A series of structural constitutional arguments lodged in multiple cases against Centers for Medicare and Medicaid Services' (CMS) authorities to negotiate prescription drug prices via the 2022 Inflation Reduction Act threaten the legitimacy of CMS program and federal agency powers.
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| http://dx.doi.org/10.1017/jme.2024.12 | DOI Listing |
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The prevalence and factors associated with potentially inappropriate medications in Chinese older outpatients with heart failure.
BMC Geriatr
December 2024
Department of Pharmacy, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China.
Background: Potentially inappropriate medications (PIMs) can lead to adverse outcomes. This study aimed to investigate the prevalence of PIMs in older Chinese outpatients with heart failure according to the 2019 Beers criteria and the factors associated with PIMs.
Methods: A cross-sectional retrospective study was conducted using electronic medical data during January 1, 2020 to December 31, 2020 from 9 tertiary medical institutions in Chengdu, China.
Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.
Pragmat Obs Res
December 2024
BIOTRONIK Inc., Lake Oswego, OR, 97035, USA.
Background: As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications.
Methods: Lead complications were identified using a combination of diagnosis and procedure codes from 2013 to 2020 fee-for-service Medicare claims data along with BIOTRONIK device registration and Medical Device Reporting data from patients implanted between 2013 and 2015 with a Solia S lead. A proof-of-concept analysis was performed using McNemar's test to compare lead complications reported in the traditional PAS with lead complications identified in the RWD.
Real-world treatment patterns, healthcare resource utilisation and costs in patients with SLE in the USA.
Lupus Sci Med
December 2024
Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
Objective: To evaluate the treatment patterns, medication adherence, concomitant corticosteroid use, factors influencing sequence of therapies (SOTs), healthcare resource utilisation (HCRU) and associated costs in adults with SLE in the USA.
Methods: Claims data from the Merative MarketScan Commercial and Medicare Supplemental Database between 2011 and 2019 were used to identify patients with incident SLE. The date of first claim with SLE was defined as the index date, with a 24-month pre-index and ≥24-month post-index period.
The Effects of Adverse Events and Associated Costs on Value-Based Care for Metastatic Pancreatic Ductal Adenocarcinoma.
J Health Econ Outcomes Res
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Milliman (United States).
Rising oncology healthcare costs have led to value-based care reimbursement models that coordinate care and improve quality while reducing overall spending. These models are increasingly important for traditional Medicare and other payers. To compare the incidence of adverse events (AEs), AE-associated excess costs, and total cost of care (TCOC) of 3 cohorts receiving first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).
View Article and Find Full Text PDFFenestrated and Branched Endovascular Aortic Repair and Mortality at Hospitals Without Investigational Device Trials.
JAMA Surg
December 2024
Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University, Baltimore, Maryland.
Importance: Fenestrated and branched endovascular aortic repairs (F/BEVAR) have been adopted by many centers. However, national trends of F/BEVAR use remain unclear, particularly at sites who perform them without an US Food and Drug Adminstration (FDA)-approved investigational device exemption (IDE).
Objective: To quantify the use of F/BEVAR in the US and to determine if mortality was different at IDE vs non-IDE sites.
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