hours). The primary outcome was risk-adjusted all-cause mortality at 12 months. Secondary outcomes included new diagnosis of AF and oral anticoagulation, bleeding, and costs. RESULTS: Among 48 901 patients with ischaemic or cryptogenic stroke, 9235 received an ILR, 29 103 long-term continuous external monitor and 10 563 Holter monitor only. Mean age was 69.9 (SD 11.9) years and 53.5% were female. During the 12-month follow-up period, patients who received ILRs compared with those who received long-term continuous external monitors had a higher odds of new diagnosis of AF and oral anticoagulant initiation (adjusted OR 2.27, 95% CI 2.09 to 2.48). Compared with patients who received long-term continuous external monitors, those who received ILRs had similar 12-month mortality (HR 1.00; 95% CI 0.89 to 1.12), with approximately $13 000 higher costs at baseline (including monitor cost) and $2500 higher costs during 12-month follow-up. CONCLUSIONS: In this large real-world study of patients with ischaemic or cryptogenic stroke, ILR placement resulted in more diagnosis of AF and initiation of oral anticoagulation, but no difference in mortality compared with long-term continuous external monitors.

Is more better? A multilevel analysis of percutaneous coronary intervention hospital openings and closures on patient volumes.

BACKGROUND: It is unknown how changes in the percutaneous coronary intervention (PCI) "built environment" have impacted PCI volumes at the community, hospital, and patient levels. This study sought to determine how PCI hospital openings and closures effect community- and hospital-level PCI volumes as well as the likelihood of receiving PCI at a low-volume hospital. METHODS: We conducted a retrospective cohort study of 3,966,025 Medicare Fee-For-Service patients in 37,451 zip codes and 2564 U.S. hospitals who underwent PCI from 2006 to 2017. We conducted community-, hospital-, and patient-level analyses using ordinary least squares regressions with fixed effects to determine changes in PCI volumes after PCI hospital openings or closures. RESULTS: Between 2006 and 2017, a total of 17% and 7% of patients lived in communities that experienced PCI hospital openings and closures, respectively. Openings were associated with a 10% increase in community PCI volume, a 2% increase in the share of elective PCI, and a doubling in the likelihood of receiving PCI at a low-volume hospital. In communities with low baseline PCI capacity, openings were associated with a 12% increase in community PCI volume, and in high-capacity communities, an 8% increase. PCI closures were associated with a 9% decrease in community PCI volume in high-capacity communities but no measurable change in low-capacity communities. CONCLUSIONS: PCI service expansion is associated with increased PCI at low-volume hospitals and a greater number of elective procedures. Increased governmental oversight may be necessary to ensure that openings and closures of these specialized services yield the desired benefits.

Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey.

Physicians' knowledge of Food and Drug Administration (FDA) approval processes is important in informing clinical decisions and patient discussions. Among a randomly selected national sample of 509 internists, cardiologists, and oncologists, 41 percent reported moderate or better understanding of the FDA's drug approval process, and 17 percent reported moderate or better understanding of the FDA's medical device approval process. Nearly all physicians thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval. Also, nearly all physicians thought that the FDA should revoke approval for accelerated-approval drugs or breakthrough devices that did not show benefit in postapproval studies. Our findings suggest that physicians commonly lack familiarity with drug and medical device regulatory practices and are under the impression that the data supporting FDA drug and high-risk device approvals are more rigorous than they often are. Physicians would value more rigorous premarket evidence, as well as regulatory action for drugs and devices that do not demonstrate safety and effectiveness in the postmarket setting.

Emergency Department Cardiac Risk Stratification With High-Sensitivity vs Conventional Troponin HEART Pathway.

Importance: Patients presenting to the emergency department with chest pain are routinely risk stratified for major adverse cardiac events using the HEART (History, Electrocardiogram, Age, Risk factors, and Troponin) score pathway, which incorporates clinical features, risk factors, electrocardiography findings, and initial serum troponin testing. A new HEART pathway incorporating high-sensitivity troponin level may improve risk stratification among patients with possible acute myocardial infarction (AMI). Objective: To compare health outcomes and resource use among emergency department patients undergoing cardiac risk stratification with a HEART pathway using conventional vs high-sensitivity serum troponin. Design, Setting, and Participants: This multicenter pre-post cohort study was conducted between January 1 and September 6, 2021, at 16 Kaiser Permanente Southern California hospitals during uptake of a high-sensitivity serum troponin assay and included 17 384 adult patients who presented to an emergency department with chest pain and were risk stratified with a HEART pathway based on conventional troponin or high-sensitivity troponin. Exposures: A HEART pathway incorporating either conventional or high-sensitivity serum troponin was used to stratify study groups for risk of major adverse cardiac events within 30 days. Main Outcomes and Measures: The primary outcome was detection of AMI in the emergency department and within 30 days. Results: Of the 17 384 patients (median age, 58 years [IQR, 45-69 years]; 9767 women [56.2%]), 12 440 (71.6%) were risk stratified with a HEART pathway based on conventional troponin, and 4944 (28.4%) were risk stratified with a HEART pathway based on high-sensitivity troponin. Detection of AMI within 30 days was higher for the high-sensitivity troponin group than the conventional troponin group (288 [5.8%] vs 545 [4.4%]; P < .001), while the 30-day all-cause mortality rate was unchanged (16 [0.3%] vs 50 [0.4%]; P = .50). In the emergency department, 228 of 4944 patients (4.6%) in the high-sensitivity troponin group received a diagnosis of AMI compared with 251 of 12 440 patients (2.0%) in the conventional troponin group (P < .001). Among those who did not receive a diagnosis of AMI in the emergency department, an additional 60 patients (1.2%) in the high-sensitivity troponin group and 294 (2.4%) in the conventional troponin group (P < .001) received a diagnosis within 30 days. Patients in the high-sensitivity troponin group had lower rates of health care use compared with the conventional troponin group, including admission (605 [12.2%] vs 1862 [15.0%]; P < .001), stress testing within 7 days (506 [10.2%] vs 1591 [12.8%]; P < .001), and coronary revascularization within 30 days (51 [1.0%] vs 244 [2.0%]; P < .001). Conclusions and Relevance: This multicenter pre-post cohort study suggests that a new HEART pathway incorporating high-sensitivity troponin may improve detection of AMI and decrease resource use among emergency department patients with chest pain.

Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity.

Little is known about the evidence to support prescription digital therapeutics, which are digital tools that rely primarily on software for diagnosis or treatment that have indications for use regulated by the Food and Drug Administration (FDA) and require a clinician's prescription. We conducted the first retrospective cross-sectional analysis of clinical studies of twenty prescription digital therapeutics authorized by the FDA and available on the market as of November 2022. Our analysis found that just two prescription digital therapeutics had been evaluated in at least one study that was randomized and blinded and that used other rigorous standards of evidence. Two-thirds of clinical studies of prescription digital therapeutics were conducted on a postmarket basis, with less rigorous standards of evidence than the standards used in premarket studies. More than half of studies did not report data on participants' race, and more than 80 percent did not report their ethnicity. More than one-third required English proficiency, and nearly half of nonpediatric studies had an upper age limit. These results suggest the need for a more rigorous and inclusive approach to clinical research supporting FDA-authorized prescription digital therapeutics. A stronger evidence base would increase confidence in these technologies' effectiveness and would enable more informed decision making about their clinical use and coverage.

Cardiac coronary tomography angiography (CCTA) use across geographical regions in the USA and the UK: a cross-sectional study.

Objective: Increased use of CT imaging has been identified as a key component of unsustainable rising healthcare costs in the USA and globally. Understanding evidence and its relation to imaging coverage policies can help identify patterns of variation to better inform high value care initiatives. This cross-sectional study evaluates regional differences in US utilisation of cardiac coronary tomography angiography (CCTA) and compares use in the USA and England. Design: We determined differences in CCTA order rates by US Medicare region and compared order rates in the US and England, compared CT scanner prevalence in the USA and UK, and reviewed the CCTA coverage policies for each region. Setting: The US and the UK. Participants: Medicare Coverage Database; Medicare 2018 Part B data; National Health Services 2018 data. Interventions: CCTA orders, CT scanner prevalence. Main outcome measures: CCTA orders per beneficiary, CT scanner prevalence, CCTA policy variation. Results: We found that CCTA coverage policies are more permissive in the UK compared with the USA. However, CT scanner prevalence per beneficiary is four times greater in the USA than the UK. There was significant variation in number of CCTA ordered per 100 000 beneficiaries between regions in England and the USA, ranging from 74 to 313 in the US and 57-317 in England. Conclusions: There is significant geographical variation in use of CCTA in both the USA and England, although overall use does not differ significantly between both countries. Similarities in order rates, despite a much higher CT scanner density in the USA, may be related to more permissive guidelines around use of CCTA in the UK. Variation in both countries may also reflect the lack of high-quality clinical outcomes data for use of CCTA, underscoring opportunities for more evidence and evidence-based policy to promote appropriate use of CCTA imaging.

A Critical Examination of Independent Medical Review Decision-making for Cardiovascular Procedures Shows Low Rate of Evidence Citation in Reviews.

BACKGROUND: The California Independent Medical Review (IMR) program was created in 2001 to provide an independent, external evaluation of insurers' denials of coverage of health services. OBJECTIVE: We sought to evaluate the quality and comprehensiveness of data used to support IMR decision-making between 2015 and 2020. RESULTS: Of the 159 cases submitted to IMR regarding denials of cardiovascular procedures, 52% of these denials were overturned by IMR, thus restoring coverage. Despite a state-wide requirement that specific references to medical and scientific evidence should be provided in IMR reviews, fewer than a quarter of reviews cited any evidence to support decision-making. Slightly more than one third of IMR review decisions were inconsistent with recommendations from professional societies and peer-reviewed evidence; the primary reason for these inconsistencies was that invasive interventions were often recommended by reviewers before utilizing guideline-directed medical or less invasive therapies. CONCLUSION: Our findings highlight an opportunity for improvement in the quality of IMR decision-making through a more consistent use of available scientific evidence to guide clinical reasoning.

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease.

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.