Latest News & Updates

CMS Investigative Study to Examine Benefit of Multi-Cancer Early Detection Tests for Medicare Beneficiaries
A Pathway to Coverage Once Tests Show Clinical Benefit a Critical Next Step WASHINGTON, DC – November 20, 2023 – Grail, LLC announced this morning that the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) study for the company’s Galleri multi-cancer early detection (MCED) test…

Medicare Physician Conversion Factor Cut 3.37% for 2024
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the 2024 Medicare Physician Fee Schedule (MPFS) and updates to the Quality Payment Program (QPP). The agency also released the 2024 Medicare Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center (ASC) Payment System final rule, along with the 340B…

What President Biden’s Executive Order On AI Means For Healthcare
On Monday, Oct. 29, President Joe Biden signed an executive order prioritizing the establishment of new safety, security, and fairness standards for artificial intelligence (AI), especially within the domain of healthcare. This directive mandates that developers of AI systems, particularly those bearing potential risks to public health and safety, must share their training data with…

Tell Congress To Cancel The Cut!
As you well know, the flawed Medicare physician payment system is in desperate need of fixing and unfortunately things are about to get worse. Recently CMS announced final plans for payment schedules for physicians and spoiler alert, it’s not good! CMS approved a 3.4% reduction in Medicare’s physician payments for 2024. That means if Congress…

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Prescribing information for Jaypirca will be posted here….

Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used…

FDA approves nirogacestat for desmoid tumors
On November 27, 2023, the Food and Drug Administration approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information for OGSIVEO will be posted here. Efficacy was evaluated in DeFi (NCT03785964), an international, multicenter, randomized (1:1), double-blind,…

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence
FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). The full prescribing information for Xtandi will be posted here. Efficacy was evaluated…
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