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.

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.

Hospital-at-Home: Multistakeholder Considerations for Program Dissemination and Scale.

Policy Points Hospital-at-Home (HaH) is a home-based alternative for acute care that has expanded significantly under COVID-19 regulatory flexibilities. The post-pandemic policy agenda for HaH will require consideration of multistakeholder perspectives, including patient, caregiver, provider, clinical operations, technology, equity, legal, quality, and payer. Key policy challenges include reaching a consensus on program standards, clarifying caregivers' issues, creating sustainable reimbursement mechanisms, and mitigating potential equity concerns. Key policy prescriptions include creating a national surveillance system for quality and safety, clarifying legal standards for care in the home, and deploying payment reforms through value-based models.