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
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 Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...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
The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more
Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) as well as private payors,...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
Report on Patient Privacy 20, no. 3 (March 2020) - As the new coronavirus, COVID-19, spreads across the United States, the HHS Office for Civil Rights (OCR) is reminding HIPAA covered entities and business associates that...more
Compliance Today (March 2020) - In January, Assistant Attorney General Jody Hunt of the U.S. Department of Justice’s Civil Division announced that it “obtained more than $3 billion in settlements and judgments from civil...more
The Department of Justice (“DOJ”) on September 18, 2019, announced a $21.36 million settlement with compounding pharmacy Patient Care America (“PCA”), two PCA executives, and private equity firm Riordan, Lewis & Haden, Inc....more
DOJ settlement signals need for enhanced False Claims Act scrutiny. Private funds continue to face heightened secondary liability risks arising from their portfolio investments....more
Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more
The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”). This much anticipated rule...more
The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more
House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to...more