False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
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
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
News Briefs - High Court to Hear Case Challenging ACA Free Preventive Care - The Supreme Court is set to hear arguments in a case challenging a provision of the Affordable Care Act that requires private insurers to cover...more
On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more
Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more
For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...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
On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more
Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more
Two landmark cases fraught with False Claim Act (“FCA”) allegations of fraudulent billing for prescription drugs against food and pharmacy chains are making their way from the Seventh Circuit to the Supreme Court....more
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more
As we reported previously in this post on our Healthcare Perspectives blog, the U.S. Supreme Court earlier this summer held that the federal government improperly lowered drug reimbursement payments to certain 340B hospitals...more
AMA Provides a No Surprises Tool-Kit - As most health care providers know by now, the No Surprises Act (NSA) prohibits out-of-network health care providers from balance billing commercially insured patients, in certain...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
In Justice Breyer’s final opinion from the bench in a 9-0 decision, the United States Supreme Court clarified that for a physician to be criminally convicted of distributing a controlled substance, the Department of Justice...more
On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more
Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more
On June 27, 2022, the U.S. Supreme Court decided Ruan v. United States, No. 20-1410, and Kahn v. United States, No. 21-5261, in a consolidated ruling. The Court held that when a criminal defendant is authorized to dispense...more
Last week, the Supreme Court released a decision relating to how the Department of Health and Human Services (HHS) requires hospitals to calculate its disproportionate share percentage. While this percentage is primarily used...more
The U.S. Supreme Court sided with medical providers on June 15, 2022, after the U.S. Department of Health and Human Services (HHS) cut Medicare Part B reimbursements to healthcare providers serving disadvantaged communities....more
In a recent unanimous decision, the Supreme Court found that the Centers for Medicare and Medicaid Services (“CMS”), part of the federal Department of Health and Human Services (“HHS”), erred when it significantly reduced...more
On 15 June 2022, the Supreme Court issued the long-awaited decision in the American Hospital Association v. Becerra case examining whether the Centers for Medicare & Medicaid Services (CMS) had the authority to make certain...more
On Wednesday, June 15, 2022, in a unanimous decision, the U.S. Supreme Court decided in favor of the American Hospital Association in the case of American Hospital Association vs. Becerra, that the nearly 30 percent cuts in...more
Wednesday, the United States Supreme Court handed down a highly anticipated, unanimous opinion, AHA v. Becerra, confirming that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure...more
Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more