Coverage Denials in Medicare Advantage-Balancing Access and Efficiency.

This essay compares Medicare Advantage's claim denials and reversals with traditional Medicare and questions whether coverage obligations are being met.

A Patient-Centered Documentation Skills Curriculum for Preclerkship Medical Students in an Open Notes Era.

Introduction: New legislation allows patients (with permitted exceptions) to read their clinical notes, leading to both benefits and ethical dilemmas. Medical students need a robust curriculum to learn documentation skills within this challenging context. We aimed to teach note-writing skills through a patient-centered lens with special consideration for the impact on patients and providers. We developed this session for first-year medical students within their foundational clinical skills course to place bias-free language at the forefront of how they learn to construct a medical note. Methods: One hundred seventy-three first-year medical and dental students participated in this curriculum. They completed an asynchronous presession module first, followed by a 2-hour synchronous workshop including a didactic, student-led discussion and sample patient note exercise. Students were subsequently responsible throughout the year for constructing patient-centered notes, graded by faculty with a newly developed rubric and checklist of best practices. Results: On postworkshop surveys, learners reported increased preparedness in their ability to document in a patient-centered manner (presession M = 2.2, midyear M = 3.9, p < .001), as rated on a 5-point Likert scale (1 = not prepared at all, 5 = very prepared), and also found this topic valuable to learn early in their training. Discussion: This curriculum utilizes a multipart approach to prepare learners to employ clinical notes to communicate with patients and providers, with special attention to how patients and their care partners receive a note. Future directions include expanding the curriculum to higher levels of learning and validating the developed materials.

Transforming Value-Based Dementia Care-Implications for the GUIDE Model.

This Viewpoint reviews the Guiding an Improved Dementia Experience (GUIDE) Model to assess its suitability in providing equitable and cost-effective dementia care and to compare it with previously introduced specialty care payment models to identify opportunities for refining payment innovation in dementia care.

Transforming Specialty Care Delivery and Payment Under Global Budgets-Insights from the Provision of Surgical Services in Maryland.

This Viewpoint discusses Maryland's global budget revenue model, which centrally regulates reimbursement rates for all payers via a hospital-specific, prospectively set cap on total annual revenue across all care sites.

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022.

This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.

Background: Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. Objective: To characterize Class I medical device recalls and corresponding recalled devices. Methods: This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. Results: There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578-42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3-11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3-30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). Conclusion: High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

Transforming Public Health Data Systems to Advance the Population's Health.

Policy Points Accurate and reliable data systems are critical for delivering the essential services and foundational capabilities of public health for a 21st -century public health infrastructure. Chronic underfunding, workforce shortages, and operational silos limit the effectiveness of America's public health data systems, with the country's anemic response to COVID-19 highlighting the results of long-standing infrastructure gaps. As the public health sector begins an unprecedented data modernization effort, scholars and policymakers should ensure ongoing reforms are aligned with the five components of an ideal public health data system: outcomes and equity oriented, actionable, interoperable, collaborative, and grounded in a robust public health system.

The Next Generation of Payment Reforms for Population Health - An Actionable Agenda for 2035 Informed by Past Gains and Ongoing Lessons.

Policy Points The predominantly fee-for-service reimbursement architecture of the US health care system contributes to waste and excess spending. While the past decade of payment reforms has galvanized the adoption of alternative payment models and generated moderate savings, uptake of truly population-based payment systems continues to lag, and interventions to date have had limited impact on care quality, outcomes, and health equity. To realize the promise of payment reforms as instruments for delivery system transformation, future policies for health care financing must focus on accelerating the diffusion of value-based payment, leveraging payments to redress inequities, and incentivizing partnerships with cross-sector entities to invest in the upstream drivers of health.

Urbanization and the Future of Population Health.

Policy Points Cities, which are where the majority of the world's population lives today, directly and indirectly shape human health and well-being. Urban health research, policy, and practice are increasingly using a systems science approach to address the upstream and downstream drivers of health in cities, which include social and environmental factors, features of the built environment, conditions of living, and health care resources. To guide future scholarship and policy, we propose an urban health agenda for 2050 focused on revitalizing the sanitation movement, integrating data, scaling best practices, adopting the Health in All Policies approach, and addressing intraurban health inequities.

Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall-the FDA's most serious designation indicating a high probability of adverse health consequences or death-as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and Setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main Outcomes and Measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and Relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.

Comparison of the Financial and Operational Characteristics of For-Profit and Nonprofit Hospitals Receiving Federal Graduate Medical Education Payments, 2011-2020.

This study compares graduate medical education (GME) payments between nonprofit and for-profit hospitals between 2011 and 2020 to assess how hospitals value GME.

Trends in Labor Unionization Among US Health Care Workers, 2009-2021.

Importance: Labor unionization efforts have resurged in the US, and union membership has been shown to improve worker conditions in some industries. However, little is known about labor unionization membership and its economic effects across the health care workforce. Objectives: To examine the prevalence of labor unionization among health care workers and its associations with pay, noncash benefits, and work hours. Design, Setting, and Participants: This cross-sectional study was conducted using data from the Current Population Survey and Annual Social and Economic Supplement from 2009 through 2021. The US nationally representative, population-based household survey allowed for a sample of 14 298 self-identified health care workers (physicians and dentists, advanced practitioners, nurses, therapists, and technicians and support staff). Exposures: Self-reported membership status or coverage in a labor union. Main Outcomes and Measures: Prevalence and trend in labor unionization. Further comparisons included mean weekly pay, noncash benefits (pension or other retirement benefits; employer-sponsored, full premium-covered health insurance; and employer's contribution to the worker's health insurance plan), and work hours. Results: The 14 298 respondents (81.5% women; 7.1% Asian, 12.0% Black, 8.5% Hispanic, 70.4% White individuals; mean [SD] age, 41.6 [13.4] years) included 1072 physicians and dentists, 981 advanced practitioners, 4931 nurses, 964 therapists, and 6350 technicians and support staff. After weighting, 13.2% (95% CI, 12.5% to 13.8%) of respondents reported union membership or coverage, with no significant trend from 2009 through 2021 (P = .75). Among health care workers, those who were members of a racial or ethnic minority group (Asian, Black, or Hispanic individuals compared with White individuals) and those living in metropolitan areas were more likely to report being labor unionized. Reported unionization was associated with significantly higher reported weekly earnings ($1165 vs $1042; mean difference, $123 [95% CI, $88 to $157]; P < .001) and higher likelihood of having a pension or other retirement benefits at work (57.9% vs 43.4%; risk ratio [RR], 1.33 [95% CI, 1.26 to 1.41]; P < .001) and having employer-sponsored, full premium-covered health insurance (22.2% vs 16.5%; RR, 1.35 [95% CI, 1.17 to 1.53]; P < .001). Union members reported more work hours (37.4 vs 36.3; mean differences, 1.11 [95% CI, 0.46 to 1.75]; P < .001) per week. White workers reported mean weekly earnings that were significantly more than members of racial and ethnic minority groups among nonunionized workers ($1066 vs $1001; mean difference, $65 [95% CI, $40 to $91]; P < .001), but there was no significant difference between the 2 groups among unionized workers ($1157 vs $1170; mean difference, -$13 [95% CI, -$78 to $52]; P = .70). Conclusions and Relevance: From 2009 through 2021, labor unionization among US health care workers remained low. Reported union membership or coverage was significantly associated with higher weekly earnings and better noncash benefits but greater number of weekly work hours.