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Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
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340B Drug Pricing Program Compliance
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Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. In this article, I discuss the consequences physicians and other medical...more
Legal liability associated with the ever-evolving opiate epidemic is continually changing and expanding. Initially, the focus was on internet pharmacies for their dispensing activities....more
The State of Ohio Board of Pharmacy recently issued a number of proposed rule sets for public comment. Notably included were new rules on the operation of office-based opioid treatment (OBOT) clinics and rules governing the...more
In part one of this series, I detailed how the U.S. Department of Justice has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. See “Part One: DOJ Devotes Resources, Vows to Come...more
Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more
Like pain clinics and pharmacies, practitioners treating substance use disorder appear to be a target for federal enforcers. Under President Trump’s administration and Alabama Attorney General Steve Marshall, law enforcement...more
Every day, medical providers are asked to serve a population that largely expects their healthcare to be free, and that everything they want is covered by insurance or government. Providers want to serve these wants and...more
The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more
- A Cautionary Tale: Takes One to Know One - Treatment with Drugs - Treatment with Exercise - Treatment with Modalities - Treatment with Injections - Quality Control for Pain Relief - Excerpt from Introduction:...more
Opioids are the mostprescribed class of prescription medications in the United States. Physicians are the legal gatekeepers for prescription medications to treat chronic pain. Over the last 10 years, prescriptions for opioid...more
On May 2, Georgia Governor Nathan Deal signed Georgia House Bill 178, making Georgia the ninth U.S. state to pass legislation regulating pain management clinics....more