Guidance Focuses on Mental Health Symptoms in Long COVID
An interdisciplinary group of physicians has released the latest guidance in its series on long COVID, this time focusing on mental health symptoms. The guidance, published by the American Academy of Physical Medicine & Rehabilitation (AAPM&R), discusses how to assess mental health systems in patients with post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, […]
FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices
The FDA has released revised draft guidance on communicating with healthcare professionals (HCPs) about unapproved uses of approved drugs and devices. Once it’s finalized, the document will reflect FDA’s stance on how companies can communicate scientific information to clinicians regarding unapproved uses of products already on the market. Comments are open through December 24. “In […]
CDC Issues Sepsis Care Guidance for Hospitals
The CDC issued new guidance to hospitals Thursday for managing sepsis and called on hospitals to do better at treating it. “Every hospital, regardless of size, location, and resources can strengthen the quality of care delivered to these patients and ensure their survival,” CDC Director Mandy Cohen, MD, MPH, said at a press conference. “That’s […]
ACP Sticks With Age 50 for Colorectal Cancer Screening
The American College of Physicians (ACP) updated guidance reaffirming its stance that colorectal cancer screening should wait until age 50 for average-risk, asymptomatic adults. The ACP recommends that clinicians “should discuss the uncertainty around benefits and harms of screening” with individuals ages 45 to 49, and that screening be dropped in asymptomatic average-risk adults older […]
All Opioid Pain Meds to Get New Safety Warnings, FDA Says
The FDA is making several updates to prescribing information for opioid pain medications to provide guidance on safe use, according to a Drug Safety Communication, including a new warning that they can increase sensitivity to pain. Changes to the prescribing information and labeling for immediate-release (IR) and extended-release or long-acting (EX/LA) opioids will be made […]
Lone star tick bites may be to blame for unexplained digestive problems
The American Gastroenterological Association (AGA) has released new clinical guidance to help physicians and patients identify if unexplained digestive symptoms are due to alpha-gal syndrome, a food allergy that is caused by lone star tick bites. The AGA Clinical Practice Update was published today in Gastroenterology. Alpha-gal syndrome is an allergy that causes your body […]
How Will Medicare’s New Drug Rebate Law Work?
WASHINGTON — The Biden administration issued initial guidance yesterday on how it plans to implement the Medicare drug rebate program, which will affect doctors who administer drugs under Medicare Part B. The program, passed in August 2022 as part of the Inflation Reduction Act, requires manufacturers who raise their drugs’ prices faster than the rate […]
Children in Clinical Trials: FDA’s Proposed Rules of Engagement
FDA issued draft guidance on ethical considerations and special safeguards for having children participate in clinical trials. The new statement addresses how to protect children in clinical investigations for drugs, biological products, and medical devices. Some of the fundamental concepts that the new guidance included for consideration by industry, sponsors, and institutional review boards (IRBs) […]
Ultrasound Guidance No Advantage for PCI Access
BOSTON — Routine ultrasound guidance for accessing the femoral vein for percutaneous coronary procedures didn’t cut down on bleeding and vascular complications, the UNIVERSAL trial showed. The primary combined endpoint of major bleeding and major vascular complications at 30 days showed no advantage to the imaging technique added to fluoroscopy, reported Sanjit S. Jolly, MD, […]
New Surprise Billing Arbitration Guidance May Give Docs More Wiggle Room
Last week, CMS updated guidance on the heavily disputed aspects of an arbitration process for resolving payment disagreements between insurers and providers under the No Surprises Act. The updates to this guidance were made in response to a Texas ruling that compelled HHS to change how dispute resolution entities would approach the pricing benchmark known […]