Insights

Facility Inspection Backlog Bogs Down FDA

August 6, 2021

The FDA accrued a massive backlog of inspections in 2020 as a result of suspensions due to the COVID-19 pandemic. They are now laying the groundwork to get site reviews back on track. 

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2021 COVID Report: “Navigating Back to Normal”

June 1, 2021

The State of the Virus & Effectiveness of Vaccine Efforts Worldwide The arrival of safe and effective COVID-19 vaccines is a major development in the coronavirus pandemic. As more people are vaccinated, families and communities will be able to gradually return to a more normal routine. There were two reports that delivered resounding evidence that…

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What We Know About Operation Warp Speed’s Distribution Process (So Far)

January 6, 2021

Operation Warp Speed, the White House COVID-19 initiative, has preliminary plans to only ship half of all vaccines available each week. The other half will be held in storage and be released just before the second dose is due for those vaccinated the first time.  Five percent of all produced COVID-19 vaccine will be held back for emergencies and states will…

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Major Changes Are Coming for E/M Visits in 2021–Are you Ready? (Part 2)

November 2, 2020

It is clear that this new method of determining the level of E/M service will require major changes to physician behavior and documentation. Providers will need detailed instructions, system changes, and practice using the new E/M codes.  New CPT Codes for Outpatient Visits Only The new changes apply only to outpatient visits, so don’t get…

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Major Changes Are Coming for E/M Visits in 2021–Are you Ready? (Part 1)

October 1, 2020

The updated code set is “the first major overhaul in more than 25 years to the codes and guidelines for office and other outpatient evaluation and management (E/M) services,” according to the American Medical Association (AMA).  Outpatient Codes Receive Overhaul The changes were designed to make E/M office visit coding and documentation simpler and more…

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The Domino Effect: Raw Material Shortages

August 31, 2020

The First Domino Last month we covered the omnipresent topic of drug shortages, an issue that never seems to completely go away. We know that these shortages are a result of typical causes such as production delays, recalls, an increase in demand, etc.  Now, we are experiencing a shortage that is directly attributed to the…

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Let’s Talk About Drug Shortages

July 29, 2020

Another casualty of the COVID-19 pandemic is drug shortages. The shortages that are caused by pandemics and natural disasters can be profound and are somewhat unpredictable but have previously only made up approximately 5% of the cause of all shortages. That said, the U.S. is experiencing a rapidly increasing frequency of drug shortages, which have…

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CORONAVIRUS UNCOVERED: COVID-19 FAQs 

March 2, 2020

If you’ve turned on any of your devices, logged into your social media accounts, caught snippets of a news report, or possibly just overheard a random conversation waiting in line at the grocery store, you know that the coronavirus (COVID-19) is the biggest global news story right now. And it is giving a deeper meaning…

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THE OPIOID EPIDEMIC (Part 2): What’s the True Fix?

January 31, 2020

OPIOID USE AND ABUSE As we described in Part 1 of our series on opiates, the opioid epidemic has had three phases: the first was dominated by prescription opioids (encouraged by “the pain movement” that began in the 1980s and 1990s), the second by heroin (which is far cheaper and easier to obtain than prescription…

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THE OPIOID EPIDEMIC (Part 1): The Pain Movement & Rise of Opiates

January 2, 2020

THE PAIN MOVEMENT  The 1980s marked the start of the “pain movement”, which centers on the idea that patients have a right to not be in pain.  An April 2017 paper published in Drug and Alcohol Dependence charts the historical course of this movement. It shows that in the mid-to-late 1980s, palliative care specialists began to advocate for…

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