Cyber Attacks and the Dark Web: Primer for Physicians.

PubMed · 2025-01-01

Difficulty With Binary Voting Among FDA Oncology Advisory Committee Members

JAMA Network Open · 2025-07-23

This qualitative study investigates the frequency of reports of difficulty in voting for drug approval by members of the Food and Drug Administration Oncologic Drugs Advisory Committee.

Electronic health record market consolidation and implications for cybersecurity

Health Affairs Scholar · 2025-08-01

Over the past decade, the electronic health record (EHR) market has become increasingly consolidated, with the majority of care delivery organizations now using 1 of 2 vendors -Epic and Oracle Health. This consolidation creates a "single-point-of-failure" tail risk for cybersecurity: 1 successful attack could expose millions of patients' private data and could potentially impact documentation, billing, and clinical care across thousands of sites. Moreover, dependence on other technology vendors, such as shared cloud hosts, broadens the potential attack surface beyond vendors' core firewalls. Given that reversing consolidation is unlikely due to high EHR switching costs, it is critical that policymakers establish safeguards that ensure robust protections for patients' sensitive data. The Assistant Secretary for Technology Policy plays a critical role in mandating certain security features through the Certified Electronic Health Record Technology Program, and this role should be expanded to provide additional oversight, given the risks presented by the current market structure. Sustained investment in regulatory oversight and continued partnerships between policymakers, care delivery organizations, and EHR vendors are essential to contain the catastrophic risk involved from this ongoing market consolidation.

Use of and Steering to Pharmacies Owned by Insurers and Pharmacy Benefit Managers in Medicare

JAMA Health Forum · 2025-01-10 · 2 citations

Importance: The prevalence of pharmacies owned by integrated insurers and pharmacy benefit managers (PBMs), or insurer-PBMs, is of growing regulatory concern. However, little is known about the role of these pharmacies in Medicare, in which pharmacy network protections may influence market dynamics. Objective: To evaluate the prevalence of insurer-PBM-owned pharmacies and the extent to which insurer-PBMs steer patients to pharmacies they own in Medicare. Design, Setting, and Participants: This cross-sectional study used Medicare Part D claims data on prescription fills for a 20% random sample of US beneficiaries enrolled from January 1 through December 31, 2021. Data were analyzed from March to November 2024. Exposures: Prescription fills. Main Outcomes and Measures: The main outcome was the share of spending filled by insurer-PBM-owned pharmacies overall, by pharmacy type (specialty and nonspecialty), and by drug class. For the top 100 specialty and nonspecialty molecules by claim volume, 2 quantities were identified for 4 major insurer-PBMs (Cigna, CVS, Humana, and UnitedHealth Group): share of the index firm's insurer claims filled by its owned pharmacies and share of other firms' insurer claims filled by the index firm's owned pharmacies. Differences between these quantities were assessed to evaluate the degree to which insurer-PBMs steered patients to their own pharmacies. Results: Among 10 455 726 patients (54.8% women; mean [SD] age, 71.8 [10.7] years), 34.1% of all pharmacy and 37.1% of specialty pharmacy spending occurred through Cigna, CVS, Humana, or UnitedHealth Group pharmacies. Among specialty molecules, market shares varied by drug class (antivirals: 18.5%; antipsychotics: 29.5%; cancer: 32.5%; disease-modifying antirheumatic drugs: 41.1%; multiple sclerosis: 64.8%; pulmonary arterial hypertension and idiopathic pulmonary fibrosis: 89.7%). Across molecule-firm combinations, a 19.8 (95% CI, 18.0-21.6)-percentage point and 13.9 (95% CI, 13.1-14.7)-percentage point greater share of claims were filled at insurer-PBM-owned pharmacies than would be expected without steering for specialty and nonspecialty categories, respectively. Conclusions and Relevance: This cross-sectional study found that insurer-PBM firms represented an important portion of the Medicare Part D market, especially for certain drug classes, and that insurer-PBM firms steered patients to their own pharmacies, despite certain pharmacy network protections in Medicare. These findings underscore the need to understand the impacts of insurer-PBM and pharmacy integration on medication access and costs for Medicare patients.

Unregulated large language models produce medical device-like output

npj Digital Medicine · 2025-03-07 · 41 citations

Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs could be induced to provide device-like CDS output. We found that LLM output readily produced device-like decision support across a range of scenarios, suggesting a need for regulation if LLMs are formally deployed for clinical use.

