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
News Briefs - New Foreign Nurse Visas Frozen by State Department - The State Department has essentially frozen foreign nurse visas for the rest of the fiscal year amid high demand, and health groups are warning it threatens...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
Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more
A ransomware attack on Change Healthcare, a technology company owned by UnitedHealth that touches one of every three U.S. patient records, has resulted in hospitals and pharmacies across New York facing a cash crunch. The...more
There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023. Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more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
The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more
Governor Gavin Newsom signed 997 bills into law in 2022, including a substantial number relating to health care. In Part II of our legislative update, we summarize many of the laws relevant to health facilities, a number of...more
Distribution: In two rulings issued on 28 September 2022, the French Supreme Court clarified the conditions under which suppliers can be held liable for failure to comply with their duty to communicate - Article L.441-1...more
With some exceptions, healthcare M&A activity is down this year compared to the record-breaking highs of 2021. Those exceptions include the hospital sector, which is still seeing fewer but significantly larger (i.e., billion...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
Learning Objectives - Describe the basic structure of a 340B program implementation at a hospital or grant-funded clinic - Illustrate the permissible and impermissible uses of 340B-priced drugs - Explain the roles of...more
Drug Pricing Initiatives: Discussion continues regarding pathways to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA). Potential approaches include a reduced or modified version of the BBBA, although details...more
On January 18, 2022, Governor Kathy Hochul released her budget proposal for State Fiscal Year 2023. While record-breaking in its size—totaling $216.3 billion—and inclusive of many investments in Medicaid and health care more...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
Drug Pricing Initiatives: Democrats are continuing to debate the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing. The budget reconciliation...more
While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
Report on Patient Privacy 21, no. 6 (June 2021) - Scripps Health in San Diego experienced what it called “an information technology security incident” from ransomware that was detected May 1, forcing some of its operations...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
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
Report on Patient Privacy 18, no. 1 (January 2021) - The HHS Office for Civil Rights (OCR) settled its 13th enforcement action in its Right of Access Initiative, first announced in 2019 to support individuals’ rights to...more