False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
Pharmacy claim reversals can be costly. Not only can they have an immediate impact on pharmacies’ cash flow; but, in many cases, they can lead to additional consequences as well. Pharmacies accused of improperly billing...more
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more
A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more
The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more
In a move that could reshape the regulatory landscape for pharmacies servicing Massachusetts residents, the Massachusetts Board of Pharmacy has announced that it will soon begin licensing nonresident pharmacies and requiring...more
Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
California AG Rob Bonta issued letters to eight large pharmacy chains and five health data companies reminding the companies of their obligations to comply with California’s Confidentiality of Medical Information Act (CMIA)...more
The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
On January 3, 2024, the New York State Office of the Medicaid Inspector General (“OMIG”) posted its 2024 Work Plan. This is the first update since its 2019 – 2020 Work Plan and OMIG notes that the Work Plan does not reflect...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more
Nevada state law requires all drug and device manufacturers doing business in Nevada to complete its Marketing Code of Conduct Annual Filing Form (previously referred to as AB128). Completed forms are due June 1st annually,...more
"Diverse Perspectives, Results Delivered comes to mind when I think about our team here at Ankura. It's how we operate every day. From the makeup of our team to the way we collaborate with clients, we are constantly striving...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
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) is tasked with combating fraud under Medicare, Medicaid, and other federally funded healthcare programs. ...more
Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more