Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,...more
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...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
News Briefs - More States Taking Steps to Control P.E. in Healthcare Settings - An increasing number of states are looking to control private healthcare operations transactions, even as the Trump administration appears likely...more
News Briefs - Lawmakers Strike Deal to Extend Expiring Healthcare Programs - Lawmakers reached a deal to extend expiring healthcare programs, lobbyists close to the issue said. The package is more robust than lobbyists...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
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
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
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
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
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
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
Headlines that Matter for Companies and Executives in Regulated Industries - Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations - Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more
In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more
On May 22, 2019, the federal Department of Health and Human Services (HHS) published a final rule that is intended to protect “individuals and health care entities from discrimination on the basis of their exercise of...more
The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more