The State of Healthcare Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
UPIC Audits
AGG Talks: Home Health & Hospice Podcast - Episode 8: Hospice Special Focus Program: Pumping the Brakes
Hospice Insights Podcast - Upping the Ante: Will CMS’s Enhanced Oversight Efforts Cause Hospices to Fold?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
The CMS Interoperability and Prior Authorization Rules
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
In mid-June, the Department of Health and Human Services (HHS) ordered the Center for Medicare and Medicaid Services (CMS) to share the personal information of millions of Medicaid enrollees with the Department of Homeland...more
Since the U.S. Supreme Court's June 2022 decision in Dobbs v. Jackson Women's Health Organization (Dobbs), hospitals and their emergency department (ED) clinicians in some states have faced significant uncertainty about their...more
Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
The Supreme Court of the United States has issued a significant healthcare decision in Medina v. Planned Parenthood South Atlantic, a case which will likely have far-reaching implications for Medicaid beneficiaries and...more
I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more
On May 29, 2025, the Department of Health and Human Services (“HHS”) rescinded its July 11, 2022 guidance (Ref. QSO-22-22-Hospitals) (the “2022 Guidance”) clarifying how the Emergency Medical Treatment and Labor Act of 1965...more
On June 3, 2025, the Trump administration announced (the Announcement) that it would no longer follow Biden-era guidance (the Guidance) that directed hospitals to provide emergency abortions to pregnant women in emergency...more
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more
The contentious Nursing Home Minimum Staffing Rule (Rule), which established minimum staffing requirements for federally funded long-term care facilities (LTC) such as skilled nursing facilities (SNFs) for Medicare and...more
It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest...more
On April 7, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated two provisions of a major 2024 CMS nurse staffing regulation requiring nursing homes to have an RN on site 24 hours a day, 7 days per week...more
As previously discussed, in Engesser v. McDonald, a class of Medicaid beneficiaries who receive personal care and home care services through New York’s CDPA Program (Consumers), and two independent living centers...more
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more
On January 17, 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury (“the Departments”) issued their 2024 Report to Congress on the enforcement and implementation of the Mental Health Parity and...more
As detailed in our previous updates, the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program or Program), which enables the federal government to negotiate prices for some of the costliest Medicare Part D...more
Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more
On the evening of January 27, 2025, the Trump Administration’s Office of Management and Budget (OMB) issued a “Memorandum for Heads of Executive Departments and Agencies” titled, “Temporary Pause of Agency Grant, Loan, and...more
Holland & Knight Health Dose 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....more
Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more
For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional....more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more