Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.
Federal Government Launches Health Care Antitrust Reporting Portal
The Justice Department, Federal Trade Commission (FTC), and HHS have created an online portal for the public to report potential anticompetitive practices in the health care sector, according to Modern Healthcare. HealthCompetition.gov is the latest effort from the Biden administration and government agencies to promote competition in health care markets in hopes ofing lower care and prescription drug costs. Examples of health care business practices that can hinder competition include collusion or price fixing among competitors, and limiting choice and fair wages for employees. The Justice Department’s Antitrust Division and the FTC will review complaints, which may lead to further action.
FDA Mandates CAR T Label Updates
The FDA has announced that cancer therapies using chimeric antigen receptor T-cell (CAR T) technology will require changes to their “boxed warning” to highlight the associated risk of T-cell blood cancer, according to Reuters. The therapies affected include those made by Johnson & Johnson, Gilead Sciences, and Novartis. The FDA is also requiring updates to other sections of the label, including patient counseling information and medication guide, warnings and precautions, and postmarketing experience. It explained that those receiving treatment with these products should be monitored throughout their life for secondary malignancies, and the manufacturer should be notified of any new malignancy.
Ozempic Babies Spark Debate About Weight-Loss Shots Used as Fertility Treatment
Questions about the safety of obesity medications during pregnancy have arisen as pregnancies are increasingly being seen in women taking them who previously struggled with fertility issues, according to Bloomberg. These stories have encouraged doctors to use them to treat polycystic ovary syndrome (PCOS), one of the leading causes of infertility in US women; however, they are doing so without much data on how the drugs impact pregnancy. Consequently, researchers are conducting studies to figure out if the drugs work for PCOS, and regulators have asked companies to collect any data they can about their use during pregnancy. The safety data look promising so far, as a recent study found no increase in birth defects among those who used the drugs in very early pregnancy compared with those who took insulin; the researchers noted that additional confirmation is needed, especially in women without diabetes.
Frameworks for Advancing Health Equity: Urban Health Outreach
May 9th 2024In the series debut episode of "Frameworks for Advancing Health Equity," Mary Sligh, CRNP, and Chelsea Chappars, of Allegheny Health Network, explain how the Urban Health Outreach program aims to improve health equity for individuals experiencing homelessness.
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CMS Medicare Final Rule: Advancing Benefits, Competition, and Consumer Protection
May 7th 2024On this episode of Managed Care Cast, we're talking with Karen Iapoce, senior director of government products and programs at ZeOmega, about the recent CMS final rule on Medicare Part D and Medicare Advantage.
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Study Highlights Significant Increases in Utilization, Spending on DMD Drugs in Medicaid
May 17th 2024The findings add to recent research on the growing utilization, expenditure, and prices of Duchenne muscular dystrophy (DMD) therapies in the current landscape, an area health care policy could potentially address.
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