The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more
On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more
During the October 11, 2023, Massachusetts Public Health Council Meeting, staff representing the Department of Public Health’s Drug Control Program introduced proposed revisions to 105 CMR 700.000: Implementation of M.G.L....more
Prescription errors, unfortunately, are common. Every year, 7,000 to 9,000 people die as a result of medication errors in the United States, making it the third most common cause of death in the country after heart disease...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to...more
In this season of goodwill, gratitude, and giving, it's worth considering that both friends and strangers can have medical needs that we can ease with little pain or inconvenience to ourselves. Here's a sampling of five ways...more
In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more
Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more
Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...more
The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more
On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more
The stain of the nation’s opioid abuse and drug overdose crisis has spread now to Bentonville, Ark., as federal prosecutors have sued Walmart, accusing the nation’s largest retailer of improperly allowing its pharmacists to...more
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances...more
In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more
Last year, the Oklahoma legislature joined a growing number of states in taking direct aim at the opioid crisis by enacting legislation designed to combat the forgery of paper prescriptions. More than a year and a half after...more
In two prior posts [Government Files Amended FCA Complaint Against Private Equity Firm and its Portfolio Company and DOJ Intervention in Healthcare Fraud Case Highlights Potential Risks for Private Equity Firms], we wrote...more