Assessing Medicare's Coverage With Evidence Development Program.

The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program provides coverage for items and services not meeting Medicare's "reasonable and necessary" standard while requiring participation in clinical studies. As additional evidence is available, CMS may reconsider CED decisions. Of twenty-six items and services in the CED program since its 2005 inception, CMS has reconsidered coverage for ten (38 percent).

Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications.

Under the 21st Century Cures Act of 2016, a summary of the evidence used to support local coverage determinations, which represent the vast majority of Medicare's coverage decisions for new technologies, must be made publicly accessible. Using reports from the Medicare Coverage Database on local coverage determinations and the medical literature, we examined the availability of these decisions and the quality of evidence cited for therapeutic drugs, biologics, and moderate- or high-risk devices during the period 2015-22 to understand whether evidence strength and generalizability differed for indications with favorable versus unfavorable coverage decisions. Evidence summaries were publicly available for 26 percent of coverage decisions originally effected during 2015-18 and 100 percent during 2019-22.

Privately negotiated facility fees at ambulatory surgery centers and hospitals.

Private negotiated facility fees at hospitals are on average double the ambulatory surgery center facility fees for common outpatient procedures.

Medical Devices Applying for Outpatient Medicare Supplemental Payments.

Importance: Medicare transitional pass-through payments (TPTPs) provide supplemental reimbursement that is intended to facilitate adoption of new devices in the outpatient setting. The US Centers for Medicare & Medicaid Services (CMS) have historically evaluated manufacturer applications for TPTPs based on newness, cost, and evidence of substantial clinical improvement, ie, the traditional pathway. In 2020, CMS introduced an alternative pathway to allow US Food and Drug Administration (FDA)-designated breakthrough devices to qualify for supplemental reimbursement without demonstrating substantial clinical improvement.

National Patterns of Remote Patient Monitoring Service Availability at US Hospitals and their Readmission Performance for Cardiovascular Conditions.

Background: Digital remote patient monitoring (RPM) enables longitudinal care outside traditional healthcare settings, especially in the vulnerable period after hospitalizations, with broad coverage of the service by payers. We sought to evaluate patterns of RPM service availability at US hospitals and the association of these services with 30-day readmissions for two key cardiovascular conditions, heart failure (HF) and acute myocardial infarction (AMI).

Methods: We used contemporary national data from the American Hospital Association (AHA) Annual Survey to ascertain US hospitals offering RPM services for post-discharge or chronic care and used census-based county-level data to define the characteristics of the communities they serve.

Adoption of the voluntary conflict of interest statement on PubMed.

In 2017, the National Library of Medicine (NLM) added a voluntary field for conflict of interest (COI) statements ("posted COI") on the abstract page of PubMed, but the extent to which it is used is unknown. This repeated cross-sectional study examined journals and articles indexed on PubMed from 2016 through 2021. We described the proportion of all journals with at least one article that included a posted COI and the percentage of all articles that included a posted COI over time.

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence.

Objectives: To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.

Design: Cross-sectional.

Setting: European Medicines Association (EMA), US Food and Drug Administration (FDA), Health Canada and Australian Therapeutic Goods Administration (TGA).

Discovery of from Infected Spiders and Analysis of the Surrounding Fungal Entomopathogen Community.

Characterization of fungal spider pathogens lags far behind their insect counterparts. In addition, little to nothing is known concerning the ecological reservoir and/or fungal entomopathogen community surrounding infection sites. Five infected spider cadavers were identified in the neo-tropical climate of north-central Florida, USA, from three of which viable cultures were obtained.

National Trends in and Concentration of Industry Payments to U.S. Psychiatrists, 2015-2021.

Industry payments to psychiatrists remain poorly characterized. Using data from the Centers for Medicare and Medicaid Services, the authors of this repeated cross-sectional study detail the extent and concentration of nonresearch industry payments to psychiatrists from 2015 to 2021. The proportion of psychiatrists receiving industry payments, payment distribution, and payment concentration among psychiatrists was assessed.

Evidence of compensation for mitochondrial reactive oxygen species increase in cytoplasmic-nuclear hybrids.

Hybrid offspring dysfunction in cytoplasmic-nuclear hybrids (cybrids) implies that one parent's mitochondrial genome is incompatible with the nuclear genome of the other parent. In , cybrids exhibit increased mitochondrial reactive oxygen species (ROS). In this study, we measured the specific activity of markers for mitochondrial abundance (citrate synthase) and antioxidant enzyme response (catalase) in four cybrid lines.

Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.

Background: Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death.