A Framework for Assessing the Permissibility of Academic Leaders’ Outside Activities

Milbank Quarterly · 2025-06-04

Policy Points Many have urged academic institutions to rethink conflict of interest policies governing leaders' outside activities, which pose not only individual conflicts for leaders themselves but institutional conflicts for their academic employers. Although the American Association of Medical Colleges and Association of American Universities have provided guidance on managing such conflicts, neither offer a structured approach for determining when and under what conditions it is appropriate for a leader to engage in specific outside activities. To address this gap, this article develops a decision-making framework that institutional oversight bodies can use to assess the permissibility of academic leaders' proposed outside activities.

Medicare Part D Preferred Pharmacy Networks And The Risk For Pharmacy Closure, 2014–23

Health Affairs · 2025-05-01

Medicare Part D plans incentivize the use of specific pharmacies through preferred networks. We found that independent pharmacies and pharmacies in low-income, Black, and Latinx neighborhoods were less likely to be preferred by most Part D plans than chains and pharmacies in other neighborhoods. Pharmacies that were not preferred by most plans were 70-350 percent more likely to close than other pharmacies.

Payments to Health Care Professionals and Teaching Hospitals by AI- and Machine Learning–Enabled Medical Device Manufacturers

JAMA · 2025-09-22 · 2 citations

This study examines the extent and nature of payments made to health care professionals and teaching hospitals by manufacturers of FDA-authorized AI- and machine learning–enabled devices.

Conflicts of Interest in Federal Vaccine Advisory Committees

JAMA · 2025-08-18 · 7 citations

This study analyzes the prevalence of reported conflicts of interest (COIs) among attendees at 2000-2024 meetings of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) and the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Impact of the MISSION Act on Quality and Outcomes of Major Cardiovascular Procedures Among Veterans

JAMA · 2025-07-31 · 4 citations

Importance: The Department of Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act expanded opportunities for veterans to obtain care outside the VA. However, the impact on health care outcomes is uncertain. Objective: To measure the MISSION Act's impact on travel times and outcomes of percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), and aortic valve replacement (AVR). Design, Setting, and Participants: This retrospective difference-in-differences cohort study included veterans receiving nonemergent/nonurgent PCI, CABG, or AVR between October 2016 and September 2022 in non-VA hospitals under MISSION Act coverage or in VA hospitals in the 48 contiguous US states or the District of Columbia. Analyses were conducted in 2023-2024. Exposures: Veterans eligible for non-VA care under the MISSION Act by living far from ( >60 minutes) the nearest VA medical center vs veterans living near (≤60 minutes) a VA medical center. Main Outcomes and Measures: Major adverse cardiovascular events (MACE), defined as rehospitalization for cardiovascular cause or mortality within 30 days of the procedure, and travel times for care were the primary outcomes. Results: The cohort comprised veterans receiving PCI (n = 43 000; 42 066 [98%] male; mean [SD] age, 69 [8.8] years), CABG (n = 23 301; 22 197 [98%] male; mean [SD] age, 69 [7.7] years), or AVR (n = 14 682; 14 336 [98%] male; mean [SD] age, 74 [9.6] years). After MISSION implementation, mean PCI travel times increased by 1.3 minutes for near patients and decreased by 29.2 minutes for far patients (difference in differences, -30.5 minutes; P < .001). Mean CABG travel times increased by 9.4 minutes for near patients and decreased by 18.1 minutes for far patients (difference in differences, -27.4 minutes; P < .001). Mean travel times for AVR increased by 10.0 minutes for near patients and decreased by 23.0 minutes for far patients (difference in differences, -33.1 minutes; P < .001). After MISSION implementation, mean PCI MACE rates decreased by 0.5 percentage points for near patients and increased by 2.3 percentage points for far patients (difference in differences, 2.8 percentage points; P <.001). Mean CABG MACE rates decreased by 6.5 percentage points for near patients and increased by 1.6 percentage points for far patients (difference in differences, 8.1 percentage points; P < .001). AVR MACE rates were not statistically different between the groups (P = .45). Conclusions and Relevance: MISSION Act implementation was associated with substantial decreases in travel times among veterans who became geographically eligible for non-VA care. For these patients undergoing PCI or CABG, MISSION Act implementation was also associated with worsened 30-day MACE rates.