News from Thursday, January 2, 2025
Articles
Trump Return Signals Move to More Flexibility in Value-Based Care
(12/31, Whitney Phelps and Jacquelyn Daniel, Bloomberg Law) reports “...More than half of Medicare participants are enrolled in Medicare Advantage organizations, which often use quality bonuses and two-sided risk arrangements to encourage high-value services...[A] Trump administration may encourage greater competition between Medicare Advantage and private plans and strengthen the Medicare Advantage program. This includes the possibility of making Medicare beneficiaries opt-in to Original Medicare, thus making Medicare Advantage the default option.” Full
IRS Moves to Amend Excise Tax Rules on Medicare Drug Price Talks
(12/31, Nyah Phengsitthy, Bloomberg Law) reports “...The Internal Revenue Service published Tuesday a proposed rule (RIN 1545-BQ92) that would lay out rules governing the imposition and calculation of the excise tax. It also would provide definitions of terms such as ‘manufacturer,’ ‘sale,’ and ‘price.’...Companies that decline to participate or don't comply with the established price will have to pay taxes that start at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.” Subscription Required
PCORI Approves $134 Million to Bolster the Infrastructure of PCORnet®
(1/2, PCORnet Blog) comments “...Funding from PCORI will be used for several initiatives to sustain, expand, and innovate the PCORnet infrastructure to enhance data quality and research capacity to support multi-site CER studies that meaningfully improve the lives of patients.” Full
AI Developers Need Real-World Data — and Atropos Health Is Stepping Up to Help
(½, Katie Adams, MedCity News) reports “...‘Using GENEVA OS, developers can train, test and validate predictive models on standardized, high-quality patient-level data. This eliminates the burdens of data acquisition and preparation, allowing for rapid model development while adhering to emerging AI assurance standards for transparency, bias detection and accuracy,’ [Atropos Health’s Brigham Hyde] declared.” Full
Press Releases
Added Benefit of Faricimab for Macular Degeneration Not Proven by Manufacturer
(12/30, IQWiG Press Release) “Since July 2024, faricimab has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined in an early benefit assessment whether faricimab offers patients benefits over ranibizumab or aflibercept. However, the drug manufacturer did not present any suitable data. Consequently, there was no proof of an added benefit of faricimab versus the comparator therapies.” Full
Journals
Effectiveness of Tofacitinib Versus Tumor Necrosis Factor Inhibitors and in Those Receiving Tofacitinib as Different Lines of Therapy in Patients with Rheumatoid Arthritis: Results from the United States CorEvitas Rheumatoid Arthritis Registry
Leslie R Harrold, et al.
December 20, 2024, Clinical Rheumatology
Comparative Effectiveness of Olodaterol/Tiotropium and Vilanterol/Umeclidinium Among COPD Patients: A High-Dimensional Propensity Score Matched New User Cohort Study in a US Medicare Population
Chintal H Shah, et al.
December 24, 2024, Expert Review of Respiratory Medicine
Intra-Aortic Balloon Pump: Overall and Temporal Trends of Comparative Effectiveness in a National Registry
Ben Cohen, et al.
December 24, 2024, Catheterization and Cardiovascular Interventions
Comparative Effectiveness of Disease Modifying Antirheumatic Drugs for Patients with Cardiac Sarcoidosis
Lisbeth Brooks, et al.
December 26, 2024, Rheumatology
Patient-Focused Drug Development and Real World Study
Haiyin Hu, et al.
December 27, 2024, Integrative Medicine Research
Comparative Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol and Budesonide/Glycopyrrolate/Formoterol Fumarate Among US Patients with Chronic Obstructive Pulmonary Disease
David Mannino, et al.
December 28, 2024, Advances in Therapy
Comparative Effectiveness and Safety of Single Inhaler Triple Therapies for Chronic Obstructive Pulmonary Disease: New User Cohort Study
William B Feldman, et al.
December 30, 2024, BMJ