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Importance: Little is known about the association between industry payments and medical device selection.Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D).Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated.Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation.Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation.Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D.Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually. [ABSTRACT FROM AUTHOR]

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria.Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals).Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ.Exposures: The DOJ investigation announcement in 2010.Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria.Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries.Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation. [ABSTRACT FROM AUTHOR]

The article discusses the key things that individual physicians and medical professionals need to do in order to assume a leadership role and bring about a clear, productive and patient-centered input. The effective implementation of the health care reform and system change will require physician commitment and involvement.

The article focuses on the option of shared decision making offered to patients instead of the earlier conventional consent procedures, particularly for hip replacement and knee osteoarthritis. It discusses how the physician reviews the options, also informing the patients about the risks involved in the treatment option. It also talks about the legislative route by Washington State encouraging shared decision making.

A response from the authors to their article "Change in Body Mass Index Associated With Lowest Mortality in Denmark," which appeared in a 2016 issue is presented.

The article discusses the need to revitalize reasonable-patient standards for informed consent through shared decision making. Topics include policy initiatives to advance informed consent with the reasonable-patient standard, informed consent and high-value patient-centered care, and the importance of implementing value-based payment models that recognize high-quality informed consent practices.

Importance: Chronic symptoms reported following an infection with SARS-CoV-2, such as cognitive problems, overlap with symptoms included in the definition of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)., Objective: To evaluate the prevalence of ME/CFS-like illness subsequent to acute SARS-CoV-2 infection, changes in ME/CFS symptoms through 12 months of follow-up, and the association of ME/CFS symptoms with SARS-CoV-2 test results at the acute infection-like index illness., Design, Setting, and Participants: This prospective, multisite, longitudinal cohort study (Innovative Support for Patients with SARS-CoV-2 Infections Registry [INSPIRE]) enrolled participants from December 11, 2020, to August 29, 2022. Participants were adults aged 18 to 64 years with acute symptoms suggestive of SARS-CoV-2 infection who received a US Food and Drug Administration-approved SARS-CoV-2 test at the time of illness and did not die or withdraw from the study by 3 months. Follow-up surveys were collected through February 28, 2023., Exposure: COVID-19 status (positive vs negative) at enrollment., Main Outcome and Measures: The main outcome was the weighted proportion of participants with ME/CFS-like illness based on the 2015 Institute of Medicine clinical case definition using self-reported symptoms., Results: A total of 4378 participants were included in the study. Most were female (3226 [68.1%]). Mean (SD) age was 37.8 (11.8) years. The survey completion rates ranged from 38.7% (3613 of 4738 participants) to 76.3% (1835 of 4738) and decreased over time. The weighted proportion of participants identified with ME/CFS-like illness did not change significantly at 3 through 12 months of follow-up and was similar in the COVID-19-positive (range, 2.8%-3.7%) and COVID-19-negative (range, 3.1%-4.5%) groups. Adjusted analyses revealed no significant difference in the odds of ME/CFS-like illness at any time point between COVID-19-positive and COVID-19-negative individuals (marginal odds ratio range, 0.84 [95% CI, 0.42-1.67] to 1.18 [95% CI, 0.55-2.51])., Conclusions and Relevance: In this prospective cohort study, there was no evidence that the proportion of participants with ME/CFS-like illness differed between those infected with SARS-CoV-2 vs those without SARS-CoV-2 infection up to 12 months after infection. A 3% to 4% prevalence of ME/CFS-like illness after an acute infection-like index illness would impose a high societal burden given the millions of persons infected with SARS-CoV-2.

Importance: New US health care payment models have increasingly incentivized health care systems to promote health and reduce health care spending at the population level, with Medicare beneficiaries representing one of the largest populations affected by new payment models. Identifying novel strategies to promote health and reduce health care spending is necessary., Objective: To assess whether the overall well-being of a population is associated with health care spending for people 65 years of age or older., Design, Setting, and Participants: This US national, population-based cross-sectional study examined the association between county well-being and Medicare fee-for-service (FFS) spending. Population well-being, a holistic assessment of the overall health of the population comprising interrelated domains, including physical, mental, and social health, as measured by the Gallup-Sharecare Well-Being Index (2010), was linked to the mean spending per Medicare FFS beneficiary (2010) and county characteristics data for all US counties assessed. The data were adjusted for prevalence of 4 low-variation conditions (hip fracture, stroke, colorectal cancer, and acute myocardial infarction) and regional penetration of Medicare Advantage. Data analyses were conducted October 13, 2016, to October 31, 2017., Main Outcomes and Measures: Mean spending per Medicare FFS beneficiary per county., Results: In total, 2998 counties were assessed using county-level mean values, with 4 to 7317 participants (mean [SD] number of participants, 755 [1220]) per county. The mean (SD) values of the demographic characteristics of the participants were 50.8% (1.3%) female, 74.9% (16.5%) white, 12.1% (13.0%) black, 4.0% (5.3%) Asian, and 13.7% (14.8%) Hispanic with a mean (SD) of the median county age of 38.2 (4.4) years. Medicare spent a mean (SE) of $992 ($110) less per Medicare FFS beneficiary in counties in the highest quintile of well-being compared with counties in the lowest well-being quintile. This inverse association persisted after accounting for key population characteristics such as median household income and contextual factors such as urbanicity and health care system capacity. Medicare spent a mean (SE) of $1233 ($104) less per Medicare FFS beneficiary in counties with the greatest access to basic needs than in those with the lowest access., Conclusions and Relevance: In this US national study, the overall well-being of a geographically defined population was inversely associated with its health care spending for people 65 years and older. Identifying this association between well-being and health care spending at the population level may help to lay the foundation for further study to first illuminate the mechanisms underlying the association and to second study interventions aimed at creating greater well-being and lower health care spending at the population level.