Podcast — Drug Pricing: How Are Payers Responding to the IRA?
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
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
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
Federal law enforcement agencies, including the U.S. Drug Enforcement Administration (DEA), have amped up their investigations into the drug ketamine in recent years, likely in reaction to some high-profile overdose deaths....more
Three appellate courts recently reversed sentences because the government did not adequately present evidence to support the alleged loss calculation underlying the court’s determination of the sentencing guidelines range. In...more
On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding...more
Last Monday, the Eleventh Circuit ruled that the Middle District of Florida’s sentence of probation for former physician Nicole Bramwell in a $4.4 million Tricare fraud case was substantively unreasonable. The district...more
For the first time, the Israel Competition Authority has opened enforcement proceedings against a monopolist for abuse of its dominant position by charging an unfairly high price. Subject to a hearing, the authority intends...more
Report on Medicare Compliance 30, no. 32 (September 13, 2021) - Saint Francis Medical Center in Missouri agreed to pay $1.625 million in a civil settlement of allegations it violated the Controlled Substances Act, the...more
Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more
As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance of...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more
On August 6, 2020, the United States Court of Appeals for the Sixth Circuit upheld the conviction of a patient recruiter in a Medicare kickback case, finding insufficient evidence to demonstrate that the recruiter was a “bona...more
The Government Accountability Office (GAO) has agreed to investigate the operations of for-profit Institutional Review Boards (IRBs) following a request made by Senators Elizabeth Warren (D-MA), Sherrod Drown (D-OH), and...more
Major shakeup at Ford, where CEO Jim Hackett is out after a three-year stint in which he “achieved mixed results” but didn’t impress Wall Street enough to keep his job. Ford has installed COO James Farley, a Toyota alum who’s...more
A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more
In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more
Omnicare and CVS Face Fraudulent Billing Lawsuit - On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...more
On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more
In a second criminal case against a pharmaceutical distributor and its executives this year, the Department of Justice has accused Ohio-based Miami-Luken and its former President and Compliance Officer of conspiring to...more
In July, The Washington Post published data showing approximately 76 billion oxycodone and hydrocodone pills were purchased and sold in the Unites States from 2006 to 2012. The data came from the Automation of Reports and...more
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC), one of the 10 largest wholesale distributors of pharmaceutical...more
Today, the Federal Government announced enforcement actions against 60 defendants in eleven federal districts, including 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professional...more
On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more
On December 17, 2018, the Department of Justice (DOJ) moved to dismiss 11 False Claims Act (FCA) cases brought by whistleblowers against pharmaceutical manufacturers and their commercial outsourcing vendors, alleging that...more