Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
News Briefs - High Court Ruling on Chevron Doctrine Could Impact Health Credit - When the Supreme Court overturned the Chevron doctrine on June 28, it ended the mandate that federal courts should defer to federal agencies'...more
News Briefs - Texas Federal Court Ruling Puts Noncompete Ban on Hold - A Texas federal court issued a preliminary injunction against the Federal Trade Commission's noncompete ban, which if implemented would allow existing...more
News Briefs - Appeals Court Rules Drug Firms Can Limit 340B Discounted Drugs - An appeals court has upheld a lower court ruling on 340B that sided with drug manufacturers. At issue is whether pharmaceutical companies can...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
News Briefs - Medicare Proposal Would Require Hospitals to Report Emissions - Hospitals for the first time could be asked to report their greenhouse gas emissions to the federal health department. A new Medicare proposal to...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
News Briefs - House Subcommittee Considering 15 Bills to Expand Telehealth - A major House subcommittee is considering 15 bills to expand access to telehealth services as the clock ticks on a Dec. 31 deadline on pandemic-era...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more
Our February Elder Law and Special Needs newsletter is now available! In this issue, our attorneys delve into timely topics such as recent legislative developments in New Jersey. Specifically, we explore new laws designed to...more
News Briefs - Experts Warn Hospitals Face Increased Risk for Cyberattacks - Cybersecurity experts are warning that hospitals around the country are at risk for attacks like the one that is crippling operations at a premier...more
News Briefs - FDA Gives First Approval of Mass Canadian Drug Imports - The Food and Drug Administration has allowed Florida to import millions of dollars' worth of medications from Canada at far lower prices than in the...more
News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more
News Briefs - Google Cloud Unveils AI to Help Doctors with Search Capabilities - Google Cloud announced new artificial intelligence-powered search capabilities that it said will help healthcare workers quickly pull accurate...more
News Briefs - AHA Urges FTC to Pull Back Pre-Merger Notification Requirements - The American Hospital Association is among those pushing back against the Federal Trade Commission's plans to update pre-merger notification...more
News Briefs - Drugmakers Prepare for Legal Battle Over Drug Price Negotiations - Major drugmakers have tailored a legal crusade against the Biden administration's drug price negotiation program that legal scholars say appears...more
News Briefs - FTC-Proposed Merger Guidelines Could Slow Healthcare Deals - Newly proposed merger guidelines from the Federal Trade Commission could chill dealmaking in the healthcare sector, as well as increase the costs and...more
News Briefs - WHO Warns Rapid Adoption of AI in Healthcare Could Be Dangerous - The World Health Organization is warning that the "meteoric" rise of artificial intelligence tools in healthcare threatens the safety of patients...more
Summary - The Department of Health and Human Services Office of Inspector General (HHS OIG) has announced its intention to comprehensively review nursing home citations issued by the Centers for Medicare and Medicaid...more
Overall, healthcare professionals are 10-15% more likely to develop substance abuse issues than the general population.[1] As addiction to prescription medication has reached nation-wide epidemic proportions, it has become a...more
The nation’s nursing homes, battered by the coronavirus pandemic, are under more fire for their resurgent reliance on powerful and risky psychiatric drugs and shaky diagnoses of mental illness to treat elderly residents, as...more
In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement...more
A federal judge recently ruled that submission of electronic data to the government can, under appropriate circumstances, give rise to liability under the False Claims Act. In U.S. ex rel. Marc Silver et al. v. Omnicare Inc....more