Physician Burnout: The Next Pandemic?
Second-Wave Contingency Planning and Risk Mitigation Strategies - Diagnosing Health Care Podcast
Long-Term Care Investigations: Critical Steps To Mitigate Risk and Protect Your Residents, Staff and Reputation
Compliance Perspectives: Health Care Compliance and the COVID-19 Virus
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
News Briefs - Congress Extends Telehealth Flexibilities for Another Six Months - Pandemic-related telehealth flexibilities set to expire March 31 have recently been extended for another six months as federal lawmakers approve...more
The Ohio Board of Pharmacy (“Board”) published two new rules aimed at preventing and rooting out dispensing errors. The first new rule requires pharmacies to implement quality assurance programs for dispensing errors. The...more
On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more
Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the...more
Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more
On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more
On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death...more
Pharmacy and Pharmacist error - A patient diagnosed with thyroid problems filled a prescription for the drug levothyroxine. It was written by the doctor for 75 micrograms. It was dispensed at 25 micrograms. Months went by...more
On October 24, 2018, President Trump signed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT...more
Opioid Education - The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled. Going forward, such...more
It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more
Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more
On January, 1, 2018, The Joint Commission’s (“TJC”) new and revised pain assessment and management standards go into effect for TJC accredited hospitals. The changes to the standards stem from a review commenced by The Joint...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
Clinicians, engineers, safety analysts and scientists at the ECRI Institute have released a looming list of things that could go wrong with modern medical devices and technology in the marketplace....more