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.

Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

BACKGROUND: Drugs and high-risk medical devices are increasingly likely to receive Food and Drug Administration (FDA) approval through expedited pathways, which has implications for informed treatment consent (i.e., consent in clinical practice). OBJECTIVE: To obtain expert opinion about the clinical and ethical implications of the increasing availability of new drugs and devices approved through expedited development and regulatory review pathways. DESIGN: Qualitative study using individual semi-structured videoconference interviews. PARTICIPANTS: National leaders in medicine, ethics, and law (n=12) with 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. MAIN MEASURES: Principal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA approval, and informed treatment consent. KEY RESULTS: Respondents pointed out that more common use of expedited pathways translates to increased reliance on surrogate measures, some with uncertain clinical significance. While expedited development and review can have advantages, participants expressed worry that physicians were unaware when medical products were expedited and did not communicate about uncertainties in knowledge about new drug or device approvals effectively with patients. Many participants felt that informed treatment consent discussions about new drugs or devices should include some explanations of expedited pathways and use of surrogate measures. CONCLUSIONS: Experts identified advantages of expediting development and of FDA flexibility in applying its standards to new drugs and medical devices, but highlighted concerns that patients may not be adequately informed about the risks of shorter review times or about uncertainties in the evidence that result. There is a need to identify approaches to ensure effective clinical use of drugs and devices when approved through expedited pathways.

Does Hospital Admission/Observation for Chest Pain Improve Patient Outcomes after Emergency Department Evaluation for Suspected Acute Coronary Syndrome?

BACKGROUND: Chest pain is the top reason for hospitalization/observation in the USA, but it is unclear if this strategy improves patient outcomes. OBJECTIVE: The objective of this study was to compare 30-day outcomes for patients admitted versus discharged after a negative emergency department (ED) evaluation for suspected acute coronary syndrome. DESIGN: A retrospective, multi-site, cohort study of adult encounters with chest pain presenting to one of 13 Kaiser Permanente Southern California EDs between January 1, 2015, and December 1, 2017. Instrumental variable analysis was used to mitigate potential confounding by unobserved factors. PATIENTS: All adult patients presenting to an ED with chest pain, in whom an acute myocardial infarction was not diagnosed in the ED, were included. MAIN MEASURES: The primary outcome was 30-day acute myocardial infarction or all-cause mortality, and secondary outcomes included 30-day revascularization and major adverse cardiac events. KEY RESULTS: In total, 77,652 patient encounters were included in the study (n=11,026 admitted, 14.2%). Three hundred twenty-two (0.4%) had an acute myocardial infarction (n=193, 0.2%) or death (n=137, 0.2%) within 30 days of ED visit (1.5% hospitalized versus 0.2% discharged). Very few (0.3%) patients underwent coronary revascularization within 30 days (0.7% hospitalized versus 0.2% discharged). Instrumental variable analysis found no adjusted differences in 30-day patient outcomes between the hospitalized cohort and those discharged (risk reduction 0.002, 95% CI -0.002 to 0.007). Similarly, there were no differences in coronary revascularization (risk reduction 0.003, 95% CI -0.002 to 0.007). CONCLUSION: Among ED patients with chest pain not diagnosed with an acute myocardial infarction, risk of major adverse cardiac events is quite low, and there does not appear to be any benefit in 30-day outcomes for those admitted or observed in the hospital compared to those discharged with outpatient follow-up.

A Policy Approach to Reducing Low-Value Device-Based Procedure Use.

Policy Points Low-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.

Automated abstraction of myocardial perfusion imaging reports using natural language processing.

BACKGROUND: Findings and interpretations of myocardial perfusion imaging (MPI) studies are documented in free-text MPI reports. MPI results are essential for research, but manual review is prohibitively time consuming. This study aimed to develop and validate an automated method to abstract MPI reports. METHODS: We developed a natural language processing (NLP) algorithm to abstract MPI reports. Randomly selected reports were double-blindly reviewed by two cardiologists to validate the NLP algorithm. Secondary analyses were performed to describe patient outcomes based on abstracted-MPI results on 16,957 MPI tests from adult patients evaluated for suspected ACS. RESULTS: The NLP algorithm achieved high sensitivity (96.7%) and specificity (98.9%) on the MPI categorical results and had a similar degree of agreement compared to the physician reviewers. Patients with abnormal MPI results had higher rates of 30-day acute myocardial infarction or death compared to patients with normal results. We identified issues related to the quality of the reports that not only affect communication with referring physicians but also challenges for automated abstraction. CONCLUSION: NLP is an accurate and efficient strategy to abstract results from the free-text MPI reports. Our findings will facilitate future research to understand the benefits of MPI studies but requires validation in other settings.

Generating comparative evidence on new drugs and devices before approval.

Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Even when active-comparator trials exist, they might not produce meaningful data to inform decisions in clinical practice and health policy. The uncertainty associated with the paucity of well designed active-comparator trials has been compounded by legal and regulatory changes in Europe and the USA that have created a complex mix of expedited programmes aimed at facilitating faster access to new drugs. Comparative evidence generation is even sparser for medical devices. Some have argued that the current process for regulatory approval needs to generate more evidence that is useful for patients, clinicians, and payers in health-care systems. We propose a set of five key principles relevant to the European Medicines Agency, European medical device regulatory agencies, US Food and Drug Administration, as well as payers, that we believe will provide the necessary incentives for pharmaceutical and device companies to generate comparative data on drugs and devices and assure timely availability of evidence that is useful for decision making. First, labelling should routinely inform patients and clinicians whether comparative data exist on new products. Second, regulators should be more selective in their use of programmes that facilitate drug and device approvals on the basis of incomplete benefit and harm data. Third, regulators should encourage the conduct of randomised trials with active comparators. Fourth, regulators should use prospectively designed network meta-analyses based on existing and future randomised trials. Last, payers should use their policy levers and negotiating power to incentivise the generation of comparative evidence on new and existing drugs and devices, for example, by explicitly considering proven added benefit in pricing and payment decisions.

Evaluating Sex Disparities in the Emergency Department Management of Patients With Suspected Acute Coronary Syndrome.

STUDY OBJECTIVE: We compare clinical management and outcomes of emergency department (ED) encounters by sex after implementation of a clinical care pathway in 15 community EDs that standardized recommendations based on patient risk, using the History, ECG, Age, Risk Factors, and Troponin (HEART) score. METHODS: This was a retrospective analysis of adult ED encounters evaluated for suspected acute coronary syndrome with a documented HEART score from May 20, 2016, to December 1, 2017. The primary outcomes were hospitalization or 30-day stress testing. Secondary outcomes included 30-day acute myocardial infarction or all-cause death (major adverse cardiac event). A generalized estimating equation regression model was used to compare the odds of hospitalization or stress testing by sex; we report HEART scores (0 to 10) stratified by sex and describing major adverse cardiac events. RESULTS: A total of 34,715 adult ED encounters met the inclusion criteria (56.0% women). A higher proportion of women were classified as low risk (60.5% versus 52.4%; odds ratio [OR] 1.39; 95% confidence interval [CI] 1.33 to 1.45). Women were hospitalized or received stress testing less frequently than men for low HEART scores (18.8% versus 22.8%; OR 0.79; 95% CI 0.73 to 0.84) and intermediate ones (46.7% versus 49.7%; OR 0.88; 95% CI 0.83 to 0.95), but similarly for high-risk ones (74.1% versus 74.4%; OR 0.99; 95% CI 0.77 to 1.28). Women had 18% lower odds of hospitalization or noninvasive cardiac testing (OR 0.82; 95% CI 0.78 to 0.86), even after adjusting for HEART score and comorbidities. Men had higher risks of major adverse cardiac events than women for all HEART score categories but the risk for men was significantly higher among low-risk HEART scores (0.4% versus 0.1%). CONCLUSION: Women with low-risk HEART scores are hospitalized or stress tested less than men, which is likely appropriate, and women have better outcomes than men. Use of the HEART score has the potential to reduce sex disparities in acute coronary syndrome care.

Evaluation of Outpatient Cardiac Stress Testing After Emergency Department Encounters for Suspected Acute Coronary Syndrome.

STUDY OBJECTIVE: Professional guidelines recommend 72-hour cardiac stress testing after an emergency department (ED) evaluation for possible acute coronary syndrome. There are limited data on actual compliance rates and effect on patient outcomes. Our aim is to describe rates of completion of noninvasive cardiac stress testing and associated 30-day major adverse cardiac events. METHODS: We conducted a retrospective analysis of ED encounters from June 2015 to June 2017 across 13 community EDs within an integrated health system in Southern California. The study population included all adults with a chest pain diagnosis, troponin value, and discharge with an order for an outpatient cardiac stress test. The primary outcome was the proportion of patients who completed an outpatient stress test within the recommended 3 days, 4 to 30 days, or not at all. Secondary analysis described the 30-day incidence of major adverse cardiac events. RESULTS: During the study period, 24,459 patients presented with a chest pain evaluation requiring troponin analysis and stress test ordering from the ED. Of these, we studied the 7,988 patients who were discharged home to complete diagnostic testing, having been deemed appropriate by the treating clinicians for an outpatient stress test. The stress test completion rate was 31.3% within 3 days and 58.7% between 4 and 30 days, and 10.0% of patients did not complete the ordered test. The 30-day rates of major adverse cardiac events were low (death 0.0%, acute myocardial infarction 0.7%, and revascularization 0.3%). Rapid receipt of stress testing was not associated with improved 30-day major adverse cardiac events (odds ratio 0.92; 95% confidence interval 0.55 to 1.54). CONCLUSION: Less than one third of patients completed outpatient stress testing within the guideline-recommended 3 days after initial evaluation. More important, the low adverse event rates suggest that selective outpatient stress testing is safe. In this cohort of patients selected for outpatient cardiac stress testing in a well-integrated health system, there does not appear to be any associated benefit of stress testing within 3 days, nor within 30 days, compared with those who never received testing at all. The lack of benefit of obtaining timely testing, in combination with low rates of objective adverse events, may warrant reassessment of the current guidelines.

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.

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

IMPORTANCE: High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. OBJECTIVE: To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). DESIGN AND SETTING: Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. EXPOSURE: Panel-track supplement approval. MAIN OUTCOMES AND MEASURES: Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. RESULTS: Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. CONCLUSIONS AND RELEVANCE: Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.