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
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under...more
News Briefs - U.S. to Accelerate Medicare Payments in Wake of Cyberattack - The U.S. government said it will accelerate Medicare and Medicaid payments to some hospitals hurt by a hack at insurer UnitedHealth's technology unit...more
It pays to look closely. Buried deep within a 205-page and 1230-page Federal Register final rules publication, the Centers for Medicare & Medicaid Services (“CMS”) initiated impactful changes for pharmacies and Durable...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
Historically, a retail pharmacy unable to fill an initial electronic prescription for Schedule II-V controlled substances could not transfer it to another pharmacy – even if the two pharmacies were affiliated and part of a...more
On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled...more
A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA’s scienter requirement refers to a defendant’s knowledge and...more
Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more
On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from...more
On June 1, 2023, in United States ex rel. Schutte v. SuperValu, Inc., the U.S. Supreme Court unanimously held that the scienter requirement of a claim brought under the False Claims Act (FCA) is evaluated based on the...more
Pharmacies and Healthcare Providers May Be Impacted - A June 1st U.S. Supreme Court (SCOTUS) decision on two whistleblower cases may have far reaching consequences for pharmacies or healthcare providers that charge a discount...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more
On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more
Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) remains unclear. President Biden has suggested splitting up the BBBA and individually passing those provisions that...more